Global Bioethics: Issues of Conscience for the Twenty-First Century (Issues in Biomedical Ethics)

ISSUES IN BIOMEDICAL ETHICS Global Bioethics

ISSUES IN BIOMEDICAL ETHICS General Editors John Harris and Søren Holm Consulting Editors Raanan Gillon and Bonnie Steinbock The late twentieth century witnessed dramatic technological developments in biomedical science and in the delivery of health care, and these developments have brought with them important social changes. All too often ethical analysis has lagged behind these changes. The purpose of this series is to provide lively, up-to-date, and authoritative studies for the increasingly large and diverse readership concerned with issues in biomedical ethics—not just health care trainees and professionals, but also philosophers, social scientists, lawyers, social workers, and legislators. The series will feature both single-author and multi-author books, short and accessible enough to be widely read, each of them focused on an issue of outstanding current importance and interest. Philosophers, doctors, and lawyers from a number of countries feature among the authors lined up for the series.

Global Bioethics Issues of Conscience for the Twenty-First Century

edited by

Ronald M. Green, Aine Donovan, and Steven A. Jauss

CLARENDON PRESS · OXFORD

1

Great Clarendon Street, Oxford ox2 6dp Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide in Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi New Delhi Shanghai Taipei Toronto With offices in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Oxford is a registered trade mark of Oxford University Press in the UK and in certain other countries Published in the United States by Oxford University Press Inc., New York  the several contributors 2008 The moral rights of the authors have been asserted Database right Oxford University Press (maker) First published 2008 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing of Oxford University Press, or as expressly permitted by law, or under terms agreed with the appropriate reprographics rights organization. Enquiries concerning reproduction outside the scope of the above should be sent to the Rights Department, Oxford University Press, at the address above You must not circulate this book in any other binding or cover and you must impose this same condition on any acquirer British Library Cataloguing in Publication Data Data available Library of Congress Cataloging in Publication Data Data available Typeset by Laserwords Private Limited, Chennai, India Printed in Great Britain on acid-free paper by Biddles Ltd., King’s Lynn, Norfolk ISBN 978–0–19–954659–6 10 9 8 7 6 5 4 3 2 1

CONTENTS

Notes on Contributors Introduction Part I: Normative Bases 1. Population-Level Bioethics: Mapping a New Agenda Daniel Wikler and Dan W. Brock 2. What Is It Like to Be a Bird? Wikler and Brock on the Ethics of Population Health Nir Eyal 3. The Evolving Norms of Medical Ethics Ezekiel J. Emanuel 4. Convergent Trends in Modern Medical Ethics: Medicine-Based Ethics and Human Rights Johannes J. M. van Delden Part II: Global Research Ethics 5. Just Research in an Unjust World: Can Harm Reduction Be an Acceptable Tool for Public Health Prevention Research? Nancy E. Kass

viii 1 13 15

37

53

77

87

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6. Harm Reduction Research: Ethics and Compliance Ana S. Iltis

117

7. Global Justice, Human Rights, and Health Ruth Macklin

141

vi / Contents Part III: Biomedical/Bioethical Collaborations 8. Achieving Global Justice in Health through Global Research Ethics: Supplementing Macklin’s ‘‘Top–Down’’ Approach with one from the ‘‘Ground Up’’ Eric M. Meslin 9. Harnessing Advanced Technologies for Global Health Equity Peter A. Singer, Archana Bhatt, Sarah E. Frew, Heather Greenwood, Jocelyn Mackie, Dilnoor Panjwani, Deepa L. Persad, Fabio Salamanca-Buentello, B´eatrice S´eguin, Andrew D. Taylor, Halla Thorsteinsd´ottir, Aneesa Walji, Abdallah S. Daar Part IV: Training Professional, Ethical Physicians

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163

179

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10. American ‘‘Medical Professionalism’’: At Home and in the World Robert Martensen

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11. Professionalism and Medical Education in the Developing World Kisali Pallangyo

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Part V: Euthanasia and Physician-Assisted Death

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12. Physician-Assisted Death: Not Just for Rich Countries Johannes J. M. van Delden and Margaret P. Battin Part VI: Global Bioethics and Religion 13. Embryo as Epiphenomenon: Some Cultural, Social, and Economic Forces Driving the Stem Cell Debate Ronald M. Green

243

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Contents / vii 14. The Role and Influence of Religions in Bioethics Denis Muller ¨ Part VII: Public Global Bioethics Consultations 15. Global Norms, Informed Consensus, and Hypocrisy in Bioethics John Harris 16. Global Norms in Bioethics: Problems and Prospects Fran¸coise Baylis Index

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NOTES ON CONTRIBUTORS

Margaret Pabst Battin, professor of philosophy and medical ethics at the University of Utah, has authored, edited, or co-edited fifteen books, including works on philosophical issues in suicide, case-puzzles in aesthetics, ethical issues in organized religion, and various topics in bioethics. She has published two collections of essays on end-of-life issues, The Least Worst Death and Ending Life, and has been the ringleader for two multiauthored projects, Drugs and Justice and The Patient as Victim and Vector: Ethics and Infectious Disease. In 2000 she was a co-recipient of the Rosenblatt Prize, the University of Utah’s most prestigious award. Fran¸coise Baylis is Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University in Halifax, Nova Scotia, Canada. She has a long-standing interest in issues of identity, community, and justice, and has published extensively on ethical issues relevant to women’s reproductive health, research involving humans (including embryo, stem cell, and cloning research), and novel technologies. Recent publications on these and related topics appear in The Hastings Center Report, the Journal of Medical Ethics, Bioethics, the American Journal of Bioethics, Public Health Ethics, Social Science in Medicine, and the Cambridge Quarterly of Health Care Ethics. Professor Baylis is an elected Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. Her biography is included in Who’s Who in Black Canada and Canadian Who’s Who. In her spare time she enjoys the vicarious pleasure of watching her daughter Kaila horseback riding and her son Jacob playing soccer. Dan W. Brock is the Frances Glessner Lee Professor of Medical Ethics in the Department of Social Medicine and Director of the Division of Medical Ethics at the Harvard Medical School. He is also Director of the Harvard Program in Ethics and Health. His research interests are in medical and population health ethics and in moral philosophy. He has published in many journals including the New England Journal of Medicine, JAMA, Science, The Hastings Center Report, Philosophy and Public Affairs, and Ethics. Recent publications

Notes on Contributors / ix include ‘‘Shaping Future Children: Parental Rights and Societal Interests,’’ Journal of Political Philosophy, 2005 and ‘‘Health Care Resource Prioritization and Rationing: Why Is It so Difficult?’’ Social Research, 2007. His current research focuses on ethical issues in the use of cost-effectiveness for health resource prioritization, and on genetic selection for enhancement and to prevent disability. Johannes (Hans) van Delden is professor of medical ethics at the University Medical Center of Utrecht University, the Netherlands. He is also a practising nursing home physician. His main fields of interests are end-of-life decisions, research ethics, and ethical issues in care for the elderly. Research in these fields led him to participate in the nationwide studies into end-of-life decisions in the Netherlands and Europe, to exploring justice issues in biomedical research involving human subjects, and to studying the quality of life of demented patients in nursing homes. He has been secretary of the International Association of Bioethics and serves on the editorial board of the Journal of Medical Ethics and Bioethics. In his spare time Hans enjoys singing in a choir. His favorite pieces are Bach’s St John Passion and Brahms’s Deutsches Requiem. Aine Donovan is Research Associate Professor and Executive Director of the Ethics Institute at Dartmouth College. Her research and publications include books and articles on military ethics, business ethics, medical ethics, philosophy of education, and issues of professionalism. She is currently working on a book about honor. Ezekiel Emanuel is Chair of the Department of Bioethics at the Clinical Center of the National Institutes of Health. He is also a breast oncologist. For twenty-five years, his research has spanned bioethical issues related to end-of-life care, the physician–patient relationship, the ethics of clinical research, especially in the international setting, the allocation of resources, and health policy. Dr. Emanuel has received numerous awards including election to the Institute of Medicine, the American Society of Clinical Oncology’s Public Service Award, Hippocrates magazine’s Ethicist of the Year Award, and a Fulbright Scholarship (which he declined). He has authored three books and edited four books. Most recently he has co-edited The Oxford Textbook of Clinical Research Ethics (Oxford University Press, 2008), Exploitation and Developing Countries: The Ethics of Clinical Research (Princeton University Press,

x / Notes on Contributors 2008), and Ethical Issues in International Biomedical Research: A Casebook (Oxford University Press, 2007). He also has written a widely praised book about health care reform, Healthcare, Guaranteed: A Simple, Secure Solution for America (Public Affairs, 2008). Nir Eyal is Assistant Professor in Global Health and Social Medicine at Harvard Medical School, and has a joint appointment at the inter-faculty Program in Ethics and Health at Harvard University. Eyal is writing a book that defends a consequentialist approach to respect for persons and applies that approach to normative questions in bioethics and political theory. Further work surrounds egalitarian theory, consequentialism, self-ownership, informed consent, markets in organs, and the medical brain drain crisis. Ronald M. Green is the Eunice and Julian Cohen Professor for the Study of Ethics and Human Values and Faculty Director of Dartmouth’s Ethics Institute. In 1996 and 1997, Professor Green served as founding director of the Office of Genome Ethics at the National Human Genome Research Institute of the National Institutes of Health. Professor Green’s research interests are in genetic ethics, biomedical ethics, and issues of justice in health care allocation. He is the author of seven books and 140 articles in theoretical and applied ethics. His most recent book, Babies by Design: The Ethics of Genetic Choice, was published in 2007 by Yale University Press. In 2005, Professor Green was named a Guggenheim Fellow. John Harris, FMedSci, is Director of the Institute for Science, Ethics and Innovation and Lord Alliance Professor of Bioethics at the University of Manchester’s School of Law. He is joint Editor-in-Chief of The Journal of Medical Ethics and has been a member of the UK Human Genetics Commission since its foundation in 1999 and is a Member of the Medical Ethics Committee of the British Medical Association. Recent books include Clones, Genes, and Immortality (Oxford University Press, 1998); John Harris, ed., Bioethics, Oxford Readings in Philosophy Series (Oxford University Press, 2001); Justine C. Burley and John Harris, eds, A Companion To Genethics: Philosophy and the Genetic Revolution, Basil Blackwell (Oxford, 2002; in Blackwell’s Companions to Philosophy series); and On Cloning (Routledge, 2004). His latest book Enhancing Evolution was published by Princeton University Press in 2007. Ana S. Iltis, PhD, Associate Professor of Health Care Ethics, Saint Louis University, St. Louis, Missouri, U.S.A. Her primary interest is human research

Notes on Contributors / xi ethics. She has published widely in the field, serves as Associate Editor of the Journal of Medicine and Philosophy and as Co-Editor-in-Chief of the Journal of Law, Medicine, and Ethics. Iltis also is Co-Editor of The Annals of Bioethics. She is currently working on a monograph on the ethical conduct of human research. Steven A. Jauss is Assistant Professor of Philosophy and Liberal Studies at the University of Arkansas at Little Rock and Instructor in the Division of Medical Humanities at the University of Arkansas for Medical Sciences. His research interests are in aesthetics and philosophy of the arts, ethical theory and biomedical ethics, and the history of modern philosophy. He has published research articles in the Journal of Aesthetics and Art Criticism and Philosophia. He enjoys spending time with his wife, who is a medical oncologist, and their 2-year-old son. Nancy Kass is the Phoebe R. Berman Professor of Bioethics and Public Health at Johns Hopkins Bloomberg School of Public Health and Deputy Director for Public Health at the Berman Institute of Bioethics. Kass’s research interests are in U.S. and international research ethics and in public health ethics. She has published on topics such as ethics and HIV, ethics and pandemic influenza preparedness, informed consent in clinical trials, and research ethics in developing countries. She runs the PhD program in bioethics and health policy at Johns Hopkins as well as the Johns Hopkins Fogarty African bioethics training program. Outside of work, she enjoys singing, running, and hanging out with her husband, three children, and fabulous extended family. Ruth Macklin is Professor of Bioethics at Albert Einstein College of Medicine in the Bronx, NY. Dr. Macklin is an adviser to the World Health Organization and the United Nations AIDS Programme, and chairs the external ethics committee of the Centers for Disease Control and Prevention. She is an elected member of the Institute of Medicine of the National Academies of Science and a past president of the International Association of Bioethics. Dr. Macklin is author or editor of eleven books and has more than two hundred published articles. Her latest book is Double Standards in Medical Research in Developing Countries, published by Cambridge University Press in 2004. Macklin has been to sixty-eight countries and is hoping to make the Travelers’ Century Club (one hundred countries) before she is too old to travel. Robert Martensen serves as Director of the Office of History and Museum at the National Institutes of Health and is a Lecturer at Harvard Medical

xii / Notes on Contributors School in its Department of Global Health and Social Medicine. A physician and historian with articles that range across the history of medicine, science, and bioethics, he is the author of two books: The Brain Takes Shape: An Early History (Oxford, 2004) and A Life Worth Living: A Doctor’s Reflections on Illness in a High-tech Era (Farrar, Straus & Giroux, 2008). In 2002 he received a Guggenheim Fellowship in History of Science. Currently, he spends his spare time writing a short introduction on palliative care for U.S. surgical residents and fixing up his new/old place in Washington, DC. Eric M. Meslin is Director of Indiana University Center for Bioethics, Associate Dean for Bioethics, Professor of Medicine, and of Medical and Molecular Genetics in the Indiana University School of Medicine. He is also Professor of Philosophy in the School of Liberal Arts, and Co-Director of the IUPUI Consortium on Health Policy, Law, and Bioethics. He was previously Executive Director of the U.S. National Bioethics Advisory Commission and has more than eighty publications on topics ranging from international health research to science policy including Belmont Revisited: Ethical Principles for Research with Human Subjects co-edited with James F. Childress and Harold T. Shapiro. In 2008 he was appointed a Chevalier de L’Order Nationale du M´erite (Knight of the National Order of Merit) by the President of France. When he is not doing bioethics, he can be found enjoying music, traveling, and collecting eggs from the family’s chickens. Denis Muller ¨ is a Professor in the Faculty of Theology and Religious Studies at the University of Lausanne, Switzerland. His research interests include modern Protestant ethics and theology, fundamental ethics, theological and philosophical anthropology, and applied ethics. He is the author of ‘‘Why Can and How Can Religions and Traditions Be Plausible and Credible in Public Ethics Today?’’ in D. Mu¨ ller, ed., Is Theological Ethics Relevant for Philosophers? Ethical Theory and Moral Practice 4/4 (2001), 329–48; Karl Barth (Paris, Le Cerf, 2005); ‘‘Bio´ethique,’’ in Encyclop´edie du protestantisme (Paris, Presses Universitaires de France-Labor et Fides, 2006), 135–54; ‘‘The Original Risk: Over-Theologizing Ethics and Under-Theologizing Sin,’’ Christian Bioethics 13 (2007), 7–23; Le football, ses dieux et ses d´emons. Menaces et atout d’un jeu d´er´egl´e (Gen`eve, Labor et Fides, 2008); as co-editor: Dietrich Bonhoeffer: Autonomie, suivance et responsabilit´e, Revue d’´ethique et de th´eologie morale (Paris, Le Cerf, 2007); and Sujet

Notes on Contributors / xiii moral et communaut´e (Fribourg, Academic Press, 2007). He enjoys novels, music, and soccer. Kisali Pallangyo is Vice Chancellor and Professor of Medicine at Muhimbili University of Health and Allied Sciences in Dar es salaam, Tanzania. His main research interests since the early 1980s have been in the area of HIV, AIDS and tuberculosis. His current research focuses on new vaccines for HIV and tuberculosis. Peter A. Singer is Senior Scientist and Co-Director of the McLaughlinRotman Centre for Global Health, Program on Life Sciences, Ethics and Policy (MRC-PLEP), and Professor of Medicine at University of Toronto. His co-author of the chapter ‘‘Harnessing Advanced Technologies for Global Health Equity’’ is Abdallah Daar, Professor of Public Health Sciences and of Surgery at the University of Toronto, Senior Scientist, Director of Ethics and Policy at the McLaughlin Centre for Molecular Medicine, and co-director of MRC-PLEP. Dr. Singer has received Canada’s highest health research awards including the Canadian Institutes of Health Research Distinguished Investigator Award and the Michael Smith Award as one of Canada’s two Health Researchers of the Year for 2007. He is a Fellow of the Canadian Academy of Health Sciences and the Royal Society of Canada. He has published over 230 research articles. He studied internal medicine at the University of Toronto, medical ethics at the University of Chicago, public health at Yale University, and management at Harvard Business School. Dr. Daar completed medical school in London, England, and pursued postgraduate clinical training in surgery and internal medicine, a doctorate in transplant immunology/immunogenetics, and a fellowship in transplantationatOxford.Hewasaclinicallecturerin Oxford forseveralyears before going to the Middle East where he helped found two medical schools. He held the Foundation Chair of Surgery in Oman for ten years before moving to the University of Toronto in 2001. He has co-authored five books and has over 300 publications to his credit. Other contributors to this chapter are Archana Bhatt, MPH Administration, Dalhousie University; Sarah E. Frew, Research Associate, MRC-PLEP; Heather Greenwood, PhD candidate, University of Ottawa; Jocelyn E. Mackie, Ontario lawyer; Dilnoor Panjwani, PhD candidate, University of British Columbia; Deepa L. Persad, Program Research Coordinator, MRC-PLEP; Fabio Salamanca-Buentello, Physician and PhD candidate, MRC-PLEP; B´eatrice S´eguin, Assistant Professor, Leslie

xiv / Notes on Contributors Dan Faculty of Pharmacy, University of Toronto and MRC-PLEP; Andrew D. Taylor, Director of Operations and Scientific Strategy, MRC-PLEP; Halla Thorsteind´ottir, Assistant Professor in the Department of Public Health Sciences at the University of Toronto and MRC-PLEP; and Aneesa Walji, JD candidate, University of Toronto. Daniel Wikler is Mary G. Saltonstall Professor of Ethics and Population Health in the Department of Global Health and Population, Harvard School of Public Health, and is a faculty member of the Harvard Program in Ethics and Health. He served as Senior Staff Ethicist for the World Health Organization, and was co-founder and former president of the International Association of Bioethics. His published work addresses many issues in bioethics, focusing in recent years on population health, including ethical issues in resource allocation and in global public health.

Introduction In September 1960 Dartmouth College and Dartmouth Medical School hosted a landmark conference on ‘‘Great Issues of Conscience in Modern Medicine.’’ That conference helped set the agenda for the emergence of the modern field of bioethics. As Albert R. Jonson records in The Birth of Bioethics, the conference ‘‘was an impressive occasion: men of science, joined by a few humanists, reflected in public about the troubling issues they saw hidden within the wonderful inventions of modern science.’’i Since that conference not only have women of science and many more than a few humanists entered the field of bioethics, but the scope of the field has also rapidly evolved. The vulnerability of patients and the availability of life-prolonging interventions continue to raise enduring questions about the role of physicians and the rights of patients in our modern health care system. In addition, bioethicists now also tackle questions—ethical, political, and legal questions—about that health care system itself and about the roles of that system’s many and various non-physician members, including nurses, researchers, insurers, hospital ethics committees, risk managers, government agencies, and even clinical bioethicists. And recent developments in medical science and technology—cloning and genetic testing, for example—have focused attention on questions that, in September 1960, were barely visible. Many of the most urgent new questions in bioethics have to do with international or global issues. Pharmaceutical companies now routinely test new drugs in resource-poor countries, where diseases that are manageable in resource-rich nations pose a deadly threat to entire peoples. ‘‘Medical tourists’’ cross borders in search of drugs or procedures that are illegal or unaffordable in their home countries. Immigrants request interventions 

Albert Jonson, The Birth of Bioethics (New York: Oxford University Press, 1998), 15.

2 / Introduction that, they sometimes discover, are much more ethically controversial in their new country than in the old. And various contemporary national health care systems differ from one another not only economically and in terms of their institutional structures, but also in terms of the specialties and services (for example, palliative care and physician-assisted death) that are available, legal, and deemed culturally acceptable. These recent phenomena raise challenging questions. What is owed to resource-poor nations whose citizens participate in risky studies? Should professional medical obligations vary across cultures? Should there be a single set of global norms in bioethics? Are approaches to medical research or end-of-life care ever ethically justifiable in some nations and economic environments but not others? For whatever reason, these global issues in bioethics have been largely neglected until only recently. In fact, it may not be much of an exaggeration to say that there is a ‘‘90/10 gap’’ within bioethics: 90 percent of the field’s energy—as evidenced by publications in major English-language bioethics journals—has been devoted to issues that have little pressing significance for 90 percent of the world’s physicians, patients, and policymakers. Ethical questions about elective medical (surgical or genetic) enhancement are, we believe, complex and important; however, it is important to remember that most of the world’s patients receive less medically necessary care than they need, and that the circumstances under which the care they do receive is provided and supported raise clearly complex and important ethical issues. The chapters in this volume, which began their life at a symposium held at Dartmouth College forty-five years after its landmark 1960 conference, draw attention to some of these pressing new global issues. Their authors include leading voices in bioethics. Some are at the forefront of the emerging field we will call global bioethics. Since global bioethics is an emerging area, it is unsurprising that there are different views—even among contributors to the present volume—about just what it might mean for bioethics to become global. For some, global bioethics research, teaching, and consultation is work that reflects the urgent need to promote global health and advocate on behalf of vulnerable, developing world populations in poor health. For others, bioethics becomes global when its practitioners look beyond the puzzles that arise against the background of their own nation’s health care and legal systems.

Introduction / 3 We identify here at least seven broad areas of global bioethics debate and inquiry, all of which are represented in this volume. The first of these concerns the normative bases appropriate for the emerging field of global bioethics. Bioethics emerged historically in the West and received most of its impetus in the past few decades in developed countries. It has tended to privilege ethical issues related to the individual physician–patient encounter. This raises the question of whether this normative foundation needs rethinking in the global context. The American philosophers Dan Wikler and Dan Brock open this section with their chapter ‘‘Population-Level Ethics: Mapping a New Agenda,’’ in which they encourage the adoption of what they call a ‘‘bird’s-eye perspective’’ in bioethics, a population health approach for which health care interventions are just one among many ethically significant ways of affecting the health of individuals in a population. Bird’s-eye bioethics, Wikler and Brock suggest, ‘‘extends naturally to a global focus’’—allows more global issues to come into view—and is better suited to the promotion of global health equity. The population-level approach to bioethics Wikler and Brock aim to promote is new partly because of its interdisciplinary character. Bioethics has, of course, always been an interdisciplinary—or at least multidisciplinary—field; however, since bird’s-eye bioethics takes as its subject ‘‘health rather than health care,’’ it ‘‘peers over’’ some disciplinary borders many bioethicists have never crossed, such as those of demography, gerontology, and theories of economic development. Further, as Wikler and Brock also stress, bird’s-eye bioethics draws on a different set of conceptual resources offered by philosophy: the population focus invites more attention to, say, theories of global justice than to the theories of right action and moral status that have long constituted the main contents of the bioethicists’ toolbox. In Chapter 2, ‘‘What Is It Like to Be a Bird?,’’ the political philosopher Nir Eyal responds to Wikler and Brock and encourages some healthy skepticism about the ‘‘special importance’’ and practical significance of the proposed shift to the bird’s-eye perspective. The issues that are visible from the bird’s eye are unquestionably important; however, what makes bird’s-eye bioethics unique and what makes it especially important compared to traditional bioethics remain, he argues, far from clear. Among other things, he observes that some of the issues raised by Wikler and Brock, such as caregivers’ obligations of confidentiality to patients in the emergency settings of war or

4 / Introduction genocide, are not population health issues so much as concerns that have already been canvassed by traditional, clinical bioethics. One especially prominent question in regard to the normative basis of global bioethics deals with the implications of global diversity for the prospects of success in the search for international norms. The third chapter, ‘‘The Evolving Norms of Medical Ethics,’’ by the physician and political philosopher Ezekiel Emanuel, offers an account of various ‘‘paradigm shifts’’ in the history of medical ethics. Emanuel’s history ends with the ‘‘free for all’’ he thinks members of the field find themselves in today. In Emanuel’s view, currentglobalcontroversiesoversuchmattersastheappropriatestandard ofcare inHIV researchreflecttheirreduciblepresenceofthesecompeting paradigms. Chapter 4, ‘‘Convergent Trends in Medical Ethics,’’ by the Dutch bioethicist and geriatrician Hans van Delden criticizes Emanuel’s history, noting respects in which it cannot accommodate (among other things) developments in bioethics in the Netherlands during the periods he discusses. What Emanuel presents as an account of the evolving norms ‘‘of medical ethics,’’ van Delden suggests, turns out to be an account of the evolving norms of medical ethics in the United States. Van Delden also challenges Emanuel’s conception of the current state of the field, noting some points of apparent convergence that tell against the ‘‘free for all’’ diagnosis. He especially emphasizes the growing importance of human rights for global medical ethics. In something of a return to the perspective offered by Brock and Wikler, he concludes with the observation that studying international issues from a justice perspective moves us away from the individual patient–physician relationship that was the focus of the language of clinical bioethics. For a variety of reasons, ranging from the global nature of some disease conditions to the offshoring of pharmaceutical research, the issue of what is owed to research subjects has been a central focus of recent global bioethics debates. The second section of this volume focuses on global research ethics. Public health scholar Nancy Kass leads off with an urgent question: ‘‘Can Harm Reduction Be an Acceptable Tool for Public Health Prevention Research?’’ The question is whether it is wrong to study the efficacy of cheaper—and presumably less effective—alternatives to the best available interventions, and to do so by denying research participants access to the best available interventions. This question, which caused intensive public controversy in the early 1990s in the aftermath of the Baltimore lead abatement study, is an issue in global bioethics, since so many of the vulnerable populations that would-be harm

Introduction / 5 reduction researchers hope to benefit are in resource-poor nations. (Indeed, the perinatal HIV transmission trials conducted in Africa and elsewhere in the 1990s were as controversial as the Baltimore study.) Kass argues that some studies of this sort can be permissible and that harm reduction, based on a public health model, is a legitimate goal of research. The challenge is to block studies that are exploitative and which do not advance public health. Kass offers seven guidelines that she thinks should be used for that purpose. One challenge that would-be global harm reduction researchers face has to do with compliance with various national and international rules governing human subjects research. Kass hopes to sidestep questions about compliance by drawing attention to the datedness of the relevant documents and the character of the problems they were designed to address. Existing regulations, she proposes, are ill-suited for helping today’s researchers ethically evaluate possible harm reduction research projects. According to philosopher Ana Iltis, whose reply to Kass (‘‘Harm Reduction Research: Ethics and Compliance’’) is included in this section as well, whether harm reduction research runs counter to existing regulations is neither irrelevant nor clear. In particular, whether recently revised and reaffirmed regulations rule out such research depends partly on how the ‘‘standard of care’’ and ‘‘minimal risk’’ standards (associated with the Declaration of Helsinki and the Common Rule within the Code of Federal Regulations, respectively) should be interpreted. After surveying the relevant interpretive disputes, Iltis challenges one of the most original proposals in Kass’s chapter, the suggestion that whether researchers can provide evidence of involvement in political advocacy (on behalf of the group the proposed harm reduction research subjects belong to) is relevant to whether their proposal should be approved. While fraught with the potential for the exploitation of—and for risk to—vulnerable populations, harm reduction research in the global setting nevertheless is intended to benefit precisely those populations. Not all research conducted across national borders is similarly motivated. For some, such research is instead an opportunity to develop—in resource-poor nations—drugs the developers expect to market only in the developed world and for the sake of a substantial profit. For resource-poor nations, allowing such research may appear to be the only way to ensure at least minimal access to expensive drugs. In ‘‘Global Justice, Human Rights, and Health,’’ philosopher Ruth Macklin asks what those who conduct research in poorer nations owe to the citizens

6 / Introduction of these nations. It is commonplace to acknowledge that benefits of some sort are owed to the community or country where the research is conducted. But this acknowledgement leaves many questions unanswered. Which—and how many—citizens in the host country are the appropriate recipients of such aid? For how long should the aid be provided? What conception of justice requires the aid, and how controversial does that conception of justice deserve to be? And should the research be regulated in accord with the standards of the pharmaceutical corporation’s home country or those of the host country? Macklin argues that there may be a shortcut to answering some of these hard questions. Existing United Nations declarations and covenants, she says, can be read as identifying an obligation that wealthy nations and their researchers have to act so as to help reduce the gap in health status and life expectancy between rich and poor nations. Global biomedical research is not just an opening for exploitation. It can also be an opportunity for genuine collaboration. The third section of this volume provides a more optimistic perspective on the ways that biomedical research and development can foster biomedical/bioethical collaborations around the world. The section begins with bioethicist Eric Meslin’s ‘‘Achieving Global Justice in Health through Global Research Ethics.’’ Meslin begins by expressing support for Macklin’s general argumentative strategy, understood chiefly as a means to encourage the promotion of global health. However, drawing on his experience of the collaborative research partnership between Kenya’s Moi University and Indiana University, he also insists that what he calls her ‘‘top–down’’ approach should be supplemented by a ‘‘ground–up’’ approach to promoting global health. The ground–up approach begins with extensive collaborative agreements between researchers, ethics committees, and institutions on both sides of the national divide. Affluent countries can make their best contribution to the poorer countries, he maintains, when they help empower local investigators and research communities to become fully involved in the research enterprise. In their chapter ‘‘Harnessing Advanced Technologies for Global Health Equity,’’ Singer et al. return to the forms of benefit that might form part of an ethic of global biomedical responsibility. They report on the prospects of molecular diagnostic technology, nanotechnology, genomics, and new technologies for vaccine and drug delivery to promote global health equity if these technologies can be rendered affordable, and they outline some strategies for making that possible. In particular, they recommend that

Introduction / 7 developing nations should aim to foster ‘‘their own indigenous health biotechnology sector.’’ Their discussion, coupled with Meslin’s emphasis on bioethical self-development, offers a vision of less developed nations as full partners in the biomedical research enterprise. Global developments place stress on the ethics of individual physicians and medical caregivers. Part IV explores the training of professional, ethical physicians in different social and cultural environments. Robert L. Martensen and Kisali Pallangyo, both of whom are physicians and medical educators, take up these questions from very different national perspectives. Martensen argues in ‘‘American ‘Medical Professionalism’: At Home and in the World’’ that practices in medical education in North America are undermining the important goal of teaching young physicians ‘‘the social and cultural anatomy’’ of medicine. What is at stake in how we design medical school curricula and residency and fellowship training programs is not only the character traits of future physicians—which mere lip service to the value of ‘‘professionalism’’ does little to shape properly—but also the ‘‘social and cultural legitimacy’’ of medicine as a profession. Among the signs of deterioration in American medical education he notes are the ‘‘empty classrooms of the pre-clinical years,’’ as note services and the internet replace the physical presence of the teacher, and the corresponding disappearance of the clinical teacher from rounds under the stress of managed care or as a result of heavy reliance on technological diagnostics. Closely examining ‘‘A Physician Charter’’ as a representation of medical professionalism today, Martensen also notes the document’s inattention to the larger social context of medicine, whether it be the conflicts produced by the strong presence of pharmaceutical companies in the medical and research setting or the brain drain as developed countries increasingly rely on immigrant physicians from poorer nations to staff their large health care systems. Although Kisali Pallangyo shares many of Martensen’s values, he also acknowledges (in ‘‘Professionalism and Medical Education in the Developing World’’) the sometimes dramatically different challenges medical educators face in the developing nation setting. In his role as Dean of the Medical School at Tanzania’s Muhimbili University of Health Sciences, Pallangyo works with colleagues who do not have the luxury of questioning high-tech medicine and specialization. Instead they face a rising tide of infectious disease that threatens to overwhelm their scant resources, and classrooms that are empty not because students get the notes on the internet but because they

8 / Introduction cannot afford the bus fare. Equally lamenting the hemorrhage of doctors from poor nations to rich, he itemizes some of the factors, beyond low salaries, that burden his students and colleagues. The fifth section, with a single chapter by Hans van Delden and Margaret Pabst Battin, continues the concern with professionalism voiced by Martensen and Pallangyo but focuses on the issue of euthanasia and physicianassisted death (PAD). As some national communities like the Netherlands experiment with new approaches to the end of life, how are we to understand the reach of the Hippocratic norms that appear to have prohibited physicians from assisting patients in dying? Van Delden, drawing on his background as a nursing home physician in the Netherlands, and Battin, an American philosopher and fiction writer, together ask (in ‘‘PhysicianAssisted Death: Not Just for Rich Countries’’) whether there is any morally relevant difference—with respect to the prospects for the moral justification of legalized PAD—between resource-rich and resource-poor nations. Their answer is both yes and no: assuming for the sake of argument that the Dutch approach to PAD is justifiable in the context of developed nations, there is no reason to believe that PAD should be unjustifiable in the context of the developing world. However, they further argue that it may be that the socalled ‘‘argument from mercy’’ provides more support for the permissibility of PAD in developing nations than it does for the permissibility of PAD in developed nations. If so, then considerations of justice suggest that, as they put it, ‘‘if PAD ought to be permissible anywhere, it ought to be permissible in developing countries.’’ Religious traditions and religious values are major factors in shaping bioethics debates around the world, particularly in issues connected with the beginning and end of life. Our sixth section focuses on global bioethics and religion. Taking as its subject current debates about human embryonic stem cells (hESCs), the chapter by Ronald M. Green, ‘‘Embryo as Epiphenomenon,’’ maintains that these debates are driven less by philosophical argumentation than by underlying value issues and social, economic, cultural, religious, and ecclesiastical realities. He points, in particular, to the role played by some conservative religious interpretations of ‘‘family values’’ in driving resistance to abortion rights, to changing gender roles, and to more permissive approaches to the expression of sexuality or sexual orientation. This religiously informed resistance partly explains the growing divide on some bioethical issues between north and south, developed and less

Introduction / 9 developed, modern and traditionalist, established and emergent societies. This deeper resistance to change, Green maintains, often underlies surface or ‘‘epiphenomenal’’ debates about the status of the human embryo. In his chapter ‘‘The Role and Influence of Religions in Bioethics,’’ the Swiss theologian and bioethicist Denis Mu¨ ller defends the positive contribution of world religions in furthering our understanding of global bioethical questions. In every moment of life, from its beginning to its end, he says, purely pragmatic and utilitarian approaches must be supplemented by what he calls a ‘‘concrete, historical and cultural, symbolical, and transcendental ‘metaphysics’.’’ Offering the example of organ donation, Mu¨ ller indicates how transcendent perspectives offered by religious traditions such as Protestant Christianity and Japanese Buddhism in different ways shape the ethical choice between implicit and explicit consent for organ donation. Developing ¨ his religiously informed ‘‘critique of bioethical reason,’’ Muller offers a view that rejects, on the one hand, a purely secular and utilitarian approach to bioethics, but is equally opposed to religious communitarian and sectarian orientations that refuse to enter into reasoned bioethical discourse. The more we meet and discuss issues of bioethics across cultures, he says, ‘‘the more we will have to be ourselves, with our own history, identity and traditions.’’ In a final section, public global bioethics consultations, we return to the challenge that global diversity poses for the prospects of success in the search for international bioethics norms. But the focus here is on a relatively new phenomenon: the processes being developed among international organizations for identifying universal norms and values, often in relation to very controversial issues. In ‘‘Global Norms, Informed Consensus and Hypocrisy in Bioethics,’’ the British philosopher John Harris questions the ‘‘wisdom and utility’’ of some of these efforts. He directs his attention to recent attempts (by UNESCO, for example) to establish global norms, especially in the areas of reproductive and genetic ethics. Such attempts are problematic in two respects, he maintains. First, the consultations often involved in such attempts do not clearly distinguish moral judgments from mere judgments about moral issues—judgments that may be informed by prejudice or by one or more non-moral normative systems. Second, the documents produced by such forms of consultation rarely provide any evidence that the consensus achieved was what he calls an informed consensus. The development of global norms, Harris argues, ‘‘should only be attempted where informed consensus has been achieved, and in the context of the detailed explanation

10 / Introduction and justification of any principles offered as part of an attempt to create informed consensus.’’ The importance of detailed explanation and justification of principles is a reminder, for Harris, of the crucial role of ‘‘philosophical analysis and argument’’ in global bioethics consultation: An essential part of the informed consensus required . . . is the appreciation and acceptance of arguments which have been tested in as many ways as possible. For example their consistency with other values and beliefs should have been explored, they must have been exposed to criticism, to counter-argument, to the attempt to find counter-examples where appropriate, they will have resisted attempts at reductio ad absurdum and survived the other ways in which argument is tested and philosophical conclusions are established.

Harris concludes his chapter with a thorough discussion of a relevant case: the European Commission search for an ‘‘ethical framework’’ for human embryonic stem cell (hESC) research—the ‘‘EUROSTEM’’ project, which Harris directed from 2002 to 2005. The final chapter is a reply to Harris by the Canadian philosopher Fran¸coise Baylis, who in ‘‘Global Norms in Bioethics’’ challenges his description of the character and goals of global bioethics consultation. In particular, Baylis draws on her own observation of Canada’s role in the development of UNESCO’s Draft Declaration on Universal Norms in Bioethics. In her view, the documents produced by global bioethics consultations are not philosophical treatises aimed as discerning the truth so much as political statements resulting from compromise. As such they can be useful both because they can give voice to well-articulated and well-defended positions, and because they are sometimes able to go beyond narrow scientific concerns in order to consider and serve ‘‘the common good.’’ Baylis concludes by emphasizing that in her view serving the ‘‘common good’’ is the most important goal of global bioethics. Unlike contemporary understandings of the public interest, the common good attends to the welfare interests of all individuals (i.e. everyone) considered as a group, not just the interests of this community, this country, this racial cluster, and so on. More attention to the common good, she urges, might help counter the ‘‘minimalism, vagueness, hegemony and anthropocentrism’’ of current UN and other public consultation documents.

Introduction / 11 Like so much in modern culture, from economics to communications, bioethics has become global. As we move across national and regional borders, issues that have been staples of bioethics inquiry, such as the rights of research subjects or end-of-life decision making, attain new complexity. New questions arise related to deep cultural differences that, in some cases, challenge the values and standards of Western biomedical ethics. The chapters in this volume are meant to further discussion in what will surely be a growing sector of bioethical concern. We may even anticipate a day when all bioethics becomes global by incorporating into its methods and content the full range of human experience and thinking.

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Part I Normative Bases

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1 Population-Level Bioethics: Mapping a New Agenda Daniel Wikler and Dan W. Brock

1. What is Distinctive in a Population Focus? A Bird’s-Eye Perspective in Bioethics Bioethics was long focused on ethical issues arising in the relationships and interactions of individual patients and their physicians, as well as individual investigators and their research subjects. Ethical issues arising at the population level are no less acute, but are much less visible to lay people, to health professionals, and to many bioethicists. The issues come into focus only when one adopts a bird’s-eye view that looks at populations. From this perspective, new issues become visible, and their close kinship to long-debated ethical questions in other fields such as population policy, environmental health, and political philosophy becomes apparent. Even as investigation, debate, and education continue in the clinical settings in which bioethics has been most at home, an extensive, new, and largely unexplored region of bioethics is coming into view. The bird’s-eye perspective of this population-level bioethics includes consideration not only of health care but of other social determinants of health, including socio-economic standing, environmental and working conditions, and social exclusion. Its subject therefore is health rather than health care alone, insofar as health can be affected by conditions and interventions in any of these domains.

16 / Wikler and Brock The focus of population-level bioethics is broader than bioethics at the clinical level not only for its concern with groups but also in that it is extended in both space and time. It extends naturally to a global focus, permitting population-level comparisons of the extent, direction, and distribution of health prospects. The least-healthy populations, most of which are in developing countries, become especially prominent from this perspective; for them, the stakes are highest and the ethical dilemmas most severe. Population-level bioethics is also extended temporally, taking into account the consequences of present day events that affect the health of future generations, and their size and makeup. In so doing, it transcends disciplinary borders into demography, gerontology, genetics, and economic development. Bioethics, as a normative discipline, draws on moral philosophy and other sources of reflection on values. But whereas clinical bioethics looks to the morality of individual conduct and character, population-level bioethics relies principally on theories of justice and other political philosophy. Where clinical bioethics speaks of the rights and responsibilities of patients and doctors, bioethics at the population level assesses the obligations of societies toward their members and each other and the norms governing complex relationships of individuals, groups, and the state. All of these distinctive features of bioethics at the population level emerge from a brief survey of some of the outstanding issues. We will not explore here any of these issues in detail, but only suggest some of the key questions that need to be addressed within each issue. Our hope in surveying these issues is to supplement clinical bioethics by stimulating more work by bioethicists and others on these population-level issues.

2. Society’s Responsibility for Health Most industrialized countries accept the World Health Organization’s dictum that stewardship of health systems is a responsibility of national governments.¹ For decades, the exception among developed countries was the United States. In the 1980s, the ‘‘Washington Consensus’’ in developmental ¹ World Health Organization, World Health Report 2000 (Geneva: World Health Organization, 2000), 119–20.

Population-Level Bioethics: A New Agenda / 17 economics raised this perspective to the level of principle for developing countries,² prompting states to privatize health care along with other basic services. Since then, seemingly inexorable increases in costs for health care have put pressure even on wealthy countries that have accepted health as a national responsibility, such as Canada, where the government’s nearmonopoly on health services has been a defining principle of national identity. At one time, social responsibility for health—either as a goal or as a reality—was a given among developed countries; the puzzle was American exceptionalism. Now, the debate is open throughout the world. What case can be made for the assumption of responsibility for health by the state?³ What form should that responsibility take? To what degree can the extent of that responsibility be guided by moral argument and to what degree must it be determined by political consensus? What effects have recent privatization efforts had on the justice of health systems in which they have taken place?

3. Individual Responsibility for Health Poor health and disability is not always a calamity that just happens to someone. We can increase our chances of staying healthy if we eat prudently, exercise, avoid tobacco and drugs, handle dangerous or toxic objects and substances with due caution, and comply with medical advice. Each of us takes chances sometimes, and some people become sick, disabled, or die as a result. What implications, if any, do these facts have for health policy and public health? Current policies do not follow a uniform pattern. Britain’s National Health Service does not generally offer tattoo removal,⁴ but will ² John Williamson, ‘‘The Washington Consensus Revisited,’’ in Louis Emmerij, ed., Economic and Social Development into the XXI Century (Washington, D.C.: Inter-American Development Bank, 1997), and ‘‘What Should the World Bank Think about the Washington Consensus?’’ World Bank Research Observer, 15/2 (August 2000), 251–64. ³ ‘‘The Importance of Social Intervention in Britain’s Mortality Decline c.1850–1914: A Re-interpretation of the Role of Public Health,’’ Social History of Medicine, 1/1 (April 1988), 1–37. Reprinted in: A. Gray, World Health and Disease: A Reader, 3rd edn (Philadelphia: Open University Press, 2001), pt 4, ch. 4. ⁴ Rudolf Klein, ‘‘Defining a Package of Healthcare Services the NHS is Responsible for: The Case Against,’’ BMJ 314/7079 (1997), 503–5; Bill New, ‘‘The Rationing Debate: Defining

18 / Wikler and Brock remove birthmarks that disfigure to a similar degree. The NHS, like public and private insurers everywhere, pays for treatment for smokers who contract lung cancer. The state of West Virginia, in the United States, has instituted a personal responsibility ‘‘member agreement’’ that beneficiaries of its health insurance program for the poor must sign and fulfill to avoid reductions in covered services.⁵ Other states do not. Should the health field find room for concepts of desert, fault, responsibility, and blame that are traditionally more at home in the courtroom?⁶ What would be the distributive effects of doing so, and would the result be fairer, particularly in light of the fact that many unhealthy behaviors such as smoking and poor nutrition are disproportionately concentrated in lower socio-economic classes?⁷ How would assignment of personal responsibility for health affect the moral norms underpinning the field of health promotion, and its inclusion on the agenda of public and international health agencies?⁸ If assignment of personal responsibility should be relevant to various health policies, should it also be reflected in individual patient care decisions by physicians at the clinical level as well? Would it be consistent to give weight to personal responsibility at policy levels, but to ignore it in clinical contexts? What would be the ethical consequences of physicians assessing not just patients’ needs for care, but also their responsibility for their health needs, in allocating their services? To the extent that health disparities can be traced to the imprudence of the poor, should this issue be regarded as a personal failing rather than as a social injustice?⁹ a Package of Healthcare Services the NHS is Responsible for,’’ BMJ 314/7079 (1997), 498–502. ⁵ , accessed June 20, 2007; Gene Bishop, M.D., and Amy C. Brodkey, M.D., ‘‘Personal Responsibility and Physician Responsibility—West Virginia’s Medicaid Plan,’’ NEJM 355/8 (August 24, 2006), 756–8. ⁶ Daniel Wikler, ‘‘Personal and Social Responsibility for Health,’’ in Public Health, Ethics, and Equity, ed. S. Anand, F. Peter, and A. Sen (Oxford: Oxford University Press, 2004). ⁷ John Roemer, ‘‘A Pragmatic Theory of Responsibility for the Egalitarian Planner,’’ Philosophy & Public Affairs, 22 (1993), 146–66; Paula Lantz et al., ‘‘Socioeconomic Factors, Health Behaviors, and Mortality Results From a Nationally Representative Prospective Study of US Adults,’’ Journal of the American Medical Association 279 (1998), 1703–8. ⁸ Howard Leichter, ‘‘ ‘Evil Habits’ and ‘Personal Choices’: Assigning Responsibility for Health in the 20th Century,’’ Milbank Quarterly, 81/4 (2003), 603–26. ⁹ Brian Barry, Why Social Justice Matters (Cambridge: Polity Press, 2005), 131.

Population-Level Bioethics: A New Agenda / 19

4. Health and Human Rights: What Relation to Population-Level Bioethics? The field of health and human rights is ubiquitous and official: it is recognized in international treaties,¹⁰ and its practitioners are found in UN agencies and in much of the world. Some work in bioethics outside the United States also draws heavily on human rights, but in the United States bioethics remains an entirely separate academic specialization. The field of human rights is largely guided by lawyers, while bioethics looks to academic philosophy. The two fields overlap but little in personnel, journals,¹¹ or conferences. Yet at the population level they address many of the same issues, such as health care priority-setting, the ethics of research with human subjects, ethical limits on public health interventions that threaten civil liberties, and public participation in health policy. Is the de facto segregation of these fields an historical accident or is it based on a rational division of labor? Would it be useful to attempt to integrate these fields, or are they best left separate?¹² How might they be effectively integrated? Is human rights theory potentially more useful for some areas of population-level bioethics than others, and if so which?

5. Priority-Setting Scarce resources require priority-setting: among treatments and interventions; among recipient populations; and in guiding research and training. These are often tragic choices. If treatment for AIDS is much less costeffective than prevention,¹³ should funds be channeled to prevention even ¹⁰ International Covenant on Economic, Social and Cultural Rights, Article 12. ¹¹ Health and Human Rights: An International Journal (Boston: Harvard School of Public Health). ¹² Jonathan M. Mann, ‘‘Medicine and Public Health, Ethics and Human Rights,’’ The

Hastings Center Report, 27 (May–June 1997), 6–13; Health and Human Rights: A Reader, ed. Jonathan M. Mann, Sofia Gruskin, Michael A. Grodin, and George J. Annas (New York: Routledge, 1999). ¹³ Kevin De Cock et al., ‘‘Shadow on the Continent: Public Health and HIV/AIDS in Africa in the 21st century,’’ Lancet, 360 (2002), 67–72; E. Marseille et al., ‘‘HIV Prevention before HAART in Sub-Saharan Africa,’’ Lancet, 359 (2002), 1851–6.

20 / Wikler and Brock as needy patients suffer and die?¹⁴ When treatment programs for AIDS lack enough money and doctors to treat everyone, should the sickest be first in priority, or should those who play essential social or medical roles such as teachers and health care workers receive priority?¹⁵ And if so, should productive workers be favored over retirees? In the WHO’s ‘‘3-by-5’’ program which aimed to place 3 million patients with HIV/AIDS on anti-retroviral therapy by the end of 2005, how should those patients have been selected from among the 6 million patients who were in need of therapy?¹⁶ If some patients are more expensive to reach and to treat in such programs, should they be abandoned in favor of patients cured more easily and cheaply? What do we need to know, or to develop, to address these moral questions? What role is there for moral reasoning, and what kind of contribution can ethics, and in particular theories of justice, make?¹⁷ In general, should priorities in the health care system mirror choices individuals make or would make in buying insurance for themselves?

6. Cost-Effectiveness Analysis (CEA) Cost-effective health interventions achieve the greatest health gains possible with the resources available. Cost-effectiveness analysis purports to offer evidence-based, objective guidance for priority-setting among health interventions, identifying those with the greatest potential health benefits given the resources available. But CEA is not value-free. On closer ¹⁴ E. Masaki et al., ‘‘Cost-Effectiveness of HIV Interventions for Resource Scarce Countries: Setting Priorities for HIV/AIDS,’’ available at . ¹⁵ R. Macklin, ‘‘Ethics and Equity in Access to HIV treatment—3 by 5 initiative,’’ World Health Organization, 2004, available at . ¹⁶ A. M. Capron and A. Reis, ‘‘Designing an Equitable Strategy for Allocating Antiretroviral Treatments,’’ PLoS Med 2/3 (2005), 69. ¹⁷ Norman Daniels, ‘‘Fair Process in Patient Selection for Antiretroviral Treatment in WHO’s Goal of 3 by 5,’’ Lancet 366/9480 (2005), 169–71.

Population-Level Bioethics: A New Agenda / 21 examinations, it is possible to identify moral assumptions that are embedded in CEA; and thereby to try to determine which of those assumptions are ethically defensible.¹⁸ For example, in a CEA one must decide whether to apply discount rates to future health benefits, as is routinely done to future costs and financial gains, and whether to give different value to health benefits for different age groups.¹⁹ The decision may have a strong effect on the relative priority given to acute versus preventive interventions and to interventions serving different age groups.²⁰ And what is the role of CEA in the moral and policy deliberation that results in prioritization for interventions?²¹ A small but important literature, to which contributions have been made by philosophers, economists, and others, identifies a number of elements in CEA that represent substantive moral commitments. Influential guidance documents have urged CEA to be as value-free as possible, but some assumptions about values are probably not eliminable and should be made explicit.²² CEA, moreover, does not offer a suitable guide for priority-setting unless it is joined by equity considerations. Those equity considerations need to be made explicit, together with the moral reasons for different positions on them, to help guide policy makers using CEAs. It is possible that equity considerations could be introduced as weights within the CEA, but it is not clear that this would be desirable, particularly in the face of widespread ethical disagreement about many of them. ¹⁸ D. Brock, ‘‘Ethical Issues in the Use of Cost Effectiveness Analysis for the Prioritization of Health Care Resources,’’ in Making Choices in Health: WHO Guide to Cost-Effectiveness Analysis, ed. T. Tan-Torres Edejer et al. (Geneva: World Health Organization, 2003); Marthe Gold et al., Cost-Effectiveness in Health and Medicine (Oxford: Oxford University Press, 1996). ¹⁹ A. Williams, ‘‘Intergenerational Equity: An Exploration of the ‘Fair Innings’ Argument,’’ Health Economics, 6 (1997), 117–32; Dan Brock, ‘‘Ethical Issues in the Use of Cost Effectiveness Analysis for the Prioritization of Health Care Resources.’’ ²⁰ Aki Tsuchiya, ‘‘QALYS and Ageism: Philosophical Theories and Age Weighting,’’ Health Economics, 9 (2000), 57–68. ²¹ C. J. L. Murray et al., Summary Measures of Population Health: Concepts, Ethics, Measurement and Application (Geneva: World Health Organization, 2002). ²² Paul Menzel, et al., ‘‘The Role of Adaptation to Disability and Disease in Health State Valuation: A Preliminary Normative Analysis,’’ Social Science and Medicine, 55/12 (2002), 2149–58.

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7. Health Measurement Individuals who submit to regularly scheduled physical examinations can chart their health states over time. On the population level, data from many individuals is combined to yield a measure of population health.²³ At the individual level, the data in the chart—blood pressure test scores, for example—may not in themselves represent any significant value judgments. ‘‘Summary measures’’ of population health, however, cannot easily avoid them. An overall measure of population health incorporates data from many tests on many people and must assign weights to each in order to compute the whole. Our estimate of the health of a population, from this perspective, reflects our measurements of the prevalence of blindness and deafness; but it also reflects our judgments of the relative degree to which these two states detract from overall health. These judgments are typically derived from research on the preferences of the general population, or of experts, and are therefore based on measurement as well. But these preferences may themselves involve value judgments. Moreover, the preferences of sub-groups may vary considerably. A much-discussed example is the difference of views between disabled and non-disabled people regarding their disability.²⁴ Blind people, for example, usually regard blindness to be less of a problem, relative to other health deficits, than sighted people do. The two groups would therefore differ in judging the contribution to population health of programs to prevent or cure blindness; and these differences would in turn affect the results of cost-effectiveness analyses of such interventions. In measuring population health, one must choose between relying on one or the other of these different sets of preferences, or else averaging or otherwise combining them, but each of these choices arguably embodies and reflects a particular set of values. Identifying the ethical assumptions and decisions built into cost-effectiveness analysis and evaluating their adequacy are ²³ Murray et al., Summary Measures of Population Health. ²⁴ Dan Brock, ‘‘Health Care Resource Prioritization and Discrimination against Persons

with Disabilities,’’ in Americans with Disabilities: Implications for Individuals and Institutions, ed. L. Francis and A. Silvers (New York: Routledge, 2000); Dan W. Brock, ‘‘Separate Spheres and Indirect Benefits,’’ Cost-Effectiveness and Resource Allocation, 1 (2003), 4.

Population-Level Bioethics: A New Agenda / 23 potential contributions for bioethics to population health. The same is true for other quantitative approaches to resource allocation, including cost-benefit analysis.²⁵

8. Health and Economic Development One of Dr. Gro Harlem Brundtland’s main objectives during her term of office as Director-General of the World Health Organization was to make health the concern not only of the health minister—often a lonely and embattled figure, perceived as a net absorber of funds—but also the ministers of finance and economic development. Her Commission on Macroeconomics and Health, chaired by the economist Jeffrey Sachs, coordinated the work of a small army of economists to make the case for health as an engine of economic development.²⁶ But is there a less welcome suggestion implicit in this approach: that higher priority should be placed on health for the productive than for the elderly, the disabled, the uneducated, and others whose health care is unlikely to yield a positive return on social investment apart from the health benefit given to these individuals?²⁷ Likewise, this approach seems to imply a higher priority for health interventions that serve more productive individuals and groups.²⁸ This result is deeply in conflict with common norms of medicine that direct physicians to focus only on patients’ needs and to ignore their social value or worth. These implications are not endorsed by WHO (nor by most others who make similar arguments for attaching high priority to health over other needs), but is this really consistent? And what follows if it is not? ²⁵ Daniel Wikler, Dan W. Brock, Sarah Marchand, and Tessa Tan Torres, ‘‘Quantitative Methods for Priority-Setting in Health: Ethical Issues,’’ in Principles of Health Care Ethics, 2nd edn, ed. R. E. Ashcroft, A. Dawson, H. Draper and J. R. McMillan (New Hoboken, NJ: Wiley, 2007). ²⁶ Commission on Macroeconomics and Health, Macroeconomics and Health: Investing in Health for Economic Development (Geneva: World Health Organization, 2001). ²⁷ Brock, ‘‘Separate Spheres and Indirect Benefits.’’ ²⁸ C. Donaldson, ‘‘Valuing the Benefits of Publicly-Provided Health Care: Does ‘Ability to Pay’ Preclude the Use of ‘Willingness to Pay’?,’’ Social Science and Medicine, 49/4 (1999), 551–63.

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9. Vulnerable Populations and Emergency Humanitarian Interventions An encounter between doctor and patient in a pleasant suburban clinic may have little in common with the attempt by a volunteer physician to minister to the needs of refugees fleeing attempted genocide or desperate victims of a natural disaster. Resources in these emergency interventions are invariably stretched to the breaking point; both patients and health workers may be agitated and frightened; mutual distrust is commonplace, and there may be no source of legitimate authority.²⁹ Yet patients do not give up their rights in these emergency situations, nor physicians their professional obligations. For example, patients may be even more sensitive than usual about lapses of confidentiality about sensitive medical information. But it is not enough for health workers in emergency humanitarian interventions simply to reaffirm their commitment to conventional medical ethics. The unconventional context of care presents novel dilemmas that need to be thought out afresh. For example, physicians may feel strongly that those fleeing a genocide have a greater claim on their services than those perpetrating it.³⁰ Such moral quandaries are exacerbated by the fragmentation of services as humanitarian agencies with diverse nationalities, goals, and modus operandi occupy the same physical space, with various levels of cooperation and competition. Should there be some common understandings of the moral rules? What should the rules be, and who should determine them?

10. Risks and the People who Bear Them In their recent broadside against cost-benefit analysis,³¹ Frank Ackerman and Lisa Heinzerling open with a telling anecdote. Two recent immigrants ²⁹ S. Lautze et al., ‘‘Assistance, Protection, and Governance Networks in Complex Emergencies,’’ Lancet, 364 (2004), 2134–41. ³⁰ J. Tobin, ‘‘The Challenges and Ethical Dilemmas of a Military Medical Officer Serving with a Peacekeeping Operation in Regard to the Medical Care of the Local Population,’’ Journal of Medical Ethics, 31 (2005), 571–4. ³¹ Frank Ackerman and Lisa Heinzerling, Priceless: On Knowing the Price of Everything and the Value of Nothing (New York: New Press, 2004).

Population-Level Bioethics: A New Agenda / 25 walking along the oceanfront in California died when struck by a car whose driver was chatting on a cell phone. The authors trace their demise to a decision by the California legislature not to ban the use of cell phones by drivers, which they say was influenced by studies that concluded that ‘‘people who are talking while driving are willing to pay a lot to talk on the phone—more than many people who face deadly risks are willing to pay to avoid the risk of being killed.’’ The authors point out that no money, no compensation, actually changes hands. The rationale for the willingness-to-pay test is that it is welfare maximizing, but why should it matter that risk imposers are willing to pay more than risk avoiders if no compensation is ever made to those who suffer the risk? The pedestrians end up in the morgue; was this result fair to them? Moreover, willingness to pay to avoid risks is strongly influenced by ability to pay, and so by inequalities in wealth, which are often unjust inequalities. Clearly, there is a moral calculus at work in these analyses, one that influences the health of populations. Is the authors’ example telling, or is it a distortion of the way that these analyses are applied to health-related policy decisions? And whatever the moral calculations actually amount to, are they justified? If the willingness to pay test is not an ethically acceptable standard for risk imposition, what would be?³²

11. Environmental Equity Some people will pay a lot to avoid living near toxic waste dumps, or in housing with high levels of lead paint, or in a flood plain. Many more would like to, but do not have the money; as a result, they are more likely to become sick. Moreover, wealthier people have a double advantage, since they are more likely to be well-educated and to know what and where the hazards are, and how to avoid them. Consequently, exposure to environmental health hazards is by no means uniform across the population. The inequity is greater still when the toxins that put some at risk result from decisions by firms to benefit their investors by skimping on pollution controls. Should ³² Jonathan Wolff, ‘‘Risk, Fear, Blame, Shame and the Regulation of Public Safety,’’ Economics and Philosophy 22 (2006), 409–27.

26 / Wikler and Brock these disparities be understood merely as yet another reason it is bad to be poor, or is there a special, distinctive, and urgent reason for attempting to achieve a more equitable pattern of immunity from environmental threats to health, even as economic and other disparities persist? Do the health effects of economic disparities have any special moral importance, and if so why and what are its implications for public policy?³³

12. Populations and Genes A century ago, the prospect of ‘‘improving’’ human heredity animated scientists, officials, and lay enthusiasts who flocked to the eugenics movement.³⁴ In the wake of Nazi barbarities associated with eugenics, it has become impolitic to speak openly about improving population health and well-being by trying to influence the kinds of people who will be born. But is this goal in fact ethically unacceptable if dissociated from other immoral features of many historical eugenics programs?³⁵ New reproductive methods present some choice among potential offspring, and more choices lie just over the horizon. No one favors a return of the coercive and punitive aspects of the old eugenics, but what of the movement’s positive goals? Are they implicit in some health programs, such as genetic screening and testing or pre-implantation genetic diagnosis that wear other labels?³⁶ If so, should they be reined in? Or can we learn from the history of the eugenics movement what safeguards must be in place to protect individual rights if we are to pursue goals of population-level genetic health?³⁷ What goals, values, and standards would we be discussing seriously at this point in this era of rapid development of genetics and associated sciences if we did not have this bogey to contend with? ³³ M. S. O’Neill et al., ‘‘Health, Wealth, and Air Pollution,’’ Environ Health Perspect, 111 (2003), 1861–70; Jonathan Levy et al., ‘‘Incorporating Concepts of Inequality and Inequity into Health Benefits Analysis,’’ International Journal for Equity in Health, 5 (2006), 2. ³⁴ Diane Paul,ControllingHumanHeredity:1865tothePresent (AtlanticHighlands,NJ:Humanities Press, 1995). ³⁵ Allen Buchanan et al., From Chance to Choice: Genes and Justice (Cambridge: Cambridge University Press, 2000). ³⁶ Daniel Wikler, ‘‘Can We Learn from Eugenics?,’’ Journal of Medical Ethics, 2 (1999), 183–94. ³⁷ Quality of Life and Human Difference, ed. David Wasserman et al. (Cambridge: Cambridge University Press, 2005).

Population-Level Bioethics: A New Agenda / 27

13. Protecting Health, Endangering Civil Liberties Conventional wisdom had only recently assured us infectious disease was a threat only to people in the poorest countries, or those who traveled there. But then came AIDS; and after that SARS; and we are now bracing ourselves for a pandemic of avian flu. AIDS and SARS tested public health protections and, in many countries, found them wanting. We now know better than to let our guard down. But is it possible to be too prepared?³⁸ What are the costs—monetary, social, legal, ethical, and psychological—of giving priority to containing outbreaks of infectious disease? Hong Kong health authorities complain today of ‘‘collateral damage’’ from the SARS outbreak, as resources are rechanneled from other needed services to guard against any threat of a new outbreak. The prospect of bioterrorism sets nations further on edge. The first price to be paid in the event of an outbreak of an uncontrollable infectious disease, however, may be our civil liberties. In the face of potential panic, how secure are these freedoms, and how secure should they be?³⁹ What sacrifices might be justified to guard health? And what sacrifices might be justified not to guard health, but to reassure the public? What lesson should other countries learn from Cuba’s success in limiting the spread of HIV by interning HIV-positive citizens?⁴⁰ Does the threat of epidemic trump all other considerations? And what if we have entered an era in which we are never entirely free of such a threat? Threats from a time-limited epidemic may at least be seen as only requiring temporary suspensions of civil liberties. But as fears of bioterrorism become permanent features of the landscape, will steps to combat bioterrorism result in permanent erosion of important civil liberties?⁴¹ ³⁸ Cass Sunstein, Laws of Fear: Beyond the Precautionary Principle (Cambridge: Cambridge University Press, 2005). ³⁹ Public Health Law and Ethics, ed. Lawrence Gostin (Berkeley: University of California Press, 2002). ⁴⁰ Nancy Scheper-Hughes, ‘‘AIDS, Public Health, and Human Rights In Cuba,’’ Lancet, 342/8877 (1993), 965–7; R. Bayer and C. Healton, ‘‘Controlling AIDS in Cuba: The Logic of Quarantine,’’ NEJM 320/15 (1989), 1022–24. ⁴¹ B. Kellman, ‘‘Biological Terrorism: Legal Measures for Preventing a Catastrophe,’’ Harvard Journal of Law Public Policy, 24 (2001), 417–85; George Annas, ‘‘Bioterrorism, Public Health, and Civil Liberties,’’ NEJM 346 (2002), 1337–42.

28 / Wikler and Brock

14. Global Aging In both developed and developing countries the most profound demographic change in this century will be the aging of the population. Since older people tend to need more health services, this trend will put new stresses on health systems.⁴² The inversion of the population pyramid, with elderly dependents looking for support from a narrowing base of productive younger people, will have ripple effects throughout society. As the number of old people rises sharply, will the cost of their care deprive younger people of their rightful standard of living?⁴³ Does equity require that countries facing the greatest age imbalance begin to limit the expectations of their older citizens? Should there be standards of equitable sharing of health resources between age cohorts, and if so how can these be established?⁴⁴ When do limits on those resources constitute unjust age discrimination?⁴⁵ A fundamental question of justice in the health sector in this century will be how resources should be distributed to different age groups.

15. Global Health Equity The biggest difference between growing up in a developing country and being a child in a rich country, it has been observed, is the experience of frequent serious illness and the ever present specter of death. The burden of disease falls disproportionately on the billions of human beings, of all ages, who make up the poor majority of the poorest countries. Which ⁴² World Health Organization, Current and Future Long-Term Care Needs (Geneva: World Health Organization, 2002). ⁴³ World Health Organization, Lessons for Long-Term Care Policy (Geneva: World Health Organization, 2002). ⁴⁴ Norman Daniels, Am I My Parents’ Keeper? An Essay on Justice between the Young and the Old (Oxford: Oxford University Press, 1998); World Health Organization, Ethical Issues in Long-Term and Home-Based Care (Geneva: World Health Organization, 2003). ⁴⁵ Dan Brock, ‘‘Justice, Health Care, and the Elderly,’’ Philosophy & Public Affairs, 18/3 (1989), 297–312.

Population-Level Bioethics: A New Agenda / 29 of these inequalities are inequitable? Why?⁴⁶ Are global health disparities unjust only if they can be traced to unjust causes—to colonialism and imperialism, to unequal leverage over tariffs, quotas, and other terms of trade, to monopoly powers enjoyed by first-world based food and drug companies, and to the long-term effects of proxy wars instigated by the Great Powers?⁴⁷ How much of the disparities in health and longevity among nations can be traced to one of these injustices? Can we distinguish health disparities that result from such injustices from other ‘‘natural’’ disparities? Are there other moral grounds for condemning these disparities even when they appear not to result from injustices?⁴⁸ And is there any reason for singling out disparities in health among the myriad effects of greater poverty? Whatever our answer to these questions, what would constitute redress?

16. Inequalities in Health within Countries Inequalities in health within national boundaries are much greater than most people realize, and in many countries they are strongly linked to socioeconomic status. For example, the difference in life expectancies between counties in the United States with the worst poverty and the highest inequality compared with counties with the highest incomes and least inequality is greater than the mortality effects of lung cancer, diabetes, motor vehicle crashes, HIV/AIDS, suicide, and homicide.⁴⁹ For many of us, these inequalities seem to be prima facie evidence of injustice; indeed to constitute ⁴⁶ Larry Temkin, Inequality (Oxford: Oxford University Press, 1993). ⁴⁷ Thomas Pogge, ‘‘Responsibilities for Poverty-Related Ill Health,’’ Ethics & International

Affairs, 16/2 (2002), 71–9. ⁴⁸ Mathias Risse, ‘‘How Does the Global Order Harm the Poor?,’’ Philosophy and Public Affairs, 33 (2005), 349–76. ⁴⁹ C. J. L. Murray et al., U.S. Patterns of Mortality by County and Race: 1965–1994 (Cambridge, MA: Harvard Center for Population and Development Studies, 1998), 1; G. Pappas et al., ‘‘The Increasing Disparity in Mortality between Socioeconomic Groups in the United States, 1960 and 1986,’’ NEJM 329 (1993), 103–9; John W. Lynch, George A. Kaplan, Elsie R. Pamuk, et al., ‘‘Income Inequality and Mortality in Metropolitan Areas of the United States,’’ American Journal of Public Health, 88 (1998), 1074–9.

30 / Wikler and Brock an injustice in themselves. But on what ethical basis does this intuition rest? As with health disparities between countries, we must ask whether all health inequalities within a country are unjust, as much of the health policy literature seems to assume?⁵⁰ Is it unjust, for example, that women outlive men in most countries?⁵¹ When are health inequalities inequities, and why? What patterns of inequality in health are the most objectionable from a moral point of view, and what kinds of changes in the distribution of health states and prospects best resolves them?⁵² Should concern for equity in health focus on inequalities between individuals or between groups, and if the latter which groups?⁵³ Should economists’ measures of income inequality, such as the Gini coefficient or the Atkinson/Kolm measure,⁵⁴ be taken over to the field of health without revision, and if so which is the most germane to ethical concerns?⁵⁵ And what, precisely, is the objectionable feature of health disparities—the gap itself, or the poor health of the worst-off?⁵⁶ Should we give lower priority to health interventions that tend to benefit healthier people, even if they are more cost-effective? How should we try to balance the goals of maximizing and equalizing population health? ⁵⁰ S. Marchand et al., ‘‘Class, Health and Justice,’’ Milbank Quarterly, 76/3 (1998), 449–67, 305–6; Norman Daniels et al., Is Inequality Bad for our Health?, ed. J. Cohen and J. Rogers (Boston: Beacon Press, 2000). ⁵¹ John Kekes, ‘‘A Question for Egalitarians,’’ Ethics 107 (1997), 658–69. ⁵² Yukiko Asada, Health Inequality: Morality and Measurement. ( Toronto: University of Toronto Press, 2007). ⁵³ Christopher Murray et al., ‘‘Health Inequalities and Social Group Differences: What Should We Measure?,’’ Bulletin of the World Health Organization, 77/7 (1999), 537–43; Paula Braveman et al., ‘‘World Health Report 2000: How it Removes Equity from the Agenda for Public Health Monitoring and Policy,’’ BMJ 323 (2001), 678–81; Yukiko Asada et al., ‘‘A Problem with the Individual Approach in the WHO Health Inequality Measurement,’’ International Journal for Equity in Health, 1/2 (2002); Emmanuela Gakidou et al., ‘‘Measuring Total Health Inequality: Adding Individual Variation to Group-Level Differences,’’ International Journal for Equity in Health, 1/3 (2002). ⁵⁴ A. B. Atkinson, ‘‘On the Measurement of Inequality,’’ Journal of Economic Theory, 2 (1970), 244–63. ⁵⁵ Ann Lecluyese et al., ‘‘Making Health Continuous: Implications of Different Methods on the Measurement of Inequality,’’ Health Econ. 15 (2006), 99–104; Allan Low et al., ‘‘Importance of Relative Measures in Policy on Health Inequalities,’’ BMJ 332 (2006), 967–9. ⁵⁶ Sarah Marchand et al., ‘‘Health Inequalities and Justice’’ in Cross-Cultural Perspectives on the (Im)possibility of Global Bioethics, ed. Julia Tao (Dordrecht: Kluwer Academic Publishers, 2002).

Population-Level Bioethics: A New Agenda / 31

17. Social Determinants of Population Health A burgeoning body of research in recent decades has demonstrated the profound impact on population health and health inequalities of social conditions such as education and literacy, socio-economic inequality, social control and supports, and a wide array of social policies concerning transportation, housing, unemployment, and so forth.⁵⁷ Indeed, together with the effects of traditional public health measures such as clean water supplies and immunization programs, these have greater impacts on health and health inequalities than does health care and inequalities in access to health care. Traditional philosophical work in theories of justice has addressed these social determinants without adequate recognition of their impact on health. To what extent—if at all—must theories of justice that address non-health domains be revised in light of our new understanding of how these domains affect health? And if they should be revised, how should they be revised? What weight should be given to the differential health impacts of social policy in such fields as education, transportation, and housing? Should we seek to require health impact assessments of policies in these domains, similar to the environmental impact assessments now often required?⁵⁸

18. Practice Implications of a Population Perspective Geoffrey Rose, the British epidemiologist, contrasted the ‘‘medical’’ and ‘‘population’’ approaches to hypertension and other risk factors that are major determinants of population health.⁵⁹ The medical strategy is to identify the high-risk individuals and treat them so as to head off their impending health problems. The population approach instead seeks to reduce the risks of the population as a whole, usually by non-individual and non-medical interventions. For example, while the medical approach would provide drugs for hypertension to the worst cases, the population approach ⁵⁷ Michael Marmot, The Status Syndrome (New York: Henry Holt, 2004). ⁵⁸ Levy et al., ‘‘Incorporating Concepts of Inequality.’’ ⁵⁹ Geoffrey Rose, ‘‘Sick Individuals and Sick Populations,’’ International J Epidemiology, 14

(1985), 32.

32 / Wikler and Brock would work toward a reduction in the salt content of processed foods, lowering everyone’s risk and thereby the number of deaths attributable to hypertension. While these approaches might be complementary, they have not received equal emphasis or funding. Should the choice between them be based on cost-effectiveness grounds, or are there other moral issues at stake? Is the medical approach more respectful of individual choice by leaving individuals free to determine what responses to risk factors for disease are appropriate for them? Or is the population approach more equitable in that it benefits even those who are not aware of their health needs or who are unable to seek care? Does the population approach impose an intervention on some members of the population who may not be significantly at risk, and if so is this an important objection to them? Does the population approach distribute its benefits more equitably by seeking to reduce the risk factor equally for all? Which is more likely to contribute to the ‘‘medicalization’’ of everyday life; and why should we be concerned if it does? What considerations should determine the relative emphasis given to the medical and population approaches for specific health risks?

19. Research Ethics and Social Justice Developing countries offer advantages to scientists and pharmaceutical firms seeking test sites for new drugs and therapies.⁶⁰ Participants’ bodies in these countries are less likely to be carrying other drugs that could confuse outcomes of trials. Higher incidence of many diseases places an adequate supply of potential participants at the hospital door so that trials can get underway quickly. Costs are often lower and regulation less strict. These advantages for sponsors and scientists, however, reflect vulnerabilities in the host population. What moral rules should govern the contract between scientists (and their sponsors) and participants in these developing-country experiments?⁶¹ Is it permissible to test products that offer little or no medical ⁶⁰ Sonia Shah, BodyHunters: Testing New Drugs on the World’s Poorest Patients (New York: New Press, 2006). ⁶¹ Dan Brock et al., ‘‘Ethical Issues in Resource Allocation, Research, and New Product Development,’’ in Disease Control Priorities in Developing Countries, ed. Dean Jamison et al., 2nd edn (Oxford: Oxford University Press, 2006).

Population-Level Bioethics: A New Agenda / 33 benefit to the local population, such as a malaria vaccination offering tourists a few days’ immunity? Can other benefits such as strengthening the health care infrastructure compensate for a lack of medical benefit? What should be the standard of care offered to participants, including those serving as controls? In particular, when other treatments have been proven effective should controls be given those treatments even when they are not available or affordable in the local setting, or may placebo controls or less than the best treatments be used? How should participants in trials in developing countries be fairly selected? Does the sponsor owe the participants or the broader community in which the trial takes place access to treatments proven effective in these trials, and if so for how long? Do they owe anything further to the community? Who would be the loser if stringent requirements along these lines were imposed and the developing-country sites became less attractive to sponsors as a result? And is this likely to happen?

20. Health System Reform While health systems have contributed to the remarkable rise in longevity enjoyed throughout the world until the AIDS pandemic, they remain inadequate to the demands placed on them. Lack of money, trained health workers, and management expertise hobble health systems in much of the developing world, even as AIDS and other emerging diseases increase the need for effective treatment. Changes in the structure, financing, and management of health systems might permit these health systems to deliver more, or deliver it more equitably, without increases in state funding, and we live in an era of unprecedented experimentation. But not all changes are improvements, even if they are labeled ‘‘reforms.’’ Are there norms that might guide health system reform so that it becomes (or remains) just? Can we specify procedural requirements on health system reform, such as public participation, transparency, and the availability of grievance procedures?⁶² And should substantive rules be specified as well, such as reducing gender, ⁶² Norman Daniels et al., Benchmarks of Fairness for Health Care Reform (Oxford: Oxford University Press, 1996); Norman Daniels and James Sabin, Setting Limits Fairly: Can We Learn to Share Medical Resources? (Oxford: Oxford University Press, 2002).

34 / Wikler and Brock racial, or ethnic discrimination, or giving special concern for the poor and other vulnerable individuals or groups?⁶³ Which health system reform efforts should be regarded as positive and negative models, respectively? What are the positive and negative effects of various forms of privatization within health care systems taking place around the world today?

21. Conclusion The population-level ethical issues surveyed in this brief account could hardly have greater importance for us as individuals, as citizens of our countries, and as a species. Even after several decades of debate over bioethics, however, debate has barely begun on most of these questions. Why have the ethical questions with the greatest scope and impact been investigated the least? The answer is largely historical. One source for bioethics is the code of conduct of medical professionals; another is the patients’ rights movement of the 1960s and later. Both of these spoke to the experience of individual doctors and patients. Population-level ethical issues in bioethics are usually invisible at this level. There has been a corresponding difference in the receptivity of the professional groups involved. While medical professionals may have opened ethical debates to patients and their advocates only grudgingly at first, these discussions have now transcended professional boundaries and are understood as issues that are of interest to everyone. Economists, demographers, and epidemiologists who work on population health focused on the scientific issues in their work; indeed, as we have pointed out, the pressing ethical questions were often not identified as such. In any case, they were unaccustomed to seeking to engage bioethicists in discussions of the ethical dilemmas they encountered; for one thing, there were very few bioethicists prepared to be engaged. But all this is, or should be, history. The issues are in view. Though still small, a promising literature has been created. Bioethics training programs have, in a few places, begun to incorporate or even emphasize populationlevel issues. And a growing number of scientists, managers, officials, and ⁶³ Johan Machenbach, ‘‘The Development of a Strategy for Tackling Health Inequalities in the Netherlands,’’ International Journal for Equity in Health, 3/11 (October 23, 2004).

