Bioethics

Bioethics

Carla Mooney

Bioethics by Carla Mooney

© 2009 Gale, Cengage Learning ALL RIGHTS RESERVED. No part of this work covered by the copyright herein may be reproduced, transmitted, stored, or used in any form or by any means graphic, electronic, or mechanical, including but not limited to photocopying, recording, scanning, digitizing, taping, Web distribution, information networks, or information storage and retrieval systems, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without the prior written permission of the publisher. Every effort has been made to trace the owners of copyrighted material.

LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA Mooney, Carla. Bioethics / by Carla Mooney. p. cm. -- (Hot topics) Includes bibliographical references and index. ISBN 978-1-4205-0117-9 (hardcover) 1. Medical ethics. 2. Bioethics. I. Title. R724.M664 2009 174.2--dc22 2009007239

Lucent Books 27500 Drake Rd. Farmington Hills, MI 48331

ISBN-13: 978-1-4205-0117-9 ISBN-10: 1-4205-0117-8

Printed in the United States of America 1 2 3 4 5 6 7 13 12 11 10 09

FOREWORD

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INTRODUCTION The Birth of Bioethics

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CHAPTER 1 The Beginning of Life

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CHAPTER 2 The Decision Makers

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CHAPTER 3 The End of Life

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CHAPTER 4 Research and Development

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CHAPTER 5 Genetic Testing and Engineering

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CHAPTER 6 81 The Future of Bioethics: Stem Cell Research and Cloning NOTES

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DISCUSSION QUESTIONS

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ORGANIZATIONS TO CONTACT

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FOR MORE INFORMATION

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INDEX

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PICTURE CREDITS

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ABOUT THE AUTHOR

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oung people today are bombarded with information. Aside from traditional sources such as newspapers, television, and the radio, they are inundated with a nearly continuous stream of data from electronic media. They send and receive e-mails and instant messages, read and write online “blogs,” participate in chat rooms and forums, and surf the Web for hours. This trend is likely to continue. As Patricia Senn Breivik, the former dean of university libraries at Wayne State University in Detroit, has stated, “Information overload will only increase in the future. By 2020, for example, the available body of information is expected to double every 73 days! How will these students find the information they need in this coming tidal wave of information?” Ironically, this overabundance of information can actually impede efforts to understand complex issues. Whether the topic is abortion, the death penalty, gay rights, or obesity, the deluge of fact and opinion that floods the print and electronic media is overwhelming. The news media report the results of polls and studies that contradict one another. Cable news shows, talk radio programs, and newspaper editorials promote narrow viewpoints and omit facts that challenge their own political biases. The World Wide Web is an electronic minefield where legitimate scholars compete with the postings of ordinary citizens who may or may not be well-informed or capable of reasoned argument. At times, strongly worded testimonials and opinion pieces both in print and electronic media are presented as factual accounts. Conflicting quotes and statistics can confuse even the most diligent researchers. A good example of this is the question of whether or not the death penalty deters crime. For instance, one study found that murders decreased by nearly one-third when the death penalty was reinstated in New York in 1995. Death 4

FOREWORD penalty supporters cite this finding to support their argument that the existence of the death penalty deters criminals from committing murder. However, another study found that states without the death penalty have murder rates below the national average. This study is cited by opponents of capital punishment, who reject the claim that the death penalty deters murder. Students need context and clear, informed discussion if they are to think critically and make informed decisions. The Hot Topics series is designed to help young people wade through the glut of fact, opinion, and rhetoric so that they can think critically about controversial issues. Only by reading and thinking critically will they be able to formulate a viewpoint that is not simply the parroted views of others. Each volume of the series focuses on one of today’s most pressing social issues and provides a balanced overview of the topic. Carefully crafted narrative, fully documented primary and secondary source quotes, informative sidebars, and study questions all provide excellent starting points for research and discussion. Full-color photographs and charts enhance all volumes in the series. With its many useful features, the Hot Topics series is a valuable resource for young people struggling to understand the pressing issues of the modern era.

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THE BIRTH OF BIOETHICS

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n 1969 medical researcher Van Rensselaer Potter first used the word bioethics to describe his idea of studying the link between human values and biological knowledge. The “bio” in bioethics comes from the Greek word bios, meaning “life.” What life means is central to the bioethics field. Life is more than a series of chemical and physical processes keeping an organism alive. Life is the human experience of joy and tragedy, beliefs and values. More than a general idea, life rests in individual people. Two transplant patients wait for a single heart. A scientist creates a baby in a laboratory, outside of the mother’s womb. An old woman suffering from terminal cancer asks to die. A young man lies in a persistent vegetative state, a respirator taking each breath for him. In these situations the definition of life becomes clouded and complicated. Questions arise—who lives, who dies, who decides? For centuries healers and doctors have dealt with life and death. Their primary role was to prevent death when possible and to keep their patients comfortable. They had no power to decide between life and death. Fate decided when it was time to live and time to die. Medical science has changed this timeless balance. Doctors and scientists can extend and create life in more ways than ever before. Life-support machines help a person’s heart beat and lungs breathe. Experimental drugs keep life-threatening illnesses like cancer and heart disease at bay for years. Babies are conceived in a petri dish. Scientists have even discovered techniques to manipulate human genes.

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THE BIRTH OF BIOETHICS

A patient is kept alive using a defibrillator, drugs, and a ventilator. These measures can extend a person's life, but some people have concerns about the quality of such a life.

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BIOETHICS The benefits of these advances are many—less disease, longer life, less suffering for some. Along with the benefits, medical advances have opened the door to new responsibilities. The burden of deciding between life and death at times now rests with people. In a perfect world, deciding who lives is easy. Everyone. In the real world, this is not possible. Resources like transplant organs and money to pay for expensive treatments are scarce. Machines can keep a heart beating and lungs breathing, but is that a life the patient would want to live? Researchers can investigate new drugs and treatments, but on whom will they be tested, and what risks will patients face? When the answer “everyone” is not possible, then who decides? In 1962 a group of scientists recognized the dangerous questions medical advances raised. They gathered in London at the “Man and His Future” conference and spent three days talking about the effects of science on human life and values. The conference opened with these words: The world was unprepared socially, politically and ethically for the advent of nuclear power. Now, biological research is in ferment, creating and promising methods of interference with “natural processes,” which could destroy or transform nearly every aspect of human life, which we value. It is necessary for . . . every intelligent individual of our world to consider the present and imminent possibilities.1 This group of scientists recognized that bioethics would never be an exact science. Different values and priorities influence each person’s view of bioethical issues. The only certainty is that bioethics will continue to evolve as medical science creates new discoveries and puzzling dilemmas.

THE BEGINNING OF LIFE

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ot long ago the questions surrounding having a child were simple. How many? Boy or girl? For those who could not conceive, choices were limited—remain childless or pursue adoption. The biggest controversy centered on pregnancy outside of marriage. Over the past few decades, however, scientific advances have changed the debate considerably. Procedures such as in vitro fertilization (IVF) and surrogacy allow childless individuals to become parents. Still, some people argue that medical intervention is moving too close to “playing God.” As more complicated techniques emerge to create a child, the ethical debate has intensified. When does life begin? When egg donors and surrogates are involved, who is the rightful parent? Does everyone have the right to become a parent no matter their age or personal situation? And who should decide?

The Dawn of Assisted Reproduction The Centers for Disease Control and Prevention defines assisted reproductive technology (ART) as “all fertility treatments in which both eggs and sperm are handled. In general, ART procedures involve surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning them to the woman’s body or donating them to another woman.”2 IVF is the most common form of ART. In the 1970s in England, John and Lesley Brown tried unsuccessfully to have a baby. They met with Patrick Steptoe, a doctor who was experimenting with in vitro fertilization. Steptoe’s team removed eggs from Lesley Brown’s ovaries. In a petri dish, 9

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BIOETHICS they fertilized Lesley’s eggs with her husband’s sperm. Another scientist, Robert Edwards, devised a nutrient solution to feed and grow the resulting embryo. Then they placed the embryo into Lesley’s uterus. Nine months later, on July 25, 1978, Louise Brown was born. She was the world’s first healthy baby born through IVF. Louise’s birth sparked controversy. Some people believed humans had no right to intervene with the natural reproduction process. Others worried medical intervention might cause birth defects. For childless couples, the Browns’ success opened a door they thought had been closed forever.

The Growth of ART At first, ART helped married women who could not conceive naturally because of fallopian tube blockages. From the start, some people were nervous about the technology. Alan DeCherney, a past president of the American Society for Assisted Reproduction, frequently spoke to people about their fear of IVF. He ex-

When Does Life Begin? In 1973 the Supreme Court issued Roe v. Wade. The decision legalized a woman’s right to an abortion during the first three months of pregnancy. The ruling jumpstarted one of the first bioethical debates across the country. Central to the abortion debate is the question, when does life begin? For some, a cluster of cells has not yet become a viable life. For others, life begins at conception, and intentionally destroying that life is murder. Decades after the Roe v. Wade decision, the abortion debate intensified again over the drug RU-486. Developed

in the 1980s, RU-486 is a “morningafter pill,” designed to prevent the implantation of a fertilized egg if taken within a few days of unprotected sex. Supporters claim it is a birth control choice when regular birth control fails. Others oppose the drug because it acts after fertilization. For many people the abortion debate is a defining issue. People on both sides debate passionately about abortion and often find little room to compromise. To this day abortion remains an issue at the forefront of American politics.

John and Lesley Brown appear with their daughter, Louise, the first healthy baby to be born through in vitro fertilization.

plained how doctors were simply getting around a roadblock that stopped sperm from swimming to an egg. “I would tell them, ‘It’s just plumbing,’” DeCherney said. “All we were doing was putting a sperm and an egg together.”3 Early success rates were low, but they improved over time. By 2005, 35 percent of IVF cycles resulted in a live birth. The patients seeking ART also changed over the years. Healthy couples who wanted to avoid a genetic disease such as cystic fibrosis or hemophilia chose IVF and genetic testing to conceive a healthy child. In addition, IVF opened a controversial door to parenthood for older women, single mothers, and same-sex partners.

A Slippery Slope As the ART patient base expanded, new techniques also developed. Steptoe and Edwards created Louise Brown by simply allowing sperm and egg to “meet” outside of the body. At the time it was a solution that closely replicated nature’s way of creating an embryo. But as the years passed, scientists took a more active role in ART. Researchers manipulated sperm. They took cells out of

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BIOETHICS embryos to test for genetic defects. They moved cytoplasm, the jellylike substance that fills a cell, from one egg into another. Even a single sperm could now be injected into an egg. “It is amazing these procedures are not more destructive,” said James Grifo, director of the division of reproductive endocrinology at New York University Medical Center. “But embryos are incredibly resilient.”4 He added that research shows most embryos correct damage on their own. If they cannot, they will die rather than develop. Still, many people worry that too much interference in reproduction could have lasting repercussions on society. Because ART procedures are relatively new, there is very little long-term The pioneering techniques of British gynecologist Patrick Steptoe (left) and British physiologist Robert Edwards led to the successful test-tube birth of Louise Brown in 1978.

THE BEGINNING OF LIFE research on the effects it has on children born from ART. Doctors do not know yet if ART causes any long-term damage to DNA. While early research has shown ART to be safe, it is unknown if damaged DNA will cause these children to develop serious medical problems as they age. “Ultimately, there’s an individual at the receiving end of these experiments. That’s what’s troubling,”5 said Mark Sauer, an infertility researcher at Columbia-Presbyterian Medical Center.

The Role of Government As ART evolves, the government’s role remains uncertain. To date, no laws in the United States restrict ART to certain patients. However, beginning in 1994, lawmakers passed legislation to ensure no government funding could be used for any research that destroyed or endangered human embryos. As a result, infertility researchers are forced to use fees charged to patients to pay for their work. For scientists at facilities supported by federal money, a catch-22 arises. There is no way to test the equipment, medicine, and procedures without an embryo. Experiments with unfertilized eggs can be taken only so far. In order to see what methods work, scientists have to conduct research tests on willing patients. “We have done the first few steps,” Grifo said. “But can you make an embryo in order to study an embryo? No. We have to tell patients that we have gotten to this point and we are ready to try it on an embryo. So we’ll try it on your embryo. We’ll try it on you.”6

Cost Versus Benefit ART is an expensive procedure. A single treatment cycle typically costs ten thousand to fifteen thousand dollars, with no guarantee of success. “IVF costs what it does because it’s a personnelintensive, high-tech service,” said David Adamson, a reproductive endocrinologist. “It requires very highly skilled people and massive amounts of time. It’s very personalized care.”7 Only a handful of states currently require insurers to partially or fully cover IVF treatments. When not legally compelled, many insurers choose not to cover IVF costs. Critics argue this puts IVF out of reach for many lower- and middle-income patients. “People who make $250,000 a year are the ones swinging the out-of-pocket costs

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A human egg is injected with a micro needle containing a single sperm. The process of in vitro fertilization typically costs between ten and fifteen thousand dollars.

for assisted reproduction,” said Pamela Madsen, the executive director of a support and advocacy group for infertile individuals. “Maybe they have to give up the vacation. The more middle class are giving up their homes, and the working poor are out of it altogether.”8

THE BABY MARKET “There is the risk that people will behave too much like consumers and say, ‘Well gee, I’m paying all this money, why can’t you guarantee me a child?’ Because it’s not a market in that sense, that anyone can promise a child.” —Debora Spar, Spangler Family Professor of Business Administration at Harvard University. Quoted in Harvard Magazine, “The Baby Business,” July/August 2006. http://harvard magazine.com/2006/07/the-baby-business.html.

In addition, the cost of IVF pressures patients and doctors to place more embryos into a woman’s uterus during a treatment cycle. A round of IVF costs the same if doctors implant one or five embryos. The more embryos there are, the better the chance at least one of them will successfully implant and develop into a baby. This saves the couple the expense of paying for multiple

THE BEGINNING OF LIFE rounds of IVF. Implanting more embryos, however, is a risky choice. It increases the chance multiple embryos will develop, leading to twins or more. Multiple births pose a greater health risk to the mother and babies and increase the pregnancy’s cost.

The Fate of Embryos An unintended complication of IVF’s popularity centers on unused embryos. In a typical treatment cycle, doctors remove and fertilize several eggs. Of the embryos that develop, they select a few to implant. But what happens to the others? Couples undergoing IVF face four options for unused embryos. They can have them destroyed, make them available for research, donate the embryos to another infertile couple, or freeze them indefinitely. “You go into it thinking ‘I want a baby,’ not ‘I will have all these moral and ethical issues,’”9 said Kelly Jo Vancelette, who decided to freeze her five embryos. One woman struggling with the decision said, “You start saying to yourself, every one of these is potentially a life.”10 For those who believe life begins at conception, destroying embryos or donating them for research are not options. “Embryo adoption is an answer to the dilemma couples who have frozen embryos may face,”11 said Peggy Low, an adoption supervisor at Bethany Christian Services. Yet some couples are reluctant to hand over embryos to another family. “I couldn’t give my children to someone else to raise, and I couldn’t give these embryos to someone else to bear,”12 said one woman. For couples on the other side, embryo adoption can feel like walking into uncharted territory. Dan and Marilou Lyons agreed to attempt conception with a donated embryo. “It was very new,” said Marilou Lyons, “but we got our son, Jared, out of it.”13 Because the embryo was already created, the cost of the procedure was about five thousand dollars, significantly less than typical IVF. Another complication arises when couples divorce. “Technology and science are leaping way ahead of the law,” said Time legal reporter Alain Sanders. “The law is struggling mightily to catch up and deal with these scientific developments.”14 In one New Jersey case, the biological father sued for custody of seven

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BIOETHICS embryos stored at a facility that planned to destroy them. Believing life begins at conception, the father wanted to block the embryo destruction and have them implanted in his new wife. His ex-wife argued that her biological children should not be born without her agreement. The court agreed with the ex-wife’s position and granted her custody of the embryos.

Egg Donation As more women tried ART, one predictor of success became apparent—the mother’s age. As a woman ages, her ability to conceive declines. According to one study, 75 percent of thirty-year-old women who try to become pregnant will conceive within one year. By age thirty-five, that number falls to 66 percent and drops further to 44 percent by age forty. By forty-five, 87 percent of women are infertile. Researchers believe this happens because older women’s eggs are not as healthy as younger eggs. For these women, ART often fails. Egg donation was a solution to this problem. Using a younger woman’s eggs and ART, older women could conceive and give birth. At first, doctors were unsure if the technique would work. Would a woman’s body accept a foreign egg? The answer was yes. Richard Paulson, chief of the fertility clinic at the University of Southern California medical school, was one of the pioneers of egg donation. At first, his program limited patients to women no older than forty. But soon, the age limit crept to forty-five. “Lo and behold, they got pregnant at the same rate as women under forty,” said Paulson. “This was the light bulb. . . . The problem must not be in the uterus. The problem must be in the egg.”15 Richard Paulson, director of the University of California Program for Assisted Reproduction, was one of the pioneers of the technology for egg donation.

THE BEGINNING OF LIFE With couples able to use younger eggs, a new dilemma arose. How to find egg donors? At first, Paulson’s group tried to find women who would donate eggs free of charge to help couples become parents. Before long, however, egg-donor agencies opened to recruit and pay young women for eggs. College students were some of the most sought-after egg donors. Now many donor agencies and prospective parents run ads in college newspapers.

THE PERFECT EGG DONOR “They are all going to be attractive. . . . It’s very competitive. If a young woman has an Ivy League background, and she’s beautiful, and she’s athletic, she’s the person who’s more likely to get chosen.” —Shelley Smith, founder of the Egg Donor Program, a California egg donor agency. Quoted in Religion & Ethics Newsweekly, “Egg Donor Ethics,” September 1, 2006. www.pbs.org/wnet/religionandethics/week1001/cover.html.

Infertile couples can search egg donation databases by race, height, eye color, blood type, and education. Sperm banks provide the same opportunity for selecting a future child’s characteristics. One difference, however, is that most egg donors come with pictures and profiles, while sperm donors only provide basic genetic characteristics. Most parents try to match donor characteristics with their own to produce a child who looks like them. Still, it is no secret that eggs from smart, pretty women are in the greatest demand and carry the highest price. Critics fear this trend demonstrates how donor databases encourage couples to select desirable traits for their child. They believe favoring attractive and intelligent donors is a step closer to eugenics, the practice of encouraging reproduction in people with desirable traits.

The Price of an Egg Some people believe human eggs, like other body parts such as kidneys and blood, should be given free of charge. Others believe women should be compensated for their time and inconvenience.

