In 1996, a 28-year-old breast cancer survivor named Joy Simha decided to take the new genetic test for the breast cancer gene BRCA1. If Simha tested positive for the gene, she would face a 50 percent to 85 percent chance of her breast cancer recurring or of developing ovarian cancer in her lifetime. As a preventive measure, she planned to have her remaining breast removed. But her oncologists at Sloan-Kettering Memorial Cancer Center in New York refused to tell her the results of her own test.
"It was just a very paternalist attitude," Simha says now. "They kept telling me, `We really feel that the results could be dangerous if they are revealed to you at the wrong time.'" So Simha took her frustration to the press. "If I did not want to know the results of my tests," she wrote to The New York Times Magazine, "I would not have given the doctors my blood."
By refusing to reveal such test results to their patient, Simha's doctors believed they were practicing medicine at the highest ethical level; keeping patients in the dark in such circumstances has been recommended by such prestigious bioethics authorities as a 53-member panel of ethicists and lawyers chaired by Stanford University law professor Henry Greely. "The test for BRCA1 should be confined to the research setting," declared the panel's report which was presented at a conference at the University of Southern California's Pacific Center for Health Policy in 1996. The ethics panel advised women not to take the commercial test for BRCA1 because "there are no known methods for preventing breast or ovarian cancer that would be particularly important to women with versions of these genes."
Nor is the panel at the USC conference alone in its opinion. In 1998, George Annas, director of the Law, Medicine, and Ethics Program at the Boston University Schools of Medicine and Public Health, conceded that the carrier of the BRCA1 gene has a high risk of contracting breast cancer. Nevertheless, he argued in his book, Some Choice: Law, Medicine, and the Market, "Since there is no way to prevent this disease, what good is knowing you will probably get it in the future?" Francis Collins, the director of the Human Genome Project, agreed in U.S. Senate testimony in 1996 that the BRCA1 test should not be commercially available to women. According to Collins, the information that a woman might get from such a test is "toxic."
But Simha's story has a happy ending. As a result of the press attention, her doctors relented and gave her the test results. She had tested negative, and she dropped plans for another mastectomy. Far from having a "toxic" result, the test actually helped Simha avoid another dangerous and painful procedure.
Furthermore, the Pacific Center was wrong in stating that there is no way to avoid breast cancer. A Mayo Clinic study published in January in The New England Journal of Medicine found that "surgery that removes the breasts as a preventive measure before the appearance of cancer reduces the risk of breast cancer by approximately 90 percent for women at moderate to high risk for the disease." That is precisely the treatment that Simha had planned. But though the Mayo study is important, it is beside the ethical point: Even in the face of medical uncertainty, such decisions should be up to Simha and other at-risk women, not a panel of imperious bioethicists.
Bioethics is a growth industry. During the past 30 years, more than 165 such centers and programs have sprung up, many of them associated with university medical schools. As Simha's case shows, bioethical pronouncements have real consequences for real people. Increasingly, bioethicists are shaping the choices that you and your family will have for future medical treatments.
The federal government has also gotten into the bioethics act. In 1989, the Ethical, Legal, and Social Implications (ELSI) program was established as an integral part of the Human Genome Project, the joint effort by the National Institutes of Health and the Department of Energy to decipher the complete genetic code of human beings. ELSI receives about 5 percent of the annual Human Genome Project budget, or between $5 million and $6 million per year, and claims that its funding "currently represents the largest single investment in bioethical research from any one source." In the past 10 years, ELSI has awarded grants that have produced more than 150 studies, reports, books, and even NPR and PBS programs.
In 1995, President Clinton, at the urging of Vice President Gore, established the National Bioethics Advisory Commission, whose 17 members include seven professional bioethicists. The NBAC, headed by Princeton University President Harold Shapiro, has issued a string of reports, most famously its recommendation that a five-year ban be imposed on efforts to clone human beings.