Population-Level Bioethics: A New Agenda / 35 others concerned with population health have had useful encounters with these discussions. Some of them may become motivated to becoming ethicists themselves. We reiterate that our aim in this chapter has been to sketch out a research agenda for a population-level bioethics to supplement the traditional focus of clinical bioethics. The latter remains important to each of us in our roles as health professionals, patients, and citizens. But the issues arising at the population level are no less grave, and though their impact on our lives as individuals is often invisible to us, it is often profound. They also help to determine which choices are available to doctors and patients in the clinic. An expansion of the field of bioethics to the population level will illuminate the traditional arena of the field while engaging, after a period of relative neglect, a host of issues of front-rank human importance.

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2 What Is It Like to Be a Bird? Wikler and Brock on the Ethics of Population Health Nir Eyal∗

Suppose that I were a bird: a very special bird, who takes an interest in the ethics of healthcare, and who can see through the walls of healthcare clinics. I could peek at a nearby clinic, perhaps in the Dartmouth Medical School (near which this conference is taking place), and watch, through the wall, healthcare providers treating a single patient. I could raise ethical questions about what I see. Is the doctor mindful enough of the patient’s medical interests? Does the doctor ask the patient’s permission before examining her body? As a bird, I could fly. I would rise in the air, hovering above Hanover rooftops, and look down at people and houses as they grow smaller and smaller. I could now see more than one patient and her medical team, because I would see many clinics and wards, perhaps at other parts of the Medical School or in other places, like the college infirmary. I could also see factors other than treatment that affect these patients’ health, for example, the level of air pollution in town and the degree that inhabitants ∗ I am grateful to Dan Brock, Ezekiel Emanuel, Samia Hurst, Matthew Liao, Dan Wikler, and the conference participants for helpful comments.

38 / Eyal help one another reach the doctor. As I continued to ascend, I might see clinics and hospital rooms, as well as other factors affecting health, in nearby Manchester, Lebanon, and, later, in the state of New Hampshire, or in the country, or in the entire world. (By then, I would have to hover in outer space, like a satellite.) I could now raise ethical questions about these ‘macro’ pictures—about healthcare systems and policy, about the population impact of other determinants of health, about the allocation of resources between different communities. Is it fair that the patients in Hanover enjoy better care than patients in some other American towns? Should we stop testing our drugs on the global poor, who lack alternative treatment? Clearly, the set of ethical questions that I could now raise would somewhat differ from the one that I was able to raise before ascending. For example, it would now make sense to evaluate the distribution of medical resources. The salience of other questions would wane—I might no longer be able to tell whether the doctor asks the patient for permission to intervene in her body. Are the distinct questions that I could raise only now, from my new vantage point, important too? Should bioethics that traditionally focused mainly on the ethical treatment of an individual patient pay attention to these questions as well? Dan Wikler and Dan Brock argue forcibly that the bird’s-eye view is important and that bioethics must take that viewpoint more often. Succinctly and suggestively, they set forth a rich research agenda for an expanding field—the ethics of population health—which judges the promotion of health from a macroscopic angle. The questions that Wikler and Brock encourage us to explore are impressively well-crafted. Many connect with particularly disturbing aspects of the grim global order that we presently tolerate. My response will seek, first, to characterize further what it is that distinguishes population health ethics from clinical bioethics. I shall also ask whether research into the ethics of population health, undoubtedly an important field, is as important as Wikler and Brock make it out to be.

1. What is Population Health Ethics? When exactly should we say of a bioethical question that it is ‘populationlevel’? Up until now I used the vivid bird metaphor, and buzz words like

The Ethics of Population Health / 39 ‘macroscopic.’ I haven’t given you a definition of population health ethics or examined whether that notion is adequately clear. We can list fields that fall under population health, reserving ‘population health ethics’ for all and only ethical questions in and about these fields. For example, many people use the term ‘population health’ for everything in the practice and policy of healthcare except medicine—namely, for public health and for the use of non-medical determinants of health to promote health.¹ For Wikler and Brock, population-level bioethics includes among other things issues that arise in emergency situations in the third world and a host of questions about priority-setting. But does the term ‘population health’ cover all these fields because they share a distinguishing feature, or just as an arbitrary umbrella concept? If the ethics of population health is to be a fruitfully demarcated field, not a somewhat random collection of subfields, then we should be able to identify a denominator common to all and only questions in population health ethics. That common denominator will mark these questions out from questions in traditional, clinical bioethics. Wikler and Brock do not specify that common denominator explicitly, but some ideas can be gleaned from their argument. One idea is that, unlike traditional bioethics, population-level bioethics does not arise in relation to individual patients. Questions in that field arise only once we look at populations. Another important idea is that population-level bioethics does not focus on relationships, or on the doctor–patient relationship. Let me say a few words on each of these ideas. Population Health, Not Individual Health Whereas old-school bioethics questions arise in relation to an individual patient, population-level bioethics ‘looks at populations . . . The focus of population-level bioethics is broader than bioethics at the clinical level [among other things] for its concern with groups.’² In a nutshell, populationlevel bioethics investigates ‘issues arising at the population level.’³ ¹ See e.g. Dan Callahan, ‘‘Ends and Means: The Goals of Health Care,’’ in Ethical Dimensions of Health Policy, ed. M. Danis, C. Clancy, and L. R. Churchill (Oxford: Oxford University Press, 2002), 6. ² Dan Wikler and Dan Brock, ‘‘Population-Level Bioethics: Mapping a New Agenda,’’ pp. 16 above. ³ Ibid.

40 / Eyal Now, that a single patient has an army of doctors clearly does not make her treatment into population health. The ‘population’ in question is one of patients, not of healthcare professionals. Population health ethics concerns ethical questions that arise when there is more than one patient, or perhaps many patients, or perhaps a ‘group’—a community or many communities of patients. We might say: If Friday were Robinson Crusoe’s doctor, questions of traditional bioethics could arise, but not questions of population-level bioethics. A single patient does not constitute a population. A definition along these lines would clarify why questions about the allocation of health resources among patients take center stage in population health ethics and, appropriately, in Wikler and Brock’s chapter. You cannot allocate resources among a single patient. It makes no sense to puzzle about the relevance of cost–benefit ratios, personal responsibility, and social responsibility for Robinson Crusoe’s just share of treatment, if Crusoe is the only patient. Questions of the legitimacy of aggregating over individuals and of sacrificing one individual’s health or personal liberty to save many others do not arise. Nor do issues of setting priorities arise among regions, among birth cohorts, and in situations of genocide. Such ‘questions’ are nonsensical absent a population. Other questions that the authors discuss could in principle arise in the context of caring for an individual patient: ‘measuring the overall health of an individual’ is not a contradiction in terms. If I used to be anorexic and now I am obese, it is possible in principle to wonder whether I am now healthier or less healthy than I used to be. However, health measurement questions are typically interesting only in relation to populations, where they help us set priorities among individuals; in that weaker sense they also ‘arise’ only at the population level. Such a definition of the ethics of population health, which emphasizes the difference between individuals and populations, is attractive, but it suffers from two problems. First, our judgments on whether a set of patients constitutes a ‘population’ change between contexts; they often depend on our prior judgments on whether the relevant issue falls under population health and its ethics. Consider for example whether two patients constitute a patient ‘population,’ or whether more are required—many, say, or an entire ‘group.’ The disclosure of a patient’s secrets to another logically requires the existence of two patients, and yet, questions about confidentiality are not questions in population-level bioethics. They are paradigm doctor–patient

The Ethics of Population Health / 41 relationship questions—suggesting that a population of only two remains for our purposes a contradiction in terms. Similarly, organ transplantation requires only two patients—a donor and a recipient; my intuition is that, for that reason, the following view, by Leon Kass, does not fall under population-level bioethics. Kass warns us about ‘presumptions and repugnances against treating the human body in the ways that are required for organ transplantation, which really is—once we strip away the trappings of the sterile operating rooms and their astonishing technologies—simply a noble form of cannibalism.’⁴ In contrast, views on the just allocation of organs among many patients come under population-level bioethics, seemingly because a patient population requires many patients. But at other times, the intuition is that a patient ‘population’ does not require great numbers or an entire social group. A doctor who wonders if morally she should forbid a sick patient to sleep at the patient’s remote home, out of concern that the patient might infect the patient’s spouse, is asking herself a question in population health ethics; and yet, the doctor’s concern may be for only two potential patients—the currently sick patient, and the spouse—and not for many patients. A health minister who wonders how ethically to allocate a health resource among patients comprising parts of two unrelated social groups is also raising a question in population health ethics, although this set of patients does not comprise any entire social group. In short, our notion of ‘population’ changes across contexts; our use of that notion seems sensitive to independent judgments that a question falls under ‘population health.’ Thus, in the infection example, the reason that the doctor’s question falls under population health ethics seems to be the similarity between that question and classical questions in public health policy. Any judgment that the question involves a ‘population’ would be derivative. There is a second reason why the inclusion of an issue within population health ethics cannot depend simply on whether the issue arises at the population level. The reason is that traditional, clinical bioethics issues arise at the population level as well. For every question about the doctor–patient relationship, you can raise that question regarding many pairs of doctor and patient. You can raise it regarding the entire population of patients. ⁴ Leon R. Kass, ‘‘Organs for Sale? Propriety, Property, and the Price of Progress,’’ Public Interest, 107 (1992), 73.

42 / Eyal Furthermore, the answer to many of these traditional questions depends in part on the impact of that answer on entire patient populations. For example, part of the reason that we tell doctors to ask each of their patients for permission prior to intervening in the patient’s body is that we are mindful of the need to maintain the trust of other patients in the medical system. These other patients might be reluctant to visit doctors if that might involve coercive treatment. On the other hand, the consumerist social culture that an excessive emphasis on choice and consent may potentially propagate would count against such emphasis. In other words, when we devise patient-level norms like the requirement of informed consent, we consider the population effects. In this sense, many non-population-level issues arise at the population level. These two reasons make it problematic to define population health ethics as the set of issues that arise at the population level. People, Not Relationships Wikler and Brock distinguish between ‘[e]thical issues arising at the population level’ and ‘ethical issues arising in the relationships and interactions of individual patients and their physicians, as well as individual investigators and their research subjects.’⁵ Could population health ethics stand out by being relatively unconcerned with relationship issues? The suggestion is that population-level bioethics focuses directly on people. What matters, from the viewpoint of that ethics, is who enjoys which benefits and harms, not the relation in virtue of which she acquired these benefits and harms—unless, of course, the nature of that relation in itself constitutes or generates an important benefit or harm. We mind who receives the surgical operation, and who benefits from exercising her autonomy in the process; we do not directly mind whose doctor is relating to her patient appropriately. The relation matters only insofar as it affects the allocation of operations, the exercise of autonomy, and so forth.⁶ This new suggestion notwithstanding, population-level bioethics can focus directly on relationships. Argumentation in the field invoke the ⁵ p. 15 above; My italics. ⁶ In correspondence, Matthew Liao made an interesting related suggestion: ‘‘Could

[H. L. A.] Hart’s distinction between general duties and special duties be used to encapsulate the difference between population-level bioethics and clinical bioethics?’’

The Ethics of Population Health / 43 propriety or impropriety of certain relationships. For example, some argue that a fully free market would be bad, or, alternatively, that racial discrimination in the allocation of care would be bad because each of these policies would interfere with proper relationships: with citizens’ relating to one another as free and equal, or with the elected representative’s relating to all with equal concern and respect. Whether or not we find such theories convincing, they are indeed theories in bioethics at the population level. As a new strain of bioethics, the absence of a focus on relationships cannot be its defining character. Another interpretation of Wikler and Brock’s remark is that populationlevel bioethics stands apart from standard bioethics by not focusing on the determinate relationship between doctor and patient (or the determinate relationship between investigator and research subject). Population health bioethics focuses instead on other relationships—such as the one between free and equal citizens—or on pertinent factors that are not relationships. But what would that mean? It could mean simply that the ethics of population health focuses on questions that arise only outside the doctor–patient relationship. But I wish to explore a more intriguing possibility: that population health ethics stands out at least in part by not saddling these questions to methods and to answers that would have been suitable for the doctor–patient relationship, but which often fail for populations. In other words, population-level bioethics is founded on the conviction that populations require distinct and potentially different methods and answers. To briefly elaborate this idea, think about a highly ethical doctor, one whose habits and attitudes are, perhaps in virtue of their typical outcomes, desirable in a doctor. More often than most of us, such a doctor feels impelled to assist people who are in medical need: such impulsive response is beneficial in a doctor. She also seldom questions very hard the moral eligibility of people in need for treatment. She tends to overlook the potential inefficiency of helping these people, instead of spending one’s time on seeking others in greater need and on preventing disease in still others. More often than not, such habits and attitudes facilitate acting as morally doctors should. They also incline the ethical doctor to favor treatment over priority-setting, over the identification of others who are not among their patients then and there and who need treatment, and over the prevention of disease. Despite being welcome in doctors, being so inclined is not always a blessing in other decision-makers who affect health—those who set health policy and whose

44 / Eyal mandate can reach further than the protection of several patients’ health. There, such inclinations can yield systematically harmful and morally wrong decisions. For example, health ministers should not play down the plight of potential future patients just because currently no one is in a therapeutic relation with them or because they have not yet contracted disease. Too often, bioethicists examine questions that arise outside the doctor’s clinic as if they arose inside one. The notorious ‘therapeutic fallacy,’ bioethicists’ and doctors’ confusion of medical research with therapy, is just the tip of the iceberg. What we may call the ‘broad therapeutic fallacy’ affects writing on health policy in general.⁷ For example, consider the bioethics community’s by and large polemic and belligerent, as opposed to constructive and creative, response to the fear that generic drugs might stifle incentives for future medical research; the attack on considering the possibility that focus on expensive treatment for HIV/AIDS may thwart the provision of cheap prevention to many in the Third World; the somewhat overblown concern at the prospect that different countries’ already different standards of care would generate different standards for the conduct of medical research. Such responses would have been fully appropriate if the suggestions concerned a doctor’s practice. An ethical doctor never denies a patient drugs in order to motivate future research; she never neglects one of her patients in order to prevent others from catching disease; and she does not have different standards for different patients. Whether these suggestions have a place in macro decision-making remains a far more complex question. Certainly creative solutions to related debacles are worth considering and should not be treated as sacrilege. The bird’s-eye view could potentially free us from the broad therapeutic fallacy—from the parochial bias inherent in thinking about everything from a present patient’s bedside. ⁷ Furthermore, it is tempting to project individual level bioethics principles onto the population level—to seek equivalents to nonpaternalism, to no-harm, to beneficence, and so forth. But often there is no equivalent, or the criteria are not the same. For example, some of the interpersonal norms arise because the recipient is a person. That cannot arise at the population level. Populations clearly are not persons (even if they are political agents). Thus, paternalistic treatment strikes many as problematic because it violates a norm related to respect for autonomous persons (but see my objections, in Nir Eyal, ‘‘Informed Consent and ‘Respect for Autonomy’ ’’ (in progress)). That central argument against paternalism may not apply on the population level, where the relevant norms may be very different.

The Ethics of Population Health / 45 Wikler and Brock encourage population-level bioethicists to consider (not necessarily to accept) policies that individual doctors clearly should not consider in their private practices: priority to necessary health workers and to AIDS patients who are cheap to reach in access to health resources; interning AIDS patients in geographically insulated societies, and so forth. Evidently, the authors are less prone to the broad therapeutic fallacy than many others are. Elsewhere, one of the authors expressly suggests that the ethical standards that are suitable for medicine need not suit health policy.⁸ This raises an interesting possibility: for the authors, population health ethics may stand out not, or not only, by the questions it asks, but also by rejecting a certain method for answering these questions, and thus by espousing potentially different answers. The proper method is not knee-jerk projection of the answer that would have been correct if the question concerned a medical practitioner at work. If this is right, then population health ethics stands out for the authors not solely by the nature of its object, but also by the distant perspective that it is willing sometimes to take towards that object. Thus understood, population health ethics is not so much a field of research as a view within, or a methodological approach to, that field. By analogy, analytic philosophy differs from continental philosophy not primarily by asking different questions but by using different methods to answer these questions.⁹ (If population-level bioethics is indeed a view or a method, then we may distinguish between extreme and moderate stripes of that ethics. Extremists hold that, when dealing with patient populations, we must always take the bird’s-eye view. Moderates hold that we must take the bird’s-eye view only sometimes. The moderates may add that tendencies that are clearly desirable in doctors and not clearly in health policy decision-makers remain desirable in such decision-makers as well on occasion. For example, a strong desire to deliver healing and palliation to suffering people without too many qualms ⁸ Dan W. Brock, ‘‘Separate Spheres and Indirect Benefits,’’ Cost-Effectiveness and Resource Allocation, 1 (2003), 4; Dan Brock, ‘‘Ethical Issues in Health Care: Resource Prioritization and Rationing.’’ Presented at the VI Annual Symposium on Biomedicine, Ethics and Society, Sandhamn, Sweden. ⁹ Alternatively, population health ethics could be both a field and a school. It raises distinctive questions and it uses distinctive methods. By analogy, primary care doctors engage in tasks other than surgery and, arguably, primary care doctors consider surgery an appropriate method less often than surgeons do.

46 / Eyal and calculations, regardless even of numbers; and a poignant and active memory of the humanity and separateness of the suffering must sometimes feature in health policy decision-making.¹⁰) To recap what I have said so far, latent in Wikler and Brock’s chapter are several slightly different characterizations of population health ethics, of which I emphasized two. One is that population health ethics deals with populations and not individuals. Another is that it deals with populations not as if they were individuals. I mentioned some problems affecting the first characterization. I leave open the question whether the second characterization accurately captures the notion of population health ethics. It’d better capture it, or there may be no such thing as the ethics of population health—just a collection of different things gathered under one suggestive title.

2. Why Are Ethical Questions in Population Health Important? Why investigate population-level bioethics? Is further inquiry in that field especially urgent? Wikler and Brock mention the traditional neglect ¹⁰ A memorable scene in Carol Reed’s cinematic masterpiece The Third Man, based on Graham Greene’s novel and screenplay, reminds us that a bird’s-eye view can occasionally be utterly inappropriate, even outside a clinical context. Holly Martins (played by Joseph Cotton) confronts his old school friend Harry Lime (Orson Welles), who sells diluted penicillin in post-war Vienna’s black market, knowing full well that the diluted drug causes the painful death of sick children. The two old friends board a giant wheel together, and Martins bitterly inquires whether his friend ever saw any of the victims. In response, Lime points through the window of the wheel cabin at the people moving like black flies at the base of the wheel, and says: ‘‘Would you really feel any pity if one of those dots stopped moving for ever? If I said you can have twenty thousand pounds for every dot that stops, would you really, old man, tell me to keep my money—or would you calculate how many dots you could afford to spare? Free of income tax, old man. Free of income tax.’’—Graham Greene, The Third Man (London: Lorrimer, 1989), 97. At the same time, I wish to emphasize, the ‘broad therapeutic fallacy’ remains a fallacy. The bird’s-eye view is often inescapable. Distant observers regularly notice pertinent aspects that nearby observers miss. In Machiavelli’s words, ‘those who paint landscapes place themselves in a low position on the plain in order to consider the nature of the mountains and the heights, and place themselves high on top of mountains in order to study the plains’—Nicol`o Machiavelli, The Prince, trans. and ed. P. Bondanella (Oxford: Oxford University Press, 2005), 5–6.

The Ethics of Population Health / 47 by bioethicists of population-level questions. But not everything that bioethicists haven’t explored is worth exploring. For example, we do not urgently require an ethics of the proper relationships among patients. Why is research urgent in the case of population-level bioethics? Some statements by Wikler and Brock suggest possible answers. First, the authors oppose traditional bioethics questions to ones in population health ethics, which are ‘the ethical questions with the greatest scope and impact.’¹¹ That may suggest that population health ethics questions have greater impact on our lives: their scopes encompass entire populations, and thus merit special attention. However, it is simply untrue that a ‘macro’ question about a patient population necessarily affects more patients than a ‘micro’ question concerning the doctor–patient relationship. A ‘micro’ question may apply in many micro contexts—all doctor–patient relationships, for example—and it may affect more lives. Consider, for example, the extensive and profound impact that micro-level reforms surrounding informed consent and end-of-life care have had on American society in recent decades.¹² Second, Wikler and Brock emphasize the importance of the social determinants of health, which, coupled with traditional public health interventions, affect health more than medicine does. For them, the social determinants come under population health.¹³ This may explain why in their views population health and its ethics are more important than medicine and its ethics. But some questions in population health do not pertain to the social determinants of health—for instance, questions regarding the distribution of medicine. Moreover, questions about the social determinants of health arise at the level of the individual patient as well, even if doctors and bioethicists often overlook these questions at that level. A doctor can in principle advise a patient to move out of a polluted neighborhood, out of a bad ¹¹ p. 34 above. ¹² I thank Zeke Emanuel for pointing my attention to recent end-of-life treatment

reforms. ¹³ ‘The bird’s-eye perspective of this population-level bioethics includes consideration not only of health care but of other social determinants of health, including socio-economic standing, environmental and working conditions, and social exclusion. Its subject therefore is health rather than health care alone, insofar as health can be affected by conditions and interventions in any of these domains’ (p. 15 above. See also p. 31).

48 / Eyal personal relationship, or out of a job that denies employees a sense of control over their work, precisely because these social determinants may affect the patient’s health. This possibility raises distinct ethical questions—for example, whether the doctor should give such advice. These ethical questions would arise at the level of the individual patient and they would pertain to the social determinants of health.¹⁴ A third and final aspect that, the authors may assume, gives populationlevel bioethics special importance is its link to issues of truly momentous gravity: population-level bioethics is broader than bioethics at the clinical level. . . in that it is extended in both space and time. It extends naturally to a global focus . . . The leasthealthy populations, most of which are in developing countries, become especially prominent from this perspective; for them, the stakes are highest and the ethical dilemmas most severe. Population-level bioethics is also extended temporally, taking into account the consequences of present day events that affect the health of future generations.¹⁵

Indeed, morally the most important feature of the choices that we make today is probably their impact on the world’s poorest people, and on environmental conditions that may blight the lives of future generations. Wikler and Brock may consider population health ethics especially important because it relates to these especially important matters. ¹⁴ I want to counter two potential replies. First, the very fact that social determinants are ‘social’ does not mean that they arise only at a population (‘social’) level: in relation to population health, ‘social determinants of health’ is simply shorthand for ‘social, behavioral, environmental, and [sometimes even] genetic determinants of health.’ They include climate conditions, genes, and other non-social factors. Even those determinates of health that are strictly speaking social are ‘social’ in an irrelevant sense. Pollution and poverty are admittedly the indirect outcomes of social choice, but they are not the outcomes of a patient population’s choice. Second, some definitions admittedly subsume the social determinants of health within population health as a definitional matter. They simply define population health as the combination of the social determinants and public health. If such definitions were satisfactory, then questions about the social determinants of health would always fall under population health. However, we seek a substantial denominator common to all components of population health ethics, and we reject a sheer ‘umbrella’ definition. Moreover, even on these definitions, many issues in population health do not pertain to the social determinants of health; the importance of the latter does not lend importance to all these issues. ¹⁵ p. 16 above.

The Ethics of Population Health / 49 But some questions in population health ethics are unrelated to global poverty or to future generations. For example, the question whether local public health measures to counter obesity are legitimate falls under population-level bioethics; that question does not address these important global and future concerns. More fundamentally, I am not sure how population-level bioethics ‘extends naturally’ in space and time to cover global and future concerns in the fashion that the authors suggest that it does. Statements of the form ‘A extends naturally to cover B’ always display the following tension. If A by definition covers B, why is the extension needed? If it doesn’t cover it, how is the extension natural? In our context, if population health ethics covers distant and future others by definition, where is the extension? If it doesn’t, how does the population perspective lead us, finally, to take these people seriously? The chapter reads as if ascension above local realities will typically do just that—perhaps by weakening the partial and parochial focus on contemporary, American patients. The authors may hope that, from the bird’s-eye view, we shall see everyone—including the victims of genocide, poverty, and future climate volatility. That hope seems overly optimistic. A macroscopic view need not expand continuously until the entire population of the planet, present and future, become visible. If I were a bird, it would remain open to me to stop my ascension just above New Hampshire, where the macro picture would not include Third World patients. I need not reach satellites or traverse continents. It would also remain open to me to stop my ascension where my national ties become especially vivid to me. Stopping there could actually detract my attention from the plights of distant non-nationals. It might seem as if, while a macroscopic view does not force me to pay attention to distant others, a strict microscopic view would force me not to give them attention. But I fail to see how it would. Distant doctors and distant patients maintain doctor–patient relationships, and normative doctor–patient relationship questions may arise concerning their relationships. In particular, Wikler and Brock point out that patients who flee attempted genocide or a natural disaster ‘may be even more sensitive than usual about lapses of confidentiality about sensitive medical information.’ To my mind, confidentiality remains in such ‘distant emergency’ situations an ‘ethical issue . . . arising in the relationships and interactions of individual patients

50 / Eyal and their physicians.’ That the situation involves a ‘distant emergency’ does not change that simple fact. It does not magically transform confidentiality into a population-level issue. In a similar vein, the authors admirably suggest that ‘The least-healthy populations, most of which are in developing countries’ must be prominent in population-level bioethics. But in my view the individuals that make up these populations must similarly take center-stage in clinical-level bioethics. The priority of these individuals does not lend priority to population-level bioethics.¹⁶ There is a further reason why the undeniable moral priority of the global poor and of future generations does not impart similar priority on academic inquiry in population-level bioethics. Population health is very important, and achieving an ethical population health policy is very important; resolving open questions in the ethics of population health policy is typically less important. For instance, treating genocide victims is extremely important; but resolving the open ethical dilemmas surrounding treatment for genocide perpetrators, as Wikler and Brock invite us to do,¹⁷ is not nearly as important. I am not saying that the question lacks importance. On the contrary, the question whether genocide perpetrators partly forfeit their rights to healthcare is deep and it has theoretical import. If they do, then the right to healthcare is partly alienable, and health is less ‘special’ than some take it to be. But by far our most urgent task in relation to genocides remains pragmatic: convincing our fellow citizens and our politicians to send plenty of doctors and equipment to genocide zones, and to create and strengthen international institutions that could minimize future genocides. Of course, important and unresolved questions concerning global poverty and the future of the planet do exist: how not to deny poor people the drugs that they need whilst motivating research to improve these drugs? How to reform our economic and industrial world order so as to reduce carbon dioxide emissions? But these questions are essentially pragmatic: economic, political, legal, medical—not primarily ethical. To resolve these open questions we need ethically minded economists, political scientists, ¹⁶ p. 16 Similarly, our societies are aging, and that lends urgency to population-level questions about the allocation of health resources among birth cohorts and among age groups. But societal aging also lends urgency to individual patient-level questions in the ethical practice of gerontology. ¹⁷ p. 24 above.

The Ethics of Population Health / 51 medical investigators, and other experts. To implement the policies that these experts prescribe we require ethically minded doctors, politicians, lobbyists, activists, and donors. We do not as much require ethicists. Our specialty as ethicists is to expose fine-grained intuitions and, with intellectual acrobatics, to derive highly surprising normative conclusions. The iniquity of the existing global order stares at the face of any decent observer.¹⁸ In short, great numbers of patients, the impact of the social determinants of health, and the extreme suffering of distant poor and future victims of climate volatility are important. But their importance does not demonstrate that inquiry into population-level bioethics is important. Some of these issues do not come under population-level bioethics, properly defined; some should have been canvassed by traditional, clinical bioethics; and some are important in ways that do not make ethical inquiry into these issues important. I do not wish to deny that population-level bioethics is particularly important. In my view, it typically is. For the time being, however, we have not encountered a systematic argument to the effect that it is.

Conclusion Wikler and Brock suggest an intriguing research agenda, and they present it with verve, ingenuity, and clarity. We need to continue to define the ¹⁸ As I was making this point during our panel, Dan Wikler, sitting on my left, emailed me his excellent ‘Why Prioritize When There Isn’t Enough Money?’, Cost Effectiveness and Resource Allocation, 1/1 (2003), 5. That important single-page paper advances ‘‘a number of justifications for efforts to improve priority setting in the face of severe [sic] shortages of resources, including the following three defenses: prioritization is needed if we are to know that prioritization is insufficient; prioritization is most important when there is little money; prioritization can itself increase resources.’’ Wikler’s startling arguments are by and large convincing. But they scarcely demonstrate the need for ethicists in the relevant prioritysetting process. They primarily demonstrate the need for ethically-minded (well-meaning, trustworthy, impartial) health policymakers in conditions of extreme scarcity. Ethicallyminded decision-makers may placate donors’ concerned about corruption and inefficiency, leading to an increase in the resources available for global health. It is also possible that the presence of ethically-driven economics and public health luminaries (or even plain old celebrities) in international bodies that facilitate the work of such decision-makers will help to increase contributions. It is far less clear to me that the presence of astute ethicists will ease donors’ concerns.

52 / Eyal new agenda, which they delineate only in broad strokes. We also need fully valid argumentation for the special importance of that agenda. If I were an ethically inquisitive bird, and if I wanted to pursue that research agenda into population-level bioethics, would I know precisely what I must look at? Would I know precisely why it is urgent that I look at it?

3 The Evolving Norms of Medical Ethics Ezekiel J. Emanuel

Medical ethics is coeval with the development of medical practice. In ancient Greece, as medicine was developing and schools of practice were evolving, it became necessary to develop codes of medical ethics. The sheer existence of the Hippocratic Oath attests to the inherent need for guidance on ethical issues in medical practice. Many of the issues addressed in the Hippocratic Oath, such as confidentiality, avoiding sex with patients, euthanasia, and abortion, are issues for medical practitioners today. Seeing a vulnerable person laid low by illness, examining his or her naked body, hearing sensitive information, and so on require that ethical norms be defined. These issues are timeless, they are inherent in medical practice. For the first 2,000 or so years of medical practice, medical ethics was governed by a physician paradigm. Medical ethics was established by physicians. This was relatively unproblematic when medical practice was a small industry, with little effect on outcomes, and there was widespread social consensus. After World War II, as medical practice began consuming an ever larger share of social resources, as the issues began to have wider social impact, and as consensus on more general ethical matters began to diminish, challenges to the physician paradigm arose. While it is a bit overly simplistic, it could be said that each decade since World War II has witnessed a new paradigm for medical ethics (see Table 3.1). Since about 1990, there has been

54 / Emanuel Table 3.1. Paradigms of medical ethics Dates

Authorities

Principles or Values

Before 1950

Physicians

1950s 1960s

Religious leaders Physicians

1970s

Philosophers

Legal Paradigm

1980s

Free for All

After 1990

Courts and legislatures Anyone and everyone

Beneficence as determined by the physician Religiously determined precepts Beneficence as determined by the physician 4 Principles: Autonomy, Beneficence, Nonmaleficence, Justice Self-determination

Physician Paradigm I Religious Paradigm Physician Paradigm II Philosophical Paradigm

Plurality of values with no hierarchy

what might be called a ‘‘free for all’’ without a reigning paradigm of medical ethics. This reflects a plurality of values with no clear social consensus on the best way to interpret, specify, and make them cohere. This has important implications for how we address bioethical issues today.

A Caveat on Paradigms The historical paradigms I am characterizing are not to be thought of as Kuhnian paradigms.¹ They tend not to be characterized by radical, instantaneous paradigm shifts. The transition between paradigms evolved over time, usually due to a crisis or focus on particular issues that forced a re-examination of the existing norms and processes of securing resolution. The ideas that evolve and are subsequently espoused have antecedents in the prior paradigm. Furthermore, the dominant ideas and values of a prior paradigm often remain operative and influential in subsequent paradigms. Indeed, distinct paradigms can coexist and it might be argued that none of the paradigms has been entirely supplanted. Finally, the dates are given as ¹ Thomas Kuhn, The Structure of Scientific Revolutions (Chicago: University of Chicago Press, 1962).

The Evolving Norms of Medical Ethics / 55 decades. Obviously, this is a heuristic device that exaggerates the demarcation between paradigms. History doesn’t change because we pass artificial markers of centuries and decades. Nevertheless, while precise dates cannot be given for each period, there are important changes between periods symbolized and encapsulated in the dominant paradigms formed by who establishes the norms, and what values are dominant.

Physician Paradigm I From ancient Greece to the 1950s or so, medical ethics was defined by physicians. According to Edelstein, the Hippocratic Oath was probably a dissident document in ancient Greece written by Pythagoreans to delineate their core beliefs about medical practice.² For a variety of reasons, the ideas contained in the Hippocratic Oath became dominant in the Western tradition with the rise of Christianity.³ For centuries it guided physician practices. At the end of the eighteenth century, Percival’s code of professional conduct, Medical Ethics; or, A Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons, became the articulation of medical ethics.⁴ It followed in the tradition of the Hippocratic Oath—a document by physicians to define appropriate medical ethical practices. A well-respected physician at the Manchester Infirmary, Percival was called upon to write a code of conduct to resolve disagreements between physicians and surgeons over who should care for patients with typhoid fever. This long code became widely influential. ‘‘At the first official meeting of the American Medical Association at Philadelphia in 1847, the two principal items of business were the establishment of a code of ethics and the creation of minimum requirements for medical education and training. . . . [I]t is clear the AMA’s first adopted Code of Ethics was based on Percival’s Code.’’⁵ The AMA Code was ² Ludwig Edelstein, ‘‘The Professional Ethics of Greek Physicians,’’ Bulletin of the History of Medicine 30 (1956), 392–428. ³ Darrel W. Amundsen, ‘‘The Physician’s Obligation to Prolong Life: An Ethical Duty without Classical Roots.’’ Hastings Center Report 8 (August 1978), 23–30. ⁴ Thomas Percival, Medical Ethics; or, A Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and Surgeons (London: S. Russell, 1803). ⁵ Council on Ethical and Judicial Affairs, Code of Medical Ethics: Current Opinions with Annotations 1998–1999 Edition (Chicago: American Medical Association, 1998), pp. x–xi.

56 / Emanuel revised multiple times, most importantly in 1957 when ten general medical ethical principles were articulated. While the AMA Code was part of a battle against non-traditional physicians, especially homeopaths, it also provided an articulation of the obligations of the physician by the physicians’ professional organization. Physicians continued to articulate medical ethics norms. One of the most influential was an article by Austin Flint, a prominent New York physician and president of the AMA, ‘‘Medical Ethics and Etiquette.’’ Flint stated that medical ethics ‘‘have more weight. Medical etiquette, on the other hand, consists of the forms to be observed in professional intercourse. These are conventional. They have not the binding force of ethical rules.’’⁶ In 1948 the World Medical Association adopted the Declaration of Geneva which again articulates a clear medical ethic in the Hippocratic Tradition: ‘‘The health of my patient will be my first consideration.’’⁷ Thus for over two millennia, from the birth of medical practice, physicians were defining the ethical norms governing medical practice. Veatch has argued that the core belief of the Hippocratic tradition is the idea that the physician’s relationship is with the particular patient and that advancing the individual patient’s well-being is the physician’s overriding obligation. We can add a third core belief, namely that it was the physician who assumed responsibility for defining what constituted the patient’s well-being. The focus of this paradigm was the medical ethical issues that arise in the physician–patient relationship. These are timeless issues that are inherent in the care of a sick, vulnerable, naked person—confidentiality, truth telling, consent, avoiding sex, and other forms of use.⁸ Importantly, this physician paradigm was reinforced by the paradigm in research ethics at the same time. Before World War II, indeed until the 1960s, the dominant model of research ethics was one in which physicianresearchers determined the norms of research and were responsible for protecting the interests of participants. That this frequently failed, and led ⁶ Austin Flint, ‘‘Medical Ethics and Etiquette: Commentaries on the National Code of Ethics,’’ New York Medical Journal, 37 (March 17, 1883), 285–90. ⁷ World Medical Association, Declaration of Helsinki, available at . ⁸ Leon Kass. ‘‘Is there a Medical Ethic?: The Hippocratic Oath and the Source of Ethical Medicine,’’ in Toward a More Natural Science (New York: Free Press, 1985), ch. 9.

The Evolving Norms of Medical Ethics / 57 to scandal, does not deny that this was the dominant paradigm of research ethics for many decades. While dominant, this physician paradigm characterized by the Hippocratic tradition interacted with other sources of ethical norms. For instance, in 1767 there was the first informed consent case in English law, Slater v. Baker & Stapleton.⁹ This might suggests it was not just physicians who defined the ethical norms but also courts. Interestingly, in justifying its decision, the court cites the ‘‘usage and law of surgeon,’’ thereby deferring to surgeons to establish the norms by which they are judged.¹⁰ Over the centuries, there were other attempts to wrest control over medical ethics from physicians—some legal, as in the Schloendorff case,¹¹ others popular, as in the anti-vaccination movements. Nevertheless, until the 1950s it is fair to say that the dominant paradigm of medical ethics was the physician paradigm.

Religious Paradigm During the 1950s medicine was becoming much more powerful, especially through technological advances such as widespread use of antibiotics, safer blood transfusions, better surgical interventions, etc. In addition there was the birth of systematic, government funded research through the NIH in the USA and MRC in Britain. These changes spurred the ever escalating attention to and interest in medical ethics that continues today. Obviously religious traditions had long considered medical ethical issues. Maimonides, one of the greatest Jewish theologians, was also a physician and wrote extensively on medical ethics. Religious medical ethics are derived from religious traditions and stand squarely within those traditions. In the 1950s a series of religious leaders begin to focus on medical ethical questions. Thus, the Protestant theologian Joseph Fletcher wrote Morals and Medicine in 1954;¹² Immanuel Jakobovits, who became the Chief Rabbi of Britain, wrote Jewish Medical Ethics in 1959;¹³ and Pope ⁹ ¹¹ ¹² ¹³

Slater v. Baker & Stapleton 95 Eng. Rep. 860 (KB 1767). ¹⁰ Ibid. Schloendorff v. Society of New York Hospital 105 N.E. 92 (N.Y. 1914). Joseph Fletcher, Morals and Medicine (Princeton: Princeton University Press, 1954). Immanuel Jakobovits, Jewish Medical Ethics (New York: Bloch, 1959).

58 / Emanuel Pius XII wrote an influential response regarding withdrawal of respirators in 1958.¹⁴ The turn to religion and religious leaders for guidance is significant. It suggests an underlying dissatisfaction with the physician paradigm—its inadequacy to provide answers to many ethical issues—and a search for more general ethical guidance. Why look to religion? One reason is that there was a pre-existing rich tradition of addressing medical ethical issues. For instance, when the Austrian anesthesiologist asked the Pope about the ethics of withdrawing a respirator, the Pope could provide an answer that invoked the traditional Catholic ordinary/extraordinary distinction as well as the principle of double effect. Similarly, the Jewish tradition had already addressed numerous medical ethical issues from terminating life-sustaining care to fertility to conflicts between mother and baby during delivery.¹⁵ A second reason is that many people consider religion the source of ethics. It is thought that the foundation of ethical claims are religion. Thus when addressing ethical dilemmas it is only natural to ask what religions answer. This paradigm might be considered a ‘‘brief interlude’’ rather than a fullfledged paradigm. It did stimulate a number of religious thinkers to begin addressing medical ethical issues over the next few decades—Ramsey, May, and McCormick in the Protestant tradition, Tendler, Bleich, and Rosner in the Jewish tradition, and Shannon, Reich, and many Vatican rulings in the Catholic tradition. This greatly enriched discussion of medical ethical issues with many fine distinctions and detailed analyses. However, it was limited—hence the suggestion of a brief interlude rather than a full paradigm. One main reason was that the religions did not answer the same question in the same way. There was no single religious approach. For instance, the Jewish approach to withdrawal of respirators is very different from the Catholic one. Furthermore, there were many people who did not turn to religion as the foundation of ethics. For them, what religions said on any ethical question was of no consequence. This emphasized the difficulty of invoking religion to guide medical ethical issues for all of society, especially one separating church and state. ¹⁴ Pope Pius XII, ‘‘The Prolongation of Life,’’ reprinted in Ethics in Medicine: Historical Perspectives and Contemporary Concerns, ed. S. J. Reiser, A. J. Dyck, and W. J. Curran (Cambridge, MA: MIT Press, 1977). ¹⁵ Jakobovits, Jewish Medical Ethics.

The Evolving Norms of Medical Ethics / 59 Nevertheless, the flurry of activity by religious thinkers at what might be considered the beginning of contemporary medical ethics is important and signals the beginning of a search for guidance beyond physicians.

Physician Paradigm II The 1960s witnessed an important and strong reaffirmation of the physician paradigm, with physicians taking the lead in addressing many pressing medical ethical issues. Several remarkable issues and events highlight this decade and demonstrate the importance still of physician-established norms. In the early 1960s, Dr. Scribner at the Seattle Artificial Kidney Center developed techniques for A-V shunting that would permit multiple dialysis sessions per week and thus chronic dialysis.¹⁶ In the early days, there were more people with renal failure than facilities to treat them. This raised the issue of selecting the few who might get chronic dialysis from among the many medically eligible. Dr. Scribner established two selection panels, the first of physicians to determine medical eligibility and the second, what became derisively known as ‘‘the God Committee,’’ composed of seven laypeople who made the ‘‘final decision.’’¹⁷ While the committee was made up of laypeople from Washington state, the entire process was established by the medical community as the right process. Importantly, the lay committee was meant to provide objective answers but also to ensure continued community support of the medical program.¹⁸ With progress in organ transplantation, there arose the need to harvest more organs from donors. This required a re-examination of the criteria of death. To address this issue, and facilitate the harvesting of more organs, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death was established. Its self-avowed purpose was ‘‘to define irreversible coma as a new criteria for death . . . [largely because] obsolete criteria for the definition of death can lead to controversy in ¹⁶ Rene Fox and Judith Swazey, The Courage to Fail (Chicago: University of Chicago Press, 1974). ¹⁷ Shana Alexander, ‘‘They Decide Who Lives, Who Dies,’’ Life, 53 (1962), 102–25. ¹⁸ Ibid.

60 / Emanuel obtaining organs for transplantation.’’¹⁹ While ultimately state legislatures had to enact changes to statutes, this 1968 paper was tremendously influential in shifting the nation to a whole brain death standard. This was a classic case of the medical profession in the form of Harvard Medical School addressing the medical ethical issue of defining death. Similarly in the area of research ethics, the famous article by Beecher was published in 1966.²⁰ This was a case of a leader in the medical profession examining and criticizing the practices of his colleagues. Beecher argued in this article not for a change of medical ethics, but a re-affirmation of what he took to be the key to medical ethics—the ‘‘more reliable safeguard’’—‘‘the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.’’²¹ It was, in Beecher’s view, the need for investigators to take the well-being of their research participants seriously, to re-affirm the Hippocratic tradition, that was key. Finally, the Declaration of Helsinki was first issued in 1964.²² While in preparation since 1953, consensus finally emerged on this guideline for biomedical research. Again, this was a classic case of the physician paradigm. While receiving advice from two physicians, the Nuremberg Code was written by judges and lawyers in the ruling of a legal proceeding. It was thought to be insufficiently sensitive to actual research practices. The Declaration of Helsinki was a response, guidelines crafted by physicians of the World Medical Association to establish the proper norms for the ethical conduct of research. After the brief religious interlude, the 1960s can be seen as an important re-affirmation of the physician paradigm—physicians determining the resolution of medical ethical issues with the well-being of their patients, as defined by the physicians, being their primary concern. Interestingly, even when problems arose, as the Beecher approach demonstrated, the solution was seen to be more physician authority, just being sure they adhered to their ethical ideal of patient well-being. The range of medical ethical issues that became prominent in this period, physician paradigm II, expanded beyond the medical ethical issues that arise ¹⁹ Ad Hoc Committee at Harvard Medical School to Examine the Definition of Brain Death, ‘‘The Harvard Criteria for Brain Death,’’ JAMA 205 (1968), 337–40. ²⁰ Henry K. Beecher, ‘‘Ethics and Clinical Research,’’ NEJM 274 (1966),1354–60. ²¹ Ibid. ²² Declaration of Helsinki.

The Evolving Norms of Medical Ethics / 61 in traditional physician–patient interactions, issues of confidentiality, truth telling, and consent, to include more social issues of rationing, definition of death, and clinical research.

Philosophical Paradigm The 1970s mark a major watershed, a concerted move away from the physician paradigm to find alternative methods to approach medical ethical issues. The dominant model becomes the philosophical paradigm. Philosophers begin to analyze medical ethical issues in a concerted and coordinated manner, and begin to articulate a method distinct from that of physiciandefined norms. A number of events and activities signal this change. One important event is the founding of both the Hastings Center in 1970 and the Kennedy Institute of Ethics at Georgetown University in 1969. These are centers where philosophers, often along with physicians and religious thinkers, addressed medical ethical issues. At both places, philosophers played important roles in defining issues and methods, and providing analyses. The Tuskegee scandal also proved critical. It finally undermined the physician paradigm in the area of research; afterwards it was impossible for physicians to assert that ethics defined by physicians with the wellbeing of the patient in mind could be trusted. In addition, Tuskegee led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. While chaired by a physician, this national commission had a philosopher as a member, and more importantly employed a number of philosophers on its staff. This led to its most important medical ethical product, The Belmont Report.²³ The original draft was crafted by the philosopher Tom Beauchamp and it justified three principles by philosophical arguments in a philosophic tone. In the late 1970s, some of the philosophers who worked on the National Commission and other philosophers were gathered at the Kennedy Institute and issued a series of books about medical ethics. The landmark Principles of ²³ The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Guidelines for the Protection of Human Subjects, available at .

62 / Emanuel Biomedical Ethics by Beauchamp and Childress (1979) and Veatch’s A Theory of Medical Ethics (1981) were vigorous rejections of the physician paradigm.²⁴ It was at this time, the late 1970s, that many philosophers—Dan Brock, Allen Buchanan, Norman Daniels, and Dan Wikler being the most prominent—became interested in medical ethical issues and focused their research on these issues. Many of these philosophers served as staff to the newly formed President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. What distinguished the philosophical paradigm was its rejection of the physician approach to bioethics. The physician paradigm began from medical practice and built up or elucidated ethical norms based on those practices. The philosophical paradigm began with a study of ethics and then applied ethical principles to medical ethical issues. Furthermore, whereas the physician paradigm viewed the physician as the expositor of medical ethics, the philosophical paradigm rejected this privileged position for the professional, and argued that the appropriate medical ethical norms were to be derived from general ethical principles. It was the philosopher who was best placed to elucidate appropriate ethical principles and to apply them to medical ethical issues. Thus, for instance, the first chapter in Beauchamp and Childress is about morality and moral justification arguing that middle level ethical principles that can be justified by utilitarian or deonotological considerations are to be applied to medical ethical dilemmas.²⁵ More directly Veatch argued: What we really have before us is a series of unsystematic, unreflective, ethical stances or traditions. What we need is some ordering of that chaos we term a tradition. . . . The only solution, I suggest, is to abandon the idea that an ethic for medicine can be based on a professionally articulated code. Medical ethics can no longer be seen as a set of principles or commitments generated from within a profession and transmitted to new members during their socialization into it. In its place, I claim, an ethics for a profession in its relationship to lay people and society in general must be the results of a process far more fundamental. It must be the result of a complex set of understandings between the professional and society [that defines] ²⁴ Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics (New York: Oxford University Press, 1979); Robert M. Veatch, A Theory of Medical Ethics (New York: Basic Books, 1981). ²⁵ Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 4th edn (New York: Oxford University Press, 1994).

The Evolving Norms of Medical Ethics / 63 what ought to be the normative ethical principles governing social relationships, including social relationships involving medical decisions.²⁶

In addition, at least at the first go around, the philosopher’s paradigm was based on four ethical principles: autonomy, beneficence, nonmaleficence, and justice. These became the principles of medical ethics. While beneficence has always had a central role in the physician paradigm of medical ethics, rights of the patient and self-determination have not. It was philosophers who brought these to medical ethics. This approach to medical ethics based on four principles became widely ingrained even in medical education.

Legal Paradigm While philosophers were articulating the philosophical paradigm and elucidating its implications for many medical ethical issues, the law began intruding more into medical ethics. Indeed the 1980s might well be seen as the decade of the legal paradigm. It arose most publicly in the area of endof-life care. The Karen Ann Quinlan case was settled in 1976, but it fostered a widespread national debate about end-of-life care that was carried out in the courts and substantially influenced by legal norms.²⁷ The 1980s, until the Supreme Court ruling in 1990 in the Cruzan case,²⁸ were distinguished by a long series of major state court rulings on end-of-life care: Brother Fox in 1981, In re Conroy in 1985, Brophy in 1986, Bouvia in 1986, In re Jobes in 1987.²⁹ Simultaneously, many of the articles in biomedical journals about medical ethics were interpretations of the legal decisions for physicians. Indeed, several careers were made by issuing a series of these interpretations. While this legalization of medical ethics was most pronounced in the area of end-of-life care, it was not limited to that realm. In 1980 the Department of Health and Human Services issued its regulations governing biomedical research and in 1991 Part A of these were endorsed by seventeen federal ²⁶ Veatch, A Theory of Medical Ethics, 5–6. ²⁷ In re Quinlan 70 N.J. 10 (1976). ²⁸ Cruzan v. Director, Missouri Department of Health 497 U.S. 261 (1990). ²⁹ In the Matter of Philip K. Eichner 420 N.E.2d 64 (1981); In re Conroy 486 A. 2d 1209 (N.J. 1985);

Brophy v. New England Hospital, Inc. 497 N.E. 2d 626 (1986); Bouvia v. Superior Court 225 Cal. Rptr. 297 (1986); In re Jobes 529 A. 2d 434 (N.J. 1987).

64 / Emanuel agencies as the ‘‘Common Rule.’’³⁰ Until this point, biomedical research was governed by guidelines issued by medical bodies, such as the Declaration of Helsinki, by practices established at medical institutions, and by some philosophical documents such as The Belmont Report.³¹ These regulations established the law on research ethics and are very much in the legal framework. The legal paradigm emphasized the courts and other lawmaking bodies as the proper arbiter of medical ethics. It also emphasized the law—the constitution and other statutes—as the proper source of guidance on medical ethical issues. Finally self-determination of the patient was the central value emphasized by the courts.

A Second Caveat To re-emphasize, these paradigms are not rigidly distinct periods with radical changes between them. This is especially obvious when it comes to the legal paradigm. After all, the law was very influential regarding informed consent. Beginning in 1957 with the Salgo case, which coined the term informed consent, and Natanson v. Kline in 1960, and extending through the federal case of Canterbury v. Spence in 1972 and Cobbs v. Grant in 1972, the basic legal requirements related to disclosure by physicians was established.³² In the process, these and other legal cases establish key rights of patients and emphasize patient selfdetermination in the area of medical care. This is obviously a very important aspect of the legal paradigm and pre-dates the 1980s. Furthermore, these cases influenced much of the philosophical discussion related to informed consent and the primacy of self-determination as a value in medical ethical issues. Indeed, the analysis present in these cases was influential in the end-of-life cases. Nevertheless, the influence of the informed consent cases ³⁰ Code of Federal Regulations, TITLE 45, Public Welfare Department of Health and Human Services, PART 46 (‘‘Protection Of Human Subjects’’), available at . ³¹ The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Guidelines for the Protection of Human Subjects. ³² Salgo v. Leland Stanford Jr. University Board of Trustees 317 P.2d 170 (Cal. Ct. App. 1957); Natanson v. Kline 350 P. 2d 1093 (Kan. 1960); Canterbury v. Spence 464 F.2d 772 (D.C. Cir 1972); Cobbs v. Grant 502 P.2d 1 (1972).

The Evolving Norms of Medical Ethics / 65 on medical ethical practice was less important than the end-of-life cases. But they do show that the proposed set of paradigms is approximate.

The Free for All Beginning in the 1990s and extending to today there has been an important breakdown in medical ethics. There is no reigning paradigm by which to analyze medical ethical cases. In the area of research ethics, some invoke the Declaration of Helsinki as the definitive standard, others reject it and invoke other guidelines and values. As the Shiavo case shows, there is disagreement about standards for care of mentally incompetent patients who left no living will. There is disagreement between the patient- and the reasonable person-centered standard for disclosure of information.³³ There is a chaotic free for all. Any approach to medical ethics is legitimate, or at least has a claim to legitimacy. Probably the best place to view this is in Beauchamp and Childress’s Principles of Biomedical Ethics. The first three editions emphasized two ethical theories—utilitarianism and deontology. But in the fourth edition, published in 1994, the chapter on types of ethical theory exploded with an additional six types, from better-defined types such as liberal individualism and communitarianism to vaguer types such as care based ethics and casuistry which are not properly types of ethical theory. Why the chaos? First, the undermining of the authority of physicians to establish medical ethical norms was successful. But there was no clear alternative. Philosophers have no exclusive claim to be authorities in this matter; they might articulate ethical norms better, but then again they might not; they might apply the norms to situations better, but there are plenty of reasons they might not, especially their distance from actual medical circumstances, lack of knowledge about relevant facts and probabilities, etc. Hence, with no one as an authority to articulate and apply medical ethical norms, everyone was equal. Second, the key principles specified by the philosophical paradigm and emphasized by the legal paradigm are hardly exhaustive. Autonomy, ³³ Jessica W. Berg, Paul S. Appelbaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 2nd edn (New York: Oxford University Press, 2001).

66 / Emanuel beneficence, nonmaleficence, and justice do not cover all relevant principles or values. Many people began to see many other relevant values or principles, such as community, family, non-exploitation, integrity, care, etc. As the philosopher Thomas Nagel claims that there ‘‘are five fundamental types of value’’: 1. Specific obligations to other people or institutions such as obligations to patients; 2. General rights everyone has such as the freedom from assault or coercion; 3. Utility or the effects of what one does on the welfare of others; 4. Intrinsic value of certain achievements or creations such as works of art or understanding supernova; and 5. Commitment to one’s own projects and goals such as mastering a work of music or visiting every country in the world.³⁴ And within each type multiple specific values. Pluralism was rife. Third, the notion that there was one conception of these critical principles or values was challenged. There are different conceptions of each value, different ways of understanding what friendship or love entail, or what constitutes beauty. This was most obvious as regards the principle of justice which was vague from the start and the ultimate acknowledgement by Beauchamp and Childress that ‘‘the construction of a comprehensive and unified theory of justice that captures our diverse conceptions may be impossible.’’³⁵ But soon it became clear that the other seemingly more settled principles were also open to multiple interpretations with very different implications for how to approach medical ethical issues. Fourth, these differing values cannot be reduced to one value or summed up in one single value such as happiness, and they can conflict. ‘‘Conflicts can arise within as well as between’’ any of the five types of values Nagel identifies.³⁶ What this means is that there is no single ordering of these values on which all considerations can be measured. Attachment to respecting individuals’ autonomy may conflict with promoting their good, attachment ³⁴ Thomas Nagel, ‘‘The Fragmentation of Value,’’ in Mortal Questions (New York: Cambridge University Press, 1979). ³⁵ Principles of Biomedical Ethics, 4th edition, 326–7. ³⁶ Nagel, Mortal Questions, 129.

The Evolving Norms of Medical Ethics / 67 to one’s family or individual projects may conflict with promoting the greater good of unrelated others, respecting the rights of a few may conflict with saving the lives of many destitute people. Finally, because of the plurality of values that may conflict, different people are likely to interpret and specify the values differently. When confronted with an issue, we analyze and elucidate what it is precisely each value entails and then how the values cohere into a whole. When we say that ‘‘reasonable people can disagree’’ we are recognizing that there are a range of reasonable answers; people can espouse the same values and yet interpret, specify, and integrate them differently, and come to different moral judgments in the very same situation.

Implications of the Plurality of Values That there are multiple values that have multiple conceptions, that these values can conflict and cannot be reduced to a single over-arching ordering has generated the free for all. There may be multiple ways to resolve moral issues all of which are ethical; different ways of interpreting, specifying, and integrating the competing values can lead to different moral judgments. This leads to moral disagreement—multiple moral perspective without one position being ethical and the other unethical. This chaos in medical ethics based on the plurality of values is not just a philosophical curiosity but has important and practical implications. I will elaborate the implications for the standard of care debate, Institutional Review Boards’ assessment of clinical research, and health policy.

Standard of Care Debate Since the AZT maternal–fetal HIV prevention trials in developing countries, there has been an extended argument about the appropriate standard of care in trials in developing countries.³⁷ The issue is whether it is ever ethical ³⁷ Peter Lurie and Sidney Wolfe, ‘‘Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries,’’ NEJM 337

68 / Emanuel to use less than the worldwide best standard of care in developing countries. The Declaration of Helsinki and some commentators says ‘‘no’’; multiple other guidelines, such as CIOMS, the Nuffield Council, and UNAIDS,³⁸ as well as independent commentators provide a qualified ‘‘yes’’ under some, restrictive circumstances; and still others argue yes where the standard of care people actually get is already less than the worldwide best standard.³⁹ One and probably the best way to understand this issue is as a matter of justice. In a clinical trial the participants should receive—at least not be denied—the medical services they are entitled to. This means that the standard of care in a research trial is determined by the services people should receive in routine medical care. As Benjamin Freedman pointed out long ago, it is ethical to use placebo as a control in a ‘‘condition whose validated optimal treatment is not made freely available to patients, because of cost constraints or otherwise.’’ He argues: Consider an unusually expensive newly introduced treatment whose marginal relative effectiveness is beyond question. . . . [Yet] a government insurer or other third party payer will not fund this drug unless its absolute benefit is shown to surpass a given threshold. . . . Is such a trial [comparing the drug to placebo] ethical? Ex hypothesi within this scenario patients are not entitled to this drug, pending a positive outcome to the proposed trial. Withholding [the drug] from the placebo cohort there does not violate their rights to treatment, and may consequently be ethically justified.⁴⁰

The issue in the standard of care debate then becomes: what medical services are people entitled to? Entitlement is a matter of justice. Justice is complex in the domestic setting and even more complex in the international (1997), 853–6; Marcia Angell, ‘‘The Ethics of Clinical Research in the Third World,’’ NEJM 337 (1997), 847–9; Harold Varmus and David Sachter, ‘‘Ethics Complexities of Conducting Research in Developing Countries,’’ NEJM 337 (1997), 1003–5. ³⁸ Council for International Organizations of Medical Science, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002); Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries (London: Nuffield Council, 2002); Joint United Nations Programme on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research (Geneva: UNAIDS, 2000). ³⁹ D. Wendler, E. J. Emanuel, and R. L. Lie, ‘‘The Standard of Care Debate: Can Research in Developing Countries be Both Ethical and Responsive to those Countries’ Health Needs?,’’ American Journal Public Health, 94 (2004), 923–8. ⁴⁰ Benjamin Freedman, ‘‘Placebo-controlled Trials and the Logic of Clinical Purpose,’’ IRB 12 (1990), 1–6.

The Evolving Norms of Medical Ethics / 69 setting. Internationally, there is controversy not just about what people are legitimately entitled to from their own society but what transfers among societies are necessary for fairness. This is highly controversial. There are at least three distinct views on international justice. The view underlying the Declaration of Helsinki conclusion is some kind of pure cosmopolitan or global equality. People throughout the world are all equally valuable. The differences in income, health services, education, and other socio-economic factors that we see between people in different countries are not justifiable; everyone is entitled to the same goods. This view would seem to point in the direction of having everyone entitled to the same healthcare services. This would mean that everyone should receive the world-wide best standard of care. There is a second, Rawlsian view of international justice, namely that international justice does not require equality among countries or peoples, and that the international community does not have an obligation to provide economic support and aid to countries except for the very poorest—what Rawls calls ‘‘burdened societies.’’⁴¹ Why? The aim of international assistance is to create just states with just institutions. A just society need not be wealthy, and ‘‘the levels of wealth and welfare among societies may vary, and presumably do so.’’⁴² What matters is a society’s culture and political institutions, ‘‘the religious, philosophical, and moral traditions that support the basic structure of their political and social institutions, as well as the industriousness and cooperative talents of its members.’’ These cannot be supplied by economic aid: ‘‘merely dispensing funds will not suffice to rectify basic political and social injustices.’’⁴³ Once a society has the minimum to permit the creation of basic just institutions, there is no obligation of the international community to provide economic aid: [The] aim is to help burdened societies to be able to manage their own affairs reasonably and rationally and eventually to become members of the Society of well-ordered Peoples. This defines the ‘‘target’’ of assistance. After it is achieved, further assistance is not required, even though the now well-ordered society may still be relatively poor.⁴⁴

This means people throughout the world will be entitled to vastly different medical services. There is no obligation on the part of the international ⁴¹ John Rawls, The Law of Peoples (Cambridge, MA: Harvard University Press, 1999), part III section 15. ⁴² Ibid., p. 107. ⁴³ Ibid., p. 108. ⁴⁴ Ibid., p. 111.

70 / Emanuel community to bring people up to the level of the worldwide best. Indeed, except for a few burdened societies, people are entitled to the very medical services they are getting. For research, this means people enrolled in a research study are entitled to what they now receive. Thus, on the Rawlsian view of international justice, the control arm of a study includes the services already received but no more. A third view might be called practical cosmopolitanism. This is a middle view between the pure cosmopolitan and Rawlsian. On this view, people are neither entitled to merely what they are receiving now, nor to equality with the most advanced countries. For a variety of reasons—previous and possibly current exploitation, unfair international agreements, trade barriers, etc.—there is an obligation of the international community to provide economic assistance. This is the cosmopolitan element. But there is no clear agreement on how much international aid is required by the demands of justice. Thus, there is no clear entitlement as a matter of justice. Fortunately, we can avoid this interminable problem because there is a strong and consistent curve relating the amount spent on healthcare with longevity as well as other measures of health (see Figure 3.1). It shows that as countries spend a small amount on healthcare there is an exponential increase in longevity which plateaus at about 70 to 73 years of age at annual per capita spending of $200–300 per year. So the practical side of practical cosmopolitanism is to state that people are entitled to $200 per year in healthcare services. Those services that would be covered for such expenditures must be the standard of care. These three different views have practical significance for the ethics of research trials in developing countries, especially determining the comparison arm of any randomized intervention trial. The pure cosmopolitan view of justice requires the Declaration of Helsinki’s worldwide best standard; the Rawlsian view of justice requires people receive the services that they are now receiving except in the very most burdened societies; and the practical cosmopolitanism view argues that participants in research are entitled to receive the services that would be provided as part of a health package for about $200 per person per year. This is a great deal, but not everything. For instance, during the disputed maternal–fetal trials in 1997 when AZT cost $800 per delivery it is very unlikely that people in Africa would be entitled to AZT on the practical cosmopolitan view. But the point is that

The Evolving Norms of Medical Ethics / 71

Figure 3.1. Association of longevity with per capita health spending.

72 / Emanuel the entitlement differs by different interpretations and specifications of international justice.

The Ethics of Clinical Research Studies The plurality of values has particular importance for how Institutional Review Boards (IRBs)—the bodies established to provide an independent assessment of the ethics research protocols—often called research ethics committees (RECs) in Europe—evaluate clinical research studies. It is widely recognized that, to be ethical, clinical research studies must satisfy eight principles.⁴⁵ It is also clear that these principles can conflict. Minimizing risk can reduce social value, obtaining consent might compromise scientific validity, and fair subject selection can be in tension with a favorable risk–benefit ratio. Different people will assess these conflicts differently. For instance, in considering whether to enroll a mentally incapacitated person on a randomized cancer chemoprevention trial there can be at least three different views. Those who stress informed consent might argue that such a person should not be enrolled since there are many eligible mentally competent individuals who can provide valid informed consent; those who stress fair subject selection might argue that mental incapacity has nothing to do with the scientific objectives of the trial and to exclude such a person if they could comply with the study’s requirements would constitute unfair discrimination; finally, those who weigh risk–benefit ratios and social value highly might argue that this person is at least as well off on the study as receiving standard care—clinical equipoise makes the study ethical for any patient—and will be contributing to social value without any increased risk. Which of the three positions is ethical? All are. They specify and integrate the eight values differently. What is the implication for IRB/REC review? IRBs/RECs should determine whether a particular ethical value is being violated by a study. If so, it ⁴⁵ Ezekiel J. Emanuel, David Wendler, and Christine Grady, ‘‘What Makes Clinical Research Ethical?,’’ JAMA 283 (2000), 2701–11; Ezekiel J. Emanuel, David Wendler, Jack Killen, and Christine Grady, ‘‘What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,’’ Journal of Infectious Disease, 189 (2004), 930–7.

The Evolving Norms of Medical Ethics / 73 is unethical. But when it is a matter of a reasonable specification and integration among different ethical values, then the proper approach is ethical tolerance. The IRB/REC should make its suggestions, provide its reasons, and engage the researchers in a reasoned deliberation on the matter. But ultimately, if the researchers’ approach is reasonable, it should defer to the researchers. It is the researchers’ not IRBs’/RECs’ study, and the researchers must expend the huge effort to implement it. The IRBs’/RECs’ elucidation may provide insights that the researchers want to adopt, but if it is not inherently superior, if the alternatives are all reasonable, then the researchers have the final say. Imposing one particular specification is precisely that, an imposition when there is no clear ethical violation. Reasonable disagreement over studies should induce ethical tolerance and default to the researchers’ perspective. The fact of ethical pluralism also suggests a fundamental problem with multiple IRB/REC reviews in multi-site studies. Because of the many different ways of interpreting and integrating values, different IRBs/RECs can come to different evaluations of the very same study. And none of the evaluations may be the ethically best. In this case, trying to adhere to different IRB/REC evaluations just means trying to adjudicate reasonable disagreement; there is no obvious best solution. Time is thus wasted with no ethical benefit.

The Ethics of Health Policy It is common for health policy makers to discuss the trade-off between equity and efficiency in any policy choice. But the financing of any health system and deciding what services should be guaranteed and which ones will be left to individual discretion will include many more values than equity and efficiency. Including all people in one publicly financed health system may be preferable because of equity concerns, but also because of political stability despite incurring higher taxes; having everyone receive the same benefit package facilitates simplicity and comparability, and reduces the opportunities for adverse selection through benefit design but limits individual choice as well as innovation and flexibility in benefit design; soliciting public input into benefit design may enhance legitimacy but can be arduous and cumbersome. Similarly, benefit design could aim at

74 / Emanuel maximizing health through adherence to strict cost-effectiveness rankings or could sacrifice some degree of health improvement to direct benefits preferentially to the most severely or acutely ill, children, the poor, people likely to return to productive work, etc. Many people emphasize equality and believe that everyone should be entitled to the same exact services, while others emphasize equality up to a point but want to permit more individual freedom of choice regarding certain services, such as expanded mental health, dental, vision or other benefits, wider range of specialists and hospitals, or shorter wait times. These choices clearly involve multiple values—equality, freedom, simplicity, stability, innovation, priority to children or severely ill, etc.—that conflict in particular issues. The large number of values requiring specification and integration, along with the many uncertainties regarding influences on individual behaviors and feasibility of implementation makes ethical evaluation of different healthcare policy options incredibly complex. People regularly find it difficult to specify how much each value should count in a decision, and even when they can specify it for one case, they find the interpretation unsuitable to the next case. In the end, they seem confident only of listing what seem like relevant considerations without being more specific. ‘‘Reasonable people will disagree’’ on such policy matters. The multiplicity and conflicting nature of values in health policy has two consequences. First, this leads to substantial frustration with ethics among health policy makers. Lists of relevant values without information about how to interpret, specify, and integrate them into a decision procedure seems unhelpful if not worthless. It is no surprise most health policy makers dismiss—or at least are highly skeptical of—the relevance of ethics. Second, the necessity of making policy decisions, especially decisions whether to cover specific drugs or procedures, induces policy makers to seek a choice procedure that can guarantee the best result. Cost-effectiveness analysis (CEA) seems to offer a quantifiable and concrete decision procedure with a definitive answer. The problem is that it does this by focusing exclusively on one value—quality-adjusted life years—while ignoring—or more accurately hiding among its many assumptions, such as the discount rate and the weighting of all life years gained regardless of age equally—many other relevant values. CEA achieves a precise answer by emphasizing a single value rather than being pluralist about values, and the cost is it falsifies what is at stake in key policy choices.

The Evolving Norms of Medical Ethics / 75 An alternative based on a pluralist understanding of values recognizes there is not a single way to establish priorities on which services to cover. Instead, many different ‘‘packages of services’’ could all simultaneously be ethically acceptable. The policy challenge is then to develop institutional structures that make it possible for people with different ways of balancing their values to obtain a package that mirrors their values.

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4 Convergent Trends in Modern Medical Ethics: Medicine-Based Ethics and Human Rights Johannes J. M. van Delden

1. Introduction The chapter by Dr. Emanuel describes the evolving norms of medical ethics over the centuries, with a special focus on the decades after World War II. It gives examples of the presumed chaos in the last and present phase by elaborating on the standard of care debate in research ethics, by discussing the problem of multiple ethical review of research and by commenting on the ethics of health policy. It is especially the first part, in which the different phases and their paradigms are described, which cause me problems. These originate from the fact that it is not clear whether the postulated paradigms really dominated the given period and whether the shifts from one paradigm to the other really occurred. Since it is not clear on what grounds we can assume a paradigm to be present or changed, the theory of the chapter I am asked to comment on is hard to verify and equally hard to falsify. My problem is augmented by the fact that Dr. Emanuel knows all this and has inserted several caveats in his text: we are not to assume rigid distinctions between the phases, nor to take paradigm shifts as radical changes, nor should we take decades too literally, he warns us.

78 / Van Delden However, since he does postulate the different paradigms and claims that in these paradigms dominant values of a certain period are visible I will comment on them. In doing so I will draw on my experience with medical ethics in the Netherlands. My comment will result in a different diagnosis of the present time. I will sketch two developments: one which takes place, at least in the Netherlands, in which physicians seem to have the opportunity to be acknowledged as moral actors again. The other is a development of a global bioethics in which human rights become more and more central.

2. The Paradigms and their Shifts Dr. Emanuel begins by sketching the first period of medical ethics as one in which the physician paradigm reigned. Although he describes paradigm shifts every decade after 1950, this first period lasts about 2,350 years: from Hippocrates (400 bc) till after World War II. For this period the primacy of the relationship between physician and patient, the centrality of the patient’s well-being, and the idea that the physician defined what was in the patient’s interest are presented as core notions. First of all, I am hesitant to define core notions for such a long period especially if they come with the claim that they have been that (core notions) all that time. Moreover, if we follow Dr. Emanuel’s own suggestion that the oath was a dissident document, it couldn’t have been a reflection of ancient medical ethics at all and at least one paradigm shift must have occurred in this long period. The idea that the oath represented a minority view in ancient Greece probably goes back to Edelstein’s reading of it as a Pythagorean manifesto, but few now support this view.¹ I therefore think that there is good reason to believe that the Hippocratic oath was consonant with the medical practices and ethics of its time. But this does not imply that I think one can claim that the oath has kept that position for nearly twenty-four centuries. We simply know too little of the relationship between ¹ D. W. Amundsen, ‘‘The Significance of Inaccurate History in Legal Considerations of Physician Assisted Suicide,’’ in Physician Assisted Suicide, ed. R. F. Weir (Bloomington: Indiana University Press, 1997); S. H. Miles, The Hippocratic Oath and the Ethics of Medicine (New York: Oxford University Press, 2004).

Convergent Trends in Medical Ethics / 79 the oath and medical ethics. The oath was rarely mentioned during the first 1,500 years of its existence.² Whatever the exact position of the oath over time may have been, it is far more interesting to look at the core notions themselves. Dr. Emanuel, citing Robert Veatch, describes these as: the primacy of the relationship between physician and patient, the centrality of the patient’s well-being, and the idea that the physician defined what was in the patient’s interest. I am not sure this reading of the Hippocratic oath is correct. I think Dr. Steven Miles has convincingly shown that the Hippocratic ethics was not as ultraindividualistic as Veatch wants us to believe and that a concern for the health of the public is present in the oath.³ Also, it is not so clear at all that Greek physicians acted paternalistically. I follow Miles again in his conclusion that the medical records of ancient Greece do not show paternalistic physicians: patients chose their physicians, were involved in decision-making, and were told the prognosis of their disease. Dr. Emanuel also claims that part of the Hippocratic oath concerns euthanasia and that this is a timeless issue, inherent in medical practice. I am afraid I have to disagree. I think that there are good reasons to believe that the oath did not address euthanasia as we know it at present. In the sentence ‘‘I will not give a drug that is deadly to anyone if asked’’ there is no syntactic relation between the person to whom the deadly drug is given and the one who asks.⁴ Furthermore it is not true that questions pertaining to euthanasia have always been present in medical practice. Euthanasia in the sixteenth and seventeenth centuries, for instance, was used as a descriptive term to describe a death that was peaceful and without agony; not to describe one that the doctor had brought about. The term even had a theological interpretation in that this euthanasia was regarded as a reward for a pious life. Euthanasia only became an issue in medical ethics when physicians got the possibility to intervene in the dying process. This happened somewhere in the nineteenth century, when morphine and chloroform became available. It was only in 1869 that William Lecky gave the term euthanasia its present meaning of intentionally ending life in order to end suffering from disease. Throughout classical antiquity, however, there was no blanket prohibition ² Miles, Hippocratic Oath. ³ Ibid. ⁴ A. van Hooff, ‘‘Antieke Artsen en Euthanasia,’’ Hermeneus, 71 (1999), 122–7.

80 / Van Delden of suicide, so why would the Hippocratic oath address that issue? As stated, the oath reflects common medical practice in ancient Greece. Therefore, the Hippocratic rule that no deadly drug shall be given probably should be read as a prohibition of murder by poisoning. After the first physician paradigm, the religious paradigm reigned from 1950 till 1960 according to Dr. Emanuel. I think this is a very vulnerable hypothesis as only a few examples are cited to support the characterization of this period. Moreover, I think Dr. Emanuel will readily agree with me that the turn to spiritual leaders is not confined to this period. As he acknowledges himself, there has been a rich tradition in Catholic moral theology which has provided modern medical ethics with notions such as the ordinary/extraordinary distinction and the principle of double effect that are still used. And also at present people turn to their spiritual leaders, examples of which I heard during a conference on Islamic medical ethics (2002 in Abu Dhabi). Were physicians absent from medical ethics in the 1950s? It may be interesting to take a short look at a booklet that was published in 1959 in the Netherlands. It was called ‘‘Medical Ethics and Rules of Conduct’’ and was published by the Royal Dutch Medical Association. This book was written by a committee that consisted of physicians only and described a professional ethics in terms of virtue ethics. The main task of a physician was to be worthy of the trust of his (not ‘‘her’’ of course!) patients by showing moderation both in professional conduct and in his private life. My point is that, at least in the Netherlands, physicians set the tone for their professional ethics in the 1950s. Since Dr. Emanuel claims that the 1960s form a second period in which the physician paradigm reigned, my suggestion is to view the whole period after World War II till 1970 as dominated by this paradigm. Attheend ofthe1960stheworld changed and Ifully supportDr. Emanuel’s suggestion of a paradigm shift there. Sociologists like Illich and Zola had unmasked medicine as an enterprise that is not always in the interest of the patient but can be harmful as well. That is why they coined the term ‘‘iatrogenesis’’. Moreover they showed that societal issues more and more were viewed from a medical perspective and criticized the power that physicians had because of this. These were also the times of the protests against the Vietnam War and the students’ revolution in Paris. Those in power were mistrusted and a need for societal control of them was widely

Convergent Trends in Medical Ethics / 81 felt. This was certainly also true for medicine. Philosophers took on the task to analyse what was going on in medicine and started to apply their methodology to this field, which was relatively new to them (‘‘How medicine saved the life of ethics’’). After the philosopher’s paradigm comes the legal paradigm, at least in Dr. Emanuel’s analysis. We are now in the 1980s and we are in the United States (!). A number of court cases are cited to show that in this period law began to intrude into medical ethics. Of course Dr. Emanuel does not claim that influential court rulings occurred only in this period, but he does claim that in this period ‘‘courts were seen as the proper arbiter of medical ethics’’. But is that enough to speak of a paradigm? It is not clear what the content of this paradigm is. It may be that the courts were considered as a proper place to solve issues, but that does not mean that it was up to them to define the criteria. I think, actually, that what the courts did was to apply the criteria laid down by the philosophers in the 1970s. Law always lags behind ethics and basically law is ethics in a condensed and minimal form. Such a development is also visible in the Netherlands where the 1980s saw a strong emphasis on patient autonomy. It was not until the 1990s that this emphasis materialized in laws in which the physician–patient relationship was characterized as a contract. From the 1990s till now is the final period discerned by Dr. Emanuel. He states that there is no reigning paradigm in this period: there is a ‘‘free for all’’, even a ‘‘chaotic’’ free for all. I have several questions concerning this characterization: What is new? Is it a problem? Is it true? What is new about there being multiple values in ethics? I do not think this is new at all. The opposition between Plato and Aristotle is not new, nor is the one between deontology and utilitarianism. If Beauchamp and Childress’s principles of biomedical ethics in the 1980s have been perceived as settled principles, open to one interpretation only, this was a mistake and one can but welcome the changed perception. I have read too many articles written in this period by authors who concluded that because of the principle X this or that was clearly wrong. If by now we have come to see more nuances I think this should be preferred. Is the existence of different views a problem? A plurality of values in my belief does not commit us to a normative relativism, as Dr. Emanuel seems to think. I do not think ethics can ever live with the idea that what is really good in one case is not so in another. Such a normative principle

82 / Van Delden would seem to violate the requirements of consistency and universalization. I believe that we can justify normative judgments by looking for principles that could not reasonably be rejected by people similarly motivated to find principles for the general regulation of behaviour.⁵ Frankena pointed to the importance of the moral point of view in this respect. In order to be able to speak of moral truth we have to be ‘‘free, impartial, willing to universalize, conceptually clear and informed about the relevant facts’’.⁶ Our judgment can be said to be true if it is or will be agreed to by everyone who takes the moral point of view. It is important to note that the existence of different views at one given moment does not falsify this position. It takes time to reach the point at which people agree about substantive ethical issues. Is there really a free for all? As I said, a process of finding the moral truth about an issue, of reaching a reflective equilibrium if you like,⁷ takes time. Therefore I am not really convinced by the examples given by Dr. Emanuel. The standard of care debate is relatively new in research ethics. Originally the ethical guidelines regulating clinical research focused on informed consent, scientific validity, and a proper balance of benefit over burdens. Ethically speaking the principles of autonomy and nonmaleficence formed the core of research ethics, the protection of the research subject being its main goal. Recent versions of international standards, e.g. the 2000 amendment of the Declaration of Helsinki and the 2002 WHO/CIOMS (World Health Organization, Council of International Organizations of Medical Science) guidelines, show a new emphasis on justice and solidarity as conditions for clinical research. One of the issues raised in these documents is the question about the treatment that should be given to subjects in the control arm of a randomized clinical trial: ‘‘the standard of care’’ debate. It is certainly true that this issue is not settled yet, but it is also true that there has been a convergence in many other issues in research ethics (e.g. the position of incompetent subjects in clinical research). To claim that an ongoing debate on one issue proves that there is a chaotic free for all seems too pessimistic to me. ⁵ T. M. Scanlon, What We Owe to Each Other (Cambridge, MA: Harvard University Press, 2000). ⁶ W. F. Frankena, Ethics (Englewood Cliffs, NJ: Prentice-Hall, 1973). ⁷ W. van der Burg and T. van Willigenburg, ‘‘Introduction,’’ in Reflective Equilibrium, ed. W. van der Burg and T. van Willigenburg (Dordrecht: Kluwer Academic Publishers, 1998).