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BIOETHICS Typically, donors receive several thousand dollars for their eggs. With eggs in short supply, the price for donation continues to increase. “Where does it stop?” asked Mark Sauer, a fertility specialist. “Egg donation is becoming like an auction.”16 Some people believe selling eggs is unethical. They believe eggs should be treated like hearts and kidneys and donated freely through a national donor system. The donors disagree. “I am going through injections daily and all sorts of medication,” said an egg donor. “I should be compensated.”17

Surrogacy If a donor’s eggs can be used to have a child, why not a donor’s uterus? After the dawn of ART, surrogacy quickly arrived as another reproductive choice. If a woman is unable to carry a child in her body, doctors can use ART to place an embryo in a surrogate mother’s uterus. The embryo can be created from the prospective parents’ egg and sperm. In this case the child is not genetically related to the surrogate mother. Alternatively, the surrogate’s eggs or donor eggs and sperm can create the embryo. In the majority of cases, surrogacy goes smoothly and as planned. But in others it does not. The case of Baby M (Melissa Stern) brought to light the ethical and legal difficulties surrounding surrogacy. Here, she is held by her father, William Stern.

THE BEGINNING OF LIFE

Helen Beasley, Surrogate Mother Helen Beasley had no intention of adding more children to her family. As a single mother, she decided to become a surrogate mother after hearing heartbreaking stories from childless couples. Through an Internet ad, Beasley agreed to carry a child for a California couple, Charles Wheeler and Martha Berman. Under the contract, Wheeler and Berman would pay Beasley twenty thousand dollars. Because the couple desired to have only one child, they included a clause in the contract that required Beasley to terminate the extra fetuses if she became pregnant with more than one baby. After Beasley became pregnant with twins, the relationship between her and

the couple soured. When the couple requested a termination of the second fetus, Beasley’s pregnancy was already in the thirteenth week. She refused, believing it was wrong and presented additional risk to her and the remaining fetus. Not wanting twins, the couple backed out of the surrogacy agreement and refused to pay Beasley. Beasley sued the couple for breach of contract and fraud. In August 2001 a California court ordered the couple to pay Beasley sixty-five hundred dollars and make future payments to her. In November 2001 Beasley gave birth to twins. At that time it was unclear if she would raise the babies or give them up for adoption.

In 1990 Anna Johnson, a California surrogate, carried a child created from the egg and sperm from Chris and Mark Calvert. Although Anna was not genetically related to the baby, she decided during her pregnancy she would not be able to give up the child. “Just because you donate a sperm and an egg doesn’t make you a parent,” said Richard Gilbert, one of her lawyers. “Anna is not just a machine, an incubator.”18 The prospective parents, Chris and Mark Calvert, disagreed. “That child is biologically Chris and Mark’s. That contract is valid,”19 said their lawyer. The courts agreed with the Calverts and awarded them custody of the child. Some people are not sure this was the right decision. “Biology does not give us an answer in this case,” said Mary Coombs from the University of Miami Law School. “Both women—the one who bore

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BIOETHICS the child and the one who provided the egg—have some biological claim to the child.”20 George Annas of the Boston University School of Medicine sides with the surrogate. “The gestational mother is the legal mother for all purposes. Biologically she’s taken the majority of the risks,”21 he said. Some states are getting involved in the debate. In April 2008 the Minnesota state legislature passed a bill that set legal guidelines for surrogate mother contracts. Under the bill, all parental rights reside with the intended parents, not the surrogate. The bill also makes the intended parents responsible for the child’s support even if they breach the contract. “This process is now totally unregulated,” said Linda Higgins, Minnesota state senator. “The bill lays out a procedure that protects all the parties in a surrogacy arrangement. It’s time to put on a level playing field all infertile couples who must use third party parentage to have children.”22

How Old Is Too Old? The success of ART, egg donation, and surrogacy has pushed the boundaries of parenthood. Nature biologically sets a mother’s age limit by gradually decreasing a woman’s fertility as she grows older. Now younger eggs and surrogate wombs allow older women to become mothers. Adriana Iliescu, a Romanian woman reported to be the world’s oldest mom, gave birth at age sixty-six in 2005. Is there a line, however, that should be drawn? At what point are parents, and mothers, too old to have children? Adriana Iliescu holds her daughter ElizaMaria. The Romanian woman’s age at childbirth, sixty-six, is the oldest on record.

THE BEGINNING OF LIFE Without regulation, fertility clinics and doctors frequently set their own age guidelines. Some develop a formula for a couple’s combined age; others set a maximum maternal age. Sometimes limits are stretched. Vicken Sahakian admits he treated a sixtyfour-year-old woman and her sixty-eight-year-old husband. After the pregnancy via surrogate miscarried, he said, “I refused to do it again with the frozen embryos.”23 The couple took their embryos to another clinic. For mothers over forty and their babies, pregnancy’s medical risks rise rapidly. Older mothers are more likely to have complications like diabetes and hypertension during pregnancy. Their risk of delivery complications and cesarean section is also higher. With additional care required for these high-risk cases, the costs of pregnancy for older women are skyrocketing. Some people also question if it is fair to bring a child into the world with parents who will be in their seventies and eighties when the child enters high school. In England doctors refused to treat a woman in her fifties, claiming she was too old for the stress of motherhood. The British secretary of health explained, “There are deep ethical considerations, and the child’s welfare must be considered. A child has a right to a suitable home.”24 The woman in question found an Italian clinic willing to treat her. At fifty-nine, she gave birth to twins.

Who Decides? As ART evolves, doctors increasingly make moral and ethical decisions. Without any substantial governmental regulation, doctors decide every day which families and children they will create and which they will not. “It’s a hell of a position to be in,” said Linda Applegarth, a psychologist for the Center for Reproductive Medicine and Infertility in Manhattan. “I don’t think this technology is here to fix every problem for every individual. People have to deal with certain losses in their lives.”25 Most clinics start with objective criteria. Patients must have a chance at a successful pregnancy, not have serious psychiatric problems, and be able to pay. Beyond that, the criteria become subjective. Age limits differ from clinic to clinic. Most doctors insist,

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BIOETHICS however, that they try to not base their judgment on the strength of a couple’s marriage or on a couple’s sexual orientation. A screening and counseling process may eliminate some patients. Mark Sauer admits to declining to treat a single woman in her forties because of her limited support network and because she was already taking care of a near-death elderly father. “There was a concern that she was replacing one with the other,”26 he said. In the end, the ethics of assisted reproduction are evolving as fast as the technology advances. As more questions and situations arise, doctors find themselves on the ethical front lines. “Who is our patient?” asked Applegarth. “Is it the two people sitting in front of me? The child potentially created? The donor of the gamete? We have to consider all of these people when we’re making these decisions.”27

THE DECISION MAKERS

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ealth care issues can affect more than just the individual. They can affect society as a whole. In these cases, decisions rest in the hands of a few people. When an infectious disease spreads out of control, public health officials can quarantine patients to halt the spread of infection. To prevent diseases such as smallpox and measles, health officials can mandate school vaccinations. Doctors also decide who receives care when technology and resources are expensive and scarce. These decision makers often face a difficult task. Choices that benefit the greatest number of people may harm some individuals. In these cases, debate swirls over where the line between individual rights and the good of society falls.

The Case of Typhoid Mary The highly publicized case of Typhoid Mary in the early 1900s illustrated the controversy between government rights versus individual rights. In 1906 Mary Mallon took a job as a cook for a family in Oyster Bay, Long Island. Within a few weeks of her arrival, several family members contracted typhoid. Typhoid is a bacterial disease usually spread by eating or drinking contaminated food or water. Health officials investigated the case and discovered several of Mallon’s previous employers also had typhoid outbreaks. They suspected Mallon might be unknowingly causing the outbreaks. When they asked her for blood, urine, and stool samples to test for the disease, Mallon refused. Eventually, the police forced Mallon to submit samples for testing. As suspected, the tests proved she carried the live typhoid bacteria. Mallon refused to believe the tests because she had never 23

Mary Mallon (foreground), known as “Typhoid Mary,” lies in bed in a medical institution on North Brother Island, New York.

contracted typhoid herself. Health officials puzzled over this question. Then they discovered Mallon could be a carrier for the disease without getting sick herself. She could, however, infect others through her cook’s job. Seeking to preserve public safety, officials quarantined Mallon against her will in a North Brother Island, New York, hospital. Three years later, in 1910, a new public health commissioner released Mallon under two conditions: She was never to work as a cook, and she was also required to keep in contact with health officials. Initially, Mallon kept her promise. But within a few years, she returned to cooking under the name Mrs. Brown. In 1915 she cooked in the Sloane Maternity Hospital. While Mallon worked there, twenty-five hospital employees contracted typhoid. When officials discovered Mallon again, they faced an ethical decision. Mallon’s refusal to stop cooking put the public in danger. They had to weigh Mallon’s individual rights against public safety. Eventually, officials returned Mallon to quarantine on North Brother Island. She remained there for the next twentythree years, until her death in 1938. Mallon’s frustration with her imprisonment was evident in a letter she wrote while on the island. “I have been in fact a peep show for everybody. Even the interns had to come to see me. . . . The tuberculosis men would say ‘There she is, the kidnapped woman,’”28 she wrote.

THE DECISION MAKERS

Recommended Immunizations, United States, 2009: Ages Zero to Six Years

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BIOETHICS Mallon’s situation drew debate from both sides. Some believed it unfair to imprison her when she had broken no laws. Others, however, believed the risk of Mallon spreading typhoid was too great.

Childhood Vaccines Years later similar debates over government versus individual rights emerged over mandatory childhood vaccines. Decades ago highly contagious diseases such as smallpox, polio, diphtheria, whooping cough, and measles disabled or killed many people. The development of vaccines allowed millions of people to be immunized against these diseases. According to the Centers for Disease Control and Prevention (CDC): The greatest success story in public health is the reduction of infectious diseases resulting from the use of vaccines. Routine immunization has eradicated smallpox from the globe and led to the near elimination of wild polio virus. Vaccines have reduced some preventable infectious diseases to an alltime low, and now few people experience the devastating effects of measles, pertussis and other illnesses.29

THE RISK OF REJECTING VACCINES “The very success of immunizations has turned out to be an Achilles’ heel. Most of these parents have never seen measles . . . so they turn their concerns to unfounded risks. They do not perceive risk of the disease but perceive risk of the vaccine.” —Mark Sawyer, a pediatrician and infectious disease specialist at Rady Children’s Hospital in San Diego. Quoted in Jennifer Steinhauer, “Public Health Risk Seen as Parents Reject Vaccines,” New York Times, March 21, 2008. www.nytimes.com/2008/03/21/us/21vaccine.html?_r=2.

Many communities mandate that all people receive vaccines to prevent the spread of disease. Despite vaccine benefits, there are risks. The CDC admits that “no vaccine is 100% safe or effective. Differences in the way indi-

THE DECISION MAKERS vidual immune systems react to a vaccine account for rare occasions when people are not protected following immunization or when they experience side effects.”30 Although rare, potentially lifethreatening side effects can include seizures, encephalitis, or allergic reactions. For these reasons, some people resist mandatory vaccinations. They believe no person should have the right to force an unwanted substance into someone’s body.

A PARENT’S RIGHT TO DECIDE “As parents, we brought our children into this world and we should be able to consent to any medical intervention that they should receive. Currently, I have to consent to surgery, why shouldn’t I have to consent to vaccinations?” —Maria Pinho, parent. Quoted in Jennifer Kohlhepp, “Parents Fight for Vaccination Choice,” (NJ) Independent, November 20, 2008. http://independent.gmnews.com/news/2008/1120/front_page/023 .html.

The Debate over Hepatitis B While many people support vaccinations for highly contagious, life-threatening diseases, the decision is harder when the vaccine is for rarer, harder-to-contract diseases. One example is hepatitis B, a chronic disease that can lead to liver problems and occasionally to death. Primarily spread by direct contact with blood and other body fluids, most new hepatitis B infections occur in teens and young adults. Immunizing high-risk groups proved ineffective against the disease, as many people did not realize they were at risk until they had already contracted it. Health officials decided to vaccinate children to protect them when they were older. The controversy over the vaccine arose when some children became sick after receiving the vaccination. Lyla Rose Belkin was a healthy five-week-old baby. After receiving a hepatitis B vaccination she became agitated and fussy. “Then she fell asleep and never woke up,”31 remembers her father, Michael Belkin. Unable to find a reason for her death, doctors blamed sudden infant death syndrome.

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A fourth grader receives the hepatitis B vaccination. There is heated debate over whether the vaccine’s risks outweigh the benefits to young children.

Lyla’s parents, however, believed the hepatitis B vaccine played a role in her death. They researched the disease, which causes liver inflammation and jaundice, and discovered it is spread through contact with body fluids during unprotected sex, blood transfusions, or sharing drug needles. Lyla’s chances of contracting the disease as a newborn were incredibly small. “It’s ridiculous to give this vaccine to a newborn. How is a baby possibly going to get hepatitis B?” Michael Belkin asked. “Vaccination can be a lifesaver if an epidemic is raging, but in this case the risk of vaccination outweighs the risk of infants getting the disease. I believe the mandatory policy for hepatitis B vaccination should be completely revoked.”32 Groups opposing the vaccine agree with the Belkins. They claim it is responsible for a variety of serious reactions, including seizures, autoimmune diseases, and multiple sclerosis. Opponents of the vaccine believe the risks far outweigh any benefit for children. “What are the chances of my child getting it from another child?” said Kathy Rothschild, a mother fighting mandatory hepatitis B vaccination in Illinois. “It’s like zero. It doesn’t exist.”33

THE DECISION MAKERS

THE NEED FOR VACCINES “A lot of us who understand childhood illness and who understand vaccines feel incredibly passionate that we cannot allow large segments of the community to go un-immunized. Kids will die.” —Jeffrey Boscamp, chair of the department of pediatrics at Hackensack University Medical Center. Quoted in Carol Ann Campbell and Susan K. Livio, “Parents, at Statehouse Rally, Protest Mandatory Vaccinations for Children,” Star-Ledger, October 16, 2008. www.nj.com/ news/index.ssf/2008/10/parents_protest_mandatory_chil.html.

Public health officials and vaccine manufacturers argue that the hepatitis B vaccine has been safely administered to over 20 million children and adults across the country. They argue the disease affects over 1 million Americans and is one hundred times more easily transmitted than HIV or AIDS. Harold Margolis, chief of the CDC’s hepatitis branch, said: All perspectives lead me to the same conclusion. Hepatitis B is a real and serious risk to infants and young children; that we have a safe, effective and proven vaccine for addressing that risk; and that as scientists, physicians, policy makers and parents, it is our responsibility to protect the current and future health of our children by broadly using this vaccine.34

Vaccines Today Today the Advisory Committee on Immunization Practices sets vaccination policies for the United States. The fifteen-member committee recommends which vaccines should be routinely given to children and adults. Frequently, state officials take the committee’s recommendations and add them to a mandatory vaccination list. Often, there is little public debate or discussion when a new vaccine is added. Public health officials believe each new vaccine benefits society by lessening the impact of another disease. They point out that preventing a disease is better than trying to treat it. Not vaccinating is

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BIOETHICS A young boy receives a vaccination. Public health officials maintain that each new vaccine benefits society, but some parents are uncomfortable with mandated vaccines.

a dangerous choice that could lead to outbreaks of disease and put entire communities at risk. This risk was highlighted in 2008 when at least 127 people in fifteen different states came down with measles. Before the outbreak, measles, which is a leading cause of child death in poor countries, had been virtually eliminated in the United States. The CDC said that the new outbreak was triggered by travelers who picked up the virus overseas and infected others upon their return to the United States. According to health officials, most of the infected people were not vaccinated against the highly contagious disease. Public health officials also point out that scientific studies continue to show that vaccines are beneficial and not harmful. Despite claims from parents that vaccines may play a role in triggering autism, scientific studies have found no clear link between the two. In addition, the Journal of the American Medical Association reported a real benefit to the national vaccine program. They found that deaths and sickness from diseases like mumps, measles, and smallpox have dropped significantly since national vaccine recommendations were implemented. Although over 90 percent of parents have their children vaccinated, a small but growing number are having second thoughts. “Parents are drawing a line in the sand,” said Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center. “They’ve been good soldiers and have given vaccines to

THE DECISION MAKERS our children in the past few decades. And now they’re saying, ‘You know, this doesn’t feel right.’”35 Some doctors have also become uncomfortable with the practice of mandated vaccines. In November 2000 the Association of American Physicians and Surgeons (AAPS) voted to pass a resolution calling for the end of mandatory childhood vaccines. “Our children face the possibility of death or serious longterm adverse effects from mandated vaccines that aren’t necessary or that have very limited benefits,”36 said Jane M. Orient, AAPS director.

Parents Refuse Mandatory Vaccinations As more people refuse vaccinations for their children, some public health officials have turned to the legal system to help enforce immunization policies. In November 2007 officials in Prince George’s County, Maryland, notified parents of more than twenty-three hundred students that they could face fines or jail time if they did not get their children immunized for chicken pox and hepatitis B as mandated by the state. “We can do this the easy way or the hard way, but it’s got to get done,” said Glenn F. Ivey, Prince George’s state attorney. “I’m willing to move forward with legal action.”1 School board chair R. Owen Johnson Jr. agreed. “This is an educational crisis,” he said. “This is a public health and a children’s rights issue.”2 Angered parents protested that they should have the right to decide what is

put into their child’s body. “There are serious considerations for safety that need to be addressed before compelling people to get vaccines,” said Jim Moody, a parent in Prince George’s County. Parents also argued for exemption waivers to be more readily available. In some cases, states allow children to opt out of certain vaccinations based on medical or religious reasons. Vaccine opponents want more states to allow waivers for philosophical differences as well. 1 Quoted in Nelson Hernandez, “Get Kids Vaccinated or Else, Parents Told,” Washington Post, November 14, 2007. www.washingtonpost.com/wp-dyn/content/article/ 2007/11/13/AR2007111301 408.html. 2 Quoted in Gary Nurenberg, “Vaccines or Else: Parents Blast Order for Schoolchildren,” CNN.com, November 17, 2007. www.cnn.com/2007/US/11/17/maryland.vaccines/ #cnnSTCText.

