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.