Convergent Trends in Medical Ethics / 83

3. Convergent Trends in Modern Medical Ethics So far my contribution can be characterized as deconstruction, which is the part philosophers seem to like most: looking for the mote in the other’s eye while ignoring the beam in one’s own (Matthew 7: 3). What constructive ideas could I contribute? I will briefly outline two developments that I take to be convergent trends in modern medical ethics: one which takes place, at least in the Netherlands, in which physicians seem to have the opportunity to be acknowledged as moral actors again. This opens the way for what I have called a medicine-based ethics.⁸ The other is a development of a global bioethics in which human rights become more and more central. For my sketch of a medicine-based ethics I have to return to the 1970s in which the philosopher’s paradigm was dominant. Often, the work of these philosophers took the form of applied ethics: general ethical principles were applied to clinical dilemmas. One of the (mostly hidden) premises was that medical practice itself contained no special characteristics that should be involved in ethical reasoning. Context, practical wisdom, medical expertise, and experience were not perceived as containing morally relevant information. To engage in ethics, one only needed to apply general theory to the concrete situation. We have now come to be highly critical of this deductivism in bioethics. Principles are by nature formulated in a contextfree way, and therefore have to be interpreted in a concrete case before they can do moral ‘‘work’’ at all. Much of this interpretation remains hidden in applied ethics. Moreover, ethics in its ‘‘application’’-form fails to take real notice of the field it is judging. I think, however, that the practice of medicine does contain its own internal norms that need to be taken into account in moral reasoning. By ‘‘norms internal to practices’’ I mean two things. On the one hand, it refers to ‘‘phronesis’’: practical wisdom that enables those working in a ‘‘praxis’’ to act and judge well in concrete cases. In this interpretation internal norms form a subtle, context-driven way of specifying the well-known principles in concrete cases. Practice-internal norms are also action guides, however. They can consist of rules and ideas about how to deal with certain situations in a morally satisfactory way. ⁸ J. J. M. van Delden, Medicine Based Ethics: Inaugural Address (Universiteit Utrecht, 2003).

84 / Van Delden If I am right so far, and if it is worthwhile from a moral point of view to determine what norms function in practice and how, I also have to describe how that information may be integrated into normative reasoning. But first I should, perhaps, respond to those who are troubled by the so-called ‘‘is–ought’’ distinction. I think it is perfectly sound to hold at the same time that empirical studies have an independent input into normative reasoning and that it is impossible to deduce an ‘‘ought’’-proposition from a series of ‘‘is’’-propositions. These statements are not contradictory, I believe, because reasons for the conclusion of an empirical ethical study will consist of far more than just empirical data. Moreover, one does not need to worry much about this matter here, because the type of information aimed at is value-laden anyway. One does not go from ‘‘is’’ to ‘‘ought’’, but tries to balance different kinds of ‘‘ought’’. An integrated empirical and normative input involves a specific approach to ethics. Contrary to the approach, which wants to use empirical facts in ethics, but which holds on to the distinctions introduced by positivism, an integrated empirical ethics tries to find alternatives. The first point that can be made is that research in empirical ethics is concerned with the moral aspects of specific practical problems. In the course of such research, questions are raised concerning the rightness of a certain course of action, what it is to be a good human being or a good thing, what it is that our duty demands that we do, and so forth. But, secondly, in its attempt to answer those questions, empirical ethics rejects the position that those answers are known a priori, and defends the belief that part of those answers must be discovered empirically. This means, among other things, that moral reasoning must involve and integrate the moral intuitions of people regarding a given case. Indeed, in the Netherlands a lot of research in medical ethics now contains empirical substudies in which the experiences and moral intuitions of care givers are used as input in the process of normative reasoning. My second contribution is to point to the idea that human rights are gaining in importance in medical ethics. I think it is a fact that medical ethics over the decades has moved from the bedside to the health care system and public health issues and from there, more recently, to matters of international distributive justice. To study such international issues from a justice perspective means that one can no longer rely on the language of clinical ethics, as this was developed in a context of the individual patient–physician relationship. Several authors have suggested that the

Convergent Trends in Medical Ethics / 85 discussion should be cast in terms of human rights, because these express fundamental values in societal terms.⁹ The move towards human rights is also visible in the final draft of the 2005 UNESCO Universal Declaration on Bioethics and Human Rights.¹⁰ In the Introduction the UNESCO general conference ‘‘recognizes that the declaration should be understood in a manner consistent with domestic and international law in conformity with human rights law’’. Although human rights are part of a trio that is invoked in several articles (‘‘human dignity, human rights and fundamental freedoms’’) the primacy of human rights becomes very clear at the end of the declaration (article 27). This article reads: ‘‘If the application of the principles of this declaration are to be limited, it should be by law . . . Any such law needs to be consistent with international human rights law.’’ The addition of ‘‘human rights’’ to the title of this declaration on bioethics during the June meeting at the Paris headquarters of UNESCO should also be seen as a sign of the centrality of human rights in this declaration. To this I should quickly add that I am certainly aware of the criticism that could be raised against human rights thinking. According to some this is only a new form of Western imperialism. The principle of respect for autonomy is the main culprit in the charge that Western bioethics is imposed on other cultures. I believe this is a mistake. The principle does not impose an absolute priority of the individual over other societal considerations. Often the universal applicability of the principle is confused with the notion that it is an absolute principle. This is a mistake. What the principle does require is recognition that individuals have basic rights to liberty and self-determination. Global bioethics could become a nightmare when it results in the promotion of a lowest common denominator or in homogenized bioethics.¹¹ ⁹ J. M. Mann, ‘‘Medicine and Public Health, Ethics and Human Rights,’’ Hastings Center Report, 27/3 (1997), 6–13; S. R. Benatar, ‘‘Global Disparities in Health and Human Rights: A Critical Commentary,’’ American Journal of Public Health, 88 (1998), 295–300; R. Macklin, Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2004). ¹⁰ T. A. Faunce, ‘‘Will International Human Rights Subsume Medical Ethics? Intersections in the UNESCO Universal Bioethics Declaration,’’ Journal of Medical Ethics, 31 (2005), 173–8. ¹¹ A.V. Campbell, ‘‘Global Bioethics–Dream or Nightmare?,’’ Bioethics, 13/3–4 (1999), 183–90.

86 / Van Delden Using what I said above about the moral point of view, however, I think human rights come a long way in approaching a moral truth. I believe they could not reasonably be rejected by people similarly motivated to find moral principles for the general regulation of behaviour.

4. Conclusion In this response I have raised a number of questions with respect to the characterization of different periods in the development of medical ethics. I also submitted the idea that two convergent trends can be discerned in modern medical ethics: the rehabilitation of medicine-based ethics and a focus on human rights in global bioethics. By doing so, I have become vulnerable to exactly the same kind of critique as I have given above. Obviously one can question whether my observations are really true. The lesson to be learned from this, I suppose, is that by describing the past in a certain way and by emphasizing certain aspects of historical periods, we have a message for today’s debate. Maybe we should focus on that.

Part II Global Research Ethics

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5 Just Research in an Unjust World: Can Harm Reduction Be an Acceptable Tool for Public Health Prevention Research? Nancy E. Kass

In recent years, two research endeavors, one international, one domestic, have been the focus of considerable ethics debate. The first was a series of HIV perinatal transmission studies conducted in the mid-1990s in resource-poor countries.¹ The second was a lead abatement trial initiated in the early 1990s in low-income housing units in Baltimore.² Both studies were accused of ¹ E. M. Connor et al., ‘‘Reduction of Maternal–Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment: Pediatric Aids Clinical Trials Group Protocol 076 Study Group,’’ NEJM 331/18 (1994), 1173–80; R. S. Sperling et al., ‘‘Maternal Viral Load, Zidovudine Treatment, and The Risk of Transmission of Human Immunodeficiency Virus Type 1 from Mother to Infant. Pediatric Aids Clinical Trials Group Protocol 076 Study Group,’’ NEJM 335/22 (1996), 1621–9. ² M. R. Farfel and J. J. Chisolm, Jr., ‘‘Health and Environmental Outcomes of Traditional and Modified Practices for Abatement of Residential Lead-Based Paint,’’ American Journal of Public Health, 80/10 (1990), 1240–5; M. R. Farfel, J. J. Chisolm, Jr., and C. A. Rohde, ‘‘The Longer-Term Effectiveness of Residential Lead Paint Abatement,’’ Environmental Research, 66/2 (1994), 217–21; M. R. Farfel and J. J. Chisolm, Jr., ‘‘An Evaluation of Experimental Practices for Abatement of Residential Lead-Based Paint: Report on a Pilot Project,’’ Environmental Research, 55/2 (1991), 199–212.

90 / Kass violating research ethics guidelines because, it was alleged, participants, or some participants, did not receive the best interventions available for the condition in question. Indeed, both studies have been compared to the U.S. Tuskegee study,³ contemporary shorthand for the most severe unethical conduct in human research. Public health professionals, however, have defended both studies, saying they not only were ethically acceptable, but were ethically required.⁴ Both case studies in question were examples of public health prevention research. Specifically, researchers were trying to identify cheaper, simpler, and more accessible prevention strategies as alternatives to existing approaches, as existing approaches were not reaching target populations. In the 1990s, AZT was shown to dramatically reduce maternal infant transmission but was projected to have little impact on the 1,000 daily global births of HIV-infected children since its cost and complexity precluded its accessibility in the developing world.⁵ As long ago as 1931 the use of lead paint was banned in Europe due to its deadly effects on children;⁶ nonetheless, in the 1990s, proper lead abatement remained as inaccessible to most at risk families in Baltimore City as AZT was to poor, global women. The ethics question raised by these studies is whether background conditions of access should prompt public health professionals to seek alternate strategies that might be more accessible, albeit potentially less effective; or whether such a response makes scientists themselves morally culpable, seeming to accept and condone the injustices that exist. To that end, this chapter will take on ³ M. Angell, ‘‘The Ethics of Clinical Research in The Third World,’’ NEJM 337/12 (1997), 847–9; Ericka Grimes v Kennedy Krieger Institute Inc. 128 (2000), available at ; R. J. Levine, ‘‘The ‘Best Proven Therapeutic Method’ Standard in Clinical Trials in Technologically Developing Countries,’’ Journal of Clinical Ethics, 9/2 (1998), 167–72. ⁴ F. Luna, ‘‘Is ‘Best Proven’ a Useless Criterion?,’’ Bioethics, 15/4 (2001), 273–88; H. Varmus and D. Satcher, ‘‘Ethical Complexities of Conducting Research in Developing Countries,’’ NEJM 337/14 (1997), 1003–5; World Health Organization (WHO), Recommendations from the Meeting on Mother-to-Infant Transmission of HIV by Use of Antiretrovirals (Geneva: World Health Organization, 1994); L. F. Ross, ‘‘In Defense of the Hopkins Lead Abatement Studies,’’ J Law Med Ethics, 30 (2002), 50–7. ⁵ WHO, Recommendations Use of Antiretrovirals. ⁶ J. Pollak, ‘‘The Lead-Based Paint Abatement Repair and Maintenance Study in Baltimore: Historic Framework and Study Design,’’ Journal of Health Care Law and Policy, 6/1 (2002), 89–108; A. Spake and J. Couzin, ‘‘In the Air That They Breathe. Lead Poisoning Remains a Major Health Hazard for America’s Children,’’ US News and World Report, 127/24 (1999), 54–6.

Harm Reduction as a Tool for Public Health / 91 the question of whether and/or how public health researchers can conduct just research in background contexts of extraordinary injustice. It should be said at the outset that the purpose of discussing these cases here is not to revisit the long debates that surrounded those particular studies. Rather, these studies are paradigmatic cases of community-based public health prevention research and the issues they raise emerge in hundreds of other studies every year. The publicity given to these two studies, however, can be a springboard to broader discussions of acceptable approaches for public health prevention trials broadly. The conclusions and recommendations provided here are intended to apply to this larger body of research, not to the two studies that catalyzed the discussion. This chapter is divided into five sections. The first section provides brief background on the two studies in question and summarizes arguments put forward in ethics debates about them. The second section calls for additional ethics guidance for public health prevention studies, suggesting that existing research ethics guidelines have failed to address such research of this type. The third section will introduce the concept of harm reduction as a possible methodologic tool for public health researchers and discuss why engaging in a harm reduction approach might be useful. The fourth section will provide a set of criteria for determining when harm reduction research is and is not morally acceptable. And, finally, the fifth section tries to anticipate and address criticisms to this same approach. Ultimately, it will be argued that harm reduction research should be an ethically acceptable tool in the public health prevention research ‘‘toolbox’’ but also that it will be justifiable only in narrowly defined circumstances. One can easily imagine how readily harm reduction as a research approach could be exploited. To that end, the chapter provides criteria that attempt to distinguish investigations that merely are expedient from investigations with reasonable likelihood of advancing domestic and global public health.

I. Case Studies 1. International Perinatal HIV Transmission Trials In 1994, the US-sponsored AIDS Clinical Trials Group study 076 and a separate French study demonstrated that administering the antiretroviral

92 / Kass drug zidovudine (AZT) to pregnant HIV-infected women and to their newborn babies greatly reduced the likelihood that the babies would be HIV-infected.⁷ This ‘‘076 regimen’’, consisting of AZT tablets for HIVinfected women during the second and third trimesters of their pregnancies, intravenous AZT during labor and delivery, and oral AZT drops for newborns for the first six weeks of life, immediately became the standard of care for HIV-infected pregnant women in the US and in Europe.⁸ In a context where children were dying daily from HIV infection, the 076 results were so dramatic—a reduction in HIV Maternal Infant transmission (MIT) from 25 percent to 8 percent—that study findings were translated into clinical practice with an urgency rarely experienced after a single clinical trial. Unfortunately, this public health advance held little immediate relevance for the poorer regions of the world, where the vast majority of perinatal HIV existed. First, the 076 regimen was estimated to cost about $800 per mother–infant pair,⁹ while resource-poor countries often spend $5–30 dollars per year on health care per capita. Second, even if the drug could be donated, the infrastructure requirements of the full regimen (receiving prenatal care as early as the second trimester, early HIV testing, and intravenous equipment available for all HIV-infected women’s births) were unrealistic in most resource-poor environments. Third, HIV-infected women in Africa and Asia were more likely to be breastfeeding their children—a practice with its own important public health benefit—yet it was not clear the degree to which breastfeeding might negate the benefits of the 076 intervention. As a result, the World Health Organization (WHO) convened a consensus conference to determine the implications of the 076 results for resource-poor countries. The consensus document acknowledged that, due to the expense and complexity of the 076 regimen, ‘‘no global recommendations regarding the use of ZDV [zidovudine, also known as AZT] to prevent maternal to infant transmission of HIV can be made.’’ Instead, a series of research recommendations emerged, most notably that ‘‘it is ⁷ Connor et al., ‘‘Reduction of Maternal–Infant Transmission’’; Sperling et al., ‘‘Maternal Viral Load’’, NEJM 335/22 (1996), 1621–9. ⁸ Centers for Disease Control and Prevention, ‘‘Recommendations of the U.S. Public Health Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immunodeficiency Virus,’’ Morbidity and Mortality Weekly Report, 43(RR-11) (1994), 1–21; WHO, Recommendations Use of Antiretrovirals. ⁹ Varmus and Satcher, ‘‘Ethical Complexities.’’

Harm Reduction as a Tool for Public Health / 93 essential to explore simpler and less costly drug regimens [in resource-poor countries] . . . Such regimens . . . should be urgently studied in randomized controlled trials . . . placebo controlled trials offer the best option.’’¹⁰ The document also said that studies ‘‘should be part of a research strategy which may reasonably be expected to lead to interventions which will be affordable, feasible, and sustainable in the same setting.’’ A series of eighteen trials was planned in developing countries ranging from vitamin A supplementation to short-course AZT trials.¹¹ Three years later (April 1997), Public Citizen Health Research group, a Washington-based advocacy organization, accused HIV researchers and funders of conducting unethical research because most of the new global trials included a placebo arm. Placebo controls, they argued, exploited poor women participating in these global trials, and created a double standard, as placebos no longer would have been allowable in U.S. prevention trials of HIV MIT prevention. Public Citizen instead advocated equivalency trials for poor countries, where simpler, cheaper regimens would be tested against the full 076 regimen.¹² Researchers and funders responded to Public Citizen by citing methodologic justifications for placebos, suggesting that equivalency trials would be inconclusive and also would take considerably longer to conduct, thus delaying the delivery of potentially effective HIV interventions to global communities.¹³

2. Baltimore Lead Study The ‘Lead-Based Paint Abatement and Repair and Maintenance Study’ (R & M Study) was initiated in 1993 as the third in a series of lead poisoning prevention studies conducted in at risk Baltimore neighborhoods. As background, it had been known for at least half a century that lead was dangerous to children.¹⁴ ¹⁰ WHO, Recommendations Use of Antiretrovirals. ¹¹ P. Lurie and S. M. Wolfe, ‘‘Unethical Trials of Interventions to Reduce Perinatal

Transmission of the Human Immunodeficiency Virus in Developing Countries,’’ NEJM 337/12 (1997), 853–6. ¹² Parenthetically, designing such a trial, whereby half the women would receive an intervention explicitly expected to be less effective than 076, was not addressed as an ethical dilemma by Public Citizen. ¹³ Varmus and Satcher, ‘‘Ethical Complexities’’; B. R. Bloom, ‘‘The Highest Attainable Standard: Ethical Issues in Aids Vaccines,’’ Science, 279/5348 (1998), 186–8. ¹⁴ Pollak, ‘‘Lead-Based Paint Abatement Study.’’

94 / Kass Thomas and Blackfan reported the first case of child lead poisoning in Baltimore in 1914,¹⁵ and in 1921, the International Labor Organization in Geneva sponsored the White Lead Paint Convention to limit the amount of lead in paint as well as the places where lead paint could be used.¹⁶ While the new use of lead paint in residences was banned in Europe in 1931,¹⁷ a similar prohibition was not enacted in the United States until 1978. In the 1990s 95 percent of Baltimore houses were built before the 1978 ban on the use of lead paint.¹⁸ Thus, most children in Baltimore lived in houses with considerable lead paint. In poor neighborhoods, where housing often was in poor condition, children were at highest risk of lead poisoning from flaking paint and lead dust.¹⁹ At the time, the Centers for Disease Control and Prevention (CDC) considered a blood lead level of 10 µg/dL to pose a risk to children. In Baltimore City in the early 1990s, blood elevations over this threshold level were at 10–15 times the national rate. In high-risk Baltimore neighborhoods, elevations were at 20–30 times the national rate, with 60 percent of children having levels over the 10 micrograms threshold. Further, fewer than half of Baltimore City children were being screened for lead levels by health care providers.²⁰ And while it had been known for decades that children were being poisoned in older and lower-income Baltimore neighborhoods, there was essentially no affordable new housing or completely abated housing. Despite considerable advocacy, no city, state, or federal governments in the United States mandated preventive abatement of any sort. Indeed, not only were landlords not required to engage in any abatement; they were not, until 1996, even required to inform residents of lead paint risks in the homes they were about to rent. Dr. Julian Chisolm was a physician and researcher at the Kennedy-Krieger Institute in Baltimore, a non-profit institute specializing in developmental disease and disabilities. Dr. Chisolm, as a clinician, treated children suffering from the effects of lead poisoning. In the early 1980s, legislation did exist to require ‘‘therapeutic abatement.’’ That is, abatement was required in the homes of children already found to have lead poisoning. Dr. Chisolm ¹⁵ Henry M. Thomas and K. D. Blackfan, ‘‘Recurrent Meningitis Due to Lead in a Child of Five Years,’’ American Journal of Diseases of Children, 8 (1914), 377–80. ¹⁶ International Labor Organization, Convention concerning the use of white lead in painting. General Conference of the International Labor Organization, 1921. Enacted 1923. ¹⁷ Pollak, ‘‘Lead-Based Paint Abatement Study.’’ ¹⁸ Ibid. ¹⁹ Ibid. ²⁰ Ibid.

Harm Reduction as a Tool for Public Health / 95 began to notice that, in following these children clinically, their blood lead levels often rose during the year abatement was implemented.²¹ Thus, in 1984–5, Dr. Chisolm and his colleague Dr. Mark Farfel conducted their first collaborative study, demonstrating that commonly used methods of abatement (such as burning, sanding, and stripping of lead paint, with no worker training about occupant protection) caused an increased risk of lead poisoning, given that lead dust was created through the process.²² This led to a change in abatement standards, first in Baltimore City in 1987, in Maryland in 1988, and federally in 1995, requiring new practices for lead paint abatement in homes. It now became forbidden to burn and scrape paint, and new standards required worker training, worker and occupant protection, and proper containment and disposal of debris. A follow up study conducted in vacant homes revealed that alternative abatement strategies (including sealing and covering lead paint, dust containment, replacement of windows, sanding of floors to make them smooth and thus cleanable, and the use of high-efficiency particle air (HEPA) vacuums) were considerably safer and more effective at reducing household lead dust levels.²³ A second follow up study three years later showed that these effects were sustained rather than temporary, with household dust levels in these vacant homes reduced, on average, by approximately 90 percent.²⁴ Thus, these studies documented significant reduction, but not total elimination, of lead dust.²⁵ Abatements in these vacant homes generally cost $12–15,000 per home. As a result of this work, Baltimore City began a pilot project of lead reduction, in consultation with Drs. Chilsolm and Farfel. Due to the high cost of these new abatement methods, however, only a few dozen homes were improved through this City program, and indeed the cost of abatement often exceeded the value of some of these dwellings.²⁶ Unfortunately, legislative proposals calling for mandatory preventive abatement of rental properties in Baltimore City, based on these research findings, were repeatedly defeated. In the early 1990s, recognizing that abatement was expensive while most lead poisoning occurred in low-income settings, several federal agencies ²¹ ²² ²³ ²⁵

Farfel, personal communication Oct 14, 2005. Farfel and Chisolm, ‘‘Health and Environmental Outcomes.’’ Farfel and Chisolm, ‘‘An Evaluation of Experimental Practices.’’ Pollak, ‘‘Lead-Based Paint Abatement Study.’’ ²⁶ Ibid.

²⁴ Ibid.

96 / Kass called for research proposals assessing the effectiveness of different types of lead reduction strategies.²⁷ As part of this initiative, the Environmental Protection Agency (EPA) in 1993 funded the ‘‘Repair and Maintenance’’ (R & M) Study to be conducted in high-risk Baltimore neighborhoods. The goal of this study was to measure both short-term and long-term effects on household and blood lead levels of three different abatement strategies, all employing methods shown in the 1991 study to be effective, One approach cost approximately $1,650, another approximately $3,500, and the last approximately $6,000–7,000. Two additional groups of homes were included in the study as controls: houses built after 1978 (and thus free of lead paint) and houses from the City’s prior abatement pilot project, whereby homes had received the comprehensive $12,000 abatement intervention. Families in all five arms of the study provided consent for monitoring of household lead dust levels and blood lead levels from the children at six-month intervals. It is highly likely that no abatement, and none of the accompanying education and ongoing monitoring, would have happened without the study. This study found that, while the most intensive level of abatement was the most effective, all three experimental arms reduced house dust lead levels by more than 90 percent and children who entered the study with elevated blood lead levels, on average, experienced a statistically significant decrease in blood lead concentration over time. Based on this study’s methods, HUD awarded thirty additional contracts around the country in fourteen cities to implement comparable interventions and to compare household and blood lead levels from various abatement strategies. After the study was over, however, two families brought lawsuits. One (Higgins) charged that they were never informed of the risks of the study and the possibility of continued lead exposure in their home. The other family (Grimes) charged that results regarding blood lead levels were not shared with the parents in a timely manner. The judge issued a strongly worded ruling revealing his view that the study, as designed, was unethical. Indeed, his ruling went beyond the particular charges, suggesting that researchers were leading participants to their death, again invoking the analogy of Tuskegee and issuing inflammatory language like, ‘‘the researchers intended that the children be the canaries in the mines, but never clearly told the ²⁷ Pollak, ‘‘Lead-Based Paint Abatement Study.’’

Harm Reduction as a Tool for Public Health / 97 parents.’’²⁸ This study prompted its own series of debates in the ethics world and precipitated the creation of a National Academy of Sciences panel to investigate the ethics of prevention research of this sort.²⁹

II. The Need for Additional Ethics Guidance for Public Health Prevention Research Assumptions behind existing research ethics guidelines may limit their ability to resolve dilemmas. In debates about the perinatal HIV trials, those who believed trials were ethical as designed and those who believed them to be completely unethical both invoked the Declaration of Helsinki as supporting their views. This led to international efforts to change language in the document in an attempt to eliminate ambiguities. And while such efforts, lengthy and contentious as they were,³⁰ resulted in a revision, it is not clear that the revisions provide clear moral or practical direction for researchers conducting studies of this sort. One might conclude that another revision is needed, or that guidelines are intended only to outline broad ethical norms. Our conclusion is different. We suggest that, when research ethics guidelines first were written thirty to forty years ago, they were responding to a very particular set of research problems that had captured the public’s attention: lack of informed consent, lack of prior review, and potential exploitation of captive and/or vulnerable populations. The effect of the guidelines, and of the regulations that followed, over the last few decades, has been stunning in those particular domains. Research norms now assume that research will not be conducted without prior review and without informed consent, and researchers know they must justify the use of vulnerable populations in their research. ²⁸ Ericka Grimes v Kennedy Krieger Institute Inc.; Myron Higgins, a minor, etc., et al. v. Kennedy Krieger Institute, Inc. 129. (2000), available at . ²⁹ B. Lo, B. and M. E. O’Connell, Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth and Families. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (Washington, DC: National Academies Press, 2005). ³⁰ C. Weijer and J. A. Anderson, ‘‘The Ethics Wars: Disputes over International Research,’’ Hastings Center Report, 31/3 (2001), 18–20; S. M. Tollman, H. Bastian, R. Doll, L. J. Hirsch, and H. A. Guess, ‘‘What Are the Effects of the Fifth Revision of the Declaration of Helsinki?,’’ British Medical Journal, 323/7326 (2001), 1417–23.

98 / Kass At the same time, research ethics guidelines, while responsive to the prevailing ethics challenges at the time, seem to be based on two assumptions about why ethics problems occur in human research. Both of these assumptions, I would argue, make the guidelines less relevant to the particular challenges posed by public health prevention studies such as the lead and HIV cases. Research ethics guidelines and regulations crafted thirty to forty years ago first seemed to assume that research violations emerge as a result of researchers’ individual or collective zeal for scientific discovery. Scientists, in their quest for answers, might unwittingly compromise subjects’ rights and welfare and exploit available yet vulnerable populations. Guidelines, in turn, were crafted to articulate a shared societal norm for research ethics in order to guard against the moral pitfall to which they believed research was most vulnerable: individual researchers’ inability to recognize when they were crossing a moral divide, blinded by their own intellectual enthusiasm. Second, research ethics guidelines seem to assume an ‘‘idealized’’ paradigm for how research fits in to scientific progress: research is undertaken to solve important health problems; once each problem is solved, society benefits, and science can move on to other health challenges. Guidelines remind researchers that, in their pursuit of answers to new scientific questions, they may not deny already proven interventions to research subjects. Implicit in guidelines is the assumption that, absent the research, the subject would have been provided the best proven treatment; the only reason a research subject would not access the best known treatment during research, then, is through the actions, again, of an overly zealous researcher, who might deny it to them or ask them to go off of it for the sake of science. Not addressed in the research ethics guidance was the far more likely explanation, at least in global public health research today, for why a research subject might not access proven interventions. To wit, widespread economic, political, and social structures themselves either create or permit inequities in access to flourish. Local, national, and international injustices explain why, before researchers even enter the picture, poor families in Baltimore are still offered rental homes dripping with lead, and women and children in poor countries were assumed in 1994 to have no chance of accessing the extraordinary public health advance of AZT to prevent MIT of HIV. Research ethics guidance is needed, then, on how to evaluate studies

Harm Reduction as a Tool for Public Health / 99 designed to reduce public health problems that exist because there is no political will to allocate the resources needed to implement already proven strategies. If this assumption is accurate, investigators and ethics boards need guidance on how and when it is acceptable morally to test interventions that may be cheaper or simpler than existing, proven ones, proposed only because of the extraordinary economic and social disparities that flourish in our society. With a snap of the fingers, millions of children in Africa and Asia could avoid HIV-infection, and millions of children in the United States could avoid the brain damage associated with lead poisoning. When this does not happen, however, how can we determine what is morally acceptable practice for scientists whose research questions emerge, in great part, only as a result of neglect in the policy world. The research questions examined in the lead and HIV trials, presumably, only existed thanks to the global denial of effective interventions to those who need them. Researchers are on shaky moral terrain, however, when they venture into contexts of extraordinary economic and political inequity. For this reason, clear frameworks and guidance are needed to ensure that researchers are reducing, rather than exacerbating, the considerable moral harm that occurs when public health improvement is denied simply because of a lack of global will. Without such guidance, it will be difficult to differentiate research that is likely to be exploitive or expedient from research that is likely to improve the public’s health.

III. Harm Reduction as a Strategy for Public Health Research Harm reduction is a strategy that is increasingly accepted and implemented in public health practice. Harm reduction in public health can be defined as any policy, program, service, or action that works to reduce, rather than eliminate, harms to health for individuals or communities.³¹ ³¹ R. Newcombe, ‘‘The Reduction of Drug Related Harm: A Conceptual Framework for Theory, Practice and Research,’’ in The Reduction of Drug Related Harm, ed. P. O’Hare et al. (London: Routledge, 1992).

100 / Kass Harm reduction is based on the assumption that, where the underlying causes of public health burden (i.e. widespread morbidity/mortality) remain difficult to eliminate, intervening to reduce some of the adverse health consequences of such root problems can result in a ‘‘net reduction in harm’’ to affected communities.³² Harm reduction is intended to be pragmatic, in terms of providing a more feasible option, and to prioritize goals, focusing on the immediate need to protect individuals from harm, while recognizing that it fits into a larger hierarchy of important public health goals.³³ Harm reduction has received the greatest publicity in practice contexts such as needle exchange to prevent HIV infection among drug users and provision of contraceptives and condoms to adolescents to prevent teen pregnancy and HIV. Harm reduction, like much of public health, is inherently consequentialist: it assumes that even incremental improvement in public health outcomes is to be valued; it also is practical, suggesting that one has a responsibility to change what can be changed, while continuing to find strategies to address the larger problems. While harm reduction in public health practice is a generally accepted tool among public health professionals, it has been controversial more broadly, particularly when, like with the examples above, it involves practices like sex and drugs that carry significant moral and political overtones. As such, public health practitioners have been accused of being indifferent to or, even worse, complicit with disquieting and harmful behaviors. As a methodologic strategy for research, however, harm reduction seems to be absent from the literature. Based on definitions of harm reduction in practice, harm reduction research might be defined as an investigative strategy to measure the effectiveness of potentially promising harm reduction strategies under controlled conditions. The goal is to determine whether strategies are effective at reducing overall morbidity and mortality, often incrementally, rather than whether they provide the best possible ³² S. Lenton and E. Single, ‘‘The Definition of Harm Reduction,’’ Drug and Alcohol Review 17/2 (1998), 213–20. ³³ UK Harm Reduction Alliance, ‘‘Ukhra, Definition of Harm Reduction 2005. Available at .

Harm Reduction as a Tool for Public Health / 101 response. Further, as defined here, harm reduction research often will be testing modifications of existing approaches. As such, they build on the proof of concept demonstrated by earlier studies. Further, they often will be proposed because the ‘‘best’’ intervention—proven in concept to be effective—is not reaching target populations due to its expense or technical complexity. According to this definition, both the lead and AZT studies are examples of harm reduction research. It is a thesis of this chapter that harm reduction studies can be an important tool of public health but also are far from simple, morally. As such, they ought to be acceptable to conduct only under carefully prescribed conditions. Harm reduction research, as defined, brings researchers into complex moral terrain. On the one hand, harm reduction research is consistent with what public health professionals do routinely: provide interventions to those who bear the burden of societal neglect, and devise and test new interventions where appropriate ones do not exist. In practice, however, harm reduction research is further asking public health researchers to develop and test interventions in situations where effective interventions do exist. The problem is one of access, not one of science and technology. This paradox of course is not new to public health. The evidence is overwhelming that clean water, existing vaccines, and better nutrition would improve global public health outcomes more dramatically than most new technologies currently under investigation. Due to a complex of political, social, and economic structures and policy decisions, much of the world does not have safe water or adequate nutrition, however, and many global clinics have shortages of even the cheapest vaccines and antibiotics. That public health researchers, in response, have developed and tested ‘‘secondlevel’’ interventions such as bed nets, oral rehydration, and micronutrient supplements is generally thought of not only as laudable, but indeed among the greatest success stories of global public health research.³⁴ Indeed, ³⁴ A. Sommer, ‘‘Vitamin A Deficiency and the Global Response,’’ Forum of Nutrition, 56 (2003), 33–5; H. W. Choi, J. G. Breman, S. M. Teutsch, S. Liu, A. W. Hightower, and J. D. Sexton, ‘‘The Effectiveness of Insecticide-Impregnated Bed Nets in Reducing Cases of Malaria Infection: A Meta-Analysis of Published Results,’’ American Journal of Tropical Medicine and Hygiene, 52/5 (1995), 377–82; C. C. Carpenter, ‘‘The Erratic Evolution of Cholera Therapy: From Folklore to Science,’’ Clinical Therapeutics, 12 (Suppl A) (1990), 22–7; ‘‘Water with Sugar and Salt,’’ Lancet 2/8084 (1978), 300–1.

102 / Kass much of the work of public health has been to identify, test, and implement strategies to reduce disease burden in settings where, if different global or local policies existed to address the larger issues, much of the public health burden would disappear. On the one hand, it is consistent with the ethos of public health to identify opportunities to help now, quickly, and effectively in order to reduce morbidity and mortality. On the other hand, there ought to be moral pause if public health research becomes too willing to accept the problems caused by unjust structures as a given, and works simply to defuse their harmful effects. Public health researchers, then, without thoughtful attention, might well be accused of simply endorsing existing and unjust structures rather than using their considerable talents to change them. Further, harm reduction as a tool of research raises additional questions that harm reduction in public health practice does not. Presumably, few will advocate that direct aid in terms of food, antibiotics, or physical protection should be denied to people who desperately need so very much more. In practice, one must help those in need in any way possible, regardless of the root causes of their desperate circumstances. In research, however, one cannot promise that one’s interventions are providing direct and tangible benefit. Some experimental interventions fail, and sometimes subjects are enrolled as controls. Research is like playing the lottery, and the wager is for a possible, rather than certain, harm reduction payoff, often to future and unspecified ‘‘others.’’ Perhaps most importantly, even where research demonstrates the efficacy of the harm reduction interventions, there still is rarely a guarantee that even these simpler harm reduction strategies will be implemented into practice where they are needed, especially given the track record of societal neglect. It is our thesis that the ethical acceptability of harm reduction as a tool for public health research depends on the ability of a given study to be acceptable according to a series of threshold considerations. These threshold considerations are designed to help researchers and reviewers determine whether the expected benefits from a ‘‘harm reduction study’’ outweigh the inherent problems harm reduction research inevitably raises. (Stated in the reverse, is more harm likely to result from conducting the study or from not conducting it?) Calling the below ‘‘threshold considerations’’ may be overreaching. It is not our belief that all of the listed considerations must be met for a given study to be acceptable. At the same time, the criteria by which to determine if a public health prevention research is

Harm Reduction as a Tool for Public Health / 103 acceptable may be somewhat different from the traditional criteria used on a research ethics checklist. For that reason, they are delineated and explained here. Further, not only is it true that all criteria are not likely to be met every time, it is also true that conducting a harm reduction study, even one that does meet a threshold level of considerations, will remain morally troubling. When one is trying to make small inroads to considerable social and political injustice, one ought to be troubled by the considerable harm that individual ‘‘subjects’’ continue to encounter, even in the context of their study participation. A relevant, although far from determinative, question is whether more harm is likely to result to individuals and communities involved in harm reduction research from enrolling, or from the study never being done. Deciding whether to approve or conduct such a study must be rational and well-reasoned, but it is unrealistic to believe it will feel completely ‘‘right.’’ It is because of the moral tension that will remain after a determination is made that each evaluation must be based on rigorous analysis to determine whether the research, on balance, is acceptable to go forward.

IV. Evaluation Criteria 1. How Inaccessible, Really, is the ‘‘Gold Standard’’ Intervention? While innumerable effective interventions are out of reach of people who need them, they vary in just how far out of reach they are. This distance can be relevant to how acceptable it is to move forward with testing an alternative strategy that may be of unproven efficacy. There are clear examples of effective ‘‘gold standard’’ interventions (including HIV therapy for many of the global poor) that recently were considered completely inaccessible and now are more widely available. Access, thus, is a moving target, and the reasons for the lack of access vary in morally relevant ways. There is a tremendous difference, practically and morally, between the gold standard intervention being clean water for a large population and a drug recommended by WHO and available currently only to the urban but not rural residents of a poor country. While

104 / Kass there is no clear line that can be drawn to delineate which interventions are too large, complex, or expensive to hold out for, the point of this consideration is to remind researchers that the fact that existing interventions are not available is not enough to consider harm reduction research acceptable in and of itself. Just how inaccessible they are is morally relevant.

2. What is the Researcher’s Track Record in Getting Previous Research Interventions Implemented into Practice? The modal type of harm reduction study, as defined here, is a study to examine the efficacy of a modification to an intervention that has become standard in more affluent settings. Further, as defined here, it is often a preventive intervention designed to reduce morbidity or mortality of an important public health program locally. The need to study the efficacy of the modification is justified, generally, by the claim that the modified strategy will have a better chance of being accessed by the local population than the gold standard has. While such a claim surely sounds sensible, it must be examined and challenged. One might reasonably assume that cheaper or simpler interventions will have a better chance of being implemented, but the logic of that assumption alone is insufficient justification. Instead, the track record of the individual researcher, collaborative group, research institution, sponsor, or local community/country of getting research findings implemented into practice should be examined, especially in the setting in which the research is proposed. If this research group has conducted eight studies previously, with spectacular findings, but, sadly, none has been implemented (often through no fault of their own), there is little reason to suspect this next study will be the one to reverse the trend. If, on the other hand, after previous studies by this team or organization, policy changes occurred and interventions were implemented, the practical justification for the compromise approach has more credibility. If communities feel they have experienced public health improvements thanks to this research team, they, and review boards, are more likely to believe public health benefit can be expected from these researchers again. Fortunately, there are innumerable examples of research being conducted in poor

Harm Reduction as a Tool for Public Health / 105 communities that resulted in real change and health improvement for the local community.³⁵

3. What Other Evidence Suggests the ‘‘Harm Reduction’’ Intervention, if Effective, might Reach the Community in the Future? While the best evidence for future implementation may be the track record of the research group, several other factors are relevant and meaningful. A commitment or strong interest from a donor organization or a request for this kind of research from a local official also can add credibility to the researchers’ claim that this compromise approach will result in access to the benefit in question.

4. Is the Study itself Likely to Provide Benefit to the Individuals Enrolled and/or to the Study Community? This consideration asks about any potential benefits from the study, separate from potential future access to the study intervention itself. In general, the greater the degree of compromise from an existing gold standard, and the greater the uncertainty about either efficacy or future access, the more tangible must be the ‘‘real time’’ benefit to individuals and/or the community involved. This is not to say that providing tangible benefit to communities during a study eliminates the need to attend to the previous criteria; to reiterate, the most important consideration is the likelihood that the harm reduction strategy will be implemented in the future. At the same time, because both efficacy and future implementation vary in their likelihood, and never can be guaranteed, and because the population is vulnerable to exploitation, other benefits should exist. For individual participants, if the study indeed is testing a modification of efficacious interventions (rather than completely novel concepts), there may be reason to believe enrollment is beneficial. Reviewers or ³⁵ R. Levine et al., Millions Saved: Proven Successes in Global Health (Washington, DC: Center for Global Development, 2004).

106 / Kass IRBs should examine how much is already known about this category of interventions and make their best determination. Some studies, also, provide ancillary benefits (in terms of other available health care, etc.), again, suggesting that benefit is likely for the individuals who enroll. Ancillary benefits also can exist for communities, and can be morally relevant when weighing the appropriateness of a ‘‘harm reduction’’ study proposal. Capacity development, in terms of improvement of clinic facilities, training of personnel, or improving the water supply, all can provide important benefit. Local input will be needed to determine what types of benefits are meaningful, and negotiations will be needed to determine what researchers and sponsors reasonably can provide. Individual and community benefits should be examined independently. In the end, like with all of the considerations listed here, if one cannot be met, the requirements to meet an adequate standard for the remaining considerations become even stronger.

5. How Susceptible is the Community to Exploitation, and What Safeguards are in Place to Minimize that Risk? By no coincidence, the very regions of this country and the world with the greatest public health problems also are the regions most susceptible to human rights violations and exploitation.³⁶ Such communities have the fewest alternatives, the greatest needs, often include individuals with the least education, and, perhaps internationally more than in Baltimore, may have an unquestioning trust of the medical and/or research establishment.³⁷ The more vulnerable a group is to exploitation or to unexamined acceptance of options presented to them, the greater the burden on researchers to guard against exploitation. This can include involvement of more empowered surrogates—individuals or groups who can speak to the interests of target populations³⁸—and it can involve extra scrutiny on the part of review ³⁶ J. M. Mann, L. Gostin, S. Gruskin, T. Brennan, Z. Lazzarini, and H. V. Fineberg, ‘‘Health and Human Rights,’’ Health and Human Rights, 1/1 (1994), 6–23. ³⁷ UNAIDS. ‘‘Ethical Considerations in HIV Preventive Vaccine Research’’ (2004), available at . ³⁸ C. Beyrer and N. Kass, ‘‘Human rights, Politics, and Reviews of Research Ethics,’’ Lancet, 360 (2002), 246–51.

Harm Reduction as a Tool for Public Health / 107 boards, as always is given to research with vulnerable groups, to ensure that risks are reasonable and benefit guaranteed. When groups are vulnerable, one cannot rely on informed consent as a safeguard to what is acceptable research. Oversight must be vigilant, and it must be mindful that research ethics demands greater protections for subjects and communities when subjects and communities cannot as readily advocate for themselves.

6. What Procedures are in Place to Solve this Dilemma? Is there ‘‘Procedural Justice’’? Harm reduction studies are, by definition, morally dilemmatic: there are moral demands to conduct a harm reduction study and moral demands never to compromise, especially when the compromises are only proposed for interventions with the poor. Ultimately, there must be fair procedures in place to balance a need for public health progress against the potential for exploitation and expediency. The degree to which studies have satisfied the above criteria will be a matter of opinion, and which criteria are given greatest weight and whose opinion counts will become determinative. Clearly, affected communities must figure prominently in procedures for making a decision about whether a particular study of this sort should be conducted. A significant responsibility of researchers, in turn, may be to enhance communities’ capacity over time to understand research designs, the epidemiology of local health problems, and ethics. One recent initiative of the NIH has that as its goal: designing mechanisms to empower communities regarding how, ethically, public health prevention research should be conducted.³⁹ At the very least, dialogue between researchers and communities helps educate communities about the importance of certain public health issues and helps inform researchers about the priorities and social context of participants. An informed and involved community will ask tough questions, and ultimately, if they sign on to a harm reduction study, can be the researchers’ strongest partner. Through their involvement, they may more fully appreciate the injustice of being offered a second-tier ³⁹ National Institutes of Health. Environmental Justice: Partnerships for Communication. ES–03–007. 2003. National Institute of Environmental Health Sciences; National Institute for Occupational Safety and Health. Ref Type: Report.

108 / Kass approach which may lead to outrage, and communities or individuals may begin to advocate in a way they never have before. Or perhaps they will decide that, after decades of inaction, they would like the information a study can provide them so they can take action into their own hands. In Baltimore, for example, community meetings can be held in which researchers present the relevant facts: homes are filled with lead; abatement strategies exist but cost $12,000; the government continues to do nothing about it; and landlords have free license to rent lead-filled homes to families with young children, year after year. One option, the researchers can explain, is to study the effectiveness of the various parts of a comprehensive abatement strategy, to see which of the pieces makes the most difference, and how much each of those costs. Families, then, might be able to implement key strategies themselves or could advocate to require landlords to implement the most effective pieces. Families, alternatively, through the process of being informed, might reject such a compromise approach as offensive to them as poorer citizens, and might organize advocacy efforts and protests to get public policy changed. Or they might decide to do both. This decision affects them more than anyone; they are, indeed, the ‘‘subjects’’ of such a decision and, as such, their input is critical. However, while the importance of community assessment is clear, it is also critical to remember that community endorsement alone does not make a study ethically acceptable.

7. Are Researchers Engaged in any Activities to Address the Underlying Problem? When harm reduction is implemented in public health practice, attempts generally are made to mediate against the underlying problem as well as to provide practical help through the harm reduction program. Thus, needle exchange programs also direct addicts to drug treatment, and condom distribution programs counsel teens about the advantages of postponing sex. Researchers, too, have a responsibility to advocate for policy changes to eliminate the need for harm reduction approaches. Lead researchers must advocate for access to existing abatement strategies, and HIV researchers must advocate for creative means of financing and distributing proven interventions for HIV. That there may be a practical need to find less expensive or simpler interventions does not relieve professionals of the

Harm Reduction as a Tool for Public Health / 109 responsibility to advocate for access to better services and treatments. Demonstration that researchers have commitments to alleviate the larger problems may, too, be a consideration in determining the acceptability of the harm reduction study. In the end, it may be relevant whether the researcher is committed to reducing the public health problem, writ large, or whether it seems the researcher is interested more narrowly in this particular scientific question.

V. Criticisms of the Harm Reduction Approach in Research We are aware that the harm reduction research approach and the considerations used, together, to judge the acceptability of such an approach are likely to be criticized. We anticipate here four general areas of criticism and try to respond to them.

1. These Criteria are too Permissive and will Perpetuate Existing Injustices Interventions for the health problems in question already exist. It is not necessary to test new interventions, particularly interventions expected to be less effective. It both delays communities’ access to the proven interventions, and it confirms that the global community is willing to provide the poor with substandard levels of care. If public health professionals are troubled that existing interventions are not reaching communities that need them, then these professionals ought to devote their considerable experience and expertise to advocating for policy change, not for conducting more research. A few public health ‘‘crusaders’’ remind us that compromise vs. wait and see are not the only choices, even in the poorest of communities. Dr. Paul Farmer found a way to raise private funds and bring HIV treatment to poor Haitians when everyone else was debating which compromise approach was most appropriate.⁴⁰ Such actions not only provide drugs to people ⁴⁰ P. Farmer, F. Leandre, J. S. Mukherjee, M. Claude, P. Nevil, M. C. Smith-Fawzi, S. P. Koenig, A. Castro, M. C. Becerra, J. Sachs, A. Attaran, and J. Y. Kim, ‘‘Community-Based

110 / Kass in need, they also serve as individual demonstration projects that other alternatives exist. From our perspective, this is the most important criticism, and one with significant moral merit. In the end, multiple and varied solutions are needed to make inroads to growing global injustice. Providing short-term help to people who need it is morally required; testing new ideas that may be locally relevant also is required, assuming the above considerations are addressed. The judge in the Grimes Baltimore lead case suggested the researchers should have moved residents to neighborhoods where lead is not a problem. While this seems unreasonable, it also is not reasonable for public health researchers, in situations where inequity is responsible for access problems, to view themselves simply as technical experts. In the end, it is our view that multiple strategies are both needed and appropriate, but the moral tension at stake in this criticism is exactly the tension that causes this context to be so troubling.

2. This Approach is too Strict—Requiring Evidence of Future Access will Make the Best the Enemy of the Good The considerations above emphasize the need to examine whether it seems likely that the modified intervention actually will reach target communities better than the ‘‘gold standard’’ intervention did. This criticism agrees that future access, of course, is the primary goal of conducting the research, but that it is unrealistic to demand some assurance of that before the study starts. Most public health interventions used today were tested merely as good ideas, with no guarantees of future implementation when first tested. When results of important studies, for example with Vitamin A or nevirapine, showed dramatic public health improvement, it was then easier to convince health ministers and donors to commit resources for implementation. Most donors and government officials will not commit to future funding, and such a criterion may result in many good ideas never being tested, and enormous potential will be lost. Approaches to HIV Treatment in Resource-Poor Settings,’’ Lancet 358/9279 (2001), 404–9; P. Farmer, F. Leandre, J. Mukherjee, R. Gupta, L. Tarter, and J. Y. Kim, ‘‘Community-Based Treatment of Advanced HIV Disease: Introducing Dot-Haart (Directly Observed Therapy with Highly Active Antiretroviral Therapy),’’ Bulletin of the World Health Organization, 79/12 (2001), 1145–51.

Harm Reduction as a Tool for Public Health / 111 This, too, is a significant criticism. We have two responses. First, the considerations listed above are meant to be examined and weighed in totality. There may be more weight for one and less weight for another. In the end, individual judgments must be made about study acceptability. The point of listing them is to identify which factors are morally relevant to allowing such types of research to go forward. Saying that the modified intervention is less expensive or simpler is not enough to justify the study being done. Instead, there must be some reason to believe that the simpler intervention will be accepted. The ‘‘evidence’’ for future implementation is unlikely to be a firm ‘‘contract’’ as has been suggested by some as that, indeed, seems unrealistic.⁴¹ Rather, it may be that the funder has a track record for policy advocacy or the research team has been collaborating with the local community enough to have a track record of change. Second, and most important, examining the likelihood of future access is not meant to apply necessarily to all research conducted in poor communities. Rather, it is listed here as a critical consideration for research pervaded by a very particular type of moral problem: there is an existing public health intervention that could be provided within the local community were there a different level or type of political will, and the study in question is a direct response to that lack of political will. Thus the explicit rationale for the study is to find interventions that have a chance of being more accessible to poor communities, by virtue of their being less expensive or less complex. When the justification for engaging in harm reduction research is based almost exclusively on the better likelihood of future access (not simply on efficacy), then demonstration of likelihood of future access must enter the equation.

3. This Approach is too Strict—Few Studies have Results that, on their own, are Ready to be Implemented as Policy To assume that one study will have results so conclusive as to change public policy shows ignorance of both science and policy making. Replication of studies is a core feature of scientific truth, and to suggest that an intervention ⁴¹ A. K. Page, ‘‘Prior Agreements in International Clinical Trials: Ensuring the Benefits of Research to Developing Countries,’’ Yale Journal of Health Policy, Law, and Ethics, 3/1 (2002), 35–64.

112 / Kass should be guaranteed future access suggests that public health programs may be implemented—presumably at great cost—with insufficient scientific validity. In response, of course policy only should be implemented when the evidence for effectiveness is solid. Discussions of future access only are relevant for interventions that have either extraordinarily dramatic results and/or interventions whose effectiveness has been validated in several studies. At the same time, when testing a modification of an existing intervention, there may be less need to replicate multiple times than when testing a truly novel concept. Both the lead and the HIV studies tested components of effective, more complex regimens. Thus the total trajectory between idea and results likely will be shorter. We acknowledge that not all harm reduction research literally will be testing modifications of existing approaches. Some harm reduction research will be testing a more novel approach, and those studies will have a higher bar to pass in terms of concluding about effectiveness. Decisions will need to be decided on a case by case basis, but the considerations for acceptability will be the same: what is the track record of investigators in getting study interventions available to communities when research is over? What related benefits are provided along the way? And how out of reach is the ‘‘gold standard’’ intervention?

4. This Approach is too Strict—If a Study Provides Benefits, it should Simply be Provided to People who are in Need It is likely true that the houses inhabited by participants in the Baltimore lead study put residents at lower risk of lead poisoning than other dwellings in which they would have lived, since all houses received some abatement, and every family received education about lead poisoning prevention. Similarly, the women in the short-course AZT trials likely received better care and, in some cases, a lower risk of having a baby infected with HIV, by virtue of being in the trials. That individual studies provide benefit to those who enroll in them is not the only relevant ethics consideration, however. Studies that provide benefit to the individuals who enroll can still be exploitive. What is complicated about research is that its ultimate goal is not to provide service. Rather, its goal is to make public health change based on

Harm Reduction as a Tool for Public Health / 113 scientific discovery. Since many studies do not yet, or do not alone, precipitate policy change, it is relevant and useful to provide benefit to study subjects. At the same time, to begin to confuse research and service purpose by placing too much emphasis on the benefits that are provided during the study itself without attention to how the study is relevant and can be part of a trajectory of public health policy change is disingenuous to the purpose of research and, in turn, to research ethics. In our saying that improving the well-being of study subjects is not enough to ethically justify a study in a poor region is not to suggest that benefits be taken away from people who desperately need them. Rather, it is to continue to push to change the norm, as necessary, by increasingly viewing research as a long-term engagement with a community, rather than a short-term treatment program. If there is no evidence that research programs lead to public health benefit among anyone beyond the individuals who took part in the study, the research enterprise clearly is failing. Fortunately, there are many examples of research collaborations leading to public health practice changes in the community, as a direct result of the research.⁴²

5. Requiring Local Input to Sort out These Dilemmatic Situations is Unrealistic Often local communities do not understand these larger issues, or they simply are attracted to the economic or employment benefits of a study coming to their community; local researchers, too, may have conflicts, given the professional and economic benefits they may reap through involvement in the research. While these criticisms are legitimate in some settings, the change in what many local communities understand about research today compared to even ten years ago is extraordinary, in terms of having more individuals with a sophisticated understanding of research, and of why research is conducted. With appropriate capacity development and simply with more experience with research, important changes have occurred in the ability of local groups ⁴² L. J. Fiedler, ‘‘The Nepal National Vitamin A Program: Prototype to Emulate or Donor Enclave?,’’ Health Policy and Planning, 15/2 (2001), 145–56; F. Nyonator, J. K. Awoonor-Williams, J. Phillips, T. Jones, and R. Miller, ‘‘The Ghana Community-Based Health Planning and Services Initiative for Scaling up Service Delivery Information,’’ Health Policy and Planning, 20/1 (2005), 25–34.

114 / Kass to advocate for themselves, and to advocate with sophistication. Ultimately, however, some local groups will not be sufficiently informed or empowered to be their own best advocate. This does not diminish our attempts to empower them, or to try to involve them where we can. Input occurs along a spectrum, not as a yes or no event. Groups can articulate what is important to them, even without understanding the specifics of a study. They can be told that there are some very expensive medicines they can fight to get, and they can also decide to figure out if other interventions also might be helpful in the meantime. The responsibility is ours to begin to frame the dilemmas as they really exist and get legitimate input about how to resolve them. That injustice in distribution will not be new to the communities in question. Framing the issues as they exist, ultimately, is respectful of communities involved, and can add some important voice to how research should be redesigned and when it is acceptable to go forward.

Conclusion Many ethical landmines can exist in the conduct of public health research, and many exist even when focusing more narrowly on research across economic and/or cultural divides. The purpose here was to examine a still more specific situation: when, if ever, can it be ethically acceptable to conduct research to find simpler or cheaper public health preventive interventions than those already proven to be efficacious? Harm reduction research is offered here as a morally acceptable approach, but one that only can be undertaken when there are good reasons to believe that the intervention (often a modification of existing approaches) will be effective and good reasons to believe that the intervention will reach those who need it. Harm reduction research will be troubling on many levels. Working within the confines of extreme injustice, one must walk a fine line between improving the situation and condoning it. How can public health professionals endorse seeming band-aid solutions for people who need so very much more? At the same time, after decades of observing little progress on the larger issues, public health professionals, whose mandate is to reduce morbidity and mortality among the public, may seek additional tools. The ultimate test of the acceptability of such an approach is indeed

Harm Reduction as a Tool for Public Health / 115 its ability to demonstrate a tangible reduction in public health harm, particularly over the long run. Yet, in the short run, this will always be uncertain, because one cannot anticipate if the intervention will be effective, and because, given a history of failing to implement other interventions, guarantees of implementation of simpler or cheaper interventions are hard to secure. When involving the world’s poorest and most vulnerable populations, the ethical stakes are higher. We owe it to these individuals as well as to the integrity of our own profession to create and abide by strict but reasonable standards for harm reduction research in public health. A reduction of public health harm must be ensured for those who have received fewer global benefits than clearly is their due.

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6 Harm Reduction Research: Ethics and Compliance Ana S. Iltis∗

I. The Importance of Harm Reduction Research Using the examples of the perinatal HIV transmission trials conducted in developing nations and the Kennedy Krieger lead abatement study conducted in Baltimore, both during the 1990s, Nancy Kass explains the background conditions that sometimes lead to harm reduction interventions and research, defends the need for some harm reduction research, and argues that harm reduction research can be permissible in principle as long as certain threshold criteria are met. I echo Kass’s general claim that harm reduction research can be permissible in principle in the face of background inequalities, injustices, or circumstances of inaccess. Later in the chapter I consider two problematic claims Kass makes: (1) that research ethics guidelines and regulations were written thirty to forty years ago and are ‘‘less relevant to the particular challenges posed by public health prevention studies’’ (p. 98) and (2) that one criterion for the ethical conduct of harm reduction research should be that the researchers also are advocates who strive to change the underlying injustices that lead to inaccess and the need for harm reduction approaches. ∗ I would like to thank Birgitta Sujdak and Alan Sanders for their help with research used in developing this chapter.

118 / Iltis Before continuing, it should be noted that Kass’s contribution to this area of concern is of great importance; much of the literature on the harm reduction studies she discusses has obscured the very problem she raises, namely whether harm reduction can be permissible in principle. Typically the debate over the HIV trials, for example, has been seen as admitting of two major camps: those who opposed the studies and those who defended them. However, there are three main positions. Those who opposed the studies fell into two categories: some argued that active-controlled equivalency studies should have been conducted to find an equivalent treatment,¹ and some held that active-controlled studies should have been conducted for the purposes of finding an effective (even if not equally effective) intervention.² These two different groups of critics rarely are distinguished. The former argues that harm reduction in this case was unacceptable; for any study to be permissible it would have had to be aimed at finding an equally effective but less costly intervention. The latter group accepts the in principle permissibility of harm reduction research but argued that the research design was unethical. The third group includes those who defended the studies as designed. Understanding the complexity of the debate over the HIV trials gives us more insight into the importance of the problem Kass has identified. The discussion of the possibility of ethical harm reduction research must address two separate points that thus far have not been carefully distinguished: (1) the in principle permissibility of harm reduction interventions or research and the circumstances under which it may be permissible to pursue harm reduction and (2) the criteria that must be met for the ethical conduct of harm reduction research. Is harm reduction rather than harm elimination in principle permissible when the reason for seeking ways to reduce rather than eliminate harm relates to background conditions of injustice or inequality? As Kass observes, this is different from aiming to reduce harm in cases in which trying to eliminate harm altogether has been ineffective for other reasons. For example, needle exchange programs aimed at reducing HIV transmission in IV drug users have been defended on the grounds that not all drug users have ¹ U. Schuklenk, ‘‘The Standard of Care Debate: Against the Myth of an ‘International Consensus Opinion’,’’ Journal of Medical Ethics, 30 (2004), 194–7. ² M. Angell, ‘‘The Ethics of Clinical Research in the Third World,’’ NEJM (1997), 847–9.

Harm Reduction: Ethics and Compliance / 119 been or will be able to quit—harm elimination has failed. In the cases Kass discusses, harm could be eliminated rather than merely reduced if resource limitations were removed. We should note that in some cases it would take more than we might realize to overcome all the resource limitations that may render harm elimination unfeasible. For example, in the perinatal HIV transmission scenario, more than a constant and cheap supply of the drugs required for the 076 protocol would have been necessary, such as a health care infrastructure that made early prenatal care routine, that could deliver the 076 protocol, and that could monitor women throughout and after their pregnancies. I support Kass’s conclusion that harm reduction is permissible in principle in situations of background inequalities by highlighting five considerations. First, the world is a less than ideal place. To suggest that public health practitioners always should aim to provide only the best interventions and that instead of seeking less expensive and perhaps less effective interventions they should be advocating for changes that will grant all access to the best interventions is unrealistic. It also ignores the short- and mediumterm needs of various populations and communities. In some cases, to advocate for change in the long run may be important, but it often is not possible to realize change immediately, meaning that many will have their needs totally unmet in the short and medium term. Even thinking of long-term changes, one must realize that ours is a pluralistic society. It is unreasonable to believe that in all cases society will be willing to implement the changes some think are necessary and appropriate to create what they believe is a just environment. We are a divided country, let alone world, and it is unrealistic to think all will share a vision of justice. Insisting on all-or-nothing approaches that either give universal access to the best or provide nothing by way of harm reduction may leave some people worse off. Second, if our standard always is ‘‘nothing less than the best,’’ we are unlikely ever to be able to ‘‘keep up’’ with meeting all the needs of all persons. As treatment and prevention options expand, and as new health threats emerge, the costs sometimes may be great and other significant barriers may emerge, making it impossible or unreasonable to provide the best to all people. Third, ‘‘the best’’ may not always be what particular persons or communities want or what is overall best for them. In the clinical setting patients

120 / Iltis sometimes accept less than the most effective treatment for a variety of reasons, including side-effects or quality of life considerations. Physicians have noted that one must avoid seeing the ideal as the only worthy target.³ Achieving an ultimate cure is not always a goal in medicine; reductions in gradations of harm matter. To treat harm reduction as impermissible for public health practice is to have a double standard. In the public health setting all-or-nothing approaches to harm elimination may leave communities without access to other benefits, making harm reduction approaches overall more beneficial than harm elimination efforts in some cases. Overall consequences are important from the public health perspective. I recognize that part of the debate is whether background injustices that generate the need for a less-than-the-best approach are illegitimate bases for pursuing harm reduction rather than harm elimination. One might argue that quality of life issues are a legitimate basis for choosing less than the most effective treatment but inability to pay should not be. Resources are limited, sometimes for reasons we may hold are unjust, but they nonetheless are limited. While we can debate the justice claim philosophically and ask what we would do in ideal circumstances, public health practitioners must face very real, practical questions about how best to meet needs and improve health in light of non-ideal circumstances. Hypothetical questions about a non-existent ideal world are irrelevant for those trying to meet the everyday needs of people who have less. Costeffectiveness is an important concern in public health precisely because public health practitioners respond to real world circumstances, needs, and limitations.⁴ Fourth, harm reduction approaches can be seen as steps in the process of improving lives rather than ultimate ends. Those who criticize harm reduction as an excuse never to maximally improve health and welfare must substantiate the claim that harm reduction efforts are not responsible attempts to respond to reality. Harm reduction need not mean that no one ought to strive for an overall better world in which specific harms can be eliminated rather than merely reduced. Nor does accepting harm ³ P. Cotton, ‘‘ ‘Harm Reduction’ Approach May Be Middle Ground,’’ Journal of the American Medical Association, 271/21 (1994), 1644–5. ⁴ D. Callahan and B. Jennings, ‘‘Ethics and Public Health: Forging a Strong Relationship,’’ American Journal of Public Health 92/2 (2002), 169–76.

Harm Reduction: Ethics and Compliance / 121 reduction imply that one thinks harm reduction is ‘‘good enough’’ for the poor. Harm reduction may be the best that can be done, given all the political, social, and economic factors that shape health and health care, at any given time. Fifth, we must overcome the concern that public health practitioners will be complicit with or at the very least appear to condone background injustices if they engage in research aimed at reducing rather than eliminating harms when the reason for pursuing harm reduction involves background resource limitations. Consider the parallel to harm reduction approaches implemented in the face of other challenges. Some have suggested that in promoting harm reduction activities, such as needle exchange programs, practitioners appear to condone illicit drug use.⁵ If we follow this reasoning, health care professionals frequently face situations in which they could be accused of condoning behavior we might believe is wrong. For example, typically we do not assert that by treating prostitutes for sexually transmitted infections (STIs) and enabling them to continue their work, physicians and nurses either condone prostitution or the life circumstances that may have led people to prostitution. Moreover, we do not hold that a physician who treats an abused woman’s injuries and in doing so enables her to maintain the semblance of a normal life in which she hides her situation has condoned her abuser’s behavior or been complicit with her abuser. In both cases, health care professionals are faced with persons in need and they respond to those needs in the best way the circumstances allow. One could insist that the prostitute agree to stop engaging in prostitution before she is to receive treatment. Or, one could hold that rather than finding ways to treat and prevent STIs one should focus one’s energies on preventing prostitution by helping women find alternative employment. One could insist that the battered woman leave her abuser and press charges before responding to her immediate need so that she is less likely to face further abuse. Or, one could hold that resources should be directed away from providing emergency treatment to battered women and toward preventing abuse altogether. These strategies, if effective, could leave the women involved better off in the end. But they may very well leave these women worse off. In an ⁵ D. C. Jarlais, S. R. Friedman, and T. P. Ward, ‘‘harm reduction: A Public Health Response to the AIDS Epidemic among Injecting Drug Users,’’ Annual Review of Public Health 14 (1993), 413–50.

122 / Iltis ideal world, the prostitute would find better work and the abused woman would not be battered, but the world is far from ideal and health care professionals have a duty to respond to needs rather than merely to engage in wishful thinking. Public health practitioners facing populations with great need and limited resources find themselves similarly situated. While they may hold that it is wrong that resources are limited because of injustices (such as exploitative wages or discrimination), or simply that it is unjust for some to be poor or for significant inequalities to exist, to refuse to act in ways that promote a population’s interests in light of the circumstances is to fail to do their duty. In attempting to avoid the appearance of condoning background circumstances of injustice or inaccess, public health practitioners who refused to engage in harm reduction activities would be failing people in need. Public health practitioners have a responsibility, like all health care professionals, to improve welfare given the current environment. As Kass warns, we must be careful that the permissibility of harm reduction is not taken as license never to aim for the best, always to select the most expedient route without due consideration of other obligations and factors. Here we must be guided by the model that guides public health ethics in general, which includes an obligation to consider the overall benefits and burdens of interventions.⁶ In some cases, attempting to implement an ideal approach is either futile or yields less overall benefit than another approach. Generally, public health ethics requires the less ideal approach in such cases. Open to debate in particular cases is the question of whether a harm reduction intervention actually yields more overall benefit than harm or whether involvement in the practice is too egregious. Two uses of harm reduction in recent literature that I suspect would raise significant points of debate are justifications of the medicalization of female circumcision/female genital mutilation,⁷ and legalization of euthanasia,⁸ on grounds that medicalization/legalization will reduce harm. Individual applications of harm reduction approaches require careful analysis, but the ⁶ J. C. Thomas, M. Sage, et al., ‘‘A Code of Ethics for Public Health,’’ American Journal of Public Health, 92/7 (2002), 1057–9. ⁷ B. Shell-Duncan, ‘‘The Medicalization of Female ‘Circumcision’: Harm Reduction or Promotion of Dangerous Practice?,’’ Social Science & Medicine, 52 (2001), 1013–28. ⁸ S. Heilig and S. Jamison, ‘‘Physician Aid-in-Dying: Toward A ‘Harm Reduction’ Approach,’’ Cambridge Quarterly of Healthcare Ethics, 5 (1996), 113–20.

Harm Reduction: Ethics and Compliance / 123 observations noted here are meant to support Kass’s conclusion that we should not deem such interventions categorically impermissible in cases in which background inequalities or injustices are the impetus for considering harm reduction interventions. Once one holds that harm reduction may be permissible in practice, one recognizes the obligation to study harm reduction interventions and determine whether they are effective and, perhaps, which are most costeffective. The history of medicine is replete with examples of persistent use of what turned out to be ineffective and even dangerous interventions.⁹ (See, for example, two papers published in 2002.¹⁰) Rather than blindly applying harm reduction interventions, there is a responsibility to test them. This should not be particularly controversial when no known, effective way of eliminating the harm exists. When attempts to reduce rather than eliminate harm are pursued even though ways of eliminating the harm are known, there is more controversy. Yet, as Kass argues, it may be appropriate to implement harm reduction interventions in such cases. Insofar as harm reduction is a permissible goal in a given instance, then the proposed interventions should be studied to determine whether they are safe and effective. As in the perinatal HIV transmission trials, we must be explicit as to whether the goal is to find an equally effective but less expensive intervention or to find one that is less expensive and possibly less effective. Only the latter is true harm reduction. Defending the in principle permissibility of harm reduction interventions and harm reduction research in the face of background inequalities or injustices is the first level of debate over harm reduction in public health. The second layer of discussion concerns whether harm reduction research can be conducted ethically and the conditions that must be met for the ethical conduct of such research. I turn now to two points Kass makes in her discussion of these issues that require further examination. ⁹ P. Cohen, ‘‘The Placebo Is Not Dead: Three Historical Vignettes,’’ IRB: A Review of Human Subjects Research, 20/2–3 (1998), 6–8; P. Cohen, ‘‘Failure to Conduct a Placebo-Controlled Trial May Be Unethical,’’ American Journal of Bioethics, 2/2 (2002), 24. ¹⁰ Writing Group for the Women’s Health Initiative Investigators, ‘‘Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results from the Women’s Health Initiative Randomized Controlled Trial,’’ Journal of the American Medical Association, 288/3 (2002), 321–33; J. B. Moseley, K. O’Malley, N. J. Petersen, T. J. Menke, B. A. Brody, D. H. Kuykendall, J. C. Hollingsworth, C. M. Ashton, and N. P. Wray, ‘‘A Controlled Trial of Arthroscopic Surgery or Osteoarthritis of the Knee,’’ NEJM 247/2 (2002), 81–8.

124 / Iltis

II. Research Ethics Guidelines and Regulations: Implications for Harm Reduction Research In the interest of defending the permissibility of harm reduction research, Kass seems to set aside the guidelines and regulations governing human research that may challenge the permissibility of certain types of harm reduction research. Kass states that: when research ethics guidelines first were written thirty to forty years ago, they were responding to a very particular set of research problems that had captured the public’s attention: lack of informed consent, lack of prior review, and potential exploitation of captive and/or vulnerable populations. . . . [R]esearch ethics guidelines, while responsive to the prevailing ethics challenges at the time, seem to be based on two assumptions about why ethics problems occur in human research. Both of these assumptions, I would argue, make the guidelines less relevant to the particular challenges posed by public health prevention studies such as the lead and HIV cases.¹¹

The guidelines and regulations governing human research may not be ‘‘less relevant’’ to public health research than to other human research and may not be as outdated as Kass’s claims suggest. Public health practice, many have argued, requires an ethical framework distinct from the ethics of clinical medical practice because public health aims primarily at improving the health of populations rather than individuals.¹² As a result, public health focuses on the health of populations and treats the rights and interests of individuals as side-constraints.¹³ In contrast, clinical medical practice typically focuses on the welfare and interests of individual patients, though this goal generates controversies when the interests or needs of different patients conflict. The high priority generally granted to individual autonomy in the context of clinical ethics is inappropriate for public health practice.¹⁴ The difference between public health ethics and clinical ethics does not necessarily translate to different standards for clinical research ethics and public health research ethics because human subjects research (whether ¹¹ Kass, ‘‘Just Research in an Unjust World,’’ p. 97 above. ¹² J. F. Childress, R. Fade, et al., ‘‘Public Health Ethics: Mapping the Terrain,’’ Journal of

Law, Medicine & Ethics, 30 (2002), 170–8. ¹³ D. Callahan and B. Jennings, ‘‘Ethics and Public Health: Forging a Strong Relationship.’’ ¹⁴ N. E. Kass, ‘‘An Ethics Framework for Public Health,’’ Public Health Matters, 91/11 (2001), 1776–82.

Harm Reduction: Ethics and Compliance / 125 clinical or public health) generally aims at securing the interests of future patients (i.e. of populations) or of study subjects in the future. The primary aim of research is not to improve the well-being or health of individual subjects. In fact, a major reason for having ethical guidelines governing research and requiring oversight of human subjects research is that the research enterprise is not aimed primarily at benefiting individual subjects. Constraints on human subjects research aim at protecting the interests of and minimizing risks and harms to individuals rather than at maximizing their well-being. Attention to issues of the therapeutic misconception and informed consent in the research ethics literature has demonstrated the importance of helping potential subjects understand that the primary aim of clinical research is not to heal or help them. There are disagreements about how far investigators should be permitted to take this distinction, as evidenced in the debate on the permissibility of placebo controlled trials.¹⁵ In short, a major distinction between clinical practice and public health practice is that the former typically aims at benefiting individual patients and the latter aims at benefiting populations. This distinction does not apply to the difference between clinical research and public health research, both of which aim primarily at generating knowledge that will benefit other people or subjects in the future. Hence the claim that public health ethics differs from clinical ethics does not necessarily mean that public health research ethics and clinical research ethics necessarily should be held to different standards.¹⁶ This may be especially true when public health researchers are not doing merely observational research but are engaged in ¹⁵ B. Freedman, ‘‘Equipoise and the Ethics of Clinical Research,’’ NEJM 317 (1987), 141–5; F. D. Miller, D. L. Rosenstein, and E. G. DeRenzo, ‘‘Professional Integrity in Clinical Research,’’ Journal of the American Medical Association, 280 (1998), 1449–54; K. Rothman and K. Michels, ‘‘The Continuing Unethical Use of Placebo Controls,’’ NEJM 331 (1994), 394–8; B. Freedman, K. Glass, and C. Weijer, ‘‘Placebo Orthodoxy in Clinical Research: Part 1. Empirical and Methodological Myths,’’ Journal of Law, Medicine & Ethics, 24 (1996), 243–51; B. Freedman, K. Glass, and C. Weijer, ‘‘Placebo Orthodoxy in Clinical Research: Part 2. Ethical, Legal, and Regulatory Myths,’’ Journal of Law, Medicine & Ethics, 24 (1996), 252–9; E. Emanuel and F. Miller, ‘‘The Ethics of Placebo-Controlled Trials: a Middle Ground,’’ NEJM 345 (2001), 915–19. ¹⁶ From time to time one finds in discussions of research ethics claims that particular types of human subjects research should be exempt from the standards established by the federal regulations governing human subjects research. For example, behavioral and social science researchers have suggested that such research should be held to different standards. The public health community at times has been criticized of engaging in such

126 / Iltis interventional studies, particularly studies that employ interventions (e.g. blood draws) and personnel (e.g. physicians and nurses) typical of clinical research. In the court ruling on the Kennedy Krieger lead abatement studies, the Maryland court went so far as to state that the investigators have a duty of care to subjects.¹⁷ While this opinion has been the subject of great controversy, it is an important decision that renders implausible the claim that the ethical guidelines and regulations are ‘‘less relevant’’ to public health research in Maryland. One court has held public health research to at least the same standard as clinical researchers, and it may have elevated the standard to which all researchers, clinical and public health alike, in Maryland are held. Moreover, the guidelines and regulations that pose the greatest challenge to the permissibility of harm reduction research have been revisited, in some cases multiple times, during the last thirty to forty years. Although many were written some time ago and in response to specific concerns, some have been revisited and there has been ample opportunity to attend to new concerns and social realities as they have been revised. Kass may want to contend that they have not appropriately attended to these new situations, but it is wrong to suggest that they are less relevant to public health research because they are decades-old when in fact the most recent versions are considerably less than thirty to forty years old. The discussion here is not a defense of the guidelines and regulations as perfect documents in need of no revision. In fact, in some cases there may well be conflicts within and among documents, and lack of specificity may impede understanding and application of the guidelines. For example, the World Medical Association’s Declaration of Helsinki suggests that subjects must receive at least the standard of care and that new interventions must be tested against the best current interventions.¹⁸ Adhering to this requirement sometimes is incompatible with another obligation outlined in the Declaration, namely the obligation to conduct research that will yield information useful to the research exceptionalism; J. M. DuBois, ‘‘Ethics in Behavioral and Social Science Research,’’ in Research Ethics, ed. A. S. Iltis (London: Routledge, 2005), 102. ¹⁷ Ericka Grimes v Kennedy Krieger Institute, Inc. 366 Md 29, 782 A2d 807 (2001), reconsideration denied (October 11, 2001), available at (accessed March 29, 2006). ¹⁸ World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects (2005). Available at .