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A Shortage of Resources In a country with the finest medical technologies and procedures, a stark truth exists. Sometimes there are not enough resources for everyone, and a choice has to be made. Medical professionals have to decide which patients will receive a lifesaving treatment and which ones will be turned away. The allocation of resources is critical to organ transplantation. Healthy organs are hard to find. People wait months or years for a chance at a lifesaving transplant. On October 8, 2008, the number of people waiting for an organ transplant exceeded one hundred thousand for the first time in history. In 2007 sixtyseven hundred people died waiting for a transplant. For kidneys, the most commonly transplanted organ, the average wait time now exceeds three years and can last up to seven. This extreme

Belding Scribner’s Dialysis Machine In 1962 Belding Scribner developed a new way to treat serious kidney disease. He used a small plastic tube, sewn into the vein or artery of the wrist, to drain a patient’s blood supply. The blood passed through a dialysis machine, where it was cleansed and returned to the patient’s body. The dialysis machine took over the kidney’s job of removing toxins from the blood. Prior to Scribner’s machine, people with end-stage kidney disease died within a few months of diagnosis. Now they could live for years with regular sessions on the dialysis machine. Quickly, Scribner’s small Seattle clinic faced an ethical dilemma. The

number of patients who needed the lifesaving treatment far exceeded what the small clinic could provide. They decided to form a committee to choose which patients would receive dialysis. As they read patient files, they struggled to decide on fair selection criteria. Should preference be given to parents of young children? Would young patients fare better than older ones? The questions grew gray, but choices still had to be made. For those who were not chosen, the outcome was simple. They died. The decisions made at Scribner’s clinic were some of the first tentative steps into bioethics.

THE DECISION MAKERS shortage of organs causes the dilemma of choosing a patient when an organ becomes available. Since 1986 the United Network for Organ Sharing has set criteria to match organs and patients. Determined to be fair, the current system allocates organs to the sickest patients and those who have been waiting the longest. Despite efforts to allocate organs fairly, the actual organ distribution process is full of inequality, critics argue. Factors such as geographic location, patient wealth, and personal history sometimes affect allocation decisions.

Distribution Inequalities The first place patients run into problems is getting on the transplant waiting list. Every patient in need of an organ is not automatically added to the list. To get on the list, patients need access to a doctor who will refer them to one of several hundred transplant centers across the country. Once referred, the patient must prove to the center he or she has the ability to pay for the transplant and for antirejection drugs after the surgery. For the pool of patients who make it this far, the center evaluates each candidate. Evaluators look at a patient’s medical history, age, and potential life span. Most centers also require patients with substance abuse problems to show they have been clean for a period of time. Evaluators may also consider a patient’s mental health history. Some programs exclude patients with different types of dementia, while others believe it is irrelevant. “Justice would seem to call for the same criteria everywhere,” said James Levenson, a professor of psychiatry, medicine, and surgery at the Medical College of Virginia in Richmond. “The countervailing argument is that we don’t have enough experience and enough data to know exactly what the right answer is.”37 Once added to the list, patients wait for an available organ. When an organ becomes available, medical professionals enter the organ’s information into the national transplant computer system. They run a recipient match program to identify transplant candidates. The program ranks patients according to who is the closest blood and tissue match, the urgency of the patient, and the length of time on the waiting list. The available organ is offered to the patient who is highest on the list. If turned down, the

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Desperate for a liver transplant, cancer patient Todd Krampitz rented two billboards advertising his plight in 2004. He received a liver but died eight months after the transplant.

organ goes to the next patient on the list, and so on until a placement occurs. Sometimes where patients live may affect how long they wait for an organ. The transplant system divides the United States into fifty-eight territories. Each has its own supply and demand for organs. Most donated organs stay within their territory, even if there are sicker patients in other territories. This system began as a way to ensure people in all regions of the country had access to organs. Some regions, like big cities with less-healthy populations, experience higher demand and longer wait lists. Knowing this disparity, wealthier patients can afford to travel to centers with more available organs and shorter wait times. For patients struggling to pay bills, travel is not an option. “Most of my patients come from the Appalachian Mountains,” said Dinesh Ranjan of the University of Kentucky. “They are not going to travel to Boston or L.A. to get a transplant. They are going to stay here and die.”38 Despite efforts to ensure fair organ distribution, some cases have stirred controversy. One way to jump ahead on the transplant list is to have a donor family specifically designate a patient as the organ recipient. In 2004 Houston doctors diagnosed thirtytwo-year-old Todd Krampitz with liver cancer and told him a transplant was his only chance to survive. Krampitz and his family decided to bypass the transplant waiting list. They launched a media campaign for a donor on highway billboards and the Internet. The plan worked, and an anonymous family donated their

THE DECISION MAKERS loved one’s liver directly to Krampitz. Unfortunately, Krampitz passed away eight months after the transplant. Annie Moore, a spokesperson for the United Network of Organ Sharing, said bypassing the established transplant system and advertising for organs is wrong. “What our board members are concerned about is that they may divert organs from patients with critical needs to those who are less ill,”39 said Moore. Families desperate to save a loved one disagree. Jennifer Hennessy’s father had been waiting three years for a liver. After hearing about Krampitz’s success, her family decided to put up their own billboard. “What I’m trying to accomplish is awareness of organ donation and getting my father a liver,” she said. “My heart goes out to other people, and that’s one of the reasons why I’m saying donations are key,” she added. “But in the same breath, it’s my father, and I’ll do anything I can to keep him alive.”40

The Price of Care The high cost of care also affects health care decisions. New technology, procedures, and medicines make it easier than ever to save a life. These advancements, however, come with a price tag. Despite the desire to give everyone access to expensive treatments and drugs, the harsh reality is that there is not enough money to pay for it all. Should these treatments only be given to those who can afford them? Or does the medical profession have a responsibility to treat all patients, regardless of their ability to pay? The American health care system is one of the most expensive in the world. In 2007 the United States spent $2.7 trillion on health care, more than any other industrialized nation in the world. Millions of dollars pour into disease research, drug development, and cutting-edge equipment testing. By the time these advances reach patients, the cost is high. “Americans rejected the tougher restrictions of managed care in the late 1990s, and yet they want all the latest advances in medical technology,” said Drew Altman, president of the nonpartisan Kaiser Family Foundation, “The inevitable result is higher costs.”41 Without health insurance and government programs like Medicaid and Medicare, few people could afford to go to the doctor.

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BIOETHICS As medical expenses rise, insurance companies and health management organizations search for ways to hold down costs. Some cost containment policies take care decisions away from doctors and patients and place them with the insurance company. At times, this approach makes sense. Requiring approval of a doctor’s treatment plan can save money by eliminating unnecessary procedures. Not every patient needs to be screened for every disease. Focusing procedures on high-risk patients is a wiser use of precious resources. In other cases, however, this cost containment approach can have dire consequences. In December 2007 CIGNA made headlines when it refused to cover the cost of a liver transplant for seventeen-year-old Nataline Sarkisyan. The California girl, who was being treated for leukemia, suffered complications after a bone marrow transplant and needed a new liver. Despite the recommendations of her doctors, the insurance company declined to cover the transplant, claiming her plan did not cover experimental, investigational, or unproven services. After nationwide protests, CIGNA reversed its decision, but it was too late. Sarkisyan died hours after the transplant approval finally arrived. “They took my daughter away from me,” said Sarkisyan’s father. “They cannot make people’s decisions if they [are] going to live or die.”42 For the over 47 million people without health insurance, the situation is worse. If they get sick, they have to decide whether to pay for health care or for other living expenses. For the uninsured, some medical providers refuse to see them at all until they prove they can pay for treatment. For years many hospitals have opened their doors to the uninsured. No patient in need was turned away. The reality of rising costs is forcing some hospitals, however, to rethink this policy. Some, like the University of Texas Medical Branch in Galveston, have decided they can no longer afford to keep treating people for free. Instead, they have created a set of rules and regulations to determine who gets what care. Undocumented immigrants only qualify for emergency care. Uninsured patients can receive basic care, but many procedures and medications are prohibited. “I’m willing to call it rationing because that’s what it is,” said Joan Richardson, the hospital’s medical director. “But, it makes me angry. That’s not what I signed on to do.”43

Some insurance companies consider transplants experimental procedures. In the case of Nataline Sarkisyan, her insurer approved a liver transplant only hours before she died.

To control costs and pay for needed medical care, Oregon has implemented a ranking system for services residents can receive under Medicaid. Under the system, 680 procedures are ranked according to their costs and benefits. The state legislature annually draws a line—how far down the list they will cover procedures. As of October 1, 2008, numbers 1 through 503 receive coverage. At number 501, removal of breast cysts is covered. At number 575, liver transplants for cancer patients are not. Critics of the Oregon ranking system claim it discriminates by depriving the poor of needed procedures. Supporters, however, argue limiting procedure costs has allowed the state to expand basic coverage to more residents. “I think there’s a certain level of primary and preventive medical services that make an enormous amount of sense to ensure that all citizens have access to,”44 said former governor John Kitzhaber. As more medical breakthroughs emerge, the search for fair and just ways to allocate scarce resources will continue. The decision makers on the front lines will face the burden of tough, sometimes unpopular, choices as they try to achieve the greatest good for the greatest number of people.

THE END OF LIFE

T

he founding of America has its roots in the protection of human liberty. The Bill of Rights guarantees certain freedoms for all Americans. The right to free speech, the right to practice a religion, and the right to bear arms are all protected. Americans have the freedom to live their lives as they choose. But should people have the same rights when it comes to the end of life? Faced with a long and painful death, some believe the end of life should also be in their control. Others argue that life should be preserved at all costs.

Euthanasia Through the Ages Helping someone die in order to end suffering is known as euthanasia. Passive euthanasia is simply removing life support or not administering lifesaving treatments. Active euthanasia occurs when a person takes steps to induce death, like taking a lethal dose of painkillers. In some cases, active euthanasia is also called assisted suicide. Euthanasia comes from the Greek word meaning “good death.” Euthanasia has existed for centuries. In Greek and Roman societies, it was not uncommon to choose voluntary death over prolonged suffering. Even then the practice was not without opposition. Jewish and Christian leaders condemned euthanasia. They believed God alone has the right to choose when each person will die. Some doctors felt the practice violated their Hippocratic oath. The perception of euthanasia became more sinister during World War II. Nazi Germany carried out a horrific plan of euthanasia against the mentally handicapped, crippled, and physically deformed. The Nazis intended to purify their gene line and 38

THE END OF LIFE eliminate those they considered to be unworthy of life. These programs eventually evolved into the genocide of German Jews.

Advances in Medicine Prolong Life Until recently most people never had to consider the option of ending their own life or the life of a loved one. Death often happened at home, with the dying person surrounded by family and friends. It may have been painful, but without treatments to prolong life, it was usually quick. In the twenty-first century, medical advances have allowed doctors to better diagnose and treat disease. With the introduction of antibiotics and vaccines, people are no longer dying of the quick bacterial and viral diseases of the past. Young people now expect to live well into old age. The definition of “old age” has also shifted, with people in their sixties and seventies frequently enjoying active and healthy lives. In some cases not all medical advances have been helpful. Doctors are now able to diagnose devastating diseases like Parkinson’s,

Bottles of antibiotics line a pharmacy shelf. People are living much longer today than in the past because of such medical advances.

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BIOETHICS a progressive illness that disrupts motor skills, speech, and balance, long before the patient exhibits major symptoms. When there is no effective cure or treatment, knowing what the future holds may be terrifying for some people. As doctors prolong life, the focus is shifting away from simply keeping people alive to helping them have a good quality of life.

Living Between Life and Death The discussion about quality of life heats up over a recent medical condition—brain death. Not long ago defining death was a simple task. When the heart stopped beating and the lungs ceased breathing, a person was declared dead. Now artificial life support can interrupt the body’s natural process of dying. Machines keep lungs breathing and hearts beating. Tubes supply food and water. Catheters eliminate waste from the body. By traditional definitions, the body is not dead. But is the person truly alive?

CHOOSING TO DIE “If I go through with it, I die as I must at some point. If I don’t go through with it, my choice is essentially to suffer, and to inflict suffering on my family, and then die.” —Craig Ewert, diagnosed with a degenerative motor neuron disease, who ended his life in 2006 via assisted suicide. Quoted in Gregory Katz, “Suicide on TV Condemned in Britain,” Seattle Times, December 11, 2008. http://seattletimes.nwsource.com/html/nationworld/2008490101_apeu britaintelevisedsuicide.html.

The concept of brain death emerged with the newfound ability to keep people alive indefinitely on life support. Brain death occurs when all brain activity stops and there is no hope of recovery. Life support will keep the patient’s lungs and heart working even though the brain is not. Some people believe holding patients in this endless limbo between life and death is a cruel punishment. In this situation, doctors and families face a new ethical dilemma—when should life support be removed?

THE END OF LIFE

The Case of Karen Ann Quinlan The choices surrounding patients on life support came to the nation’s attention in the 1970s. On April 15, 1975, twenty-oneyear-old Karen Ann Quinlan arrived at the hospital unconscious after a night of drinking and ingesting the tranquilizer Valium. She stopped breathing on at least two occasions, causing severe brain damage. Doctors put Quinlan on a respirator. Weeks later, she still had not regained consciousness. Unconscious, she relied on the respirator and a feeding tube to live. When her parents, Joe and Julia Quinlan, realized Karen was not going to recover, they faced a terrible choice. Should they continue to let her live hooked up to machines but unaware of Julia Quinlan holds a copy of her book My Joy, My Sorrow, an account of her family's decision to remove her daughter Karen Ann Quinlan from life support in 1975.

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Nancy Cruzan On January 11, 1983, Nancy Cruzan lost control of her car and crashed. Before paramedics were able to restore her breathing and heartbeat, Cruzan’s brain was deprived of oxygen for several minutes. As she lay in an unconscious state, doctors inserted a feeding tube with her family’s consent. After several years, Cruzan’s family faced the reality that she would never get better. After accepting this hard truth, Nancy’s family asked the hospital to remove her feeding tube. To the Cruzans’ surprise, the hospital refused. Officials told the Cruzans they needed to get a court order to have the tube removed. The Cruzan case eventually landed in the U.S. Supreme Court. The Court

ruled against the Cruzans but left the door open for a new trial if there was evidence of Nancy’s wishes before the accident. With three friends testifying about conversations with Nancy regarding living on life support, the Cruzans won a second time with the Missouri trial court. This time there was no appeal. On December 14, 1990, eight years after Nancy’s accident, doctors removed her feeding tube. She passed away on December 26. After the Cruzan case, the federal government passed the Patient SelfDetermination Act. Under the act, all hospitals must counsel patients about living wills and health care planning.

the world around her? Or should they turn off the machines and allow Karen to die? The Quinlans eventually asked the hospital to turn off Karen’s respirator. This sparked debate across the country. Supporters believed allowing Karen to die was compassionate. Others called it murder. The Quinlans disagreed. “We didn’t ask for Karen to die,” said her mother, Julia. “We just asked for her to be removed from technology and be placed in a natural state.”45 Joe Quinlan took his case to the New Jersey courts, asking to be appointed Karen’s guardian. As her guardian, he would have the authority to direct the hospital to turn off Karen’s respirator. The Quinlan family was united in their belief that they, not doctors or courts, should make decisions for Karen. “What right have you . . . to make decisions about my daughter’s life,” asked Julia Quinlan. “Will you be at the grave when she dies? Will you ever

THE END OF LIFE visit her grave? Will you cry yourself to sleep night after night, and just dread holidays to occur because you have to celebrate without her? No, I’m afraid not.”46 The New Jersey Supreme Court granted Karen’s father’s request. The Quinlans had Karen’s respirator removed. To everyone’s surprise, however, Karen continued to live for ten more years, until she died of pneumonia in 1985. The Quinlan case brought the discussion about life support into Americans’ living rooms. A few years after Quinlan’s death, another young woman’s case would further intensify the debate.

Terri Schiavo At twenty-six, Terri Schiavo collapsed in her Florida home, suffering a heart attack. Paramedics performed CPR and restarted her heart several times with defibrillation paddles. Months later, Schiavo remained unconscious. Doctors believed her brain had been irreversibly damaged when her heart had stopped beating. Schiavo’s brain stem still functioned, so her heart beat and she could breathe without machines. She was, however, completely unaware of her surroundings. Doctors called Schiavo’s condition a persistent vegetative state (PVS). PVS patients are not brain-dead. Their eyes may be open and they may utter sounds without meaning. They may appear to smile, grimace, or cough. Despite these actions, a PVS patient’s brain has been so damaged there is no thinking, no feeling, and no consciousness. If the condition does not improve within three months, doctors consider it permanent. The criteria for diagnosing PVS are very specific. According to neurologist Ronald Cranford: “If there is any small amount of thinking or feeling or awareness or consciousness, then the patient is not in a persistent vegetative state. This is a complete lack of consciousness.”47 Over the next several years, Schiavo remained in a vegetative state. A feeding tube provided her fluids and nutrients to sustain her life. In 1998, after Schiavo’s most recent neurological exam again concluded she had little chance of improvement, Michael Schiavo, her husband, filed a petition in the Florida courts seeking authorization to remove Terri’s feeding tube. According to Michael, he was trying to make a decision based on what Terri would have wanted.

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BIOETHICS Terri’s parents, Bob and Mary Schindler, refused to give up hope their daughter might one day recover. Terri smiled at her mother, they said, and still demonstrated some responsive behavior. They went to court to stop the removal of Terri’s feeding tube. Given the chance, they argued, Terri would want to live. Michael disagreed. He believed Terri would not want to be kept alive in her current condition. For the next seven years, the legal battle raged. During this time, the media publicized Terri Schiavo’s case widely. Soon, families across America knew about Schiavo and formed opinions over the legal struggle to remove her feeding tube. Supporters argued artificial feeding was a form of treatment, since Schiavo was unable to eat or swallow on her own. They believed the feeding tube, like a respirator, should be removed if there was no hope of recovery. Others strongly disagreed. One woman wrote to Florida governor Jeb Bush that “if a person in Florida stopped feeding and watering their dog, they would be punished for cruelty to animals. This is a human life we are talking about here.”48 Terri Schiavo's family holds a press conference to announce the launch of the Terri Schindler Schiavo Foundation in March 2006.

THE END OF LIFE The battle over Terri Schiavo continued through trials, depositions, hearings, and appeals. Twice artificial nutrition and fluids were stopped and then restarted. Even the state of Florida and the federal government tried unsuccessfully to stop the removal of Schiavo’s feeding tube. Finally, in 2005 the courts upheld Michael Schiavo’s status as Terri’s guardian and approved his request to remove her feeding tube. On March 18, 2005, doctors removed the tube one last time. Thirteen days later, Terri died. After her death, an autopsy revealed Terri Schiavo’s brain was severely damaged. It was less than half the weight of a normal brain for a woman her age. The persistent vegetative state diagnosis was most likely exactly right.