In January, Gore announced at the annual meeting of the American Association for the Advancement of Science that the administration plans to increase direct federal funding for bioethical research by $10 million. While such amounts may sound small, they leverage a lot of power. And that power is growing at the expense of individual choice.
A self-conscious marriage of philosophy and policy, bioethics began in a very different spirit. It was born in the 1960s as a counterbalance to "doctor-knows-best" paternalism. Then, it focused on increasing the autonomy of patients in their relations with doctors, hospitals, researchers, insurers, and government agencies. Early bioethicists successfully challenged researchers to be more respectful of their patients/subjects and demanded that they obtain informed consent before treatment or experimentation.
The field received a major boost in the early 1970s, when it was revealed that doctors working with the U.S. Public Health Service had enrolled 399 black men in Tuskegee, Alabama, as part of a study that followed the course of their syphilis infections without treating them. The resulting scandal underscored the urgent need for better protections for research subjects and led to the expansion and strengthening of the institutional review board (IRB) system. All federally funded research using human subjects must receive approval from an IRB that makes sure the benefits of the research outweigh the risks and the researchers have obtained the informed consent of the subjects. Today, there are some 4,000 IRBs reviewing research proposals. While not perfect, the IRB system has been an effective mechanism for protecting patients and research subjects.
But as the Simha case shows, many bioethicists are now rediscovering the virtues of paternalism. This time, bioethicists themselves want to determine what patients need to know and what treatments they should get–bioethicist-knows-best, if you will. What they claim to know best is not only that patients' choices should be limited but that social interests should supersede personal considerations and that the mechanism of the market has no place in medical treatment.
For example, genetic testing–the issue in Simha's case–is exploding. More than 450 tests for genetic disorders are now available. This disturbs those bioethicists who have assumed the position that medical ignorance is medical bliss.
"Ninety-nine percent of all of our genetic tests tell you something that there is nothing you can do about for yourself," says Boston University's Annas. He cites the test for Huntington's disease, a devastating degenerative neurological condition that generally strikes middle-aged adults. According to Annas, the test tells a patient, "You're going to die this horrible death, and there's nothing you can do about it." Thus, he says, the tests end up creating pathology in people who are healthy but who now think that they are sick.
But while the availability of treatment may be the only relevant consideration for Annas, patients may have excellent reasons of their own for wanting the information that a biotech diagnostic test might offer them. Instead of debilitating patients, the results may well give them a chance to shape their lives, careers, and reproductive choices appropriately. A man who learns at age 20 that he will contract the dementia of Huntington's in his mid-40s might decide to lead an entirely different life, skipping the corporate grind for any number of alternatives. Or he might choose not to have children so as not to risk passing on the disease.
Telling someone that his chances of early-onset heart disease are greater than average may or may not make him feel worse, but it could well energize him to do something about it: more frequent heart sonograms, cholesterol-lowering drugs, exercise. Annas' view seems to be based on the assumption that everyone is a depressive fatalist.
Gregory Stock, the director of the UCLA Program on Medicine, Technology, and Society, finds the idea that bioethicists would withhold genetic test results from a patient "very offensive." Bioethicists, he says, have "a lack of faith in the individual, essentially."
Genetic testing is not only about disease. Commercial labs now offer cheap, simple, and highly accurate genetic paternity tests through the mail. Simply wipe the inside of a child's cheek with a cotton swab, send it in with $350 to $500, and the results are back in a week or so. The simplicity and lower costs have boosted the number of paternity tests from 80,000 in 1988 to more than 200,000 in 1998. Those seeking paternity tests may have good reason: One-third of DNA paternity tests indicate that the man being tested is not the biological father of the child in question.
Characteristically, bioethicist Eric Juengst, formerly the director of the ELSI program and now at Case Western Reserve, denounces the new paternity tests and asks, "what is the benefit to the child and society of seeking this information?"