Harm Reduction: Ethics and Compliance / 127 local population.¹⁹ In the perinatal HIV transmission trials, a major point of debate has been whether testing the new intervention against the 076 protocol would have yielded data relevant to the developing countries in which the studies where being conducted.²⁰ If it is not possible to obtain data relevant to a population by testing an intervention against the best current intervention, then one must decide how to conduct research compatible with the relevant rules, guidelines, and regulations when there is such a conflict. Is there an absolute rank ordering among such principles? If so, what is it? If not, how are we to navigate such conflicts? The Declaration of Helsinki does not acknowledge the potential conflict nor suggest ways of mediating the tension. Despite the concerns with the existing guidelines and regulations, it is not plausible to suggest that they are less relevant to public health research because they are old when, in fact, some of those that offer the greatest challenge to the permissibility of harm reduction research have been reviewed recently and in the wake of harm reduction studies. To be sure, the spirit of Kass’s claims is not one of ignoring the requirements for the ethical conduct of research and I do not mean to suggest that she thinks public health researchers are above standards of ethical practice. Nevertheless, her claim could be interpreted as such by some, and attempting to set aside the regulations and guidelines will not convince those who opposed the lead abatement and HIV trials Kass discusses. Those who oppose the studies very well may hold that the guidelines and regulations apply or that the principles embodied in them apply to human research. Insofar as we do take existing guidelines and regulations seriously for human research and insofar as we seek to consider the permissibility of public health research in general and harm reduction research in particular in light of those guidelines and regulations, a series of questions emerges about the interpretation and application of those documents. These questions must be settled in particular ways if the research proposed is to be found permissible. Kass does not specify which guidelines and regulations she ¹⁹ Ibid. ²⁰ Satcher Varmus, ‘‘Ethical Complexities of Conducting Research in Developing Coun-

tries,’’ NEJM (1997), 1003–5; S. Ellenberg and R. Temple, ‘‘Placebo-Controlled Trials and Active Control Trials in the Evaluation of New Treatments: Part 2: Practical Issues and Specific Cases,’’ Annals of Internal Medicine, 133/6 (2000), 464–70.

128 / Iltis finds problematic and deserving of a place on the sidelines of public health research. I consider here three examples of guidelines or regulations that challenge the permissibility of harm reduction research. I take these to be reasonable illustrations of the types of guidelines and regulations to which Kass refers. These examples include requirements found in the Common Rule (within the Code of Federal Regulations), the Declaration of Helsinki, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects published by the Council for International Organizations of Medical Sciences (CIOMS). One challenge to the permissibility of harm reduction research involving children found in the Common Rule (45CFR46), last reviewed in 1991, concerns the amount of risk subjects may be exposed to in research. There is disagreement over how to interpret the federal definition of ‘‘minimal risk’’ (45CFR46.102.i) and how to interpret standards for risk in the context of pediatric research. The Common Rule defines minimal risk as ‘‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests’’ (45CFR46.102.i). There has been ongoing disagreement about precisely what this means.²¹ There also is disagreement about whether minimal risk is an absolute standard or whether it is relative to the daily life risks of individual subjects.²² The controversy over how to define ‘‘minimal risk’’ may jeopardize the permissibility of conducting at least some harm reduction research involving children that I believe Kass holds is justifiable. ²¹ C. Weijer, ‘‘Thinking Clearly about Research Risk: Implications of the Work of Benjamin Freedman,’’ Institutional Review Board: A Review of Human Subjects Research, 21/6 (1999), 1–5; L. M. Kopelman, ‘‘Children as Research Subjects: A Dilemma,’’ Journal of Medicine and Philosophy, 25/6 (2000), 745–64; Jeffrey Janofsky and Barbara Starfield, ‘‘Assessment of Risk in Research on Children,’’ Journal of Pediatrics, 98 (1981), 842–6. ²² L. M. Kopelman, ‘‘Children as Research Subjects: A Dilemma’’; id., ‘‘Group Benefit and Protection of Pediatric Research Subjects: Grimes v. Kennedy Krieger and the Lead Abatement Study,’’ Accountability in Research, 9 (2002), 177–92; id., ‘‘Moral Problems in Assessing Research Risk,’’ Institutional Review Board, 22/5 (2002), 3–6; id., ‘‘Pediatric Research Regulations under Legal Scrutiny: Grimes Narrows their Interpretation,’’ Journal of Law, Medicine & Ethics 30 (2002), 38–49; id., ‘‘What Conditions Justify Risk Nontherapeutic or ‘No Benefit’ Pediatric Studies: A Sliding Scale Analysis,’’ Journal of Law, Medicine, and Ethics, 32/4 (2004), 749–58; L. F. Ross, ‘‘Do Healthy Children Deserve Greater Protection in Medical Research?,’’ Journal of Pediatrics, 142 (2003), 108–12; B. Freedman, A. Fuks, and C. Weijer, ‘‘In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children,’’ Hastings Center Report, 23/2 (1993), 13–19.

Harm Reduction: Ethics and Compliance / 129 Pediatric research may be conducted only if it can be approved under one of four categories. These are: • 45CFR §46.404 Research not involving greater than minimal risk. . . . • 45CFR §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. . . . • 45CFR §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition. • 45CFR §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The fourth category rarely is used and itself has been the subject of great controversy.²³ This leaves the first three categories as the focus of concern. To enroll children in a study that exposes them to more than minimal risk, the study must present the prospect of direct benefit or the study must present only a minor increase over minimal risk and promise to generate information vital to the understanding or amelioration of the child’s disorder or condition. It is not permissible to enroll children in research that exposes them to any more than minimal risk, even if they would be exposed to that risk in their normal daily lives, if the study does not offer them direct benefit or meet criteria for 406 approval. If minimal risk is interpreted absolutely, it will be difficult to approve any harm reduction research that aims at increasing public health overall by reducing (rather than eliminating) harm if it does not pose direct benefit to subjects. For example, to study the impact of partial lead abatement in homes, one needs to place children in homes that have been partially abated and compare their blood lead levels to those of children in homes that have been fully abated and homes without lead paint (and perhaps to children in homes that have not been abated or to historical controls). The goal is not to benefit subjects and it is not necessarily expected that their participation will benefit them directly. Placing children in homes that have been only ²³ L. F. Ross, ‘‘Convening a 407 Panel for Research Not Otherwise Approvable: Precursors to Diabetes in Japanese American Youth as a Case Study,’’ Kennedy Institute of Ethics Journal, 14/2 (2004), 165–86; L. M. Kopelman and T. F. Murphy, ‘‘Ethical Concerns about Federal Approval of Risky Pediatric Studies,’’ Pediatrics, 113/6 (2004), 1783–9.

130 / Iltis partially abated places them at more than minimal risk if minimal risk is understand absolutely.²⁴ Only children in fully abated homes or homes that were built without lead paint would be considered to be at minimal risk according to an absolute standard interpretation of minimal risk. Assuming an absolute standard of minimal risk and assuming that one cannot hold that the study poses a prospect of direct benefit to subjects, then it most likely would be deemed impermissible. (If the study aimed at comparing two or more methods of full lead abatement, then it could be considered minimal risk. But such a study would not be a harm reduction but rather a harm elimination study. The reason for pursuing the harm reduction approach is that, overall, it might mean more children would be exposed to less lead than if the only option available were full abatement.) One way someone might hold that such harm reduction research could be considered permissible according to the federal regulations and approved under category 404 is to hold that the research itself is not placing the child at risk. For that to be the case, researchers would have to study only children already living in homes with lead paint, they would have to study them in those same homes (e.g. they could not help them move to comparable homes or even homes that were better than the previous ones but still affected by lead), and researchers could play no role in encouraging them (either directly or indirectly) to remain in those homes.²⁵ A second possibility is to adopt a relative standard for minimal risk. One could hold that minimal risk refers to ‘‘those ordinarily encountered in daily life’’ but that ‘‘daily life’’ is understood as referring to each individual person’s daily life. A child who would otherwise be living in a home that had at least as much lead as the homes that had been only partially abated would be considered eligible to participate in the study. The study could be approved under 404; one of the inclusion criteria would be that the child currently was exposed to at least as much lead paint in her or his home as the child would ²⁴ One can imagine that someone could argue that this is not the case. Minimal risk should be understood absolutely, but it should be understood in light of the daily life risks of persons who face greater rather than lesser risks. ²⁵ If, as the Maryland court in Grimes stipulates, investigators have a duty of care toward their subjects, then investigators in this scenario might have a responsibility to encourage the parents/guardians involved to move to homes without lead paint. They could not simply refrain from encouraging them to stay in poor housing but they would be obligated to encourage them to move.

Harm Reduction: Ethics and Compliance / 131 be exposed to in the study. This relative standard has been criticized by some for permitting injustice and facilitating exploitation.²⁶ (This issue of relative versus absolute risk also applies to discussions of the perinatal transmission of HIV trials.) One could argue that the research offered subjects the prospect of direct benefit such that it could be approved under 405. To defend this claim, one could consider the living conditions one would expect a child to have if the child did not participate in the study with the living conditions of that child in the study. One could assert that most likely the children in the study would have been living in homes with high levels of lead paint that were to receive no abatement if they did not participate in the study; by participating in the study some were living in homes with no lead paint or that had been abated and others were living in homes that had lead paint but that would receive some level of abatement. One could argue that all the homes in the study represented an improvement over the homes one would have expected the children to be living in if they did not participate in the study and on this basis one could claim that study participation was beneficial because it provided them with the prospect of a better living situation (and with one that was no worse than what they otherwise would have had). Or, one could consider the benefits of study participation to include frequent monitoring of blood lead levels and the benefits to be gained by the children after the study was over if the study led to improved abatement of homes in their area and so on. The Grimes court did not accept such claims of direct benefit.²⁷ The court held that in fact the study placed children at risk for no direct benefit. Different understandings of what counts as a benefit and a risk to children who participate in research affect assessments of the permissibility of harm reduction studies that include children. An alternative is to try to approve such a study under category 406 by demonstrating that it exposes children to a minor increase over (absolute) minimal risk and that it may generate information that is vital to understanding or ameliorating the condition of subjects. For that to be possible, one would have to hold that children who are exposed to lead in their homes have a disorder or condition. One consideration is whether persons who are ²⁶ Kopelman, ‘‘What Conditions Justify Risk Nontherapeutic Studies.’’ ²⁷ Kopelman, ‘‘Pediatric Research Regulations’’.

132 / Iltis known to be at risk for a disorder or condition ever count among those who have one, that is, whether being at risk for something itself is a disorder or condition. There is a long-standing debate in the research ethics literature as to the permissibility and interpretation of the disorder or condition clause in category 406.²⁸ In short, to conduct some of the harm reduction research Kass cites while acting in accordance with the federal regulations, one must come to certain conclusions about how to interpret the definition of minimal risk, what it means for research participation to offer the prospect of direct benefit, and/or how to define what it means for a child to have a disorder or condition. The potential challenges to harm reduction research posed by the federal regulations should not be dismissed on the basis that the regulations are less relevant to public health research. The regulations, which are not thirty to forty years old, raise concerns that should be acknowledged. This is not to say that the regulations are perfect as written and in no need of revision. Because harm reduction research sometimes may be critical to improving health and well-being, in fact we should look seriously at the challenges posed by the current regulations and guidelines, determine whether those documents can be interpreted appropriately in ways that will render permissible the research, and ask whether any revisions should be made. A second challenge to the permissibility of harm reduction research comes from the Declaration of Helsinki, last revised in 2000 with clarifications added in 2002 and 2004. Statement 29 in the Declaration holds that: The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.

The note added in 2002 to clarify this requirement states that: The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be ²⁸ National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children (Washington D.C.: U.S. Government Printing Office, 1977); Ross, ‘‘Do Healthy Children Deserve Greater Protection in Medical Research?’’; Kopelman, ‘‘Pediatric Research Regulations’’; A. E. Shamoo and C. A. Tauer, ‘‘Ethically Questionable Research with Children: The Fenfluramine Study,’’ Accountability in Research, 9 (2002), 143–66.

Harm Reduction: Ethics and Compliance / 133 used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: • Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or • Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

One has to ask what it means for something to be standard of care (and hence required to be provided for all subjects). There is an ongoing debate in the literature regarding the definition of ‘‘standard of care’’.²⁹ Emphasis has been on the question: is standard of care global or local, or is there only one worldwide standard of care? Some have argued that standard of care should be understood within the context of the community in which the research is being conducted.³⁰ Others have defended a global standard of care, arguing that the developed world standard should apply to all for the purposes of evaluating the ethics of proposed trials, in part because failure to hold investigators to one global standard of care would lead to exploitation.³¹ Some have held that the developed world standard should apply in all cases except in those very rare circumstances when one has good reason to believe that the standard proven treatment will not work in the study population.³² If one adopts a global standard of care, it may be difficult or sometimes impossible to conduct certain types of harm reduction research. There may be cases in which it is possible to conduct harm reduction research but ²⁹ A. J. London, ‘‘The Ambiguity and The Exigency: Clarifying ‘Standard of Care’ Arguments in International Research,’’ Journal of Medicine and Philosophy 25 (2000), 379–397. ³⁰ D. Resnik, ‘‘The Ethics of HIV Research in Developing Nations,’’ Bioethics, 12/4 (1998), 286–306; R. K. Lie, E. Emanuel, C. Grady, and D. Wendler, ‘‘The Standard of Care Debate: The Declaration of Helsinki Versus the International Consensus Opinion,’’ Journal of Medical Ethics, 30/2 (2004), 190–3. ³¹ Schuklenk, ‘‘The Standard of Care Debate’’; P. Lurie and S. M. Wolf, ‘‘Unethical Trials of Interventions to Reduce Perinatal Transmission of the HIV in Developing Countries,’’ NEJM (1997), 853–6. ³² Angell, ‘‘The Ethics of Clinical Research in the Third World.’’

134 / Iltis studies must be designed differently, namely they must test proposed harm reduction interventions against the global standard of care/best proven methods. Doing so may raise methodological concerns. In other cases it may not be possible to design a valid study to test a harm reduction intervention against the global standard of care, in part because it may be impossible to provide the global standard of care to certain populations. Rather than set aside this potential challenge to harm reduction research, we should acknowledge it and engage it. The debate must be settled in a particular way if the harm reduction research Kass defends will be permissible. We must seriously consider the standard of care debate and either defend the local or global standard (or some intermediate) approach or argue that investigators simply do not have an obligation to provide standard of care to subjects. But we ought not assert the importance of harm reduction research and the irrelevance of those guidelines and regulations that would stand in its way. The CIOMS guidelines are a third example of a recently revised (2002) set of ethical guidelines that challenge the permissibility of harm reduction research.³³ Guideline 8 states that: For all biomedical research involving human subjects, the investigator must ensure that potential benefits and risks are reasonably balanced and risks are minimized. • Interventions or procedures that hold out the prospect of direct diagnostic, therapeutic or preventive benefit for the individual subject must be justified by the expectation that they will be at least as advantageous to the individual subject, in the light of foreseeable risks and benefits, as any available alternative. Risks of such ‘beneficial’ interventions or procedures must be justified in relation to expected benefits to the individual subject. • Risks of interventions that do not hold out the prospect of direct diagnostic, therapeutic or preventive benefit for the individual must be justified in relation to the expected benefits to society (generalizable knowledge). The risks presented by such interventions must be reasonable in relation to the importance of the knowledge to be gained.

In the commentary on this guideline, it is stated that ‘‘To minimize risk when the intervention to be tested in a randomized controlled trial is designed ³³ B. A. Brody, ‘‘Conflicts of Interests and the Validity of Clinical Trials,’’ in Conflicts of Interest in Clinical Practice and Research, ed. R. G. Spece, Jr., D. S. Shimm, and A. Buchanan (New York: Oxford University Press, 1996), 407.

Harm Reduction: Ethics and Compliance / 135 to prevent or postpone a lethal or disabling outcome, the investigator must not, for purposes of conducting the trial, withhold therapy that is known to be superior to the intervention being tested, unless the withholding can be justified by the standards set forth in Guideline 11.’’³⁴ As Kass notes, research ethics guidelines are written with the assumption that subjects otherwise would receive interventions known to be effective. In many cases, however, this is untrue because subjects do not have access to treatments or other interventions outside of the research context. This situation raises questions about what should be considered standard of care and what it means for an investigator to withhold a therapy. If a subject would not receive an intervention outside the research context, does failure to provide it constitute withholding of therapy? If subjects would not have access to better housing outside the research context, does placing them in housing comparable to what they otherwise would have constitute a failure to withhold an effective intervention? In evaluating interventions that provide less than the ideal interventions, some may hold that one should distinguish between ‘‘actively preventing access to treatment’’ (as in the USPHS/Tuskegee Syphilis Study) and not providing subjects with something they otherwise would not have access to anyway. Accepting this distinction may make it possible to interpret research ethics guidelines and regulations in ways that sometimes render permissible some harm reduction research. Of course, this interpretation and others discussed in this chapter are controversial. The above are only three examples of current debates and points raised in the guidelines and regulations governing human research that challenge the permissibility of harm reduction research or the permissibility of certain types of harm reduction research, such as those in which test interventions ³⁴ CIOMS Guideline 11, n. 50, states that: As a general rule, research subjects in the control group of a trial of a diagnostic, therapeutic, or preventive intervention should receive an established effective intervention. In some circumstances it may be ethically acceptable to use an alternative comparator, such as placebo or ‘‘no treatment’’. Placebo may be used: when there is no established effective intervention; when withholding an established effective intervention would expose subjects to, at most, temporary discomfort or delay in relief of symptoms; when use of an established effective intervention as comparator would not yield scientifically reliable results and use of placebo would not add any risk of serious or irreversible harm to the subjects.

136 / Iltis are studied against a local standard of practice or availability rather than the interventions known to be most effective. Other areas of debate pertinent to Kass’s analysis include disagreement over: what it means to ensure that an intervention is expected to benefit a population in the future; what it means for an intervention to become reasonably available in the future; and what it means to exploit a community or person.

III. Researchers and Advocacy After establishing the importance of harm reduction research and setting aside the challenges posed by research ethics guidelines and regulations, Kass turns to the important question of the conditions that should be met or at least considered in designing harm reduction studies and determining whether specific studies are ethical and may be approved. All seven of her threshold criteria point to the moral complexity of harm reduction research. I focus on the seventh criterion. Kass states that among the factors that should be considered in determining whether a harm reduction study should be considered acceptable is whether the researchers are ‘‘engaged in any activities to address the underlying problem’’ of injustice or inaccess.³⁵ She claims that researchers ‘‘have a responsibility to advocate for policy changes to eliminate the need for harm reduction approaches.’’³⁶ Kass seems to propose engagement in social and political advocacy as a moral badge investigators may wear to certify that they are good people who think the inaccess they are responding to is an instance of injustice and to prove that they are not complicit with the injustice. By serving as advocates researchers can demonstrate that they are ‘‘committed to reducing the public health problem, writ large’’ and that it may be important to the permissibility of the study whether this is true or whether the researchers are ‘‘interested more narrowly in this particular scientific question’’.³⁷ Kass seems to suggest that unless researchers are crusaders for a particular vision of social justice, they may be unfit to conduct certain types of scientific research. The idea that investigators may be, let alone ought to be, advocates in the same area in which they work is troubling on several levels. First, ³⁵ Kass, ‘‘Just Research in an Unjust World,’’ p. 108 above. ³⁶ Ibid. ³⁷ Ibid., p. 109.

Harm Reduction: Ethics and Compliance / 137 the claim seems to be that a person’s professional qualifications depend in part on his or her political views and engagement in political activity. Second, the skills of a good political advocate and those of a good researcher may be very different; it may be best that researchers spend their time and energy conducting research and not playing politician or lobbyist. The third concern is perhaps the most serious. Kass’s claim raises a fundamental question about the role of scientific experts in society and in politics and about the necessary conditions for the conduct of well-designed, objective research. Researchers with a political agenda may have conflicts of interest, though not necessarily financial ones, that could preclude objectivity in trial design, research conduct, interpretation of data, and reporting of results. Much has been written on the impact financial conflicts of interest may have on the research enterprise,³⁸ but ideological or other conflicts may also shape research, sometimes unconsciously and in subtle ways.³⁹ The moral badge of honor may in fact be worn over the badge certifying an investigator as an objective scientist. This is a very serious concern.

IV. Conclusion My goal has been to situate Kass’s analysis within the broader context of the research ethics literature and to identify specific concerns raised by her important attempt to defend the permissibility of harm reduction research. Rather than accept the claim that the research ethics guidelines and regulations that would disallow harm reduction research are old and less relevant to public health research, Kass’s analysis should be seen as a call to engage a wide range of issues that have long been debated in the research ethics literature. These debates should continue in light of the important ³⁸ J. A. Goldner, ‘‘Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach,’’ Journal of Law, Medicine, and Ethics, 28/4 (2000), 379–404. ³⁹ Brody, ‘‘Conflicts of Interests and the Validity of Clinical Trials’’; M. J. Cherry, ‘‘Financial Conflicts of Interest and the Human Passion to Innovate’’ in Research Ethics, ed. A. S. Iltis (London: Routledge, 2005), 147; S. Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley: University of California Press, 1996); R. Quigley, ‘‘Advocacy and Community: Conflicts of Interest in Public Health Research,’’ in Public Health Policy and Ethics, ed. M. Boylan (Dordrecht: Kluwer, 2004), 223.

138 / Iltis place harm reduction research and interventions can play in promoting public health. Failure to settle some of those debates in particular ways may make it difficult if not impossible to engage in some of the harm reduction research well-intentioned public health researchers would like to conduct. We should take Kass’s recognition that existing guidelines and regulations may render some research impermissible not as an invitation to set aside ‘‘old’’ documents but as a challenge to think seriously about research ethics, the need to develop appropriate regulations and guidelines, and the importance of updating and revising documents. I suspect Kass would support this claim. I considered three examples of guidelines and regulations that have been revisited fairly recently that challenge the permissibility of harm reduction research. These are not documents that may be set aside as old or not pertinent to public health research. In fact, there may be good reason to recognize that public health studies and clinical research share some important similarities and should be governed by comparable guidelines and regulations. If, in fact, harm reduction research can be ethical in principle and in practice, a claim Kass makes, then it is necessary to take seriously the challenges posed by contemporary research ethics guidelines and regulations and in the literature. Moreover, we should be skeptical of Kass’s threshold criterion that would require or recommend that researchers act as social and political advocates as a condition for approval of harm reduction research. Kass thinks this requirement protects such researchers from the accusation of moral complicity; it raises serious concerns about the appropriateness of tying political activity to the conduct of scientific research and leads to the possibility of conflicts of interest that could compromise the quality of research. At the very least, it could lead to the perception that the results cannot be relied upon as objective. In addition, in a society that values political freedom, it would be strange to condition professional scientific activity upon a person’s political values and activities. For reasons Kass discusses in detail and which I consider briefly here, harm reduction practices may be of great importance to improving the health and well-being of populations. If one is to implement effective harm reduction practices, one must conduct harm reduction research, and thus it is important that the research ethics literature and guidelines and regulations governing human research respond to the need to conduct harm reduction research. Kass takes an important step in suggesting some

Harm Reduction: Ethics and Compliance / 139 threshold criteria that should be adopted to distinguish acceptable harm reduction research proposals from unacceptable ones. For reasons suggested in this chapter, her recommendations should serve as the starting point for conversation rather than as criteria adopted by any government or professional body.

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7 Global Justice, Human Rights, and Health∗ Ruth Macklin

Global bioethics embodies two overarching concerns. The first relates to the international research enterprise, which I shall refer to as global research ethics. The second concern is how—not whether—the fruits of research can be madeavailablethroughouttheworld.Ireferto thisasglobaljusticeinhealth.More specifically, the unprecedented growth of research across national borders, especially in developing countries, poses the following question: How does research in widely different social and economic contexts challenge the accepted norms of research or even compel their revision? The gap between industrialized nations and developing countries in their populations’ access to essential medications and health services prompts the question of whether there is a right to health care services that all human beings possess. If so, how can such rights be promoted and realized in differing economic and cultural environments? Both global research ethics and providing access to medicine and health care in developing countries ultimately rest on a conception of global justice. Thischapteraddressesbothtopicsand arguesfortheinterconnectednessof the research enterprise and global health. The structure of the argument is as ∗ Portions of this chapter are excerpted from Ruth Macklin, Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2007).

142 / Macklin follows. If one concurs with the widely acknowledged premise that research should be relevant to the health needs of the population where the research is conducted, the next step is to determine whether medical research can be justified in resource-poor countries if no benefits accrue to the population when the research is concluded. Again, there is general agreement that the answer is ‘‘no,’’ but disagreement exists about what should be the nature or type of benefits. Some commentators, and several guidelines and recommendations, call for health-related benefits, specifically, provision of the successful products of research conducted in the developing country. But this poses the question of why health-related benefits of research should stop at national boundaries, which in any case are often artificial remnants of the colonial era (many countries in Africa, for example). One interpretation of global justice suggests that the obligation of wealthy nations toward resourcepoor countries extends to making an effort to reduce the gap in health status and life expectancy between rich and poor nations. Cast in terms of human rights rather than countries’ obligations, this conclusion is buttressed by provisions in several United Nations declarations and covenants.

Global Research Ethics Recent years have witnessed an unprecedented increase in biomedical and epidemiologic research carried out in developing countries. The great majority of such research is currently sponsored and conducted by private industry. As the U.S. National Bioethics Advisory Commission reported: The current landscape of international research . . . reflects the growing importance of clinical trials conducted by pharmaceutical, biotechnology, and medical device companies. Over the last 40 years, U.S. funding of all research and development has seen a dramatic shift in its primary source from the public to the private sector. Although the U.S. government has continued to increase its investment in biomedical research, private industry funding has increased much more rapidly.¹

These developments have raised myriad questions about the ethical standards employed in and required for the conduct of research in developing ¹ National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Bethesda, MD, 2001), 3.

Global Justice, Human Rights, and Health / 143 countries. One question is whether the populations in resource-poor countries are being somehow exploited.² The questions include by-now familiar concerns about ‘‘double standards,’’³ for example, the design of placebo-controlled studies that could not be ethically conducted in the United States but have been construed as ethically acceptable in developing countries; the level of care and treatment provided to participants in clinical trials in resource-poor countries; the adequacy of prospective ethical review of proposed research in countries that have had relatively little experience until now, and more. Attention to the foregoing issues has been evident in bioethics journals, such as the Hastings Center Report, Bioethics, Journal of Law, Medicine, and Ethics, Journal of Medicine and Philosophy; in major medical journals (New England Journal of Medicine, Lancet, British Medical Journal); the popular press (Washington Post, New York Times); and reports by national commissions and other prestigious bodies, such as NBAC and the Nuffield Council on Bioethics.⁴ There has been a growing consensus on some of the numerous topics addressed in these articles and reports, but disagreement remains on other key items. One of the enduring points of controversy is whether researchers or sponsors have ongoing obligations to the community or country when the research is concluded. International guidelines and recommendations in the NBAC and Nuffield reports have proposed that successful products of research be made available at least to the participants who still need such products after their participation has ended. The Declaration of Helsinki includes the following provision in paragraph 30: ‘‘At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.’’⁵ ² Robert A. Crouch and John D. Arras, ‘‘AZT Trials and Tribulations,’’ Hastings Center Report, 28/6 (1988), 26–34; Leonard H. Glantz, George J. Annas, Michael A. Grodin, and Wendy K. Mariner, ‘‘Research in Developing Countries: Taking ‘Benefit’ Seriously,’’ Hastings Center Report, 28/6 (1998), 38–42. ³ Ruth Macklin, Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2004). ⁴ Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries (London: Nuffield Council on Bioethics, 2002). ⁵ World Medical Association, Declaration of Helsinki (1964, as amended by the WMA 52nd General Assembly, Edinburgh, 2000). But see the ‘‘Note’’ to the Declaration added in 2002, available at .

144 / Macklin Another strong requirement is found in a guidance document for preventive HIV/AIDS vaccine research: ‘‘Any HIV preventive vaccine demonstrated to be safe and effective . . . should be made available as soon as possible to all participants in the trials in which it was tested.’’⁶ The NBAC report contains the following, weaker recommendation: Researchers and sponsors in clinical trials should make reasonable, good faith efforts before the initiation of a trial to secure, at its conclusion, continued access for all participants to needed experimental interventions that have been proven effective for the participants. Although the details of the arrangements will depend on a number of factors (including but not limited to the results of a trial), research protocols should typically describe the duration, extent, and financing of such continued access. When no arrangements have been negotiated, the researcher should justify to the ethics review committee why this is the case.⁷

This recommendation is weaker than the requirements of Helsinki and the UNAIDS guidance document because it contains a loophole, allowing the researcher to provide a justification that an ethics review committee may accept. Nevertheless, NBAC locates this point in a conception of justice: justice as reciprocity. Justice as reciprocity . . . is concerned with what people deserve as a function of what they have contributed to an enterprise or to society. In the context of clinical trials, justice as reciprocity could mean that something is owed to research participants even after their participation in a trial has ended, because it is only through their acceptance of risk and inconvenience that researchers are able to generate findings necessary to advance knowledge and develop new medical interventions.⁸

When it comes to providing benefits to the community or country when research is concluded, matters are much less clear. On the one hand, there is a growing presumption that benefits of some sort are owed to the community or country where the research is conducted. A report in 1990 of the Commission on Health Research for Development noted what has become known as the 90/10 gap: only 10 percent of spending for research and development is directed at the health problems of 90 percent of the world’s population. Intuitively, this situation is unjust. Yet myriad questions ⁶ Joint United Nations Programme on HIV/AIDS, Ethical Considerations in HIV Preventive Vaccine Research (Geneva: UNAIDS, 2000), 13. ⁷ NBAC, Ethical and Policy Issues, 74. ⁸ Ibid. 59.

Global Justice, Human Rights, and Health / 145 remain unanswered. What conception of justice is involved? Can it stand up to scrutiny? What sorts of benefits are appropriate or required? And who should decide: sponsors and researchers? Decision makers from developing countries? Here again, a look at existing international guidelines and recommendations from reports yields a mixed picture. The Declaration of Helsinki says that ‘‘Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.’’⁹ This sets up a presumption, but the brevity and absence of further explication leaves crucial questions wide open: What are the criteria by which ‘‘likelihood of benefit’’ is to be determined? And what degree of likelihood is necessary? In contrast, UNAIDS Guidance Point 2 contains a stronger requirement not found in other guidelines or documents: ‘‘Any HIV preventive vaccine demonstrated to be safe and effective . . . should be made available as soon as possible . . . to other populations at high risk of HIV infection.’’¹⁰ It may well be that this requirement is easier to fulfill in the case of HIV/AIDS preventive vaccines than for other potential products, since vaccines are generally less expensive than many therapeutic agents and what would be required is a one-time administration followed by boosters rather than, say, a lifetime of frequent administration of a pharmaceutical product. The commentary following Guidance Point 2 states that the discussion about making a successful vaccine available should begin before the trial commences, mentions the elements that should be included in the discussion, and indicates who should be the parties to the discussion. The NBAC report also states a presumption in favor of providing successful products of research to the community or country, but with a similar loophole found in the earlier provision about post-trial benefits to participants: Research proposals submitted to ethics review committees should include an explanation of how new interventions that are proven to be effective from the research will become available to some or all of the host country population beyond the research participants themselves. Where applicable, the investigator should ⁹ Declaration of Helsinki, para. 19. ¹⁰ Joint United Nations Programme on HIV/AIDS, Ethical Considerations, 13 (emphasis

added).

146 / Macklin describe any pre-research negotiations among sponsors, host country officials, and other appropriate parties aimed at making such interventions available. In cases in which investigators do not believe that successful interventions will become available to the host country population, they should explain to the relevant ethics review committee(s) why the research is nonetheless responsive to the health needs of the country and presents a reasonable risk/benefit ratio.¹¹

Unlike the justification NBAC gives for providing the successful products of research to participants who still need them (‘‘justice as reciprocity’’), NBAC does not appeal to justice as the basis for making post-trial products available to the wider community. One commentator argues explicitly against the idea that justice requires making successful products of research available to the community: Distributive justice requires that each social member receives a just distribution of the benefits and burdens of society, i.e., what he or she deserves from being a member of the society. The question here is why do the members of the community who did not participate in the experiment deserve to receive the benefits of the experiment? They did not have to bear burdens as the test subjects do—or those the sponsoring agencies or pharmaceutical companies are required to shoulder—but receive an enormous benefit at no real cost to themselves.¹²

This analysis construes distributive justice to be a matter of what is owed to individuals, based on their contribution to an activity. However, a broader conception of justice takes the unit of analysis to be the community or country, not the individuals residing there. Solomon Benatar criticizes the above-noted analysis as serving ‘‘only to entrench further a neo-liberal economic mind-set deeply inimical to the progress required to rectify some of the widening disparities in wealth and health that characterize an increasingly unstable world.’’¹³ On this account, it is the 90/10 gap that constitutes the injustice and attempts to reduce or eliminate the gap the obligation imposed by justice. Possibly the earliest recommendation regarding the provision of post-trial benefits is that of the Council for International Organizations of Medical ¹¹ NBAC, Ethical and Policy Issues, 74. ¹² D. R. Cooley, ‘‘Distributive Justice and Clinical Trials in the Third World,’’ Theoretical

Medicine, 22 (2001), 157. ¹³ Solomon R. Benatar, ‘‘Global Disparities in Health and Human Rights: A Critical Commentary,’’ American Journal of Public Health, 88 (1998), 295–300.

Global Justice, Human Rights, and Health / 147 Sciences (CIOMS). The CIOMS position on this point was first stated in its 1993 international guidelines for biomedical research, and reiterated in its 2002 revision: Before undertaking research in a population or community with limited resources, the sponsor and the researcher must make every effort to ensure that: • the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and • any product developed will be made reasonably available to that population or community.¹⁴

The CIOMS guidelines do not make explicit reference to justice as the basis for this recommendation. Nevertheless, an effort to achieve some measure of global justice is one possible basis for an obligation to provide the successful products of research. The particular conception of justice that is relevant to this situation is ‘‘to people according to their needs,’’ in the recognition that the resource-poor community or country has need for the fruits of medical research. The principle of beneficence provides another source for the obligation to provide the successful products of research to those in need. Some people have questioned the first condition in the CIOMS guideline. Critics argue that the motive of altruism should allow volunteers to participate in research even if they receive no benefits and the community or country where they live will also not benefit from the research. Why should altruistic individuals in a northern country not be permitted to volunteer for, say, malaria research in which neither they nor other residents of their country will benefit? Another potential objection to the CIOMS condition is that a particular research project may not be able to be conducted in a developing country that could benefit from the results, whereas the same research might be able to be carried out in another country that would not stand to benefit. What would be wrong with such an arrangement? Both criticisms have merit, in principle. However, there is little evidence that the majority of individuals who volunteer for research do so out of sheer altruism. Altruistic motives are often combined with the hope of some direct benefit from research but, even in that case, altruism is much less likely in resource-poor countries whose inhabitants lack access to basic ¹⁴ Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002), 51.

148 / Macklin health care and medical services. Participation in a research project typically confers some health-related benefits that may not be available to large numbers of people in developing countries. As for the second potential objection to the CIOMS condition, it is hard to think of concrete examples of why research could not possibly be conducted in a particular country that could potentially benefit from the results but that same research could be conducted in another country whose inhabitants could benefit. Nevertheless, if such a situation did exist, it could be an exception to the overwhelming presumption stated in the first of these two conditions in the CIOMS guideline. The second condition has received more serious and sustained objections. Critics have argued that if a guarantee to make products available were required before research could be initiated, it would prevent much important research from being conducted. The Nuffield Council report makes this point, arguing that if sponsors of research—including large pharmaceutical companies—were required to provide post-trial benefits in the form of successful products, many would simply cease to sponsor and conduct research in developing countries. The reason is that they would be unable to afford the cost without curtailing other research. Both the conclusion and the reason may well be true. What is false, however, is the premise that it is the researchers or sponsors alone that would have to bear the burden of ensuring access to the fruits of research when trials have been concluded. One group of commentators has issued a specific series of criticisms of the CIOMS guideline.¹⁵ They argue not only that a scheme to ensure ‘‘fair benefits’’ to developing countries need not include provision of the products of research, but also that the CIOMS guideline is flawed in other ways. The authors advance several arguments, the first of which is that the ‘‘reasonable availability’’ requirement guarantees a benefit that may not be a fair benefit. For example, in ‘‘research in which the subjects would be exposed to great risks or the sponsors stand to benefit enormously, reasonable availability may be inadequate and unfair.’’¹⁶ This is surely an odd criticism, since research regulations and guidelines all require that risks be ‘‘reasonable’’ in light of ¹⁵ Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, ‘‘Moral Standards for Research in Developing Countries,’’ Hastings Center Report, 34/3 (2004), 17–27. ¹⁶ Ibid. 20.

Global Justice, Human Rights, and Health / 149 anticipated benefits. Especially in the case of research that is not intended to provide direct benefit to participants, it is hard to imagine a research ethics committee approving a study that exposes subjects to ‘‘great risks.’’ As for the enormous benefits to sponsors, that may well be the case in a large number of drug studies from which pharmaceutical manufacturers expect to derive huge profits. That’s why they are in this business, after all. A second criticism by this group is that for very low- or no-risk research in which the benefits to sponsors are minimal, it could be unfair to sponsors to require them to make the product available. But tying the provision of successful products of research to the level of risk that participants undergo misses the entire point of the ethical requirement. Take vaccines, for example. Most vaccine studies pose low risk to subjects, especially in phase III trials where safety has been well established and the purpose is to demonstrate efficacy. Moreover, unlike other pharmaceutical products, vaccines typically provide a much lower financial return to the sponsor. Yet preventive vaccines are precisely the sort of products that ought to be made available to populations at risk for HIV/AIDS, malaria, and other dread diseases. The degree of benefits sponsors realize is just as irrelevant to this ethical requirement as is the level of risk the research participants undergo. A more telling challenge is the authors’ claim that requiring a prior agreement to supply a specific product resulting from successful research can turn out to be a ‘‘ ‘golden handcuff,’ constraining rather than benefiting the population.’’¹⁷ The population would be committed to using that specific product, even if a better one (more efficacious, fewer side effects) comes along at a later time. No one should be bound to use a product that is inferior to one that comes along at a later time. Furthermore, it would be unreasonable to require company A—which tested the original successful product—to purchase drugs from company B, which manufactures a better product at a later time. This is a legitimate criticism, which could be met by laying out appropriate conditions in contractual form in a prior agreement negotiated by the various parties. The authors have additional criticisms of the ‘‘reasonable availability’’ requirement: (a) it involves a very narrow notion of benefits—successful products of research; (b) it applies only to a narrow range of research, the phase III testing of drugs or biologicals; (c) the promised benefit is ¹⁷ Ibid. 22.

150 / Macklin uncertain, since it is contingent on the success of the product being tested; (d) making available successful products of research does not avoid the problem of ‘‘undue inducement’’ of a deprived population; (e) researchers and sponsors cannot guarantee ‘‘reasonable availability’’; (f ) the very idea of the requirement is paternalistic, since it implies that officials or the population in the country cannot make their own autonomous decisions. Each of these criticisms deserves a considered response, but the reply to several can be brief. It is true that providing the successful products of research is a narrow benefit; but it does not preclude the possibility of providing other benefits as well, such as training local researchers, helping to build a health infrastructure, and general capacity building. Yes, the benefit is health-related but that is the point of doing research in the first place: to respond to the health needs and ultimately to improve the health of the population. Linking the type of benefit to the type of activity seems fitting, albeit somewhat narrow. And yes, the benefit does apply to a narrow range of research and that is the precise intention: to ensure that the community or country whose population serves as research participants stands to gain something from research that yields successful products. The point of the requirement is to change the historical pattern of research conducted in developing countries, whereby the successful products that resulted became available only in industrialized countries where people could afford them. Since phase I and II studies do not measure efficacy, and very many do not go on to phase III, it would be difficult if not impossible to make such a requirement apply to that level of research. The critics point to a difficult problem in saying that the benefits are uncertain because the research may not yield successful products. This, too, might be handled in stipulations in the prior agreement. In the event that the research yields no successful product, other ‘‘fair benefits’’ (of the sort these authors favor) should apply. It is not an either-or situation: either successful products or no benefits to the population. On the matter of undue inducements, it is time this red herring were laid to rest (if that is what one does with herring). Let us consider who will receive the benefits of research that yields successful products. In the situation under discussion, it is not the research participants themselves, since they are already receiving the product as research participants and presumably will not need it after the study is over. If, however, they have a chronic condition or a disease such as HIV/AIDS and do still need the product

Global Justice, Human Rights, and Health / 151 when the research is concluded, it would be unethical to fail to continue to provide it. Moreover, if the control group receives a placebo during the study or an inefficacious comparator, they are owed the successful product at the conclusion of the research (see the above discussion of paragraph 30 of the Declaration of Helsinki). It stretches matters considerably to maintain that the promise of successful products to the community or country would unduly induce some individuals to volunteer for the research. The critics contend that the requirement to make products reasonably available is paternalistic. It does not permit leaders of a country or representatives of the population to decide what they would like by way of benefits, thus denying them their autonomous right to decide. It is true that there is an element of paternalism in this requirement. So, too, however, is there an element of paternalism in the more fundamental ethical requirement that research should be responsive to the health needs of the population where the research is carried out. Suppose the leaders of a strife-ridden country were to say to researchers or sponsors: ‘‘Never mind the successful products of research. What we need are arms to combat our neighbors. Even a large segment of our healthy population will die in a conquest by our oppressive enemy. You may conduct your research here on the condition that you reimburse us with money for armaments when you realize a profit.’’ Would it be unacceptably paternalistic to refuse that request? More likely, however, the leaders would not mention what they would propose to do with the monetary profits they might ask for. The sad story of corruption and malfeasance by autocratic leaders in many developing countries suggests that it would be a bad idea to leave the decision about what should count as benefits entirely in the hands of leaders of countries where research is conducted. A final point in this group’s criticisms is that researchers and sponsors cannot guarantee ‘‘reasonable availability.’’ Point well taken; there are few guarantees in life. However, the wording of the CIOMS guidelines says nothing about guarantees; nor does it require that researchers and sponsors be the ones to provide the product. Here, again, is the CIOMS guideline: ‘‘the sponsor and the researcher must make every effort to ensure that any product developed will be made reasonably available to that population or community.’’ The role of the researcher and sponsor is to arrange or

152 / Macklin negotiate what has been called a ‘‘prior agreement.’’¹⁸ Who the parties to that agreement may be is discussed in the next section. In spite of the flaws in their criticisms of prior agreements, this group made several positive suggestions for a broad framework of fair benefits. These include providing collateral health services that are unnecessary for the research itself, both for the research participants and for the population; public health measures for the country or community; long-term research collaboration; and sharing of financial rewards from research results, including intellectual property rights. The framework also includes two important procedural features: community involvement at all stages of the research process and transparency, in the form of a central, publicly accessible repository of benefits agreements. This broader framework of benefits is not incompatible with making products reasonably available, and this group acknowledges as much in its inclusion of the intervention itself, if proven effective.

Who Would Pay for Post-Trial Products? The first mistake of those who criticize the requirement to make products reasonably available is to assume that the sponsors of research would be the ones to bear the burden of paying for or providing the successful products of research. That would be unrealistic and inappropriate, opponents argue, as the Nuffield Council maintains. A second mistaken assumption is that governmental agencies that sponsor research, such as the U.S. National Institutes of Health or the U.K. Medical Research Council would bear the burden of paying for ART for infected vaccine trial participants. But those agencies operate under a mandate to design and conduct research, not to provide medical services. Their budgets do not provide for health services, except perhaps for research-related injuries that occur during a clinical trial. A third assumption is that developing country governments would have to bear the burden of paying for and providing the products of research. However, ministries of health in resource-poor countries could ¹⁸ Alice K. Page, ‘‘Prior Agreements in International Clinical Trials: Ensuring the Benefits of Research to Developing Countries,’’ Yale Journal of Health Policy, Law, and Ethics, 3/1 (2002), 35–64.

Global Justice, Human Rights, and Health / 153 not possibly bear that burden, given the other demands on their overall budgets. Moreover, many drugs would be expensive and the cost of some could not be known in advance. If none of the above parties would not be solely responsible for providing post-trial products, then who would?

Global Health and Justice To answer this question, it is necessary to cross the bridge between the concerns of global research ethics and the broader terrain of global justice in health. A partial answer is provided by the growing number of public–private partnerships dedicated to making needed medications available to resourcepoor countries. At least with regard to the three main devastating diseases in those countries—HIV/AIDS, tuberculosis, and malaria—the following developments have radically altered the prospects for availability over the past few years. • The Global Fund to Fight AIDS, Tuberculosis, and Malaria provides a mechanism for developing countries to have greater access to drugs and to make them available to their populations. The Global Fund formally adopted the stance of encouraging poor countries to purchase generic drugs instead of the more costly brand-name drugs still under patent protections by the big pharmaceutical companies. This approach was designed to enable manufacturers of generics in countries like Brazil and India, which have that capability, to sell their products to other resource-poor countries. Since the role of the Global Fund is to provide grants to countries that apply for them, requiring countries to buy the lowest drugs of guaranteed quality will be a more efficient and effective use of the fund’s money. • Other public–private partnerships are growing in number and commitment. For example, the Botswana–Gates–Merck partnership is a promising model of success for HIV/AIDS. • One of several public–private partnerships actively combating malaria is Medicines for Malaria Venture (MMV). This was among the first of these public–private partnerships established to tackle a major global disease. The initiative arose from discussions between the World Health Organization (WHO) and the International Federation

154 / Macklin of Pharmaceutical Manufacturers Associations (IFPMA). Other partners in the early, exploratory discussions were the Global Forum for Health Research, the Rockefeller Foundation, the World Bank, the Association of the British Pharmaceutical Industry, and the Wellcome Trust, a British philanthropic foundation. • Another global partnership to fight malaria was established in November 1998. This organization, called Roll Back Malaria, was founded by several international agencies, including the World Health Organization, UNICEF, and the World Bank. • One of the more recent efforts to provide access to treatment for people in developing countries was the World Health Organization’s ‘‘3 × 5 Initiative,’’ a program WHO launched (together with the Joint United Nations Programme on HIV/AIDS) in December 2003 aimed at providing antiretroviral treatment to 3 million people living with AIDS in developing countries by the end of 2005. WHO and UNAIDS did not provide a major portion of the funding for this ambitious effort, but took a leadership role in partnerships that included governments of WHO members nations along with industry and other organizations in the private sector. Although the ‘‘3 × 5 Initiative’’ did not reach its goal by the end of 2005, it laid the groundwork for WHO’s current initiative called ‘‘Universal Access.’’¹⁹ The Commission on Macroeconomics and Health proposed a joint agreement among pharmaceutical companies and low-income countries, in collaboration with WHO, to set guidelines for pricing and licensing of production of drugs for the low-income countries. These guidelines would work as follows. They would ‘‘provide for transparent mechanisms of differential pricing that would target low-income countries . . . and identify a designated set of essential medicines . . . at the lowest viable commercial prices.’’²⁰ It is clear that these developments must rely on the cooperation and collaboration of the pharmaceutical industry. To date, that has remained ¹⁹ World Health Organization, available at . ²⁰ World Health Organization, Report of the Commission on Economics and Health, Macroeconomics and Health Investing in Health for Economic Development (2001), 89. Available at .

Global Justice, Human Rights, and Health / 155 a mixed picture. On the one hand, drug companies have lowered the prices of a number of their products, making them more affordable yet still out of reach of the poorest countries. On the other hand, however, they have continued to thwart efforts to increase the availability of much cheaper, generic drugs—those for which the Global Fund to Fight AIDS, Tuberculosis and Malaria has declared a clear preference. In the World Trade Organization’s agreement known as TRIPS—Trade Related Aspects of Intellectual Property—the concept of a national health emergency is a key condition that opens the door to loosening the strict patent protections that have reigned under the influence of the global pharmaceutical industry. The question for global justice in health is whether the goal of promoting health merits exemption from the rules that govern world trade in all other commercial products. The stated purpose of intellectual property rights—patents, in particular—is to encourage commercial investments in research and development. Industry spokespersons maintain that patent protections are necessary for promoting research, and the resulting products benefit everyone, poor nations included. The international trade agreements that protect the financial interests of patent holders in world markets have come under increasing scrutiny in the health arena. Critics of globalization claim that the WTO’s protection of patents is responsible for the many ills that globalization produces, including poor health of vast numbers of people in developing countries.²¹ The TRIPS agreement, which became operative in January 1995, requires all member countries to respect the patents held by pharmaceutical and biotechnology companies and to pass laws respecting medical patents. Although the patent system serves the interests of manufacturers, the system is viewed by many to be in the public interest, as well as a benefit to the financial interest of industry. One description of the TRIPS Agreements describes it as ‘‘an attempt at the multilateral level to achieve the difficult task of balancing the public health interest in providing incentives for research and development into new drugs with the public health interests of making existing drugs as accessible as possible.’’²² ²¹ Peter Singer, One World: The Ethics of Globalization (New Haven: Yale University Press, 2002); M. G. Bloche and E. R. Jungman, ‘‘Health Policy and the WTO,’’ Journal of Law, Medicine & Ethics, 31/4 (2003), 529–45. ²² Jayashree Watal, ‘‘Background Note,’’ Prepared for WHO-WTO Workshop on Differential Pricing and Financing of Essential Drugs (April 8–11, 2001), 7.

156 / Macklin There is one provision in this agreement that enables countries to make an exception to the rule that requires respecting the patent rights of pharmaceutical companies. That provision permits countries to manufacture copies of patented drugs in case of a ‘‘national emergency.’’ The mechanism for this is to obtain a ‘‘compulsory license’’ to make a generic copy of a drug, and the patent holder is paid a reasonable royalty under this arrangement. Somewhat less certain under this provision has been the ability of a country to import a generic copy of a patented drug. An obvious question is what constitutes a ‘‘national emergency’’? Arguably, the AIDS epidemic in countries with a high prevalence rate would qualify. Does the same hold for countries with a high incidence and prevalence of malaria and tuberculosis? Drug companies and their international umbrella organization, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), have long resisted efforts to invoke the provision that would allow countries to make or import generic copies of patented drugs under the compulsory licensing clause. What should developing countries do in the face of the strong TRIPS agreement, the strength of the pharmaceutical industry, and their supporters in the U.S., the European Union, Switzerland, Japan, and other industrialized countries with huge drug companies? One bioethicist has the following suggestion: When developing countries choose not to respect product patents as their only effective means of making available pharmaceuticals necessary to save lives and protect the health of their citizens, doing so is arguably a step forward to greater justice between the developed and developing world; this may be a case where two wrongs make a right, that is where existing global injustices make not respecting product patents, which in the absence of those injustices would be wrong, all things considered, morally justified.²³

Yet India, one of the countries with the largest capacity for manufacturing generic copies of patented drugs, decided in 2005 to adhere to the WTO requirements. The Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful industry trade group, immediately issued the following press release, praising the Indian government for its wise action: ²³ Dan W. Brock, ‘‘Some Questions About the Moral Responsibilities of Drug Companies,’’ Developing World Bioethics, 1/1 (2001), 37.

Global Justice, Human Rights, and Health / 157 March 23, 2005 Washington, D.C.—PhRMA members welcome the passage today of India’s Patents Third Amendment Bill, 2005. This legislation is a milestone for the Government of India, re-establishing patent protection for pharmaceutical products in India. With the passage of this legislation, India has taken an important step toward complying with its obligations under the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). However, America’s research-based pharmaceutical industry does remain concerned about a number of late amendments to the bill that may bring India into conflict with its minimum international obligations . . . . When India joined the WTO in 1994, it agreed to implement patent protection for pharmaceutical products, among a range of patent protections included in the TRIPS Agreement, by January 1, 2005. Patent protection for pharmaceutical products will provide India’s scientists with incentives to discover and develop new life-saving drugs.²⁴

A U.K. government report issued in March 2005 issued a plea to the pharmaceutical industry, which it called ‘‘the ethical case for action.’’²⁵ The report urges pharmaceutical companies to make drugs more affordable, especially for the least developed countries. The main recommendation of the U.K. report was to allow differential pricing for drugs, a mechanism the report says is ‘‘economically and commercially viable.’’ Differential pricing (also called ‘‘equity pricing’’ or ‘‘preferential pricing’’) is defined as follows: ‘‘setting the price of essential drugs in a way that reflects countries’ ability to pay, as measured by their level of income.’’²⁶ The concept of differential pricing must be distinguished from the situation throughout the world in which different countries charge different prices for the same drugs. The latter situation results from the policies that individual countries ²⁴ Pharmaceutical Research and Manufacturers of America, 2005, available at . ²⁵ Department for International Development (DFID), ‘‘Increasing People’s Access to Essential Medicines in Developing Countries: A Framework for Good Practice in the Pharmaceutical Industry’’ (2005), available at . ²⁶ WHO Secretariat, ‘‘More Equitable Pricing for Essential Drugs: What Do We Mean and What are the Issues?’’ Background paper for WHO-WTO secretariat workshop on differential pricing and financing of essential drugs (Hosbjor, Norway: April 8–11, 2001).

158 / Macklin have established to regulate the drug market for their own people. Variations also are traceable to taxes, import duties, wholesale and retail markups, and other factors. Different prices for drugs in various countries are typically not the result of a deliberate and systematic international policy, whereas ‘‘differential pricing’’ has precisely that aim and structure. The aim of a policy of differential pricing is obvious: to enable low-income countries to gain access to essential drugs for their populations. In lowincome countries, both the government and the majority of the population are unable to afford drugs that are needed for a variety of treatable conditions. Out-of-pocket payments rather than prepaid insurance are the primary mechanism in most poor countries. Pharmaceutical companies have traditionally opposed tiered pricing for drugs, even when it enables poor countries to purchase medications that would otherwise not be affordable for their populations. The worry is that the phenomenon known as ‘‘parallel trade’’ or ‘‘parallel importing’’ will undermine the profits of the companies. The U.K. report acknowledges this danger, and includes recommendations to industry on how to minimize this risk to their profits or even avoid the risk entirely. It remains to be seen whether the pharmaceutical industry will respond to this ‘‘ethical case for action,’’ although it is fair to say that some drug companies have already taken the lead in lowering prices of antiretroviral drugs and, in some cases, supplying medications to very poor countries free of charge.

Global Health and Human Rights Although human rights declarations and treaties do not mention justice explicitly, several human rights instruments address the right to health. Article 27 of the Universal Declaration of Human Rights identifies one pathway to a right to health that links to research and its successful products: ‘‘Everyone has the right freely . . . to share in scientific advancement and its benefits.’’ To share in the benefits of scientific advancement can be interpreted to mean that the fruits of biomedical research must be made available to everyone who needs information or products developed in such research. In another leading document, Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) addresses ‘‘the right of everyone to the highest attainable standard of physical and mental

Global Justice, Human Rights, and Health / 159 health,’’ requiring governments to take certain defined steps, including ‘‘the prevention, treatment and control of epidemic, endemic, occupational and other diseases’’ and ‘‘the creation of conditions which would assure to all medical service and medical attention in the event of sickness.’’ The wording of Article 12 recalls the preamble of the 1946 constitution of the World Health Organization, a member of the United Nations family of organizations: ‘‘The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social conditions.’’ One of the tasks of the United Nations committees authorized to monitor the implementation of human rights treaties is to make ongoing reviews of progress in light of changing circumstances. This process results in the periodic issuing of General Comments. One pertinent example is a comment issued by the Committee on Economic, Social and Cultural Rights when it revisited Article 12 of the International Covenant on Economic Social and Cultural Rights: the right to the highest attainable standard of health. The committee observed that much has changed in the world health situation since the ICESCR was adopted in 1966, noting that more determinants of health are now recognized, such as resource distribution and gender differences.²⁷ The Comment identifies accessibility as one of the essential elements required for fulfilling the right to health. This includes accessibility to health facilities, goods, and services with four overlapping dimensions: nondiscrimination (accessibility to everyone), physical accessibility, economic accessibility, and information accessibility. In addition to enumerating various detailed actions that governments must undertake in order to respect, protect, and fulfill their obligations regarding this right, the Comment includes a section on international obligations. It refers states parties to a declaration that ‘‘proclaims that the existing gross inequality in the health status of the people, particularly between developed and developing countries . . . is politically, socially and economically unacceptable and is, therefore, of common concern to all countries.’’²⁸ Compliance with their ²⁷ Committee on Economic, Social and Cultural Rights, ‘‘Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,’’ General Comment no. 14, E/C.12/2000/4 (August 11, 2000). ²⁸ Ibid. 11.

160 / Macklin international obligations requires countries with available resources to ‘‘facilitate access to essential health facilities, goods and services in other countries, wherever possible and provide the necessary aid when required.’’²⁹ It is clear from this detailed commentary on the right to the highest attainable standard of health that wealthier countries (among those that have ratified the ICESCR) have international obligations to assist in providing access to health facilities, goods, and services to resource-poor countries. Although only states parties are accountable to fulfill this and other human rights obligations, the Comment also addresses non-state actors. It states that all members of societies have responsibilities regarding the right to health, including intergovernmental and nongovernmental organizations, civil society, and the private business sector. The Comment specifically identifies the World Trade Organization (WTO), which is a member of the United Nations system, as one of the organizations that should cooperate effectively with states parties regarding the implementation of the right to health. So, even though there is no mention of global justice in health in these United Nations human rights covenants or in the General Comments issued by monitoring bodies, implicit in these documents is a conception of justice: what wealthy nations owe to poor nations in the sphere of human health. A recommendation issued by the Office of the United Nations High Commissioner for Human Rights and the Joint United Nations Programme on HIV/AIDS indicates what would achieve a goal of justice in global health: States and the private sector should pay special attention to supporting research and development that address the health needs of developing countries. In recognition of the human right to share in scientific advancement and its benefits, States should adopt laws and policies, at the domestic and international levels, ensuring that the outcomes of research and development are of national and global benefit, with particular attention to the needs of people in developing countries and people who are poor or otherwise marginalized.³⁰

Actions in the service of that goal have already begun. To achieve the long-range goal, even greater collaboration between governments and the private sector are needed. ²⁹ Committee on Economic, Social and Cultural Rights, ‘‘Substantive Issues,’’ 11–12. ³⁰ Office of the United Nations High Commissioner for Human Rights and the Joint

United Nations Programme on HIV/AIDS, HIV/AIDS and Human Rights: International Guideline, Revised Guideline 6 (New York and Geneva: United Nations, 2002).

Part III Biomedical/Bioethical Collaborations

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8 Achieving Global Justice in Health through Global Research Ethics: Supplementing Macklin’s ‘‘Top–Down’’ Approach with one from the ‘‘Ground Up’’ Eric M. Meslin∗

Introduction International research raises challenging ethical issues for researchers, study participants, review committees, investigators, sponsors, institutions, and the countries in which the research is undertaken. This is so because in addition to the problems of informed consent, recruitment of participants, and protection of confidentiality, additional features such as geography, economic status, culture, and politics influence the conduct ∗

The author has been a consultant to Eli Lilly and Company on issues related to international research. The Indiana University Center for Bioethics is supported in part by the Indiana Genomics Initiative (INGEN), which is supported by the Lilly Endowment, Inc. Research for this chapter was also supported in part by a grant from the International Development Fund, Indiana University.

164 / Meslin of research.¹ But even more than this, we have come to appreciate that international research—in its simplest form, research undertaken by researchers from one country in another country—is inextricably linked to broader questions of international health and health care. Ruth Macklin recognizes this link and argues forcefully for the ‘‘interconnectedness of the research enterprise and global health.’’ A powerful example of the connection between the two is the challenge of determining to whom benefits emerging from a study (if any arise) should be provided, for how long, and on whose shoulders should any obligation be placed to provide such benefits? Macklin’s chapter provides a thoughtful approach for thinking about this compound question (which I refer to in more detail below), and about broader questions on achieving true justice in global health. My strategy in this chapter will depart from the usual model where commentators are asked to critique the content of a paper. This model of academic critique certainly has its place and can be valuable in pointing out inconsistencies in argumentation, unstated premises, and unintended consequences. I have a different motivation: I am going to grant much of what Macklin argues as being able to stand on its own two feet. This is not because Macklin’s thesis is problem-free, or that there are no inconsistencies, unstated premises, or consequences she failed to appreciate. Rather, it is because I find many of her arguments to be sufficiently provocative and compelling to stand on their own. Indeed, Harold Shapiro and I made some of these same arguments several years ago, albeit not quite as elaborately or eloquently, in an article in the New England Journal of Medicine,² that summarized many of the conclusions from the National Bioethics Advisory Commission (NBAC) report on international research.³ Given that many of NBAC’s initial recommendations and arguments were first developed and/or proposed by Macklin in her capacity as a senior consultant and project director for this ¹ A. Shamoo, ‘‘Debating Moral Issues in Developing Countries: Addressing the Health Needs of Host Nations while Guarding against Subject Exploitation and Other Pitfalls,’’ Applied Clinical Trials, 14/6 (2005), 86–96; A. J. London, ‘‘Justice and the Human Development Approach to International Research,’’ Hastings Center Report, 35 (2005), 24–37. ² H. T. Shapiro and E. M. Meslin, ‘‘Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries,’’ NEJM 345 (2001), 139–41. ³ National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Report and Recommendations ( Rockville, MD, 2001).

Health Justice through Global Research Ethics / 165 report during the time I was NBAC’s Executive Director, it understandable that I would have a certain affinity for them.⁴ But there is a second reason for taking this somewhat non-traditional approach: I am getting impatient with the pace with which the translation of good argumentation into action is occurring on matters of urgency like global health. Like Macklin, I am committed to seeing substantive and meaningful change in the world, to seeing real reform in the way that the benefits of medicine, science, and technological innovative can be made available to those people who desperately need it. Some of the impediments to this goal have to do with getting clear about how best to define the problem of global justice. Other impediments have to do with the ways in which goals are implemented. Macklin’s project focuses substantially on the former strategy. I intend to focus on the latter and make no apology for avoiding the more traditional task of critique. So, instead of a granular examination, I intend to supplement her argument, to address an issue that if left unattended will eventually undermine the strong foundation she has provided. To do this I will focus the frame of reference on the obstacles to actual implementation. Here’s what I intend to argue: 1. Ultimately, the goal of achieving global justice in health through research will only occur if serious efforts to build capacity are undertaken. While a term much in vogue, ‘‘capacity-building’’ tends to follow a top–down approach in which efforts are focused on developing policy, procedures, regulations—whether in the form of actual economic initiatives or the establishment of common principles and commitments—and hope that a type of ‘‘trickle-down’’ phenomenon will occur where the intended beneficiaries of such approaches will actually benefit. These approaches have certain limitations. Macklin’s chapter falls into the top–down category because its main strategy is to explicate (elegantly, I must say) various conceptions of global justice. 2. From this it follows that achieving global justice in health will not occur without a bi-directional approach that involves capacity ⁴ It should be noted that a number of the commission’s conclusions and recommendations departed from Macklin’s original proposals, a point that Macklin makes both in her chapter in this volume, and more extensively in her book Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2004).

166 / Meslin building both from the top down, and from the bottom (or ground) up. By capacity building from the ground-up I am referring to the process of fashioning collaborative agreements and understanding between institutions, ethics reviews committees, and researchers in real time who focus on joint interpretations of important concepts, principles, and plans. These approaches also have limitations, but have many underappreciated benefits. 3. To demonstrate the value of ground-up approaches, I offer two examples from current collaborations we have undertaken with colleagues at Moi University Faculty of Health Sciences in Eldoret, Kenya.⁵

1. Capacity Building from the Top Down Over the past fifteen years the world has witnessed tremendous growth in international collaborative research. Between 1990 and 1999 the FDA reported a sixteen-fold increase in the number of foreign clinical investigators conducting FDA-regulated research, and an equally impressive growth in the number of countries (from 28 to 79) in which this research was now occurring.⁶ Yet the U.S. has been slow to adapt its regulatory regime to these new international research realities, and the evidence is found in several places: • The federal system for the protection of human subjects is still something of a patchwork domestically since only sixteen of the more than sixty federal agencies have agreed to be bound by the Federal Policy ⁵ Much of the material is drawn from the following: E. M. Meslin, J. E. Sidle, K. WoolsKaloustian, K. Salmon, C. Chuani, and E. Were, International Research Ethics: A Needs Assessment of Research Ethics Capacity at Moi University and Indiana University, Final Report. June 2005, available at ;D. N.Shaffer,J. Y.Greene,S.Kimaiyo,J.Sidle, J. Ballidawa, E. M. Meslin, V. Yebei, and W. M. Tierney, ‘‘Equitable Treatment for HIV/AIDS Clinical Trial Participants: A Focus Group Study of Patients, Researchers, and Health Administrators in Western Kenya,’’ Journal of Medical Ethics, 32 (2006), 55–60; J. E. Sidle, E. Were, K. Wools-Kaloustian, C. Chuani, K. Salmon, W. Tierney, and E. M. Meslin, ‘‘A Needs Assessment to Build International Research Ethics Capacity,’’ Journal of Empirical Research in Human Research Ethics, 1/2 (2006), 23–38. ⁶ Office of the Inspector General, DHHS. ‘‘The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects,’’ OEI-01-00-00190, September 2001.

Health Justice through Global Research Ethics / 167 for the Protection of Human Subjects (45 CFR 46, Subpart A, also known as the Common Rule);⁷ • Even in areas of research jointly regulated by the Common Rule and the FDA there are substantive differences on critical ethical issues such as informed consent;⁸ • Until recently there has been little detailed guidance by the Office of Human Research Protections or the FDA about the conduct of international research, leaving investigators (in the U.S. and abroad) to determine how best to comply with U.S. regulations. The growth in international research has been accompanied by a commensurate growth in the development of proposed guidelines, regulations, and policies by countries and organizations. National and transnational efforts to provide substantive guidance on the ethics of international research has become a growth industry. Indeed, one of the more visible features of the current bioethics and public policy landscape is the existence of national and transnational bioethics commissions and advisory bodies which are focusing on that ethical, legal and policy issue in research involving humans.⁹ By the end of the 1980s, national bioethics commissions had been established in many other countries including Australia, Canada, Denmark, France, Hungary, Luxembourg, Malta, the Philippines, Sweden, the United Kingdom, and Zimbabwe. In 2005 national bioethics commissions existed in more than eightyfive countries, on every continent of the globe except Antarctica.¹⁰ A number of African countries have established national guidelines, including Uganda,¹¹ ⁷ National Bioethics Advisory Commission, Research Involving Human Participants (2001). ⁸ B. J. Evans, ‘‘Inconsistent Regulatory Protection Under the U.S. Common Rule,’’

Cambridge Quarterly Healthcare Ethics (2004), 366–79; B. J. Evans and E. M. Meslin, ‘‘Encouraging Translational Research through Harmonization of FDA and Common-Rule Informed Consent Requirements for Research with Banked Specimens,’’ Journal of Legal Medicine, 27/2 (2006), 119–66. ⁹ See E. M. Meslin and S. Johnson, ‘‘National Bioethics Commissions and Research Ethics,’’ in The Oxford Textbook of Clinical Research Ethics, ed. E. Emanuel, R. Crouch, C. Grady, R. Lie, F. Miller, and D. Wendler (New York: Oxford University Press, 2008) pp. 187–97. ¹⁰ World Health Organization, Department of Ethics, Trade, Human Rights and Health Law, ‘‘Interactive Bioethics Commission Map,’’ available at . ¹¹ National Consensus Conference on Bioethics and Health Research in Uganda, ‘‘Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda,’’ Kampala, Uganda: National Consensus Conference, 1997.

168 / Meslin Kenya¹² and South Africa.¹³ Others, including Congo, Ivory Coast, Malawi, Tanzania, Sudan, and Zambia, have well-established research oversight systems. This emphasis on guideline development is not surprising. Ethical research involving human participants must satisfy both substantive and procedural requirements. Substantive requirements are used by ethics review committees when they assess the ethical acceptability of research protocols. In the United States, the substantive requirements for ethical research involving human participants are found in the Common Rule. Procedural requirements are those relating to the mechanism of ethics review, such as an institutional review board (IRB) competent to assess compliance with substantive ethical requirements. Prior review and approval of a study by an IRB is, therefore, the principal procedural mechanism by which substantive ethical protections for human participants can be assured. The common focus of each of these efforts—regulations, policies, guidelines—is that they are top–down: they are developed by groups of experts from a distance with the goal of producing a generalizable and therefore universalizable instrument whose impact will be felt by a great many people. Like all deductive efforts—whether the goal is to define concepts, or to refine or propose guidelines or standards—there is a presumption that the efforts will succeed because they provide greater clarity, a common language, or a more understandable interpretation of a particular problem. In short, they are valuable because they are intended to be useful for researchers, whether in Canada or Cameroon. The reality is different. The language found in these documents is usually the final product of a consensus process that must satisfy legal, regulatory, and political goals. But even after agreement is reached, there are difficulties. Like trickle-down economics it is always difficult to ensure that the documents will be accessible to all who would benefit from them. In the case of researchers in economically developing countries, where access to the internet may be inconsistent, there will always be challenges as simple as obtaining the documents themselves. And as with ¹² R. N. Oduwo, K. M. Wassunna, and J. R. Rashid, Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya, National Council for Science and Technology Publication 45 (Nairobi: National Council for Science and Technology, 2004). ¹³ Medical Research Council (South Africa), ‘‘Guidelines on Ethics for Medical Research: MRC’’ (1994); available at , accessed April 11, 2006.

Health Justice through Global Research Ethics / 169 the ‘‘broken telephone’’ it is always difficult to ensure that the message contained in a guidance document will be the same message received by the end user. Guidelines are meant to guide, and as such they can still be interpreted in very diverse ways, particularly at the local level. This is why among the more challenging ethical issues in international research is the problem of achieving harmonization.¹⁴ Consider the issue of whether research subjects should be provided with continued access to a drug that has been proven to be safe and effective in a clinical trial. While there are nearly 100 domestic and international guidelines for the protection of human subjects, the vast majority are silent on this issue.¹⁵ Where they do exist, as Macklin notes, ‘‘a look at existing international guidelines and recommendations from reports yields a mixed picture.’’ One of the more important new developments in top–down capacity building is the recent interest in a provision of the U.S. regulations that permits federal departments that are signatories to the Common Rule to make a formal determination that another country’s guidelines provide protections that are ‘‘substantially equivalent’’ to those found in the Federal Policy. Two U.S. agencies have the authority to make determinations of ‘‘equivalency’’ found at 45 CFR 46.111(h): the Office of Human Research Protections (OHRP) and the U.S. Agency for International Development (USAID). While the ability to make determinations of equivalency has existed in U.S. regulation since 1981, no country’s guidelines have been formally determined to have met this standard. However, in March 2005, following a report of an OHRP Working Group, a draft policy was released by OHRP outlining criteria for determining equivalency.¹⁶ The renewed interest is a welcome development in an ongoing, international effort to ¹⁴ G. B. Tangwa, ‘‘Between Universalism and Relativism: A Conceptual Exploration of Problems in Formulating and Applying International Biomedical Ethical Guidelines,’’ Journal of Medical Ethics, 30 (2004), 63–7. ¹⁵ National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Commissioned Papers and Staff Analysis (Bethesda, MD, 2004). ¹⁶ Office of Human Research Protections, DHHS, ‘‘Protection of Human Subjects, Proposed Criteria for Determinations of Equivalent Protection’’, Federal Register, 70/57, Friday, March 25, 2005/Notices; available at (accessed April 11, 2006). The Equivalent Protections Working Group report is available at .

170 / Meslin harmonize research ethics regulations.¹⁷ Activities at the level of regulatory reform and guideline development are positive and productive signs of capacity building. They are necessary to achieve global justice in health, but not sufficient.

2. Capacity Building from the Ground Up In contrast with top–down approaches, many of the authoritative bodies cited above call for specific initiatives to be undertaken at the local level. In its 2001 report on international research NBAC recommended that U.S. sponsors should develop and implement strategies that assist developing countries in building local capacity for designing, reviewing, and conducting clinical trials and that assist in building capacity for ethics review committees in developing countries to conduct scientific and ethical review of international collaborative research projects.¹⁸ Other organizations have made similar recommendations, including the World Health Organization,¹⁹ the Joint United Nations Program on HIV/AIDS (UNAIDS),²⁰ the Council for International Organizations of Medical Sciences (CIOMS)²¹ and the Nuffield Council on Bioethics.²² Two general types of capacity building from the ground up have been suggested. The first is to enhance the capacity of researchers in developing countries to conduct research through a variety of methods including training and education of potential researchers, and providing infrastructure to permit research to continue after a particular ¹⁷ J. V. Lavery, M. McDonald, E. M. Meslin, ‘‘Research Ethics across the 49th Parallel: The Potential Value of Pilot Testing ‘Equivalent Protections’ in Canadian Research Institutions,’’ Health Law Review, 13 (2005), 85–96. ¹⁸ US National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Bethesda, MD: NBAC, April 2001). ¹⁹ World Health Organization, ‘‘Operational Guidelines for Ethics Committees that Review Biomedical Research (Geneva: WHO Document TDR/PRD/ETHICS/2001). ²⁰ Joint United Nations Program on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document (Geneva: UNAIDS, 2000). ²¹ Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993). ²² Nuffield Council on Bioethics, The Ethics of Research Related to Health Care in Developing Countries (London: Nuffield Council on Bioethics, 2005).

Health Justice through Global Research Ethics / 171 study is completed. The second type is to build local expertise to conduct scientific and ethics review of research protocols, some of the early support for which first emerged from separate studies conducted for NBAC by Nancy Kass and Adnan Hyder, Jeremy Sugarman and Patricia Marshall, and by the Commission’s own comparative analysis of twenty-five national and international documents addressing the protection of human research participants.²³ Research ethics capacity building from the ground up looks very different from top–down approaches. The principal difference is the relevance of local circumstances: capacity building from the ground up begins with a commitment to develop a partnership among collaborators that will provide specific benefits to all of them (ideally in the short and long run). It occurs where there is a desire to seek agreements in an atmosphere of trust and mutual respect. By agreements I am referring not only to the kind of instruments Alice Page has described—prior agreements by parties that specify the content and nature of any obligations to provide benefits.²⁴ I am also referring to the face-to-face engagement between researchers, administrators, ethics review committee members, research participants, and the communities from which they come. This type of capacity building can only occur when you are sitting with someone in the same room, when you are struggling to explain terms and concepts (even when English is the common language of the conversation), and when you are focusing on specific research topics and problems. The difference between top–down and ground–up approaches is like the difference between flying over a country in an airplane and walking the streets of the village. In what follows I give two examples of ground–up approaches that have emerged from our efforts with colleagues Kenya. Indiana University has a long-standing commitment to international collaboration, primarily with a number of other universities in Sub-Saharan Africa. Among IU’s most important relationships is the fifteen-year partnership between the IU ²³ National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, ii. Commissioned Papers and Staff Analysis (Bethesda MD, May 2001). ²⁴ A. K. Page, ‘‘Prior Agreements in International Clinical Trials: Ensuring the Benefits of Research to Developing Countries,’’ Yale Journal of Health Policy, Law, and Ethics, 3/1 (2002), 35.

172 / Meslin School of Medicine (IUSM) and Moi University Faculty of Health Sciences (MUFHS), in Eldoret, Kenya.²⁵ Located in the northern Rift Valley, Eldoret has a population of 100,000 and is the home of the Moi Teaching and Referral Hospital, the primary referral hospital for western Kenya serving a catchment area of approximately 13 million people. The partnership between IUSM and MUFHS is unique: IUSM worked with MUFHS to physically build this hospital from the ground up; IUSM sends medical students and faculty every year to teach and provide care, and MUFHS medical students come to IU; and the universities have jointly launched one of the most successful HIV prevention and treatment programs in Africa. MUFHS is now moving to become a research-based institution as well. Its faculty are now submitting grant applications to the NIH, through an Office of Research and Sponsored Programs. Moi has an IRB, called an Institutional Research Ethics Committee, that recently received a federalwide assurance from OHRP. In short, it has built the infrastructure for research ethical (literally) from the ground up.