A Patient’s Right to Decide The well-publicized cases of Karen Ann Quinlan and Terri Schiavo inspired families to talk more openly about their wishes for treatment at the end of life. The practice of advance directives and living wills became more common. People wanted to leave specific instructions for doctors and loved ones about the choices they wanted made at the end of life. In a 2004 study, however, two-thirds of doctors said they would ignore advance directives in cases where a patient’s prognosis remained hopeful or family members disagreed. Doctors also noted advance directives can be vague, asking for “no heroics” but not defining what that means. Some point to cases where patients have left instructions not to be put on a respirator, but doctors will violate the request if they believe the machine will only be needed for a short period of time. “It’s impossible for people to fine-tune what they want and don’t want in the way of medical care in advance,” said Alan Meisel, a professor of law and bioethics at the University of Pittsburgh. “They never know what the situations will be. They’re particularly complex and constantly changing.”49 For a few people, there is time to decide what treatment they will or will not accept at the end of life. Andrew James Turner Jr., a seventy-three-year-old cancer patient, announced to family in May 2004 that he was having his feeding tube removed and would refuse all further treatment and food. “If you have any

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BIOETHICS comments about that, I will listen to them,” he said. “But this is my decision.”50 Five weeks later Turner died peacefully at home.

Choosing a Good Death Sometimes controlling death is more than refusing treatment. For some people, actively choosing the time, place, and manner of death is a basic human right. The practice of suicide is not new. However, early laws allowed states to penalize those who committed suicide. In 1828 New York was the first state to outlaw assisted suicide. Many states followed New York’s lead and passed similar laws. As more people die of protracted illnesses like heart disease, cancer, and stroke, the topics of suicide and assisted suicide have resurfaced. Faced with the prospect of a slow, painful death, people increasingly support taking an active role in death. In a 2004 Gallup poll, 65 percent of people said a doctor should be allowed to assist a suicide when a person was in pain and dying from an incurable disease. “People are definitely more open about it than in the past,”51 said Leonard A. Sharzer, a doctor and bioethicist.

The Face of Assisted Suicide—Jack Kevorkian For many people the subject of doctor-assisted suicide will be forever intertwined with former pathologist Jack Kevorkian. In the Detroit suburbs in 1990, Dr. Kevorkian hooked up fifty-four-year-old Janet Adkins to a homemade suicide machine in the back of a Volkswagen van. Kevorkian showed Adkins, who had early stage Alzheimer’s, how to press a button to inject drugs into her body. The drugs would render her unconscious and eventually stop her heart. When the news broke about Kevorkian’s role in Janet Adkins’ death, many people were alarmed and confused. Authorities charged Kevorkian with Adkins’ murder, but the charges were dismissed for lack of evidence. Jack Kevorkian, a controversial proponent of the right to die, assisted patients in committing suicide.

THE END OF LIFE Kevorkian was not finished. He began a campaign to support the right to die. Over the next eight years, “Dr. Death,” as he was labeled, would help more than 120 people achieve their own deaths. Finally, in 1998 Kevorkian crossed the line from assisted suicide to active euthanasia by giving a terminally ill patient, who could not press a suicide button on his own, a lethal injection. Kevorkian videotaped the death and allowed it to be aired on 60 Minutes. Prosecutors used the video evidence to convict Kevorkian of seconddegree murder, and Dr. Death finally went to prison. Kevorkian’s extreme methods inspired outrage from many people. The American Medical Association (AMA) condemned his actions. Others believed in his cause but not his methods. “He did a lot for the national dialogue . . . but he also got carried away,”52 said Lloyd E. Levine, a member of the California State Assembly.

Legalizing Assisted Suicide As interest in assisted suicide grew, several states considered laws to legalize the practice. In 1997 Oregon became the first state to allow doctor-assisted suicide. Under Oregon’s Death with Dignity Act, a doctor can prescribe drugs to help a terminally ill patient hasten his or her own death. The act includes several requirements that serve as safeguards to prevent abuse, including requiring two separate requests, a written request with nonfamily witnesses, and a second doctor’s review of the diagnosis and approval that the patient’s judgment is not impaired. In addition, the doctor cannot personally administer the drugs to end the patient’s life.

LEGALIZE ASSISTED SUICIDE “I think the word ‘suicide’ conjures up someone despondent, who doesn’t want to live—but I want to live. . . . I just want to make the process of dying easier for my family and myself. The alternative, the morphine drip, is kind of frightening to me.” —Mary, a fifty-nine-year-old woman dying of cancer. Quoted in Claudia Rowe, “Family Fights for Assisted Suicide Vote,” SeattlePI.com, July 3, 2008. http://seattlepi.nwsource.com/local/369419_suicide03.html.

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In passing the 1997 Death with Dignity Act, Oregon became the first state to allow doctor-assisted suicide for terminally ill patients.

Supporters of Oregon’s act credit it for bringing the subject of hastening death into the spotlight. “It’s crazy for it to be under the table in this way,” said Howard Grossman, executive director of the American Academy of HIV Medicine. “It needs to be in the light of day so people can make a rational decision, not regulated by fear, not based on pain or fear of being a burden.”53 Edward Wellwood’s wife agrees with the Death with Dignity Act. In 2003 her husband was diagnosed with Lou Gehrig’s disease, which attacks neurons in the brain, eventually leading to total paralysis and death. Wellwood was afraid of living in an inert body and wiping out his family’s savings with a long illness. One day he left a note for his wife, drove to a motel, and shot himself in the heart. His wife wishes there had been a legal way for him to end his life. “If he knew he could have a safe, easy out, he could have had another year,”54 she said. Opponents argue the risk to patients and society of assisted suicide is too high. Who defines terminally ill? How will doctors

THE END OF LIFE ensure patients have exhausted all other pain management options and are of sound mind to make this decision? Even more distressing, in an atmosphere of skyrocketing health care costs, will there be pressure to choose suicide as the most cost-effective alternative? “We say we want this because of choice,” said Kenneth Stevens, chair of the radiation oncology department at the Oregon Health and Science University in Portland. “My concern is, in the future, will this become the only choice?”55 The American Medical Association clearly stated its opposition to doctor-assisted suicide in a brief to the Supreme Court: “The power to assist in intentionally taking the life of a patient is antithetical to the central mission of healing that guides both medicine and nursing. It is a power that most health care professionals do not want and could not control.”56

CHOOSING LIFE “How do you teach your children how to cope with life and death? I want to show them death is part of life, not to be feared. You can’t hide from it, can’t deny it.” —Barbara Bentz, a cancer patient who is against assisted suicide. Quoted in John Iwasaki, “Oregon Offers Lesson in Legal Assisted Suicide,” SeattlePI.com, October 16, 2008. http://seattlepi.nwsource.com/local/383727_oregon17.html.

On the other side, the AMA does support a doctor’s primary goal when a patient is dying—to manage pain. To relieve suffering, doctors often prescribe heavy painkillers like morphine. While lessening pain, these drugs can also kill. This causes a “double effect.” To keep a patient comfortable, a doctor can prescribe as much of the drug as needed, even if it will shorten the patient’s life. “We will give whatever it takes to relieve the suffering, and whether or not it crosses the line into intending to hasten death is something we don’t talk about as a rule,”57 said Deborah L. Volker, assistant professor of nursing at the University of Texas. Some people believe the practice of double effect is crossing the line and doctors should be held accountable for their actions.

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The Hospice Alternative For some people there is another choice besides assisted suicide and a long, painful death. According to the American Cancer Society Web site: Hospice is a philosophy of care. The hospice philosophy or viewpoint accepts death as the final stage of life. The goal of hospice is to enable patients to continue an alert, pain-free life and to manage other symptoms so that their last days may be spent with dignity and quality, surrounded by their loved ones. Hospice affirms life and does not hasten or postpone death. Hospice care treats the person rather than the disease; it focuses on quality rather than length of life. It provides family-centered care and involves the patient and the family in making decisions. Hospice care can be provided at home, in a hospital, nursing home, or private hospice facility. Most hospice care occurs at home with family members serving as primary caregivers. Supervised by a hospice doctor, nurses teach families to care for their loved one. Social workers help families and patients accept the situation. Volunteers visit with families and offer breaks for caregivers.

For most people, the greatest fears about dying are losing control, feeling pain, and being alone. Hospice supporters believe end-of-life care helps patients overcome these fears and experience a better quality of life in their final days. American Cancer Society, “What Is Hospice Care?” www.cancer.org/docroot/ETO/content/ETO_2_5X_What _Is_Hospice_Care.asp?sitearea=ETO.

The hospice philosophy views death as the final stage of life, in which terminally ill patients are surrounded by loved ones and made as comfortable and pain-free as possible.

THE END OF LIFE

Discrimination Against the Vulnerable Others worry greater acceptance of assisted suicide could lead to abuse and discrimination against society’s vulnerable groups. They believe the elderly, uninsured, and disabled might be pressured to choose suicide. “It is far more expensive to provide high quality pain management than it is to offer a lethal prescription,”58 said Tracy E. Miller, a visiting scholar at the Mount Sinai School of Medicine. Duane French, paralyzed in an accident, voiced his concerns about legal assisted suicide. “People with disabilities will think, I should do this—give up, die, disappear—for everyone else,” he Paralysis victim Duane French believes that passage of laws allowing assisted suicide could lead to abuse and discrimination against vulnerable groups, such as people with disabilities.

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BIOETHICS said. “And doctors would be complicitous, encouraging. It comes down to: Is it worth it to go on? The public is going to be saying no, and doctors are not immune to that.”59 Assisted suicide supporters dispute these fears and point to a 2007 study of assisted suicide in Oregon and the Netherlands, one of the few countries that allows assisted suicide. It showed no bias against the poor, uneducated, disabled, or mentally ill. Instead, the study found the people who requested assisted suicide were generally better educated and better off financially than the general public. The study also found that, following passage of Oregon’s Death with Dignity Act, only 292 patients in the state had actually chosen to end their lives with a lethal prescription.

“A SLIPPERY SLOPE” “If we ever decide that a poor quality of life justifies ending that life, we have taken a step down a slippery slope that places all of us in danger.” —C. Everett Koop, former U.S. surgeon general. Quoted in William H. Colby, Unplugged: Reclaiming Our Right to Die in America. New York: AMACOM, 2006, p. 185.

The inevitability of death is certain. The manner in which people will face death is not. Does a belief in the sanctity of life overcome individuals’ right to control their final act—their death? As medical technology advances, new ethical questions surrounding the end of life are sure to emerge. Some, like Booth Gardner who suffers from Parkinson’s disease, believe the issue is simple. Gardner says, “My life, my death, my control.”60

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oes the search for a cure justify harm to an individual? Scientists researching new drugs and therapies walk a thin line between society’s future good and individual safety. All research involves a level of risk. The hard part is deciding when the risk becomes too high. Historically, doctors tested new medicines and treatments by simply giving them to patients. By noting each patient’s experience, the doctor learned which treatments seemed to be effective and which did not. This trial-and-error method was not very efficient. Doctors could not be sure if the results were affected by outside factors or if they could be duplicated in other patients. Beginning in the nineteenth century, doctors searched for a more systematic way to learn about disease and treatments. The beginnings of human research emerged in clinics and laboratories. When healthy participants were needed, the researchers often tested drugs and procedures on themselves. As researchers turned to outside patients for testing, the ethical questions around clinical research began to form.

The Nuremberg Code In the 1940s ethics of medical research exploded on front-page headlines. In Nazi Germany doctors conducted a series of inhumane and unnecessary medical experiments on concentration camp prisoners. After World War II, a series of war crimes trials held in Nuremberg, Germany, revealed the horrific details of the Nazi experiments. As a result, the trial judges created the Nuremberg Code, a set of research principles focused on the rights of human participants rather than the interests of scientists. 53

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BIOETHICS The Nuremberg Code states that “the voluntary consent of the human subject is absolutely essential”61 for participation in medical research. The code defines patient consent and discusses a patient’s right to withdraw from a research study. It also obligates a scientist to stop research if continuing would harm the participants. The World Medical Association (WMA) addressed research on humans in its 1964 Declaration of Helsinki. In the declaration, the WMA discussed protections for disadvantaged patients: Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who will not benefit personally from the research and for those for whom research is combined with care.62 The Nuremberg Code and the Helsinki Declaration are worldwide guidelines on the ethical treatment of human research subjects. As more potential lifesaving drugs and cutting-edge therapies emerge, the opportunity for human research continues to expand. As researchers push forward, the principles of the Nuremberg Code and the Helsinki Declaration stand to protect the rights of human research subjects.

The Role of Clinical Trials When a scientist creates a new drug or therapy, studies called clinical trials test the treatment to determine if it is safe for the general public’s use. A treatment could be a drug, medical device, vaccine, or gene therapy. Most potential treatments begin testing with animals. Then, if proven safe and promising, the treatments move into clinical trials with humans. A potential treatment passes through four phases of clinical trials before it is approved by the Food and Drug Administration (FDA). Researchers generally perform clinical trials at hospitals or research centers, where patients can be carefully monitored and get medical treatment if needed.

Clinical trials are studies that test medical treatments to determine whether they are safe for use by the general public.

In Phase I trials, researchers test a small group of twenty to eighty healthy patients to evaluate a drug’s safety, set dose ranges, and determine if there are any side effects. In Phase II, a larger group of one hundred to three hundred people receive the drug. These participants generally have the disease the treatment targets. During this phase, researchers evaluate how effective the treatment is and continue to assess its safety. If a treatment appears to be acceptably safe and effective, it moves on to Phase III testing.

BUILDING PUBLIC SUPPORT FOR CLINICAL TRIALS “It’s important that we have the rapport with the public that allows them to trust us with this program. Without people willing to participate, there won’t be any clinical trials.” —Bernard A. Schwetz, acting director of the Office for Human Research Protections. Quoted in Carol Rados, “Inside Clinical Trials, Testing Medical Products in People,” FDA Consumer Magazine, September/October 2003. www.fda.gov/FDAC/features/2003/503 _trial.html.

Phase III testing involves even greater numbers of people with the disease, usually around one thousand to three thousand subjects.

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Animal Testing For many new drugs and treatments, the first step in testing involves animals. Research on animals has played an important role in almost every major medical advancement in the past century. Scientists use animals because of the similarities they have with humans. Learning how a drug interacts in an animal provides valuable clues as to how it will affect humans.

The majority of lab animals are rats and mice bred specifically for research purposes. Rodents are used often because of their short life span, which allows scientists to see how a disease progresses almost in “fast-forward” mode. Scientists claim medical breakthroughs such as bone marrow transplant techniques, polio immunizations, and cloning of the first gene would not have been possible without animal research. In addition, medical care for cats, dogs, and other animals has also advanced through discoveries found in animal research. Despite the benefits of animal research, some people oppose the use of animals for medical experiments. One group, People for the Ethical Treatment of Animals (PETA), believes that all animal testing is inhumane. It supports using new research methods such as computer modeling, cell cultures, and human studies to replace animal studies.

The majority of animals used for medical testing are mice and rats bred specifically for that purpose.

RESEARCH AND DEVELOPMENT Testing in this phase monitors effectiveness, safety, and side effects. It also compares the treatment with any existing treatments for the disease. As more people are tested over longer periods of time, researchers might discover rare side effects. Frequently, the Phase II and III studies divide patients into two groups. One group receives the treatment being tested. The other group, called the control group, receives either the standard treatment or a placebo. To eliminate any bias, drug trials are often conducted as “blind” studies. Neither the doctors nor the patients know who is getting the new drug. By comparing the results of the two groups, researchers can better understand the effects the new treatment has on patients. The final stage of clinical trials, Phase IV, often occurs after the treatment is approved for general use. These trials collect information about long-term effects and usage.

Who Participates? People agree to join clinical trials for different reasons. Some want to help researchers advance medical knowledge about a disease. For others, standard treatment has failed to cure their illness. A clinical trial represents their last hope. In 2001 Carolyn Meritt was about to have a stem cell transplant to treat mantle cell lymphoma, a cancer of the lymph nodes. When she learned about a clinical trial studying a new treatment for her lymphoma, she decided to apply. “I was going ahead with the stem cell transplant because I thought I had no other options,” she said. “Part of the reason I decided to do this study was so that maybe what they learned through me would help other people with mantle cell lymphoma.”63 Meritt was accepted into the trial. After a year of treatment through the trial, Meritt’s lymphoma went into remission. To determine which volunteers will be accepted into a trial, researchers develop eligibility requirements. These guidelines often include age, sex, type and stage of disease, previous treatment history, and general medical condition. These guidelines help exclude people who have a greater risk of being harmed in the trial. The trial’s team of doctors and nurses examine each potential participant to determine which ones are eligible for the study.

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BIOETHICS Not all volunteers are accepted into a clinical trial. Some do not meet eligibility requirements. Some trials may not have an available spot. For patients without options, being excluded from a trial can be devastating. Cheri Gunvalson spent years advocating for money to research her son Jacob’s disease, Duchenne muscular dystrophy, which causes muscle degeneration and eventually paralysis and death. Without treatment, sixteen-year-old Jacob was not expected to live past his twenties. When he applied to enter a clinical trial for a promising experimental drug, he was denied. Cheri Gunvalson felt betrayed. In July 2008 she filed suit against the biotechnology company, asking for access to the drug. According to her lawsuit, the drug is “Jacob’s last, best and only chance to slow, stop or even reverse the effects of his condition. Without it, Jacob will not survive.”64 In December 2008 a federal appeals court reversed a lower court ruling and determined that the company did not have to provide the experimental drug to Jacob.

THE BENEFITS OF RESEARCH “The biotechnology medicines that have been produced in the last decade or so have transformed lives in a remarkable way and that technology has enormous potential for creating many more valuable medicines.” —Gordon Duff, Chair of the UK Committee on Human Medicines. Quoted in Matt Wilkinson, “Duff Reports on Clinical Trial Safety,” DrugResearcher.com, December 8, 2006. www.drugresearcher.com/Research-management/Duff-reports-onclinical-trial-safety.

Because experimental drugs can be the last hope for terminal patients, some people advocate a “compassionate use” policy. In these cases the patient could enroll in a single-patient study or be allowed into the clinical trial even if he or she did not meet formal eligibility requirements. The results would be excluded from trial data. Some doctors and researchers, however, are hesitant about compassionate use of experimental drugs. “The burden is on everyone to ensure that safety is kept in mind in each step and that we don’t get ahead of ourselves in our enthusiasm,”65 said Richard

RESEARCH AND DEVELOPMENT

A medical student participating in a clinical trial receives an experimental flu vaccine.

Finkel, an expert in Duchenne at the Children’s Hospital of Philadelphia. Deciding which patients have access to an experimental drug outside of a clinical trial can be complicated. Often drug supply is limited and expensive. “There are definitely issues of fairness,” said Susan Goold, director of bioethics at the University of Michigan Medical School. Families also need to realize that working as advocates for medical research does not entitle them to receive the drugs. “You have to recognize this may not directly benefit your loved one,”66 said Goold.

Assessing Risk and Protecting Patients For patients accepted into clinical trials, there are risks. Side effects can be unpleasant and serious. Most side effects are temporary and stop when the treatment ends, but some may be permanent. For these reasons, it is critical for researchers to explain all known risks before the trial. If a new risk emerges during the trial, the researchers should inform all participants.