"A lot of people have grown up with healthy and stable families in the ignorance of their parental status with no harm done," Juengst told the Dallas Morning News in 1998. He added the information "erodes the…unconditional acceptance of our children with all their surprising traits and maybe their genes." He added that "adoptees can testify that there's a lot more to being a family than just genetic links." Of course, adoptive parents choose to rear genetically unrelated children; cuckolded husbands may want the option.
More important, Juengst's view is a typical example of how the bioethical community elevates the presumed claims of society over the rights of individuals to choose. A similar claim is made by Arthur Caplan, the director of the Center for Bioethics at the University of Pennsylvania, who has been dubbed "the man to call on bioethics" and "America's most visible commentator on bioethics" by The Chronicle of Higher Education. In his 1997 book, Am I My Brother's Keeper?: The Ethical Frontiers of Medicine, Caplan makes the remarkable assertion that "assisted reproduction, unlike sexual reproduction, is a social enterprise. It requires the involvement of many third parties as well as significant amounts of social resources. In ordinary circumstances, individuals do not need society's help to make babies. In extraordinary circumstances, they can only do so with that help. What level of help society is willing to tolerate, provide, or pay for moves assisted reproduction beyond the boundaries of personal choice and individual liberty."
But couples using assisted reproductive technologies don't use "social resources"; they use personal resources. In fact, infertility treatments are not covered by most health insurance policies, so couples pay for treatments directly out of their own pockets. Also, it's not "society's help" that they seek but a doctor's help. And finally, society can "tolerate" a lot more than it is willing to "pay for."
Similarly, Daniel Callahan, co-founder of America's most prestigious bioethics think tank, the Hastings Center in Garrison, New York, argues in his 1998 book, False Hopes: Why America's Quest for Perfect Health Is A Recipe for Failure, that "coercive efforts to change unhealthy behavior" are justified because "bad individual health behavior…does harm to others, even if the health risk-takers pay their own health care costs. Money is diverted from other uses, personnel are diverted from other patients, and lives are wasted that could serve us all." Of course, every personal decision diverts money and personnel from one use to another. Callahan's logic leaves no room at all for individual freedom–everything belongs to "society."
Patient autonomy, some bioethicists argue, has gone too far; they rue what they call the "absolutizing of autonomy." Since the free market is the pre-eminent arena for exercising autonomy, many bioethicists harbor a deep antipathy toward it. Indeed, their distrust of the market is at the root of the bioethical opposition to new reproductive technologies.
Bioethicists used to worry about the moral standing of in vitro fertilization (IVF) and surrogate motherhood. Now many of them want to impose regulations on fertility clinics. Why? Caplan thinks "the free market is a dangerous, costly environment for making babies; caveat emptor is not a sufficient ethic to guide the creation of new lives." He further asserts in his book that "at a minimum, policies must be put in place stating who can use reproductive technologies, including statements about age, the existence of infertility, and the need for a stable, psychologically fit parent or parents."
Annas agrees. "Because of the commercial nature of the enterprise, I think there should be national regulation for the whole fertility industry," he says. "Society has an interest in children born through reproductive technology. We're the only country that has a market in human eggs, permits payment to surrogate mothers, and lets the private market dictate what's done."
The prestigious magazine Science jumped on the regulatory bandwagon last year, when it published an article noting that "unlike other areas of medical innovation, no comprehensive regulatory framework exists in the United States for alternative reproductive technologies." The authors, of course, recommended that "a federal oversight mechanism" be established.
But has this lack of federal oversight resulted in abuses? Caplan cites a few battles involving embryo custody or contested surrogacy, but the truth is that problems have been rare. As for safety, the birth defect rate for IVF babies (150,000 of them have been born) is lower than for children who are born in the normal way.
The vast majority of parents using IVF have gone away happy. It is the same in any market: There are a few operators who defraud their clients or treat them negligently, but in the overwhelming majority of transactions, both parties benefit. New reproductive technologies may be technically sophisticated, but there is nothing so unusual about them that standard ethical and legal principles cannot be used to restrain or punish unscrupulous or careless practitioners. Conventional child protection laws safeguard the rights of children born through IVF, just as they do for any children. Annas and Caplan do not make a strong case for federal oversight of the highly successful and innovative fertility industry.