3a. Capacity Building from the Ground Up (I): Experiences of Research Participants Any attempt to understand the problem of post-trial obligations must include efforts to understand this issue from the perspective of many different people, perhaps most critically those who participate (or are eligible to participate) in the trial itself. While the literature on this subject has grown, with many ‘‘top–down’’ approaches suggested, little in the way of data and ‘‘ground–up’’ information has been presented. We recently gathered data on the experiences of research participants that provide an example of how a ground–up approach might be useful in thinking about the broader problem of achieving global justice in health through research.²⁶ ²⁵ Available at . ²⁶ D. N. Shaffer, V. N. Yebei, J. B. Ballidawa et al., ‘‘Equitable Treatment for HIV/Aids

Clinical Trial Participants: A Focus Group Study of Patients, Clinician-Researchers, and Administrators in Western Kenya,’’ Journal of Medical Ethics, 32 (2006), 55–60. The information that follows is excerpted from this study.

Health Justice through Global Research Ethics / 173 We conducted eleven focus group sessions involving eighty-nine participants from the Moi Teaching and Referral Hospital and the Mosoriot Health Center, which serves a widespread rural population of approximately 40,000 people and is located approximately 30 kilometers southeast of Eldoret. The purpose of the study was to describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations of researchers during and after an HIV/AIDS clinical drug trial. Participants included potential HIV/AIDS clinical trial participants, clinician-researchers, and administrators, and they each discussed issues surrounding a hypothetical clinical trial investigating HIV/AIDS drug therapy. The main conclusion was that Kenyan patients, clinician-researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long-term obligation to HIV/AIDS clinical trials participants. Consider this typical response expressed by one individual with HIV/AIDS from Mosoriot: I feel that since there is nothing that is impossible, maybe that doctor may have those drugs and he wants to use them on me as a research and they may work properly. If he takes me to the laboratory and I may find there is no virus, there he has a right to discontinue the use once he is sure that I am healed. But if I am not completely healed, he should not stop the drugs.

As important and powerful as the focus group data are in their support of the goal of ensuring access to useful therapy, there was an equally clear appreciation for those circumstances in which drug treatment could be stopped after a trial. Reflecting the important value placed on the patient–doctor relationship in Kenya, patients in the Eldoret focus groups accepted that there were two conditions under which it would not be unfair to stop providing a drug after the completion of a trial: first, it would not be unfair if/when doctors recommended that therapy be stopped. Second, patients felt therapy could be stopped following a trial if a cure were to become available or if drug resistance developed. Like the patients themselves, clinician-researchers recognized several conditions under which the provision of continued treatment would not be appropriate: uncertain drug efficacy and serious drug toxicity were situations where it may be justified to discontinue therapy. Clinician-researchers also felt that therapy could be discontinued at some point following the trial if participants were fully informed prior to the trial that treatment would

174 / Meslin be of limited, of finite duration and would be stopped once the trial was over. These data can be added to a growing list of other studies on patient and research subject attitudes towards clinical trials in developing countries. But data alone is not sufficient for capacity building from the ground up. To really see how this approach might work, consider a second example from our work in Kenya.

3b. Capacity Building from the Ground Up: Ideas about Fairness from Researchers It was obvious that while the longstanding IU–Moi Partnership had much to be proud of with respect to enhancing capacity in teaching and clinical care, both institutions recognized that a legitimate partnership in research required a deliberate effort to identify common barriers to and opportunities for collaborative research. Neither university had superior knowledge or experience in contrast with the other—and both had expertise that the other did not. With this as a foundation, we conducted a Workshop on International Collaborative Research in Eldoret in February 2003, the goal of which was to develop a collaborative approach between the universities for conducting research that was sensitive to local values and consistent with accepted principles of research ethics.²⁷ The workshop brought together participants from MUFHS, IUSM, Brown University, and the Fogarty International Center at NIH. The agenda was jointly developed by Moi and IUSM participants. The format included panel presentations on institutional policy issues and discussion of ongoing, active Moi and IU collaborative protocols. A number of case examples were raised, evidencing an impressive degree of commonality between the two universities. Both groups described common problems with informed consent, ethics review procedures, and interpretation of existing guidelines. Equity ²⁷ A more comprehensive discussion of the workshop (from which this discussion is drawn) can be found in J. E. Sidle, E. Were, K. Wools-Kaloustian, C. Chuani, K. Salmon, W. Tierney, and E. M. Meslin, ‘‘A Needs Assessment to Build International Research Ethics Capacity’’ (n. 5 above).

Health Justice through Global Research Ethics / 175 and justice issues were raised by representatives from both groups. Indeed, the ongoing discussion in the literature regarding post-trial obligations was replicated at the workshop with a particular emphasis on whether conducting clinical trials for HIV prevention in Kenya would create additional obligations at the end of these studies to provide continuing care to patients. We recognized that each of these topics had been discussed in the literature, but experiencing the presentations face-to-face was a valuable way of assessing the extent to which agreement might be reached on any of the issues themselves. Indeed, many participants were struck by how universal these issues were: that difficult ethical issues in the Kenyan examples were directly relevant to the U.S. context, and vice versa. We also agreed that discussion was a necessary but not a sufficient first step to building research ethics capacity. We wanted to put it in writing. There are many written documents that can be used to codify agreements and expectations among groups, falling along a spectrum: at one end of the spectrum are more legally oriented and rulebased documents, the goal of which is to specify particular obligations, duties, rights and responsibilities. Institutional policies have such characteristics, as do government regulations, case law and international treaties. Common to each of these legal instruments is that some form of sanction or action will be applied against the person or group in the event of non-compliance. At the other end of the spectrum are more aspirational documents, the goal of which is to announce or proclaim joint commitments to common values and ideals without specifying consequences of non-compliance. Value statements, communiqu´es, international declarations, and memoranda of understanding (MOU) are examples of such documents. IUSM and MUFHS chose to use an MOU because it best reflected a shared commitment by both institutions to a set of common interests and concerns on matters of research ethics. The MOU was not intended to be a statement of standard operating procedures or rules for compliance between the universities. Indeed, we emphasized throughout the workshop that coming to agreement about the issues that affected researchers and review committees at both institutions was an important first step in a longer process of developing shared policies and procedures. The specific language relating to equity and post-trial obligations appeared in the MOU as follows: We are committed to working towards mechanisms to provide fair distribution of benefits for individuals, communities and institutions.

176 / Meslin We recognize that determining equity in research must be considered within the context of the longstanding IU-Moi Partnership. We recognize that inequities may be identified within an institution or between institutions. Although we agree that this MOU is not an appropriate means to redress these inequities, we agree that any such inequities should be addressed by an appropriate institutional framework.

We identified six factors that contributed to the success of our effort. • An existing relationship on which to build capacity • An event or meeting that focuses the task, with equal representation in planning the agenda and in all activities • Work from actual research protocols and existing policies from each institution, rather than hypothetical cases • Content expertise in the rules, procedures and policies governing research ethics in both institutions and in both countries • Senior leadership from both universities present for the entire workshop • Ongoing commitment to enhanced capacity that will continue after the event itself—whether these will be joint publications, grants or SOPs. The MOU was not, however, the end of the process. We completed a needs assessment of research ethics capacity at both institutions.²⁸ This provided more concrete means for understanding how to provide education and training, policy development, and standard operating procedures for both Moi and IU, as they work to conduct collaborative clinical trials.

Conclusion I suggested at the beginning of this chapter that the goal of achieving global justice in health through research will only occur if serious efforts to build capacity are undertaken, and specifically that ‘‘top–down’’ approaches needed to be supplemented with approaches that worked from the ‘‘ground ²⁸ J. E. Sidle et al., (n. 5 above).

Health Justice through Global Research Ethics / 177 up.’’ I explained how the latter differs from the former and gave two illustrative examples from the Moi University–Indiana University partnership. This partnership, like countless others already in place around the world, are examples of productive face-to-face engagement between many interested parties. Engagement occurs (and works best) when partners jointly work towards understanding the terms, ideas, concepts, and plans necessary for true partnering in international research. If collaborations among a small group of institutions can be made to work, it may make efforts at more regional and transnational capacity building that are much more likely to succeed. It may be the idle speculations of a hopeless (or hopeful) optimist, but I am convinced that the goal of achieving global justice in health through research will be achieved more quickly and more productively if top–down approaches are supplemented by bottom–up approaches in which individuals and their organizations work together. In the effort to describe certain critical challenges for achieving global justice, Macklin has mapped critical moral terrain from a birds-eye perch. But that hard work will go for naught without further cartographic efforts that focus on the enduring challenges of navigating terrain from ground level.

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9 Harnessing Advanced Technologies for Global Health Equity Peter A. Singer, Archana Bhatt, Sarah E. Frew, Heather Greenwood, Jocelyn Mackie, Dilnoor Panjwani, Deepa L. Persad, Fabio Salamanca-Buentello, B´eatrice S´eguin, Andrew D. Taylor, Halla Thorsteinsd´ottir, Aneesa Walji, Abdallah S. Daar∗

Innovation in science and technology (S&T) has significantly contributed to medical advances and has consequently had a large impact on public health. ∗ The authors would like to acknowledge Jessica Mustachi for her editorial assistance. All authors are at the McLaughlin-Rotman Centre for Global Health, Program on Life Sciences, Ethics and Policy, University Health Network and University of Toronto. Funding is provided by Genome Canada through the Ontario Genomics Institute, the Grand Challenges in Global Health Initiative (Bill and Melinda Gates Foundation), the Ontario Research and Development Challenge Fund and the Canadian Institute of Health Research. Other project funders and co-funders can be found on our website (http://www.mrcglobal.org). Abdallah S. Daar and Peter A. Singer are supported by the McLaughlin Centre for Molecular

180 / Singer et al. However, the benefits of this progress have yet to be equally shared. Millions of people in developing countries continue to face health challenges that no longer burden the industrialized world. With pandemics such as HIV/AIDS plaguing countries in sub-Saharan Africa, life expectancies in this region are 40 years and falling—nearly half of those in developed countries. This immense disparity in global health equity is perhaps the greatest ethical challenge of our time.¹ Traditional approaches to bioethics have either focused on the individual and management of the physician–patient relationship, or on the national population and allocation of institutional and national public health resources.² These approaches, however, fail to address health inequities on a global level. A global approach to bioethics, one that places importance on the interests and needs of the majority of the world’s population, can offer a pragmatic and interdisciplinary mode of thought to effectively address global health challenges. What values might underlie such an exercise? The keystone of this perspective is global solidarity, as it is necessary to promote global equity, as well as the remaining five values: respect for human life; the intertwined relationship between human rights, responsibilities, and needs; ensuring freedoms; democratic principles of accountability, representation, cooperation and good governance; and environmental sustainability.³ Simply espousing the values of global bioethics is not enough to reduce disparities in global health; these values must be made applicable to real world challenges to be successful. Four transformative steps can achieve this goal: (1) developing a global state of mind; (2) promoting long-term self-interests; (3) facilitating global engagement; and (4) enhancing scientific knowledge for the production of global public goods, with genomics as an example.⁴ The term good refers to a spectrum of pure private to pure public goods. The majority of goods are private, excludable items; that is, individuals can be Medicine; Peter A. Singer is supported by a Distinguished Investigator award from the Canadian Institutes of Health Research. ¹ S. R. Benatar et al., ‘‘Global Health Ethics: The Rationale for Mutual Caring,’’ International Affairs, 79 (2003), 107–219. ² D. L. Persad et al., ‘‘Enabling Knowledge Societies in Developing Countries: The Example of Genomics,’’ International Journal Biotechnology, 8 (2006), 4–22. ³ Benatar et al., ‘‘Global Health Ethics,’’ 107–219. ⁴ Persad et al., ‘‘Enabling Knowledge Societies,’’ 4–22.

Harnessing Technologies for Health Equity / 181 prohibited from consuming them. They are also rivalrous in that upon their consumption, no other individual can consume them. Conversely, public goods are both non-excludable and non-rivalrous, such as a street sign that benefits all and cannot be expended. Global public goods, as mentioned above, have a characteristic publicness that spans national borders. Genomics is neither a purely private good nor a purely public good, but its association with knowledge production and its potential to span national borders gives it characteristics like those of a global public good. Viewing genomics in this way, as a global public good, widens the potential for driving forces in scientific activity from solely privately driven market forces, and therefore provides a greater platform from which to use genomics to improve human health.⁵ Using a global bioethics approach to help address inequities in global health, the Program on Life Sciences, Ethics and Policy (PLEP), based at McLaughlin-Rotman Centre (MRC) for Global Health at the University Health Network and University of Toronto, has identified three overarching questions:⁶ Which new technologies are most likely to improve the health of people in developing countries? How can developing countries harness these technologies for health development? What can the global community do to assist developing countries? With a global bioethics perspective, the goal of addressing these questions is to strengthen the use of S&T in improving global health.

The United Nations Millennium Development Goals The causes of global health inequities are complex and have received renewed international focus as a result of the United Nations (UN) Millennium Development Goals (MDGs). In 2000, as part of a commitment to reduce poverty and strengthen sustainable development, all 189 UN members adopted the MDGs. These defined targets, accompanied by indicators to ⁵ H. Thorsteinsd´ottir, A. S. Daar, R. D. Smith, and P. A. Singer, ‘‘Genomics: A Global Public Good?’’ Lancet, 361/9361 (2003), 891. ⁶ P. A. Singer and A. S. Daar, ‘‘Harnessing Genomics and Biotechnology to Improve Global Health Equity,’’ Science, 294 (2001), 87–9.

182 / Singer et al. measure them, serve as an international standard for quantifying progress.⁷ (See Table 9.1 for details.) Seven of the eight goals focus on improving development: eradicate extreme poverty and hunger; achieve universal primary education; promote gender equality and empower women; reduce child mortality; improve maternal health; combat HIV/AIDS, malaria, and other diseases; and ensure environmental sustainability. The final goal calls for the creation of a global partnership for development as a means to achieve the MDGs.⁸ To assist developing countries in achieving these goals, the Millennium Project has established ten task forces, one of which is the Task Force on Science, Technology and Innovation (Task Force 10), in which several PLEP members participate. The report from Task Force 10 titled Innovation: Applying Knowledge in Development has stressed that one key underlying factor of global health inequity is knowledge, particularly of S&T. Former UN Secretary General Kofi Annan supports this view and has stated that ‘‘In the world of the 21st century, critical issues related to S&T confront every nation . . . Today, no nation that wants to shape informed policies and take effective action on such issues can afford to be without its own independent capacity in S&T.’’⁹

The Potential Contribution of Genomics to the UN MDGs One tool in the S&T toolkit is the field of genomics, which we define as the powerful new wave of health-related life sciences energized by the human genome project and the knowledge and tools it is spawning. In 2001 we conducted a foresight exercise to examine the potential role that genomics and biotechnology can play in global health, entitled Top 10 Biotechnologies for Improving Health in Developing Countries. An international panel ⁷ T. Acharya, A. S. Daar, H. Thorsteinsd´ottir, E. Dowdeswell, and P. A. Singer, ‘‘Strengthening the Role of Genomics in Global Health,’’ PLOS Medicine, 3/1 (2004), 40. ⁸ United Nations Millennium Development Goals, ‘‘UN Millennium Development Goals 2007,’’ available at <www.un.org/millenniumgoals/>. ⁹ Kofi Annan, ‘‘Science for All Nations,’’ Science, 303 (2004), 925.

Harnessing Technologies for Health Equity / 183 Table 9.1. United Nations Millennium Development Goals Goals

Targets

1. Eradicate extreme poverty and hunger

1. Halve, between 1990 and 2015, the proportion of people whose income is less than one dollar a day 2. Halve, between 1990 and 2015, the proportion of people who suffer from hunger 3. Ensure that, by 2015, children everywhere, boys and girls alike, will be able to complete a full course of primary schooling 4. Eliminate gender disparity in primary and secondary education, preferably by 2005, and to all levels of education no later than 2015 5. Reduce by two-thirds, between 1990 and 2015, the under-five mortality rate 6. Reduce by three-quarters, between 1990 and 2015, the maternal mortality ratio 7. Have halted by 2015 and begun to reverse the spread of HIV/AIDS 8. Have halted by 2015 and begun to reverse the incidence of malaria and other major diseases 9. Integrate the principles of sustainable development into country policies and programs and reverse the loss of environmental resources 10. Halve, by 2015, the proportion of people without sustainable access to safe drinking water 11. By 2020, to have achieved a significant improvement in the lives of at least 100 million slum dwellers 12. Further develop an open, rule-based, predictable, non-discriminatory trading and financial system

2. Achieve universal primary education

3. Promote gender equality and empower women

4. Reduce child mortality 5. Improve maternal health

6. Combat HIV/AIDS, malaria, and other diseases

7. Ensure environmental sustainability

8. Develop a global partnership for development

184 / Singer et al. Table 9.1. (Continued) Goals

Targets 13. Address the special needs of the Least Developed Countries 14. Address the special needs of landlocked countries and small island developing states 15. Deal comprehensively with the debt problems of developing countries through national and international measures in order to make debt sustainable in the long term 16. In cooperation with developing countries, develop and implement strategies for decent and productive work for youth 17. In cooperation with pharmaceutical companies, provide access to affordable, essential drugs in developing countries 18. In cooperation with the private sector, make available the benefits of new technologies, especially information and communications

Source: The World Bank Group. ‘‘A Complete Listing of the Goals, Targets, and Indicators for MDGs, 2004,’’ available at

of twenty-eight scientists, approximately half of whom work in developing countries, underwent three rounds of deliberation to identify the primary genomics-related biotechnologies which can help reduce disparities in global health equity. In addition to their rankings, panelists also provided the following criteria for their decisions: impact; burden, appropriateness; feasibility; addressing knowledge gaps; and indirect benefits. The top three rankings were: molecular diagnostics; recombinant vaccines; and vaccine and drug delivery.¹⁰ See Table 9.2 for a listing of the top ten biotechnology ¹⁰ A. S. Daar, D. K. Martin, S. Nast, A. C. Smith, P. A. Singer, and H. Thorsteinsd´ottir, Top 10 Biotechnologies for Improving Health in Developing Countries ( Toronto: University of Toronto Joint Centre for Bioethics, 2002).

Harnessing Technologies for Health Equity / 185 Table 9.2. Top ten biotechnologies that can improve health in developing countries 1. Modified molecular technologies for affordable, simple diagnosis of infectious diseases 2. Recombinant technologies to develop vaccines against infectious diseases 3. Technologies for more efficient drug and vaccine delivery systems 4. Technologies for environmental improvement (sanitation, clean water, bioremediation) 5. Sequencing pathogen genomes to understand their biology and to identify new antimicrobials 6. Female-controlled protection against sexually transmitted diseases, both with and without contraceptive effect 7. Bioinformatics to identify drug targets and to examine pathogen-host interactions 8. Genetically modified crops with increased nutrients to counter specific deficiencies 9. Recombinant technology to make therapeutic products (e.g. Insulin, interferons) more affordable 10. Combinatorial chemistry for drug discovery Source: A. S. Daar, D. K. Martin, S. Nast, A. C. Smith, P. A. Singer, and H. Thorsteinsd´ottir, Top 10 Biotechnologies for Improving Health in Developing Countries (Toronto: University of Toronto Joint Centre for Bioethics, 2002).

applications. Below, we explore the top three applications of biotechnology in greater detail.

1. Modified Molecular Technologies for Affordable, Simple Diagnosis of Infectious Diseases As infectious diseases are responsible for nearly half of all deaths in developing countries, affordable and efficient diagnostic tools can greatly assist in improving global health by controlling the spread of disease and identifying appropriate treatments. Molecular diagnostics, therefore, prevailed as the most promising biotechnology for improving health in developing countries; particular emphasis was given to polymerase chain reaction (PCR) tests, monoclonal antibodies, and recombinant antigens. These tools are effective at detecting infections, cancers, and many other diseases, and although costs may initially be problematic, their affordability will increase with wider use and local manufacturing.

186 / Singer et al.

2. Recombinant Technologies to Develop Vaccines against Infectious Diseases Vaccines, or compounds that stimulate the body to produce a protective immune response, have the ability to reduce or eradicate disease. Through the use of recombinant technologies, existing vaccines can be made safer and more effective, and novel vaccines can be produced. Methods such as genetically attenuated vaccines, subunit vaccines, viral vector vaccines, and edible vaccines can provide a cheaper form of immunization than that obtained by traditional methods.

3. Technologies for more Efficient Drug and Vaccine Delivery Systems Drug and vaccine administration in developing countries is currently unsafe, costly and can be, in the case of long-term drug regimens, quite complex. Technologies have the potential to create safer syringes, offer injections that cross the skin gently, provide more affordable treatment by eliminating the costly need for refrigeration, and reduce the number of doses required per drug regimen. Genomics, therefore, can provide safer and more effective ways of introducing drugs and vaccines into the body. In our role as the Genomics and Nanotechnology Working Group of Task Force 10, we responded to international attention on global health with our report Genomics and Global Health. The report maps the top ten biotechnologies identified in our foresight exercise against the MDGs, to demonstrate the potential utility of genomics-related technologies in meeting some of these goals, namely: promote gender equality and empower women; reduce child mortality; improve maternal health; combat HIV, malaria, and other diseases; and ensure environmental sustainability.¹¹ A complete table of these goals and the corresponding genomic technologies can be found in Table 9.3. ¹¹ T. Acharya, A. S. Daar, E. Dowdeswell, P. A. Singer, and H. Thorsteinsd´ottir, Genomics and Global Health: A Report of the Genomics Working Group of the Science and Technology Task Force of the UN Millennium Project ( Toronto: University of Toronto Joint Centre for Bioethics, 2004).

Harnessing Technologies for Health Equity / 187 Table 9.3. Genomics and related technologies that can support the MDGs Goals

Statistics/facts

Biotechnology to address MDG

3. Promote gender equality and empower women

In 2001, 57% of HIV cases in sub-Saharan Africa were women Average HIV infection rates in teenage girls are five times higher than those in teenage boys About 11 million children die before reaching their fifth birthday

• Female control over STD transmission protection • Vaccine and drug delivery

4. Reduce child mortality

5. Improve maternal health

Over 500,000 maternal deaths per year

6. Combat HIV, malaria, and other diseases

HIV/AIDS, malaria, and tuberculosis are responsible for more than 6 million deaths worldwide

• Molecular diagnostics • Vaccine and drug delivery • Recombinant vaccines • Female control over STD transmission protection • Nutritionally enriched GM crops • Combinatorial chemistry • Molecular diagnostics • Vaccine and drug delivery • Recombinant vaccines • Female control over STD transmission protection • Nutritionally enriched GM crops • Combinatorial chemistry • Molecular diagnostics • Vaccine and drug delivery • Recombinant vaccines • Female control over STD transmission protection

188 / Singer et al. Table 9.3. (Continued) Goals

7. Ensure environmental sustainability

Statistics/facts

5 million deaths per year can be attributed to waterborne diseases

Biotechnology to address MDG • Bioremediation (using living organisms to degrade/transform hazardous organic contaminants) • Sequencing pathogen genomes • Bioinformatics • Enriched GM crops • Combinatorial chemistry • Bioremediation

Source: T. A. Acharya, S. Daar, E. Dowdeswell, P. A. Singer, and H. Thorsteinsd´ottir, Genomics and Global Health: A Report of the Genomics Working Group of the Science and Technology Task Force of the UN Millennium Project (Toronto: University of Toronto Joint Centre for Bioethics, 2004)

The Potential Contribution of Nanotechnology to the UN MDGs Building upon our biotechnology study, we recently identified and ranked the ten applications of nanotechnology most likely to benefit the developing world in the next ten years. The sixty-three members of our international panel considered the criteria established in the biotechnology study for each proposed application. We achieved a high degree of consensus on the resulting ranking, particularly for the top four applications; all panelists cited at least one of the top four applications in their personal top four rankings, with the majority citing at least three. See Table 9.4 for a listing of the top ten applications. The top three rankings were: energy storage, production, and conversion; agricultural productivity enhancement; and water treatment and remediation. Below, we explore these top three applications of nanotechnology in greater detail.

Harnessing Technologies for Health Equity / 189 Table 9.4. Top ten applications of nanotechnology to improve health in developing countries. Ranking

Applications of nanotechnology

Examples

MDGs affected

1.

Energy storage, production, and conversion

7

2.

Agricultural productivity enhancement

3.

Water treatment and remediation

• Novel hydrogen storage systems based on carbon nanotubes and other light-weight nano materials • Quantum dot-based photovoltaic devices and organic light-emitting devices fabricated from quantum dots • Carbon nanotubes in composite film coatings for solar cells • Nanocatalysts for hydrogen generation • Hybrid protein-polymer biomimetic membranes • Nanoporous zeolites for slow release and efficient dosage of water and fertilizers for plants, and of nutrients and drugs for livestock • Nanocapsules for herbicide delivery • Nanosensors for soil quality and for plant health nanosensors • Nanomagnets for removal of soil contaminants • Nanomembranes for water purification, desalination, and detoxification • Nanosensors for the detection of contaminants and pathogens • Nanoporous zeolites, nanoporous polymers, and attapulgite clays for water purification • Magnetic nanoparticles for water treatment and remediation • TiO2 nanoparticles for the catalytic degradation of water pollutants

1, 4, 5, 7

1, 4, 5, 7

190 / Singer et al. Table 9.4 Ranking

Applications of nanotechnology

Examples

MDGs affected

4.

Disease diagnosis and screening

4, 5, 6

5.

Drug delivery systems

6.

Food processing and storage

7.

Air pollution and remediation

• Nanoliter systems (Lab-on-a-chip) • Carbon nanotube-based sensor arrays • Quantum dots for disease diagnosis • Magnetic nanoparticles as nanosensors • Antibody-dendrimer conjugates for diagnosis of HIV-1 and cancer • Nanowire and nanobelt nanosensors for disease diagnosis • Nanoparticles as medical image enhancers • Nanocapsules, liposomes, dendrimers, buckyballs, nanobiomagnets, and attapulgite clays for slow and sustained drug release systems • Nanocomposites for plastic film coatings for food packaging • Antimicrobial nanoemulsions for applications in decontamination of food equipment, packaging, or food • Nanotechnology-based antigen detecting biosensors for identification of pathogen contamination • TiO2 nanoparticle-based photocatalytic degradation of air pollutants in self-cleaning systems • Nanocatalysts for more efficient, cheaper, and better controlled catalytic converters • Nanosensors for detection of toxic materials and leaks • Gas separation nanodevices

4, 5, 6

1, 4, 5

4, 5, 7

Harnessing Technologies for Health Equity / 191 Table 9.4. (Continued) Ranking

Applications of nanotechnology

Examples

MDGs affected

8.

Construction

7

9.

Health monitoring

• Nanomolecular structures to make asphalt and concrete more robust to water seepage • Heat-resistant nanomaterials to block ultraviolet and infrared radiation • Nanomaterials for cheaper and durable housing, surfaces, coatings, glues, concrete, and heat and light exclusion • Self-cleaning surfaces (e.g. windows, mirrors, toilets) with bioactive coatings • Nanotubes and nanoparticles for glucose, CO2 , and cholesterol sensors and for in situ monitoring of homeostasis • Nanosensors for pest detection • Nanoparticles for new pesticides, insecticides and insect repellents

10.

Vector and pest detection and control

4, 5, 6

4, 5, 6

Source: F. Salamanca-Buentello, D. L. Persad, E. B. Court, D. K. Martin, A. S. Daar, and P. A. Singer, ‘‘Nanotechnology and the Developing World,’’ PLOS Medicine, 2/4 (2005), e97.

1. Energy Storage, Production, and Conversion Nanotechnology can provide inexpensive, clean, and reliable ways to harness renewable resources for the world’s growing population. Using nanotechnology, developing countries can become self-sufficient in their energy source and reduce dependence on non-renewable sources such as fossil fuels. Taking advantage of the ample sunlight received in most developing countries, the materials and technology needed to convert light into electric energy can be made more efficient and affordable than what is currently achievable through the use of nanomaterials such as quantum dots and nanotubes. Fuel cells require the harnessing of hydrogen from water, a task currently limited

192 / Singer et al. by several factors. In addition to allowing for hydrogen to be obtained using solar energy, using a process known as electrolysis, nanotechnology can also provide solutions to limitations of storage and transport. Carbon nanotubes can store 20 times more hydrogen than currently used compounds and are 100 times stronger than steel. As a result, they can store hydrogen at both very low and high pressures and reduce escape of the small element from tanks and pipes.

2. Agricultural Productivity Enhancement Nanotechnology can be used in the development of a range of inexpensive applications to increase soil fertility and crop production, thereby helping to eliminate malnutrition, a contributor to more than half the deaths of children under 5 in developing countries. Using nanotechnology, it is possible, for example, to design zeolite nanoparticles with pores of different sizes, to be used for more efficient, slow and thorough release of fertilizers, or for more efficient livestock feeding and delivery of drugs. Similarly, nanocapsules can release their contents slowly and in a controlled manner, increasing the efficacy of the substances delivered, such as herbicides.

3. Water Treatment and Remediation Safe water supplies, clean water, and water-related diseases such as cholera, typhoid, and schistosomiasis are undeniable concerns for the majority of the world’s population. Nanotechnology can serve as a method of water purification, detoxification and desalination in a more efficient, affordable and portable manner than the current method, which employs bacterial and viral filters. Nanofilter systems use intelligent membranes to filter out bacteria, viruses, and many other water contaminants that cannot pass through them. Water can also be purified using nanoporous zeolites, attupulgite clays, and nanoporous polymers, which can all bind to large numbers of bacteria, toxins, and organic contaminants. Nanomagnets are another form of nanotechnology that can be used for water purification. Also called magnetic nanoparticles and magnetic nanospheres, these particles can remove oil and other organic pollutants from water. Brazilian researchers have developed superparamagnetic nanoparticles that can be spread over a wide area in dust-like form and used to remove heavy metals from soil and water.

Harnessing Technologies for Health Equity / 193

Figure 9.1. Comparison between the Millennium Development Goals and the nanotechnologies most likely to benefit developing countries in the 2004–14 period. Source: F. Salamanca-Buentello et al., ‘‘Nanotechnology and the Developing World,’’ PLOS Medicine 2/4 (2005) e97.

To explore whether nanotechnology can have an impact similar to that of biotechnology on sustainable development, we also mapped the top ten applications of nanotechnology to the UN MDGs. As shown in Figure 9.1, the top ten nanotechnologies, like genomics, have the potential to contribute to achieving the MDGs.

The Use of Biotechnology by Developing Countries to Meet Local Needs Our Genomics and Global Health report illustrated that developing countries must be key actors in using genomic-based technologies to address local health needs. For that to become a reality, developing countries themselves must build capacity in genomics and be active in developing their own solutions to domestic health problems. Some developing countries have

194 / Singer et al. begun to build capacity in health biotechnology and a few have reached a level of capacity where they are able to develop new health products for their populations. In order to assess the potential of advances in genomics and biotechnology to address health needs in various developing regions of the world, we organized a series of Genomics Policy Courses, held in Africa (ten African countries, in association with the African Centre for Technology Studies),¹² India (in association with the Indian Council of Medical Research),¹³ the Eastern Mediterranean Region (thirteen countries, in association with the WHO/Eastern Mediterranean Regional Office),¹⁴ the Latin American and Caribbean region (twenty-two countries, in association with PAHO, UNESCO, and UN University) and China (nine countries, in association with the University of Hong Kong). The courses familiarized participants with the status and implications of genomics and biotechnology for health in their region and provided frameworks for analyzing and debating issues of health policy to help understand, anticipate, and influence the social, legal, ethical, and regulatory frameworks. We also began developing a cross-sectoral network of opinion leaders to share perspectives and build relationships. Numerous concrete impacts have evolved from our courses. During the course held in China, the organizers of the Human Genome Organization Pacific Pan-Asian Single-Nucleotide Polymorphism (SNP) Initiative invited some of the countries registered in the course to participate and this was subsequently implemented. Furthermore, the recommendations from the course in Oman were adopted by Eastern Mediterranean Regional Office (EMRO) Ministers of Health just two weeks after the course. Finally, following the course in Venezuela, Dr. Abdallah Daar was invited to act as an advisor to the government of the Bahamas in building capacity for genomics and biotechnology. ¹² A. C. Smith, J. Mugabe, P. A. Singer, and A. S. Daar, ‘‘Harnessing Genomics to Improve Health in Africa: An Executive Course to Support Genomics Policy,’’ Health Research Policy and Systems, 3/1 (2005), 2. ¹³ T. Acharya, N. K. Kumar, V. Muthuswamy, A. S. Daar, and P. A. Singer, ‘‘Harnessing Genomics to Improve Health in India: An Executive Course to Support Genomics Policy,’’ Health Research Policy and Systems, 2/1 (2004), 1. ¹⁴ T. Acharya, M. A. Rab, P. A. Singer, and A. S. Daar, ‘‘Harnessing Genomics to Improve Health in the Eastern Mediterranean Region: An Executive Course in Genomics Policy,’’ Health Research Policy and Systems, 3/1 (2005), 1.

Harnessing Technologies for Health Equity / 195 In order to better understand what developing countries themselves are accomplishing in genomics, in addition to these courses we conducted case studies of the health biotechnology innovation systems in seven countries. These case studies were done in collaboration with an international group of experts that either lived in the countries we studied or have an intimate knowledge of any one of them. The national innovation systems we investigated were Brazil, China, Cuba, Egypt, India, South Africa, and South Korea. South Korea is not a developing country but is an example of a newly industrialized country that we included for comparison. We collected several categories of data and relied heavily on semi-structured interviews with people in the developing countries. In total, we spoke with 207 experts and participants involved in health biotechnology development in developing countries. These interviewees came from academia, public research institutions, firms, regulatory agencies, and various institutions. The results of this study were published as an entire Nature Biotechnology supplement titled Health Biotechnology Innovation in Developing Countries. As a result of this analysis, we identified lessons learned by developing nations that can help other less industrialized countries foster their own indigenous health biotechnology sector. We also developed recommendations on how to harness genomics and biotechnology to develop local capacity and ultimately improve health in developing countries. It has to be recognized, however, that innovation is complex and no single model for health biotechnology development exists. Many of the developments in the innovating developing countries we studied are context-specific and so not all the lessons identified in one country can be automatically implemented in other countries. The study identified many key factors involved in each of the success stories, such as the focus on the use of biotechnology to meet local health needs. For instance, South Africa has prioritized research on HIV/AIDS, its largest health burden, and developments are underway for a vaccine against the strain most prevalent in the country; Egypt is responding to its insulin shortage by focusing its research and development efforts on the drug; Cuba developed the world’s only meningitis B vaccine as a response to a national outbreak; and India has reduced the cost of its recombinant hepatitis B vaccine to well below that in the developed world. Publications on health research in each of these countries follow the same trend of focusing on local health needs.

196 / Singer et al. Political will is another important factor for establishing a successful health biotechnology sector, as long-term government support was integral in all seven case studies. In efforts to promote development of health care biotechnology, governments have relied on diverse policy measures. They have developed specific polices, provided funding and recognition for the importance of research, responded to the ongoing challenges of brain drain, and offered biotechnology enterprises with incentives to overcome problematic economic conditions. From our study it is clear that health biotechnology policies should not just be add-ons, but need to be integrated into the wider policy environment. Close linkages and active knowledge flows are imperative as well. Whereas in some countries, such as Cuba, strong collaboration and linkages yield successful health biotechnology innovation, a lack of these factors in other countries like China, Brazil, and Egypt have partially diminished innovation efforts. Many of the countries have begun to actively encourage close collaboration and linkages to further develop national S&T innovation. Defining niche areas, such as preventative vaccines, emerged as another key factor in establishing a successful health biotechnology sector. Some of the countries have also relied on their competitive advantages to capitalize on its extensive knowledge in information technology; this is the case of South Korea’s focus on bioinformatics, for example. The recent UN Commission on Private Sector and Development, chaired by Paul Martin and Ernesto Zedillo, emphasized the important role that the domestic private sector plays in the social and economic development of developing countries. In their 2004 report Unleashing Entrepreneurship, Making Business Work for the Poor, the Commission highlighted how the managerial, organizational, and technological innovation in the private sector, particularly the small and medium enterprise segment, can improve the lives of the poor by empowering citizens and contributing to economic growth. The work of the UN Commission also emphasized the lack of knowledge about best practices and the need for more sustained research and analysis of what works and what does not when attempting to harness the capabilities of the private sector in support of development. Our study identified private sector development as essential for the translation of health biotechnology knowledge into products and services. South Korea significantly surpassed all other countries in this respect,

Harnessing Technologies for Health Equity / 197 with policies in place to assist technology transfer and allow university professors to create private firms. China has also promoted enterprise formation, converting existing research institutions into companies. Given its potential to improve both health and economic performance, we are currently investigating the role of the health technology sector in developing countries in addressing local health needs as well as what policies or practices could make that role more effective. This project will expand upon our recent studies of health biotechnology innovation systems in developing countries, those of the UN Commission on Private Sector and Development,¹⁵ and key findings of others such as C. K. Prahalad.¹⁶ It will address the question of how different actors can mutually encourage sustainable investment by the private sector in developing countries into health technologies targeted to address local health needs. The goal is to formulate a policy framework that addresses the needs of the private sector in order to promote innovation in health technologies. The first step involves identifying the incentives for and barriers to investment as well as the factors that distinguish successful business strategies in developing versus developed countries. This analysis is already being used in Ghana and Tanzania to provide heads of state and science ministers in developing countries with specific guidance and good practices for implementing innovation policies that utilize the strengths of both the public and private sectors in developing and implementing health technology to address local health needs.

The Use of Nanotechnology by Developing Countries to Meet Local Needs The lessons and recommendations obtained from our biotechnology study can also inform the use of nanotechnology in developing countries. According to a preliminary study in which we surveyed existing nanotechnology ¹⁵ United Nations Development Program Commission on Private Sector and Development. Unleashing Entrepreneurship: Making Business Work for the Poor (New York: United Nations Development Program, 2004). ¹⁶ C. K. Prahalad, The Fortune at the Bottom of the Pyramid: Eradicating Poverty through Profit (Philadelphia: Wharton School Publishing, 2004).

198 / Singer et al. research in developing countries,¹⁷ many nations in the developing world have already begun exploring the uses of this new technology to meet local health needs. Using a number of methods, we were able to categorize countries based on the degree of government support for nanotechnology, whether or not this support included a formal government funding program, the level of industry involvement, and the amount of research being completed in academic institutions and research groups. The information obtained provides a good overview of the general level of nanotechnology activity in select developing countries. This preliminary study revealed a surprising amount of nanotechnology research and development activity. We clustered the developing countries into three groups: front runners (China, South Korea, India), middle ground (Thailand, Philippines, South Africa, Brazil, Chile) and up and comers (Argentina, Mexico).

What the Global Community Can Do to Assist There are a number of significant actions that the global community can take in partnership with developing countries to foster the use of new technologies for health development.

Global Governance One of the major conclusions of the Genomics and Global Health report is the proposal for the creation of a Global Genomics Initiative (GGI). With strong representation from the developing world in a partnership between industry leaders, citizens, academics, non-governmental organizations, and government officials, the network could serve as a governance mechanism at the global level to ensure the effective application of genomics to worldwide challenges.¹⁸ Consequently, this global network initiative ¹⁷ E. B. Court, A. S. Daar, E. Martin, T. Acharya, and P. A. Singer, ‘‘Will Prince Charles et al. Diminish the Opportunities of Developing Countries in Nanotechonology?,’’ Nanotechonology, 3 (2004), 3. ¹⁸ T. Acharya, et al., Genomics and Global Health: A Report of the Genomics Working Group of the Science and Technology Task Force of the UN Millennium Project ( Toronto: University of Toronto Joint Centre for Bioethics, 2004).

Harnessing Technologies for Health Equity / 199 could share and promote the health and environmental benefits being created through genomics-related technologies worldwide, contributing significantly to improving health and development outcomes in developing countries.

International Partnerships The formation of a GGI could also promote partnerships between industrialized countries and the developing world. We are currently conducting a survey to identify the experiences and understand the barriers and needs of Canadian biotechnology Small to Medium Sized Enterprises (SMEs) regarding international commercialization into emerging markets (for example China, India, Brazil, Mexico, and South Africa) and developing country markets (for example Bangladesh, Kenya, Bolivia, and Ethiopia).

Grand Challenges A grand challenge is a specific barrier that, if removed, would help us solve important health problems with a high likelihood of local and/or global impact and feasibility.¹⁹ Directing funding and efforts towards critical barriers in global health is one way to help ensure large returns on investment and significant impacts on global health. One program that is taking such a focused approach is the Grand Challenges in Global Health (GCGH) Initiative, created by the Bill and Melinda Gates Foundation to identify bottlenecks in science and technology that need to be resolved in order to help address the most critical health problems in the developing world related to infectious diseases. The Ethical, Social and Cultural (ESC) Program of the GCGH Initiative is housed at the MRC and it addresses ESC issues that arise in the context of these forty-four projects to facilitate successful technology development and adoption. At the MRC, we are also leading the Grand Challenges in Chronic Non-Communicable Diseases initiative in collaboration with the Oxford Health Alliance, Canadian Institutes of Health Research, and the UK Medical Research Council. This project is modeled on the Foundation for the NIH/Bill and Melinda Gates Foundation’s Grand ¹⁹ H. Varmus, R. Klauner, E. Zerhouni, T. Acharya, A. S. Daar, and P. A. Singer, ‘‘Public Health: Grand Challenges in Global Health,’’ Science, 302/5644 (2003), 398.

200 / Singer et al. Challenges in Global Health initiative. Using a modified Delphi method with panel experts from around the world, we created consensus on what the grand challenges in chronic non-communicable diseases are in order to direct appropriate funding and attention towards these critical barriers.

Helping to Secure Funding Industrialized countries also have an important role to play in helping to secure the funding necessary to address global health challenges, from both national and international foundations, as well as through collaboration among industrialized countries. These funds could be significantly increased if industrialized nations adopted the target set in February 2004 by Paul Martin, Prime Minister of Canada: that 5 percent of Canada’s research and development investment be used to address developing world challenges. This remarkable commitment is an example of how rich countries can contribute to innovation around S&T in developing countries.

Facilitating Knowledge Repatriation by Diasporas Part of the success of the Chinese health-related biotechnology innovation system was due to its response to the challenges of brain drain by offering repatriation incentives to its expatriates. While attracting expatriates is one solution, it is probably an unrealistic option for many developing countries who suffer from brain drain. Increased international migration of skilled workers is inevitable and it is most dramatic in those countries whose resources are already limited. Consequently, inequalities in socio-economic development are reinforced while countries in the industrialized world, such as Canada, benefit from this migration.²⁰ We thus have a moral obligation to create closer cooperation between losing countries in the South and gaining countries in the North. With this in mind, we interviewed sixty skilled professionals working in the life-sciences, who have immigrated from developing countries to ²⁰ D. Spurgeon, ‘‘Immigrants Help Offset Canada’s Brain-Drain Crisis,’’ Nature, 405/6787 (2000), 604.

Harnessing Technologies for Health Equity / 201 Canada, to understand how they can contribute to S&T innovation in their country of origin and/or other developing countries. There is a paucity of qualitative data on factors that would encourage immigrant skilled workers to contribute to development and innovation in developing countries. Data from recipient countries on issues related to migration of skilled workers, such as results uncovered in this study, will therefore be useful to the governments of developed and developing countries in helping them devise their own policies for harnessing diaspora skills for development. We have already begun to share knowledge with the Ghanaian government on how best to make use of willing diaspora populations in strengthening the local S&T innovation system.

Ethics, Regulation, and Public Engagement The building of regulatory capacity is a necessary step in harnessing biotechnology to address global health challenges. Regulatory capacity is essential in order to not only ensure the safety of products but also to provide an enabling environment for the commercialization of health products. For example, high costs for product certification negatively affect product prices and may make health products inaccessible for those who need them most. Similarly, if regional regulatory structures are not harmonized, costs for product certification increase and it is more difficult to share technology across borders. Public engagement is also a vital step, as failure to do so could have disastrous consequences for the use of biotechnology to improve health in developing countries, as was the case with genetically modified (GM) foods.²¹ In an effort to promote public engagement around biotechnology and global health, we have developed an engagement platform called Engage.²² It is an internet-based global demonstration project with a goal to raise awareness among the general public on important global health issues and the technologies that can be harnessed to address them. WaterEngage and MalariaEngage platforms have already been developed. ²¹ P. A. Singer and A. S. Daar, ‘‘Avoiding Frankendrugs,’’ Nature Biotechnology, 18 (2000),

1223. ²² See and for more information.

202 / Singer et al.

Limitations S&T alone are not the answer to sustainable development challenges. Biotechnology and nanotechnology, like any other waves of S&T, are not silver bullets that will magically solve the multifaceted health challenges of developing countries. Nevertheless, S&T are a critical component of development.²³ The 2001 Human Development Report clearly demonstrates the role of S&T in reducing mortality rates and increasing life expectancy between 1960 and 1990.²⁴ Indeed, these technologies hold great potential for improving health worldwide. Examination of the political and economic aspects of the genomics and nanotechnology sectors is also a necessary component in determining the valuable role of these technologies in addressing global health inequality. These issues are obviously important; however, discussing them in a way that will address them adequately is beyond the scope of this paper. What must be highlighted though is the risk of developing inappropriate technology. Technology must be culturally and environmentally appropriate, for example, and one way to ensure appropriateness is to involve end users of technology in the process of development from design to implementation and evaluation.

Conclusion: The Role of S&T in Global Health Equity Emerging technologies clearly have the potential to improve the health of millions of the world’s poor and hence play a significant role in reducing the global health equity gap. However, a view that extends beyond biotechnology and nanotechnology is required in order to truly harness the potential of S&T to improve global health. Other areas can also have a large impact on ²³ Jeffrey Sachs, ‘‘The Essential Ingredient,’’ New Scientist, 175 (2002), 2352. ²⁴ United Nations Development Programme (UNDP), Human Development Report (New York:

UNDP, 2001).

Harnessing Technologies for Health Equity / 203 increasing global access to health care. Regenerative medicine, for example, has tremendous therapeutic potential; autologous bone marrow stem cells are currently being tested in patients for treatment of heart disease,²⁵ a promising development in light of the dramatic increase in levels of cardiovascular disease in developing countries.²⁶ Similar to our studies in biotechnology and nanotechnology, we have conducted a Delphi study of the top ten applications of regenerative medicine that can improve health in developing countries. Please refer to Table 9.5 for the top ten regenerative medicine applications. Table 9.5. Top ten applications of regenerative medicine 1. Novel methods of insulin replacement and pancreatic islet cell regeneration for diabetes 2. Autologous cells for the regeneration of heart muscle after myocardial infarction and cardiomyopathies 3. Immune system enhancement by engineered immune cells and novel vaccination strategies for infectious disease 4. Tissue engineered skin substitutes, autologous stem or progenitor cells, intelligent dressings, and other technologies for skin loss 5. Biocompatible blood substitutes for transfusion requirements 6. Umbilical cord blood banking for future cell replacement therapies and other applications 7. Tissue engineered cartilage, modified chondrocytes, and other tissue engineering technologies for traumatic and degenerative joint disease 8. Gene therapy and stem cells transplants for inherited blood disorders 9. Nerve regeneration technologies using growth factors, stem cells, and synthetic nerve guides for spinal cord and peripheral nerve injuries 10. Hepatocyte transplants as replacement therapy for chronic liver diseases or liver failure Source: H. L. Greenwood, P. A. Singer, G. P. Downey, D. K. Martin, H. Thorsteinsd´ottir, and A. S. Daar, ‘‘Regenerative Medicine and the Developing World,’’ PLOS Medicine, 3/9 (2006), 0003. ²⁵ E. C. Perin et al., ‘‘Improved Exercise and Ischemia 6 and 12 Months after Transendocardial Injection of Autologous Bone Marrow Mononuclear Cells for Ischemic Cardiomyopathy,’’ Circulation, 110 (11 Suppl 1) (2004), II-213–II-218. ²⁶ World Health Organization (WHO), World Health Report 2003: Shaping the Future (New York: WHO, 2003).

204 / Singer et al. We emphasize that we are not suggesting the use of S&T as a replacement for current methods to address global health and sustainable development concerns. However, S&T innovation is an important component in any effort to reduce disparities in global health. To this end, discussions of global health equity should extend to S&T in order to harness their potential for improving health in the developing world.

Part IV Training Professional, Ethical Physicians

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10 American ‘‘Medical Professionalism’’: At Home and in the World Robert Martensen∗

Introduction Since the 1990s, leaders in U.S. and Western European medicine have generated ‘‘medical professionalism’’ initiatives as means to enhance medicine’s social contract. This chapter explores their recent and self-conscious attention to physician values, behaviors, and relationships in medical teaching, research, and ‘‘the clinical enterprise.’’ Major questions this chapter addresses include the following: Along with scientific and technical training, how should medical educators educate medical students, residents, and fellows to make sound judgments in the face of uncertainty, which I expect most readers would agree is the hallmark of good medical practice? How should medical leaders guide organized medicine for the twenty-first ∗ When the author presented the original version of this paper, he was on the faculty of Tulane Medical School. In 2007 he joined the National Institutes of Health, where he serves as Director, Office of NIH History. Robert Martensen’s views in this essay do not necessarily reflect those of the NIH or the U.S. government.

208 / Martensen century?¹ How does American ‘‘medical professionalism’’ resonate in international contexts, especially in developing nations? In form, this essay is a hybrid: part history, part memoir, and part prescriptive advice. My intention is to stimulate reflective analysis, not to provide a synoptic overview of the professionalism movement.

Background on the ‘‘Professionalism Movement’’ A generation ago, when I was a medical student, medical school deans did not routinely invoke ‘‘medical professionalism’’ as their pedagogical lodestar. Instead, their mantra was ‘‘caring and competence.’’² For the ‘‘caring’’ part, medical leaders during the 1970s imported ethicists, literary experts, and other humanists into training programs with the expectation that inculcation with their perspectives would at once curb ethical transgressions in research and enhance physician compassion in routine clinical practice.³ Meanwhile, routine use of standardized patients, ASCIs, simulators, lengthening residences, and burgeoning fellowships meant that ‘‘competence’’ continued to get its due. Few medical leaders spoke explicitly then of a need to bolster the medical profession’s social contract with the greater world, but that was the implied motive for the new emphasis on ethics and humanities. Compared to the earlier turn to medical humanism, which was characterized by physicians looking outside their professional cohort, the new ‘‘medical professionalism’’ is the creation of physicians. The push for professional self-awareness typified by ‘‘white coat’’ ceremonies for entering medical students—increasingly popular in the U.S., if not elsewhere—has come from physicians, not ethicists. The working party behind the Royal College of Physicians 2005 report on medical professionalism—Doctors in ¹ The opening passages are drawn from p. xi of the Royal College of Physicians Working Party report of 2005, Doctors in Society: Medical Professionalism in a Changing World. The document credits Richard Horton for drafting most of it. ² Byron Good, Medicine, Rationality and Experience (Cambridge: Cambridge University Press, 1994). ³ Albert R Jonsen, A Short History of Medical Ethics (New York: Oxford University Press, 1999); David J. Rothman, Strangers at the Bedside (New York: Basic Books, 1991).

Professionalism and Medical Education / 209 Society—contained many physicians in leadership roles in the U.K. and a nurse, but no full-time ethicists.⁴ The rapid emergence of ‘‘professionalism’’ and its authorship by physicians raises at least three questions: ‘‘Why professionalism?’’ ‘‘Why now?’’ and ‘‘What kind of professionalism?’’ In short, what kinds of social and cultural work do medical leaders want ‘‘professionalism’’ programs to do, and can the programs do the work? For discussion purposes, the text I will focus on is ‘‘A Physician Charter’’ of 2005, which is part of the Medical Professionalism Project of the foundations of the American Board of Internal medicine, the American College of Physicians, and the European Federation of Internal Medicine.⁵

‘‘A Physician Charter’’ The Charter is short, its six half pages consisting of a Preamble, three Fundamental Principles, ten Professional Responsibilities, and a Summary. Right from the beginning, the Charter contains a striking paradox: although it asserts that ‘‘Professionalism is the basis of medicine’s contract with society,’’ it never explicitly defines ‘‘professionalism.’’ I find this odd, a point I shall return to later. (In comparison, the Royal College of Physicians 2005 definition is succinct. Medical professionalism, which they believe ‘‘lies at the heart of being a good doctor,’’ consists of a ‘‘set of values, behaviours, and relationships that underpin the trust the public has in doctors.’’⁶) Instead of explicit definition, the Charter enunciates three ‘‘fundamental principles’’ of professionalism, which are: (1) the ‘‘principle of primacy of patient welfare,’’ which it equates with altruism; (2) the ‘‘principle of patient autonomy;’’ (3) the ‘‘principle of social justice.’’ Ten ‘‘responsibilities’’ subsequently flesh out these principles in terms of a physician’s commitments to himself—to remain competent, for example—and to his community, such as his commitment to ‘‘improving access to care.’’ In terms of content, the Charter incorporates most of the ingredients of the ‘‘four principle’’ ⁴ Op. cit. 2005. ⁵ ABIM Foundation, ACP Foundation, European Federation of Internal Medicine, ‘‘A

Physician Charter’’ (Philadelphia: Medical Professionalism Project, 2005). ⁶ Royal College of Physicians, Doctors in Society, Summary.

210 / Martensen approach in bioethics first enunciated by Tom Beauchamp and James Childress in the 1970s,⁷ such as the principle of autonomy, and combines them with professional etiquette, such as managing conflicts of interest.⁸ The Charter tends to state these in the impersonal rhetoric of verifiable performance objectives—‘‘maintenance of professional competence’’ in favor of ‘‘teaching and learning,’’ for example.⁹ Perhaps because of its joint European/American sponsorships, the Charter places more emphasis on equitable distribution of medical resources than purely U.S. iterations of professionalism.¹⁰ What’s not to like? Indeed, the Charter sounds fine on the surface. But in terms of medical schools, once one goes under the surface, what does the Charter mean? Does it reflect the reality of current U.S. teaching, research, and clinical activities? Are medical institutions modeling what their leaders propose to their students and to the world? Or, is it possible that the Charter—not all of it, but a good bit of it—is little more than a recitation of hollow pieties? If this is true, even in part, it is worth discussing on two counts. First, and obviously, medical educators and leaders should not be promoting intellectual incoherence. Second, and more consequential, physicians, like other professionals, do enormous harm when they (we) create large slippages between what they say is important—the official culture—and the way they behave, especially if the behavior is more than a trifle hypocritical. In short, if organized medicine wants to affirm its social contract, its leaders and educators need to walk the walk that they talk. ⁷ Thomas Beauchamp and James Childress, Principles of Biomedical Ethics, 5th edn (New York: Oxford University Press, 2001). ⁸ Marcia Angell, ‘‘Is Academic Medicine for Sale?,’’ NEJM 342 (2000), 1516–18; S. M. Wolfe and David J. Rothman, ‘‘Medical Professionalism: Focusing on the Real Issues, NEJM 342 (2000),1284–6. ⁹ U.S. educators in medical professionalism, such as Ronald Epstein and Edward Hundert, are developing assessment methods that combine qualitative and quantitative perspectives. See their ‘‘Defining and Assessing Professional Competence,’’ Journal of American Medical Association, 287/2 (2002), 226–35. ¹⁰ Examples include Edmund D. Pellegrino, ‘‘Medical Professionalism: Can It, Should It Survive?’’ Journal of the American Board of Family Practice, 13/2 (2000),147–9; American Council of Graduate Medical Education (ACGME) Outcome Project, ‘‘Advancing Education in Medical Professionalism (2004)’’; Kenneth M Ludmerer, ‘‘Instilling Professionalism in Medical Education,’’ Journal of American Medical Association, 282 (1999), 881–2; Herbert M. Swick, ‘‘Toward a Normative Definition of Medical Professionalism,’’ Acad Med. 75 (2000), 612–16.

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The Empty Classrooms of the Pre-Clinical Years What would a Chartist find, for example, if she or he visited a basic medical science lecture hall these days? In most schools visitors often would find a mere handful of students facing a lecturer giving a desultory reading of his or her Power Point images. Most students would not bother to come, and all would avail themselves of the note taking service. Moreover, neither the students nor the faculty would make much fuss about this pedagogical charade. Is this what is meant by professionalism? Suppose that one went before the public (or just one’s state legislators for those in publicly funded medical schools) and announced that only 10 or 15 percent of the school’s first and second-year medical students bothered to come to class. I expect the public or the legislators would express astonishment; they might even call the school’s teaching practices ‘‘unprofessional.’’ Alternatively, suppose that the American Association of Medical Colleges were to convene a conference on technology and medical education in the basic sciences. Suppose it were possible—and it is technically—to provide a standardized on-line basic science curriculum for the nation’s 120-odd medical schools using the best teachers in the land—virtual teaching and testing by way of computer. It would take only about twelve faculty members to handle the entire basic science curriculum. Each school could set up local groups of faculty facilitators and students for the occasional small group meeting. Think of the money to be saved, not to mention the likely improved quality in the educational experience. Would this be professional? Suppose one went even further into the virtual world. Suppose that anyone with the requisite undergraduate science courses, acceptable MCATs, and a satisfactory psychological profile as measured by standardized personality tests could enroll on-line in medical basic science. Some test threshold could be easily established for determining passing scores. Presto! No more expensive admissions department, or at least a very streamlined one. A true democratization of medical education. And so forth. . . In either case—the pathetically empty actual classrooms of the present or the active virtual classrooms of the present and indefinite future—professionalism in medical school teaching deserves more than lip service. If one were to explore the reasons medical classrooms are empty—even as

212 / Martensen USMLE Step 1 Exam pass rates remain high¹¹—several dismaying factors merit attention, not least of which is a decline in the teaching morale of junior basic scientists who are increasingly charged with teaching medical students. Another is pedagogical reliance on information absorption models of learning that verge on the bulimic. Is the ideal presentation one that generates an exam-worthy factoid every fifteen minutes of class time on average? Do most multiple-choice tests, which are the only kind administered in U.S. medical schools and Step Exams, measure understanding and knowledge or just knowledge, and factoid knowledge at that? But then outstanding teachers exist, technology makes their insights readily available to many, and pedagogical imaginations flourish in different schools. The decline of the basic science classroom as the locus of medical teaching also reflects fundamental shifts in biomedical science that have occurred since the 1970s. The reality, painful for some to acknowledge, is that the pedagogical subspecies known as the ‘‘physician-scientist,’’ that individual who combined excellence in teaching with distinction in research and patient care, verges on extinction.¹² One reason is that clinical expertise no longer has much to do with advanced laboratory science of the kind that merits extramural financial support. Compared to the 1970s, few physicians without PhD-level training in the sciences remain competitive for R01-level NIH grants, for example. And the reverse is also true: major research advances in biomedical science bear an increasingly tenuous relation to everyday clinical practice, at least for generalist physicians. In terms of basic science, the bedside and the lab, joined on the wards at Johns Hopkins in Osler and Halsted’s time and in contact for almost a hundred years afterward, have gone their separate ways, at least in the U.S. and other rich countries. Moreover, the basic science that really does matter in practice is taught during residency and fellowship. No one can say basic science teaching is not ‘‘professional,’’ but these shifts in the relationship of basic science to praxis in a specialist-dominated practice ¹¹ The United States Medical Licensing Exams are multiple-choice exams that all U.S. medical students must pass in order to graduate and obtain a state medical license. They occur in stages, beginning with completion of pre-clinical science courses at the end of the second year. ¹² A. L. Mark and R. P. Kelch, ‘‘Clinician Scientist Training Program: A Proposal for Training Medical Students in Clinical Research,’’ J. Investig. Med. 49/6 (2002), 486–9.

Professionalism and Medical Education / 213 environment, which I find largely unacknowledged in pre-clinical course syllabi, call for imaginative engagement. Medical education in developing countries, in contrast, may not have experienced such cognitive disconnects. Where high-tech ‘‘big science’’ is not the norm, one can argue that physicians should teach basic science—with PhDs—and that medical students should learn basic laboratory techniques. After all, once MDs are out in practice in developing societies, they may need to be expert in physical diagnosis and routine laboratory procedures, as MRIs and automated labs may not be readily at hand. If this is so, then medical educators in rich countries may have little to offer their counterparts in developing ones. On multiple levels, Cuba, which has a burgeoning biotechnology and excellent public health, may be a more suitable model for medical educators and practicing physicians in Botswana than Harvard. This was not the case fifty years ago, when medical students in Botswana and the U.S. would both have learned how to apply Gram’s stain to bacteria. For U.S. physicians, such a skill no longer has practical use, but in sub-Saharan Africa it may.

The Disappearance of the Experienced Clinical Teacher Fortunately, one seldom hears clinical teachers refer to patients as ‘‘clinical material’’ anymore, as they occasionally did in the 1970s. Nonetheless, other trends have arisen that challenge professionalism in clinical teaching. The first, which has been widely noted in professionalism literature, is that it is increasingly difficult for experienced physicians to spend adequate time as bedside teachers.¹³ Managed care plans exert seemingly relentless pressures on physicians to see more patients in the same amount of time than formerly. As a clinical instructor in emergency medicine at San Francisco General Hospital in the late 1970s, for example, I was surrounded by sufficient other junior and senior faculty colleagues so that I could work with third and fourth year students in some depth. When we saw a patient with bubonic plague, for example, we could confirm the diagnosis in the ED because we ¹³ Kenneth J. Ludmerer, Time to Heal (New York: Oxford University Press, 1999).

214 / Martensen took the time to stain the aspirate of a bubo and see the organism.¹⁴ (In the meantime, resident labs have by and large disappeared from EDs and wards, and students would not know how to do the tests anyway since wet lab instruction has largely disappeared from basic science curricula.) In comparison, in the EDs of Brigham & Women’s Hospital and the University of Kansas Medical Center, where I served as an attending physician during the 1990s, sometimes one staff attending was responsible for seeing forty to fifty patients in eight hours, and ten or more of them would need in-patient admission. Students who tagged along with ED attending physicians had the benefit of seeing many sick people, which is worth something, but the attendings did not have time to teach them much. Increasingly, students are being taught by residents, who are by and large taught by residents. When I was a medical student at Dartmouth in the early 1970s, Dr. Tom Almy, then Chief of Medicine and an outstanding teacher, often conducted teaching rounds, and he called on students, and we knew we had to be prepared. Almy and those of his generation, like their teachers, were shaped by an Oslerian aesthetic that considered the actual patient as a text and the direct doctor–patient encounter as the lesson.¹⁵ If one wanted to understand patients and their diseases, their logic ran, one not only had to become a skilled listener and interrogator of their history, one had to know how to apprehend their condition through careful physical examination. That skills in physical diagnosis have declined is a commonplace much bemoaned by older physicians these days, occasionally with remarks disparaging the examination skills of younger colleagues. Disparagement may be beside the point, however, for the reality is that imaging technologies, laboratory tests, and software now provide sensitive and specific information that surpasses much of what could be gleaned from the most astute physical exam of yore. The counter is that a patient’s history—if elicited carefully—often contains the diagnosis—a truism that high-tech approaches tend to elide. What then, is the most professional way to conduct hospital-based teaching? Is it better to spend most of the time at the bedside, as Dr. Almy did, or instead to meet briefly at the bedside and ¹⁴ Robert Martensen, ‘‘Plagues and Patients,’’ in Clio in the Clinic, ed. Jacalyn Duffin (New York: Oxford University Press, 2004). ¹⁵ William Osler, Principles and Practice of Medicine, 1st edn (New York: Appleton, 1892).

Professionalism and Medical Education / 215 perform an abbreviated exam before retreating to a remote conference room for extended review of data, images, and decision trees? To judge by how they spend their teaching time—bedside versus conference room—it seems that for many younger academic physicians, contact with the actual patient has become a footnote to virtual engagement in the conference room via imaging monitors, laboratory printouts, and PDAs. If perceptions of ideal professional teaching hinge, in part, on what generation one is in, what seems clear in the U.S. is that advanced technology, including diagnostic software, which offers so much, has not been integrated into clinical teaching in ways that make full use of the doctor–patient encounter. Whether increasing reliance on testing—and the concomitant decline of the ‘‘patient as text’’—has led to a decline in critical thinking is another matter.

Growing Divergence between Clinical Teaching in the U.S. and the Rest of the World Increasingly, America spends vastly more money per year per student training doctors than anywhere else in the world. From the use of ‘‘standardized patients’’ to teach first and second-year students the arts of interviewing and physical exam, to the plethora of diagnostic tests senior students are encouraged to order on patients, and onward through expensive CME courses, our approach consumes vast amounts of money and relies heavily on technology. Moreover, its tendency to encourage profligacy of diagnostic tests and procedures trains students to do more of the same during their subsequent practices. Indeed, even in Western Europe, not to mention Argentina or eastern Africa, doctors are trained and train themselves by very different means and methods, which is a subject Dr. Pallangyo addresses. On a personal note, Dr. Pallangyo’s account reinforces what occurred in my adopted city of New Orleans during the first weeks that followed Hurricane Katrina. Two physicians, one sent from the Federal Emergency Management Agency (FEMA) and Dr. Brobson Lutz, a prominent local internist, former health director of the City of New Orleans, and longtime French Quarter resident (and my personal physician), each set up emergency clinics in the French Quarter when power, communication, and transportation were almost nil. The FEMA physician’s ‘‘clinic’’ was

216 / Martensen located inside a hotel, which made him virtually invisible to those in need. Consequently, he saw relatively few patients. According to Dr. Lutz, the FEMA physician said he could hardly practice medicine without an adjacent lab, EKG, X-ray, etc. (None of this functioned then in New Orleans.) In comparison, Dr. Lutz plastered a large banner—‘‘French Quarter Health Clinic in Exile’’—across the front of his home, and organized volunteer paramedics and neighborhood runners to bring the infirm and at-risk elderly to his home-cum-clinic for evaluation and limited treatments as well as deliver care in their homes. He and his cohort also organized food and hydration for those in need in the neighborhood. Their diagnostic devices consisted of manual blood pressure cuffs, stethoscopes, battery-operated blood glucose monitors and the like. (All New Orleans hospitals were then closed, and the power was off everywhere.) Dr. Lutz readily admits that those who sought him for vaccinations against feared epidemics did not need them, but he also recently told me that it was his and the paramedics’ clinical experience, emphasis on neighborhood organization, and street smarts that enabled their ‘‘clinic’’ to save several who otherwise would have likely perished from disease or dehydration. Are we training our medical students so they could do the same in a similar situation? Should we be, or should we be content to train them in the matrix of high-tech approaches? If we in the U.S. are comparatively profligate in our use of resources in training doctors, many medical schools in other parts of the world have been profligate in admitting large numbers of students they cannot adequately train. Through adoption of policies that encourage almost ‘‘open admission,’’ medical schools in Argentina, Italy, Germany, and elsewhere from the 1970s onward routinely have matriculated hundreds or a thousand students each year without any expectation that they are qualified, that the institutions will provide them with adequate facilities, or that more than a small minority will actually become doctors. Granted, the deans of these schools did not determine these admissions policies on their own. Many national governments since the 1970s have adopted ‘‘open admissions’’ policies to their universities in general, not just to their medical schools. Nonetheless, the question remains: In terms of the need for physicians to be knowledgeable and technically competent, is it professional for medical leaders to accept grossly inappropriate policies concerning standards in medical education?

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Professionalism in the Context of American Specialism Much more than their counterparts in other advanced economies, and in striking contrast to the situations Dr. Pallangyo describes, most American physicians practice in loosely organized networks of specialist fiefdoms. As in a parody of the European Middle Ages, each fief, despite nominal ties to a regional overlord or central authority, retains considerable autonomy. Each maneuvers for its specialty’s interests in preference to other specialties, and each more or less governs its own replication. One result of such decentralized power is that the U.S. has many more specialists, both relatively and absolutely, than any other country in the world. Meanwhile, major payers, such as Medicare, mostly operate on a fee for service pattern, and they tend to pay more for procedures and facilities than they do for evaluation and advice.¹⁶ Any discussion of ‘‘professionalism’’ in American medicine takes place in this context, a world in which patients tend to have direct access to specialists, and the specialists and hospitals determine the flow and extent of treatment.¹⁷ During the past thirty years, ‘‘more’’ has become the defining characteristic of this model, as American medicine generates ever more specialists and procedures. Even so, as the Dartmouth Health Atlas and other outcome studies have noted, ‘‘more’’ in terms of tests and procedures does not necessarily mean ‘‘better’’ in terms of health outcomes. Indeed, it often means less. According to Elliot Fisher, MD, one of the Dartmouth researchers commented, ‘‘America could send a third of its specialists to Africa and improve the health of both continents.’’¹⁸ The intersection of structural issues—specialist fiefdoms and cultural values—‘‘more is better’’—largely define U.S. medicine these days, especially in comparison to other models in Canada, Europe, and Asia. Yet the Charter does not address this. Should it? It depends on how one ¹⁶ On relationships between concentration of specialists and outcomes, see Katherine Baicker and Amitabh Chandra, ‘‘Medicare Spending, the Physician Workforce, and Beneficiaries’ Quality of Care,’’ Health Affairs, 7 (April 2004), 184–97. ¹⁷ Sharon R. Kaufman, . . . And a Time to Die: How American Hospitals Shape the End of Life (New York: Scribner, 2005). ¹⁸ Elliott Fisher, as quoted in Dartmouth Medicine (summer 2005), 29.

218 / Martensen defines ‘‘professionalism.’’ If one accepts a narrow or strict definition, then the answer is ‘‘No,’’ as the twenty-seven recognized U.S. specialties all promote competence actively among their members. But if one gazes outward from the specialties to the larger society, then perhaps skepticism is in order. The Charter hints at a ‘‘Yes,’’ as when it lauds measures to ‘‘optimize the outcomes’’ and ‘‘minimize overuse of health care resources.’’ I am not sure what this means, however. Suppose I am an orthopedic surgeon and my group in a medium-sized Southern city wants to develop our own state-of-the art orthopedic surgical clinic separate from our community hospital. We will control our own operative spaces, and our business advisors and attorneys tell us that our net share of facility fees may double our net incomes. According to the Charter, is that professional or not professional or somewhere in between? That the proliferation of specialist boutique hospitals and clinics owned by proceduralist physicians threatens to disarticulate the community hospital and fracture its medical staff is not in doubt. Specialty boards may not be concerned about them in terms of their impact on the larger profession, but the fate of general hospitals affects public perception of most physicians—not to mention hospitals. The development merits consideration, yet the U.S. medical professionalism movement to date has mostly ignored it. Nor does the Charter give much guidance to appropriate use of health care resources, including physicians, on a global basis. Like the umbrella organizations that supervise American medical schools, residences, and specialist fiefdoms, many U.S. physicians bemoan ‘‘overuse’’ even as they express little concern that U.S. training programs suck up a sizable percentage of global physician talent. From the perspective of developing countries with truly scarce resources for medical training, the issue is huge, however. Suppose one is the health minister of a developing nation allocating monies for health care education. The tendency of one’s medical graduates to emigrate to rich countries raises difficult questions. Should one expand the country’s medical schools, for example? Given the fact that medical organizations in rich countries directly and indirectly encourage bright physicians to immigrate, would it not be better for developing nations to allocate resources to other initiatives, such as large-scale training programs for field health workers, expanded vaccination campaigns, enhanced female

Professionalism and Medical Education / 219 literacy, and wells for clean water?¹⁹ Should it be a goal of poor countries to turn out physicians who will leave home to tend to rich foreigners? The failure of organized U.S. (and U.K. and Canadian) medicine to restrain their appetites in this regard makes a mockery of resolutions in the Charter and elsewhere concerning ‘‘overuse.’’ Non-European plants and medicinal substances have been a major component of international trade since Europeans began importing cinchona (quinine) from Peru in the sixteenth century. What rankles contemporary leaders in countries whose past includes colonization by Europeans, however, is a growing effort by European and U.S. pharmaceutical firms to gain proprietary control of promising therapies derived from their flora and fauna. What bothers them is not necessarily that they are being exploited, as one health minister told me at a 2002 conference in Brasilia, but that the terms of the exploitation are too unfair.²⁰ It makes little sense to South Americans to permit firms based in rich countries to patent genetic blueprints of indigenous materials in order to make medicines that most of their citizens cannot afford. Nor are they about to sanction wholesale resource depletion of their environment’s medicinal life forms. Another complaint, repeatedly phrased in terms of ‘‘North’’ and ‘‘South’’ in international bioethics meetings I have attended, is that, according to spokesmen for the South, medical research in the North devotes 90 percent of its vast funds on diseases that affect only 10 percent of the globe’s population. If the new professionalism movement in the North assumes that its principle of social justice has a global context, which it self-evidently does, then Northern medical leaders need to engage seriously with their Southern colleagues and others to address egregiously unjust global patterns of biomedical trade and research.²¹ ¹⁹ Paul Farmer, Infections and Inequalities: The Modern Plagues (Berkeley: University of California Press, 1999); J. W. Lee, ‘‘Science and the Health of the Poor,’’ Bulletin of the World Health Organization, 81 (2003), 473. ²⁰ 6th International Congress of Bioethics, Brasilia, November 2002. I heard similar comments in hallways and sessions from health ministers of several South American countries. ‘‘Social Justice’’ was the theme of the 7th Congress, which was held in Sydney, Australia, in 2004, where U.S. practices received more extensive and pointed criticism in formal sessions. ²¹ Farmer, Infections and Inequalities; Amartya Sen, Inequality Reexamined (Cambridge, MA: Harvard University Press, 1992).

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‘‘Professionalism,’’ Bioethics, and the Biomedical Enterprise Given the conceptual similarities between traditional bioethics and most current iterations of ‘‘medical professionalism,’’ it is worth examining how bioethical approaches have played out in the day-to-day management of clinical medicine, including human subjects research in domestic contexts. Consider, for example, how bioethicists and promoters of the new ‘‘professionalism’’ might consider the following application to an IRB for a Phase II trial. As part of a multi-center trial organized by a major pharmaceutical firm, a faculty investigator applies for approval of a hypothetical drug with promise against breast cancer. The IRB, which is led by a well-respected senior ethicist who considers himself middle-of-the-road politically, is attentive to both procedural and substantive issues. The IRB finds some procedural problems concerning subject recruitment and recommends changes, which the investigator makes. For discussion purposes, suppose the investigator is being paid substantial bonuses by the pharmaceutical concern that used government-sponsored research to develop the drug. Suppose the cancer center of the hypothetical medical center is operated by a division of the pharmaceutical company’s parent corporation. Suppose another division of that corporation, a chemical company, releases a lot of potential cancer-causing pollutants into the U.S. environment. The IRB might consider, briefly, the fact that the drug, investigator and clinical center have important financial links with one another, but that, in itself, would not provoke the IRB to reject the application. The reason is that the IRB’s vantage point does not include terrain outside the institution’s walls and relevant oversight regulations, and FDA review of product applications does not attempt to provide comprehensive review of conglomerates. While such an IRB may be hypothetical, the situation is based on real life. The maker of tamoxifen, which is widely used in breast cancer prevention and treatment, is AstraZeneca, which also operates an Ohio chemical plant that in 1996 was the ‘‘third-largest source of potential cancer-causing pollution in the United States.’’ AstraZeneca, which created Breast Cancer Awareness Week in partnership with the American Cancer Society in 1985, also has owned the Salick chain of cancer

Professionalism and Medical Education / 221 treatment centers.²² Would anything in the Charter question these relationships? During the past thirty years biomedicine, now firmly in the hands of corporations in the United States and elsewhere, has become a biomedical industrial complex that routinely conflates ‘‘health’’ with its own interests and disciplinary perspectives.²³ Many physicians in practice and research inside and outside academic medicine make large sums through their commercial tie-ins with biomedical enterprises. Commercial values suffuse many leading U.S. medical schools in the form of initiatives to increase academic–industrial partnerships. The trend began accelerating with passage of the Bayh-Dole Act in 1980. Bayh-Dole’s original intent was to encourage growth of tech-based small businesses by permitting them at no cost to own patents that arose from federally sponsored research. Universities successfully lobbied to be included as ‘‘small entities’’ with the understanding that they would not develop the patented technologies but instead license the patents. Academic–industrial partnerships took off in the late 1980s with the passage of the Technology Transfer Act of 1986. Universities such as MIT and Stanford, who were concerned about the fall-off in Defense Department research contracts as the Cold War faded, lobbied heavily for its passage and have subsequently expanded their technology transfer operations dramatically. In essence, the post-1980s system operates as follows: Public funds from the NIH and NSF provide universities with research infrastructure at little cost to themselves, corporations get the research for free or close to it, and both benefit from commercial applications of that research. Some physicians, such as Thomas Stossel at Harvard, vigorously support the arrangement, while some eminent university leaders, such as Derek Bok, question rampant commercialization of the academy.²⁴ ²² S. Batt and L. Gross, ‘‘Cancer, Inc.,’’ Sierra (September–October 1999), 36–41; S. Batt. Patient No More: The Politics of Breast Cancer (Charlottetown, PEI, Canada: Gynergy, 1994); Robert Procter, Cancer Wars: How Politics Shapes What we Know and Don’t Know about Cancer (New York: Basic Books, 1995); Robert Martensen, ‘‘Thought Styles among the Medical Humanities: Past, Present, and Near-term Future,’’ in Practicing the Medical Humanities, ed. Ron Carson, Chester Burns, and Thomas Cole (Hagerstown, MD: University Publishing Group, 2003), 99–123 (9). ²³ Marcia Angell, The Truth about the Drug Companies: How They Deceive Us and What to Do about It (New York: Random House, 2004). ²⁴ Thomas Stossel, ‘‘Regulating Academic–Industrial Research Relationships—Solving Problems or Stifling Progress?,’’ NEJM 353/10 (2005), 1060–5; Derek C. Bok, Universities in

222 / Martensen Not only do research-intensive medical schools borrow heavily against anticipated income streams from academic–industrial partnerships, they also leverage their anticipated revenues from patient care. According to a 2004 survey by the American Association of Medical Colleges, ‘‘hard’’ revenues from tuition and endowment make up less than 10 percent of the average medical school’s budget. In 1983, in comparison, ‘‘hard’’ revenues typically supported 60 to 70 percent of their budgets.²⁵ Increasingly, medical schools are quietly readjusting their missions in favor of expansions into high-revenue patient care activities and reduction of lowmargin activities, such as diabetes-management clinics.²⁶ Several universities are hiring consultants who specialize in remaking academic tenure so as to reward faculty members participating in academic–industrial partnerships or performance of high-margin procedures and penalize those who do not. Given that financial conflicts of interest are no longer incidental in academic medicine and some professional organizations but central, what does it mean, as the Charter declares, to have a ‘‘commitment to maintaining trust by managing conflicts of interest?’’ Most of the language of the Charter and other professionalism declarations in this area derives from the current AMA Code of Ethics. As the AMA produced its first Code of Ethics in 1847 and has issued several revisions since, historical review of their evolution provides clues in terms of how ethical ‘‘management’’ tends to take place. What historical review of successive iterations of the AMA’s Code of Ethics from the mid-nineteenth century onward reveals is that medical ethical codes tend to accommodate shifts in values of influential parties, not constrain them.²⁷ the Marketplace: The Commercialization of Higher Education (Princeton: Princeton University Press, 2003). ²⁵ AAMC/Harvard Medical School Executive Development Seminar for Associate Deans and Department Chairs; presentation by Lily Marks, ‘‘Medical School Economics & Departmental Financial Management,’’ October 10, 2006, Fort Lauderdale, FL. ²⁶ Ian Urbina, ‘‘In the Treatment of Diabetes, Success Often Does Not Pay,’’ 3rd of 4 articles in series ‘‘The Business of Care,’’ New York Times, January 11, 2007. ²⁷ Charles Rosenberg, ‘‘Codes Visible and Invisible: The Twentieth-Century Fate of a Nineteenth-Century Code,’’ in Robert Baker, Arthur Caplan, Linda Emanuel, et al., The American Medical Ethics Revolution: How the AMA’s Code of Ethics has Transformed Physicians’ Relationships to Patients, Professionals, and Society (Baltimore: Johns Hopkins University Press, 1999), 207–18.