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BIOETHICS To protect participant safety, the government and medical institutions monitor and inspect clinical trials. “Between the FDA, the help of other government agencies, the review by the Institutional Review Boards, the required monitoring of studies by industry or private sponsors, and the required oversight and reporting by investigators and their staff,” said David Lepay, director of the FDA’s Good Clinical Practice Program, “a lot of people are looking out for the research subject’s safety.”67 Despite research guidelines and protections, there are still cases where researchers have ignored patient rights in pursuit of medical knowledge. These cases illustrate the devastating effects that can happen when research goes wrong.

The Tuskegee Syphilis Study In the early 1900s syphilis was common among African American men living in the South. At the time there was no cure for the disease. Untreated, syphilis could lead to organ damage and possibly death. To better understand the disease, the U.S. Public Health Service decided to conduct a study of untreated syphilis in 1932. Along with the Tuskegee Institute in Alabama, the researchers recruited four hundred poor black men. Participants received free medical care, food, transportation, and burial fees. In exchange the men allowed researchers to examine them over the years. Researchers did not tell the men they would not receive treatment for their disease. In fact, researchers never even told the men they had syphilis. Instead, doctors called their condition “bad blood,” a term also used for fatigue and anemia. The point of the study, which the patients did not know, was to see how the disease progressed without treatment. When the study began, researchers did not see an ethical problem with this approach. There were no effective treatments for syphilis at the time. Therefore, patients in the study would fare no worse than others. By 1947 medical research had proved that penicillin was a safe, effective cure for syphilis. Tuskegee researchers, however, wanted to continue their research on the untreated disease. As a result, they chose to withhold the lifesaving medicine from the men. Even more chilling, the researchers convinced other health agencies also to withhold treatment from the men.

RESEARCH AND DEVELOPMENT

The Willowbrook Study Willowbrook State School, a New York home for the mentally disabled, was the site of a secret medical study in the 1960s. Because of its unclean state, many Willowbrook residents contracted the hepatitis virus. Researchers wanted to learn about the disease and test a potential treatment, gamma globulin. In a secret study, researchers decided to infect Willowbrook children with the hepatitis virus. Some patients were fed infected stool extracts. Others were given injections of the virus. While Willowbrook closed its doors due to overcrowding during these years, the study ward remained open. For some parents the only way to get their child admitted to Willowbrook was to agree to participate in the study.

Researchers defended their infection of the children. They claimed the children would get hepatitis anyway and would receive better care in their controlled research environment. Critics denounced the study, claiming parents and children were given little choice about whether to participate and were misled. According to David Rothman, author of The Willowbrook Wars: “The word that runs through the consent form again and again is prevention. We are going to prevent this disease in your child. But of course, it was completely misleading. Deceitful.” Quoted in Eyewitness News Investigators, “Shocking New Willowbrook Legacy,” WABC-TV New York. www.columbia.edu/cu/news/clips/2005/02/02/shock ingnewABC.pdf.

Young patients sleep on carts at Willowbrook State School in New York in 1972. Patients at the facility were deliberately infected with the hepatitis virus to enable researchers to study the disease.

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An African American man with syphilis is injected with a placebo during the Tuskegee Experiment. Although penicillin had emerged as an effective treatment for the disease, U.S. government researchers deliberately withheld treatment from the experiment’s subjects.

Without penicillin, syphilis progressed in the men. Some went blind. Others had major organ failure. Still more developed dementia. If they died, researchers performed autopsies to learn how the disease spread throughout the body and killed. The deliberate withholding of treatment continued for forty years. Finally, in the 1970s the media reported the study’s abuses in national newspapers. The study was shut down. By that time, dozens of men had died. Wives and children had been infected with the disease. Senator Edward Kennedy led congressional meetings about the Tuskegee research abuses, leading to a complete reworking of federal regulations for research with humans. In 1997 the U.S. government formally apologized for the unethical study. President Bill Clinton said: To the survivors, to the wives and family members, the children and the grandchildren, I say what you know: No power on Earth can give you back the lives lost, the pain suffered, the years of internal torment and anguish.

RESEARCH AND DEVELOPMENT What was done cannot be undone. But we can end the silence. We can stop turning our head away. We can look at you in the eye and finally say, on behalf of the American people: what the United States government did was shameful. And I am sorry.68

The Death of Jesse Gelsinger Research abuses exist in even more recent times. In the 1990s gene therapy offered hope to cure a range of genetic diseases. In its basic form, gene therapy attempted to replace defective genes with healthy ones to cure or prevent illnesses like cystic fibrosis and hemophilia. “We had got ourselves all hyped up,” said W. French Anderson, a scientist who researched gene therapy, “thinking there would be rapid, quick, easy, early cures.”69 Biotech companies spent millions of dollars on research. By 1999 over four thousand patients were involved in gene therapy clinical trials. Jesse Gelsinger wanted to be one of those trial patients. The eighteen-year-old suffered from a genetic disease called ornithine transcarbamylase (OTC) deficiency. OTC patients are missing enzymes that filter ammonia out of the blood. Without these enzymes a toxic ammonia buildup can lead to coma, brain damage, and death. Most infants with severe OTC suffer brain damage. Half die within the first month of life. Gelsinger, fortunately, had a milder form of the disease. A small portion of his cells still produced the missing enzyme. He managed the disease by keeping to a strict low-protein diet and taking medications to reduce ammonia levels in his body. When Gelsinger’s pediatric geneticist told him about a clinical trial being conducted at the University of Pennsylvania, he immediately wanted to sign up. The study was testing the safety of a gene therapy treatment for babies with severe OTC. Gelsinger knew the trial would not help him, but he hoped the research might eventually find a way to eliminate the restrictive diet and thirty-two pills he took every day. “What’s the worst that can happen to me?” he asked a friend. “I die, and it’s for the babies.”70

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BIOETHICS Gelsinger’s family and doctors supported his desire to be in the trial. His father, Paul Gelsinger, remembers saying, “Wow, Jess, they’re working on your disorder. Maybe they’ll come up with a cure.”71 When Jesse and his family met with researchers, they felt assured the trial was safe. The consent form did not list any serious human reactions. Happy to be helping others with his disease, Jesse agreed to participate in the trial. “He was going to help save lives,” said his father. “The doctors told him it was a very unselfish act.”72 On September 13, 1999, Gelsinger received his first infusion of the healthy genes. Within hours, however, things began to go wrong. Gelsinger developed a life-threatening clotting disorder that broke down his red blood cells faster than his liver could metabolize them. Within four days multiple organs failed, and doctors declared Gelsinger brain dead. Surrounded by family, Gelsinger died. Gelsinger’s death shocked his doctors and the medical community. He was the first patient known to have died as a result of gene therapy. “I think it’s a perilous time for gene therapy,” said LeRoy Walters, a bioethicist at Georgetown University. “Until now, we have been able to say, ‘well it hasn’t helped many people, but at least it hasn’t hurt people.’ That has changed.”73

NO ROOM FOR MISTAKES “If we ask patients to participate in moving science forward, then we must be assured that gene therapy clinical trials are safe. . . . There is absolutely no room, no place for mistakes that compromise patient safety.” —Senator Bill Frist. Quoted in Michael Bellomo, The Stem Cell Divide. New York: AMACOM, 2006, p. 201.

More troubling, FDA investigators found the University of Pennsylvania OTC researchers had violated ethical standards in several ways. They did not properly inform Gelsinger of the trial’s risks. No mention was made to prospective participants about lab monkeys that had died during similar testing. In addition,

RESEARCH AND DEVELOPMENT the consent form Gelsinger and other patients signed was not approved by the FDA. Researchers let the study continue even after some subjects developed toxic reactions. In addition, some of the researchers had a financial stake in the company developing the experimental drug. During testimony at a Senate subcommittee meeting, Paul Gelsinger said, “I encouraged my son to do this. But I wasn’t given all the information.”74

What Is Acceptable Risk? The case of Jesse Gelsinger illustrates a highly debated topic in research bioethics. Was the risk researchers allowed Gelsinger to take acceptable? Acceptable risk varies from patient to patient. Factors such as age, general health, and prognosis influence whether a risk is acceptable. For eighteen-year-old Jesse Gelsinger, leading a relatively healthy life, the risk of death does not seem acceptable against the limited benefit he received from the trial. For terminally ill patients, the acceptable risk may be higher if the experimental treatment offers their last hope of survival. Research and clinical trials with human subjects is an integral part of bringing new treatments to the public. Researchers will continue to understand risk and make decisions on what is acceptable. Their informed decisions will help medical research balance the safety of patients with the search for cures.

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nside every cell thousands of genes control the characteristics that make each person unique. Scientists study genes, how they interact with each other, and how people pass them on to their children. As the understanding of genes has increased, scientists have also begun to understand genes’ role in devastating diseases. As research looks for ways to test genes for disease and manipulate genes to cure disease, the debate arises. When does human intervention into the basic code of life go too far?

The Early Research In 1953 James Watson and Francis Crick discovered the famous double-helix structure of DNA. The DNA double helix is like a rope ladder, built from four chemical bases. The order of these bases gives instructions on how to build and maintain an organism, just like the letters of the alphabet are used in a certain order to create words and sentences. With Watson and Crick’s discovery of the DNA “sentence,” scientists were able to study the code of life. Long sections of DNA strands make up genes. Genes give the instructions that control each person’s characteristics. Researchers believe that humans have approximately twenty thousand genes, located on forty-six rodlike structures called chromosomes in the nucleus of each cell. Each person has two copies of each gene, one from each parent. A person’s hair color, height, and level of intelligence are controlled by his or her genes. Sometimes as genes are copied into millions of cells, a mistake occurs. The chemical bases can be mixed up, omitted, or repeated. These mistakes can cause serious diseases like cystic fibrosis, which causes thick mucus to clog lungs and lead to life66

GENETIC TESTING AND ENGINEERING threatening lung infections; or Huntington’s disease, which causes a progressive loss of physical control and mental ability. Most single-gene diseases require that a person inherit two defective genes, one from each parent. People with only one defective gene will often not have the disease. Instead, they are carriers and may pass the defective gene to their children. Scientist James Watson stands behind a model of the DNA double helix, which he and Francis Crick discovered in 1953.

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Testing Genes for Disease As knowledge of the human genome grew, doctors better understood the relationship between disease and genes. Genetic testing emerged when doctors realized some fatal illnesses were more common in certain families and ethnic groups. Testing these patients helped doctors to identify the disease-causing genes. In adults most genetic testing is used to diagnose disease or identify the patient as a carrier of the genetic disease. Doctors can also use genetic testing to assess a person’s risk of getting certain diseases. The more doctors know about a patient’s genes, the better they can treat, cure, or prevent illness. To do a genetic test, doctors remove a blood or skin sample from the person. A copy of the person’s chromosomes and DNA exists in each cell of the sample. Laboratory doctors examine and sequence the DNA to determine if there are any gene mutations. If a mutation exists, the person may have the disease or may be a carrier. There are gene tests for more than thirteen hundred diseases, with many more in development. Early tests focused on singlegene diseases like cystic fibrosis or hemophilia. As genetic screening has advanced, however, scientists have studied the genetic links to more complex diseases with multiple genes and factors. Genetic tests for some of these common illnesses, like type 2 diabetes, Alzheimer’s, heart disease, and depression, are in development. Doctors warn, however, that a positive test result for a disease caused by multiple genes and factors does not guarantee a patient will get the disease. The result simply helps to assess the patient’s risk.

Knowledge—Benefit or Curse? For patients, the ability to test for genetic diseases can have many implications. After testing positive, patients have a better understanding of their risk of getting the disease. As a result, they may decide to alter their diet and lifestyle to reduce other risk factors. They may be more diligent about medical exams and paying attention to warning symptoms. They may also decide to undergo aggressive preventative treatment.

GENETIC TESTING AND ENGINEERING

The Human Genome Project In 1990 international scientists undertook a massive project to better understand human genes. By 2003 the Human Genome Project mapped the complete set of human DNA and identified the genes contained. More than fourteen hundred disease genes were identified. Supporters believed this knowledge would lead to better treatment of genetic disease and illness. The project designers recognized that the project would bring new ethical dilemmas. In response, the designers established the Ethical, Legal and Social Implications (ELSI) program. It was the world’s largest bioethics program and became a model for ELSI programs around the world. Some issues the program studied included: • Who should have access to personal genetic information, and how will it be used?

• How does personal genetic information affect an individual and society’s perceptions of that individual? • Should testing be performed when no treatment is available? • Should parents have the right to have their minor children tested for adult-onset diseases? • Where is the line between medical treatment and enhancement? To educate scientists and the general public about these issues, the ELSI researchers created publications and resources. Many can be found on the ELSI Research page of Human Genome Project’s Web site. Human Genome Project Information, “Ethical, Legal, and Social Issues Research.” www.ornl.gov/sci/tech resources/Human_Genome/research/elsi.shtml.

Robert Waterston, head of the Washington University Genome Sequencing Center, announces the release of the map of the human genetic code.

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A skin sample is removed from a patient's hand; such samples are used in genetic testing.

Genetic testing can have an incredible impact on a person’s life. Jana and Tom Monaco’s third child, Stephen, developed a lifethreatening stomach virus when he was three that caused severe brain damage. Doctors diagnosed Stephen with a rare disease called isovaleric acidemia (IVA). People with IVA are unable to metabolize an amino acid found in dietary protein. Unknowingly, Jana and Tom were carriers of the disease and had passed the gene to Stephen. When Jana became pregnant again, the Monacos decided to test the fetus for the disease. The fetus tested positive for IVA, which made it possible for doctors to give baby Caroline medication at birth to prevent the disease’s devastating effects. In addition, the Monacos knew how to monitor Caroline’s diet to keep her healthy. The difference between the two children is striking. Nine-year-old Stephen is unable to walk, talk, or feed himself. Caroline is an active, healthy four-year-old. “Genetic testing gave Caroline the future that Stephen didn’t get to have,”75 said Jana.

GENETIC TESTING AND ENGINEERING For some people the knowledge provided by genetic testing is crucial. Kim Wolfe saw her mother suffer through breast cancer treatments. When her mother tested positive for a gene that dramatically raises the risk of breast and ovarian cancer, Wolfe decided to have herself tested. After discovering she also had the gene, Wolfe chose aggressive treatment before she showed any signs of cancer. She underwent surgery to have her breasts and ovaries removed. “I feel a hundred bricks have been lifted off of me,” Wolfe said. “The genetic testing is the most wonderful thing. You can look into a crystal ball and almost see your future . . . and then do something about it.”76 The value of genetic testing becomes less clear when it involves a disease with no treatment or cure, like early onset Alzheimer’s or Huntington’s. “Genetic testing offers us profound insight,” said

Amniocentesis is a procedure in which a sample of amniotic fluid surrounding a fetus is extracted for genetic testing prior to birth.

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BIOETHICS Stephen Gruber from the University of Michigan. “But it has to be balanced with our ability to care for these patients.”77 Shana Martin watched her mother battle Huntington’s, a disease with no current cure or treatment. She decided not to take a genetic test herself. “I don’t know how well I’d handle a positive result, and with how happy I am right now, that would just put a real shadow over my life,” she said. “I’m much more comfortable with it being an unknown.”78 Others feel the need to know. Stephanie Vogt’s paternal grandfather and his three brothers all had Huntington’s. “As soon as I found out there was a test, I just had to do it,” she said. For Vogt the test came back positive. Knowing what her future holds is not easy. Some days she is frightened. “But most of the time,” she said, “I’m comfortable with the fact that I have the knowledge.”79

Privacy Concerns Privacy concerns have dampened the enthusiasm over genetic testing. Some people worry genetic test results could cause social embarrassment or discrimination. They fear insurance companies will raise premiums or refuse to cover individuals who test positive for expensive diseases. Knowing genetic test results, employers might not hire a candidate who will have future health problems, costing the company time and money. Even current employees worry their jobs may be at risk if employers learn they have tested positive for a disease that will require time off and expensive treatments. Because of these concerns, some patients have decided not to have genetic testing done. Others have the tests done quietly through at-home mail-in kits and keep the results to themselves. Victoria Grove used a home test kit to see if she was at risk for a genetic form of emphysema, a progressive lung disease that causes shortness of breath and makes physical activity difficult. When the results were positive, Grove decided against telling her doctor, fearing she would not be able to get health insurance. “Something needs to be done so that you cannot be discriminated against when you know about these things,” she said. “Otherwise you are sicker, your life is shorter and you’re not doing what you need to protect yourself.”80 Employers claim discrimination is prohibited by the Americans with Disabilities Act. Insurers also dismiss discrimination

GENETIC TESTING AND ENGINEERING fears. “It’s an anecdotal fear,” said Mohit M. Ghose, a spokesperson for America’s Health Insurance Plans. “Our industry is not interested in any way, shape or form in discriminating based on a genetic marker.”81 The Council for Responsible Genetics believes people should still be cautious about their genetic information. They have documented at least five hundred cases of genetic discrimination. In one case Heidi Williams’s insurance company refused to cover her two children after learning they carried a gene that put them at risk for developing emphysema or liver disease. “They made me feel guilty for needing a parent’s peace of mind in regard to my children’s future health,” she said. “Many people are afraid to come forward . . . because they are afraid of the retribution that may not only be taken against them but could be taken against their families as well.”82 Privacy concerns also have an impact on genetic research. Scientists complain discrimination fear prevents patients from entering research studies. “We’re at a tremendous crossroads,” said Susannah Baruch, senior policy analyst for the Genetics and Public Policy Center at Johns Hopkins University. “Genetic testing has the potential to revolutionize the delivery of healthcare. But that won’t happen if people are afraid their genetic information will be used against them.”83 In May 2008 the U.S. government took a step to protect patients from genetic discrimination. It passed the Genetic Information Nondiscrimination Act. The law prohibits insurers from raising premiums based on genetic test results. It also prohibits requiring genetic tests as a condition of coverage. Further, the law prohibits employers from using genetic information to discriminate against employees or job candidates. “Individuals no longer have to worry about being discriminated against on the basis of their genetic information, and with this assurance, the promise of genetic testing and disease management and prevention can be realized more fully,”84 said Sharon Terry, president of the Coalition for Genetic Fairness.

Preimplantation Genetic Diagnosis Genetic testing is being used in other ways as well. A woman undergoing in vitro fertilization can request genetic testing for an embryo

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BIOETHICS before it is implanted in the uterus. This procedure, called preimplantation genetic diagnosis (PGD), screens out any embryos with positive results. Doctors perform PGD on a six-to-eight-cell embryo by opening the embryo’s outer shell with a micro needle and removing a single cell. A lab tests the cell for a variety of genetic mutations. Most people use PGD to screen for abnormal chromosomes that may lead to miscarriage, chromosome disorders such as Down syndrome, and genetic diseases like cystic fibrosis. Others test for a tissue match with a sibling with a devastating disease, hoping the resulting baby’s umbilical cord blood will provide lifesaving cells to the older child.

