14 / April 1998 Illinois Issues
ETHICAL
As medical science quickens the pace of what's possible,
Essay by Howard Wolinsky When, in February 1997, Scottish scientists introduced Dolly, a lamb they claimed had been cloned from a single cell of an adult sheep, she did more than give new meaning to the notion of identical twins. Dolly touched off an international debate over the implications of this new means of creating life. The most famous lamb since Bo Peep's became the latest innocent bystander caught in the web of an age-old conflict: the struggle between science and ethics, the tension between what can be and what should be, the battle between what is possible and what is right. President Bill Clinton, concerned about the impact of cloning on respect for human life, called in his new National Bioethics Advisory Commission to explore the implications of the new technology. The panel heard testimony on the technique from ethicists, religious leaders and scientists. Harold Shapiro, president of Princeton University and chairman of the panel, said cloning posed fundamental questions about the value of life. "Like all great moral issues there is no permanent consensus. Society can just reach a temporary resolution that seems to make sense in their times," he told reporters. The commission supported a ban on human clones and research restrictions on the new technique. After all, the Scottish researchers produced a largenumber of deformed creatures before they finally succeeded with Dolly. Clinton translated the ethics panel's report into proposed legislation for a five-year ban on human cloning. He doesn't oppose research on human or animal DNA, which potentially could result in new understandings of and treatments for disease. Bills on cloning lay dormant until January 1998 when a Chicago physicist-turned- fertility-researcher, Richard Seed, told National Public Radio about plans to clone humans, a disclosure that quickly brought a renewed urgency among policy-makers to ban human cloning. Medical ethicists may not have moved Congress to act, but they helped create a framework for exploring the issue. Just a generation or so ago, this would have been impossible because medical ethicists were a virtually unknown profession in this country. Although their influence in public policy debates and the need for their counsel are growing, ethicists generally remain outside the loop of decision-making. Their role is somewhat akin to that of economists in setting economic policy, although no ethicists have reached the stature of economist Alan Greenspan, who single-handedly can affect mortgage rates and the direction of the stock market. For various reasons — the nature of politics, the irresistible lure of Illinois Issues April 1998 / 15
With the rapid changes expected in the years ahead, ethical counsel will be in greater demand and medical ethicists likely will have a greater say in policy. Notably, fast-moving developments in genetics will call upon ethicists and policy-makers to grapple with powerful new tools that not only have the potential to find cures for cancer and AIDS, but could mark a person for a lifetime as a likely victim of Alzheimer's or another disease. Likewise, the aging of the baby boomers, a huge population accustomed to doing things its own way, will pose new challenges regarding allocation of resources for health care and approaches to death and dying. Over the past three decades, concerns about the potential abuse of science and about the potential abuse of rights of patients and subjects of medical experiments have led to the blossoming of medical ethics in the United States. Though large-scale and systematic abuses may no longer be occurring in this country, in recent years ethicists have found much to be troubled by: giving investigational vaccines and drugs to military personnel during the Gulf War, transplanting baboon hearts into dying babies, implanting artificial hearts into adults with heart disease and running clinics providing new reproductive technologies and cancer therapies that put business interests before ethical concerns. Still, though medical ethicists have served on major advisory panels dealing with public policy, their sway has been greatest in hospitals and medical institutions, where they help set institutional policies and help physicians cope with the problems posed by individual cases. As Arthur Caplan, a prominent biomedical ethicist and director of the Center for Bioethics at the University of Pennsylvania, puts it: "Medical ethicists have had a legislative or policy impact, but in any given year much more at the bedside than at the legislature, and more federal impact than state." Nevertheless, policy-setters at the state and federal levels increasingly are encountering a maze of issues in the wake of advances in medicine. Paul Simon, the songwriter, put it ironically: "The Boy in the Bubble" from the Graceland album says we are living in a time "of miracles and wonders." The dizzying pace of science and technology — from making babies in new ways to keeping people alive with transplants from baboons and pigs to deciding when to turn treatments off at the end of life — has created challenges for policy- makers and medical ethicists alike. Though it is as fresh as the evening news, medical ethics is not new. Hippocrates, the Greek physician, is not only the father of modern medicine, but also of medical ethics. Four centuries before Christ, Hippocrates said physicians should not give poisons to patients and should advocate for the patient's interest. Not that there was a 16 / April 1998 Illinois Issues consensus in the ancient world. As Supreme Court Justice Harry A. Blackmun, formerly an attorney for the Mayo Clinic, indicated in the 1973 Roe v. Wade case that established the constitutional right to abortion in this country, Hippocrates opposed abortion, while Plato was pro-choice. Skipping ahead to the 19th and 20th centuries, science made major advances in understanding the causes of disease and in developing techniques to prevent, relieve and cure it with vaccines, antibiotics and surgery.