Professionalism and Medical Education / 223 When a large historical force—in this case the valorization of personal gain and ascendance of neoconservative ideology that has occurred in the U.S. since the late 1970s—achieves a critical mass in terms of influential adherents, ethical codes, including the AMA’s and the Charter, tend to accommodate the change in medicine as well as in the culture at large. The AMA’s 1957 iteration of its ‘‘Principles of Ethics,’’ for example, declares that ‘‘a physician should limit the sources of his professional income to medical services actually rendered by him, or under his supervision to his patients. His fee should be commensurate with the services rendered and the patient’s ability to pay.’’ The AMA’s 1980 version, in comparison, makes no mention of physicians’ business practices except to decry ‘‘fraud or deception.’’²⁸ Putting aside questions of the appropriate valence for pursuit of profit in estimations of professional virtue, numerous empirical accounts of American practices reveal the uncomfortable reality that the U.S. biomedical enterprise does badly in relative and absolute terms of outcomes compared to rich countries such as France, where the average citizen lives a few years longer, and even moderately poor ones, like Costa Rica, where average life expectancy is within a year or two of that in the United States.²⁹ Even more troubling is the possibility that the large social claims that biomedicine has successfully made, aided partly, I would argue, by the legitimacy bioethics endorsements have afforded, may have displaced communitarian health care approaches that have a better track record of improving health on a population basis.³⁰ Meanwhile, in the U.S. at least, the process of socializing costs and privatizing benefits continues to flourish. Does the new ‘‘medical professionalism’’ propose anything different? ²⁸ Baker et al., American Medical Ethics Revolution, 355–9. ²⁹ The Dartmouth Atlas of Health Care contains many outcome analyses of the specialist-intense U.S. model. Its website is: . On ‘‘more

is not better,’’ see John E. Wennberg, ‘‘Variation in Use of Medicare Services among Regions and Selected Academic Medical Centers: Is More Better?,’’ the 2005 Duncan Clark Lecture of the New York Academy of Medicine, available on the Dartmouth Atlas website. The Dartmouth Atlas project has received long-term funding from the Robert Wood Johnson Foundation. ³⁰ For a history of community health centers, see the National Health Policy Forum Background Paper of August 31, 2004 (prepared by Jessamy Taylor), ‘‘The Fundamentals of Community Health Centers,’’ available at .

224 / Martensen To its credit, the Charter emphasizes distributive justice in the health care system, which it defines as ‘‘the fair distribution of health care resources.’’ Access to care and a fair distribution of ‘‘finite resources’’ form the two prongs of the Charter’s approach, which is expansive. For example, in discussing access, the Charter emphasizes public health approaches, such as improving public education so as to ameliorate the harmful effects of poor education on health. What the Charter does not address is the inherent tension between any physician’s devotion to his individual patient—the classic therapeutic dyad with its venerable moral patina—and public health perspectives informed by a moral calculus derived from utilitarian philosophy. How does one serve both masters in the quotidian of a medical practice? The dilemma is real and will become increasingly felt. In the absence of national guidelines for what is in and out of the diagnostic and treatment picture—rationing—physicians increasingly will be pressed to serve as dual agents. It seems to me that codes of ‘‘professionalism’’ could provide a real service to physicians if they at least acknowledged the dilemma. Instead, the Charter notes the two goals—altruism for individual patients and public health perspectives—without identifying tensions that arise from trying to serve both of them simultaneously. At some point, external forces will compel physicians to take our heads out of the sand. In the meantime, corporate viewpoints suffuse ever larger areas of academic medicine, and many of us are doing just fine playing ostrich. This may be ‘‘professional,’’ but I doubt it is a kind of professionalism that will burnish the public’s trust.

Professional Authority and the Democratization of Medical Knowledge Suppose one were to define medical ‘‘professionalism’’ not as the Charter does, which is to avoid definition per se in favor of recitation of principles and duties, but in terms of the social distinctiveness of professional work. According to the current Oxford English Dictionary, the definition is simple: a ‘‘professional’’ is a person ‘‘trained and skilled in the theoretic or scientific parts of a trade or occupation, as distinct from its merely mechanical parts; that raises his trade to the dignity of a learned profession.’’ The OED

Professionalism and Medical Education / 225 then provides its customary quotes drawn from early usages of the word. According to the OED, ‘‘professional’’ in terms of work made an early appearance in an English gazette in 1898: ‘‘There is a vast difference between professional and ordinary gardeners. I (a professional gardener) am competent to give a lecture on botany and horticulture.’’ Though the quote addresses levels of gardening in the late nineteenth century, not levels of medical expertise today, it may reveal something of the situation we physicians find ourselves in currently. In both cases, gardening and medical care, a crucial difference between then and now is the democratization of heretofore arcane knowledge. That Latin terminology in both has given way to vernacular terms is a marker for the shift, but only a marker. The prime mover has been the dramatic rise in power of vernacular approaches to all aspects of life made possible by the Internet. Nothing like it in scale has occurred since the invention of inexpensive mass printing near the end of the fifteenth century. I mention the technological shift to mass printing not to provide an aside on the history of technology, but rather to foreground what came next: the general crisis of authority that occurred in early modern Europe. Although the shift took a few decades to develop momentum, it did not take long for the spread of mass literacy and vernacular Bibles—the primary repository of crucial knowledge in those societies—to upset established hierarchies in religion, politics, and the professions. Inexpensive health guides proliferated, and professional monopolies in medicine and surgery weakened, as did, eventually, medical licensing.³¹ Indeed, from the beginning of the Reformation in the early sixteenth century, one can trace, along with the emergence of organized resistance to Roman Catholicism, the rise of alternative medicine, not to mention calls for more representative forms of government. In terms of their power to transform professional authority, the social impact that the Internet and ‘‘best practice’’ algorithms are exerting and will continue to exert represents a sea change. Not only can a physician’s recommendations be scrutinized by his or her newly savvy patients with their Internet print-outs and support groups—the medical Bibles and Bible study groups of today—but Medicare or Aetna or one’s state licensing board has ³¹ Robert L. Martensen, The Brain Takes Shape: An Early History (New York: Oxford University Press, 2004).

226 / Martensen electronic compilations of treatment outcomes at the individual and group levels. And all of it can easily be made public. This new transparency and democratization of medical knowledge profoundly challenges physicians as professionals where it really counts: an MD’s claim to have a vastly different level of knowledge compared to his patients. Meanwhile, diagnostic and therapeutic machines get ever ‘‘smarter’’ thanks to the algorithmic sophistication of their software. The convergence of algorithmic technology and valorization of private interests exerts seemingly relentless pressure on medicine to become less professional in the sense I have been using the OED’s definition. Indeed, that is probably why the counter move to ‘‘professionalism’’ gained force so quickly in the U.S. in the early 1990s, for it was then that Internet health guides took off, Wall Street colonized large sections of health care, and state medical licensing boards began to make public the disciplinary profiles of individual physicians.

Conclusion Can learned medicine maintain itself as a revered profession—a corporation or body of learned people in the original medieval sense—when all its elements, from first-year students to the medical schools themselves to the specialists withdrawing from community hospitals to build their own clinics, behave as though they are preoccupied with self-advantage? Though it is the subject of another paper, I would argue that the increasing inability of American doctors to behave as a unified profession makes us even more vulnerable than we would be otherwise to the de-professionalization factors noted previously. Medicine has been an organized profession since the Renaissance, but only intermittently in Europe and the United States has it garnered substantial social and cultural authority. It is worth remembering that what many older physicians consider the profession’s social heyday—the middle decades of the twentieth century, when deference to doctors was widespread and profound—may have been an historical anomaly. Those born early in the twentieth century witnessed an extraordinary transformation of the disease burden, as vaccines prevented many epidemics, antibiotics provided genuine

Professionalism and Medical Education / 227 cures for otherwise lethal infections, effective metabolic interventions, such as insulin, transmuted the course of heretofore lethal derangements, and surgery perfected safe and effective extirpations for localized diseases, such as Cushing’s operative success with pituitary adenomas. The medical profession celebrated itself, and was celebrated by the public in turn, as worthy of the highest social esteem.³² All that was new, for as recently as 1900, American physicians strove to stay ahead of barbers in income and catch up with lawyers.³³ Absent the development of definitive treatments or preventives for the diseases that kill most Americans these days—cancer, heart disease, pulmonary disease, and metabolic diseases such as diabetes—it is difficult to imagine a reprise of the dramatic rise in social and cultural prestige that U.S. physicians collectively experienced during the middle of the twentieth century. (It is also difficult to imagine the healer’s social contract dissolving, if only because the bond is so venerable. As historian Henry Sigerist pointed out, the ancient medicine man (or perhaps woman) was the first person a tribe released from the obligation to procure food.³⁴) It would be one thing if the current U.S. pattern of atomized scramble and hustle could deliver what it promises, the best health care in the world. Physicians might be frustrated at some of the new hurdles we find ourselves obliged to navigate, though at least we could say the public interest is well served. But in terms of health in the aggregate, America pays the most and gets the least for its medical expenditures of any economically developed country in the world.³⁵ Such a dismal performance, while not strictly a function of ‘‘medical professionalism,’’ nonetheless does little to enhance the profession’s social esteem. American biomedical science and technology continue to lead the world, and our postgraduate training programs, especially those in procedurally ³² Paul Starr, The Social Transformation of American Medicine (New York: Basic Books, 1982). ³³ Robert L. Martensen, ‘‘Physicianhood in the 1890s,’’ Journal of the American Medical

Association, 276/12 (1996), 1005; idem, ‘‘Discounted Fees: the Past in the Present,’’ Journal of the American Medical Association, 273/8 (1995), 605. ³⁴ Henry Sigerist, History of Medicine, i. Primitive and Archaic Medicine (New York: Oxford University Press, 1951); ii. Early Greek, Hindu, and Persian Medicine (New York: Oxford University Press, 1961). ³⁵ Robert M Tenery, Jr. ‘‘The Challenge of Universal Access to Health Care with Limited Resources’’ in Baker et al., American Medical Ethics Revolution, 252–63.

228 / Martensen intense specialties, draw gifted applicants from everywhere. U.S. medical journals and prowess in biostatistics and epidemiology are important public goods on a global basis. Nonetheless, in terms of values, behaviors, and relationships as they are lived—the essence of professionalism—it is difficult to maintain that current U.S. ‘‘medical professionalism’’ has much to offer its global counterparts.

11 Professionalism and Medical Education in the Developing World Kisali Pallangyo

Introduction Dr. Robert Martensen, I believe, was trained, practices, and teaches in the USA and therefore understands very well American medical education and practice. I have a very different background from that of Dr. Martensen, in that most of my medical training took place in a developing country, Tanzania; except for a few years of postgraduate training in the industrialized world, I have been practicing and teaching in Tanzania for almost three decades. I would therefore take the advantage of my different background and experiences to expand the scope of the discussions to include medical education in developing countries in order to enrich discussions on the subject. Dr. Martensen’s chapter discusses the subject of medical education in the twenty-first century as it applies to the USA and to a large extent to industrialized Western Europe. The subject is very relevant, timely, and pertinent, as is the aspect of medical education that Dr. Martensen has chosen to discuss—which is how directing medical education will influence

230 / Pallangyo the social and cultural dimensions of healthcare as well as instilling and maintaining professionalism into healthcare professionals in the making. He reminds the reader of the typical curricula and the different training stages namely: Basic Sciences, Clerkship, Residency, and thereafter Fellowship that doctors in the USA and Western Europe go through before they emerge into practice. In practice the specialty credentials need to be regularly renewed for which the State Licensing Boards demand CME hours. He has brought up important and complex issues at the various stages of training that need to be examined and consensus built where appropriate. It is anticipated that any educational reforms to be made will be driven by shortcomings of the curriculum rather than by enthusiasm for change. In contrast, in sub-Saharan African countries and elsewhere in developing countries, newly graduated medical doctors go through a period of internship, usually one year, after which they obtain their license to practice. Many such young professionals practice in urban or isolated rural hospitals, often on their own. The licensing authorities are generally weak and do not require CME hours, nor is there need to renew the licenses. Training of doctors to work under such conditions needs to take these harsh realities into account and prepare them accordingly. Whereas until a decade or so ago infectious diseases were responsible for the bigger part of medical conditions in the developing countries, currently most of these countries are reckoned to be going through a rapid epidemiology transition with non-communicable diseases adding to the disease burden due to rapid urbanization and increase in aging population. For example, the morbidity and mortality due to non-communicable diseases (NCD) and injuries in sub-Saharan Africa is projected to increase from 28–60 percent and 35–65 percent respectively between 1990 and 2020, making these groups of diseases a major health burden in the developing countries. In addition, the HIV/AIDS pandemic (and the associated poverty) that started in the 1980s has had and will continue to have a far more significant impact on the economies and healthcare systems in the developing countries than in developed economies such as the USA during the twenty-first century. The curriculum for training doctors for the developing countries therefore has to take cognizance of these major causes of morbidity and mortality and adequately prepare the graduates to meet the anticipated challenges. Educating doctors for the twenty-first century is no small challenge. We are going through a phase in human social development beyond the

Professionalism in the Developing World / 231 era when the doctor was seen as the all-knowing sage, and the patient the obedient and subservient customer. Many are the times when the physician today is faced with a patient who, thanks to the Internet and the information superhighway, knows more about his/her condition than the physician; whether the physician admits it or not is another matter. The democratization of medical knowledge may leave the physician with one place to take refuge, and that is in being a compassionate and caring physician to his patients. The gradual replacement of History of Medicine by Medical Ethics can be seen as a rather natural process. A firm foundation in the History of Medicine is not unimportant; learning about the heroes and heroisms of old can influence students’ thinking and shape future careers. It reminds me of the English king who said to a young surgeon in connection with the swelling he had presented with, ‘‘young man just how do you intend to treat me?’’ (emphasis on ‘‘me’’). The surgeon replied, ‘‘Your Majesty, I am going to provide you with the very best treatment possible. I will treat you exactly as I treat every single one of my patients.’’ It takes guts to say that to a king, but the level of integrity that leads to such a statement is inspiring, indeed. On the other hand, medical ethics should be considered as a branch of general ethics. Therefore, it would be incorrect to divorce ethics in medicine from ethics in everyday life; hence its undisputed relevance and application in medical practice on a daily basis. In the Western context ethics often revolves around issues of research, use of technology in medicine, life support and end of life, organ harvest and transplantation, high-tech treatment for infertility, application of cloning, and the like. In the third world ethics is more about issues like access to basic healthcare, counseling and testing in HIV/AIDS, counseling on inheritance of widows of dead brothers, and the choice between using available resources for providing renal replacement therapy for end stage renal disease for a few but needy patients who will die without it, on one hand, and providing control and treatment of diseases such as acute diarrhea and malaria for millions of the populations, on the other. Consequently, while basic ethical principles of beneficence (and its companion in arms, nonmaleficence), patient autonomy, and justice are universal, different concepts in religion, philosophy, and/or in socio-cultural-economic practices/norms may impact on ethics. It is therefore the judicious balance between these

232 / Pallangyo concepts/obligations that determines acceptable ethical decisions in a given clinical situation.

The Physician Charter The exposition of the Physician Charter certainly raises many questions and has therefore facilitated Dr. Martensen’s intention to provoke discussion. That it is imperative for teachers of future medical professionals to be role models for their students and trainees cannot be overstated. The emphasis on what the role modeling involves is dependent on the socio-cultural environment. Americans may not need to have this spelled out to them by a non-American, but in the third world it can be about what you will do and what you will not do to survive financially on a monthly salary of a few hundred dollars from your official employer, who expects you to spend the working day teaching and rendering clinical services as well as other duties and responsibilities, when an hour or two per day once or twice a week spent at a private clinic in town can earn you several fold your official monthly salary. The problem is, there are many such clinics in town, and all may be beckoning. Where do you draw the line? Dr. Martensen makes the observation that leaders at all stages of training of doctors, viz. medical school deans, directors of residency/fellowship programs/review committees, etc., see the need for physicians to become acquainted with the social and cultural dimensions of healthcare. (For what reasons he did not say, but I assume it is to enable the physician to better serve the society.) Although this realization has been there for some decades, the curriculum revisions required towards this goal have been inadequate or not made at all. Clearly medical educators have not been walking their own talk. Why haven’t most medical schools allocated the appropriate number of hours for teaching/learning the anatomy and physiology of the social and cultural status of their communities/societies to enable their graduates to better serve the society? Is the emergence of a ‘‘professionalism movement’’ not an attempt to fill the gaps created by inadequacies in the medical school and/or residency curriculum. Even more important we must ask ourselves whether

Professionalism in the Developing World / 233 ‘‘professionalism’’ is the right answer to the shortcomings of medical training of our times. Dr. Martensen observes that ‘‘the Physician Charter asserts that Professionalism is the basis of medicine’s contract with the society.’’ Indeed most medical educators would agree that medical schools and other institutions central to the training of physicians should be accountable to their sponsors and finally to the society. Accountability in this context does not mean uncontrolled interference but rather that an institution is obliged to explain its actions and have its successes and failures examined in a transparent fashion within the context of agreed rights and responsibilities. This in turn will help to identify parts of the curriculum that need to be improved/changed to prepare the graduate to serve the society better. Consequently, the evaluation of the success or failure of such programs should not be limited to pass rates and rating among medical faculties/colleges but must include assessment of how well educators and graduates are accountable to the society.

The Expansion of Medical Education in Developing Countries Beginning in the latter half of the twentieth century, developing countries have experienced a huge demand for higher education as a result of expanded enrollment into secondary education. Even more important, the demand is based on a real and urgent need for trained human resources in all sectors including health. By and large, public institutions in these countries have not been able to meet this continuing and growing demand, and therefore private providers such as for-profit entities, not-for-profit organizations, and religiousgroupshavebeenencouraged to establishand manageinstitutionsof higher learning including medical schools to complement the enrollment into public-owned institutions. This demand-driven rapid expansion of institutions operated by private providers has at times been unplanned and, not infrequently, chaotic. The faculty in many such institutions is usually grossly inadequate in both quality and numbers, as are teaching and lab facilities. To compound the problem, the accreditation authorities are weak and/or there is relaxation of national regulations. The end result is provision of poor-quality education.

234 / Pallangyo On the other hand, public institutions of higher learning including medical schools have been required to increase their enrollment several fold without adequate and proportional increase in the faculty, lecture rooms, lab facilities, clinic space, students’ accommodation, and other required facilities. Public-owned medical schools therefore have to devise strategies to address the challenges brought about by increased student enrollment to minimize the consequential toxic effects on their ability to provide good-quality education. These trends in both private and public medical schools are certain to continue into the twenty-first century and therefore medical educators in the developing countries will for some time be called upon to respond to these challenges.

The Enigma of the Empty Classroom The partly (or mostly) empty classroom is not confined to the developed world, but the reasons for it may be different from those in developing countries. If lectures are minimally informative and boring, can you blame the students for staying away? If students do not see the lecture as an interesting, intellectually stimulating, and challenging experience, and if they can access the same or better-quality information without leaving their bedroom, why should they bother to attend the lecture? While few would dispute the special value of the conventional classroom lecture, the challenge to the teacher is to come up with a creative, interactive, user-friendly method of presentation that will attract the young student of today back to the classroom. Sometimes the student feels reading the provided handout, accessed through a friend who attended the lecture, suffices—it may be more interesting and informative than attending the lecture. The availability of information on the Internet at the touch of a button is not to be seen as a curse that keeps students out of the lecture hall but a unique opportunity to be taken advantage of. The possibility of posting a programmed set of material(s) on the web for students to access and work through interactively, then coming for small group discussion of the same with a teacher as moderator may offer a near optimal learning environment. One of the questions is, are there enough

Professionalism in the Developing World / 235 faculty for meaningful group discussion? Due to a variety of factors public medical schools in developing countries often have a dearth of faculty required to handle rather large numbers of students at any one time. Under such circumstances it is quite difficult to conduct group discussions with small numbers of students, and large groups are not likely to be productive. In Africa, and perhaps other parts of the developing world, the two-thirds empty classroom may be because the students do not have the bus fare to commute to the school from the hostel. In Tanzania and various other African countries Internet facilities are fairly well developed, and it would make a great deal of sense to provide students with some online materials as a supplement to direct contact interaction. This makes even more sense when we are dealing with classes with big numbers of students. Obviously, there is a shift of paradigms in designing and delivering medical curricula, and teachers need to be ready and willing to break out of the old mold. As educators we should be agents of change to address challenges of the day and not agents of preserving norms/practices that no longer work. The empty classroom phenomenon provides a great opportunity to revisit methods of teaching basic sciences!

Disappearance of the Experienced Clinical Teacher Good clinical practice in medicine requires education, knowledge, and wisdom born out of experience. It is my conviction that clinical medicine has to be taught and its path illuminated so that a student who aspires to this practice is shown the way. Indeed it is the moral obligation and ethical responsibility of the senior medical educators and the society to ensure that this is done. Dr. Martensen tells his reader about the ‘‘unavailability’’ of the experienced clinical teacher for bedside teaching and the disappearance of side rooms for performing simple rapid diagnostic tests in the US since the 1990s. Sadly, similar trends have occurred in Africa albeit due to a variety of reasons including socioeconomic factors and increased patient load. This in turn has had a negative impact on patient care, teaching, and learning, and indeed, on professionalism.

236 / Pallangyo In developing countries the teacher-clinician is faced with the same if not larger loads of patients to look after, in addition to teaching and having to do research and publish as a requirement for tenure and promotion. He/she also faces the dilemma of working for an employer, usually the government, who pays a salary that can meet only a small fraction of his/her needs. There is pressure, therefore, to find time and energy to perform activities with other employer(s), official or unofficial, to make ends meet. Such arrangements often have an obvious and serious impact on the clinician’s effectiveness in teaching and professionalism. In addition, labor disputes with the employer and strikes demanding better salaries are not uncommon, and if and when such incidences occur, the image of the profession in the eyes of the public is put to the test. Here we are talking about those who decide to stay and brave the prevailing conditions at home. There are those who opt to migrate to richer countries where working conditions are more attractive and personal incomes are higher. These become part of the increasingly disturbing statistics of medical migration. Should such doctors be considered as having gone on strike for ever (as far as their countries are concerned), or are they just exercising their basic human rights? Whether they stay and pretend to teach just as their employer pretends to pay them, or leave and go where the grass is greener, the education of future doctors takes its toll. In many institutions in the developing world, teaching by residents (which is very much better than nothing) is neither organized nor institutionalized, and is therefore largely insignificant. Needless to say, teaching by the resident should supplement and complement, not replace, teaching by the accomplished teacher who, hopefully, is more effective and is, in any case, employed to teach. In the wake of the sophistication in diagnostic technology, the practice (or is it the need?) to take from the patient and record a detailed and informative history as well as a thorough physical examination has gradually diminished. In the developing world, where technology is neither readily available nor well developed, teaching in medicine still puts great emphasis on the art of taking a good detailed history and thorough systematic examination. One would like to hope that this art, even in the advent of high-tech diagnostics, would not be lost from medical education and practice. Perhaps the pendulum of medical education and medical practice in the developed world needs to swing back some. For this to happen, however, remuneration

Professionalism in the Developing World / 237 for non-procedure-based patient services have to be acknowledged and rewarded fairly.

The Tribulations of Specialization Dr. Martensen makes the point that in the USA, perhaps more than in other developed economies, the socio-cultural environment has encouraged the growth of specialties and subspecialties, with consequences on medical education, healthcare, and cost of care. Whereas the public and the healthcare system in the US (and other similar economies) are concerned with the phenomenon of specialization (over-specialization?) in the medical fields, many developing countries continue to experience a severe shortage of doctors and other healthcare workers. In 2004, for example, Tanzania had a population of over 35 million and only about 1,000 doctors practicing in both private and public healthcare facilities, giving on average a doctor population ratio of 1 : 35,000 compared to about 1 : 300 in high-income economies such as the USA. During the same period in one-third of the 117 district hospitals in the country there wasn’t a single medical officer (MD) and in about 38 percent of such facilities there was only one doctor. Rural district hospitals serve populations of about 100,000 to 700,000 and may be located as far as 200 km away from some of the households. This paucity of doctors is not unique to Tanzania but rather a common finding in many developing countries. Although it is probable that the scarcity of doctors as seen today in developing countries may be minimized in the future, it may take decades, given the weaknesses of the economies of such countries, the impact of the HIV epidemic, and the migration of doctors and other skilled workers to the industrialized countries. In most of sub-Saharan African countries general internists, surgeons, etc. may only be found practicing in the major cities. Consequently, unlike in the USA, patients do not normally have easy access to doctors, let alone specialists. Nonetheless, provision of healthcare in these developing countries and particularly in the cities has a large component of private hospitals, clinics, and boutiques. Some of such facilities are owned and run by physicians as individuals or in organized groups. Admittedly, these

238 / Pallangyo facilities are an important component of the healthcare system and help to decongest the usually overcrowded and supplies-deprived public health facilities. Privately operated facilities may engage the services of doctors employed in the public health sector who wish to supplement the usually meager salaries given by the government. Furthermore at times physicians working in the university/public hospitals advise patients to consult them at such private clinics/hospitals and not infrequently such action may raise difficult ethical issues. On the one hand it could be interpreted as abuse of influence/power for financial gains on the part of the doctor. At times, however, some private hospitals may be better equipped with diagnostic and therapeutic facilities and thus be potentially beneficial to the patient notwithstanding the financial gains to the doctor that may be inherent within such practices. On the other hand, the general tendency to performing more investigations and procedures in private facilities may support the belief, sometimes held by some members of the general public, that such facilities are not different from high street retail shops or any other business. Indeed, at times, the doctors/specialists have to play the tune called by the proprietor that may have direct conflict with acceptable moral and ethical practices. The impact of such practices on the medical profession is, indeed, a cause for concern. When reference is made to appropriate use of healthcare resources in a global context, especially human resources, this touches a raw nerve in the developing world. The US and other healthcare systems in the Western world generate a loud hissing sound as they suck up doctors, perhaps in the name of residency training programs, from parts of the world with one doctor to 30,000 persons in the population into their system that has one doctor for every 300 persons. Doctors do not leave their countries only due to poor salaries but also due to a number of other reasons including lack of opportunities for postgraduate training, inadequate technological and intellectually supporting environment, underfunding of health services facilities, and hostile political environment. The issue of brain drain (or is it brain hemorrhage?) is therefore complex and there are no easy solutions to it. It is important to appreciate the fact that although the phenomenon of brain drain occurs in all countries, in developing countries which have few doctors, the negative impact of such migration can be enormous.

Professionalism in the Developing World / 239

Conclusions Medical schools and other institutions central to the training of physicians must be accountable to the sponsor and finally to the society they serve. The need to train young medical professionals in the social and community aspects of medicine is greater today than ever. Despite their faults, traditional curricula have managed to produce humane and conscientious doctors with a solid knowledge base that equips them for a career in the broad spectrum of medicine. However, these curricula need to be reviewed regularly and developments in communication technology and other technologies taken advantage of. Curricula for twentyfirst-century physicians should prepare students to learn not only what is known now but also to continuously update their knowledge. New technology-based tools for gathering knowledge must be central elements of their education and curricula should be designed so that the students learn how to learn. Notwithstanding the role of new technologies in the training of doctors for the twenty-first century, the need to equip physicians with the right attributes and inculcate a breadth of vision that transcends the mere acquisition of knowledge is even more important to minimize the potential harm that a physician heavily dependent on technology is likely to do to his/her clients.

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Part V Euthanasia and Physician-Assisted Death

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12 Physician-Assisted Death: Not Just for Rich Countries∗ Johannes J. M. van Delden and Margaret P. Battin

1. Introduction There is broad recognition of the fact that continuing medical treatment is not always beneficial to the patient, nor need it always be what the patient wants. This has led to a debate about the way physicians may or may not be involved in the end of life of patients. On what grounds can they withhold or withdraw treatment? Could there be a justification for the active ending of life of the patient? This debate is certainly not typical for any one country, rather it has, we believe, a global character. Much of this debate has been done in developed countries, but in developing countries (e.g. Colombia) the debate is present as well, even when not considered a top priority regarding public health issues and ∗ Part of this chapter draws on previous work which was published as: Florencia Luna and J. M. van Delden, ‘‘Physician Assisted Death: Only for Developed Countries? Latin America as a Case Study,’’ J. Pall. Care, 20/3 (2004), 155–62.

244 / Van Delden and Battin even though there are no reliable data about the prevalence of end-of-life decisions. While we do not want to deny the heterogeneity across developing countries,¹ we recognize, at the same time, that two features are common to most of these countries: poverty and inequality. For some few inhabitants of these countries, all that modern health care can offer is affordable; for most others, not even a decent minimum is available. It is precisely this characteristic that prompts the question that we pose here: do these circumstances justify a more restrictive approach to end-of-life issues in developing countries? With respect to end-of-life decisions we will focus on voluntary euthanasia and physician-assisted suicide. Although there may be morally relevant differences between the two in some respects, for the purpose of this chapter we will treat them as two of a kind, and will use the term ‘‘physician-assisted death’’ (PAD) to refer to both decisions. In this chapter we want to answer the following question: if we assume that PAD is morally justified in industrialized countries, should we accept it for developing countries as well or are there relevant moral reasons to refuse it there? At stake therefore is the moral relevance of differences between countries. We will not argue for the moral justification (or lack of justification) of PAD as such, but will instead analyse whether there are special reasons for treating developing countries differently from developed countries. To do this, we will sketch the main arguments with which positions pro and contra PAD are substantiated in the bioethical literature.² If we want to hold to different moral positions for different places, we will have to argue for the moral relevance of the difference. Simply pointing to different circumstances or different cultural backgrounds will not suffice. ¹ United Nations Development Programme, Human Development Report, 2004, available at . ² D. Brock, ‘‘Voluntary Active Euthanasia,’’ Hastings Center Report, 22/2 (1992), 10–22; J. J. Finns and M. D. Bacchetta, ‘‘Framing the Physician-Assisted Suicide and Voluntary Active Euthanasia Debate: The Role of Deontology, Consequentialism, and Clinical Pragmatism,’’ Journal of the American Geriatric Society, 43 (1995), 563–8; M. P. Battin, ‘‘Euthanasia and Physician Assisted Suicide,’’ in Margaret Pabst Battin, ed. Ending Life: Ethics and the Way We Die (New York: Oxford University Press, 2005).

Physician-Assisted Death: Not Just for Rich Countries / 245

2. Common Arguments pro and contra Physician-Assisted Death 2.1. Arguments pro Physician-Assisted Death The two fundamental values that support the acceptance of physicianassisted death are autonomy and well-being. We follow Feinberg in differentiating between autonomy as a right and as a value (or ideal).³ Autonomy as a value refers to the interest persons have in living their own lives according to their own conceptions of a good life. The right of self-determination protects the value of autonomy by ensuring that persons, assuming they meet certain criteria for competency, are left free to act on these decisions (limited by the harm principle, of course). Autonomous decision-making is of value in the last period of one’s life as well: many people will want to maintain the quality of their life in that period as much as (or even more than) before. These people may also want to influence the circumstances and timing of their dying and death. The counterargument will deny that the person who requests physicianassisted death really wants to die: with careful attention for the ‘‘question behind the question’’ the request to die will surely turn out to be something else. There is some truth in this, since people sometimes do request PAD for other reasons than wanting to die—they may be depressed, afraid, feel guilty about something, or have other reasons. What this fact justifies, however, is serious attention for the motives of the person who asks for PAD, not a dismissal of all requests, nor of PAD as such. Another counterargument will deny that choosing one’s own death falls within the scope of self-determination: according to this view a person’s freedom cannot be extended to allow for the removal of the very condition for freedom: life itself. On this view, we cannot justify supporting someone’s choice of death on the grounds that it is good for him, while also denying the existence of another value, embodied in him.⁴ While we ³ J. Feinberg, Harm to Self: The Moral Limits of the Criminal Law, iii (Oxford: Oxford University Press, 1986). ⁴ J. D. Velleman, ‘‘A Right of Self-Determination?,’’ Ethics, 109 (1999), 606–28.

246 / Van Delden and Battin acknowledge the consistency of this argument, we do not think it rules out the possibility of PAD altogether. Recognizing the interest-independent value of a person, on the contrary, is essential to the notion of ‘‘dying with dignity’’. In some cases of unbearable suffering, however, life itself has become undignified. In those cases a person cannot sustain both life and dignity. Paradoxically then, respect for an object of dignity can sometimes require its destruction. Often the counterargument of life being an unalienable right is supported by drawing a parallel with slavery: people are not free to sell themselves into slavery, thus giving up freedom. But as Frances Kamm stated, this is a false analogy.⁵ Requesting for physician-assisted death involves waiving one’s right to go on living, not turning the right over to someone who then has power over that person. The second value supporting PAD is patient well-being, or rather the absence of well-being. Obviously, the person who requests PAD will not consider his or her life as a benefit but will have come to see it as a burden. It should be noted that in most systems tolerating PAD the patient’s opinion alone, even if competent, is regarded as necessary but insufficient evidence that continued life for him or her is worse than life at all. The physician will have to judge the clinical situation and the patient’s prospects as well. The Dutch law on euthanasia states for instance that ‘‘unbearable suffering without prospect of relief’’ is one of the conditions for performing PAD, to be determined by the physician.⁶ This condition necessarily sets limits on the patients’s right of self-determination. The justification of this limitation lies in the role of the physician: physicians always need justification for their acts other than patient preferences. Under Dutch law, they must see assistance in dying as a medical necessity: that is, it must be the case that they cannot help the patient avoid or end unbearable suffering in any other way that is acceptable to the patient. The result of this view of PAD is that medical values play a substantial role in the end of life, since whether or not ⁵ F. Kamm, ‘‘Physician-Assisted Suicide, the Doctrine of Double Effect, and the Ground of Value,’’ Ethics, 109 (1999), 586–605. ⁶ J. J. M. van Delden, J. J. F. Visser, and E. Borst-Eilers, ‘‘Thirty Years of Experience with Euthanasia in The Netherlands: Focusing on The Patient as a Person’’ in Physician-Assisted Dying: The Case for Palliative Care and Patient Choice, ed. T. Quill and M. Battin (Baltimore: Johns Hopkins University Press, 2004), 202–16.

Physician-Assisted Death: Not Just for Rich Countries / 247 physician-assisted death is justifiable becomes largely a matter of medical discretion.⁷ The counterargument will deny that there can ever be (or at least far too seldom to justify a policy) medical circumstances that would justify the physician complying with a request for PAD. According to this view good palliative care can relieve almost all suffering, albeit sometimes at the cost of consciousness as in terminal sedation.

2.2. Arguments contra Physician-Assisted Death There would also seem to be two major lines of arguments against PAD. The first is the deontological view that the deliberate killing of innocent persons (in casu the patient) is always wrong. Often this view will be stated with reference to the sanctity of life. Against this claim it will be argued that most opponents of PAD do accept the forgoing of life-sustaining treatments, including withholding treatment, withdrawing treatment, and terminal sedation that involves the non-use of artificial nutrition and hydration. This dual position of accepting the latter but rejecting PAD would seem to rest on the moral relevance of the distinction between killing and letting die. Proponents of PAD will reject the moral relevance of that distinction, whereas opponents of PAD will hold on to it. With respect to sanctity of life, some proponents of PAD would state that the principle holds for all those who share certain religious beliefs, e.g. the Judeo-Christian tradition. This is not to say that those outside that tradition think that life is of no value, only that this person may hold on to a more qualified version of the doctrine of the sanctity of life, allowing for the taking of innocent life at the request of the person concerned. More likely, they will reject the religiously-based distinction between ‘‘innocent’’ life and other life, pointing out that such on some versions the sanctity-of-life view would permit ‘‘non-innocents’’ to request and receive aid in dying but not allow it for ‘‘innocents’’—a clear perversion of respect for life. The second line of argument against PAD would hold that although PAD may be justified in some specific cases, accepting it on a policy level would lead to several undesirable consequences. Against this second claim it will ⁷ J. J. M. van Delden, ‘‘Slippery Slopes in Flat Countries,’’ Journal of Medical Ethics, 25 (1999), 22–4.

248 / Van Delden and Battin be argued that evidence shows that countries tolerating PAD have not slid down the slippery slope.⁸ Opponents of PAD however usually have a completely different interpretation of the same data.⁹ However, the disagreement is not about the correct interpretation of data alone. There is also disagreement about the consequences of a policy which would tolerate PAD and about the relative importance of different effects of such a policy. These utilitarian arguments focus on effects in different realms such as the clinic, the law, public policy, or society. We will describe these effects here briefly, and will return to them while we address some aspects of the situation in developing countries. Positive effects of a policy which tolerates PAD will be that people who want PAD can get it. A second, similar but distinctive, effect is that people who think that they might want it under certain future circumstances may feel reassured that they could indeed get it, should they ever want it. Another positive effect would be that there will be less agony caused by irrelievable pain in the terminal phase of a disease. Negative effects that are mentioned are: permitting PAD would erode trust in doctors, would weaken society’s commitment to provide optimal palliative care or the legal prohibition of homicide. Most importantly, however, tolerating cases of voluntary PAD would lead to active physicianassisted death being performed in other cases as well, endangering especially the frail, disabled, and economically disadvantaged members of society. This is also known as the slippery slope argument.

3. Different Places, Different Morals? We now turn to the question which is at the heart of this chapter: are there morally relevant differences between developed countries and developing ⁸ A. van der Heide, L. Deliens, K. Faisst, et al., ‘‘End-of-Life Decision-Making in Six European Countries: Descriptive Study,’’ Lancet, 362 (2003), 345–50; M. P. Battin, et al., ‘‘Legal Physician-Assisted Dying in Oregan and the Netherlands: Evidence Concerning the Impact on Patients in ‘Vulnerable’ Groups,’’ J Med Ethics 33 (2007), 591–7. ⁹ J. Keown, ‘‘Euthanasia in The Netherlands: Sliding Down the Slippery Slope?’’ in Euthanasia Examined, ed. J. Keown (Cambridge: Cambridge University Press, 1995), 261–96; H. Hendin, ‘‘The Dutch Experience,’’ in The Case against Assisted Suicide, ed. K. Foley and H. Hendin (Baltimore: Johns Hopkins University Press, 2002).

Physician-Assisted Death: Not Just for Rich Countries / 249 countries, which would justify different policies with respect to physicianassisted death? In order to answer this question we will go over the arguments described in the previous section.

3.1. Arguments pro Physician-Assisted Death At first sight it may seem obvious that the first of the two major arguments supporting PAD (autonomy) will do so equally well in the United States, Canada, and the Netherlands as in developing countries. Autonomy is grounded in the respect that we owe to human beings as human beings. This respect for autonomy is a moral obligation in affluent countries as much as in developing countries. This is also reflected in the UNESCO declaration on universal norms in bioethics which was adopted in October 2005.¹⁰ However, it is often claimed that in developing countries autonomy is frequently or routinely constrained. Lower levels of education in developing than in developed countries, at least among the poor, mean less familiarity with legal options, including options in medical contexts, less capacity to choose among them, and less ability to negotiate a complex health care system. Illiteracy means that people are unable to read resource materials, utilize print and digital information sources such as newspapers, journals, and the web; less able to express their wishes in writing; and so on. Such limitations particularly constrain women, for whom levels of education are typically much, much lower in developing countries, but all—both women and men—suffer from the limitations of autonomy that poor education means. Low levels of education are not the only limitation on autonomy in developing countries. Low socioeconomic position means much less capacity to negotiate and utilize a system, assert one’s rights, explore and pay for alternatives. Low levels of political power and high levels of prejudice of various forms, including race and class prejudice between and among various subgroups, clans, tribes, and so on, may also exacerbate the constriction of autonomy: the preferences and wishes of people of the group against which prejudice is directed are often not regarded by the politically controlling group as worthy of respect. This catalogue of reasons for which ¹⁰ UNESCO, Universal Declaration on Norms in Bioethics and Human Rights (Paris: UNESCO, 2005).

250 / Van Delden and Battin autonomy is said to be limited in the developing world could be greatly extended: the point is that the poor and disadvantaged have less say than the powerful in how their lives go. Thus, given these challenges to the very possibility of genuine autonomous choice, the argument from autonomy for PAD appears to be undercut. In spite of these constraints, however, we think that people have the right to be treated as autonomous persons. It may be that the possibilities to effectuate one’s decision are limited by the circumstances but it does not follow that the possibilities to decide are limited as well. In the previous section we mentioned two other counterarguments against patient autonomy as a reason for accepting PAD: the dispute about the real meaning of a request for PAD and the rejection of the freedom to annihilate freedom by taking life. Whatever one thinks of these counterarguments, we submit that their force (or weakness) is exactly the same, whether applied to affluent or to developing countries. With respect to well-being it goes without saying that unbearable suffering is not an exclusive feature of affluent countries. It might be true that there is even more of this kind of suffering in developing countries, since there is less access to adequate health care. In Argentina, for example—though hardly among the poor nations— palliative care, designed to reduce or eliminate pain especially in terminal illness, is barely available. Palliative care is not recognized as a medical specialty in Argentina, and payment for palliative care is not included in most health plans.¹¹ As of May 2005, there were just four palliative care beds in hospitals in Buenos Aires, serving a country with a population of almost 40 million. Or consider Saudi Arabia, also a nation of comparative affluence: Although a palliative care service had been established at the King Faisal Specialist Hospital and Research Center in Riyadh in 1992, it was not until a joint symposium of Saudi physicians and the European Society for Oncology took place a decade later that a fatwa was obtained from the religious authorities to condone the use of morphine, recognized as the most effective palliative drug—indeed, the gold standard of pain control—in ¹¹ G. C. de Simone, ‘‘Palliative Care in Argentina : Perspectives from a Country in Crisis,’’ in Pain and Palliative Care in the Developing World and Marginalized Populations: A Global Challenge, ed. M. R. Rajagopal, D. Mazza, and A. G. Lipman (Binghamton, NY: Haworth Medical Press, 2003), 23–43.

Physician-Assisted Death: Not Just for Rich Countries / 251 patients with advanced cancer.¹² One commentator, recognizing the scope of poverty and lack of resources even in the midst of affluence, describes this palliative care program as ‘‘a commendable initiative—one of the few islands of care in a sea of suffering.’’¹³ Consider Thailand: one early study reported that HIV/AIDS patients with were told by their doctors upon diagnosis that ‘‘nothing could or would be done for them’’; the study comments with a good deal of irony that this ‘‘evidently did not help their pain management.’’ This study further reports that, in part due to social isolation and negative attitudes about HIV/AIDS as well as physician fears of opioid addiction and the strict national drug legislation in Thailand, many patients both in centres and in the community ‘‘have to endure unrelieved pain.’’¹⁴ In India, palliative care facilities for AIDS patients are practically non-existent, and for patients with cancer, late diagnosis compounds problems of pain control: patients commonly first present and are diagnosed only after they have developed ‘‘huge ulcers, often with maggot infestation,’’ and pain management is correspondingly more difficult. Furthermore, many states in India have no medical facilities that dispense morphine, and palliative care is not in any case available to the needy: poverty is so pervasive, comment observers, that one is often ‘‘overwhelmed with the enormity of the problem’’ and the evident impossibility of providing adequate pain control.¹⁵ In the thirty-six Western Pacific Region countries, less than half (48%) of patients and families are informed of the possibility of alleviating symptoms of disease among the dying, only a fifth (21%) of primary care health workers receive training in palliative care or work in hospitals that have adopted WHO guidelines for palliative care, and in only 41% of these Western Pacific Region countries is morphine available at the primary care level.¹⁶ And as of 2003 in Uganda, legally prescribed morphine for palliative care is available only to people ¹² A. Nixon, ‘‘Palliative Care in Saudi Arabia: A Brief History,’’ in Pain and Palliative Care in the Developing World, 45–9. ¹³ M. R. Rajagopal, ‘‘Commentary: Lessons Learned from Saudi Arabia,’’ in Pain and Palliative Care in the Developing World, 51–2. ¹⁴ M. Spencer, ‘‘Pain Relief in Thailand,’’ in Pain and Palliative Care in the Developing World, 53–64. ¹⁵ M. R. Rajagopal and C. Venkateswaran, ‘‘Palliative Care in India: Successes and Limitations,’’ in Pain and Palliative Care in the Developing World, 121–8. ¹⁶ S. Pampallona and P. Bollini, ‘‘Palliative Care in Developing Countries : Why Research is Needed,’’ in Pain and Palliative Care in the Developing World, 171–82.

252 / Van Delden and Battin who have access to doctors—and so excludes residents of many rural areas of Uganda.¹⁷ As stated in the previous section, the voluntary request of a patient is a necessary but not a sufficient condition for a physician to comply with that request. The physician must also be convinced that there is unbearable suffering without the prospect of relief. In the Netherlands, for example, a case of PAD will not be accepted when a reasonable palliative alternative exists. This means that one assumes that there is suffering that could be adequately relieved though in fact it is not, and suffering that is relievable only by death. The frequency of the latter kind of suffering is the subject of fierce debates, but that debate need not be addressed here. Our problem is with the word ‘‘could’’ because in order to know what is possible you have to define your scope. Does this refer to possible relief anywhere in the world or to generally locally available treatments? What standard of care should be applied to evaluate the request for PAD of a person in a developing country who suffers unbearably: a global or a local standard? Interestingly, the question concerning the standard of care at the moment is hotly debated in quite another context: that of international clinical research projects. Clinical research is conducted according to international (ethical) guidelines, for example the World Medical Association Declaration of Helsinki. Originally these ethical guidelines focused on informed consent, scientific validity, and a proper balance of benefit over burdens. In recent versions of the guidelines a new (additional) emphasis can be discerned. The new emphasis reflects the idea that we should prevent one part of the world becoming the experimental garden of another part. This is a real danger when one considers the comparator in randomized clinical trials. Some have suggested that we can offer a placebo (i.e. no therapy) to control groups when the research subjects are not denied care or treatment they would ordinarily get.¹⁸ Thus subjects might be identified and studied but left untreated because of the poor local standard of care. Others would ¹⁷ Helen Livingstone, ‘‘Pain Relief in the Developing World: The Experiences of Hospice Africa-Uganda,’’ in Pain and Palliative Care in the Developing World, 107–18. ¹⁸ R. K. Lie, ‘‘Justice and International Research,’’ in Biomedical Research Ethics: Updating International Guidelines, ed. R. J. Levine, S. Gorovitz, and J. Gallagher (Geneva: CIOMS, 2000).

Physician-Assisted Death: Not Just for Rich Countries / 253 consider this use of a placebo as exploitative and argue for a global standard of care.¹⁹ However, we see relevant differences in the case of PAD. In the case of a research project someone (a researcher) tries to find respondents with a certain disease, and then provides the intervention only to some of them, knowing what could be done to treat the condition of all of them. Not providing treatment in those cases amounts to negligence. In the case of PAD the physician who knowingly withholds treatment is not the cause of the patient’s suffering; it is a terminal illness that is doing so. Therefore, we think it would be unfair to deny someone’s request for PAD because maybe (possibly) somewhere in this world a treatment exists that could relieve that patient’s suffering. The world need not become ideal before we can justifiably grant a request for PAD (setting aside the question whether in such a world one would ever ask for PAD). Of course, this situation speaks for improving palliative care facilities, expanding the availability of morphine (the gold standard), and improving access for all residents of a region to adequate terminal care, and in the bargain increasing education, enhancing empowerment, and ending poverty. In the meantime, however, people in the third world continue to die in pain. Thus the pervasiveness of untreated and in the third-world context untreatable pain strengthens in our belief the ‘‘pro’’ side of the argument concerning PAD. The heightened likelihood of dying in unremediable pain speaks for allowing the person who wishes it to receive assistance in dying.

3.2. Arguments contra Physician-Assisted Death We mentioned two lines of argument against PAD: a deontological and a utilitarian one. The deontological one referred to the difference between acts and omissions and to the sanctity of life. Again, we believe there is no relevant difference between affluent and developing countries with respect to the applicability of these specific arguments. The second line of argument against PAD focuses on several undesirable consequences a liberal public ¹⁹ R. Macklin, Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2004); F. Luna, ‘‘Is ‘Best Proven’ a Useless Criterion?,’’ Bioethics, 15 (2001), 273–88.

254 / Van Delden and Battin policy would have in different realms such as the clinic, the law, public policy, or society. We will now try to evaluate these different effects for developing countries. 3.2.1. Erosion of the Moral Centre of Medicine Often the fear is expressed that accepting PAD would make people lose trust in their physicians. Note that there is some vagueness in this expression. If it means that physicians will no longer be committed to prolonging life in all circumstances, this is surely correct. The whole debate about end-of-life decisions in medical care is a response to the idea that extensive, unwanted life-prolongation is not justifiable in all circumstances in the first place. The moral centre of medicine should not be vitalism; rather, it should be the well-being of the patient. We therefore submit that physicians who do not show what the French call acharnement th´erapeutique (best translated as ‘‘therapeutic stubbornness’’) but who are prepared to evaluate the effect of their treatment from the perspective of the patient will gain in trust. A second interpretation would concern the moral basis for accepting PAD. If there were a right to die in which self-determination is interpreted as a right to do with your life whatever you want, then indeed that basis might erode trust. The trust involved, however, does not concern only physicians but rather the trust people have in each other. Such an individualistic account of autonomy would leave little room for relations of trust at all.²⁰ However, such an individualistic account of autonomy need not be the basis for accepting PAD. Moreover, if such an account were to prevail, then not accepting PAD would certainly not be the solution to this problem. The expression above may also mean that accepting PAD on request may lead to non-voluntary cases. That would amount to the slippery slope argument, to which we will return below. At this juncture, however, we should point to the erroneous assumption in this interpretation. The assumption seems to be that once given the opportunity to kill their patients, physicians will take it. There is no evidence for this assumption. On the contrary, the common behaviour of physicians is to cure or to relieve suffering, and of the many requests for assistance in dying made in ²⁰ O. O’Neill, Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press, 2002).

Physician-Assisted Death: Not Just for Rich Countries / 255 the Netherlands and elsewhere, only a fraction are granted. This is probably true for virtually all physicians in all countries, including those in developing countries. 3.2.2. Erosion of Society’s Commitment to Provide Optimal Care A second undesirable consequence of a liberal policy on PAD concerns society’s commitment to provide optimal medical care. When euthanasia is available as a cheap alternative, it is said, people without adequate health care might feel pressured to make that choice. Since the difference between developed countries and developing countries is to a large extent an economic one, the discussion of this argument will be very relevant for our purposes. We should start by saying that there is some empirical evidence that end-of-life decisions in developed countries do not lead to savings of cost.²¹ For example, it has been estimated that PAD would save less than 0.1 per cent of the health expenditure in the US.²² Of course, the fact that in these studies patients with end-of-life decisions are assumed to have access to as much care as other patients can only be interpreted against a background of a situation of relative wealth. But what about the relation between society’s commitment to care and PAD? It is sometimes argued that PAD cannot be made available to people in vulnerable groups—whether specific groups in the first world or, we might add, the huge poverty-stricken populaces of the third—because that would lessen pressures for the improvement of background circumstances. What is particularly disturbing about the argument that PAD must not become available to people in vulnerable groups is the usually tacit assumption that the sufferings of those who, because they are in vulnerable circumstances where PAD cannot be allowed, will serve as leverage for improving the provision of such things as adequate terminal care, adequate pain control, and the like. The evidence appears to be the other way around. Pain ²¹ E. J. Emanuel, ‘‘Cost Savings at the End of Life: What Do the Data Show?,’’ Journal of the American Medical Association, 275 (1996), 1907–14; J. Teno, J. Lynn, A. F. J. Connors, et al., ‘‘The Illusion of End-of-Life Resource Savings with Advance Directives,’’ Journal of the American Geriatric Society, 45 (1997), 513–18. ²² E. J. Emanuel and M. P. Battin, ‘‘What are the Potential Cost Savings from Legalizing Physician-Assisted Suicide?,’’ New England Journal of Medicine, 339 (1998), 167–72.

256 / Van Delden and Battin management was improving in the Netherlands before PAD was fully legalized, but has continued to do so at an increasingly rapid rate.²³ In Oregon, it has been particularly since the original passage of the Death with Dignity Act in 1994—implementation of which was delayed until 1997—that pain control has been extensively improved, reflected in higher rates of morphine usage, better access to hospice care, higher rates of advance directives, and higher rates of death at home rather than in institutional settings. It is legalization or the prospect of immediate legalization which appears to contribute to the improvement of terminal care and pain control at least in developed countries. Consequently the argument that not permitting PAD will serve as leverage for better pain control and terminal care is not only callous in the extreme towards those suffering inadequately controlled pain now—in Kantian terms, these people are being used for the benefit of others, being treated as mere means to ends that do not have to do with themselves—but there is evidence suggesting that it does not work, or not as well as legalizing PAD. The argument might also mean that people without adequate medical care will opt for PAD for financial reasons. As stated above there are good arguments to hold that an individual who has no access to health care can justifiably ask for PAD. At the same time it is clear that from a public health perspective the response to poor population health should be the improvement of health care, not legalizing PAD. The focus of health policy should be on gains in life-expectancy and on improvements of palliative care for persons for whom this goal was not reached. We urge that countries—both those legalizing PAD and those not doing so—should have a system of health care that does provide a decent minimum of care to its inhabitants, care not restricted to but certainly including palliative care. Allowing PAD without striving for a decent health care would exclude people from a normal range of opportunities and would thereby amount to a violation of human dignity. In principle, countries that want to develop a liberal policy towards PAD have a strong obligation to improve (access to) palliative care at the same time, and while we insist on the importance of this principle, we do not believe that respect for the wishes of the dying should remain hijacked by unrealized social goals. ²³ A. L. Francke, Palliative Care for Terminally Ill Patients in the Netherlands ( The Hague: Ministry of Health, 2003).

Physician-Assisted Death: Not Just for Rich Countries / 257 3.2.3. Erosion of General Legal Prohibition of Homicide Another counterargument against tolerating PAD could be that it undermines the fundamental prohibition in civilized societies against killing. The classical arguments against this position are that carefully circumscribed exceptions (e.g. a policy should tolerate PAD only on request) and a system of societal control should minimize the danger. This is easier said than done, however. Even in the Netherlands, where the euthanasia law is supported by a large majority of the population and of physicians, physicians have had difficulty in being transparent, though the frequency with which cases of euthanasia are reported to the review committees has increased over the years from a small fraction to 80 per cent.²⁴ One could imagine other systems of control that are less dependent on the willingness of physicians to report cases, but this is clearly a question that merits more attention than can be given here. The problem of societal control might prove even bigger in developing countries than in others. In some of these, widespread bureaucratic and police corruption make it almost impossible to organize an effective control system, at least if that system involves monitoring from the outside. In such circumstances the introduction of PAD seems difficult since the chance of misuse would appear to be increased, but if the principal method of social control is reliance on the conscience and professionalism of physicians, this does not follow. We recognize that outside perceptions of graft and corruption in governmental structures in many impoverished countries make the question of legalized PAD particularly challenging, but insist that such considerations be balanced against the concerns of individual patients for easier, more humane ways of dying, especially where because of limited resources for pain and symptom control their situations are likely to be far worse. We have now touched on the issue of human rights. We by no means claim that all developing countries show little respect for human rights, or that so-called developed countries do much better in this respect. But at the same time we feel it is reasonable to state that some of these countries do not have a strong tradition of respect for human rights. If this is true, then this might provide a background in which human life is not valued the ²⁴ Van der Heide et al., ‘‘End-of-Life Practices in the Netherlands under the Euthanasia Act,’’ NEJM 356/19 (2007), 1957–65.

258 / Van Delden and Battin way it should be. Respect for human rights again is important for accepting a liberal policy with respect to PAD. The claim that you need respect for human rights and human life in order to be able to tolerate PAD might sound paradoxical. At first sight, one might think that proponents of PAD are the ones who show a lack of respect for human life; that interpretation is mistaken, however. As pointed out above, sometimes illness and dying come with such suffering that life is reduced to pointless surviving resulting in an undignified end of life. If all other palliative measures fail, then PAD may be justified in such cases. Respect for human rights, thus, also requires accepting a liberal policy with respect to PAD in the interests of the patients who wish to use it. 3.2.4. Slippery Slope Last but not least is the slippery slope argument. The claim is that when you start with justifiable cases (e.g. voluntary) of PAD you will end up with unjustifiable (e.g. non-voluntary) cases. Especially when the policy specifies that there should be unbearable suffering for a request of PAD to be fulfilled, it will be hard to deny PAD to suffering incompetent patients who cannot make such a request but would surely have done so, were they competent. Both in the medical ethics literature and in court decisions it has been held unreasonable to continue life-sustaining treatment for a now-incompetent patient if it is demonstrated that the patient would not have wanted it. Thus the competent patient’s right to refuse treatment has been extended to incompetent patients. Although this logic might be applied to PAD as well, we now have empirical evidence to the contrary. It is certainly true that non-voluntary cases do occur in the Netherlands, but what we also know is that the occurrence did not increase in the Netherlands between 1991 and 2005; on the contrary, it decreased. We also know that the prevalence is much higher in other countries (Australia, Belgium) that did not slide down the slope by tolerating euthanasia for years after years.²⁵ A European study conducted in Belgium, Denmark, Italy, the Netherlands, Sweden, and Switzerland, ²⁵ H. Kuhse, P. Singer, P. Baume, M. Clark, and M. Rickard, ‘‘End-of-Life Decisions in Australian Medical Practice,’’ Medical Journal of Australia, 166 (1997), 191–6; L. Deliens, F. Mortier, J. Bilsen, et al., ‘‘End-of-Life Decisions in Medical Practice in Flanders, Belgium: A Nationwide Survey,’’ Lancet, 356 (2000), 1806–11.

Physician-Assisted Death: Not Just for Rich Countries / 259 using the same study design as the one used in previous studies in the Netherlands and in Belgium, found that in all countries except for the Netherlands and Switzerland (which have a liberal policy towards assisted suicide) the incidence of non-voluntary cases was higher than for physicianassisted death on request of the patient.²⁶ Apparently, the occurrence of non-voluntary cases of PAD is at least independent from toleration of PAD and it may even be the case that an open and liberal policy is negatively associated with non-voluntary PAD. This might also be true for developing countries. It may very well be that non-voluntary cases of PAD already exist, without control or real knowledge of the scope of it. If end-of-life decisions are made in a context in which it is hard to discuss them, this creates the danger of arbitrariness on the part of physicians. End-of-life decisions are then taken without the request of the patient or without a frank discussion with the families. Hence, we think avoiding an open discussion is not an alternative: a transparent and public debate is essential in which all interested parties can express themselves. One cannot deny, however, that a policy tolerating PAD leads to a continuous discussion about the borders of such a practice. All legal systems allowing assistance in dying have interpreted the issue as being part of medical practice. However, assistance in dying is not only asked for in order to bring an end to severe refractory physical suffering; requests may also partly or even predominantly originate from psychosocial or existential problems and in many cases the exact origin may not be identifiable. Legislation of physician-assisted dying therefore inevitably involves further discussion of the medical borders of this practice: should it, for example, be allowed for types of suffering that do not originate from physical diseases per se, such as mental suffering due to depression or being tired of life at a very high age? Furthermore, it can be questioned whether assistance in dying should exclusively be given by physicians, especially when existential elements of suffering predominate. When society asks physicians to (also) act upon existential judgements they are not trained to make, the result is not only an extra emotional burden for physicians, but may also constitute a threat to the credibility of the moral and legal ²⁶ A. van der Heide, L. Deliens, K. Faisst, et al., ‘‘End-of-Life Decision-Making in Six European Countries: Descriptive Study.’’

260 / Van Delden and Battin framework for the acceptance of physician assistance in dying. Such debates, however, do not show that a slippery slope is at work, but rather that society protects against the occurrence of a slippery slope in part by open debate.

4. Conclusion We think that arguments in favour of accepting PAD apply at least equally strongly in developing countries as in affluent countries. The heightened likelihood of dying in unremediable pain strengthens the argument for legalization of PAD. Therefore we think that if PAD ought to be permissible anywhere, it ought to be permissible in developing countries. To be sure, some of the counterarguments merit special attention in developing countries, and legalizing PAD should go together with adequate health care, including adequate palliative care, and with an adequate form of societal control of PAD, yet we also recognize that the plight of people who are dying in poor countries without adequate care is as important to respond to as that of people dying in more fortunate circumstances. Would dying people in the third world actually seek PAD to avoid dying in pain, were it available to them? Surely the answer would vary from culture to culture as a function of beliefs about the significance of pain, the meaning of death, and similar matters. But the question we raised is whether aid in dying should be made available in the third world as a matter of policy to those who want it. Given that adequate pain treatment is simply not available and evidently will not be available any time soon in the third world, we can only guess that some will want PAD—maybe many, maybe not. Pain management in the developed world already falls far short of what it might achieve. People dying in the developing world, the studies cited earlier suggest, have far less adequate pain management—‘‘a sea of suffering,’’ the commentator on the situation in Saudi Arabia described it. Nevertheless, we have no way of knowing who would choose PAD or why, and because the topic is not much discussed in the developing countries, there are few spokespersons for the vast numbers of third-world poor who might tell us what they would choose if the option of assisted dying

Physician-Assisted Death: Not Just for Rich Countries / 261 were open to them. Yet the proportion of dying people in the developing world who would actually choose PAD makes no difference to the moral argument here; the question is whether PAD should be permitted, if anyone wants it and a willing provider can be found. We think the answer must be yes.

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Part VI Global Bioethics and Religion

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13 Embryo as Epiphenomenon: Some Cultural, Social, and Economic Forces Driving the Stem Cell Debate Ronald M. Green

On July 19, 2006, U.S. President George W. Bush vetoed a bill that would have greatly expanded federal funding for human embryonic stem cell (hESC) research and permitted the derivation of new hESC lines from frozen embryos remaining from IVF. Bush announced his veto surrounded by eighteen families who had ‘‘adopted’’ ‘‘snowflake babies,’’ frozen IVF embryos not used by other couples to have children. This event, rich in symbolism, illustrates how politicized the debates about hESC research have become. It hints at some of the more fundamental cultural, social, and economic forces driving the controversy, not only in the U.S. but in Europe and elsewhere. It also tells us something about the limits of philosophical argumentation as a way of understanding and resolving the intense debates occasioned by hESC research. That our hESC debates are not simply about good or bad ethical arguments becomes clearer when we see that President Bush’s veto evidences a deep contradiction. On the one hand, the President was prepared to marshal the

266 / Green full power of his presidency, exercising his first veto in six years in office, in order to protect frozen human embryos from being destroyed to make new hESC lines. In the President’s words he opposed the legislation because it ‘‘would support the taking of innocent human life in the hope of finding medical benefits for others.’’¹ On the other hand, the President said—and did—nothing about the medical procedure, IVF, that made the ‘‘snowflake’’ babies available in the first place. Although he was prepared to slow progress on a biotechnology that could save the lives of children and adults, he was completely silent about the massive use of IVF, involving the routine creation and destruction of supernumerary embryos, by people for the purpose of having children of their own. No legislation has ever emerged from the Bush White House (or any preceding ‘‘right-to-life’’ administration) proposing to limit access to IVF or restrain IVF practitioners in any way.² Like almost all but a small handful of opponents of hESC research, Bush was intensely solicitous of the welfare of the spare IVF embryos that could be used for stem cell derivation but simultaneously heedless of the hundreds of thousands of embryos that have been created and then left behind in assisted reproductive technologies. This neglect of embryos is not confined to IVF. It also manifests itself in connection with natural reproduction.³ For example, it has long been known that there is an extremely high rate of embryo loss associated with conception and pregnancy. Estimates vary, but it is almost certain that at least half of all fertilized human ova arrest somewhere in early development, never going on to a completed pregnancy. If human embryos are the moral equivalent ¹ Charles Babington, ‘‘Stem Cell Bill Gets Bush’s First Veto,’’ Washington Post, July 20, 2006, p. A04, available at . ² In March 2004, the President’s Council on Bioethics, a Bush-appointed advisory body led at that time by the bioethicist Leon Kass, who had a long record of opposition to assisted reproductive technologies, issued its report, Reproduction and Responsibility: The Regulation of New Biotechnologies (Washington, March 2004). This report promised, in its earliest drafts, to recommend new legal restraints on the practice of IVF. However, partly in response to heated criticism from IVF practitioners and patient groups, the final report offered little more than recommendations for enhanced monitoring of the outcomes of IVF clinical practice. The report is available at . ³ For a discussion of the neglect of natural embryo loss by hESC research opponents, see Katrien Devolder and John Harris, ‘‘The Ambiguity of the Embryo: Ethical Inconsistency in the Human Embryonic Stem Cell Debate,’’ Metaphilosophy, 38/2–3 (2007), 153–69.

Understanding Global Stem Cell Debates / 267 of children and adults, as many opponents of hESC research insist, this amounts to the catastrophic loss of perhaps a hundred million ‘‘human’’ lives worldwide each year.⁴ Yet no one in the global health establishment or a U.S. administration has ever proposed devoting significant research funding to address this problem. Budget requests for the National Institutes of Health’s National Institute for Child Health and Human Development, the U.S. agency closest to this issue, do not even identify early pregnancy loss or early miscarriage as a research priority.⁵ It does not explain this moral indifference to say that many of these deaths are the result of ‘‘natural’’ processes such as chromosomal aneuploidies. Disease conditions like cancer, malaria, or AIDS that we regard as major global health problems are also the result of natural processes. Nor does it help to say that these disease-related deaths are not intentionally caused, and therefore are morally different from the deliberate destruction of embryos for hESC research. That the infection of children by malaria or HIV/AIDS is not deliberate has not reduced our moral commitment to combating the spread of these diseases. While appeal to an omission/commission distinction may slightly mitigate blame for this massive loss of embryonic life, it cannot justify the total neglect of it. How, then, can we explain this deep inconsistency in attitudes toward the embryo on the part of opponents of hESC research? Philosophers and bioethicists who have addressed this question appear to believe that the core problem here is simply a matter of sloppy thinking. Identifying and removing these inconsistencies, the work of moral philosophy and bioethics, thus becomes a way of resolving our stem cell debates. Because moral positions must be internally coherent, those who champion the sanctity of the early embryo are presented with a choice: either evidence and justify your full commitment to the embryo, or bring your views on stem cell research into conformity with your actual attitudes and treatment of the embryo. Since few opponents of hESC research are likely to commit to massive programs of embryo rescue or alter reproductive practices that ⁴ I base this estimate on the projection that the world will add approximately 1 billion between 1998 and 2009—Carl Haub, ‘‘Global and U.S. National Population Trends,’’ Consequences, 1/2 (summer 1995), available at ; World Bank, ‘‘World Population Growth,’’ available at . ⁵ See NICHD, Congressional Budget Justification FY 2007, available at .

268 / Green occasion embryo death, it follows that they must rethink their opposition to hESC research. Unfortunately, philosophical arguments of this sort have had little impact. Opponents of hESC research continue their resistance to embryo destruction in the face of repeated demonstrations of the apparent contradictions in their position. This has led some students of the stem cell debates to seek a deeper understanding of the factors at work behind and beneath some of these surface arguments. Recently, some scholars of the U.S. abortion debates have drawn attention to the ways in which the fetus and the embryo have both become symbols for a larger set of value conflicts occasioned by social and cultural changes. One of these scholars, Janet Dolgin, sees these debates as pitting against each other two visions of the place of the individual in society. ‘‘One vision,’’ she says, is ‘‘linked with religious orthodoxy and served by tradition. It values fixed roles, social hierarchy, and social loyalty within communal, and especially familial, settings.’’⁶ The competing vision is linked with secularism and modernity. It values autonomous individuality and choice. During the late twentieth century, the divide between these two visions was widened by the feminist movement, which championed women’s autonomy and saw access to reproductive health services and abortion as essential to it. In the United States, the Supreme Court decision Roe v. Wade sharpened the conflict by effectively (if not intentionally) siding with the feminist position against traditionalist opposition to abortion. From 1973 onward, the debates about the moral status of the fetus thus became surrogates for much deeper social and cultural changes that were working their way not only through U.S. society, but also in Europe and other regions where modernization was creating tensions between competing visions of gender, sexuality, family, and social roles. When viewed in this context, some of the apparent inconsistencies in the pro-fetus, pro-embryo position begin to make better sense. The bioethicist Dena S. Davis also notes the tolerance of IVF by many hESC opponents even as they vehemently resist lifesaving hESC research. She calls this ‘‘the puzzle of IVF,’’ and tries to explain it in terms of the deeper value conflicts I have mentioned. Abortion and our treatment of the human embryo ⁶ Janet L. Dolgin, ‘‘New Terms for an Old Debate: Embryos, Dying, and the ‘Culture Wars,’ ’’ Houston Journal of Health Law & Policy, 6 (2006), 249–73 at 253–4.

Understanding Global Stem Cell Debates / 269 have stirred such intense controversy because they have exposed our sharp disagreements over the role of women, the meaning of human sexuality, and the importance of the traditional family. But IVF connects with a very different, even opposing value constellation. In Professor Davis’s words, ‘‘While the embryo in the abortion context is . . . a stand-in or replacement for concerns about family life and structure, the embryo in the context of IVF exists primarily to allow married, heterosexual, economically stable couples to ‘complete’ their families by having children.’’⁷ Once we see this, the symbolism and underlying coherence of President Bush’s veto event becomes more evident. On this occasion, the embryo, now symbolized by each of the ‘‘snowflake’’ babies in its parent’s arms, is an epiphenomenon. The deeper message the President is sending to his religiously traditionalist voter base by means of an embryo-protecting veto is that he joins them in opposing those who would privilege scientific progress and individual choice over the sanctity of family life and traditional family roles. Opposition to cultural elites is a further dimension of the conflict over embryos. Scholars like Dolgin and Davis are right to signal the presence in these debates of competing visions of gender, family, and society. But there is also a set of regional, social, and economic tensions at work feeding the debate. In the United States, this takes the form of opposition by populations in the South, Southwest, and more agrarian parts of the Midwest to values and attitudes found in the bi-coastal, especially northern regions of the country. To a large extent, the South was left behind by the first waves of modernization. Bitter feelings dating from the Civil War era created there a kind of cultural resentment aimed at northern and bi-coastal cultural elites. Among the foes were the northeastern educational and media establishments, and the federal government (not least of all the federal judiciary, which was viewed as responsible for forced integration during the civil rights struggles of the mid-twentieth century).⁸ ⁷ Dena S. Davis, ‘‘The Puzzle of IVF,’’ Houston Journal of Health Law & Policy (2006), 275–96 at 292. The link between family values and hESC research is sometimes made explicit in interviews with evangelical voters: Michael Luo, ‘‘Evangelicals See Dilemmas in G.O.P. Field,’’ New York Times, July 8, 2007. ⁸ Kevin Phillips, American Theocracy: The Peril and Politics of Radical Religion, Oil, and Borrowed Money in the 21st Century (New York: Viking, 2006), ch. 5; Glenn Feldman, ‘‘The Status Quo Society, the Rope of Religion, and the New Racism,’’ in Glenn Feldman, ed., Politics and Religion in the White South (Lexington: University Press of Kentucky, 2005), 287–352; Glenn

270 / Green As the South and its cultural sphere grew in economic and political importance from the 1970s onward, resentments crystallized around issues that symbolized the cultural and regional divide. Almost anything associated with race became implicated, from voter registration initiatives to school bussing. The gay liberation movement furnished a new opportunity for the expression of cultural antagonism, with gay marriage recently becoming the foremost symbol of the divide.⁹ And, of course, there was Roe v. Wade, the icon for judicial activism and the imposition of federal government policy over state or regional autonomy. With the advent of stem cell research, the soil was thus well prepared to make the embryo a further vehicle for the expression of these deep regional conflicts. It is hardly surprising that when the South and its affiliated cultural regions finally attained control of the federal government, first in the Reagan and most decisively in the two Bush presidencies, this outcast, anti-government values agenda would, paradoxically, become federal policy. Now it was up to the states associated with the older ruling elites, notably California, Illinois, and the states of the Northeast, to try to reassert their hegemony through programs of ambitious support for stem cell research.¹⁰ In all of this, once again, the embryo is an epiphenomenon of much broader societal divisions. I believe that the regional social, cultural, and economic forces driving the embryo debate are not confined to the U.S. The emerging split among Anglicans over the roles of women and gay people in the church suggests that the divide between north and south, developed and less developed, modern and traditionalist, established and emergent societies is also playing a role in other religious-ethical debates. I believe, as well, that some of the divisions in Europe on the stem cell issue have to do with conflicts between nations at different stages of social and economic development and between those at the periphery and those at the center of the European Feldman, ‘‘Epilogue: Ugly Roots: Race, Emotion, and the Rise of the Modern Republican Party in Alabama and the South,’’ in Glenn Feldman, ed., Before Brown: Civil Rights and White Backlash in the Modern South ( Tuscaloosa: University of Alabama Press, 2004), 268–309. ⁹ Feldman, ‘‘The Status Quo Society,’’ 323–4. ¹⁰ Jodi Rudoren, ‘‘Stem Cell Work Gets States’ Aid after Bush Veto,’’ New York Times,

July 25, 2006; Nicholas Wade, ‘‘California Maps Strategy for its $3 Billion Stem Cell Project,’’ New York Times, October 11, 2005; Constance Holden, ‘‘Massachusetts Proposes $1 Billion Plan’’ Science, 316 (May 18, 2007), 966; Associated Press, ‘‘Maryland: Stem Cell Grants,’’ New York Times, May 19, 2007.

Understanding Global Stem Cell Debates / 271 community.¹¹ This picture is somewhat clouded by social and historical particularities. For example, the recent emergence of Spain as a champion of stem cell research reflects the electoral success of a socialist government and a rejection of a long history of clerical intervention in society. In Germany, the political weight of the Catholic south has combined with a history of eugenic abuses to produce a very conservative national response to reproductive and genetic issues. Until recently, Norway, with its conservative Lutheran and evangelical churches, has been a peripheral and cultural outlier in the otherwise liberal Scandinavian north.¹² Norway’s relative lack of a biotechnology sector, as compared with other Nordic nations, and its long tradition of resistance to cultural innovations among its eastern neighbors, may also play a role.¹³ There is also the special role played in these debates around the world by the Roman Catholic Church. Here, it seems, we have the clear primacy of an ethical-religious position: the absolute sanctity accorded to prenatal human life from conception on. Indeed, the Roman Catholic position is so absolute that it avoids many of the inconsistencies displayed by others on the pro-embryo side of the debate. With rigorous logic, Catholic teaching opposes both stem cell research and IVF, the latter because it is regarded as a deformation of human sexuality and parenting and because it involves the willingness to create and discard human embryos.¹⁴ In 2004, under pressure from the Vatican, Italy passed one of the most restrictive laws governing assisted reproductive technologies. Couples using IVF in Italy must limit themselves to the creation and transfer of no more than three embryos. Embryos cannot be frozen or discarded, and, regardless of the ¹¹ LeRoy Walters, ‘‘Human Embryonic Stem Cell Research: An Intercultural Perspective,’’ Kennedy Institute of Ethics Journal, 14/1 (2004), 3–38; Cynthia Fox, ‘‘Cloning Laws, Policies, and Attitudes Worldwide: Where Does Your Country Currently Stand on Therapeutic Cloning?’’ IEEE Engineering In Medicine and Biology Magazine (March/April 2004), 55–61. ¹² Fox, ‘‘Cloning Laws,’’ 57. ¹³ On this matter, I appreciate the input of my European (especially Norwegian) colleagues at our workshop ‘‘Going to the Roots of the Stem Cell Controversy, Workshop 4, Winning Words,’’ held in Sommarøy, Norway, 14–15 June, 2007. ¹⁴ The Catholic position on ARTs receives formal expression in Congregation for the Doctrine of the Faith, ‘‘Donum Vitae: Instruction on Respect for Human Life in its Origin and on the Dignity of Procreation; Replies to Certain Questions of the Day,’’ 1987, available at .

