Beyond the FDA

The Wall Street Journal made effective literary use of the iconography of the protest in its editorial two days afterward, which described the "battle between people who have all the time in the world and people who have little time left in their lives."^[76] But what the Journal may have failed to observe was how the activists themselves had already set their sights well beyond the walls of the FDA building. Though the main goal, to be sure, was access to treatments,

in pursuit of that goal activists had to engage with the researchers and the health professionals, the pharmaceutical houses and the insurance companies, NIAID and the NCI and the Department of Health and Human Services. For all its importance as a symbolic target, the FDA was just one player; and the demonstration in Rockville, for all its significance in the construction and legitimation of a nationwide movement, in a sense represented the end of an era. Arguments about competing philosophies of drug regulation would continue. But the more activists learned about the FDA's drug approval policies, the more they became enmeshed in debating the details of what counted, in the agency's eyes, as "good science." And the more they became concerned with the science of clinical trials, the more the focus of their energy shifted from the FDA to NIAID. "While the question of a person's freedom to use a treatment whether or not it works is indeed an important issue," commented AIDS Treatment News in 1988, heralding this new turn, "the more important question is what treatments do in fact work, and how can the evidence be collected, evaluated, and applied quickly and effectively."^[77]

Of course, these two issues—the ethics of access to therapies and the methodology of clinical trials—often came together in concrete ways. For example, some worried about the potential conflict between access and research: would unrestricted access to experimental treatments hamper researchers' abilities to conduct trials? After all, if every person with AIDS could obtain an experimental drug with a minimum of hassle, why would anyone enroll in a clinical trial? In effect, the capacity to conduct clinical trials presupposed coercion through control of the supply of the drugs. Researchers and health officials took this point for granted; for example, Ellen Cooper, the head of the FDA's Antiviral Drug Division, argued in JAMA that "a national policy of early widespread availability of unproved experimental agents would slow or even halt the completion of controlled clinical trials through which therapeutic advances are established and then improved on. …"^[78] Recalled Cooper: "I really understood, or emphathized with, where they were coming from, which is … the individual patient with a life-threatening disease."^[79] But in her view, it was a simple question of the greatest good for the greatest number; and the individual's right to treatment would have to take a back seat to research that could benefit the public at large.^[80]

AIDS activists protested the implicit coercion, suggesting, in Martin Delaney's words, that it was "morally offensive [to] use access to

treatment as a lever to force subjects into studies. The fact that such an argument is openly made demonstrates how detached the regulators' mindset has become."^[81] But to the extent that activists succeeded in swaying researchers and government officials on this point, they did so by turning the argument on its head. "The policy of restriction," said Delaney, addressing the 1988 meeting of the Infectious Diseases Society of America, "is itself destroying our ability to conduct clinical research." Delaney explained: "AIDS study centers throughout the nation tell of widescale concurrent use of other treatments; frequent cheating, even bribery, to gain entry to studies; mixing of drugs by patients to share and dilute the risk of being on placebo; and rapid dropping out of patients who learn that they are on placebo. … Such practices are a direct result of forcing patients to use clinical studies as the only option for treatment." If these policies continued, Delaney warned, "it will soon be impossible to conduct valid clinical AIDS research in the US."^[82]

This was a forceful argument that spoke to researchers' basic interests while playing on their fears. Continuing in his role as the defender of good science, Delaney proposed the solution: "If patients had other means of obtaining treatment, force-fitting them into clinical studies would be unnecessary. Volunteers that remained would be more likely to act as pure research subjects, entering studies not solely out of a desperate effort to save their lives." Their motivations for doing so might be altruism or a desire to obtain other tangible rewards of clinical trial participation, such as access to free, high-quality medical care.

Over the next few years, treatment activists would pursue a three-pronged agenda, one that Delaney's solution in many ways suggested. First, they would fight with the FDA over what counted as sufficient proof of safety and efficacy in a medical emergency, speeding up the approval of a number of drugs, particularly ones that treated opportunistic infections associated with AIDS. Second, in the case of experimental drugs still being tested, they would press for institutionalized mechanisms of "expanded access" outside of the framework of clinical trials. And third, they would seek to transform the clinical trials themselves, to make the trials more relevant, more humane, and more capable of generating trustworthy conclusions. This complex agenda would require a thoroughgoing engagement with the biomedical establishment—an encounter that would have important implications for the practice of medical research, the dynamics of the movement, and the establishment of certainty or uncertainty about specific experimental treatments.