The Nuremberg Code, which came out of the trial, called for some simple, but profound changes in medical research. Among other things, the code required researchers to obtain voluntary, competent and informed consent from their subjects 'and also required researchers to avoid harming their subjects physically or mentally. Though much heralded today, the Nuremberg Code was not heeded by many U.S. researchers. Caught up in the beliefs of their own culture, they saw the atrocities of Nazi medicine as something that was performed by third-rate doctors under the sway of an evil political system without recognizing that in some cases they were themselves involved in atrocities. Five thousand miles from Nuremberg, Germany, in impoverished Macon County,Ala., nearly 400 African-American men with syphilis were left untreated by U.S. Public Health Service researchers who were trying to determine the natural history of venereal disease. The so-called Tuskegee study began in 1932, 15 years before the Nuremberg Code was drafted, and continued lone after its adoption. Caplan calls the Tuskegee experiment "America's Nuremberg." This wasn't the only abuse by American researchers. In the post-war era, researchers exposed innocent people to radiation and hallucinogenic drugs and infected mentally disabled patients in the Willowbrook Mental Institution in New York with deadly and disabling hepatitis B. Nazi doctors were tried at Nuremberg/or atrocities performed in the name of science. But 400 African- American men went untreated so U.S. researchers could track the course of venereal disease. One medical ethicist calls that 1930s experiment America's Nuremberg.' Modern interest in biomedical ethics was sparked in the late 1960s by growing concerns about abortion and the potential use of aborted fetuses in experimentation, says George Annas, an attorney and medical ethicist who chairs the Health Law Department at Illinois Issues April 1998 / 17 the Boston University School of Public Health. Annas, author of the landmark The Rights of Patients, says the controversy over psycho surgery, the treatment of mental illness with controversial brain surgery, and later the Tuskegee case led Congress to establish the National Commission for the Protection of Human Subjects of Biomedical and Behavorial Research. The commission, which ran from 1974 to 1978, "essentially framed the entire system of human research review. There has not been a major problem in this area for 30 years," says theologian Albert Jonsen, a commission member who teaches ethics in medicine and chairs the program at the University of Washington School of Medicine in Seattle. These and related developments led to medical ethics becoming a formalized area of study for scholars from varied backgrounds. Today, there are about 2,000 professional medical ethicists in the United States, coming from such academic disciplines as law, medicine, philosophy, political science and theology. And there are 25 master's and doctorate programs in medical ethics in this country. "The next generation of medical ethicists will have gone through these programs," says Caplan, who has a doctorate in philosophy and is author of the newly published book, Am I My Brother's Keeper? The Ethical Frontiers of Biomedicine. "When I got into this field in 1978, my worry was whether it was a fad: Would it follow consciousness studies, or some other intellectual trend and simply disappear? It has been fascinating for me to see it actually institutionalize and face questions about power and accountability and training and licensure. When I came into medical ethics, it was just something that you did because you were interested in the issues, not a career." The bioethics boom has accompanied and been fueled by rapid advances in medical science. Institutional review boards, ethics committees and staff ethicists at research hospitals have attempted to anticipate and address problems arising from new therapies and research protocols. Every new medical development, such as enabling infertile couples to have babies created from fertilization in a lab dish, or saving a dying child with a transplant of a liver slice taken from a healthy parent, brings breakthroughs and new dilemmas. In the 1970s, the ability of doctors to keep patients in "persistent vegetative states" for years, breathing though brain dead, raised such questions as whether families have the right to "pull the plug." In the 1980s and the 1990s, patient advocacy groups, including those for people with AIDS, have attacked the medical establishment over such issues as slow access to experimental therapies and the design of studies, concerns over confidentiality, including the tracing