Becoming Experts

"The general public, and even most AIDS organizations and activists, do not yet realize that we already have an effective, inexpensive, and probably safe treatment for AIDS." This was the characterization of AZT offered by John James, editor and publisher of a San Francisco-based newsletter called AIDS Treatment News (ATN ), in its third issue, published May 1986. Yet large-scale studies of AZT, James reported, were still several months away from starting, and "if all goes well, your doctor might be able to get AZT in about two years." This was hardly an acceptable time frame in James's view, and he offered a simple justification for his position: "We should point out that ten thousand people are expected to die of AIDS in the next year. And with deaths doubling every year, a little math shows that a two-year delay between when a treatment is known to work and when it becomes available means that three quarters of the deaths which ever occur from the epidemic will have been preventable."^[45]

Of course, James's grim logic hinged on the meaning of the deceptively straightforward phrase "when a treatment is known to work": what do we mean by "known," and what do we mean by "work"? As far as James was concerned, though the effects of long-term use indeed remained unknown, it was clear that AZT did something . But from the standpoint of researchers—at least when speaking in their official capacities—it was precisely the point of the next round of testing to determine whether AZT in fact worked. Furthermore, as James himself fully realized, the sort of evidence that impressed him would not get Burroughs Wellcome past the front door of the FDA.

A former computer programmer with no formal medical or scientific training, James had just launched what would become the most prominent grassroots AIDS treatment publication in the United States.^[46]ATN rapidly emerged as a crucial resource for doctors and patients alike; within a year, it had a circulation of thirty-five hundred.^[47]

The newsletter provided the latest inside word on the up-and-coming drugs as well as the alternative therapies that didn't make it into formal clinical trials. It would go on to engage as well in a sweeping and detailed critique of the federal drug-testing and regulatory enterprise. As Debbie Indyk and David Rier have noted in a study of grassroots AIDS publications like ATN , such organs of communication effectively "[circumvent] the assessment of gatekeepers such as [medical journal] reviewers and editors. …" The result has been not only that more, and more varied, material has made it "through the net," but that "researchers, clinicians, and patients often confront new data almost simultaneously—sometimes, patients even see it first. …"^[48]

In those early days, James had another pressing goal—to convince other activists and AIDS organizations that a new task confronted them. Already they had become experts about prevention strategies, antibody testing, antidiscrimination legislation, and the health care delivery system. Now it was time to learn a new set of tricks. "So far, community-based AIDS organizations have been uninvolved in treatment issues, and have seldom followed what is going on," wrote James in a call to arms in that same May 1986 issue. "With independent information and analysis, we can bring specific pressure to bear to get experimental treatments handled properly. So far, there has been little pressure because we have relied on experts to interpret for us what is going on. They tell us what will not rock the boat. The companies who want their profits, the bureaucrats who want their turf, and the doctors who want to avoid making waves have all been at the table. The persons with AIDS who want their lives must be there, too [emphasis added]." To "rely solely on official institutions for our information," James bluntly advised, "is a form of group suicide."^[49]

Over the following months, James elaborated this strategy for engagement with clinical research. It wasn't that the researchers conducting AIDS clinical trials were evil or incompetent, but that they were "too close to their own specialties and overly dependent on the continued good graces of funding sources" to be capable of generating or publicly communicating an objective assessment of treatment research issues. On the other hand, these researchers were crucial sources of data: "Physicians and scientists already have pieces of the information, and they need someone they can talk to who can put the pieces together and let people know what is going on." There was nothing pie-in-the-sky, James insisted, about proposing that lay activists could

become experts themselves: "Non-scientists can fairly easily grasp treatment-research issues; these don't require an extensive background in biology or medicine."^[50]

It was the right time to pay attention to the organization of clinical trials. With $100 million in federal funding, the NIH was in the process of setting up a nationwide network of fourteen research centers, dubbed AIDS Treatment Evaluation Units (ATEUs), which sought to enroll an additional one thousand of the nation's ten thousand living AIDS patients in government-sponsored Phase II trials of a select group of drugs, including AZT, foscarnet, HPA-23, and ribavirin.^[51] Following the standard NIH procedure for "extramural research" (so called to distinguish it from the NIH's own in-house or "intramural" research), NIH would farm out the work to researchers, mostly at academic centers, who had designed and submitted the study protocols and would serve as the principal investigators for the studies.

But the process of setting up the ATEUs was slow and chaotic. Since HIV was an infectious agent, the National Institute of Allergy and Infectious Diseases, under the leadership of Anthony Fauci, had claimed ownership of AIDS treatment research. NIAID, however, had never organized clinical trials on this scale, and Fauci would soon be subjected to intense criticism by activists for what appeared to be incompetence. If Fauci were less intent on amassing power within the federal health bureaucracy, some suggested, he would have left AIDS treatment research with the NCI, where it began, relying on that institute's proven expertise in organizing large, multisite clinical trials for cancer therapies.^[52]