But their case against the market goes well beyond a call for oversight. "I think that most people in the bioethics field feel that medical care is not a market good," asserts Annas. "Medical care is different from food, clothing, and shelter, all of which are market goods. It's about human mortality and human suffering, and market things are not." Consequently, Annas is a strong proponent of creating a government-financed national health care plan. "I think that that is the number one ethical issue in medicine today," he says.
Callahan concurs. He argues that we should adopt "a steady-state, equitable medicine [that] will have to limit, not expand, patient choice. It will require frank rationing. It will work to resist patient demands, particularly demands stimulated by market pressure and incentives."
Prominent bioethicists oppose the market in medicine because, they argue, when a person is sick, he or she is particularly vulnerable. Sick people can't make good decisions and can't shop around for the care they need. Money is no object: Patients just want to be cured. Thus, medical care is different from food, clothing, and shelter, all of which are market goods. But is that true? Is a sick person really more vulnerable than someone who is starving, or naked, or stuck outside in the cold?
These same sick people, who are too vulnerable to shop for medical care, are nevertheless able to give informed consent and make life-and-death decisions about their medical treatment, at least according to the original impulse behind the bioethical movement. Indeed, bioethicists advise people to craft advance directives about their medical care so that if they become incapacitated their wishes will be known. But it's apparently too much to expect them to make advance arrangements for choosing and paying for their medical care. There is no reason why most people can't shop for medical care in advance, check out doctors and medical facilities ahead of time, and purchase as much insurance as they think prudent.
"I think that the objections of people like George Annas and Daniel Callahan turn on an unsustainable egalitarianism of envy, or on an unjustifiable abhorrence for the market where the market is seen in itself as being bad," says Baylor College of Medicine bioethicist and physician Tristam Engelhardt.
The bias toward egalitarianism is pervasive among establishment bioethicists. "We should give universal access to a basic minimum of health care before going on to new, more expensive, extreme measures that will benefit only a small portion of the population," says Annas. "With 43 million uninsured, should we be trying to introduce these very expensive procedures into medicine?" Callahan also wants a health care system "in which further scientific gains are not deployed until earlier ones are fully utilized." Translation: No one should get a new treatment until everyone first has access to all of the old treatments.
"I think that Callahan is taking the view that it is more important to suffer than to have inequality," says Engelhardt. "And I think that it's a very implausible view."
Engelhardt contrasts Callahan's "egalitarianism of envy" (taking away a good from someone because others don't have it) with an "egalitarianism of altruism" (providing a good to someone who does not have it). Following the ethical nostrums of Callahan and Annas would prevent people from buying life-saving treatments that they want and can afford. But more important for those of us who cannot afford any given treatment, such bioethical barriers would drastically slow medical advances, because new treatments to which we might gain access in the future will not be developed.
As UCLA's Gregory Stock puts it, "You're getting the rich to pay for R&D. What better research subjects could you have? They are knowledgeable about the risks of the technology and can pay for it."
The issues of patient choice and the future of medical progress converged recently at a meeting of the National Bioethics Advisory Commission. A worried father named Sidney Gunst Jr. testified before the federal body in favor of allowing research on human embryonic "stem cells," which are cells derived from human embryos that have the potential to become any type of tissue. Stem cells could one day be used to cure diabetes and Alzheimer's disease, and to replace damaged tissue. Gunst's 4-year-old son has had open-heart surgery to repair a defective aortic valve, and he will need more surgery when he becomes a teenager. Gunst and many researchers think that stem cell research could lead to better transplant therapies for his son. But he is worried that the NBAC or Congress might try to stop such research.