PREIMPLANTATION GENETIC DIAGNOSIS “Where do you draw the line? On the one hand we have to view this as a positive in terms of preventing disability and illness. But at what point are we engaging in eugenics and not accepting the normal diversity within a population?” —Mark A. Rothstein, director of the Bioethics Institute at the University of Louisville School of Medicine. Quoted in Amy Harmon, “The Problem with an Almost-Perfect Genetic World,” New York Times, November 20, 2005. www.nytimes.com/2005/11/20/weekinreview/20harmon.html.

Despite its lifesaving promise, PGD is not infallible. Doreen Flynn’s daughter, Jordan, has Fanconi anemia, a genetic disease that leads to bone marrow failure and a high risk of cancer. Without a bone marrow transplant from a healthy sibling, it was unlikely Jordan would live past her early twenties. Doreen turned to PGD to select embryos with the best chance to offer lifesaving marrow for Jordan. Using screened and tissuematched embryos, Doreen became pregnant with twins. When the babies were two months old, they both tested positive for Fanconi anemia. “You feel so guilty because you’re trying to help one daughter and you end up hurting two other children,” said Doreen. “Now we understand that it’s not an exact science and there’s room for error.”85

GENETIC TESTING AND ENGINEERING As genetic testing advances, PGD can also screen for a growing number of treatable diseases. After watching several family members die from an inherited form of colon cancer, Chad Kinsgbury and his wife, Colby, decided to undergo in vitro fertilization and PGD to prevent conceiving a child with the defective gene. Chad has no regrets. “I couldn’t imagine them telling me my daughter has cancer,” he said, “when I could have stopped it.”86 Some people take offense at labeling certain embryos undesirable. “It’s like children are admitted to a family only if they pass the test,” said Denise Toeckes, who has tested positive for a breast cancer gene mutation. “It’s like, ‘If you have a gene, we don’t want you; if you have the potential to develop cancer, you can’t be in our family.’”87

Wrongful Birth Helen Schirmer carried a genetic disorder called trisomy 22. The active trisomy 22 disorder causes mental retardation and severe physical disabilities. Although Schirmer did not have the active disorder, she had a one-in-three chance of passing the damaged gene to her children, with a son more likely to be affected. When Schirmer became pregnant in 1997, she and her husband decided to have genetic testing performed on the fetus. If the fetus had the active form of trisomy 22, the Schirmers planned to terminate the pregnancy. When doctors reported the test was negative and the fetus was probably a girl, the Schirmers continued the pregnancy.

In September 1997 Schirmer gave birth to a son, Matthew, who had the active trisomy 22 genetic defect. As a result, Matthew had severe mental and physical impairments. At six, Matthew still could not speak, stand, crawl, feed himself, or use the bathroom. The Schirmers sued Helen’s doctors, the hospital, and the scientists who performed the genetic test. They claimed if the doctors had done their jobs competently, Matthew would never have been born. The Ohio Supreme Court’s ruling granted the Schirmers payment for pregnancy and birth expenses but excluded costs for Matthew’s ongoing care, stating that the disabling condition existed at conception and was not caused by the doctors.

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BIOETHICS Others fear the growing interest in testing for treatable diseases may lead to the greater use of PGD to select characteristics based on preference. Already, it is possible to test embryos for inherited deafness or a predisposition to arthritis or obesity. Genetic tests can easily be used to select a baby’s sex. “From a technology perspective we can test anything,” said Mark Hughes, director of the Genesis Genetics Institute in Detroit. “The issue becomes what is considered serious enough to warrant such testing and who decides that.”88

USING GENETIC TESTS TO SELECT A BABY “I don’t think testing for freckles or blond hair or musical aptitude is a morally bad thing to do. I think parents will want to do it, so I think this will expand rapidly.” —Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. Quoted in Emily Singer, “Choosing Babies,” Technology Review, March/April 2007. www.technologyreview.com/biomedicine/18303/page1/.

In the United States, PGD is not regulated, so the decisions on what testing is appropriate and ethical are made by doctors and their patients. “The clinics are the gatekeepers,” said Vardit Ravitsky, a bioethicist at the University of Pennsylvania. “If you have cash and can find a clinic to provide the service, you can get it, whether it’s a test for Huntington’s disease or sex selection.”89 Disability advocates fear that as more parents choose PGD to limit their chances of having a disabled child, discrimination against the disabled will increase. “We’re trying to make a place for ourselves in society at a time when science is trying to remove at least some of us,” said Andrew Imparato, president of the American Association of People with Disabilities. “For me, it’s very scary.”90 Others believe genetic difference, including disability, is what makes each person unique. “Would I choose to have my child have a disability?” said Lisa Hedley, president of the Children of Difference Foundation and mother of a child with dwarfism. “No.

GENETIC TESTING AND ENGINEERING It’s difficult for her. It’s difficult for everyone. But difference is what makes the world go round.”91

REGULATION OF GENETIC TESTING “I definitely think the government has a role to play in regulating the safety and quality of tests . . . but the final choice, once tests are considered to be scientifically legitimate, should be left up to patients and physicians.” —David Adamson, president of the American Society for Reproductive Medicine. Quoted in Emily Singer, “Choosing Babies,” Technology Review, March/April 2007. www.technologyreview.com/biomedicine/18303/page1/.

The high cost of PGD may be a barrier to some families. If only the wealthy can afford to screen out genetic disability and disease, some fear PGD may be the first step toward a genetic class divide. The wealthy become genetically healthier, while the poor are left to deal with disease and disability. In the end the decision to have PGD comes down to a personal choice. Patients weigh the procedure’s risks against the reasons for the test. According to Kathy Hudson, director of the Johns Hopkins Genetics and Public Policy Center, “In the case of a family who’s facing a one in four or a one in two chance of having a child with a fatal genetic disease, the context is quite different from those who want to pick the sex of a kid.”92

Beyond Diagnosis—Using Gene Therapy for Treatment With science’s expanding knowledge of the human genetic code, research is moving beyond diagnosis and focusing on ways to use genes to treat, prevent, and cure disease. If scientists can identify defective genes, why not find a way to replace them with healthy genes? Somatic gene therapy attempts to treat a specific disease by replacing defective or missing genes. To deliver the normal DNA into a patient’s cells, scientists use viruses as the vehicle to deliver

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Somatic gene therapy provides relief for children born with severe combined immune disorder (SCID), or “bubble boy disease.” This breakthrough came too late for David Vetter (pictured in 1976), who resided in a bubble until his death in 1984.

GENETIC TESTING AND ENGINEERING the healthy genes. They infect the patient’s target cell, hoping the virus vehicle will unload the healthy DNA, which will then begin working properly. Problems can arise if the healthy DNA arrives at the wrong place in the patient’s DNA sequence. Somatic gene therapy treats a specific patient, but does not affect future generations. Germ-line therapy, however, targets the defective genes in a patient’s germ, or reproductive, cells. Changes to these germ cells would get passed down to the patient’s children and could spare future generations from a genetic disease. The idea of germ-line therapy is still theoretical. The technology to use it in humans does not yet exist. For many people, changing the genetic code of future generations is morally wrong and too risky. Millions of genes interact with each other in ways that are not yet fully known. Changing the code may trigger unexpected side effects in future generations. At that time, there may be no way to reverse the damage. In addition, the future children affected by germ-line therapy will not have a choice in deciding whether or not to have the treatment; the choice will have already been made for them. Because of these concerns, no U.S. government funding is currently used for germ-line therapy research in humans. Convinced somatic gene therapy was the “next big thing” in medicine, scientists scrambled in the 1990s to research methods and conduct clinical trials. Several hundred tests were done, most with little success. Deaths in trials, including the death of Jesse Gelsinger in 1999, raised concerns that researchers were recklessly pursing science and not following adequate safety precautions. In a federal panel reporting on gene therapy, Stuart Orkin said there were large numbers of clinical trials, “many of which have been approved without extraordinary oversight in terms of scientific or clinical benefit.”93 Success finally arrived in 2000 when French scientists reported a breakthrough in a study of infants with severe combined immune disorder (SCID). SCID was commonly known as “bubble boy syndrome.” Children with the disorder were required to spend their lives in a germfree bubble to protect their fragile immune systems. Many died before their first birthday.

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BIOETHICS French scientists took bone marrow cells from each child in the study. They added viruses to carry healthy immune system genes to these cells. Then they injected the modified cells back into the patients’ bone marrow. The virus copied the new healthy genes in the patients. Within three months, the infants were home, living like normal children. Within ten months, doctors declared their immune systems completely normal. “It’s a very exciting study,” said R. Michael Blaese, head of ValiGen’s human therapeutics division. “This would probably be the first example in any disease where gene therapy could be a fully successful treatment. You can’t distinguish these patients from normal.”94 Despite their success, unintended consequences arose three years later. Three of the ten infants developed leukemia, and one died. This confirmed a risk the gene therapy scientists had suspected. The viruses that were used to deliver healthy genes could trigger cancer if they lodged in a patient’s DNA near a cancercausing gene. Trials of similar therapies were halted while researchers studied why some of the children developed cancer. But many called for the trials of lifesaving therapy to continue. “When you consider the risk to the patient of the treatment, you also must consider the risk to the patient of no treatment,” said a grandmother of an SCID patient. “That’s the other side of this coin.”95 At an FDA panel hearing on gene therapy trials, Paul Gelsinger, Jesse’s father, summed up the dilemma: “You are in a quandary now, because you have an ethical concern that you may be creating a problem in these kids that they didn’t have before. But you have also given them a viable treatment.”96 Today the hope remains of using gene therapy for treating incurable diseases. According to Theodore Friedmann, director of the University of California–San Diego’s gene therapy program, gene therapy offers “new and definitive approaches . . . that were previously only the stuff of dreams and scientific fantasy. . . . It’s going to be difficult. Yet medicine has always had to work with imperfect knowledge and technology.”97

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING

B

iotechnology continues to make new discoveries and push boundaries. The coming years will bring advances and new possibilities for scientists to find ways to treat, cure, and prevent disease. Some of the most exciting possibilities rest in the emerging research on stem cells and cloning. While most knowledge is still theoretical, scientists believe these fields will be keys to curing patients with conditions like Parkinson’s, cerebral palsy, and Alzheimer’s. Despite bright possibilities, ethical controversy and debate exist. Is there a point where the advancement of science damages the future of the human race?

A Sheep Is Born—Reproductive Cloning A clone is a group of cells or an organism like a plant, animal, or human that forms from a single cell of another organism. The clone and the cell’s source are genetically identical. In the 1993 movie Jurassic Park, scientists used the blood of extinct dinosaurs, captured in a preserved mosquito, to clone new dinosaurs for a theme park. The science used in this movie seemed pure Hollywood magic until 1997, when a sheep named Dolly was introduced to the world.

THE POTENTIAL TO CURE ILLNESS “Science has presented us with a hope called stem cell research, which may provide our scientists with many answers that for so long have been beyond our grasp. I just don’t see how we can turn our backs on this.” —Former First Lady Nancy Reagan. Quoted in Michael Bellomo, The Stem Cell Divide. New York: AMACOM, 2006, p. 98.

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The birth of the first cloned mammal, Dolly the sheep, ignited a storm of controversy over reproductive cloning.

Dolly was the first mammal to be cloned. Scientists in Scotland took the nucleus and DNA from an adult ewe’s cell. They emptied a second ewe’s egg and inserted the genetic material from the first ewe into the empty egg. Then they implanted the egg into a third ewe. She became pregnant, carried the lamb to term, and gave birth to Dolly. Dolly was the exact DNA replica of the first ewe, from whose genetic material she was created. In addition, her birth occurred without the involvement of a male parent. This complex procedure is called reproductive cloning. When the news of Dolly raced around the world, a furious debate arose over cloning. Now that scientists had successfully cloned a sheep, what if they took the next step and cloned a human?

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING

Milk from a Cloned Cow Since the birth of Dolly the cloned sheep, the prospect of cloning animals is no longer science fiction. In fact, at agricultural shows across the country, the presence of cloned animals is steadily increasing. The ability to clone prize dairy cows, steers, and hogs will allow farmers to improve the quality of entire herds. If this happens, milk and meat from second- and third-generation cloned livestock would be available to enter the food supply. Consumer groups and some members of Congress have fought against the sale of food from cloned animals. They argue there has not been enough scientific research on the effects of cloned food to declare it safe to eat. The elevated risk of health problems early in life that

some cloned animals develop is another factor that supports restrictions on food from cloned animals. In response to these concerns, the FDA conducted studies of the meat and milk of cloned animals. In January 2008 the FDA declared that “the risk assessment did not identify any unique risks for human food from cattle, swine or goat clones, and concluded that there is sufficient information to determine that food from cattle, swine and goat clones is as safe to eat as that from their more conventionally bred counterparts.” Quoted in Andrew Martin, “F.D.A. Says Cloned Animals Safe to Eat,” New York Times, January 15, 2008. www .nytimes.com/2008/01/15/business/15cnd-clone.html.

Diners in a Tokyo restaurant eat beef from a cloned cow. Some groups argue that there is insufficient research on the effects of eating cloned food, but, in a January 2008 study, the U.S. Food and Drug Administration could not identify any risks.

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BIOETHICS People envisioned scenarios where cloning could give a dead child back to grieving parents. Cloning paired with designer genes could yield strong and smarter humans. Sports teams loaded with clones of the best players would be unbeatable. Many people feared that a future of manufacturing children was quickly approaching. In reaction to the human cloning debate, ethics councils and legislatures around the world condemned the use of cloning to produce a human child. In 2005 the United Nations backed a worldwide ban on all forms of human cloning.

THE UNITED NATIONS SUPPORTS A BAN ON HUMAN CLONING “This declaration shows once and for all this is not all about the religious right. A decent society doesn’t build the foundations of its biomedical science on the creation and destruction of human embryos.” —William B. Hurlbut, a Stanford University ethicist who served on President George W. Bush’s Council on Bioethics. Quoted in Colum Lynch, “U.N. Backs Human Cloning Ban,” Washington Post, March 9, 2005. www.washingtonpost.com/wp-dyn/articles/A18205-2005Mar8.html.

Many scientists around the world called for and supported these bans. They reported safety issues in animal cloning that resulted in failure or in embryos with severe abnormalities. Dolly the sheep showed signs of premature aging and was eventually put to sleep at age six, half the typical life span for a sheep. It is still unknown if the cloning triggered Dolly’s aging. Because of the unresolved safety and ethical issues, most scientists have no intention of creating human clones. Instead, they see possibilities in another type of cloning—therapeutic.

Therapeutic Cloning In theory, both forms of cloning, reproductive and therapeutic, create a genetically identical embryo. In therapeutic cloning, however, the embryo is not grown into a baby but is instead used

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING

A researcher at Seoul National University in Korea prepares to inject a somatic cell into an enucleated bovine egg. In therapeutic cloning the embryo is used to harvest stem cells.

to harvest stem cells. Stem cells have the ability to renew themselves through cell division and can become, or differentiate into, a range of specialized cell types. Scientists envision a future where they would be able to grow these stem cells into other tissues and organs, which could then be transplanted into patients. The possibilities of therapeutic cloning seem endless. Cloned brain cells would treat Parkinson’s disease, and new pancreatic cells would treat diabetes. The use of organs cloned from a patient’s own cells would eliminate the needless deaths of people waiting on organ transplant lists. Organ rejection would no longer be a problem for transplant patients, eliminating the need for a lifetime of expensive antirejection drugs. One day therapeutic cloning may even be able to treat spinal cord and other physical injuries as well. “The bottom line is that for treatment of human disease, [cloning] is really the closest to creating cures for disease,”98 said Xiangzhong Yang, a professor of animal science

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BIOETHICS and director of the Center for Regenerative Biology at the University of Connecticut. To date, creating stem cell lines through therapeutic cloning has been difficult. Success in cloning human embryos remained elusive. However, in January 2008 a California research team reported they had cloned a human embryo, an important first step toward the promise of personalized stem cell medical treatment. “The ability to produce embryo stem cells from cloned human embryos would create entirely new opportunities to study inherited diseases,”99 said Ian Wilmut, creator of Dolly the sheep. Despite the potential benefits, there are safety issues involved with using stem cells for therapeutic cloning. To work with the stem cells, scientists put the cells in a culture that encourages them to grow and replicate. This culture, which contains growth factors and chemicals, may affect the cells in unknown ways. Researchers have seen mutations in cells that have been sitting in these cultures for long periods of time. Some of these mutations have led to cancer.

The Stem Cell Debate Most people do not have a problem with growing new tissues and organs to save human lives. The ethical debate arises, however, over the use of stem cells. The two main types of stem cells are embryonic stem cells and adult stem cells. Adult stem cells, found in adult tissue, help to repair the body and replenish normal turnover of blood, skin, or intestinal cells. Unlike embryonic stem cells, adult stem cells are limited in the range of cells they can become. Through bone marrow transplants, adult stem cells have been used successfully to treat leukemia and other bone and blood cancers. Because no embryos are destroyed and donors knowingly give consent, most people have no ethical problems with the use of adult stem cells in research and therapies. Embryonic stem cells do not have the limitations of adult stem cells. Taken from an embryo at approximately day five of development, embryonic stem cells have the unique ability to become any one of the more than two hundred cell types in the human body. This ability is called pluripotency, and it allows the cells to develop into virtually any type of tissue or organ in the human body.

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING

Speaking at a medical conference on cloning and organ storage in 2000, Pope John Paul II made clear the opposition of the Catholic Church to stem cell research.

Many researchers see embryonic stem cells as holding the key to a greater understanding of disease and developing new treatments. Studying stem cells may help scientists learn more about how they develop into specialized cells and what errors happen during cell development to trigger disease. Researchers also hope that one day stem cells will be used to make new cells and tissues to treat disease. One day patients with diabetes may be able to produce insulin after receiving healthy insulin-producing stem cells. Cardiac patients could receive specialized cells that enable them to grow new cardiac tissue to replace a damaged heart.

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BIOETHICS In 1998 James Thomson at the University of Wisconsin became the first scientist to remove stem cells successfully from a human embryo. The process destroyed the embryo. At the time Thomson had some reservations about his research. “If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough,” he said. “I thought long and hard about whether I would do it.”100 He decided to proceed because he believed the work was important to learning why cell error occurred during development. What Thomson did not anticipate, however, was the firestorm of debate over stem cells that would erupt.

AN EMBRYO IS A LIFE “Make no mistake, that a cluster of cells is the same way you and I . . . started our lives. One goes with a heavy heart if we use these [embryonic cells] . . . because we are dealing with the seeds of the next generation.” —President George W. Bush. Quoted in Albert R. Jonsen, Bioethics Beyond the Headlines: Who Lives? Who Dies? Who Decides? Lanham, MD: Rowman & Littlefield, 2005, p. 133.