272 / Green impact on the mother’s health, all the embryos must be transferred to her womb.¹⁵ The Catholic position is not entirely free of inconsistencies. Despite the Church’s militant opposition to both abortion and embryo destruction, it has hardly ever spoken out to call for research to reduce the massive loss of early embryonic life in natural conception. This suggests that deeper sociological and cultural forces also shape the Church’s strong stand against the deliberate destruction of prenatal life. In fact, while opposition to abortion has long been a part of official Catholic moral theology, the intensity of Catholic involvement with this issue is fairly recent. One reason for this is the relative absence of challenges to the historic Catholic position until the mid-twentieth century. Liberalized abortion laws in the U.S. and Europe then provoked Church leaders to action. But social factors also played a role. Abortion rose to prominence in Catholic teaching during the period when the Church was facing a crisis of identity.¹⁶ In Europe, the post-war period saw a rise in secularism and consumerism that made inroads even among traditionally Catholic constituencies. In the U.S., the election of John F. Kennedy as president in 1960 marked the end of nearly a century of immigrant Roman Catholicism. During the long immigrant period, Catholic identity sustained the millions of working-class Irish-, Italian-, German-, and Polish-American immigrants in the face of discrimination and it also offered the Church an assured place among American Catholics. As Richard Alba observes, ‘‘[E]thnic communities and cultures serve vital human needs because they provide enduring personal identities amid the social flux of a rapidly changing society and also provide communities of solidarity that are larger than face-to-face groups and are smaller than the whole ¹⁵ V. Fineschi,M. Neri,and E. Turillazzi,‘‘TheNew ItalianLaw onAssisted Reproduction,’’ Journal of Medical Ethics, 2005/31 (2004), 536–9. The law has created new ethical conundrums for some Italian citizens using IVF. See Sophie Arie, ‘‘Woman Forced to Have Three Embryos Implanted is Allowed Fetal Reduction to Save Her Life,’’ British Medical Journal, 329/71 ( July 10, 2004), 71. ¹⁶ There are few studies of how or why abortion emerged as a defining moral issue in contemporary Catholicism, although histories of American Catholicism do indicate its move to salience in the post-Roe v. Wade period. See e.g. Patrick W. Carey, American Catholics: A History (Westport, CT: Praeger, 2004), 133; Joe Feuerherd, ‘‘Politics and the Pro-life Movement,’’ National CatholicReporter,January 17,2003,availableat .

Understanding Global Stem Cell Debates / 273 society.’’¹⁷ As immigrant and ethnic identities waned, however, the Church was faced with the question of how it could continue to elicit the support of its members. What could it offer to its members that was both religiously distinctive and able to build organizational loyalty? These questions were sharpened by the reforms of the second Vatican Council which, in the minds of many traditionalist Catholics, removed or weakened familiar features of Catholic life and identity. As Kerry N. Jacoby observes, ‘‘The Church, as Roe came down, was in a crisis of authority, leadership, and respect. The youth were leaving, the clergy were in rebellion, and few things seemed secure in the Catholic World.’’¹⁸ More recently, in Europe, ethnic immigration from largely non-Catholic (and Muslim) regions of Africa and Asia has further challenged the authority and hegemony of the Church in its traditional culture-sphere. Coupled with a sense of demographic threat as Catholic populations fail to grow at the same rate as non-Catholic immigrant ones, this has occasioned Papal and other statements urging a return to traditional Christian values, including ‘‘family’’ values and opposition to abortion.¹⁹ During the 1970s and 1980s, some Catholic leaders, both in the U.S. and abroad, saw a path that led through a program of strong support for social justice, and advocacy for the poor, including new Hispanic immigrants and African Americans. (In Latin America, this same impulse took the form of liberation theology and the ‘‘preferential option for the poor.’’) However, in the U.S., this social justice strategy was limited by the economic ascent of many Catholics into the middle and upper classes²⁰ and there and elsewhere by the discomfort of the Catholic leadership with a radical and confrontational economic position. Under the guidance of a series of traditionalist popes, the Vatican instead chose opposition to abortion as a hallmark of global Catholicism. The issue has since come to define ¹⁷ Richard D. Alba, ‘‘The Twilight of Ethnicity among American Catholics of European Ancestry,’’ Annals of the American Academy of Political and Social Science, 454 (1981), 86–97. ¹⁸ Kerry N. Jacoby, Souls, Bodies, Spirits: The Drive to Abolish Abortion since 1973 (Westport, CT: Praeger Books, 1998), 36. ¹⁹ Address by Pope Benedict XVI to the Austrian President and the Diplomatic Corps, ‘‘Abortion, Euthanasia, a Childless and ‘Spiritually Old’ Europe,’’ AsiaNews, September 8, 2007, available at . ²⁰ Lisa Keister, ‘‘Upward Wealth Mobility: Exploring the Roman Catholic Advantage,’’ Social Forces, 85/3 (March 2007), 1–31, available at .

274 / Green conservative, devotional Catholicism. In the words of one commentator, ‘‘by the mid-1970s . . . the pro-life movement had become the dominant focus of Catholic action and even identity in the culture war.’’²¹ To those who ask, ‘‘Why should I be a Catholic?’’ the answer was, ‘‘Because you are among those idealists that oppose the modern ‘culture of death,’ which includes such things as abortion and embryonic stem cell research.’’ By rejecting values associated with ruling cultural elites, many American Catholics who long felt marginalized by liberal American values have thus been able to maintain their stance of cultural opposition. The intense in-group reinforcement once provided by ethnic identity and the shared experience of cultural difference and discrimination is now partly sustained by a countercultural religious-ethical position. The stance has further served institutional needs by affording the Church an active presence in national affairs. Since the mid-1970s, the U.S. Conference of Catholic Bishops’ Secretariat for ProLife Activities has been a major center of opposition to embryo and hESC research.²² This same office has not chosen to risk the organizational capital it has accumulated in the abortion and stem cell debates by openly challenging American Catholics’ widespread use of IVF. Thus the Catholic position on these matters is driven at least as much by underlying organizational and social concerns as by moral commitments. How does this understanding of the forces driving the hESC debate help us understand the prospects of moving toward a resolution of our differences? First, and most obviously, it suggests that, despite the professional conceit of bioethicists like myself, rigorous moral argumentation will not by itself end these debates. The resistance to hESC research is too firmly allied

²¹ David J. Merkowitz, ‘‘In Essentials, Unity; In Non-Essentials, Liberty; In All Things, Charity,’’ Catholic Telegraph (online), available at . ²² For a discussion of the role of this office in our embryo research debates, see my The Human Embryo Research Debates: Bioethics in the Vortex of Controversy (New York: Oxford University Pres, 2001), ch. 1; a landmark event was the publication by the National Conference of Catholic Bishops of the ‘‘Pastoral Plan for Pro-life Activities’’ (November 20, 1975), available at . For a discussion of the institutional Church’s involvement in the right-to-life movement, see Frederick S. Jaffe, Barbara L. Lindheim, and Philip R. Lee, Abortion Politics: Private Morality and Public Policy (New York: McGraw-Hill, 1981), ch. 6.

Understanding Global Stem Cell Debates / 275 with powerful social and cultural interests to melt away in the sunlight of philosophical illumination. Second, this analysis tells us that because they are driven by powerful social, cultural, or economic forces, these epiphenomenal positions will most likely change only with shifts in the underlying forces sustaining them. Many possible transformations might be imagined, but two in particular come to mind. The first are biomedical developments that move hESC research toward clinical implementation. At present, opposition to hESC research is a relatively cost-free stance that permits those adopting it to reap many symbolic and organizational rewards. This could change if hESC research fulfills its therapeutic promise. For the past few years, I have been predicting that our stem cell debates will end abruptly the day after the first diabetic child walks out of a stem cell clinic cured of the disease. Once families must choose between embryos and treatments for sick loved ones, the full gravity of these commitments will become clearer. Then, the family-values component of the anti-hESC position will be internally challenged, as people will ask how they best can express their commitment to the welfare of families and children. Is it by opposing the destruction of human embryos, or by turning spare, and otherwise doomed, embryos to human benefit? When that happens, I believe, many of the opponents will look anew at their real valuation of the early embryo, and most will opt for cures. (To some extent, this argument works in the opposite direction. If adult stem cell research were to fulfill its promise, or if hESC alternatives such as direct cellular reprogramming not requiring the destruction of embryos were to become available,²³ then hESC research opponents will be heartened and confirmed in their opposition.) Even dramatic therapeutic benefits, however, are unlikely by themselves to alter the Roman Catholic and some related religious positions. I have argued that, from an ecclesiastical perspective, the opposition to secular and

²³ President’s Council on Bioethics, ‘‘Alternative Sources of Pluripotent Stem Cells: A White Paper.’’ Washington, D.C., May 2005; see the recent research reports on direct cellular reprogramming by K. Takahashi et al., ‘‘Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors,’’ Cell, 131 (November 30, 2007), 861–72, and J. Yu et al., ‘‘Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells,’’ Science, 318 (21 December 2007), 1917–20.

276 / Green modernizing cultural movements is one of the attractions of this stance, so it is unlikely to change in the face of therapeutic achievements, any more than the Catholic birth control position has changed in the face of pressing demographic or family realities. It is also true that, just as they have ignored the Church’s formal teachings on birth control, abortion, and IVF, most Roman Catholic laymen will ignore the Church’s position on hESC therapies if cures become available. However, it could happen that many devotional Catholics, eager to signal their resistance to modernity and the surrounding liberal culture, might come to see their commitment to the embryo as a distinctive feature of their faith, leading to continuing sectarian opposition to hESC therapies. This is one reason that I have argued for the development of ethically universal hESC lines, using new technologies that make it possible to derive hESC lines without the destruction of living embryos.²⁴ It is also a good reason to seek scientific alternatives, such as direct cellular reprogramming. By accommodating sectarian and devotionalist concerns now, before they have hardened into a defining feature of religious identity, we could avoid creating ethical, religious—and clinical—problems in the future. Economic realities could also play a role in moving things forward. In the United States, states like California, Illinois, Massachusetts, and New Jersey have important Roman Catholic populations, but they are also major centers of biotechnology research and development. In Scandinavia, opposition to hESC research has been strongest in Norway, which has an energy-focused economy and is less reliant on pharamaceutical and biotechnology industries than its neighbors. In Asia, especially centers like Singapore, fewer oppositional religious values and high interest in biotechnology combine to foster interest in stem cell research. One does not have to adopt a Marxist view of the world to believe that moral positions are hard to sustain when one’s economic interests are at risk, but this is even truer when the moral positions are themselves incoherent or at least not fully compelling. An epiphenomenon is a secondary phenomenon that occurs alongside a primary phenomenon. I have argued that the commitment to the welfare of the human embryo that animates much of the current ethical objection ²⁴ Ronald M. Green, ‘‘Can We Develop Ethically Universal Embryonic Stem Cell Lines?’’ Nature Reviews Genetics, 8 ( June 2007), 480–5.

Understanding Global Stem Cell Debates / 277 to hESC research is epiphenomenal in this sense. It grows out of a soil of deeper social, economic, cultural, and ecclesiastical realities, and deeper value debates. Bioethicists can contribute to these debates by pointing to problems in surface argument. But they must never lose sight of the deeper social realities at work. Unless these deeper realities are addressed, it will be hard to achieve forward movement in our stem cell and related reproductive medicine debates.

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14 The Role and Influence of Religions in Bioethics∗ Denis Muller ¨

Iproposeto treatthequestionoftheroleand influence ofreligions in bioethics from three successive points of view. After (I) sketching a general framework for taking into account the theoretical dilemmas posed by the relationships between religion, basic ethics, and applied bioethics, I briefly offer (II) the example of the transplantation of organs and the understanding of gift that illustrate the stakes and implications of the theoretical controversy, and then (III), speaking from the Protestant tradition, I propose my own normative thesis with respect to these relationships.

I. General Issues and Questions Bioethics has undeniably become one of the key disciplines of contemporary ethics.¹ This results especially from the complexity and enormous stakes of the biotechnologies. Everyone feels involved in this issue, even though ∗

Translated from the French by Ronald M. Green.

¹ Guy Durand, Introduction g´en´erale a` la bio´ethique. Histoire, concepts et outils (Montreal and Paris:

Fides and Cerf, 1999); Gilbert Hottois, Qu’est-ce que la bio´ethique? (Paris: Vrin, 2004); Lisa Sowle Cahill, Theological Bioethics: Participation, Justice, and Change (Washington: Georgetown University

280 / Muller ¨ bioethics, as a body of practice and knowledge, has a tendency to concentrate on exceptional situations that can lead to the neglect of other ethical issues, such as questions of social justice (including North–South relations, development, poverty, etc.). In addition, the North American, European, and Western origins of bioethics have had ambivalent effects on the status of bioethics discourse and on the place of religious perspectives in a lay or secular context. One therefore witnesses the development of two contradictory tendencies: in one direction, a laicization or increasing secularization of bioethics, with the risk of this exercising a sort of monopoly over the inherent interdisciplinarity of the field and of sidelining the contribution of religious ethics to public debate; and, in the other direction, especially in the U.S., a very active re-theologizing of ethics (see the journal Christian Bioethics), as part of a massive effort directed at the political recovery of bioethics by conservative religious forces, notably those associated with Evangelical Protestantism. Faced with these positions that tend to make bioethics a surrogate for political, economic, and religious disputes of a highly partisan nature, Protestant ethics must answer questions not only about its specific bioethical positions, but also about how faith is related to the actual transformation of our relations to the living world, to technology, to the plurality of convictions and religions, and to democracy.² Protestant ethics has no self-sufficiency. It is not only a part of Christian ethics as a whole, but, as such, one particular contribution among other religious and non-religious contributions. For that reason, Protestant ethics has to do with religious ethics as a whole and shares in a very intensive and demanding inter-religious dialogue, not only to fulfill religious and communitarian needs, but also to contribute to a universal ethics. Religious ethics and inter-religious dialogue and confrontation belong to the substance of Protestant, Christian ethics and should not be understood as optional parts of it. Born in the United States in the 1960s, bioethics has spread throughout the whole world. Its rapid success is largely a function of developments in the life sciences and therefore of the wealth of the Western world. It could appear as a luxury for privileged people. But its issues are laden Press, 2005); Denis Mu¨ ller, ‘‘Bio´ethique,’’ in P. Gisel, gen. ed., Encyclop´edie du Protestantisme (Paris and Geneva: Presses Universitaires de France and Labor et Fides, 2006), 135–54. ² Jeffrey Stout, Democracy and Tradition (Princeton: Princeton University Press, 2004).

Role and Influence of Religions in Bioethics / 281 with consequences for the sphere of medicine and the life sciences and raise questions of justice and equity not only between individuals but also between peoples and continents. The allocation of resources and benefits (for example in the questions raised by organ transplantation) is a planetary problem beyond national or regional health care systems. In the same way, AIDS today raises ethical questions on every continent. Africa, for example, constitutes a dramatic priority often forgotten in our strategies and thinking as members of more privileged countries. It is hard to deny that the commercial policies of the multinational pharmaceutical industry bar access by the poor to generic medications and anti-retroviral therapies. The medicine of catastrophic situations also poses formidable ethical problems. It not only establishes triage (a criterion of urgency) as an ethically superior norm, surreptitiously finding support in military ethics and utilitarian modes of thinking, but it also tends to make it appear that the current state of world conflict, and particularly the glaring and growing disparities between the North and South and between rich and poor nations, are nothing more than a passing fact. The tragic state of the world leads every day to many difficult and admirable interventions by teams of emergency workers expressing the depths of the universal human conscience. The events of September 11, 2001 have shaken our religious, moral, and political certitudes, demanding of us new ethical reflection about terrorism, the role of the American empire, and global injustice.³ Will the natural disaster of Sumatra and neighboring countries on December 26, 2004, with its 300,000 dead and missing persons, find its Voltaire to express—beyond the questions of theodicy once raised by the Lisbon earthquake—the ethical and political questions emerging about the inequality of men and women according to their place of birth, the destiny created by their place on the social ladder, and the risks of their geographic or geopolitical situation? Rather than confining itself within strictly biomedical problems and ruminating infinitely, in a sort of narcissistic solipsism, about paradoxes in the concept of autonomy, or ratifying the cynical states of the soul associated with medical-scientific ³ Frank Lentricchia and Stanley Hauerwas, eds., Dissent from the Homeland: Essays after September 11 [2002] (London: Duke University Press, 2003); Jacques Derrida and Ju¨ rgen Habermas, Le ‘‘Concept’’ du 11 septembre. Dialogues a` New York [Octobre–D´ecembre 2001] avec Giovanna Borradori (Paris: Galil´ee, 2004).

282 / Muller ¨ power in exponential expansion, will a new critical and cosmopolitan bioethics manage to transform the realities of social, economic, and political justice? Faithful to its inspiration and its dynamic principles, a Protestant ethic worthy of its name will not rest with a narrow defense of conscience and individual responsibilities; far from being a petit bourgeois ethic based on a ‘‘Church of individuals,’’ it will be a cosmopolitical social ethic inspired by a liberating ecclesial practice on a global scale. This also means that it must cultivate strong contacts with the people belonging to other world religions. One witnesses today on all sides efforts to marginalize religious bioethics and to replace it with one that is rational and secular. This parallels the movement observed in ethics debates generally. However, this does not mean that religious convictions should be kept apart from bioethical argumentation. In the concrete situation of hospitals and research centers, as in the daily practice of medicine, bioethics is confronted by a multiplicity of religious and philosophical perspectives. An approach that is purely argumentative and discourse-oriented does not provide sufficient room for this plurality of convictions. In France, the ‘‘Comit´e consultatif national d’´ethique’’ (CCNE) contains representatives of the ‘‘spiritual families,’’ but has trouble recognizing the positive role that religious traditions can play. The influence of a narrow and strict secularism impedes a real, public, and open debate with and between members of the world religions. In contrast, a strictly communitarian approach, like that which is sometimes developed in the United States, has the opposite risk of stopping merely with a juxtaposing of differing convictions.⁴ Bioethics raises a number of specific questions that a considerable body of publications permits one to analyze. The question of thematic delimitation is posed in an increasingly sharp way.⁵ One could cite among the themes generally belonging to bioethics all the problems at the beginning of life (abortion, prenatal and preimplantation diagnosis, assisted reproduction, in particular IVF, contraception), and at the other end, questions related to death and dying, curative and palliative care, euthanasia, and assisted ⁴ Denis Mu¨ ller, ‘‘Confrontation des traditions et intensit´e de la v´erit´e; une approche francophone et protestante du d´ebat sur les communautarismes,’’ Recherches de Science Religieuse, 95/1 (2007), 41–60. ⁵ Hottois, Qu’est-ce que la bio´ethique?

Role and Influence of Religions in Bioethics / 283 suicide. But one should not exclude from the domain of bioethics in a larger sense such questions as those relating to drugs, addictions of all kinds, eugenic science, and the quality of life, genetic manipulations, congenital deformities, human experimentation, organ transplants, programs of public health, psychiatry, psychosurgery and the control of behavior, the choice of changing one’s sex, the relationships of health to disease, informed patient consent, the physician–patient relationship, and respect for life and the place of suffering. One might also add to this the themes of animal experimentation, accident prevention, environmental protection, and sexual morality. At the same time, this almost infinite expansion of the field of bioethics itself raises a number of questions. Let us signal some of them: (a) It is not always clear whether bioethics is limited to the field of biomedical ethics or whether it should really approach the entirety of ‘‘biopolitical’’ questions connected to biotechnology on one side and the life sciences on the other. (b) In the opposite direction, the extension of bioethics to the most cutting-edge life sciences (genetics, genomics, proteomics) appears to distance it more and more from the realities of daily medical practice which we encounter for the most part as normal situations and as involved individuals (patients, clients, users, next of kin, taxpayers). A return to medical ethics ‘‘in the old style,’’ notably in the form of clinical ethics, and the increasing appeal of narrative approaches evidences the concerns aroused by the excessive domination of the bioethical paradigm. (c) Bioethics wants to be interdisciplinary, but it is hard to understand where it situates itself as a discipline of knowledge and research. On one hand, it appears to be a new and less confined way of doing ethics, or of discussing the progress of medicine and biotechnologies, but, on the other hand, it has itself become a powerful agent of ethical reflection, with the risk of monopolizing the field intellectually and economically. Thus, paradoxically, and from a democratic and social perspective, one should ask whether the growth in power of bioethics does not present an ethical risk. (d) Bioethics has happily, but quite slowly, integrated in its basic principles (autonomy, nonmaleficence, beneficence, and justice as the fair

284 / Muller ¨ distribution of research risks and benefits) with larger ethical values such as social justice, solidarity, the defense of the weak and vulnerable. But one can ask whether bioethics, far from exhausting all the ethical and moral possibilities, should not assume a more relative place within a perspective that gives greater attention to the social, economic, and political dimensions of ethics, both at the national and international levels. (e) Bioethics quite often centers itself on medicine and biotechnologies, but that often takes place to the detriment of reflection on health in general, on public health and questions of prevention (drug addictions, tobacco use, pollution, ecology, the cult of the automobile, etc.). Will it allow itself to embrace these questions within bioethical reflection, or must we not instead recognize that bioethics represents a paradigm limited by its own objects, bio-medical and bio-technology, dependent on cultural and economic realities connected with rich, over-developed, and privileged Western civilization? (f) In the same sense, is bioethics as universal as it pretends and believes itself to be?⁶ The presence of more cultural models obliges us to raise the question and testify to the fact that bioethics, far from being unified, depends on contradictory currents of thought and ethics (I could evoke here again the oppositions between different versions of universalism and communitarianism). (g) Finally, bioethics has frequently fallen back on secular or laicist models in order to avoid burying itself under the debris of religious and theological conflicts that dot the terrain of medicine, health, and the life sciences. But that has not always allowed it to calmly engage questions of faith and belief. This last remark brings us back to the main question of this contribution. I can formulate it now in the following way: is it possible to affirm a formal unity and universality of bioethics when we consider the great diversity of religious convictions, beliefs, and practices all around the world in every national or regional society? Or, to put it in a more radical way: in order to save the coherence of bioethics as a unique discipline and a common practice, should we not purify it from all references to or interventions from ⁶ Durand, Introduction g´en´erale a` la bio´ethique.

Role and Influence of Religions in Bioethics / 285 religions, religious arguments, religious leaders, and religious adepts? Is not secular bioethics the only acceptable and universal form of bioethics.

II. Organ Transplantation and Understanding of Gift as a Test If we want to answer these questions in a convincing way we need to understand and demonstrate that, in every bioethical topic, religious arguments almost always play an important role, and that the content brought by them cannot simply be translated or even eliminated by a purely secular and neutral language or discourse. But this first point must be supplemented with a second. Even if we are able to understand and show that religious arguments can possess their own coherence and power, that does not mean that they should be recognized and accepted as rational arguments. In order to be understood and integrated in the public debate, religious arguments still must be formulated in a universal way and not simply as a call to personal witness or adherence to a particular faith. In other words, they must attain a true degree of formal universality and not merely be affirmed. I must add an additional level of analysis. Bioethical issues are not only present in bioethical cases or quandaries. They also involve worldviews, attitudes, and beliefs. One of the main themes of bioethics has to do with the beginning and the end of life, with human birth and death. This is not a purely rational, secular, or philosophical problem. It is also a metaphysical one. And to treat metaphysical problems in a proper way, we need to take into account all the resources of the human experience with metaphysical issues: speculative philosophy (or metaphysics), philosophy of religion, theologies (Christian, but also ancient Greek, Jewish, Muslim, etc.—even if not every religion recognizes or practices theology as such). My contention, both metaphysical and theological, is that contemporary bioethics very often runs the risk of privileging the beginning and the end of life, and forgetting the intervening period of the historical and personal life of human beings and their social, economic, cultural, and

286 / Muller ¨ political location.⁷ I believe we must see that many bioethical questions are composed of factors and considerations that are much larger and richer. We need a concrete, historical and cultural, symbolical, and transcendental ‘‘metaphysics.’’ I prefer to say: we need a post-metaphysical understanding of the meaning of the limits of the embodied human experience. The ‘‘metaphysical’’ or ‘‘theological’’ presupposition of my contention is that immanent human life has always to do with a form of transcendence, religious or not, secular or divine, metaphysical or post-metaphysical. In this sense, bioethics cannot exist without a systematical treatment of the infinite or of the absolute, understood as the constitutive limit and horizon of human life in the world. The transplantation of organs offers a good test of the indispensable difference in operating here between a bioethics that limits itself to bios, in the sense of a narrow biological immanence, and a Christian bioethics of zoe in which biographical life alone is sacred.⁸ More generally, I think that the three monotheist religions open onto a personal and spiritual dimension of life which, far from remaining enclosed in a biological immanence, is oriented toward a liberating and reconciling transcendence. The ultimate issue of the donation of organs is precisely that of the meaning of donation, and thus of the ethical and spiritual exchange of which human beings are capable. For too long, the accent of bioethical discussions has been placed on the biological and medical conditions of organ donation (definition of brain death, the meaning of interventions while the heart is beating, explicit or implicit consent), while the real question is that of the gratuity of the offer in the entirety of such donations and not just in a single instance of decision. It is appropriate to speak of the gift that is involved because of everything that transpires here, not in the technical acts and procedures, but in the spiritual movement of the donor and family, in the sort of voluntary and disinterested religious offering that occurs or is anticipated. This is why the explicit consent of the donor—which can express itself in a donor card, a reflection of deliberate and free solidarity—will always be preferable from an ethical standpoint to an implicit consent which tends, in a bureaucratic ⁷ Cahill, Theological Bioethics; Mu¨ ller, ‘‘Bio´ethique.’’ ⁸ Denis Mu¨ ller, ‘‘Why and How Can Religions and Traditions be Plausible and Credible in

Public Ethics Today?,’’ Ethical Theory and Moral Practice, 4/4 (2001), 329–48; Nigel Biggar, Aiming to Kill: The Ethics of Suicide and Euthanasia (London: Darton, Longman and Todd, 2004).

Role and Influence of Religions in Bioethics / 287 and technocratic way, to do nothing more than remedy the human deficit in desire, when it is this deficit that is the ultimate source of the scarcity of organs. In relation to the preceding, it seems even more important to affirm that a strong tendency appears to be emerging, on the international level, to put in question the gratuity of organ donation and to replace it with the pure commercialization of organs, an approach that is at once cynical, utilitarian, and hyper-liberal. The metaphysical and theological point, in terms of the kind of transcendence involved in this case, is that of the anthropological dimension of donation and gift. If every human being can express his or her deepest identity by freely giving an organ for the love and sake of another human being, without any coercion, pressure, or interest, this means that the gift is a transcendental possibility of human identity and being. Transcendental possibility means here that the gift is not just a natural power of man, but a possibility which comes to him from ‘‘outside’’ or from ‘‘above.’’ The gift is something given, a gracious event, a surprise. It has to be experienced in its own transcendence, as a divine or supernatural proposal.

The Buddhist Debate on Transplantation and the Shared Methodological Dilemma For a certain time, the discussion in Japan has been focused on this question, because it could seem that a precise, Japanese Buddhist view of the continuity between the self and the body (through total reincarnation) would be absolutely opposed to the very idea of transplantation. But on another side, Buddhist ethics is centered on both the intention (as opposed to the act) of compassion, which go far more in the direction of an acceptance of transplantation.⁹ But it is also important to note that a good reason to resist to organ transplantation can also derive from a high conception of the gift: Japan has insisted on the necessity of explicit consent,¹⁰ as has Switzerland.¹¹ We ⁹ Michele Aramani, Bioetica e Religioni (Milan: Paoline, 2007). ¹⁰ Robert M. Veatch, Transplantation Ethics (Washington, DC: Georgetown University Press,

2000). ¹¹ Mu¨ ller, ‘‘Dons d’organes pr´elev´es sur le cadavre. Pourquoi la solution du consentment explicite me paraˆıt davantage conforme a` l’´ethique,’’ Bioethica Forum, 33 (2001), 2–4.

288 / Muller ¨ see here how two conceptions of ethics, a more anthropological-substantial one and a more pragmatic one, can lead to strong antagonisms; from this point of view, one could say that Buddhist ethics and Christian ethics are confronted with identical methodological dilemmas; both in Buddhism and in Christianity you can find tenets of a more anthropological, and tenets of a more pragmatic view of ethics. One’s conclusions are also very much dependent on the historical and cultural context. American Christianity (in its complex differentiation) or American Buddhism are not identical with European Christianity (Northern, Southern, Central, etc.)¹² or Japanese Buddhism.¹³ Buddhism in itself contains for instance many different views on self agency, soul, and body. You can find also deontological arguments for a strong conception of gift, and rather utilitarian arguments for a more instrumental understanding. In this sense, religion and faith do not overdetermine ethical convictions and decisions, even if they play an important role in the formation of the identity, character, and personality of the religious agents.¹⁴

III. Normative Recapitulation on the Subject of the Relations among Religions, Basic Ethics, and Applied Bioethics Returning briefly to Christianity, the time is ripe to give voice once again to the gospel message at the heart of bioethical inquiry. A ‘‘zoe-ethic’’¹⁵ is needed in contrast to a mere biological vitalism if one refuses to rest on a purely utilitarian vision of life, nature, and human beings. Other religions, not only the other monotheistic ones, have to think about this kind of ¹² Vigen Guroian, ‘‘Differentiation in Christian Ethics,’’ in The Blackwell Companion to Religious Ethics, ed. William Schweiker (Malden, MA, and Oxford: Blackwell Publishing, 2005), 214–26. ¹³ Thomas P. Kasulis, ‘‘Cultural Differentiation in Buddhist Ethics,’’ in The Blackwell Companion to Religious Ethics, 297–311. ¹⁴ Jean-Fran¸cois Collange, La vie. Quelle vie? Bio´ethique et protestantisme (Lyons: editions Oliv´etan, 2007). ¹⁵ Ibid.; Ronald M. Green, ‘‘Foundations of Jewish Ethics,’’ in The Blackwell Companion to Religious Ethics, 166–75.

Role and Influence of Religions in Bioethics / 289 transcendental, divine dimension. But in what condition and in what way is it possible to imagine such a renovation of bioethics? The Christian theological ethic can be defined in terms of the two major traditions of Western history, Roman Catholicism and Protestantism. The moral theology of Catholicism—notably in its recent official evolution, as found in the encyclical Veritatis Splendor (1993)—seems marked by a rigorously deontological vision, which is not surprising given the powerful degree of centralization of the hierarchical structure and the role played by the magisterium. It is also distinguished by a long tradition of wise casuistry. It is important to note that moral theology has relations as an equal with canon law and, as a result, finds itself strictly tied to the juridical preoccupations of the Church. But the ties of this moral theology with doctrinal theology—especially with the most recent developments in basic and systematic theology—remain somewhat tenuous. In the domain of bioethics, Protestant approaches are, in certain respects, radically different. Lacking a centralized authority, Protestantism has always been and still is diverse in its forms. It does not make sense to speak of a ‘‘Protestant bioethics’’ in the sense that one speaks more commonly of ‘‘Roman Catholic bioethics.’’ The principal reason for this difference is also owed to an important degree to the law of nature. Not only does Catholic ethics have a tendency to base itself on a positive valuation of nature (human nature and of the natural world where human beings exist), but, even more, it tends to stress the importance of the correspondence of nature and reason, to the extent that the ethical task for human beings is seen to require following the ends of nature (created by God), and to orient oneself to the eternal divine law that is the foundation of the moral law. Protestant ethics for the most part adopts a rather pessimistic vision, at least much more realist and critical of nature and reason. The debate touches as much on anthropology as on the doctrine of salvation. Man remains at a distance from God and is never capable of raising himself to God’s level (at least that is the criticism Protestantism often aims at Catholicism in a summary fashion). Protestantism is not oriented toward good or bad forms of personal behavior so much on the central act of justification in which ethics is rooted and from which it is inseparable.¹⁶ One nevertheless observes an inverse tendency in ¹⁶ Denis M¨uller, ‘‘The Original Risk: Over-Theologizing Ethics and Under-Theologizing Sin,’’ Christian Bioethics, 13 (2007), 7–23.

290 / Muller ¨ many currents and in different epochs of Protestant ethics: as a consequence of insisting on salvation by faith alone and on the unconditional justification of man by God, one has been able to lose sight of ‘‘the price of grace,’’ and succumb to a lax fideism, removed from all sense of political or economic reality and any real interest in applied ethics. In the domain of bioethics as well as other domains of ethics this has sometimes led in reaction to a more or less general acceptance, often implicit and surreptitious, of what amounts to utilitarianism. Traditionally and in the present day, Protestant bioethics is founded in principle on the Bible as the necessary and appropriate source of authority. It is always wise to start with the broadest possible scriptural principles in their diverse forms throughout the Bible. It is nevertheless clear that the developments of theological bioethics has coincided with the questioning of biblical writings in terms of their authority and interpretation. The idea of the unity of the Bible has been seriously challenged. Furthermore, biblical writings have their proper context and cultural frame. To put it simply, which elements are determined by a cultural context and which can transcend that context? What interpretive steps apply to technical phenomena, among others, that were unknown to the biblical texts? I am clearly in favor of a critical, reflexive, and hermeneutical use of the Bible, in the sense of a permanent balance between the biblical sources, the history of their interpretation, the positive and negative sides of confessional and denominational traditions.¹⁷ After all, Protestants also have positive traditions in theology and ethics, like Luther, Calvin, Puritan democratic ethos, Methodist or Baptist practical and political engagement, liberal openness, pietist spirituality and commitment, etc., and must face the challenges of today’s sociological context and ethical dilemmas. To be faithful to Protestant traditions, however, does not mean that we have to accept a fundamentalist, ‘‘Evangelical’’ (in the narrow sense) approach to the biblical text. Sola scriptura (one of the main sources of Protestant theology and ethics from the time of the classical Reformers) is neither to be isolated from the other hermeneutical principles (particula exclusiva) of the Reformation (sola fide, sola gratia, solus Christus), nor is it to be ¹⁷ Gene Outka, ‘‘Christian Ethics?’’ in The Blackwell Companion to Religious Ethics, 197–203; Jef Van Gerwen, ‘‘Origins of Christian Ethics,’’ ibid. 204–13.

Role and Influence of Religions in Bioethics / 291 understood independently of the cultural, historical, and sociological frame of modern, liberal, and democratic societies.¹⁸ In this sense, we must strongly reject the George W. Bush conservative evangelical stream in the United States today. But a purely ‘‘tribalistic, fideistic and sectarian’’¹⁹ re-theologization of ethics like the narrow model proposed, in the other political camp, by Stanley Hauerwas and some of his unconditional disciples (going back to a Barthian neo-orthodoxy), also remains very ambivalent and suspect.²⁰ We can observe, in different components of today’s world Christianity, a tendency to organize and to justify political and social conservatism with the aid of old-fashioned and regressive models of theology and theological ethics: traditionalist, antimodern, and integrist temptations of some Roman Catholic currents, evangelical fundamentalism, anti-liberal re-theologization of ethics, nostalgic regression to the Orthodoxy of the first millennium (Engelhardt) or even Radical Orthodoxy (Milbank and Pickstock).²¹ Concretely, this means that in very concrete areas like abortion, procreative medicine, stem cell research, or public recognition and acceptance of gays and lesbians, a literalist, neo-orthodox, and anti-liberal position has no chance at all to really address the personal and social concerns of many people. The Bible (or any other religious source) is not a reservoir of moral recipes, but it can become a source of inspiration and critical reflection to illuminate ethical demands and dilemmas and invent new modes of common responsibility. Christian ethics as such has not to be preor antimodern (after all, the Gospel, like every living, powerful religious source, is modern) but must face the challenges of modernity in an intellectual and theological spirit of freedom, critical reason, and democratic conviction.²² ¹⁸ Guroian, ‘‘Differentiation in Christian Ethics.’’ ¹⁹ James Gustafson, ‘‘The Sectarian Temptation: Reflections on Theology, the Church,

and the University,’’ Proceedings of the Catholic Theological Society, 40 (1985), 83–94. ²⁰ Stanley Hauerwas, ‘‘Christian Existence Today,’’ in Essays on Church, World, and Living in Between (Durham, NC: Labyrinth Press, 1988); Stout, Democracy and Tradition. Denis Mu¨ ller, Karl Barth (Paris: Le Cerf, 2005). ²¹ In the same sense, Collange, La vie. Quelle vie? Bio´ethique et protestantisme. See also Jewish ethics’ resistance to biological vitalism, Green, ‘‘Foundations of Jewish Ethics,’’ 168. ²² Denis Mu¨ ller, L’´ethique protestante dans la crise de la modernit´e. G´en´ealogie, critique, Reconstruction (Paris and Geneva: Le Cerf and Labor et Fides, 1999); idem, ‘‘Confrontation des Traditions.’’

292 / Muller ¨ Certainly, every monotheistic religious ethics has to deal with the place and meaning of God, grace, and redemption as pillars of the ethical interpretation of human beings as free and responsible agents or subjects.²³ The three monotheisms have in common a deep and strong feeling for the revelatory and holy character of the transcendental dimension of human immanence, world contingency, and historicity. Following another path, most of the oriental religions, like the different varieties of Hinduism and Buddhism, propose their own version of transcendence and immanence. Nevertheless, as I have tried to show, there are no absolute differences—only relative differences—between Christian ethics, other monotheist ethics, and other religious ethics, and many of the disagreements between particular ethical systems derive much more from different views of ethics per se. Overlapping correlations between rival traditions and religions are very often possible.²⁴ For that formal reason, the prospects for a reasonable, pragmatic universal, or planetary ethics seem to be rather good. The appearance of bioethics forms a major component in this already complex question of the historical and contemporary relationships between religion and medicine. In what ways have the religious convictions of Christian bioethicists affected their approach and responses to precise dilemmas? Instead of focusing their questions on the relationships between health, illness, human destiny, and salvation, some Christian bioethicists, too interested in adopting a stance supportive of biomedical research, risk following an agenda imposed from without by the so-called march of progress and by the combined pressures of science and the media. Does this program of pre-established bioethics not tend to legitimate existing medical and scientific practices rather than raise questions about the basic presuppositions of medical care, and does it not do so in such a way that theological questions can never be understood? The development of ethics into an autonomous discipline handed over to experts or professional ethicists goes back barely a century. Before that, ethics was, at least in the West (North America and Western Europe) an integral part of theology. I am certainly not capable of saying in what way defining our ethic as Christian might distinguish it conceptually and methodologically from other forms of ethical reflection, but there are two questions I can pose to anyone ²³ Schweiker, ed., The Blackwell Companion to Religious Ethics. ²⁴ Mu¨ ller, ‘‘Confrontation des Traditions.’’

Role and Influence of Religions in Bioethics / 293 who wants to advance these discussions. First of all, does a theological ethic have the resources needed to lead it to its proper objective? Second, can the theologians specialized in bioethics who furnish themselves with appropriate methods and concepts make themselves understood by their lay dialogue partners in these bioethical debates? The systematic implications of these remarks are evident: a critique of bioethical reason, in order to avoid slipping into cynicism or a reactionary retheologization, should consider the religious drive that is the root of bioethics as a human project in quest of a sense of transcendence or a significant totality. Laicism or secularism completely misses this issue, banking on a limitless autonomy of the individual and an achieved secularization of the world. But we must always consider the general situation of world religions in the ethical debate. Even if my own perspective is obviously limited to Christianity, I do not think that the epistemological and methodological situation of other world religions is totally different. Of course, Christians, Muslims, Jews, Buddhists, and Hindus don’t have the same idea of the community of believers to form the objective or normative framework of their religion. Therefore the links between personal faith, religious practice, and belonging to a precise community or church do not have the same meaning and same intensity for them all. This fundamental religious difference has ethical consequences. Do the Christian, the Buddhist, the Jew, the Hindu, or the Muslim possess only an individual vision and ethical practice, or does a sense of collective belonging to a community or church influence the content and implications of their ethics? My personal and perhaps provocative claim is as follows: in our world of rapid changes, enormous globalization, and intensive cultural exchanges and dialogues, the more we meet, discuss, and share (and we must do everything to favor and stimulate doing so), the more we will have to assume our own religion or faith as an individual, totally engaged, and personal decision.²⁵ The more we open ourselves to others, the more we will have to be ourselves, with our own history, identity, and traditions. Both ²⁵ Take for instance the very controversial and open debate on human reproductive cloning in Denis Mu¨ ller and Hugues Poltier eds., Un homme nouveau par le clonage? Fantasmes, raisons, d´efis (Geneva: Labor et Fides, 2005), with the somewhat opposing contributions of Lebaczq, Pence, Green, on one side, Collange, Mu¨ ller, or Ansermet, on the other side, and Engelhardt with his own, distinctive position.

294 / Muller ¨ liberalism and communitarianism, taken absolutely, are bad solutions and weak alternatives. In every religion, whatever its historical and sociological form, the place of individuals and of free conviction and practice will become more and more important, and the religious organizations will have to adapt to such a cultural revolution. Concretely, this mean that in the near future, and even today, no authority, church, magisterium, or dogmatic insistence (even Roman Catholic, Orthodox, or traditionalist) will be able to impose on its own members a fixed, absolute, and unanimous doctrine of faith and/or morality. The time has come for a liberal, self-responsible ethic, in living dialogue with one’s own faith, conviction, and spiritual life. Of course this revolution will be a special challenge for authoritarian, fideistic, integrist, and fundamentalist religious groups, communities, and churches. But liberal believers and communities will also have to adapt themselves to the new situation, being invited to accept coexistence, in a really liberal democracy, with other traditions, sensibilities, and habits. The victory of true liberalism can never mean the hyper-liberalistic destruction of the opponents. In the same way, the brilliance of an authentic religion and ethic (in the subjective view of its adherents or in the objective recognition by others) can never extinguish the rights of other traditions, beliefs, moral habits, and initiatives. Such, then, is the dialectic of bioethical reason that I am interested in proposing and developing as an alternative to the dangerous illusions of a conscienceless exercise of the will to biomedical power. Theologians and religious leaders have a particular responsibility, taking into account public opinion, not to erect their discourse and positions into undiscussable absolutes; they may of course, while respecting others’ opinions, develop and defend their own strong faith positions on biomedical questions. But they must also encourage real, deep, and convincing freedom of thought, both within their religious community and in their exchanges with others. These are the very important conditions of a pluralistic and respectful ethical public discussion.

Part VII Public Global Bioethics Consultations

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15 Global Norms, Informed Consensus, and Hypocrisy in Bioethics John Harris

It has been said that morality is the science of the good. If it is, then surely ethics is the study of that science.¹ Usually ‘‘moral and ethical’’ are words that are linked almost as synonyms, and few would be able to articulate any supposed differences between them. I shall continue this somewhat lazy tradition and try to say something about moral and/or ethical decisionmaking. This chapter has two central themes. The first is the nature of ethical reasoning; the second will concern some of the main influences or pressures upon the way in which we do that reasoning in contemporary society. Since morality is the science of the good, ethical judgments are often expressed in terms of what is good or bad, right or wrong. However, claims about ethics, assertions that conduct or outcomes are right or wrong, can be ¹ This chapter draws on arguments first presented in my ‘‘The Scope and Importance of Bioethics’’, in John Harris, ed. Bioethics, Oxford Readings in Philosophy (Oxford: Oxford University Press, 2001), 1–22. In the preparation of this chapter I acknowledge the stimulus and support of the ‘European Project on Delimiting the Research Concept and the Research Activities (EU-RECA)’ sponsored by the European Commission, DG-Research, as part of the Science and Society research programme—6th Framework.

298 / Harris faulty in two important ways. Because saying so does not make it so, ethical judgments can simply be wrong—that is, erroneous; but judgments can also comprehensively fail to be ethical judgments for another reason. Ethical judgments can be erroneous in all the ways that other judgments can be—for example because they are based on false or unsubstantiated premises or because the arguments that support them are invalid or flawed or because the evidence which is cited in their support is mistaken, inconclusive or irrelevant. Whether or not ethical judgments can be ‘‘true’’ or objectively certain is a more complex matter—a matter of the logic of moral discourse—and beyond the scope of our reflections here. This may seem a strange claim to make but an analogy might help. We may not know whether or not any ethical judgments are objectively true in the way we do not know whether judgments about the existence of God or whether or not there are sentient beings on other planets are ultimately true. But this ultimate uncertainty about the truth of a class of claims does not show that we cannot be sure that many claims within that class are erroneous if the arguments or evidence (or a combination of the two) which supposedly support them are flawed or false. For example, even though we don’t know the truth about the existence of God or whether or not she is omnipotent, we do know that she cannot make a stone that is so heavy that she cannot lift it.

I. Global Norms The universality and the objectivity of ethics are implied by the nature of ethics itself. What would it be to believe that killing the innocent, or slavery, for example, are wrong but also think they are only wrong for me, or only wrong for this community or this society or in this day and age? Suppose we said, ‘‘it’s wrong for us to kill the innocent or to own slaves but of course other people or other societies or other epochs can do as they please.’’ Or worse, suppose we said, ‘‘we should not be killed or enslaved by anyone,² but of course it would not be wrong for us to do the killing or the ² As Aristotle notoriously did. Politics 1256b . I would like to thank Lisa Bortolotti, Katrien Devolder, and Søren Holm for helpful comments.

Norms, Consensus, Hypocrisy in Bioethics / 299 enslaving.’’ The manifest absurdity, not to say inconsistency and hypocrisy, of such a position establishes that, whatever the deep structure of ethical theory,³ at the surface where we all live, ethics is essentially both universal and objective. In a witty letter which has been circulating on the internet,⁴ the anonymous author imagines himself questioning Dr Laura, a fundamentalist Christian who apparently believes in and seeks to impose on others the rules contained in the ‘‘abominations of Leviticus’’: Lev. 25: 44 states that I may indeed possess slaves, both male and female, provided they are purchased from neighbouring nations. A friend of mine claims that this applies to Mexicans, but not Canadians. Can you clarify? Why can’t I own Canadians? My uncle has a farm. He violates Lev. 19: 19 by planting two different crops in the same field, as does his wife by wearing garments made from two different kinds of thread (cotton/polyester blend). He also tends to curse and blaspheme a lot. Is it really necessary that we go to all the trouble of getting the whole town together to stone them?—Lev. 24: 10–16. Couldn’t we just burn them to death at a private family affair like we do with people who sleep with their in-laws (Lev. 20: 14)?

If ethical relativism were plausible we could simply say that these things were wrong for the Jews in antiquity but not for their Christian or even for their Jewish successors in the twenty-fist century. But it is witty, and a telling condemnation of fundamentalism, because it is not plausible to think that God has changed his mind about the wickedness of certain practices (at least in the absence of an authoritative statement by the deity recording this change) or because if it was wrong then it must also be so now or vice versa.⁵ The position which is opposed to a universalist view of ethics, a view that treats moral judgments as making claims to universal validity and applicability, namely some form of relativism, has no merit whatever. One simple consideration shows the truth of this. Moral Relativism holds that moral values and principles are the products of society in a way that permits ³ I believe that their deep structure also reveals ethics to be essentially universal and objective in precisely the same way that science is. That, of course, rules out neither conflict nor rival explanations of ‘‘reality’’. ⁴ Available at . Accessed 16 January 2006. ⁵ See also Ronald Dworkin, ‘‘Objectivity and Truth: You’d Better Believe It’’, Philosophy & Public Affairs, 25/2 (spring 1996).

300 / Harris different values to be valid for different societies or for the same people or nation or society at different times. As we shall see below, this can be true of different normative systems, the rules of a club or the precepts of a religion, but not of morality. This is because all moralities can and do develop and change. Moral advance (or decline) or the possibility of moral change or hopefully of moral progress is a feature of all moralities. Because I am an optimist I will talk only of moral progress, and moral progress depends upon (is a product of) the valid criticism of morality. A good reason for changing moral values is as good (must be as good) when expressed from within a society or moral system as when voiced from without. Of course it may be more acceptable, in the sense that people are more ready to consider and accept it, when expressed from within, but this is a psychological not a moral or logical consideration. Valid criticism, logic, is relative to neither time nor place; good arguments can travel to us across time and space, they can come from within or without a society or moral community and in principle can come from any temporal direction, the past or the future. In short, valid or even persuasive arguments are neither necessarily relative to time nor place: neither geography nor chronology affects validity, it follows that morals are not essentially relative.⁶ Equally, valid criticism is not the prerogative nor the unique capacity of a particular social nor economic nor religious group, nor nation, nor state, nor ethnic group, nor species. A relativist might respond that criticism from outside would only be acceptable if it appealed to values that were already an acceptable part of the moral system in question. This is either an empirical claim which it is impossible to finally establish or it is offered as a sort of necessary truth. In either case the claims are as almost certainly false as ‘‘almost certainty’’ permits, it being impossible to know in advance what insights, perspectives, or arguments will strike us or indeed anyone as compelling or even worth investigating. It is improbable that we could know for all time that nothing from outside our moral system would ever strike us as compelling or important or that no one within our moral system would ever have a transforming insight or an argument or set of analogies that were sufficiently unprecedented to confound the sceptic. ⁶ I realize of course that these points are suggestive rather than conclusive, but they are effective against relativism in that they throw down a brief but effective challenge that must be met (and as far as I know has never effectively been met) before relativism can gain a foothold on our attention.

Norms, Consensus, Hypocrisy in Bioethics / 301 These features of what we can call ‘‘common sense morality’’ and of the logic of argument lead naturally, but highly problematically, to pressure for global norms in ethics and hence also in bioethics. But, as we shall see, while ethics is global in the sense that its principles and precepts are necessarily universal and objective, the establishment or the attempts to establish global norms in bioethics is inimical to the nature of ethics and to the ways in which universal values are established and maintained.

Consultation The most prominent and perhaps the most important recent attempt to establish global or universal ethical and regulatory norms in the field of bioethics is the recent UNESCO initiative to establish ‘‘global norms on bioethics’’. This process was finally completed in October 2005 with the adoption and publication of the Universal Declaration on Bioethics and Human Rights.⁷ This document, and the story of its evolution, teaches us a number of important lessons about both the wisdom and utility of so-called global norms. UNESCO makes a strong point about the role which consultation played in this process and the role of consultation in arriving at ethical principles is instructive. As UNESCO themselves said of the draft dated February 2005: This Preliminary Draft Declaration on Universal Norms on Bioethics was finalized by the International Bioethics Committee (IBC) at its Extraordinary Session on 28 January 2005 after six meetings of its Drafting Group held between April and December 2004, three sessions of IBC (April 2004, August 2004, January 2005), two written consultations ( January–March 2004 and October–December 2004), numerous consultations at international, regional and national levels (including within the framework of the UN Interagency Committee on Bioethics), a session of the Intergovernmental Bioethics Committee (IGBC) and a joint session of IBC and IGBC ( January 2005).⁸ ⁷ Universal Declaration on Bioethics and Human Rights. Adopted by acclamation 19 October 2005, 23rd Session of the General Conference of UNESCO, available at . Accessed 7 January 2005. ⁸ SHS/EST/CIB-EXTR/05/CONF.202/2 Paris, 9 February 2005. There is a more recent draft: SHS/EST/05/CONF.204/3 REV Paris, 24 June 2005 and now a final text, but since I am here interested in the evolution of the norms I quote from the February draft.

302 / Harris This preamble to the February 2005 draft of the UNESCO document shows UNESCO believes strongly that the consultation process strengthens and to some extent legitimates their enterprise. To see the extent to which this may be true we need to reflect on the nature of initiatives such as that of UNESCO. What is the role and purpose of consultations such as those that UNESCO has taken such pride in undertaking? The main purpose is of course to find out what others think of the norms contained in the UNESCO document.⁹ That is to say, to find out whether the norms of those consulted reflect or are congruent with those arrived at by UNESCO’s ethics committee.

Judgments about Ethics and Ethical Judgments Discovering what people think about issues of ethical significance is not the same as discovering their ethical values. And finding out what they think it acceptable to do about issues of ethical importance is not the same as finding out what they find ethically acceptable. This is because judgments about matters of ethical significance are not necessarily ethical judgments. ‘‘Morality’’ is just one of the normative systems which operate within any society, although it is arguably the one to which all others are answerable. Other normative systems include the rules governing religious observance, rules of good manners or etiquette, and, of course, the legal system. Then there are the rules of particular professions, occupations, corporations, or clubs that are often rather misleadingly referred to as codes of professional ethics or corporate ethics. The terms ‘‘right’’ and ‘‘wrong’’ are characteristically used to enforce the rules of all normative systems, so that it is always ‘‘wrong’’ in some sense to defy the rules of a normative system. For these reasons many people use a term like ‘‘wrong’’ to describe actions or practices forbidden by a normative system that they happen to accept, and this often leads to the false conclusion that morality is relative to a particular normative system from which moral precepts are derived.¹¹ ⁹ Although of course there are many possible reasons. ¹⁰ Here the argument draws on a more extensive study of these issues in Harris ‘‘The

Scope and Importance of Bioethics’’, 1–22. ¹¹ So that when opinion samplers ask whether people believe something is right or wrong they may be receiving information about what a particular normative system enjoins or forbids and not information about the moral beliefs of those who accept this system.

Norms, Consensus, Hypocrisy in Bioethics / 303 But saying that something is morally wrong implies more than the fact that it is forbidden by a normative system that the agent accepts. It implies that it is forbidden by that system because it is morally wrong or that in addition to it being forbidden by that system it is also morally wrong. Similarly with personal judgments that are not made simply in accordance with the rules of a normative system. When we ask someone whether they think this or that to be ‘‘right’’ or ‘‘wrong’’, ‘‘good’’ or ‘‘bad’’, ‘‘acceptable or unacceptable’’, the answer may reveal their prejudices or personal aversions or likes rather than information about their morality or their moral views or judgments, properly so called. When we hear that a consultation process has taken place, we are entitled to ask why the opinions of those consulted matter, why we should take any notice of them. They may be experts of various sorts or simply members of the public, citizens; but whoever they are, if they are reporting their moral opinions or views, then they are entitled to our attention and our respect in a way that would certainly not be the case if what we were receiving were simply their prejudices, personal preferences and aversions, or expressions of distaste or disgust. It is therefore crucial that we have a way of telling which is which when we are offered the results of public consultation. And of course more, we need to have set up that consultation in a way that enables these distinctions to emerge. I invite readers to reflect as to whether any public consultation exercises of which they are aware are either designed to capture this distinction or permit the distinction to become visible from the reported data. Moral judgments and opinions, expressions of moral principle and moral outlook, command respect because they are expressions of the individuals’ values and of their considered positions. Moreover a moral judgment has to meet certain minimum standards of evidence and argument. And when it meets these standards it not only commands a respect not due to prejudices or personal preferences and aversions but it engages with a process that enables general conclusions to be drawn, conclusions which are relevant and can be valid beyond the confines of a particular society or normative system.¹² ¹² Ronald Dworkin has discussed some of the factors that make judgments moral judgments and which can defeat an individual’s claim to be acting from moral conviction. See Ronald Dworkin, Taking Rights Seriously (London: Duckworth, 1977), 252–3.

304 / Harris

II. Informed Consensus and Global Norms Where philosophical analysis and argument are deployed to establish, support, and justify ethical conclusions, these conclusions not only demonstrate how far they are from prejudices and gut reactions but are part of a process of reasoning and argument that can lead, through informed consensus, to the expressions of value which have some chance of standing the tests of argument and of time and achieving, or at least approaching, the universality required for Global Norms. An essential part of the informed consensus required for this to happen is the appreciation and acceptance of arguments which have been tested in as many ways as possible. For example, their consistency with other values and beliefs should have been explored, they must have been exposed to criticism, to counterargument, to the attempt to find counter-examples where appropriate, they will have resisted attempts at reductio ad absurdum, and survived the other ways in which argument is tested and philosophical conclusions are established.¹³ On an alliterative connection with ‘‘informed consent’’ which relies on what might be called ‘‘epigrammatic validity’’, we can call this process ‘‘informed consensus’’.¹⁴ Essential to this process is the ‘‘information’’ which must include appropriate evidence and argument and, very much as in the informed consent process, must be ‘‘on the record’’, visible for all to see and subject to rigorous examination. Where, and to the extent that, informed consensus can be reached, ethical judgment can not only claim universal status, but actually achieve it. In sum, all ethical judgments necessarily claim universal status and validity but these claims are very often contested. That is characteristic of all the controversial areas of morality. Only to ¹³ In so far as philosophical conclusions are ever ‘‘established’’. ¹⁴ The process I describe as one characterized by ‘‘informed consensus’’ is not of course

new or original. I simply give my preferred name to a process of reasoning and persuasion and dialectic long familiar in philosophy. Most recently the practice of naming this process has been revived by John Rawls and Norman Daniels, both of whom termed processes very like this processes of achieving ‘‘reflective equilibrium’’. I prefer ‘‘informed consensus’’ because it appeals to concepts more generally familiar in bioethics, in policy making and in normal educated conversation. See John Rawls, A Theory of Justice (Cambridge, MA: Harvard University Press, 1971), 48–51 and 120, and Norman Daniels Justice and Justification (Cambridge: Cambridge University Press, 1996), esp. 1–10, 21–6, 48–50.

Norms, Consensus, Hypocrisy in Bioethics / 305 the extent that informed consensus is achieved and contention resolved do the judgments move from hypothesis to fact. In this sense the process of establishing moral judgments is very like that of establishing scientific hypotheses. And this brings us back to a discussion of the sort of bioethics exemplified by the various UNESCO documents we have been considering, but found in far too many declarations, reports, and ethical framework documents of statements of ethical principles or guidelines. Very often there is only the briefest of supporting arguments or explanation of the norms expressed in such documents. Argument is indeed often altogether excluded from the reports, perhaps because it seems insufficient to support the resonant conclusions and portentous pronouncements they so often contain. This is the case with the evolutions of the UNESCO Universal Declaration on Bioethics and Human Rights. To take another example first, unfortunately also from UNESCO, the Universal Declaration on the Human Genome and Human Rights:¹⁵ ‘‘[p]ractices which are contrary to human dignity, such as reproductive cloning of human beings shall not be permitted’’.¹⁶ The document contains not a single argument in support of this claim, nor any indication as to just what is meant by ‘‘human dignity’’.¹⁷ The Council of Europe is another offender. Its Convention on Human Rights and Biomedicine states that ‘‘The human body and its parts shall not, as such, give rise to financial gain.’’¹⁸ Not a breath of argument supports this fiat and while many see it as an attempt to minimize the unjust exploitation of vulnerable human beings, one might have expected some empirical ¹⁵ United Nations Educational, Scientific and Cultural Organization, Universal Declaration on the Human Genome and Human Rights, published (as a pamphlet) 3 December 1997. ¹⁶ Ibid., Article 11. I have discussed the ethics of payment for human tissue and organs and bodily services inter alia in ‘‘Scientific Research is a Moral Duty’’, in John Harris, Wonderwoman & Superman: Ethics & Human Biotechnology (Oxford: Oxford University Press, 1992; paperback 1993), 271; Journal of Medical Ethics, 31/4 (April 2005), 242–8. ¹⁷ For chapter and verse see my ‘‘Genes, Clones and Human Rights’’, in Justine C. Burley, ed., The Genetic Revolution and Human Rights: The Amnesty Lectures 1998 (Oxford: Oxford University Press, 1999), 61–95. ¹⁸ Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo 04.4.1997, available at , Article 21.

306 / Harris evidence as to the dangers of exploitation, some analysis of the concept of ‘‘exploitation’’ and some guidance on how to distinguish payments for goods and services which are exploitative from those which are not. Finally, some detailed argument to support a conclusion with very far reaching effects would seem to me to be a minimum requirement. Without these we have no reason to think such a judgment any better than an expression of bare prejudice.¹⁹

The New United Nations Declaration on Human Cloning On 8 March 2005 the United Nations issued a press release noting that ‘‘The General Assembly this morning adopted the United Nations Declaration on Human Cloning, by which Member States were called on to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.’’²⁰ This simply repeats the rejections of cloning noted above, but at least in the case of the UN some member states offered reasons both for and against the resolution in their statements to the General Assembly. The full Declaration on Human Cloning has six main elements;²¹ members states are called upon to adopt the following measures to: (a) protect adequately human life in the application of life sciences; (b) prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life; (c) prohibit the application of genetic engineering techniques that may be contrary to human dignity; (d) prevent the exploitation of women in the application of life sciences; (e) adopt and implement national legislation to bring into effect paragraphs (a) to (d); ¹⁹ The insertion of the phrase ‘‘as such’’ may weaken the force of this fiat but again some account of just how this apparent qualification is to be interpreted and why it has been inserted would be helpful. ²⁰ Press Release GA/1033 8/3/2005, Fifty-Ninth General Assembly Plenary 82nd Meeting (AM). ²¹ United Nations General Assembly, Resolution Adopted by the General Assembly: United Nations Declaration on Human Cloning. Fifty-ninth session, Distr.: General 23 March 2005.

Norms, Consensus, Hypocrisy in Bioethics / 307 (f ) take into account the pressing global issues such as HIV/AIDS, tuberculosis, and malaria, which affect in particular the developing countries. The implication of the United Nations Declaration on Human Cloning is that, for example, the ban on human reproductive cloning is required to prevent the exploitation of women, adequately to protect human life in the application of life sciences, to prohibit the application of genetic engineering techniques that may be contrary to human dignity, and so on. What is lacking is any evidence or arguments that would explain just how and why either therapeutic or reproductive cloning might or could in fact have any of these effects and what would constitute evidence to support such claims. One possible line of thought which might explain what is behind the UN Declaration is to be found in the so called ‘‘Explanatory Memorandum’’ of the UNESCO Draft Declaration.²² While it gives no arguments or ethical analysis which indicate the basis on which it arrived at its various conclusions, the Memorandum however insists is ‘‘not an authoritative interpretation’’. Here UNESCO does offer one gloss on the idea of human dignity invoked, as we have seen, against cloning in the Universal Declaration on the Human Genome and Human Rights. In the Explanatory Memorandum (Article 4—para. 40) it states: ‘‘Respect for human dignity flows from the recognition that all persons have unconditional worth, each having the capacity to determine his or her own moral destiny.’’ It is interesting to note that we know that reproductive cloning does not affect this capacity, since no one has ever claimed that monozygotic twins are incapable of developing such capacities and indeed all the empirical evidence shows that they are. Although the Universal Declaration refers only to therapeutic cloning, it is worth noting that the explanatory gloss could not apply either to therapeutic cloning where the cloned embryos (currently nowhere grown beyond fourteen days’ development) are not going to develop into fetuses, let alone persons; it is clear that no such capacities are possessed by creatures without even the first signs of a central nervous system that could develop ²² Explanatory Memorandum on the elaboration of the Preliminary Draft Declaration on Universal Norms on Bioethics, UNESCO SHS/EST/CIB-CIGB/05/CONF.202/4 Paris, 21 February 2005.

308 / Harris into a brain or any conscious capacities. Thus none of the cloned embryos created as part of a so-called ‘‘therapeutic cloning’’ stage in the search for human stem cells made compatible with potential recipients, has ‘‘the capacity to determine his or her own moral destiny’’. It follows that none of these embryos can be protected by requirements to protect human dignity understood as UNESCO understands the term. If this is right, it would apply also to the United Nations Declaration on Human Cloning since, in so far as there exists an explanation as to how human dignity might be engaged by the practice of cloning in any of its forms, it is obvious that no form of cloning violates human dignity understood in the UNESCO way. We then must ask in what other actual or conceivable ways any form of cloning or genetic engineering techniques might be contrary to human dignity. The use of the term ‘‘inasmuch’’ is telling. Clause (c) calls on nations to ‘‘prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life’’. This leaves open the possibility that the degree to which cloning is incompatible with human dignity is zero! If, for example, the UN had called upon nations to prohibit all forms of human cloning ‘‘inasmuch as they expose humanity to the risk of a new and lethal infectious disease’’, then we would all say ‘‘yes, but what is the evidence that cloning involves any such risk?’’ And we would probably conclude that ‘‘inasmuch as there is no evidence of any such thing no action is required’’. In the case of the UN Declaration therefore we should say ‘‘yes, inasmuch as they are incompatible with human dignity they should be banned; but inasmuch as there is no evidence of any such thing and no coherent account of human dignity which even indicates the barest possibility of any such thing, the Declaration is of no effect or use.’’ Returning to the most recent UNESCO Universal Declaration on Bioethics and Human Rights,²³ in the section entitled ‘‘Application of the Principles’’ we find Article 18 which states: (a) Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Every endeavour should be made to use the best available scientific knowledge and methodology in addressing and periodically reviewing bioethical issues. ²³ Universal Declaration on Bioethics and Human Rights.

Norms, Consensus, Hypocrisy in Bioethics / 309 (b) Persons and professionals concerned and society as a whole should be engaged in dialogue on a regular basis. (c) Opportunities for informed pluralistic public debate, seeking the expression of all relevant opinions, should be promoted.

And Article 20 states: ‘‘Appropriate assessment and adequate management of risk related to medicine, life sciences and associated technologies should be promoted.’’ As far as I am aware, the only practice that UNESCO has thus far identified as unambiguously contrary to human dignity is, as noted above, human reproductive cloning. Since UNESCO have never offered any arguments as to why or how reproductive cloning is (or could be) contrary to human dignity, it is difficult to know whether or not they complied with 18 (a) above. But since this conclusion about cloning was a last-minute addition to the Universal Declaration on the Human Genome and Human Rights shortly after the birth of Dolly was announced, there is reason to be sceptical about the quality of any evidence or argument considered.

Bioethics, Global Norms, and Informed Consensus The problem with UNESCO’s efforts at articulating global norms is that they have deliberately excluded all evidence and argument from the various documents setting forth their normative conclusions, so that we have no basis on which to distinguish these purported norms from prejudices, simple preferences, or aversions. The grounds on which respect for the norms might be built are entirely absent. This, it seems to me, sends out the worst possible message about bioethics, the way it works, its value, and claim to our attention. It also offers the worst possible lesson about science or about democratic values. We should never accept ethical conclusions on the authority of others. If all you need are conclusions, the answers to ethical problems, without any of the evidence or argument that might explain and justify those answers, then you might as well sit at the feet of a shaman or a guru or receive the answers to ultimate questions from a computer. In a justly celebrated work on this subject the English philosopher Douglas Adams produced a famous ‘‘thought experiment’’. In this thought experiment, a classic device of contemporary philosophy, Adams imagines that hyper-intelligent pan-dimensional beings built a computer to answer

310 / Harris the ultimate question—the meaning of Life, the Universe and Everything.²⁴ Before the computer could deliver its answer philosophers representing ‘‘the Amalgamated Union of Philosophers, Sages, Luminaries and Other Thinking Persons’’ bursts in with objections to the whole enterprise. Their objections were not a little self-interested: ‘‘Truth is quite clearly the inalienable prerogative of your working thinkers. Any bloody machine goes and actually finds it and we’re straight out of a job aren’t we? I mean what’s the use of our sitting up half the night arguing that there may or may not be a God if this machine only goes and gives you his bleeding phone number the next morning?’’ The computer, ‘‘Deep Thought’’ by name, to which the sages and luminaries objected did eventually produce its answer to the ultimate question of ‘‘Life, the Universe and Everything’’. As is now well known the answer was ‘‘42’’! The problems with this answer are now common knowledge throughout the known universe. However, this common knowledge does not seem to have percolated down to UNESCO, the United Nations, and the Council of Europe. One of the many problems with Deep Thought’s answer is that without the evidence and argument that might support and indeed explain the answer, it is not only useless but discreditable. No one should accept answers to crucial questions on the authority of any body or person, legal, real, or fictional, charged with finding the answer, whether they are Deep Thought or UNESCO (its terrestrial equivalent). To this extent the Amalgamated Union of Philosophers, Sages, Luminaries and Other Thinking Persons were right. Not of course right to claim a monopoly on attempts to grapple with the ultimate question or indeed any question; but rather right in that any answer should never be taken on trust but accepted (if at all) because the arguments and evidence that justify, explain, and sustain it are available to public scrutiny and have been exhaustively examined and tested and have not been refuted. Because of attempts to promulgate global norms effectively ‘‘out of thin air’’ and in the absence of the essential supporting evidence and argument and the continuing process of evaluation required to establish the informed consensus on which objectivity and hence the acceptability of these norms ²⁴ Douglas Adams, The Hitch-Hikers Guide to the Galaxy (London: Pan Books, 1979), ch. 25, 125 ff. Those only familiar with this famous work of philosophy via the film of the same name will not be familiar with some of the above events or quotations.

Norms, Consensus, Hypocrisy in Bioethics / 311 can be built, ethics is marginalized and we (the public, the citizens, the people) are encouraged to accept moral precepts on authority rather than on their merits. This is not only inimical to ethics properly understood, but is the product of a totalitarian mentality which promotes blind acceptance and discourages the debate, argument, and reflection which are essential not only to the practice of ethics but also to the democratic process. The UNESCO documents are the clearest demand that we take our values on trust from an unelected group of luminaries who effectively hold themselves out as above and beyond reason and argument. As with science, any objectivity that ethics can command flows from the quality of the evidence and argument which supports it. Objective positions in science and in ethics are those supported by the best combination of evidence and argument around which consensus is built by a process of testing and confirmation. Only in the Bible, or in similar documents,²⁵ are norms established by fiat. In science, in philosophy as well as in a democratic process they are, or should be established if at all by informed consensus.

III. Some Practical Proposals at the Beginnings of Informed Consensus I now make some proposals and some necessarily brief arguments which are directed at the early stages of the process of informed consensus just discussed and in discussing the issue of scope in the context of an attempt to produce ethical guidelines, I try to say something about the limits of informed consensus. In doing so, I should here declare both an interest ²⁵ Laws, statutes, and other legal instruments are of course other examples. ²⁶ This section draws heavily on a paper by John Harris, Louise Irving, and Lisa Bortolotti,

‘‘An Ethical Framework for Stem Cell Research in the European Union’’, Health Care Analysis, 13/3 (2005), 157–62. I am indebted to my colleagues Louise Irving and Lisa Bortolotti for much of this section. Work on the EUROSTEM Ethical Framework was funded by a project grant from the EC—DG research ‘‘Quality of Life and Management of Living Resources Programme’’. The full draft text of the EUROSTEM ethical framework and a full list of the EUROSTEM partnership can be found at . The EUROSTEM Ethical Framework Document also draws on some arguments, particularly those concerning the role of ‘‘scope’’ that I developed with John Sulston. See John Harris and John Sulston ‘‘Genetic Equity’’, Nature Reviews Genetics, 5 (October 2004), 796–800.

312 / Harris and a conflict of interests. The interest is that, despite the criticisms above, I have potentially culpable involvement in documents introducing ethical principles. For three years from 2002 to 2005 I directed a project for the European Commission called ‘‘EUROSTEM’’. Here I describe some of our conclusions. I would like to make it clear that both the EUROSTEM Ethical Framework Document and the Final Report of the project of which it forms part contain detailed arguments in support of the conclusions to which they come and these conclusions are those of the EUROSTEM partnership as a whole and not simply of myself. These arguments and the conclusions are offered for debate and consideration. The potential conflict of interest is that in presenting some of the conclusions and processes of EUROSTEM I am speaking here unequivocally in my own voice and providing both my personal commentary on the Draft Ethical Framework developed by EUROSTEM and relating it to attempts to provide Global Norms in Bioethics, something we in EUROSTEM were definitely not attempting. What follows is my personal take on the EUROSTEM process but I freely draw on the work of my colleagues in EUROSTEM to develop the ideas.²⁷ The European Union is an interesting and perhaps surprisingly diverse context in which to discuss the ethics and regulation of science. A hitherto insoluble problem has been the task of developing ethical principles which do not founder on the radically different attitudes taken to the question of the moral status of the human embryo. In EUROSTEM, we suggest that this problem can be solved by concentration on the scope of principles. We also emphasize that European research should be funded in a way that does not discriminate between individual states and researchers in the EU and, finally, we note that the availability of any eventual embryonic stem cell therapies will pose a dilemma for those countries and those people that have declared stem cell research to be unacceptable. All of these elements say something important about the extent and limits of Global Norms. There are substantial differences in legislation across the member states of the EU. The UK and Belgium have legally permitted the creation of human embryos for research purposes, while states such as France and Denmark allow stem cell research on supernumerary embryos (under certain conditions). At the other end of the spectrum, countries such as ²⁷ I hope it is clear that my debt to all those who participated in EUROSTEM is immense.

Norms, Consensus, Hypocrisy in Bioethics / 313 Germany, Austria, and Ireland explicitly prohibit stem cell research on so called ‘‘spare embryos’’ and the creation of human embryos for research.²⁸ These differences appear to reflect radically different moralities and moral perspectives but in fact the differences, though radical and intractable, are part of remarkably similar moral perspectives and are consistent with a remarkably homogeneous moral community within Europe. The ethical framework of EUROSTEM takes as a point of departure the powerful obligation we have to pursue, support, and participate in scientific research. Such an obligation stems from a number of independent considerations. First, medical research is a necessary component of the rule of rescue—our duty to help those in need. Moreover, according to the ‘‘Do-No-Harm’’ and ‘‘Beneficence’’ principles we have a moral obligation to further medical research for its potential benefits to those affected by diseases and those who care for them. We accept in our lives the benefits derived from past medical research, and basic fairness suggests that we should, for our part, continue to contribute to that social practice (in this case, medical research), which is likely to produce similar benefits in the future. Finally, we derive a more general benefit from living in a society that pursues and actively accepts the benefits of research and where research and its fruits are given a high priority. The knowledge that research is ongoing into diseases or conditions from which we do not currently suffer but to which we may succumb makes us feel more secure and gives us hope for the future, for ourselves and our descendants, and others for whom we care. However, freedom of research is not unlimited and it should be undertaken responsibly in accordance with accepted moral principles. In the context of stem cell research a major, and hitherto insoluble, problem has been the task of drafting ethical principles which do not founder on the radically different attitudes taken to the question of the moral status of the human embryo. Positions diverge dramatically on this issue, as some regard the early embryo as simply a cluster of cells whereas others conceive it as a human being worthy of the dignity and status granted to other human beings. No ethical framework could hope to resolve these ²⁸ For a full account see ‘‘Survey on Opinions from National Ethics Committees or Similar Bodies, Public Debate and National Legislation in Relation to Human Embryonic Stem Cell Research and Use (2004)’’, vol. i, ed. Line Matthiessen-Guyader, Directorate E, Biotechnology, Agriculture and Food.

314 / Harris differences, and they present a major challenge to anyone proposing Global Norms in Bioethics. But in identifying basic principles on which we can agree despite disagreeing on the status of the embryo, we can achieve a workable and tolerant research environment. To do this we need to think carefully about scope and be very explicit as to the role that it plays in the understanding and interpretation of principles. Disagreements over the moral status of the human embryo are often framed in terms of human rights and human dignity; such ideas in one form or another command almost universal respect. It would be surprising if they did not since they are the philosophical equivalents of ‘‘motherhood and apple pie’’. While human rights and human dignity find few detractors there are always disagreements about the scope of such principles. In this context scope concerns the class of individuals protected by the principles and the precise nature of the protections the principles afford. Differences over whether or not embryos and fetuses are included within the scope of ‘‘human persons’’ and over whether a right to life or the obligation to respect the sanctity of life permits war or capital punishment have always existed alongside almost universal respect for ‘‘the sanctity of life’’. Acceptance of basic principles and agreement about the scope of the principles are always distinct issues. Those disagreeing about the moral status of the embryo do not usually disagree about the ethics of murder. They differ, rather as to whether or not a particular case is in fact a case of murder, or whether the individual killed was a person in the relevant sense.²⁹ Thus we can see that there is a remarkable consensus at the level of fundamental moral principles which can be maintained if we remember that the differences are differences not about fundamentals, not differences about the fundamental value of human life, rather they are differences about what is to count as protected human life for the purposes of applying agreed principles. EUROSTEM proposed a principle of respect for persons, which can be understood in terms of respect for the autonomy of the individual and concern for the welfare of persons. How this principle is to be applied will depend on the scope of the term ‘‘person’’. The notion of scope can thus ²⁹ A recent case turning on the status of the human embryo in the European Court of Human Rights concerned just this question of scope. See The European Court of Human Rights [CASE OF Vo v. FRANCE (Application no. 53924/00) Strasbourg 8th July 2004]. See Harris and Sulston, ‘‘Genetic Equity’’.