"Every time a surgeon removes cancer from a patient, rather than letting him die, he plays God," testified Gunst. "Every time penicillin is prescribed to combat infection…or a C-section is performed to ensure a safe delivery; or an organ is transplanted rather than allowing nature to take its course–a doctor is playing God. The history of human survival is the history of man playing God."
Gunst is right to be concerned. Although sentiment on the commission generally favors stem cell research, some NBAC members have expressed reservations about it. In its recent draft report on embryonic stem cell research, the commission moves beyond philosophical deliberation to an assertion of regulatory authority. It declares that it "is charged with developing guidelines and regulations as they relate to bioethical issues arising from research on human biology and behavior (including the clinical applications of that research)." The draft adds that the commission "has an opportunity to provide a broad public policy framework for research that can prospectively anticipate [sic] scientific developments."
But even if the NBAC does give a general go-ahead for embryonic stem cell research, the commission may not approve the creation of embryos specifically to generate stem cells. Instead, the NBAC apparently will recommend that research be conducted only using embryos created first for in vitro fertilization and later donated by couples after their infertility treatments have concluded. This restriction, should it be adopted, could slow progress in stem cell research since Geron Corp. is already trying to create human embryos as sources for stem cells. The Geron researchers are doing this by inserting the genetic material from mature human cells into enucleated human eggs. If this restriction were to remain in force, it would prevent the development of the most promising stem cell treatments–the growth of new tissues using embryonic stem cells created from a specific patient's own cells. Thus, Gunst's son would be prohibited from taking one of his skin cells, putting its nucleus into an enucleated human egg, and growing new heart tissue for a perfect transplant.
Even if the commission doesn't actually ban a technology, the mere fact that it could do so has a chilling effect on biotechnological research. Scientists and companies will feel that they must submit their projects to the judgment of the NBAC before investing time and money in promising new treatments.
The whole concept of the NBAC and the ELSI program is ill-conceived. The commission may say it wants to "prospectively anticipate" problems, and ELSI was designed to be "a program that would anticipate potential problems before they actually occurred and identify possible solutions to the problems." But a mind-set that involves constantly and anxiously scanning the horizon for problems greatly increases the chances that you will eventually find them, even when they don't really exist. Agencies like the NBAC and ELSI focus on the problems a new technology might present, tending to overlook potential benefits. "Because there is a desire to get diversity on these commissions, you will always have a significant representation of those who are opposed to the technology," says Stock. "So when you reach a consensus within a committee like the NBAC it will tend to be very biased towards being very cautious."
Says Annas, "The job of ethicists is not to facilitate people doing new things, but to raise difficult questions. We're not supposed to be cheerleaders for every new thing that comes down the pike." The central question for Annas is, "What's the downside?"
Furthermore, the institutional dynamic of such proto-regulatory commissions forces them to worry about the political troubles that they will face should they approve something that later goes wrong. The NBAC, like the Food and Drug Administration, has every incentive to say no or "go very slow" to any new technologies.
"Many bioethicists argue that we need to stop developing these new technologies and then talk about whether we should allow them to go forward," says Stock. "They want technology to stop so that they can design the perfect system."
NBAC Chairman Harold Shapiro hotly rejects the notion that his commission retards biotech research. "There is no evidence that the work of commissions like this slows down research," he says. "No one has ever demonstrated that research has been slowed down without merit. There are no examples of that."
Others differ. "They'd surely have to be slowing research down," says Engelhardt. "Think about how Hillary Clinton probably impacted negatively important pharmaceutical research when she was [pushing a national health care plan] at the beginning of President Clinton's term. She had the view that progress should be slowed in order to favor a cost containment….So you can easily imagine how any commission under those circumstances would generate morbidity and mortality costs for people because technology is not being developed in a timely fashion." In other words, fear of government intervention causes biotech companies to delay research and development, ultimately increasing both sickness and death.