When news of Thomson’s success hit the media, many people quickly took sides. Supporters believed stem cell research brought hope to the millions of people living with and dying of serious diseases. In an August 2000 speech, President Bill Clinton spoke about stem cells and his commitment to funding more research. “We’ve had story after story . . . of the potential of stem cell research to deal with these health challenges,” he said. “And I think we cannot walk away from the potential to save lives and improve lives, to help people literally to get up and walk, to do all kinds of things we could never have imagined, as long as we meet rigorous ethical standards.”101 Others could not condone the destruction of an embryo. While they supported research to cure and treat serious disease, doing so at the expense of human life was not an option. Pope John Paul II described the Catholic Church’s opposition to stem

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING cell research by writing, “Human embryos obtained in vitro are human beings and are subjects with rights; their dignity and right to life must be respected must be respected from the first moment of their existence.”102 Critics of stem cell research also opposed the creation of embryos specifically for research use.

LIFT RESTRICTIONS ON STEM CELL RESEARCH “It does not follow that the theology of a few should be allowed to forestall the health and well-being of the many. And how can we affirm life if we abandon those whose own lives are so desperately at risk?” —Ronald Reagan Jr., son of the former president and stem cell research supporter. Quoted in Michael Bellomo, The Stem Cell Divide. New York: AMACOM, 2006, p. 98.

Some people called for a compromise between the two sides. With the increase in in vitro fertilization procedures at fertility clinics around the country, many embryos sat unused. For couples who had finished building their families, these embryos would never become babies. Instead of destroying or discarding them, the embryos could be used for stem cell research. “It makes sense to me that it’s a better moral decision to use [human embryos] to help people than just to throw them out,” said James Thomson. “It’s a very complex issue, but to me it boils down to that one thing.”103

Revisiting Adult Stem Cells For those who opposed embryo destruction, the use of adult stem cells was the technology of choice. One of the biggest drawbacks to using adult stem cells, however, was their limited ability to grow into other types of cells. This allowed adult stem cells to work well only for certain therapies. In November 2007 researchers made an exciting announcement. They discovered a way to take adult skin cells and regress the cells back to an embryonic state. “The fact that you can do something in adult cells to reprogram them was absolutely

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Stem cells are prepared for later therapeutic use. In late 2007, researchers discovered a way to regress adult skin cells back to their embryonic state.

THE FUTURE OF BIOETHICS: STEM CELL RESEARCH AND CLONING novel,” said Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute. “It goes against everything that everyone had ever thought about the abilities of adult cells.”104 The reprogrammed adult cells, called induced pluripotent stem cells, or iPS cells, seemed to offer the same promise of embryonic stem cells. In addition, iPS cells did not involve making or destroying human embryos. These cells also provided scientists a way to produce genetically matched cells without cloning or egg donation. “Everyone was waiting for this day to come,” said Tadeusz Pacholoczyk, education director at the National Catholic Bioethics Center. “You should have a solution here that will address the moral objections that have been percolating for years.”105 Despite the optimism surrounding iPS cells, scientists cautioned that the need for embryonic stem cells would not disappear overnight. “You never could have made a [reprogrammed] cell without an embryonic stem cell to compare to, to tell you what a pluripotent cell was,” said Robb MacLellan of the UCLA David Geffen School of Medicine. “[Reprogrammed cells] are still very

Banking on Cord Blood A less-publicized source of stem cells is cord blood. Cord blood is the blood remaining in the umbilical cord and placenta after birth. Previously thrown out as medical waste, cord blood is now considered valuable. Like bone marrow, it is a rich source of stem cells. These stem cells are the building blocks for red blood cells, platelets, and the body’s immune system. They have the ability to become many types of body cells and can be used to repair or replace damaged cells in the body.

While not as versatile as embryonic stem cells, cord blood stem cells have an advantage over bone marrow stem cells. Cord blood cells are less mature. When used in transplants, the patient’s body is less likely to attack cord blood cells as “foreign.” Therefore, cord blood cells are less likely to trigger rejection in patients. Cord blood technology can be used to treat over seventy types of genetic illnesses. Scientists hope advances in stem cell research will open the door for even more uses of cord blood.

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BIOETHICS preliminary, and they will need a lot of work before you can say that they would be better or equivalent to embryonic stem cells.”106 The risk of cancer is another concern about iPS cells. To reprogram the adult cells, scientists used four viruses to insert a gene into the cell’s DNA. These insertions sometimes turn off tumorsuppressing genes, causing a cancer to grow out of control. In addition, one of the genes used to regress the adult cells was known to increase the risk of cancer. According to Robert Lanza, chief scientific officer of Advanced Cell Technology, the FDA “would never allow us to use those virally modified cells in patients.”107 To solve the cancer risk, scientists are studying new ways to regress adult cells without viruses or cancer-causing genes.

The Future of Stem Cells Despite the creation of iPS cells, there is still a long road ahead for stem cell research and therapies. “Even though we have this nice new source of cells, it doesn’t solve all the downstream problems of getting them into the body in useful form,”108 said James Thomson. In labs growing the cells into heart cells, nerve cells, or whatever tissue is needed has proven extremely difficult. In animal experiments to date, most cells have died. “The actual survival of the cells is so poor, this is going to be a huge issue before it will be clinically applicable,”109 said Robb MacLellan. Many scientists believe effective stem cell therapies are still years away from human trials. The more immediate use for stem cells may be for researching and understanding disease. That knowledge could develop more conventional medicines and therapies. “It’s likely that studying human disease is on a faster track than using stem cells for transplant therapy,”110 said Fred Gage of the Salk Institute. As stem cell research moves into the future, the ethical debate will continue. New techniques and therapies unheard of today are sure to spark new debate and ethical challenges. With each discovery, researchers will attempt to balance the sanctity of life with the hope of a cure for millions of seriously ill people. According to Kenneth R. Chien of the Harvard Stem Cell Institute, the future of stem cell research is “exciting.” He also warns, “There’s still a lot more work to do.”111

Introduction: The Birth of Bioethics 1. Quoted in Albert R. Jonsen, Bioethics Beyond the Headlines: Who Lives? Who Dies? Who Decides? Lanham, MD: Roman & Littlefield, 2005, p. 14. Chapter 1: The Beginning of Life 2. Centers for Disease Control and Prevention, “Assisted Reproductive Technology: Home.” www.cdc.gov/art. 3. Quoted in Gina Kolata, “Scientists Face New Ethical Quandaries in Baby-Making,” New York Times, August 19, 1997. www.nytimes.com/specials/women/warchive/970819_1649 .html. 4. Quoted in Kolata, “Scientists Face New Ethical Quandaries in Baby-Making.” 5. Quoted in Kolata, “Scientists Face New Ethical Quandaries in Baby-Making.” 6. Quoted in Kolata, “Scientists Face New Ethical Quandaries in Baby-Making.” 7. Quoted in Conceive Online, “How Much Does It Cost?” www.conceiveonline.com/index.php?option=com_con tent&task=view&id=162&Itemid=137. 8. Quoted in Anne Adams Lang, “For Infertility Treatments, Now You’re Covered, Now You’re Not,” New York Times, June 21, 1998. www.nytimes.com/specials/women/nyt98/ 21lang.html. 9. Quoted in Yonet Shimron, “Couples with Leftover Embryos Face Legal and Ethical Dilemmas,” North Carolina Center for Reproductive Medicine, July 27, 2007. www.nccrm .com/latest/couples-with-leftover-embryos-face-ethicallegal-dilemma.html.

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BIOETHICS 10. Quoted in Liza Mundy, Everything Conceivable: How Assisted Reproduction Is Changing Men, Women, and the World. New York: Knopf, 2007, p. 293. 11. Quoted in Jan Galletta, “Embryo Adoption Offers Couples Unconventional Way to Have Babies,” Chattanooga (TN) Times, November 18, 2007. 12. Quoted in Mundy, Everything Conceivable, p. 293. 13. Quoted in Galletta, “Embryo Adoption Offers Couples Unconventional Way to Have Babies.” 14. Quoted in Jessica Reaves, “When a Couple Divorces, Who Owns the Embryo?” CNN.com, June 2, 2000. http:// archives.cnn.com/2000/LAW/06/02/embryo6_2.a.tm. 15. Quoted in Mundy, Everything Conceivable, p. 49. 16. Quoted in Jim Hopkins, “Egg-Donor Business Booms on Campus,” USA Today, March 15, 2006. www.usatoday.com/ money/industries/health/2006-03-15-egg-donors-usat _x.htm. 17. Quoted in Hopkins, “Egg-Donor Business Booms on Campus.” 18. Quoted in Andrea Sachs, “And Baby Makes Four: A New Custody Battle Intensifies the Debate over Surrogacy,” Time, August 27, 1990. 19. Quoted in Sachs, “And Baby Makes Four.” 20. Quoted in Sachs, “And Baby Makes Four.” 21. Quoted in Sachs, “And Baby Makes Four.” 22. Quoted in Patrick Condon, “Minnesota Senate Approves Bill for Surrogate Mother Contracts,” Winona (MN) Daily News, April 17, 2008. www.winonadailynews.com/articles/2008/ 04/17/mn/08mn.txt. 23. Quoted in Mundy, Everything Conceivable, p. 51. 24. Quoted in Margaret Carlson, “Old Enough to Be Your Mother,” Time, January 10, 1994. www.time.com/time/mag azine/article/0,9171,979942,00.html. 25. Quoted in Frank Bruni, “For Reproduction Doctors, the Science Is the Easy Part,” New York Times, July 8, 1997. http:// query.nytimes.com/gst/fullpage.html?sec=health&res=9905 E6DA1739F93BA35754C0A961958260. 26. Quoted in Bruni, “For Reproduction Doctors, the Science Is the Easy Part.”

NOTES 27. Quoted in Bruni, “For Reproduction Doctors, the Science Is the Easy Part.” Chapter 2: The Decision Makers 28. Quoted in Nova, “The Most Dangerous Woman in America: In Her Own Words,” PBS, October 12, 2004. www.pbs.org/ wgbh/nova/typhoid/letter.html. 29. Centers for Disease Control and Prevention, “History of Vaccine Safety.” www.cdc.gov/vaccinesafety/basic/history.htm. 30. Centers for Disease Control and Prevention, “History of Vaccine Safety.” 31. Quoted in Sue A. Blevins, “Shots in the Dark: Who Should Decide Which Vaccinations Children Receive?” Reason, July 1999, p. 49. 32. Quoted in Blevins, “Shots in the Dark,” p. 49. 33. Quoted in Martha Irvine, “Debate Growing over Hepatitis Vaccination for Children, Young Adults,” Los Angeles Times, January 4, 1998. http://articles.latimes.com/1998/jan/04/local/me-4988. 34. Quoted in Congress Daily AM, “Parents Fight Against Mandatory Hepatitis B Shots,” May 19, 1999. 35. Quoted in Irvine, “Debate Growing over Hepatitis Vaccination for Children, Young Adults.” 36. Quoted in AAPS, “Doctors’ Group Votes to Oppose Vaccine Mandates,” November 2, 2000. www.aapsonline.org/press/ nrvacres.htm. 37. Quoted in Gina Kolata, “Getting on a Transplant List Is the First of Many Hurdles,” New York Times, June 10, 1995. http://query.nytimes.com/gst/fullpage.html?res=990CE7DC 113AF933A25755C0A963958260. 38. Quoted in Alan Zarembo, “Death by Geography,” Los Angeles Times, June 1, 2006. http://articles.latimes.com/2006/ jun/11/local/me-transplant11. 39. Quoted in New York Times, “Worth Noting: Family Uses Billboard to Try to Save Father,” December 19, 2004. http:// query.nytimes.com/gst/fullpage.html?sec=health&res=9B03 EEDC1230F93AA25751C1A9629C8B63. 40. Quoted in New York Times, “Worth Noting.” 41. Quoted in Marc Kaufman and Rob Stein, “Record Share of Economy Spent on Health Care,” Washington Post, January

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BIOETHICS 10, 2006. www.washingtonpost.com/wp-dyn/content/arti cle/2006/01/09/AR2006010901932.html. 42. Quoted in CBS2.com, “Cancer Girl’s Lawyer Blames CIGNA for Her Death,” December 20, 2007. http://cbs2.com/lo cal/nataline.sarkisyan.CIGNA.2.615167.html. 43. Quoted in Robert Bazell, “Rationing Health Care Among the Uninsured,” MSNBC.com, February 24, 2004. www.msnbc .msn.com/id/4363789. 44. Quoted in Neal Conan, “Analysis: Rationing of Health Care,” Talk of the Nation, NPR Radio Transcript, September 24, 2003. Chapter 3: The End of Life 45. Quoted in Michael Vitez, “Fighting for the Right to Die: Terri Schiavo’s Husband and Karen Ann Quinlan’s Mother Tell of Battles to Honor Loved Ones,” Philadelphia Inquirer, May 1, 2006. 46. Quoted in Vitez, “Fighting for the Right to Die.” 47. Quoted in William H. Colby, Unplugged: Reclaiming Our Right to Die in America. New York: AMACOM, 2006, p. 10. 48. Quoted in Colby, Unplugged, p. 33. 49. Quoted in Maria Gallagher, “Poll: Doctors Won’t Always Follow Living Will, Euthanasia a Concern,” Lifenews.com, August 22, 2004. www.lifenews.com/bio431.html. 50. Quoted in John Schwartz, “New Openness in Deciding When and How to Die,” New York Times, March 21, 2005. www.nytimes.com/2005/03/21/health/21dying.html. 51. Quoted in Schwartz, “New Openness in Deciding When and How to Die.” 52. Quoted in Monica Davey, “Kevorkian Freed After Years in Prison for Aiding Suicide,” New York Times, June 2, 2007. www.nytimes.com/2007/06/02/us/02kevorkian.html. 53. Quoted in Schwartz, “New Openness in Deciding When and How to Die.” 54. Quoted in Schwartz, “New Openness in Deciding When and How to Die.” 55. Quoted in Schwartz, “New Openness in Deciding When and How to Die.”

NOTES 56. Quoted in Colby, Unplugged, p. 195. 57. Quoted in Schwartz, “New Openness in Deciding When and How to Die.” 58. Quoted in James Dao, “Suicide Ruling Raises Concern: Who Decides?” New York Times, April 4, 1996. http://query.ny times.com/gst/fullpage.html?sec=health&res=980DE0D F1339F937A35757C0A960958260. 59. Quoted in Daniel Bergner, “Death in the Family,” New York Times, December, 2, 2007. www.nytimes.com/2007/12/02/ magazine/02suicide-t.html?scp=3&sq=Death%20in%20the %20Family&st=cse. 60. Quoted in Bergner, “Death in the Family.” Chapter 4: Research and Development 61. Quoted in National Institutes of Health, “Directives for Human Experimentation: Nuremberg Code.” http://ohsr.od.nih .gov/guidelines/nuremberg.html. 62. The World Medical Association, “Policy.” www.wma.net/e/ policy/b3.htm. 63. Quoted in Carol Rados, “Inside Clinical Trials, Testing Medical Products in People,” FDA Consumer Magazine, September/October 2003. www.fda.gov/FDAC/features/2003/503_ trial.html. 64. Quoted in Reed Abelson, “Advocating a Treatment, but Denied Access to It,” New York Times, July 17, 2008. www.ny times.com/2008/07/17/business/17dystrophy.html?scp =1&sq=Advocating%20a%20Treatment,%20but%20De nied%20Access%20to%20It&st=cse. 65. Quoted in Abelson, “Advocating a Treatment, but Denied Access to It.” 66. Quoted in Abelson, “Advocating a Treatment, but Denied Access to It.” 67. Quoted in Rados, “Inside Clinical Trials, Testing Medical Products in People.” 68. Quoted in National Public Radio, “Remembering Tuskegee,” July 25, 2002. www.npr.org/programs/morning/features/ 2002/jul/tuskegee. 69. Quoted in Sheryl Gay Stolberg, “The Biotech Death of Jesse

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BIOETHICS Gelsinger,” New York Times, November 28, 1999. www.ny times.com/library/magazine/home/19991128mag-stol berg.html. 70. Quoted in Stolberg, “The Biotech Death of Jesse Gelsinger.” 71. Quoted in Stolberg, “The Biotech Death of Jesse Gelsinger.” 72. Quoted in Richard Jerome, Jerry Kammer, and Matt Birkbeck, “Death by Research,” People, February 21, 2000. www.people.com/people/archive/article/0,,20130547, 00.html. 73. Quoted in Stolberg, “The Biotech Death of Jesse Gelsinger.” 74. Quoted in Jerome, Kammer, and Birkbeck, “Death by Research.” Chapter 5: Genetic Testing and Engineering 75. Quoted in Claudia Kalb, Anne Underwood, and Jonathan Mummolo, “Peering into the Future,” Newsweek, December 11, 2006, p. 52. 76. Quoted in Matthew Herper and Robert Langreth, “Will You Get Cancer?” Forbes, June 18, 2007, p. 52. 77. Quoted in Kalb, Underwood, and Mummolo, “Peering into the Future.” 78. Quoted in Kalb, Underwood, and Mummolo, “Peering into the Future.” 79. Quoted in Kalb, Underwood, and Mummolo, “Peering into the Future.” 80. Quoted in Amy Harmon, “Insurance Fears Lead Many to Shun DNA Tests,” New York Times, February 24, 2008. www .nytimes.com/2008/02/24/health/24dna.html. 81. Quoted in Harmon, “Insurance Fears Lead Many to Shun DNA Tests.” 82. Quoted in Laura B. Benko, “Testing the Limits of Care; Concern About ‘Genetic Discrimination’ from Employers and Insurers Trying to Keep Costs Down Casts a Pall on Genetic Testing,” Modern Healthcare, February 13, 2006. 83. Quoted in Benko, “Testing the Limits of Care; Concern About ‘Genetic Discrimination’ from Employers and Insurers Trying to Keep Costs Down Casts a Pall on Genetic Testing.”