of sexual contacts, and whether physicians could assist terminally ill patients in taking their own lives. Margaret Battin, a philosopher and medical ethicist at the University of Utah School of Medicine in Salt Lake City, says medical ethics can find its roots as a discipline that examines the underpinnings of the assumptions made about health care. She says such probing aids in the public policy process: "Public policy- makers need to draw on something. They can't simply draw on public opinion. They can't simply draw on religious pressure. They can't simply draw on political impulse. They certainly should attend to the basic ethical issues." Ethicists participate inthe public policy arena in a variety of ways. They serve on expert panels that advise Congress and the president, a notable example now being the National Bioethics Advisory Commission that came out on the cloning issue. For the past decade, the state of New York has had a standing ethics committee that has advised the governor on such issues as death and dying and physician-assisted suicide. Ethicists also influence policy through their statements to legislative committees about issues like cloning and in court testimony on the subject of death and dying. Battin, for instance, says she has served on commissions and committees dealing with such issues, but also meets informally with legislators and state officials. Caplan chairs an advisory committee on blood safety for the U.S. Department of Health and Human Services that grappled with such thorny questions as boosting the supply of products made from blood. He also helped legislators in New York develop new policies to procure organs by requiring that families be requested to donate organs of dying family members. Linda Emanuel, a medical doctor and director of the Institute of Ethics at the Chicago-based American Medical Association, the physician organization that has dealt with ethical issues since it was founded in 1847, says, "Clearly, over the last couple of decades, there's been an exponential growth for roles of professional ethicists." The number of policy committees with slots for ethicists has been growing, she notes. Faced with rapid change in our society, legislators and policy-makers at the state and federal levels increasingly turn to medical ethicists to help them understand the new issues and what might be done to formulate laws and regulations. Jonsen, who examines the development of the field in his new book, The Birth of Bioethics, explained the role of the biomedical ethicist. He says ethicists "are, almost all of them, scholars ensconced in university settings: They are not politicians, policy mavens, lobbyists, etc. Bioethics, as it has developed over the last 30 years, is both a scholarly discipline and a public discourse. Bioethicists help frame issues, but seldom are they crucial figures in the way decisions are made." He says they examine "whether questions are rightly put, arguments logically formulated, consequences properly evaluated." The discourse, he adds, "may go on (or go off the track) regardless of what they do, but very often they contribute to its being carefully 18 / April 1998 Illinois Issues directed. Still, the ethicists are, as such, really very much in the background." Legislators have recognised that medical ethicists can help illuminate issues in thorny medical matters. For example, Caplan says, when considering a law to prosecute parents of Christian Science children who died from being deprived of medical care, Minnesota legislators, informed by medical ethicists, crafted a compromise bill. It required the reporting of sick children to public health departments, while requiring public health workers to be trained to work with parents whose religious views reject medical care. Medical ethicists participated in the debate and writing of state legislation on "advance directives," including living wills, in California, Illinois, Massachusetts, Minnesota, Pennsylvania, Wisconsin and virtually every other state. Caplan, who has been one of the higher profile medical ethicists because of his witty and incisive Caplanisms used to describe ethical problems to reporters on deadline, says of the biomedical ethicist's role, "I always think about bioethics in terms of two metaphors: First, as paratroopers coming in when a fight or battle starts. You might get caught in a crossfire, but you arrive early and try to figure out the situation, see what's going on, scope out the terrain, see if you can get the thing settled before it escalates into a full-fledged war. The other metaphor is that bioethics is like an ambassador between the world of the hospital and the world of public policy."
