Rights, Risks, and Ethics

The extensive literature on the ethics of clinical research^[27] reflects considerable emphasis on protection of human subjects in biomedical experimentation. This, however, is a rather recent development that has paralleled the rise in importance of the randomized clinical trial both in biomedical fact-making and in regulatory decision making.^[28] As historian David Rothman has described, the pivotal moment occurred in 1966 with the New England Journal of Medicine' s publication of a whistle-blowing review article by Henry Beecher, replete with disturbing, recent examples of unethical and potentially harmful experimental research. Beecher catalogued incidents of "investigators who had risked 'the health or the life of their subjects' without informing them of the dangers or obtaining their permission"—for example, withholding penicillin from servicemen with streptococcal infections as part of a study of an alternative therapy.^[29] These revelations were followed a few years later by public outrage and congressional hearings in response to news media disclosures about the Tuskegee syphilis study, conducted openly for decades under the auspices of the U.S. Public Health Service, in which hundreds of poor, black sharecroppers were denied existing treatment so that researchers could study the "natural history" of the disease.^[30] In 1974 Congress created the National Commission for the Protection of Human Subjects, which issued guidelines on research. In addition, the

NIH began requiring that each research center seeking federal funds for biomedical research on human subjects establish an "institutional review board" to evaluate the ethics of each proposed research "protocol" (the plan for the study).^[31]

As Rothman and Harold Edgar have noted, the irony in these protective measures and in the new regulatory regime at the FDA was that they ran counter to the egalitarian and libertarian trends of the 1960s and 1970s in general and to the critique of paternalistic medicine in particular. "Just when patients secured greater autonomy—the right to know a diagnosis, to accept or refuse treatment—the experts at the FDA and review boards controlled the right to regulate new drugs and research protocols."^[32] Soon AIDS patients and their advocates began rebelling against what they saw as well-intentioned but deadly paternalism. Activists like Delaney would exert a demand for greater patient autonomy by challenging medical authority from two directions at once. On one hand, they would insist that patients interested in trying experimental drugs should have the right to assume risks rather than endure the benevolent protection of the authorities. On the other hand, they would criticize certain approved and accepted research methods, like trials in which some patients received placebos, characterizing them as unethical for subjecting patients to unfair risks that the patients did not want to assume.