Actually, the NBAC is not powerful enough for many bio-ethicists. Annas wants to "move beyond an advisory committee and establish a regulatory commission, a federal Human Experimentation Agency, with both rule-making and adjudicatory authority." Annas' proposed agency would promulgate rules and have authority to review and approve or disapprove of biotech and biomedical research proposals. The agency would regulate research and treatments involving xenografts, artificial organs, embryo research (including cloning), and genetic engineering. It would also "recommend legislation to Congress, including, for example, a ban on the sale of human embryos." Annas concludes, "I would hope that it would slow things down."
The breakthrough in stem cell research was underwritten by the private Geron Corp., because the federal ban on experimenting with embryos doesn't extend to the activities of private companies. Annas' all-encompassing Human Experimentation Agency would close that loophole. Geron would be forced to submit its stem cell research proposal for approval. If such an HEA had existed, the usual caution of the bureaucrat doubtlessly would have slowed, if not stopped altogether, the development of stem cell technology.
The guiding star for the HEA would be an idea imported from radical environmentalism: the precautionary principle. (See "Precautionary Tale," April.) As Annas interprets the principle, those who propose major changes in the way that human beings live "would have the burden of proving that there is an important societal purpose for such an experiment before it is permitted." This principle shifts the burden of proof from critics and would-be regulators to innovators and researchers. Why does Annas want to make this shift? "Because the truth of the matter is that whoever has the burden of proof loses," he admits, "and so far the critics have always had the burden of proof, so they always lose."
But the creation of a central bioethics regulatory agency is too modest a goal for Daniel Callahan. "Can religion or bioethics or some other social group or force in our society call science to account when necessary?" asks Callahan. He notes that religion has lost much of its former cultural authority. In his view, bioethics could fill at least part of this vacuum. He envisions a bioethics that can say no to technological progress; a bioethics that transforms itself into a sort of intellectual counterculture standing in opposition to "scientific ideology." Science, asserts Callahan, "desperately needs to have a serious and ongoing challenger…a David against its Goliath." The discipline of bioethics, as he imagines it, would not just have power over treatment choices and research agendas; it would play a central role in defining the "good society."
"Good science cannot tell us how to organize good societies or develop good people (or even tell us how to define `good') or tell us what is worth knowing," writes Callahan in the May 1996 issue of Society. Bioethicists, the new cultural clerics, would play that role, perhaps with inquisitional powers.
These are grandiose visions of cultural revolution. What we need instead is a return to the roots of bioethics: respect for patient autonomy as a central value. Such a modest bioethics would focus on helping patients and their families sort out the confusing choices before them in light of their own values. In fact, that's exactly what most working bioethicists do today: They work at hospitals, clinics, and research facilities talking with real people who need someone to help them make sense of the possibilities and perils that new medical technologies offer.
The moral work of bioethics should advance case by case, building a kind of common law morality in which bioethical principles arise from the accumulation of cases and evidence over time. As UCLA's Stock argues, "We should push forward while the technologies are young and mitigate problems as they arise."
Ultimately, biotechnology is no different from any other technology: People must be allowed to experiment with it in order to find its best uses. Inevitably, people will make mistakes. They will sometimes perform acts with unfortunate ethical consequences. But we learn from our mistakes. Ethical anticipation in the face of rapid change is a recipe for stagnation (and as it happens, that is the real goal of many committed egalitarian bioethicists). It is also futile: The smartest commission ever assembled simply does not have the creativity of millions of human beings trying to live the best lives they can with the help of new technologies.
"One of the greatest hopes for average people throughout the world is biotechnological progress," says Engelhardt. "I think that those who speak against the hope of that kind of progress speak against the hopes of millions of sick and dying people."
Callahan admits that "part of the problem with a society addicted to scientific progress is that we can hypothesize harms but we simply can't make a very convincing case that the potential harms are enough to impose limits to a technology. People think that if we begin setting limits, soon there will be no way to stop the intrusion of limits on technological progress."
It turns out, to Callahan's dismay, that ordinary people like Joy Simha and Sidney Gunst are a lot warier of bioethicists than they are of biotechnology.