and sperm donors; clarify paternity and maternity obligations on the part of couples who use reproductive technology to make babies; make sure policy is clear about what happens to embryos and babies if there is a divorce, death or impairment of the couple using the technology; insist on doctor-specific data about success rates; mandate follow-up studies for kids made by single parents or older moms. To date, they all listened attentively but have done nothing. "For a host of political reasons, ranging from lobbying by the in-vitro fertilization industry to fears of entanglement in the abortion debate, no state has done anything." In general, he says of policy-makers, "They do consult; they don't necessarily heed. They often ask, but it's politics, so what ultimately drives the decision may have little to do with ethics." Ezekiel Emanuel, an oncologist and ethicist at the Harvard School of Medicine, is a former member of the National Bioethics Advisory Commission and served on Clinton's task force to reform the health system. He also has had contact with policy- makers at the state level. And he says issues raised by medical ethicists ought to receive attention at the local as well as the national level. "Some state legislatures and state government officials are very sophisticated and thoughtful, and some are clueless," Emanuel says. "It is a generalization that only the federal government has the resources. In some states that's true. In some states that's not. I have seen extremely progressive and thoughtful approaches by various state officials and legislation. It depends on how much time, concentration and brain power people want to bring to bear to the problems. "I don't think it is an inherent thing that states are always less equipped than the federal government. Quite the contrary, the federal government can be under the gun and hardened to political and ideological battles that states have been able to avoid in some places." Some ethicists do consider the states "less equipped" because they have Illinois Issues April 1998 / 19 fewer staff members and less money than the federal government and are less experienced in grappling with biomedical ethical issues. Yet because legislation on insurance primarily is a state issue, for instance, the states have been ahead of the federal government on passing laws to prevent insurance discrimination based on genetic testing. Caplan says he expects the states to spend more time on medical ethics in the future as more issues are handled at the state level. In order for state policy-makers and medical ethicists to become more familiar with each other, he favors having medical ethics students, who often spend time in hospitals, also serve internships in state agencies and offices. Some states notably Illinois — have had to play catch-up in relating ethical concerns to public policy. Steven H. Miles, an internal medicine specialist and ethicist at the Center for Bioethics at the University of Minnesota, worked in Illinois a decade ago, an experience that left a negative impression of policy-makers. "Illinois was not a leader on medical ethics issues," he says. In fact, he blames the absence of leadership for a notorious 1989 case in which a father, Rudy Linares, held medics at bay with a gun as he disconnected his brain-damaged son from a respirator after he had been told — via an answering machine — that the hospital had concluded it was forbidden under Illinois law from pulling the plug.
David Thomasma, a medical ethicist and philosopher who directs the Medical Humanities Program at Loyola University Medical Center in Maywood, says, "Dr. Miles is right. We were behind the eight ball, but we have made progress." Thomasma says the Linares case led attorneys, ethicists and others to form a commission sponsored by the Cook County state's attorney to examine end-of-life care. This resulted in Illinois' Health Care Surrogate Act, which clarified patient rights by setting up a hierarchy of family members and friends to make decisions about with- drawing treatment. Even so, he says, ethicists and policy-makers have little contact. And he blames the ethicists. He notes the medical schools and major medical centers in the Chicago area formed the Chicago Clinical Ethics Program a decade ago. While the group has held seminars, it has not fulfilled its role as a think tank to advise policy-makers on ethical issues, says Thomasma, who was the program's founding president. "I don't want to blame the legislators. There is a critical mass of medical ethicists in Chicago. We could be in the forefront. The ethicists need to be more active and let the legislators know we're here." Thomasma says that Illinois is behind California, New York and Minnesota on addressing issues involving medical ethics, but ahead of most of the other states. With the help of medical ethicists, legislators could pass laws that anticipate and prevent problems. Instead, he say, the typical pattern in Illinois and other states is 20 / April 1998 Illinois Issues for legislators to react in a knee-jerk manner. "The legislators tend to respond to lurid instances, such as 'drive-through' births." How do medical ethicists decide what is "ethical"? Caplan says ethicists first get disputing parties together to see if they agree on factual descriptions of policy questions. Sometimes, a simple exploration of an issue can lead to resolutions. Ethicists seek frameworks for ethical analysis from religion and secular philosophy as well as the law to classify problems. "Some people think they are fighting about whether it is all right to experiment on embryos. But if you show them what is being experimented on are really human eggs, they don't have the same moral reservations about that. They may have thought eggs and embryos have equal status. They come to see that they don't, so ethical analysis may shift their views about whether it is all right to do experiments on eggs." Ethicists go through existing areas of agreement to look for precedents or analogies that might apply to whatever issue they currently are examining. By examining problems in this fashion, ethicists can see whether some answers already exist, or whether they have entered uncharted territory. Ezekiel Emanuel says public policy and medical ethics ought to follow the model of science: Collect data on the issue at hand before new laws and regulations are passed, and conduct research afterwards on its impact. As an example, he cites living wills, created under state laws to allow patients to gain control over their medical care. He says that while there has