NOTES 84. Quoted in Nation’s Health, “New U.S. Genetic Nondiscrimination Law Named a ‘Tremendous’ Victory,” August 2008, p. 10. 85. Quoted in Laurie Tarkan, “Screening for Abnormal Embryos Offers Couples Hope After Heartbreak,” New York Times, November 22, 2005. www.nytimes.com/2005/11/22/health/ 22gene.html. 86. Quoted in Amy Harmon, “Couples Cull Embryos to Halt Heritage of Cancer,” New York Times, September 3, 2006. www.nytimes.com/2006/09/03/health/03gene.web.html. 87. Quoted in Harmon, “Couples Cull Embryos to Halt Heritage of Cancer.” 88. Quoted in Harmon, “Couples Cull Embryos to Halt Heritage of Cancer.” 89. Quoted in Emily Singer, “Choosing Babies,” Technology Review, March/April 2007. www.technologyreview.com/bio medicine/18303/page1/. 90. Quoted in Amy Harmon, “The Problem with an AlmostPerfect Genetic World,” New York Times, November 20, 2005. www.nytimes.com/2005/11/20/weekinreview/20har mon.html. 91. Quoted in Harmon, “The Problem with an Almost-Perfect Genetic World.” 92. Quoted in Tarkan, “Screening for Abnormal Embryos Offers Couples Hope After Heartbreak.” 93. Quoted in Gina Kolata, “In a First, Gene Therapy Saves Lives of Infants,” New York Times, April 28, 2000. http:// partners.nytimes.com/library/national/science/health/04280 0hth-gene-therapy.html. 94. Quoted in Kolata, “In a First, Gene Therapy Saves Lives of Infants.” 95. Quoted in Sheryl Gay Stolbery, “Panel Advises Resuming Gene Studies,” New York Times, October 11, 2002. http:// query.nytimes.com/gst/fullpage.html?res=9E04E3DF143AF 932A25753C1A9649C8B63. 96. Quoted in Stolbery, “Panel Advises Resuming Gene Studies.” 97. Quoted in Horace Freeland Judson, “The Glimmering Promise of Gene Therapy,” Technology Review, November 2006. www.technologyreview.com/biomedicine/18096/.

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BIOETHICS Chapter 6: The Future of Bioethics: Stem Cell Research and Cloning 98. Quoted in William Hathaway, “Cloning Advance, with Question Marks,” Hartford (CT) Courant, November 15, 2007. 99. Quoted in Fiona MacRae, “Monkeys Take Us a Step Closer to Human Cloning,” Daily Mail, November 15, 2007, p. 44. 100. Quoted in Gina Kolata, “Man Who Helped Start Stem Cell War May End It,” New York Times, November 22, 2007. www.nytimes.com/2007/11/22/science/22stem.html. 101. Quoted in Michael Bellomo, The Stem Cell Divide. New York: AMACOM, 2006, p. 92. 102. Quoted in Christine Vestal, “Stem Cell Research: At the Crossroads of Religion and Politics,” Pew Research Center, July 18, 2008. http://pewresearch.org/pubs/903/stem-cellresearch. 103. Quoted in Bellomo, The Stem Cell Divide, pp. 139–40. 104. Quoted in Patrick Barry, “Potent Promise: Back to the Womb,” Science News, September 13, 2008, p. 16. 105. Quoted in Gina Kolata, “Scientists Bypass Need for Embryo to Get Stem Cells,” New York Times, November 21, 2007. www.nytimes.com/2007/11/21/science/21stem.html. 106. Quoted in Barry, “Potent Promise.” 107. Quoted in Andrew Pollack, “After Stem-Cell Breakthrough, the Work Begins,” New York Times, November 27, 2007. www.nytimes.com/2007/11/27/science/27stem.html. 108. Quoted in Pollack, “After Stem-Cell Breakthrough, the Work Begins.” 109. Quoted in Barry, “Potent Promise.” 110. Quoted in Sharon Begley and Jeneen Interlandi, “Reality Check on Embryonic Debate,” Newsweek, December 3, 2007, p. 52. 111. Quoted in Pollack, “After Stem-Cell Breakthrough, the Work Begins.”

Chapter 1: The Beginning of Life 1. How has science opened doors for childless couples? What methods exist to help them become parents? 2. When embryos created for in vitro fertilization are not used, what happens to them? 3. When multiple people are involved in the creation of a child— parents, surrogates, sperm and egg donors—what are the rights and responsibilities of each? Chapter 2: The Decision Makers 1. How do mandatory vaccination programs protect society from disease? Why do some people refuse vaccinations? 2. When a resource shortage exists—like organs available for transplant—what is the fairest way to allocate them? Should allocations be made to those who have been on the waiting list the longest? Or should factors such as age and anticipated outcome influence allocation decisions? 3. How should patients’ ability to pay affect the type and quality of medical care they receive? In what cases, if any, is it reasonable to deny care? Chapter 3: The End of Life 1. How have advances in medicine caused people to live longer than in prior generations? 2. How has the definition of death changed from years past? 3. According to the author, what are the advantages and disadvantages of legalizing doctor-assisted suicide? Chapter 4: Research and Development 1. What role do clinical trials play in bringing a new drug or therapy to the public? What advantages and disadvantages are there for patients in a clinical trial? 101

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BIOETHICS 2. In the Tuskegee study, how did researchers violate patient rights? What should they have done to treat study patients fairly? 3. What is acceptable risk? How does it vary from person to person? Chapter 5: Genetic Testing and Engineering 1. According to the author, what are the advantages and disadvantages of testing adults for a genetic disease? 2. In what ways is preimplantation genetic diagnosis (PGD) beneficial? How is it harmful? 3. What is the difference between somatic and germ-line gene therapy? According to the author, what are the advantages and disadvantages of each? Chapter 6: The Future of Bioethics: Stem Cell Research and Cloning 1. What is the difference between reproductive and therapeutic cloning? What uses do scientists envision for cloning? 2. What are the differences between adult stem cells and embryonic stem cells? According to the author, what are the advantages and disadvantages of each? 3. The discovery of regressed adult cells, iPS cells, is a recent breakthrough in stem cell research. What benefits do iPS cells have, and what are the risks associated with them?

Action Bioscience 6379 Safford Terrace North Port, FL 34287 phone: (941) 423-8636 fax: (941) 423-4486 Web site: www.actionbioscience.org Action Bioscience is an award-winning educational resource that promotes bioscience literacy. Genetics and biotechnology are two topics discussed in detail in numerous articles. The Web site has a searchby-topic feature that allows users to pinpoint exact areas of interest. American Society for Bioethics and Humanities (ASBH) 4700 W. Lake Glenview, IL 60025-1485 phone: (847) 375-4745 fax: (847) 375-6482 e-mail: [email protected] Web site: www.asbh.org The ASBH is a network of leaders and professionals dedicated to making a difference in the bioethics and medical humanities fields. The society sponsors educational meetings and publications about bioethical subjects. Center for Bioethics and Human Dignity 2065 Half Day Rd. Deerfield, IL 60015 phone: (847) 317-8180 fax: (847) 317-8101 e-mail: [email protected] Web site: www.cbhd.org 103

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BIOETHICS The Center for Bioethics and Human Dignity explores bioethical issues from a Christian perspective. The organization produces a variety of live, recorded, and written resources on bioethical issues. National Catholic Bioethics Center (NCBC) 6399 Drexel Rd. Philadelphia, PA 19151 phone: (215) 877-2660 fax: (215) 877-2688 Web site: www.ncbcenter.org/index.asp The NCBC strives to promote human dignity in health care and the life sciences in accordance with the teachings of the Catholic Church. The organization offers various educational and publishing materials, workshops, and seminars. National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, MD 20892 phone: (301) 496-4000 e-mail: [email protected] Web site: www.nih.gov The NIH, part of the U.S. Department of Health and Human Services, conducts and supports medical research. NIH scientists investigate ways to prevent disease, as well as the causes, treatments, and even cures for common and rare diseases. The Web site has a special section devoted to stem cell research. University of Pennsylvania Center for Bioethics 3401 Market St., Ste. 320 Philadelphia, PA 19104 phone: (215) 898-7136 Web site: www.bioethics.upenn.edu/index.php The Center for Bioethics is a leader in bioethics research and a world-renowned educational and research facility. The center offers information about bioethics in the news, recent projects, upcoming bioethics events, and faculty talks.

Books Linda Jacobs Altman, Bioethics: Who Lives, Who Dies, and Who Decides? Berkeley Heights, NJ: Enslow, 2006. William H. Colby, Unplugged: Reclaiming Our Right to Die in America. New York: AMACOM, 2006. Roman Espejo, ed., Biomedical Ethics. San Diego: Greenhaven, 2002. Albert R. Jonsen, Bioethics Beyond the Headlines: Who Lives? Who Dies? Who Decides? Lanham, MD: Rowman & Littlefield, 2005. Rose M. Morgan, The Genetics Revolution: History, Fears, and Future of a Life-Altering Science. Westport, CT: Greenwood, 2006. Liza Mundy, Everything Conceivable: How Assisted Reproduction Is Changing Men, Women, and the World. New York: Knopf, 2007. Carrie L. Snyder, ed., Opposing Viewpoints: Euthanasia. Farmington Hills, MI: Greenhaven, 2006. Periodicals Daniel Bergner, “Death in the Family,” New York Times, December 2, 2007. Sheryl Gay Stolberg, “The Biotech Death of Jesse Gelsinger,” New York Times, November 28, 1999. Internet Sources National Institutes of Health, “Directives for Human Experimentation: The Nuremberg Code.” http://ohsr.od.nih.gov/guide lines/nuremberg.html. Nova, “The Most Dangerous Woman in America,” PBS, October 12, 2004. www.pbs.org/wgbh/nova/typhoid. Web Sites Bioethics Resources on the Web, National Institutes of Health 105

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BIOETHICS (http://bioethics.od.nih.gov). This Web site provides links, articles, and other research on a variety of bioethical issues. The President’s Council on Bioethics (www.bioethics.gov). This site has reports, transcripts, articles, and background information about bioethical issues.

A Adamson, David, 77 Adkins, Janet, 46 Advance directives, 45 Advisory Committee on Immunization Practices, 29 Altman, Drew, 35 American Cancer Society, 50 American Medical Association (AMA), 47, 49 Amniocentesis, 71 Anderson, W. French, 63 Animal testing, 56 Annas, George, 20 Applegarth, Linda, 21, 22 Assisted reproduction technology (ART) age of mother and, 20–21 definition of, 9 growth of, 10–11 See also In vitro fertilization Assisted suicide, 46–47 potential for discrimination in, 51–52 Association of American Physicians and Surgeons (AAPS), 31 B Baby M (Melissa Stern), 18 Baruch, Susan, 73 Belkin, Lyla Rose, 27–28 Belkin, Michael, 27–28 Bill of Rights, 38 Blaese, R. Michael, 80 Boscamp, Jeffrey, 29

Brain death, 40 Brown, John, 9, 11 Brown, Lesley, 9, 11 Brown, Louise, 10, 11 Bush, George W., 88 Bush, Jeb, 44 C Centers for Disease Control and Prevention (CDC), 9, 26, 30 Chien, Kenneth R., 92 Clinical trials, 54–55, 57 participation in, 57–59, 59 protection of participants in, 59–60 Clinton, Bill, 62–63, 88 Clone(s) definition of, 81 of human embryo, 86 Cloning. See Reproductive cloning; Therapeutic cloning Compassionate use, 58–59 Compassionate use policy, 58–59 Cord blood, 91 Council for Responsible Genetics, 73 Cranford, Ronald, 43 Crick, Francis, 66 Cruzan, Nancy, 42 Cystic fibrosis, 66–67 D Death with Dignity Act (Oregon, 1997), 47–48, 48

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BIOETHICS Declaration of Helsinki (World Medical Association, 1964), 54 DNA, 66 Doctors, 45 Dolly (cloned sheep), 81–82, 82, 84 Drugs experimental, 58–59 for pain, 49 See also Clinical trials Duchenne muscular dystrophy, 58 E Edwards, Robert, 10, 11, 12 Egg donation, 16–17 compensation for, 17–18 Embryos fate of unimplanted, 15–16 human, cloning of, 86 resilience of, 12 Ethical, Legal and Social Implications (ELSI) program, 69 Euthanasia, 38–39 F Finkel, Richard, 58–59 Fisher, Barbara Loe, 30–31 Food and Drug Administration, U.S. (FDA), 54, 83 French, Duane, 51, 51–52 Friedman, Theodore, 80 G Gage, Fred, 92 Gelsinger, Jesse, 63–65, 79 Gelsinger, Paul, 64, 65, 80 Gene therapy abuse in clinical test of, 63–65 somatic, 77, 79–80 Genes, 66 Genetic Information Nondiscrimination Act (2008), 73

Genetic testing, 68, 70, 70 privacy concerns with, 72–73 regulation of, 77 value in diseases without cures, 71–72 Ghose, Mohit M., 73 Goold, Susan, 59 Grifo, James, 12 Grossman, Howard, 48 Grove, Victoria, 72 Gruber, Stephen, 71–72 Gunvalson, Cheri, 58 H Health care, cost of, 35–37 Hedley, Linda, 76–77 Hennessy, Jennifer, 35 Hepatitis B vaccine, 27–29 Higgins, Linda, 20 Hospice care, 50 Hudson, Kathy, 77 Hughes, Mark, 76 Human Genome Project, 69 Huntington’s disease, 67 Hurlbut, William B., 84 I Iliescu, Adriana, 20 Imparato, Andrew, 76 In vitro fertilization (IVF), 9, 13 genetic diagnosis and, 73–77 Induced pluripotent stem cells (iPS), 91–92 Infectious diseases, control of, 23 Isovaleric acidemia (IVA), 70 Ivey, Glenn F., 31 J John Paul II (pope), 87, 88–89 Johnson, R. Owen, Jr., 31 Journal of the American Medical Association, 30 Jurassic Park (film), 81

INDEX K Kennedy, Edward, 62 Kevorkian, Jack, 46, 46–47 Kingsbury, Chad, 75 Kitzhaber, John, 37 Krampitz, Todd, 34, 34–35 L Lepay, David, 60 Levenson, James, 33 Life debate over beginning of, 9 medical advances prolonging, 39–40 Living wills, 45 Loring, Jeanne, 89, 91 M MacLellan, Robb, 91–92 Mallon, Mary (Typhoid Mary), 23–24, 24, 26 Margolis, Harold, 29 Martin, Shana, 72 Measles, vaccination against, 30 Medicine, advances in, 39–40 Meisel, Alan, 45 Miller, Tracy E., 51 Monaco, Caroline, 70 Monaco, Jana, 70 Monaco, Stephen, 70 Monaco, Tom, 70 Moody, Jim, 31 Moore, Annie, 35 Mothers, ART and age of, 20–21 N Nazi Germany, 38–39, 53 Nuremberg Code, 53–54 O Oregon assisted suicide in, 47–49, 52 Medicaid ranking system in, 37

Organ transplantation, 33–35 Orient, Jane M., 31 Orkin, Stuart, 79 Ornithine transcarbamylase (OTC) deficiency, 63 P Pacholoczyk, Tadeusz, 91 Painkillers, 49 Patients’ rights, 45–46 Paulson, Richard, 16, 16, 17 People for the Ethical Treatment of Animals (PETA), 56 Persistent vegetative state (PVS), 43 Pinho, Maria, 27 Pluripotency, 86 Polls. See Surveys Preimplantation genetic diagnosis (PGD), 73–77 Privacy, 72–73 Public Health Service, U.S., 60 Q Quality of life, 40 Quinlan, Joe, 41, 42 Quinlan, Julia, 41, 41–43 Quinlan, Karen Anne, 41–43 R Ranjan, Dinesh, 34 Reagan, Nancy, 81 Reagan, Ronald, Jr., 89 Reproductive cloning, 81–82 safety of meat/milk from animals created by, 83 Research clinical trials, 54–55, 57 on embryonic stem cells, 87–89 ethics of, 53–54 stem cell, 89, 92 Resources, allocation of, 32–33 Richardson, Joan, 36 Roe v. Wade (1973), 10

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BIOETHICS Rothman, David, 61 Rothschild, Kathy, 28 S Sahakian, Vicken, 21 Sarkisyan, Nataline, 36, 37 Sauer, Mark, 13, 18, 22 Sawyer, Mark, 26 Schiavo, Michael, 44, 45 Schiavo, Terri, 43 Schindler, Bob, 44 Schindler, Mary, 44 Schirmer, Helen, 75 Schirmer, Matthew, 75 Schwetz, Bernard A., 55 Severe combined immune disorder (SCID), 79–80 Sharzer, Leonard A., 46 60 Minutes (TV program), 47 Stem cells adult vs. embryonic, 86 reprogrammed adult, 89, 91–92 Steptoe, Patrick, 9, 11, 12 Stern, William, 18 Stevens, Kenneth, 49 Suicide. See Assisted suicide Surrogacy, 18–20 Surveys of doctors on following advance directives, 45 on physician-assisted suicide, 46 Syphilis, Tuskegee Institute study of, 60, 62, 62–63 T Terry, Sharon, 73 Therapeutic cloning, 84–86 Thomson, James, 88, 89

Toeckes, Denise, 75 Trisomy 22, 75 Turner, Andrew James, Jr., 45–46 Tuskegee syphilis study, 60, 62, 62–63 U United Network for Organ Sharing, 33 United States, health care spending in, 35 V Vaccines, childhood, 26–27 for hepatitis B, 27–29, 28 parents’ refusal of, 30–31 public health benefits of, 29–30 recommended immunizations, U.S. (table), 25 Vetter, David, 78 Vogt, Stephanie, 72 Volker, Deborah L., 49 W Wade, Roe v. (1973), 10 Walters, LeRoy, 64 Waterston, Robert, 69 Watson, James, 66, 67 Wellwood, Edward, 48 Williams, Heidi, 73 Willowbrook study, 61 Wilmut, Ian, 86 Wolfe, Kim, 71 World Medical Association (WMA), 54 Y Yang, Xiangzhong, 85–86

Cover photo: Tipp Howell/Taxi/Getty Images Maury Aaseng, 25 AP Images, 12, 16, 18, 28, 34, 41, 48, 50, 51, 67, 78, 83, 85 © Bettmann/Corbis, 11, 24 © Gene Blevins/Los Angeles Daily News/Corbis, 37 China Photos/Getty Images, 56 © Corbis Sygma, 62 © Bogdan Cristel/Reuters/Corbis, 20 © Owen Franken/Corbis, 90 Getty Images, 82 © Medical-on-Line/Alamy, 7 © Melba Photo Agency/Alamy, 14 Jeff J Mitchell/Getty Images, 30 © Phototake Inc./Alamy, 71 Bill Pierce/Time Life Pictures/Getty Images, 61 © Vincenzo Pinto/Reuters/Corbis, 87 Bill Pugliano/Getty Images, 46 Joe Raedle/Getty Images, 39 © Reuters/Corbis, 69 Klaus Rose/dpa/Landov, 70 Chip Somodevilla/Getty Images, 44 Alex Wong/Getty Images, 59 © Ira Wyman/Sygma/Corbis, 55

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Carla Mooney lives in Pittsburgh, Pennsylvania, with her husband and three children. She received her bachelor of science degree from the University of Pennsylvania. Mooney has written several books and articles for young readers.

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