Norms, Consensus, Hypocrisy in Bioethics / 315 be used as a mechanism to allow a number of basic principles to be widely accepted by individuals who have radically different views on the status of the early embryo. Those who believe that the early embryo is a person will likely permit research only on adult stem cells or cord blood-derived stem cells,³⁰ or only when research can be achieved while preserving the embryo. Those who believe that the early embryo is not a person are likely to accept research on early human embryos and will have different interpretations of the scope of principles such as ‘‘Do-No-Harm’’ and ‘‘Respect for Persons’’. It is important to allow for such differences, not only in the EU but throughout the world, and that is why the notion of scope is valuable in creating some basis for agreement on the basics while respecting the autonomy of the individual states or indeed individual moral agents, to reflect what is, in the scale of things, a relatively minor, though still important difference about the scope of the principles.

Research, Therapeutic Tourism, and Protection of Researchers The significant differences in legislation across the EU inevitably creates dangers for the individual researchers that engage in collaborative work. It would be consistent with the Treaty of Rome,³¹ which promotes freedom and safe conditions for workers, if researchers in one member state are rendered liable to criminal charges or discrimination if they cooperate with researchers in another member state where one state forbids and the other permits the research they are doing. The ethical framework includes radical recommendations in relation to the protection of individual researchers. To the extent that national laws prevent cooperation and collaboration between researchers, nation states and the European Commission are called upon to work actively to find solutions for this problem, as the solutions cannot be the responsibility of individual researchers. We conclude that no one working in the EU should be punished or rendered liable to prosecution, restriction or discrimination for ³⁰ G. Kogler et al., ‘‘A New Human Somatic Stem Cell from Placental Cord Blood with Intrinsic Pluripotent Differentiation Potential’’, J. Exp. Med. 200/2 (2004), 123–35. ³¹ Treaty of Rome (1957), available at .

316 / Harris undertaking research that is permitted in that country. Moreover, European research should be funded in a way that does not discriminate between individual states and researchers in the EU. There are parallels here for attempts to develop Global Norms.

Profiting from Evil? A crucial issue, not only for Europe but for any attempts at universal standards, concerns the availability of any eventual stem cell therapies. We noted at the start the duty of governments to serve and protect the health needs of their citizens. The European ideal, no less than basic decency, requires that any therapies developed from stem cell research be made generally available in the EU and indeed throughout the world. This is of course ‘‘benefit sharing’’ and it is widely acknowledged now as a fundamental moral duty. It is this requirement and indeed the inevitability of this process that will eventually lead to a real consensus on stem cell research. For if, as most stem cell researchers expect, there will indeed prove to be important stem cell-derived therapies and if these in part flow from research or cell lines that are embryo-derived, then not only will the pressure to make these therapies generally available be morally overwhelming, it will also be politically decisive. Those countries and those people that have declared embryonic stem cell research to be unacceptable seem not to have taken on board the dilemma that will arise if such therapies are proved. They will either have to share the benefit and share the guilt or deny the benefit and accept the guilt for that. In short, does the unacceptability of the research entail the unacceptability of the therapies? If it is true that those who will the end will the means also, then we can look forward to a harmonious research environment in Europe. If not, then the free movement guaranteed by the Treaty of Rome will take on new importance and ‘‘therapeutic tourism’’ will become a permanent feature of the European scene. We will return to the issue of profiting from evil when we formulate conclusions below. One lesson I believe that a project like EUROSTEM can present for others interested in developing ethical principles for application across wide and diverse populations is an emphasis on tolerance and solidarity which were always at the heart of EUROSTEM, a commitment to mutual respect and

Norms, Consensus, Hypocrisy in Bioethics / 317 to acceptance of the idea that even radical differences on something as important as the status of the human embryo can be part of an atmosphere of mutual respect and tolerance and recognition that differences about the scope of principles do not necessarily reflect radically opposed or incompatible values or moralities. This is why it is important to highlight the very wide consensus that exists about principles such as the value of life, and recognize that differences about the scope of such principles, while crucial, are not presumptive evidence of moral turpitude in those who differ from ourselves about the scope of the principles we share. This is also why the development of Global Norms should only be attempted where informed consensus has been achieved, and in the context of the detailed explanation and justification of any principles offered as part of an attempt to create informed consensus.

IV. Conclusions While ethical judgments and principles are all objective in form, that is, they make a universal appeal and claim universal application, their claim, not to universality but to truth is often contested. In so far as consensus can be reached just so far are claims to objectivity or ‘‘truth’’ in ethics supported. As with science this ‘‘truth’’ or objectivity may only be provisional—always susceptible to revision or modification in the light of new evidence or more convincing arguments. My defence of Informed Consensus is not therefore a programme for action but a reminder of the minimum conditions which any claim to have achieved informed consensus and therefore to have found a basis for Global Norms must meet. A brief discussion of the crucial issue of the interpretation of principles and the attention which must be paid to the issue of the scope of agreed principles will help to focus the meaning of informed consensus. This will help to reveal both the extent and the limits of informed consensus and hence of Global Norms in Bioethics. Part of the process of creating informed consensus will be practical rather than theoretical. The idea of ‘‘scope’’ is helpful in that it reminds us that all principles require interpretation and that agreement on very basic values such as the value of life are the basis of more detailed or fine-tuned agreement. However, arguments for establishing the scope of principles, like

318 / Harris the principles themselves, have to meet the usual tests for the adequacy and validity of arguments. They cannot simply be stipulated to include or exclude the embryo, for example. One of the most important of such tests and one which also tests moral sincerity is consistency in the application of our beliefs. That is why it matters that countries such as Germany, for example, which has an ‘‘Embryo Protection Act’’ and are theoretically committed to the moral importance of the embryo and the protection of its life or dignity, nonetheless permit abortion and the use of the combined oral contraceptive pill. It is well known but not often emphasized that the so-called combined oral contraceptive—‘‘the pill’’ which is the standard oral contraceptive has multiple modes of operation, one of which is to prevent implantation of the fertilized embryo between five and eight days after conception. Ironically the operation of the pill involves the death of embryos at precisely the stage of development at which stem cells are usually harvested for human Embryonic Stem Cell (hESC) research. At five to eight days the cells have not begun to specialize (which takes place at implantation in vivo) and so are still almost certainly totipotent and therefore can, in theory, be made to specialize into required cell types. It is thus inconsistent to permit use of the multiple oral contraceptive, ‘‘the pill’’, while objecting to therapeutic cloning on any grounds which appeal to the protection of the embryo or protection of its moral status of dignity. Those who believe ‘‘the embryo is one of us’’,³² and object to Assisted Reproduction, in part because of its high wastage rate for embryos, but ³² Maurizio Mori gives the following account of the origin of the expression ‘‘the embryo, one of us’’: ‘‘The story is the following: It was used by Prof. Francesco D’Agostino, Chair of the Italian National Ethics Committee, when he presented the result of the Report of the Italian National Committee for Bioethics to the media in 1996. He said more precisely that the Committee had stated the human embryo is to be treated as one of us. Of course it was immediately shortened to the more famous form. There is, however, at least one book with such a title: Gino Concetti, L’embrione Uno di Noi (Roma: Vivere, 1997). The phrase ‘the embryo is one of us’ is now also associated with Pope John Paul II, and is widely used in pro-life discourse; see Congregation for the Doctrine of the Faith, ‘Instruction on Respect for Human Life in its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day,’ available at http://www.vatican.va/roman curia/congregations/cfaith/documents/rc con cfaith doc 19870222 respect-for-human-life en.html and also the Statement by the Canadian Conference of Catholic Bishops on Bill 13, ‘An Act Respecting Assisted Human Reproduction,’ available at http://www.cccb.ca/PublicStatements.htm.?CD=&ID+1258.’’

Norms, Consensus, Hypocrisy in Bioethics / 319 do not also object to normal sexual reproduction with a wastage rate of approximately 80 per cent are equally inconsistent.³³ Embryo loss in normal sexual reproduction including unprotected intercourse is certainly very high. There is the loss to be associated with every live birth as well as the loss that occurs routinely in unprotected intercourse where no birth eventuates. To this must be added embryo loss as a direct result of a number of widely used methods of ‘‘contraception’’. In connection with embryo loss associated with sexual reproduction, Robert Winston gave the figure of five embryos lost for every live birth.³⁴ Anecdotal evidence to me from a number of sources confirms this high figure but the literature is rather more conservative, making more probable a figure of three embryos lost for every live birth.³⁵ Ronald Green has suggested that between two-thirds and three-quarters of all embryos do not implant.³⁶ Additional embryo loss occurs, as already noted, as a result of the operation of the combined oral contraceptive pill. Equally the so-called ‘‘morning after’’ contraceptive pill also prevents implantation as does the Intra Uterine Device or coil. The combined effects of these various contraceptive methods increase the tally of embryo loss as a ‘‘side effect’’ of human sexuality, but it is impossible to arrive at reliable estimates as to the total numbers of embryos involved. Thus normal human sexuality is a fully voluntary activity which is a prolific killer of embryos. The fact that these deaths occur ‘‘in a good ³³ I have discussed these inconsistencies at length elsewhere. See John Harris ‘‘The Use of Human Embryonic Stem Cells in Research and Therapy’’, in Justine C. Burley and John Harris, eds., A Companion to Genethics: Philosophy and the Genetic Revolution (Oxford: Basil Blackwell, 2002), 158–75, and John Harris ‘‘Stem Cells, Sex and Procreation’’, Cambridge Quarterly of Healthcare Ethics, 12/4 (2003), 353–72. See also ‘‘The Great Debates: Julian Savulescu and John Harris’’, Cambridge Quarterly of Healthcare Ethics 13/1 (2004), 68–96; my contributions to this debate: ‘‘Sexual Reproduction is a Survival Lottery’’, 75–90, and Julian Savulescu and John Harris ‘‘The Creation Lottery: Final Lessons from Natural Reproduction: Why Those Who Accept Natural Reproduction Should Accept Cloning and Other Frankenstein Reproductive Technologies’’, Cambridge Quarterly of Healthcare Ethics, 13/1 (2004), 90–6. ³⁴ Robert Winston provided this figure some years ago in a personal communication. ³⁵ See Charles E. Boklage ‘‘Survival Probability of Human Conceptions from Fertilization to Term’’, International Journal of Fertility, 35/2 (1990), 75–94; also Henri Leridon, Human Fertility: The Basic Components (Chicago: University of Chicago Press, 1977). Again, in a recent personal communication, Henri Leridon confirmed that a figure of three lost embryos for every live birth is a reasonable conservative figure. ³⁶ See R. M. Green, The Human Embryo Research Debates (New York: Oxford University Press, 2001), n. 185.

320 / Harris cause’’ or as part of ‘‘normal life’’ does not seem an impressively powerful moral excuse for those who highly value embryo protection. Unprotected intercourse like many forms of protected intercourse is profligate of human embryos. Only barrier methods of contraception minimize embryo loss and only abstinence is completely effective from this perspective.

Does Benefiting from Evil Involve Inconsistency and Hypocrisy? It is perhaps not inappropriate to emphasize the bottom line, which is surely that if the use of human embryos for the creation of stem cells or for therapeutic cloning is unethical, as the French and the Germans, the Irish and the Maltese (through their laws and regulations) imply, then those nations will certainly not want to benefit from wrongdoing. One way of demonstrating this would of course be to agree in advance to forgo any benefits from such wrongful research and to deny their people the benefits of therapies that might be developed in this way. This is also the only consistent course for Americans who agree with George W. Bush. Moreover, if such research is really the equivalent of killing persons, then it would not be inconsistent to punish, for example, German or American citizens if they travel to benefit from evil as much as if they seek to do so at home. Katrien Devolder has developed an advance directive, a so called ‘‘living will’’, by which those who believe human ES cell research is wicked could commit themselves in advance to forgoing any benefit or receiving therapies derived in ‘‘immoral’’ ways.³⁷ Such a course would obviously be a minimally decent choice for those who regard human ES cell research as immoral. If, as is more likely, people facing terrible diseases will not want to turn their backs on effective treatments and governments will find it hard to deny their people such treatments, then hard choices will have to be made. The process of debating these choices will, I believe, reveal more about the basis of informed consensus concerning the embryo, and will pave the way for a truly informed consensus, not only about fundamental principles but also about the concept of scope than has hitherto been possible. ³⁷ Katrien Devolder, ‘‘Advance Directives to Protect Embryos?’’, Journal of Medical Ethics, 31/9 (September 2005), 497–8.

Norms, Consensus, Hypocrisy in Bioethics / 321

Is it Always Wrong to Permit Oneself to Benefit from Evil? The suggestion that we act inconsistently or hypocritically if we accept the benefits of processes we believe to be wrong or even evil seems harsh and even perhaps simply wrong. Consider a society which debates the proposal to build a dam to provide increased water resources and hydro-electric power.³⁸ Some people object to the project on ethical grounds, they oppose the compulsory relocation of some people whose houses will be submerged if the dam is built and they have objections based on the alleged adverse environmental impact of the project. Though their objections are certainly ethical, they lose the argument and the democratic process approves the building of the dam. Would they then be wrong, hypocritical or inconsistent to use the electricity and water provided by the dam? It seems not, but what’s the difference between this case and that of embryo destruction? There are many, but one set of differences seems telling. In the case of the dam, the evils are significant but they are the sorts of evils which, inter alia, the democratic process is there to balance against other comparable evils: shortage of water and electricity and the problems that such shortages may entail, for example. Having participated in the democratic process which is there to attempt to achieve a balance or reasonable trade-off between goods and evils of these and related sorts, we not only are not obliged to continue to oppose them, we are obliged to accept the results of the democratic process, not of course necessarily to drink the water and consume the electricity but certainly to accept the right of others so to do. Moreover few would criticize us if we also use these products of an act or process we believe to be morally wrong, perhaps not least because in complex modern societies we have few alternatives to centrally provided water and power. However, there are some evils that are so great that they cannot simply be resolved by subjecting the decision as to whether they should be done or not to the democratic process. Murder is surely one of these. That is why those who object to embryo research and instrumental use because they regard the embryo as one of us can and should neither accept the practices, nor the benefits of those practices, if they truly believe that killing an embryo is killing a person with the same moral and political status as you or me. If ³⁸ I owe this example to Guido Pennings.

322 / Harris they do accept the fruits of practices which are in their judgment the moral equivalent of murder, they are not only ‘‘scoundrels and substractors’’,³⁹ but also hypocrites and murderers. Thus while Global Norms can express broad principles about which informed consensus has been achieved and this could be a useful step towards enhancing the recognition and importance of moral considerations in public and private life, it is incumbent upon those who make distinctions about the scope of such principles to be consistent in the application of their arguments and to justify the refinements they propose. Countries which permit abortion, embryo experimentation and assisted reproduction, so called therapeutic cloning and hESC research, are consistent in their application of scope to the principle of the value of life.⁴⁰ Those who permit only some of these are not consistent in the application of their principles and those who permit none but permit normal sexual reproduction are also inconsistent in their application of principles concerning the moral status of the embryo. Those who develop Global Norms perhaps can and should leave the ironing out of issues of scope and consistency to individual nations and indeed individual citizens. However, it is of course incumbent upon nations and individuals to do just this. Resonant appeals to Global Norms concerning the status or dignity of the embryo to justify, for example, the banning of hESC research or therapeutic cloning from countries or individuals which permit the use of the combined oral contraceptive or allow abortion is just plain hypocrisy. ³⁹ Shakespeare, Twelfth Night, Act I, Scene iii. ⁴⁰ Though in so far as it is believed that reproductive cloning violated this principle this

consistency is compromised.

16 Global Norms in Bioethics: Problems and Prospects Fran¸coise Baylis∗

John Harris deplores the uncritical acceptance and validation of ethics data from public consultations and, in ‘‘Global Norms, Informed Consensus, and Hypocrisy in Bioethics,’’ he argues at length against the mistaken view that ethics opinions espoused by experts of various sorts or simply members of the public qualify as sound ethics judgments. Harris also bemoans the absence of philosophical analysis, evidence, and argument in international ethics policy documents,¹ and on these grounds argues against undue deference to the ethics conclusions of international organizations. In his opinion, only moral judgments that are supported by evidence and reasoned argument and are available for analysis and critique are deserving of our attention and respect. Nothing else should hold sway. Against this backdrop, Harris criticizes the views and arguments of those who rely on claims about moral status and human dignity to restrict or, worse, prohibit human embryonic stem cell (hESC) research and cloning for biomedical research. In particular, Harris is critical of ∗ Thanks to Tim Krahn and Lynette Reid for helpful comments on an earlier draft of this chapter. ¹ Harris in the preceding chapter refers to, ‘‘declarations, reports and ethical framework documents of statements of ethical principles or guidelines’’ (p. 305).

324 / Baylis individuals, organizations, and governments who support a ban on hESC and cloning research while simultaneously allowing the use of combined oral contraceptives and abortion, and tolerating the loss of embryonic life associated with normal sexual reproduction. With great rhetorical flourish, Harris dismisses such views on the moral unacceptability of hESC and cloning research as deeply hypocritical. For my own part, I have some sympathy with aspects of the overall project described above. However, I object to a number of Harris’s assumptions and claims and, moreover, I find that his conclusions are wanting in several important respects. I begin my analysis with a summary of the problems with global norms as recounted by Harris and, where I am in agreement with Harris on the nature of the problem, I attempt to further develop his claims. This is followed by a critique of some of the assumptions and claims made by Harris with which I disagree. I conclude with a plea that philosophical bioethics turn its attention from the traditional concerns of mainstream bioethics to consider more carefully our obligations to promote the common good and the public interest.

The Problems with Global Norms, according to Harris A problem for ethics, according to Harris, is that some people mistakenly believe that morals are essentially relative, when ethical relativism has no merit whatsoever. Harris insists that ‘‘ethics is essentially both universal and objective’’ (p. 299) and that morals develop and change in response to reasoned arguments. On his view, ‘‘valid or even persuasive arguments are neither necessarily relative to time nor place: neither geography nor chronology affects validity, it follows that morals are not essentially relative’’ (p. 300). While others might disagree with this analysis and insist that morals is not simply the science of logic, for Harris ‘‘moral progress depends upon (is a product of) the valid criticism of morality. A good reason for changing moral values is as good (must be as good) when expressed from within a society or moral system as when voiced from without’’ (p. 300). A problem with this understanding of ethics, however (as Harris readily admits), is that

Global Norms in Bioethics / 325 it leads ‘‘to pressure for global norms in ethics and hence also in bioethics’’ (p. 301). The problem with global norms in bioethics, as Harris sees it exemplified in international policy documents, including the UNESCO Universal Declaration on Bioethics and Human Rights,² is that although ‘‘ethics is global in the sense that its principles and precepts are necessarily universal and objective, the establishment or the attempts to establish global norms in bioethics is inimical to the nature of ethics and to the ways in which universal values are established and maintained’’ (p. 301). Harris asserts that universal values or global norms cannot be identified effectively through public consultation. The proponents (and practitioners) of public consultation, on the contrary, maintain that the nature and scope of the consultation process both strengthen and legitimate not only the enterprise, but the outcome(s). On their view, our universal values, our global norms, can be identified and legitimated through public consultation. Harris disagrees. The problem with identifying global norms through public consultation, according to Harris, is that such consultation may do little more than reveal the public’s ‘‘prejudices or personal aversions or likes rather than information about their morality or their moral views or judgments, properly so called.’’ (p. 303) This possibility raises important questions about moral authority and moral legitimacy. Harris asks somewhat provocatively, ‘‘why the opinions of those consulted matter, why we should take any notice of them’’ (p. 303). The risk with public consultation, according to Harris, is that decision-making will be informed by ‘‘prejudices, personal preferences and aversions, or expressions of distaste or disgust’’ (p. 303). Harris insists that by comparison, ‘‘[m]oral judgments and opinions, expressions of moral principle and moral outlook, command respect because they are expressions of the individuals’ values and of their considered positions’’ (p. 303). Instead of public opinion, we need informed consensus that results from a process of careful reasoning, informed argument and rigorous examination. ² UNESCO, Universal Declaration on Bioethics and Human Rights, October 19, 2005, available at (accessed June 10, 2007).

326 / Baylis An essential part of . . . informed consensus . . . is the appreciation and acceptance of arguments which have been tested in as many ways as possible. For example, their consistency with other values and beliefs should have been explored, they must have been exposed to criticism, to counter-argument, to the attempt to find counter-examples where appropriate, they will have resisted attempts at reductio ad absurdum and survived the other ways in which argument is tested and philosophical conclusions established. (p. 304)

In this way alone, ‘‘judgments move from hypothesis to fact’’ (p. 305). The problem with international bioethics documents that espouse global norms, according to Harris, is that they fail to make transparent and available for critical examination any evidence and arguments in support of the norms they entrench in policy documents. Without access to the evidence or arguments on the basis of which so-called global norms are identified, it is not possible for us to evaluate their moral soundness or to affirm with any confidence that these norms are anything more than the bare ‘‘prejudices and gut reactions’’ (p. 304) of those with power and privilege. In addition to the problem of missing ‘‘philosophical analysis and argument . . . to establish, support, and justify ethical conclusions’’ (p. 304) on occasion, there is also the problem of missing definitions for key terms and concepts. To demonstrate this point, Harris cites the Universal Declaration on the Human Genome and Human Rights which stipulates that: ‘‘[p]ractices which are contrary to human dignity, such as reproductive cloning of human beings shall not be permitted.’’³ Nowhere in the document is ‘‘human dignity’’ defined, however. This necessarily precludes any common understanding (hence, any meaningful endorsement) of the conclusion. Moreover, one could argue that compliance with this directive would be next to impossible without an adequate definition for the standard to be observed. Alternatively, at times definitions are provided (or hinted at), but their explanatory and justificatory force is limited. To illustrate this point, Harris ³ UNESCO, Universal Declaration on the Human Genome and Human Rights, November 11, 1997, available at (accessed June 10, 2007).

Global Norms in Bioethics / 327 makes reference to the following statement on human dignity in the UNESCO Explanatory Memorandum on the Elaboration of the Preliminary Draft Declaration on Universal Norms on Bioethics: Respect for human dignity flows from the recognition that all persons have unconditional worth, each having the capacity to determine his or her own moral destiny. Showing disrespect to human dignity could lead to the instrumentalization of the human person.⁴

According to Harris, if this UNESCO statement on human dignity applies to the earlier Universal Declaration on the Human Genome and Human Rights (and there is reason to make this assumption),⁵ then it is unclear how a commitment to respect human dignity (now understood in terms of the unconditional worth of all persons owing to the capacity of each to determine his or her own moral destiny) warrants a prohibition on cloning humans, since creating humans using this technology would have no impact on this capacity. Harris further argues that if this understanding of human dignity applies to the United Nations Declaration on Human Cloning, then it is unclear how states are to understand their obligation to ‘‘adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.’’⁶ Interestingly, however, Harris offers no comment on whether, or how, cloning humans could lead to the instrumentalization of the human person. ⁴ UNESCO, Explanatory Memorandum on the Elaboration of the Preliminary Draft Declaration on Universal Norms on Bioethics, May 4, 2005, available at (accessed June 10, 2007). ⁵ The directive to the UNESCO International Bioethics Committee in Article 24 of the Universal Declaration on the Human Genome and Human Rights stipulates: ‘‘The International Bioethics Committee of UNESCO should contribute to the dissemination of the principles set out in this Declaration and to the further examination of issues raised by their applications and by the evolution of the technologies in question. It should organize appropriate consultations with parties concerned, such as vulnerable groups. It should make recommendations, in accordance with UNESCO’s statutory procedures, addressed to the General Conference and give advice concerning the follow-up of this Declaration, in particular regarding the identification of practices that could be contrary to human dignity, such as germ-line interventions’’ (emphasis added). ⁶ United Nations, United Nations Declaration on Human Cloning. Resolution adopted at the 59th session of the General Assembly, 82nd plenary meeting, March 8, 2005, available at (accessed June 10, 2007).

328 / Baylis And now we get to the crux of the problem for Harris with international efforts to prohibit hESC and cloning research through appeal to so-called global norms. The problem with these efforts is that typically little evidence or argument is provided to support or explain the norms advocated. According to Harris, The problem with UNESCO’s efforts at articulating global norms is that they have deliberately excluded all evidence and argument from the various documents setting forth their normative conclusions so that we have no basis on which to distinguish these purported norms from prejudices, simple preferences, or aversions. The grounds on which respect for the norms might be built are entirely absent. This, it seems to me, sends out the worst possible message about bioethics, the way it works, its value, and claim to our attention. It also offers the worst possible lesson about science or about democratic values. We should never accept ethical conclusions on the authority of others. (p. 309)

Harris maintains that moral precepts should not be accepted on the basis of authority, but only on the basis of their merits established by informed consensus—‘‘a process of reasoning and persuasion and dialectic long familiar in philosophy’’ (n. 14 in Harris). As regards the particulars of hESC and cloning research, Harris suggests that ‘‘there is remarkable consensus at the level of fundamental moral principles.’’ (p. 314) According to Harris, we are almost all committed to human rights and human dignity; our problem is in reaching agreement on the scope of these terms. From my perspective, herein lies the rub . . . If we take an argument in standard form and find that the truth value of one or more of the premises is contested (because of lack of agreement or equivocation on the scope of key terms), we can’t generate an uncontested conclusion.

The Problems with Harris, according to Baylis First, Harris mistakenly assumes that the main purpose of public consultation is to discover what people think about issues of ethical significance. He criticizes this endeavor on the grounds that this exercise will not necessarily elicit information about ethical values, nor will it provide evidence as regards what is ethically acceptable. Harris writes, What is the role and purpose of consultations such as those that UNESCO has taken such pride in undertaking? The main purpose is of course to find out what others

Global Norms in Bioethics / 329 think of the norms contained in the UNESCO document. That is to say, to find out whether the norms of those consulted reflect or are congruent with those arrived at by UNESCO’s ethics committee.’’ (p. 302)

Unlike Harris, I have not had the privilege of working on an international ethics policy initiative. On the basis of my experience with national ethics initiatives (in Canada and the U.S.), however, I would not identify eliciting individuals’ views and values (or even their considered opinions) as the primary goal of public consultation. In my experience, the goal of public consultation is very often not so much to ‘‘hear the voice of the people’’ as it is to be able to make the claim that ‘‘we consulted the public.’’ This difference in perspective is important insofar as it calls into question the influence of the consultation process on the content of any particular ethics policy document. In my view, Harris errs in supposing that those who arrange public consultations are genuinely interested in public views and values, and take these as the basis for the principles or the directives ultimately espoused in international ethics policy documents. I could provide a number of examples in support of my claim, but will restrict myself to a brief comment on the UNESCO Universal Declaration on Bioethics and Human Rights.⁷ At the outset of this project, international consultations were held on the scope of this Universal Declaration. These consultations revealed a majority preference for a broad understanding of the key term ‘‘bioethics’’—one that would encompass environmental issues. The International Bioethics Committee (IBC) rejected this majority opinion and elected to work with a much narrower understanding of bioethics—one that focused on biomedical and (eventually) health issues.⁸ My point here is that there is no necessary link between what the public opines (whether sound moral judgments or simple prejudices) and the interests of committee members, the outcomes of committee deliberations, and the will of governments that endorse (or not) proposed global norms. Lest I be misunderstood here, I do not mean to suggest that all public consultations always and only serve as window dressing; much depends ⁷ UNESCO, Universal Declaration on Bioethics and Human Rights. ⁸ Explanation provided by Michele Jean then Chair of the International Bioethics

Committee, at a national invitational meeting in Ottawa, February 7, 2005 hosted by the Canadian Commission for UNESCO.

330 / Baylis on how we understand the terms ‘‘public’’ and ‘‘consultation.’’ Again, an example from the UNESCO Universal Declaration on Bioethics and Human Rights will serve to illustrate the point.⁹ From the first to the fourth draft of the Declaration on Universal Norms on Bioethics there is no Article that promotes and protects the interests of vulnerable persons, groups, or populations. However, subsequent drafts and the final text of the Universal Declaration on Bioethics and Human Rights do evidence concern for human vulnerability. No doubt, several factors explain the introduction of an Article on respect for human vulnerability and personal integrity, but for the record I can document the following. On February 7, 2005, a national invitational meeting, hosted by the Canadian Commission for UNESCO, was held in Ottawa to discuss and debate the fourth draft of the Draft Declaration on Universal Norms on Bioethics.¹⁰ Under contract from Health Canada, my colleagues and I prepared a background report for this invitational meeting critically assessing its merits and limitations from a Canadian perspective. In our background report and at the February meeting, my colleagues and I noted: Persons, groups, or populations can be vulnerable as a consequence of diminished capacity or as a consequence of social, economic, or other power imbalances. The vulnerable whose interests we are committed to protecting include those who are vulnerable whether for medical or non-medical reasons. Dependence on medical care and medical expertise is itself a form of vulnerability. . . . In addition, medicine is practiced in a context of power imbalances created by economic inequalities, social stigmatization, etc., by which some are disadvantaged in their access to health care. . . . In light of this central concern of bioethics with protection of the vulnerable, the absence in the Draft Declaration of any reference to such an obligation is striking.¹¹ ⁹ UNESCO, Universal Declaration on Bioethics and Human Rights. ¹⁰ UNESCO, ‘‘Elaboration of the Declaration on Universal Norms on Bioethics: Fourth Outline of a Text,’’ December 15, 2004, available at (accessed June 10,

2007). ¹¹ Fran¸coise Baylis, Natalie Ram, and Lynette Reid, ‘‘Evaluating UNESCO’s Document: Elaboration of the Declaration on Universal Norms on Bioethics: Fourth Outline of a Text in a Canadian Context,’’ January 28, 2005, available at (accessed June 10, 2007).

Global Norms in Bioethics / 331 Significantly, the next draft, titled the Preliminary Draft Declaration on Universal Norms on Bioethics, attended to the issue of vulnerability in Article 26(c) on International cooperation: States should respect and promote solidarity between and among States, as well as individuals, families, groups and communities, with special regard for those rendered vulnerable by disease or disability or other personal, societal or environmental conditions and those with the most limited resources.¹²

A few months later, at the second session of the intergovernmental meeting of experts, Canada argued that concern for vulnerable individuals and groups should have a more prominent place.¹³ In the final text of the Universal Declaration on Bioethics and Human Rights, the text above on international cooperation appears verbatim under Article 24 (3). In addition, a commitment to the protection of vulnerable persons and groups is entrenched in Article 8 on Respect for human vulnerability and personal integrity: ‘‘In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.’’¹⁴ Thus evidence suggests that not all public consultations function merely as window dressing. Indeed, it would appear that some types of consultation with some types of public can bring improvement through lobbying, reasoned debate, and argumentation. A second problem with Harris’s configuration of the issue is that he fails to situate the project of developing global norms in its broader political context. Here I am speaking to the criticism that international ethics policy documents typically fail to include philosophical analysis, sound evidence, and valid arguments in support of their conclusions. It seems to me that this criticism is misplaced insofar as these international documents are not philosophical treatises aimed as discerning the truth. Rather, they are ¹² UNESCO, ‘‘Preliminary Draft Declaration on Universal Norms on Bioethics,’’ February 9, 2005, available at (accessed June 10, 2007). ¹³ UNESCO, ‘‘Compilation of Proposed Amendments Submitted by Members States,’’ June 6, 2005. See pp. 8 and 37, available at (accessed June 10, 2007). ¹⁴ UNESCO, Universal Declaration on Bioethics and Human Rights.

332 / Baylis political documents—the product of politics and compromise. Their aim is not to identify the ‘‘examined truth’’ (and provide detailed arguments in support thereof) but (sometimes at considerable intellectual cost) to get a formal (sometimes very weak) international consensus—consensus that is often replete with minimalist and vague claims to which ‘‘all’’ can agree.¹⁵ Another example from the Universal Declaration on Bioethics and Human Rights makes this point. At the aforementioned meeting in February 2005, I pointed out that the fourth draft of the Draft Declaration on Universal Norms on Bioethics had lots of ‘‘motherhood and apple pie’’ statements and not much else. There was, for example, no strong claim about a universal right to access basic health care, and the same criticism can now be leveled at the Universal Declaration on Bioethics and Human Rights. To be precise, this Universal Declaration does include a statement on the value of health promotion and high-quality health care. It also includes a statement requiring that ‘‘progress in science and technology should advance access to quality health care.’’ It does not, however, include a clear statement about a right to access basic health care (See Article 14—Social responsibility and health). Now this is not surprising from a political perspective. For example, one could hardly expect the United States to sign an international document that challenged its deep commitment to a health care strategy (I cannot bring myself to call this a ‘‘system’’) that leaves millions of people both under- and un-insured. However, the omission of a right to access basic health care is both surprising and unacceptable from an ethics perspective. At this same February 2005 meeting, insisting further on my point about the absence of substance, I noted that although the 1997 Universal Declaration on the Human Genome and Human Rights included a clear prohibition on cloning for reproductive purposes, the fourth draft of the Draft Declaration on Universal Norms on Bioethics did not cite this prohibition. On this point, the Chair of the IBC responded that the Committee could not include such a clear unequivocal statement and still hope to get consensus on the document they were drafting.¹⁶ There was no discussion about the merits of ¹⁵ David Benatar, ‘‘The Trouble with Universal Declarations,’’ Developing World Bioethics, 5/3 (2005), 220–4. ¹⁶ Michele Jean, then Chair of the International Bioethics Committee, national invitation meeting in Ottawa, February 7, 2005.

Global Norms in Bioethics / 333 endorsing or rejecting the prior norm as sound ethics policy, just a simple recognition of the current political climate. Res ipsa loquitor. Years ago Dan Brock insisted that there is a deep conflict between the goals and constraints of the public policy process and the aims of academic scholarly activity in general and philosophical activity in particular. . . . Truth is the central virtue of scholarly work. . . . Whether the results are unpopular or in conflict with conventional or authoritative views, determining the truth to the best of one’s abilities is the goal. In philosophy, especially, nothing is immune from question and criticism; all assumptions are open to and must withstand critical scrutiny. . . . [For the philosopher] no change is too far reaching if persuasive argument supports it. For seasoned policymakers and bureaucrats, on the other hand, who have lost as many battles as they have won and who are constantly subject to the competing forces and interest groups active in the policy process, all is not immediately possible. Many issues are not on their agenda because they are not politically feasible.¹⁷

The point then, in relation to Harris’s criticism about the absence of rigorous philosophical analysis in international ethics policy documents, is that this is not the place to look for careful scholarly, philosophical work in ethics. This does not mean, however, that evidence and argument do not undergird such documents even when these are clearly the product of political compromise. The critical issue is whether sound evidence and valid argument are available in supporting documents. A third problem with Harris’s argument is his failure to appreciate fully the issue of essentially contested concepts as a significant limit on his proposed informed consensus process. Following W. B. Gallie, essentially contested concepts are ‘‘concepts the proper use of which inevitably involves endless disputes about their proper use on the part of their users.’’¹⁸ On this view, essentially contested concepts are always (and properly so) the subject of genuine debate that can be ‘‘sustained by perfectly respectable arguments and evidence’’ without being amenable to resolution by informed discussion. Universal agreement is not possible. On the one hand, Harris appears to recognize the problem of essentially contested concepts in his brief discussion on the impossibility of resolving ¹⁷ Dan Brock, ‘‘Truth or Consequences: The Role of Philosophers in Policy-Making,’’ Ethics, 97/4 (1987), 786–91. ¹⁸ W. B. Gallie, ‘‘Essentially Contested Concepts,’’ Proceedings of the Aristotelean Society, 56 (1956), 167–98.

334 / Baylis differences of opinion on the moral status of the developing human embryo because of disagreement on the scope of the concept of ‘‘human person.’’ But then he seems to suggest that this disagreement can somehow be set aside to ‘‘achieve a workable and tolerant research environment’’ (p. 314) through agreement on the fundamental moral principle of ‘‘the sanctity of life’’ (a principle later referred to as the ‘‘value of human life’’). Harris maintains that there is a remarkable consensus at the level of fundamental moral principles which can be maintained if we remember that the differences are differences not about fundamentals, not differences about the fundamental value of human life, rather they are differences about what is to count as protected human life for the purposes of applying agreed principles. (p. 314)

Harris allows that we can all agree on the principle of respect for persons and continue to disagree on the scope of the term ‘‘person.’’ While Harris’s statement may be descriptively accurate, it is unclear what moral work is being done here. Does Harris mean to suggest that we can all agree on the moral wrong of murder and not worry about which killings count as murders? And does Harris imagine that somehow this would facilitate ‘‘a workable and tolerable research environment’’? Further, Harris elides an important moral burden when presenting us with the EUROSTEM understanding of the principle of respect for persons, as ‘‘respect for the autonomy of the individual and concern for the welfare of persons’’ (p. 314). This significantly narrows the scope of the concept of person and hardly suggests an understanding of the essentially contested nature of the concept of personhood. My final comments on Harris’s chapter have to do with his argumentative style as well as the substance of his argument on the moral acceptability of hESC and cloning research. As I read him, Harris derides and taunts those who do not share his views on the permissibility of such research. For example, he blithely dismisses his would-be opponents—those who ‘‘truly believe that killing an embryo is killing a person with the same moral and political status as you or me’’ (p. 321)—as not only likely ‘‘ ‘scoundrels and substractors’ but also hypocrites and murderers’’ (p. 322). Hardly the way to solve moral problems by informed consensus. Harris suggests that if one sincerely believes that hESC and cloning research aren’t simply reprehensible but fundamentally evil, then one

Global Norms in Bioethics / 335 should not want to benefit from hESC research. He then predicts that once stem cell therapies derived from human embryos are available, most everyone, including those who object to the means of developing these therapies because this involves the destruction of human embryos, will want access to them and governments will be hard pressed not to provide such access. Next, Harris asks rhetorically, ‘‘[D]oes the unacceptability of the research entail the unacceptability of the therapies?’’ (p. 316) According to Harris the answer to this question is unequivocally ‘‘yes.’’ In his view, if the research is unacceptable, then so too are the fruits of this research. Insisting on this point, Harris is at pains to show that this case of benefiting from evil is different from other cases that might, at first glance, appear analogous. Harris considers a hypothetical situation where persons object on moral grounds to the building of a dam for hydro-electric power, but then later benefit from the use of electricity and water provided by the dam. According to Harris these persons would not be wrong, hypocritical, or inconsistent. In his view, their initial objections can be understood as legitimate participation in the democratic process, the results of which they are now obliged to accept. In contrast, the ethical issue at stake in the hESC and cloning debate is of a different order. This debate is not merely about compulsory relocation of some individuals and concerns about environmental impact, this is about the evil of murder—an evil that ‘‘cannot simply be resolved by subjecting the decision . . . to the democratic process’’ (p. 321). Leaving aside this attempt at nuance, Harris’s claim that benefiting from the fruits of research is unethical, if the research itself is unethical, begs the question. Harris presupposes that which needs to be proven, namely that the use of stem cell therapies derived from human embryos and cloning research—as opposed to the manner in which these therapies were developed—is wrong. Benjamin Freedman addresses this issue most eloquently in regard to the use of Nazi experimental results. He very carefully argues that one can draw a moral distinction between the use of data from the Nazis’ experiments with humans and the manner of its acquisition.¹⁹ Our use of this data and our acceptance of the benefits derived therefrom do ¹⁹ Benjamin Freedman, ‘‘Moral Analysis and the Use of Nazi Experimental Results,’’ in When Medicine Went Mad: Bioethics and the Holocaust, ed. A. Caplan (Totowa, NJ: Human Press, 1992), 141–54.

336 / Baylis not commit us to change our views about the ethics of research involving humans. We can accept the medical benefits of these heinous studies while at the same time continuing to condemn the research on which these benefits depend as ‘‘wicked.’’ In so doing, we do not ourselves join the ranks of the wicked or the hypocritical pace Harris. A second example of hypocrisy, according to Harris, is when governments and individuals seek to prohibit hESC and cloning research but willingly accept/tolerate the death of embryos in circumstances other than medical research (such as abortion, the combined oral contraceptive pill, and normal sexual reproduction). The problem with this example, however, is that Harris fails to acknowledge important distinguishing features between these states of affairs—features that limit the strength of the analogy. For example, the in vivo or in vitro status of the embryos and the intentionality of the relevant moral agents very much matter. First, with abortion and the use of abortifacients (including some oral contraceptives) it matters that the embryos are in women’s bodies and not in a Petri dish, as is the case with hESC and cloning research. The competing rights claims of the pregnant or potentially pregnant woman are a morally relevant consideration. Second, with normal sexual reproduction it matters for those who are trying to achieve a pregnancy and to have a baby that the goal is to create new life, not destroy it as is the case with hESC and cloning research. Harris ignores this fact with his taunting description of human sexuality as ‘‘a fully voluntary activity which is a prolific killer of embryos’’ (p. 319). A further problem with Harris’s argument is his apparent acceptance of the underlying assumption that the debate about hESC and cloning research should remain focused on the moral status of developing human life. There are, however, a host of other legitimate ethical concerns surrounding this research, and in failing to challenge this narrow focus, Harris is complicit with those who misdirect our attention away from the broad range of ethics issues deserving of critical analysis. In my view, it would have been helpful for Harris to critically assess the merits of some of these other ethics issues. As I have argued elsewhere: There are . . . difficult questions about the commodification of reproductive tissues (both gametes and embryos): Should we pay for these tissues, or not? If so, how much should we pay? There are also legitimate concerns about the twin risks of coercion and exploitation of women (and couples) who provide the reproductive tissues for

Global Norms in Bioethics / 337 research. Another set of concerns have [sic] to do with the timing and the circumstances under which women (and couples) are asked to execute advance directives for the future possible research use of reproductive tissues. Equally important are the myriad ethical issues associated with possible future clinical trials involving hESC transplantation. There are not only the familiar questions about who sets the research agenda, but also questions about equitable access to clinical trials and potential future therapies. For example, given the likely high cost of any eventual therapy that might be developed from hESC research, is it morally acceptable to allocate significant public resources to expensive interventions that may ultimately only benefit a privileged few? Questions of distributive and social justice abound. Finally, there are questions about the ethics of enhancement. No doubt, the initial goal of hSEC [sic] transplantation will be therapeutic, but inevitably there will be efforts to use hESC transplantation in pursuit of non-therapeutic goals. For example, one can easily imagine future attempts at neural stem cell transplantation to improve cognition. Should these efforts be prohibited or promoted?²⁰

Perhaps Harris does not address these ethics questions because he (like so many others) assumes that the answers to these questions are irrelevant if the moral status issue remains contested. But if Harris so assumes, then he errs both by failing to appreciate the essentially contested nature of the concept of person and also by failing to recognize that one or more of the ethics issues identified above may be sufficient reason to prohibit hESC and cloning research, the question of moral status notwithstanding.

A New Ethics for Global Bioethics If philosophical bioethics is to make a meaningful contribution to global bioethics, it must devote intellectual energy to the problem of the common good and the need to distinguish the ‘‘common good’’ from the ‘‘public interest.’’ Why? Because without understanding the scope and moral force of these distinct concepts, we are not in a position to critically evaluate ethical frameworks currently being developed for public health ethics or global bioethics. For example, Harris tells us that the point of departure for the EUROSTEM ethical framework was ‘‘the ²⁰ Fran¸coise Baylis, ‘‘Embryological Viability,’’ American Journal of Bioethics, 5/6 (2005), 17–18.

338 / Baylis powerful obligation . . . to pursue, support and participate in scientific research . . . [that is] undertaken responsibly in accordance with accepted moral principles’’ (p. 313). But what if the guiding norms are not the familiar mainstream, ethical principles of autonomy, beneficence, nonmaleficence, and justice? What if the focus is on the common good and the public interest? In traditional formulations, the common good captures that which all of us and our descendants (i.e. future generations) have a common interest in, namely an interest in ‘‘self-protection or preservation from threats to all kinds of [our] welfare.’’²¹ This common interest includes such public goods as clean air, water, peace, order, security, and public safety. Public goods are ‘‘goods which cannot feasibly be enjoyed by one person without being enjoyed by everyone.’’²² The common good, so defined, contrasts markedly with most contemporary understandings of the public interest. A careful review of the philosophical literature on the public interest reveals several discrete understandings of this concept.²³ First, there is the public interest defined in terms of due process. On this view, the public interest is simply the outcome of fair, inclusive, accessible, and transparent decision-making procedures. Second, there is the public interest as informed by public opinion surveys. Here, the public interest is that which is consistent with the interests of a substantial majority of the public. Third, there is the utilitarian understanding of public interest with its focus on cost–benefit analysis. On this view, the public interest is that which results from a careful balancing of different competing interests—individual, sectional, and societal interests. Fourth, there is the public interest as shared values. ²¹ Dan E. Beauchamp, ‘‘Community: The Neglected Tradition of Public Health,’’ in Public Health Ethics: Theory, Policy and Practice, ed. Ronald Bayer, Lawrence Gostin, Bruce Jennings, and Bonnie Steinbock (Oxford: Oxford University Press, 2007), 45–56. ²² Leslie A. Pal and Judith Maxwell, ‘‘Assessing the Public Interest in the 21st Century: A Framework. A paper prepared for the External Advisory Committee on Smart Regulation,’’ 5 (Ottawa: Canadian Policy Research Network, January 2004), available at (accessed June 10, 2007). ²³ The ‘‘public interest’’ is notoriously difficult to define. A very helpful review of the relevant literature can be found in Pal and Maxwell, ‘‘Assessing the Public Interest in the 21st Century.’’ While I am grateful for their comprehensive review of the literature, and I generally agree with their proposed classification of the different meanings of the term, I maintain that the common good stands outside of the public interest—it is not merely another understanding of the public interest.

Global Norms in Bioethics / 339 The public interest is that which affirms a shared set of normative principles for a discrete public. With these definitions, important moral differences between the common good and the public interest emerge. The common good, unlike contemporary understandings of the public interest, attends to the welfare interests of all individuals (i.e. everyone) considered as a group, not just the interests of this community, this country, this racial cluster, and so on. Second, the common good, unlike the public interest, does not simply reflect the ideals that permeate liberal affluent society, namely consumption and competitiveness.²⁴ Third, the common good is never about procedures for decision-making, majority opinion, the intensity and satisfaction of preferences, numerical majorities, or even shared values. Rather, the common good is about compelling community interests that are essential for both survival and general well-being, such as health and safety, and to which the market, property, and individual liberty are subordinate.²⁵ To be clear, while many use the terms common good and public interest interchangeably, I maintain that these concepts are distinct in morally relevant respects, and that we err in using these terms synonymously. On this view, contra Harris, ‘‘the duty of governments to serve and protect the health needs of their citizens’’ (p. 316) does not begin and end with a commitment to scientific research. The overarching duty of governments is to promote and protect both the common good and the public interest and, when these conflict, to privilege the common good (i.e. those goods that cannot be enjoyed by one without, at the same time, being enjoyed by everyone). If we think back to the Universal Declaration on Bioethics and Human Rights, a clear a priori commitment to the common good might have allowed for a broader understanding of the key term ‘‘bioethics’’ and might even have invited evidence and arguments against what David Benatar identifies as the minimalism, vagueness, and hegemony of anthropocentricism of the current Universal Declaration on Bioethics and Human Rights.²⁶ ²⁴ Brian Barry, ‘‘The Public Interest,’’ Proceedings of the Aristotelian Society, supp. vol. 38 (1964), 1–18. ²⁵ Beauchamp, ‘‘Community: The Neglected Tradition of Public Health,’’ 46. ²⁶ David Benatar, ‘‘The Trouble with Universal Declarations,’’ 220–4.

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INDEX

abortion 53, 268–9, 273–4 absolute vs. relative risk and harm reduction research 130–1 academic–industrial partnerships 221–2 Ackerman, Frank 24–5 active-controlled studies 118 acute vs. preventive interventions and priority-setting 21 Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death 59–60 Adams, Douglas 309–10 adult stem cell research 275 advocacy, political/social 6, 93, 108–9, 113–14, 138 age factor in health care priority-setting 21 aging of global population 28 agricultural productivity technologies 192 AIDS, see HIV/AIDS Alba, Richard 272 allocation of health resources, see priority-setting Almy, Tom 214 American Medical Association (AMA) Code 55–6, 222–3 Annan, Kofi 182 assisted reproduction technologies 266, 268, 271, 274, 318–19 AstraZeneca 220–1 authority of physician: erosion of 224–6, 231 in physician-assisted death 246, 248, 252, 254, 259 autonomy of patients: developing countries’ limitations on 249–50 as medical ethics principle 54, 63, 81–2, 85 and physician-assisted death 245, 249–50, 254 as Physician Charter principle 209

AZT for HIV transmission prevention 91–3, 118–19, 127 Baltimore lead abatement study 93–7, 126, 129–32 Bayh-Dole Act (1980) 221 Beauchamp, Tom 61–2, 65, 210 Beecher, Henry K. 60 Belmont Report, The (Beauchamp) 61 Benatar, Solomon 146 beneficence principle 54, 55–7, 59–61, 63, 147 best intervention availability, see standard of care Bible as guide to bioethics 290–1 bioethics: application to social justice issues 49–51 defining the field of 83, 283–6 interdisciplinary aspect of 15–16, 283 introduction to 1–11 theological basis of 290–2 universality claims for 284–5, 292, 298–305, 312–13, 324–8 see also global bioethics; medical ethics; population-level approach biotechnology 182, 184–8, 193–8; see also human embryonic stem cell (hESC) research bird’s-eye perspective, see population-level approach Birth of Bioethics, The (Jonson) 1 brain death, defining 59–60 brain drain from developing countries 200–1, 218–19, 236–38 Brock, Dan 62, 333 Brundtland, Gro Harlem 23 Buchanan, Allen 62 Buddhism 287–8 Bush, George W. 265–6

342 / Index Canada’s health service 17 caring and competence focus of medical profession 208 Catholic Church 57–8, 271–4, 289 Catholic moral theology 80 Centers for Disease Control and Prevention (CDC) 94 Childress, James F. 62, 65, 210 Chisolm, Julian 94 Christianity: Catholic Church 57–8, 80, 271–4, 289 Protestant tradition 58, 279–82, 286–94 civil liberties 27 clinical practice: and advocacy 108–9 commercialization of 220–4, 287 disconnection from research 212–13 distancing of bioethics issues from 283 and harm reduction approach 102–3, 121–2, 124–6, 138 and normative bases for global bioethics 82–4 specialization and professionalism 212–13, 217–19, 237–8 teaching in 213–16, 235–7 see also individual physician–patient relationship cloning, prohibitions on human 306–9, 327 Comit´e consultatif national d’´ethique (CCNE) 282 commercialization of research and practice 220–4, 287 Commission on Health Research for Development report 144 Commission on Macroeconomics and Health (WHO) 23, 154 Commission on Private Sector and Development 196 common good vs. public interest 337–9 Common Rule (Federal Policy for the Protection of Human Subjects) 64, 128–32, 166–9 common sense morality 301 communalism vs. individualism in bioethics 16–18, 85, 268–9, 272–3, 293 community hospital, specialist clinic threat to 218

competent vs. incompetent patients and physician-assisted death decision 258–9 compulsory license mechanism for increasing health product availability 156 confidentiality, patient–physician 40–1, 49–50, 53 conflicts of interest in medical community 221–2, 226 consultation, role in normative formation 301–3, 325–6, 328–31 contested concepts 333–4 contraceptives and embryonic destruction 318 controlled studies 93, 118, 143, 151, 253 Convention on Human Rights and Biomedicine 305 cost-effectiveness analysis (CEA) 20–1, 24–5, 74 Council for International Organizations of Medical Sciences (CIOMS) 128, 134–5, 146–52, 170 Council of Europe 305 Cruzan case (1990) 63 cultural influence on ethics 231–2, 268–9, 274–7; see also religion Daniels, Norman 62 Dartmouth Health Atlas 217 Davis, Dena S. 268–9 death, criteria for, and medical ethics evolution 59–60 Declaration of Geneva 56 Declaration of Helsinki: on developing world research ethics 252–3 and harm reduction research 97, 126, 128, 132–4 and norms for research ethics 60, 65, 68–9 on obligations to subject communities 143, 145 Declaration on Human Cloning 306–8 developed world: vs. developing world in medical ethics issues 231 European perspective on medical ethics history 77–86 funding capabilities for technology support to developing world 200

Index / 343 individual physician–patient relationship focus in 3, 214, 236 medical education vs. developing 213 and national government responsibility for health 16–18 obligations to developing world 5–6, 142–58, 160 and physician-assisted death 243–4, 247–61 stem cell research issue in Europe 270–1, 312–17 universalizing of bioethical norms in 312–13 see also United States developing world: autonomy limitations in 249–50 biomedical research in 91–3 brain drain from 200–1, 218–19, 236–8 developed world’s obligations to 5–6, 142–58, 160 disproportionate level of disease in 28–9 global bioethical focus on 2 health services access limitations 141, 155–8 and physician-assisted death 243–4, 247–61 and population-level approach 16 professionalism, issues in 7–8, 213, 216, 229–39 research ethics, issues in 1, 5–6, 32–3, 93, 142–52, 166–76, 219 standard of care challenges 67–72, 90, 92 technology’s role in health for 180, 182, 184–8, 193–9 developmental economics 16–17 Devolder, Katrien 320 differential pricing for health products 157–8 direct cellular reprogramming 275–6 Doctors in Society 208–9 Dolgin, Janet 268 drug delivery systems for developing world 186–8 drug testing in developing countries 1, 5–6, 32, 91–3 economic development, population-level approach 23 Edelstein, Ludwig 55 education, medical 207, 211–16, 218–19, 230–7, 239

efficiency considerations in health policy 73–5 embryonic stem cell research, see human embryonic stem cell (hESC) research empirical ethics 84 end-of-life care 63, 247–8, 250–1, 253; see also physician-assisted death (PAD) energy storage, production, and conversion technologies 191–2 Engage platform 201 enhancement vs. therapy 2, 337 environmental equity, population-level approach 25–6, 48 Environmental Protection Agency (EPA) 96 epigrammatic validity 304 equity considerations in health policy: vs. efficiency 73–5 and population-level approach 21, 23, 25–6, 28–33, 48, 180 religious ethical perspective on 281–2 equity pricing for health products 157–8 equivalency vs. controlled studies 93, 118 ethical relativism 299–300, 302, 324 ethical tolerance 73 ethics, see bioethics; moral judgment etiquette, professional 210 eugenics 26 Europe, stem cell research issue in 270–1, 312–17 European perspective on medical ethics history 77–86 European Union and ethical decision making 312–13 EUROSTEM 312–17 euthanasia 53, 79, 254, 258–9; see also physician-assisted death (PAD) Evangelical Protestantism and re-theologizing of ethics 280, 290–1 evil, benefiting from 320–2 exploitation by research: and placebo controls 93, 143, 253 safeguarding against 5–6, 106–7, 126, 143 of therapeutic resources 219 UNESCO’s effort to avoid 330–1 face-to-face engagement in research support for local communities 171, 175

344 / Index fair subject selection issue 72, 97, 126 Farfel, Mark 95 Farmer, Paul 109 Federal Policy for the Protection of Human Subjects (Common Rule) 64, 128–32, 166–9 Feinberg, J. 245 financial survival considerations for developing world physicians 232, 236 Fisher, Elliot 217 Fletcher, Joseph 57 Flint, Austin 56 Food and Drug Administration (FDA) 167 Frankena, F. 81 free for all in medical ethics 65–7 Freedman, Benjamin 68, 335 Gallie, W. B. 333 generic drugs, pharmaceutical companies’ objections to 155 genomics 26, 182, 184–8, 193–9 Genomics and Global Health 186–8, 198 Genomics Policy Courses 194 gift, organ donation as spiritual 286–8 global bioethics 1–11; see also normative bases for global bioethics; population-level approach Global Fund to Fight AIDS 153 Global Genomics Initiative (GGI) 198–9 global health equity 28 global justice in health 141, 153–8, 164–6 global research ethics 141 gold standard (intervention), see standard of care good, societal: and ethical decision making 297–8 private vs. public 180–1 Grand Challenges in Chronic Non-Communicable Diseases initiative 199 Grand Challenges in Global Health (GCGH) Initiative 199–200 Green, Ronald 319 ground-up approach to capacity building for local communities 170–7 harmonization of national guidelines on ethical research 169 harm reduction research: advocacy by researchers 108–9, 136–7 criticisms of 109–14

ethics guidance in 5, 97–9, 114–15, 124–36 exploitation safeguards for local subjects 106–7 implementation of intervention success 104–5, 110–12, 115 importance of 117–23 introduction to 89–91 lead abatement study 93–7, 126, 129–32 local community benefit analysis 104–9, 112–14, 131 modal 104 perinatal HIV transmission trails 91–3 procedural justice in 107–8 and standard of care provision 90, 92, 95, 103–4, 135 as strategy for public health research 99–103 Hastings Center 61 Hauerwas, Stanley 291 Health Biotechnology Innovation in Developing Countries 195 health outcomes, U.S. shortcomings in 217, 223, 227 health policy 73–5 Heinzerling, Lisa 24–5 hESC (human embryonic stem cell) research, see human embryonic stem cell (hESC) research Hippocratic oath 53, 55, 78–9 history, patient, developed vs. developing world on 214, 236 history of medicine in medical education 231 HIV/AIDS: clinical drug trial researchers’ obligations 173–6 impact on developing world 230 partnerships to fight AIDS 153–4 perinatal HIV transmission trails 91–3, 118–19, 127 vaccine research 144 human cloning, prohibitions on 306–9, 327 human dignity, definitional assumptions about 305–9, 314, 327 human embryonic stem cell (hESC) research: cloning for 308

Index / 345 consistency issue in applying moral judgment to 317–24, 334–7 ethical concerns surrounding 336–7 informed consensus on 312–19, 328 and natural loss of embryos in sexual reproduction 266, 272, 319–20, 336 overview of 8–9 political and cultural issues in U.S. 265–77 therapeutic benefits of 275 therapy availability 316–17 human rights issue 19, 84–6, 106–8, 158–60, 257–8 humanitarian interventions 24, 49–50 iatrogenesis 80 ill-gotten gains 320–2 incompetent vs. competent patients and physician-assisted death decision 258–9 Indiana University School of Medicine (IUSM) 171–6 individual physician–patient relationship: bioethical focus on 1, 3, 214, 236 confidentiality in 40–1, 49–50, 53 democratization of 224–6, 231 equity criterion in treatment in 23 Hippocratic oath’s focus on 56, 79 impact at population level 41–2 loss of clinical teaching focus on 214–15 and measurement of health 22 vs. population-level approach 15, 31–2, 34–5, 38–51 and post-trial therapy obligation 173 vs. public health approach 124–6 individualism vs. communalism in bioethics 16–18, 85, 268–9, 272–3, 293 inequality, see equity considerations in health policy infectious diseases 27, 185–6, 230; see also HIV/AIDS informed consensus and global norms 9–10, 304–22, 325–6, 333–4 informed consent right for patients 57, 64–5, 72, 97, 287–8 Innovation Applying Knowledge in Development 182 institutional review boards (IRBs) 72–3, 168 intentionality of moral agents, importance of 336

interdisciplinary aspect of bioethics 283 International Bioethics Committee (IBC) 329 International Covenant on Economic, Social and Cultural Rights (ICESCR) 158–60 International Ethical Guidelines for Biomedical Research Involving Human Subjects 128, 134–5 International Federation of Pharmaceutical Manufacturers Associations (IFPMA) 153–4, 156 International Labor Organization 94 Internet as medical information resource 225, 234 interventions, medical: availability of preventive 90–1, 92, 95, 98–9, 103–4, 114 emergency humanitarian 24, 49–50 harm reduction implementation success 104–5, 110–12, 115 obligation to provide access 4–5, 101–2 priority-setting for preventive 21, 27 see also standard of care in-vitro fertilization (IVF) and stem cell research 266, 268, 271, 274, 318–19 irreversible coma and brain death 59–60 is-ought distinction 84 Jacoby, Kerry N. 273 Jakobovits, Immanuel 57 Jewish Medical Ethics (Jakobovits) 57 Jewish tradition in medical ethics 57–8 Joint United Nations Programme on HIV/AIDS 160 Jonson, Albert R. 1 judgments about ethics vs. ethical judgments 9, 302–3 justice: and aging population care 28 application of bioethics to 49–51 and availability of prevention interventions 90–2, 95, 98–9, 103–4, 114 developed world’s obligations to developing world 5–6, 142–58, 160 and harm reduction research 107–10, 118–19, 121–2 and health care access inequities 25 in health care on global scale 141, 153–8, 164–6

346 / Index justice: (cont.) and health status inequities 29–30 international 69–70 as medical ethics principle 54, 63 and norms for health 3–4 as Physician Charter principle 209 and plurality of values 66 and poor’s responsibility for health 18 population-level approach to 24–5, 32–3 and priority-setting for health care provision 20 procedural 107–8 Rawlsian view of 69–70 as reciprocity 144–6 religious perspective on health inequities 281–2 and standard of care debate 68–9, 82 Kamm, Frances 246 Kass, Leon 41 Kennedy Institute of Ethics 61 Kennedy-Krieger Institute 94 Kenya/Indiana University collaboration 171–6 killing, moral prohibition on, and personhood definition 321–2 killing vs. letting die and physician-assisted death 247, 257 knowledge repatriation to developing world 200–1 Kuhn, Thomas 54 Lead-Based Paint Abatement and Repair Maintenance Study (R & M Study) 93–7, 126, 129–32 Lecky, William 79 legal paradigm in medical ethics 63–5, 81 liberal religion, contribution to universal bioethics 294 life expectancy and health expenditure 71 local community: ground-up approach to capacity building for 170–7 impact of harm reduction research on 104–9, 112–14, 131 importance of face-to-face engagement with 171, 175 involvement in research 6

researchers’ and sponsors’ obligations to 142–53 in standard of care debate 119–20, 133–4 technology tools for meeting health needs of 193–8 top-down approach to capacity building for 166–70 see also subjects of research Lutz, Brobson 215–16 Maimonides 57 malaria, partnerships for fighting 153–4 Maternal Infant Transmission (MIT) of HIV 91–3, 118–19, 127 measurement of health, population-level approach 22–3, 40 medical ethics: caveats on paradigms 54–5, 64–5, 77 curriculum for 211–13, 234–5 free for all in 65–7 and health policy 73–5 importance of 231 introduction to 53–4 legal paradigm 63–4, 81 overview of 4 philosophical paradigm 61–3, 80–1, 83 physician paradigm 53–7, 59–62, 78–9, 83–4 plurality of values issue 54, 66–7, 72–4, 80–2 religious paradigm 57–9, 80 and research ethics 72–3 response to 77–86 standard of care debate 67–72, 82 Medical Ethics (Percival) 55 ‘‘Medical Ethics and Etiquette’’ (Flint) 56 ‘‘Medical Ethics and Rules of Conduct’’ 80 medical knowledge, democratization of 224–6, 231 medical tourism 1; see also therapeutic tourism Medicines for Malaria Venture (MMV) 153 memorandum of understanding (MOU) between researchers and subjects 175–6 metaphysical aspect of bioethics 285–6 Miles, Steven 79 Millennium Development Goals (MDGs) 181–93

Index / 347 minimal risk standards 5, 128–32, 134–5 modernization and conflict over embryonic personhood 268 modified molecular technologies for diagnosis 185 Moi University Faculty of Health Sciences (MUFHS) 172–6 molecular diagnostics 185 monoclonal antibodies 185 moral judgment: ascertaining truth/objective certainty of 298 contextual diversity in 22 in cost effectiveness analysis 21 and harm reduction research dilemma 90–1, 97–8, 101–3 in hESC research 317–24, 334–7 and individual responsibility for health 18 vs. judgments about morals 9, 302–3 plurality of values challenge for 67 practical application in medicine 83–4 and priority-setting for health care provision 20 see also justice; normative bases for global bioethics Morals and Medicine (Fletcher) 57 motivations for requesting physician-assisted death 245, 252 Nagel, Thomas 66 nanotechnology 188–93, 197–8 National Bioethics Advisory Commission (NBAC) report 143–6, 164–5, 170–1 national bioethics commissions, development of 167–8 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 61 national health care systems: as locus of societal responsibility for health 16–17 variation in 1–2 National Health Service, Great Britain 17–18 Netherlands, The, health care in 78 90/10 gap in research benefit distribution 144, 146, 219 non-communicable diseases as issue for developing world 230

non-voluntary euthanasia 254, 258–9 nonmaleficence principle in medical ethics 54, 63, 82 normative bases for global bioethics: clinical practice argument for 82–4 consultation’s role in 301–3, 325–6, 328–31 diversity challenge for 3–4 informed consensus role in 9–10, 304–22, 325–6, 333–4 international efforts to create 60, 65, 68–9 need for development of 2–3 politics of 331–4 universality, claims for 298–303, 312–13, 324–8 valid argument and evidence in 297–8, 300–1, 303–11, 323, 326–8 see also medical ethics; moral judgment Nuffield Council on Bioethics 143, 148, 152, 170 Nuremberg Code 60 076 regimen HIV transmission prevention 91–3, 118–19, 127 objectivity of ethics 299–301, 317 Office of Human Research Protections (OHRP) 167, 169–70 Office of the United Nations High Commissioner for Human Rights 160 optimistic vs. pessimistic visions of human nature 289–90 organ donation 9, 41, 59–60, 286–8 PAD (physician-assisted death), see physician-assisted death (PAD) pain management, developed vs. developing world 247, 250–1, 260 palliative care vs. physician-assisted death 248, 253 paradigms in medical ethics 54–65, 77–9, 80–1, 83–4 parallel trade issue 158 partnerships, public–private, for health benefit provision 153–4, 160, 196–7, 199 patent protection barriers to health product availability 155–7 patients, see rights of patients; individual physician–patient relationship

348 / Index Percival, Thomas 55 perinatal HIV transmission trails 91–3, 118–19, 127 personhood, embryo/fetus and 268–74, 314–15, 321–2, 334 pessimistic vs. optimistic visions of human nature 289–90 pharmaceutical companies: and medical professionalism 7, 220–1 in partnerships for health benefit provision 153–5 profit motive and obligations to developing world 149, 158 resistance to compromises in patent rights 155–8 Pharmaceutical Research and Manufacturers of America (PhRMA) 156–7 philosophy: argument and analysis in consultation 84, 302–3, 331–4 paradigm in bioethics 61–3, 80–1, 83 see also moral judgment; normative bases for global bioethics physical diagnosis, developed vs. developing world’s focus on 214–15, 236 physician-assisted death (PAD): arguments against 247–8, 253–60 arguments in support of 245–7, 249–53 developing vs. developed countries on 243–4, 247–61 and Hippocratic oath 53, 79 introduction to 243–4 overview of 8 religious stands on 57–8 Physician Charter 209–10, 217–18, 221, 224, 232–3 physician paradigm in medical ethics: critique of structure 78–9 original 55–7 overview of 53–4 philosophical challenge to 62 reaffirmation of 59–61, 83–4 physicians: authority and responsibility in physician-assisted death 246, 248, 252, 254, 259 bioethical focus on role of 1 brain drain from developing countries 200–1, 218–19, 236–8

and commercialization of medicine 221 financial survival considerations for developing world 232, 236 see also professionalism; individual physician–patient relationship physician–scientist, decline of 212 Pius XII, Pope 57–8 placebo controls 93, 143, 151, 253 plurality of values issue in medical ethics 54, 66–7, 72–4, 80–2 politics: advocacy by researchers 6, 93, 108–9, 113–14, 138 and biotechnology in developing countries 196 and global norm development 331–4 of stem cell research 265–77 polymerase chain reaction (PCR) tests 185 population health care ethics 39 population-level approach: and aging of global population 28 challenge to 37–52 and civil liberties 27 cost-effectiveness analysis 20–1 and definition of population 40–1 and economic development 23 and emergency humanitarian interventions 24 equity considerations in 21, 23, 25–6, 28–33, 48, 180 and eugenics 26 and harm reduction research 124 health measurement 22–3, 40 and health system reform 33–4 and human rights 19 importance of 34–5, 46–51 vs. individual physician–patient relationship 15, 31–2, 34–5, 38–51 introduction to 15–16 priority-setting 19–21, 23, 40, 51 n. 18 relationship component of 42–6 research ethics and justice 32–3 risk-bearing and justice 24–5 social determinants of health 31 societal vs. individual responsibility for health 16–18 treatment implications of 31–2 poverty as bioethical subject 49–50 practical cosmopolitanism 70–2 practice, see clinical practice

Index / 349 Prahalad, C. K. 197 preferential pricing for health products 157–8 prejudices vs. ethical judgments 9, 302–3, 325 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 62 preventive interventions: availability of 90–2, 95, 98–9, 103–4, 114 priority-setting for 21, 27 see also harm reduction research Principles of Biomedical Ethics (Beauchamp and Childress) 62, 65 prior agreements by researchers 151–2 priority-setting: and harm reduction research 100, 120, 122–3 population-level approach 19–21, 23, 40, 51 n. 18 for preventive interventions 21, 27 private and public sector relationship: in health benefit provision 153–4, 160, 196–7, 199 in medical education 233–4 in specialized medical practice 238 procedural justice in harm reduction research 107–8 productive vs. nonproductive populations and health provision priority-setting 23 products of research: local community benefit analysis 104–9, 112–14, 131 90/10 gap in distribution of 144, 146, 219 providing to subject communities 142–55, 157–8 and researchers’ purpose 112–13 therapeutic benefits of stem cell research 275 professionalism: background of movement 208–9 clinical teaching in U.S. vs. rest of world 215–16 and commercialization of research and practice 220–4, 287 definition 224–5 and democratization of medical knowledge 224–6, 231

developing world perspective on 7–8, 213, 216, 229–39 introduction to 207–8 lack of basic medical science teaching 211–13, 234–5 loss of experienced clinical teachers 213–15, 235–7 overview of 7 Physician Charter 209–10, 217–18, 221, 224, 232–3 and specialization 212–13, 217–19, 237–8 summary of challenges facing 226–8 profiting from evil problem with stem cell therapies 316–22, 334–5 Program of Life Sciences, Ethics and Policy (PLEP) 181–2 Protestant tradition in medical ethics 58, 279–82, 286–94 public and private sector relationship, see private and public sector relationship Public Citizen Health Research group 93 public health issues 79, 101–2, 124–6, 224; see also harm reduction research; population-level approach public interest vs. common good 337–9 quality of life and physician-assisted death 245–6, 250, 254 Quinlan, Karen Ann 63 R & M Study (Lead-Based Paint Abatement and Repair Maintenance Study) 93–7, 126, 129–32 Rawls, John 69–70 reasonable availability requirement for product of research provision 149–52 reciprocity, justice as 144–6 recombinant technologies 185–6 regenerative medicine, applications of 203 relationships and individual vs. population-level perspectives 42–6, 49–50 relative vs. absolute risk and harm reduction research 130–1 relativism, ethical 299–300, 302, 324 religion: and embryonic personhood 268–9, 271–4 overview of issues 8–9, 279–85

350 / Index religion: (cont.) spirituality of organ donation 285–8 zoe-ethic position 288–94 religious paradigm in medical ethics 57–9, 80 renewable energy technologies 191–2 research ethics: and commercialization of research 220–4, 287 in developing world 1, 5–6, 32–3, 93, 142–52, 166–76, 219 and differential standards of care 44 disconnection of research from clinical practice 212–13 ground-up approach to capacity building for local communities 170–7 institutionalizing of 56 international norms for 60, 65, 68–9, 128, 134–5, 252–3 introduction to 141, 163–4 legal regulations governing 63–4 and medical ethics evolution 72–3 moral obligation to conduct medical research 313 overview of 4–6 philosophical paradigm for 61 and physician paradigm 55–6, 60 and plurality of values challenge 72–4 population-level approach to 32–3 and protection of researchers 315–16 and standard of care debate 33, 67–72, 82, 252–3 top-down approach to capacity building for local communities 166–70 see also exploitation by research; harm reduction research; human embryonic stem cell (hESC) research; products of research; subjects of research research ethics committees (RECs) 72–3 resident labs, decline of 214 resource-poor nations, see developing world rights of patients: bioethical focus on role of 1 in emergency humanitarian interventions 24 and human right to health 158–60 individual and population-level perspectives 42, 49–50

informed consent 57, 64–5, 72, 97, 287–8 legal protection of 64–5 as medical ethics principle 63 and physician-assisted death 245–6 to self-determination 54, 63–4, 245–6 see also autonomy of patients risk-benefits ratio in medical ethics 72 risk to research subjects, analysis of 5, 128–32, 134–5, 148–9 Roe v. Wade 268, 270, 273 Roll Back Malaria 154 Roman Catholic Church 57–8, 271–4, 289 Rose, Geoffrey 31 Royal College of Physicians 209 Royal Dutch Medical Association 80 Sachs, Jeffrey 23 sanctity of life: biological vs. spiritual approaches to 286–7 Catholic Church’s position on 271–2 and inconsistencies on embryos’ status 267 and physician-assisted death 247, 253 and scope of human personhood 314–15 secular vs. religious bioethics perspectives 268–9, 272–3, 282, 284–5, 293 self-determination of patients 54, 63–4, 245–6 sexual reproduction, embryo loss in normal 266, 272, 319–20, 336 Shapiro, Harold 164 Shiavo case 65 Slater v.Baker & Stapleton 57 slippery slope argument against physician-assisted death 247–8, 254, 258–60 social determinants of health 15, 29–30, 31, 47–51 societal control and physician-assisted death issue 257 societal vs. individual responsibility for health 16–18, 85, 268–9, 272–3, 293 specialization and professionalism 212–13, 217–19, 237–8 standard of care: accessibility challenge for 101, 103–4, 110–11, 118–20, 252–3

Index / 351 availability and physician-assisted death choice 255–6 challenges for developing world 67–72, 90, 92, 250–3 entitlement 68, 70 in harm reduction research 90, 92, 95, 103–4, 135 interpretation issues for researchers 5 and justice issue 68–9, 82 local vs. global 119–20, 133–4 and research ethics 33, 67–72, 82, 252–3 state-sponsored health care systems’ role 16–17 stem cell research, see human embryonic stem cell (hESC) research subjects of research: fair selection issue 72, 97, 126 international research guidelines for 128, 134–5 protection of 61, 64, 106–7, 128–32, 166–9, 172–6 risk analysis for 5, 128–32, 134–5, 148–9 Task Force on Science, Technology and Innovation (Task Force 10) 182 teaching, medical 207, 211–16, 218–19, 230–7, 239 technology: assisted reproduction 266, 268, 271, 274, 318–19 developing nations’ application to health 180, 182, 184–8, 193–8, 199 funding issues 200 genomics application to global health 182, 184–8, 198–9 Grand Challenges in Global Health Initiative 199–200 introduction to 179–81 knowledge repatriation issue 200–1 limitations of 202 and loss of contact with patient in diagnostic process 215 Millennium Development Goals overview 181–4 nanotechnology 188–93, 197–8 regulation factor in ethical use of 201 summary of role in global health 202–4 see also human embryonic stem cell (hESC) research Technology Transfer Act (1986) 221

thematic delimitation in bioethics 282–3 Theory of Medical Ethics, A (Veatch) 62 therapeutic fallacy 44–5 therapeutic lead abatement 94–5 therapeutic products of research, see products of research therapeutic tourism 1, 315–16 3 x 5 Initiative, WHO 154 top-down approach to capacity building for local communities 166–70 Top 10 Biotechnologies for Improving Health in Developing Countries 182, 184–5 Trade Related Aspects of Intellectual Property (TRIPS) 155–6 transcendental possibility in bioethics 287–8, 292 Tuskegee scandal 61, 90 UNAIDS guidance document 144–5 undue inducements to participate in research 147–8, 150–1 UNESCO Universal Declaration on Bioethics and Human Rights: and global norms in bioethics 301–2, 305, 308–9, 311, 326–30 and medical ethics evolution 85 and physician-assisted death 249 political issues in development of 332–4 United Nations: Commission on Private Sector and Development 196 Declaration of Geneva 56 Declaration on Human Cloning 306–8 High Commissioner for Human Rights 160 Joint United Nations Programme on HIV/AIDS 160 Millennium Development Goals 181–93 Universal Declaration of Human Rights 158 World Trade Organization 155, 160 see also Declaration of Helsinki; World Health Organization (WHO) United States: clinical teaching vs. rest of world 215–16 Common Rule for research ethics 64, 128–32, 166–9 health outcome shortcomings in 217, 223, 227

352 / Index United States: (cont.) hESC research issues in 265–77 specialization, proliferation in 217–19 Universal Declaration of Human Rights 158 universality claims for bioethics: and global norms in general 298–303, 312–13, 324–8 religious common ground on 284–5, 292 through informed consensus 304–5 Unleashing Entrepreneurship: Making Business Work for the Poor 196 U.S. Agency for International Development (USAID) 169 utilitarianism in Protestant bioethics 290 vaccines 149, 186–8 value, Nagel’s types of 66–7 Veatch, Robert 56, 62–3 Veritatis Splendor 289 voluntary euthanasia, see physician-assisted death (PAD) vulnerable populations, bioethical respect for 4–5, 24, 97–8, 330–1

Washington Consensus 16–17 water treatment and remediation technologies 192–3 well-being and physician-assisted death 245–6, 250, 254 White Lead Paint Convention 94 whole brain death standard 60 Wikler, Dan 62 Winston, Robert 319 World Health Organization (WHO): Commission on Macroeconomics and Health 23, 154 HIV/AIDS initiatives 154 and human right to health 159 and IFPMA initiatives 153–4 on 076 HIV prevention results 92–3 and society’s responsibility for health 16 World Medical Association (WMA) 56, 60 World Trade Organization (WTO) 155, 157, 160 076 regimen HIV transmission prevention 91–3, 118–19, 127 zidovudine (AZT) 91–3, 118–19, 127 zoe-ethic position 288–94