been a great emphasis on encouraging people to use living wills, research has shown that fewer than 25 percent of people actually fill them out. Policy ought to be a dynamic force that can be molded and changed to meet societal needs based on such data, Emanuel says. "You need to know where the pivotal points are, where the real hang-ups are. Is it that doctors are not honoring living wills? Is it the fact that they're not educated about them? Is it that [living wills] are not in the patients' charts? There are lots of questions there." Ethicists agree that their greatest success has been in protecting the subjects of medical research from abuses and giving patients more control over whether to receive treatment and when to withdraw it. Thomas Murray, director of the Center for Biomedical Ethics at Case Western Reserve University in Cleveland and a member of the National Bioethics Advisory Commission, says a significant public policy contribution of medical ethics has been providing patients with greater control over their end-of-life decisions, including such advance
Illinois Issues April 1998 / 21 directives as living wills and durable powers of attorney. "Chances are, anybody who has seen a relative die appreciates the value of an advance directive," he says. Some remain skeptical about the ability of ethicists to lift the moral standard of science, medicine and public policy. Boston University's Annas, a legal scholar and social critic, maintains that the law, rather than the deep thoughts of ethicists, is what establishes ethical standards. "Most of American bioethics is the law. It is the law, no matter what people want to think it is. Doctors buy into that, and they worry about being sued and go before the legislature to try to pass immunity statutes on topics as diverse as stopping at an accident scene, stopping treatment, brain death, organ transplantation and even assisted suicide. They're constantly looking for immunity from the law, and often even trying to eliminate the basic right of their patients to sue them for medical malpractice. "The law sets minimal morality — the morality of duty, what you have to do not to get sued, basically not to get into trouble. You'd like ethics to be higher, to be more the morality of aspirations, to do good, to go beyond staying out of jail or keeping your medical license. That's what ethics should be about. But the tendency is always to go to the lowest common denominator, like asking the question: Can I get sued? "Of course, in a pluralistic society, where there is no shared religion or ethos, the law is really the cement that binds the society together. In this respect, bioethics serves primarily to help lawmakers decide whether or not to legislate in a particular area, such as protecting research subjects or writing living wills, and sometimes can help courts in deciding about the wisdom of adopting a new constitutional right, such as a right to physician-assisted suicide." Annas argues that the courts often play the lead role. "The right to refuse treatment is a fundamental legal right, and would have continued to be upheld by the courts with or without whatever the ethicists had to say," he says. There are other reasons the influence of ethicists has been restricted. Ethicists agree, for example, that they have devoted a lot of their efforts to such high-tech issues as cloning while giving short shrift to such basic concerns as the access to health care of more than 40 million uninsured Americans and the problems posed by managed care that are rapidly changing payment arrangements as well as traditional doctor-patient relations. • "Bioethics has not figured out what to do with managed care. It is kind of startling that key issues about rationing and allocation [spending limited resources] are actually made by business people, not doctors. It doesn't have much to say yet about how to make managed care more ethical or whether managed care could at all be ethical. In that area, it has been a failure," says Caplan. He adds: "There's a lot of literature on cloning, baboon transplants and the artificial heart. There's a tiny pile of literature on everyday life in the nursing home, which affects more lives. As a result, people tend to equate bioethics with the analysis of cutting-edge, and disturbing new There are reasons the influence of ethicists has been restricted. Ethicists agree, for example, that they have devoted a lot of their efforts to such high-tech issues as cloning while giving short shrift to such basic concerns as the access to health care of more than 40 million uninsured Americans and the problems posed by managed care. technologies, while a lot of it should be concerned with what it's like if you don't want to have a roommate in the nursing home who yells all the time." What issues will be on the front burner in the years ahead? The ethicists agree that as the baby boom becomes the elder boom, reproductive technology, including cloning, medical genetics, access-to-care issues, the problems of managed care, and end-of-life and equity issues will be the hot topics for policy-makers and ethicists. Utah's Battin says, "There will be some tension over assisted reproductive techniques. Cloning is only one component. The technology keeps developing: genetic engineering, designer babies, sex selection, development of extrauterine forms of gestation." In fact, she expects male pregnancy to become an issue. She says gay couples and heterosexual couples who wish to share child- birthing chores or in which the woman has fertility problems will be seeking out these new technologies. She says: "I know of fertility clinics that have requests from men [to be impregnated by using such] procedures. The ones I know of have been turned down." Meanwhile, the boom in medical genetics has been raising concerns about people losing jobs and insurance coverage because they have defects in such genes as BRCA 1 and BRCA 2 that could lead to breast and ovarian cancer in women. Illinois has been among the states addressing these worries by barring job and insurance discrimination based on the results of genetic tests. Concerns about genetics will mount as scientists — by 2005 or before — complete searching through human genetic material for links to disease. Some ethicists already have devoted a lot of attention to these issues as a result of Congress' earmarking a portion of the funding for the Human Genome Project to research on the project's ethical implications. Medical ethicists and policy- 22 / April 1998 Illinois Issues
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