A Lab of One's Own
By the mid-1980s, some groups of community physicians had banded together with patient groups to pioneer new forms of knowledge-making. Instead of waiting for NIAID to test drugs in its lengthy, cumbersome clinical trials at academic centers, primary-care physicians and people with AIDS decided to go about designing such trials themselves. "By integrating scientific trials with normal medical practice, community-based trials allow credible testing of treatment options with far less administrative delay than usually involved, and at far less cost," said John James in AIDS Treatment News . As Mary-Rose Mueller has detailed in an analysis of community-based research, this endeavor served as "a form of professional resistance [by community physicians] to academic medicine" and an opportunity for them to stake out a new jurisdiction within professional practice. At the same time, community-based research promised to bring scientific knowledge-production closer to popular control. Scientists' power, as Bruno Latour has emphasized, stems at least in some measure from their possession of laboratories; now the AIDS movement sought to build its own.
As John James explained in 1988, two very different models of community-based research had arisen. In San Francisco in 1985, researchers such as Donald Abrams, associated with the University of California at San Francisco and San Francisco General Hospital, had formed the County Community Consortium (CCC), a coalition of San Francisco physicians with AIDS practices. The original purpose had been to improve communication between researchers and doctors and disseminate information about treatments more rapidly. Over time, as some of the primary-care doctors became interested in participating in research, the CCC evolved into a mechanism for organizing community-based trials. The idea was that physicians would distribute drugs, monitor patients, and collect data as an integral part of their
regular clinical work with patients. And it wasn't a new idea: in many ways it resembled the community-based cancer research effort sponsored by the NCI, called the Community Clinical Oncology Program. "We have a distinct advantage in being able to follow up patients, because the research is being done where the patients are getting their primary care," commented Abrams, the head of the CCC. "So even if the patient stops participating in the study, we still know … what sort of outcomes they have…."
The second model was pioneered by people with AIDS in New York City, who worked together with a number of activist doctors, including the maverick Joseph Sonnabend. Frustrated by the slow pace of federally sponsored treatment research, they founded an organization called the Community Research Initiative (CRI), which opened its doors in May 1987 under the sponsorship of the local PWA Coalition, the advocacy group run by people with AIDS. From the start, people with AIDS or HIV infection participated in decision making about what trials CRI should conduct and even how they should be organized, "[setting] policies on placebo use, and [insisting] that trials under [CRI] sponsorship be effectively open to women and minorities, not only to gay men." The effect of such community participation, argued James, was to ensure smoother trials and higher levels of "compliance" with the protocols: "Such prior community involvement in policy issues around the selection and conduct of trials makes recruitment easier and increases patient-experimenter cooperation, for example by greatly reducing any need to 'cheat' in the study by taking other drugs without telling the researchers." Community-based research was not suited for high-tech trials requiring sophisticated lab tests that the average primary-care physician did not have the equipment to perform. But other trials, involving minimal data collection, could easily be conducted out of doctors' offices. Drug companies, also impatient with the NIAID trials system, proved interested in the concept as well, and soon CRI had a number of contracts to conduct studies for different companies, both large and small.
Still, community-based research invited skepticism. "Traditional researchers thought that community doctors would not be sophisticated enough to run trials," said Mathilde Krim, whose organization, AmFAR, would later become a chief funder of community-based research. "But actually they were highly sophisticated…. After all, they had been managing the disease for years." This sort of "hands-on" expertise did not, in itself, establish community-based research as
credible in the eyes of mainstream researchers or government health officials, who were more invested in a conception of medicine as "science," not "art." Rather, public demonstration of the credibility and viability of community-based AIDS research came with the testing of aerosolized pentamidine, a form of prevention against deadly pneumocystis pneumonia. It was a therapy that community-based research at the CCC and CRI effectively rescued after NIAID bungled its own efforts to test it.
In February 1987 researchers recruited by NIAID to participate in its clinical trials program rated research into prophylactic aerosolized pentamidine as a high priority: preventing pneumocystis pneumonia was a much better therapeutic strategy than simply treating people once they contracted the disease. But it wasn't until June the following year that researchers actually began to recruit patients into the NIAID trials, after more than a year of writing and rewriting the protocols and negotiating with Lyphomed, the manufacturer of the product. Meanwhile, in May 1987, a group of activists including Michael Callen, the well-known dissenter on the HIV hypothesis who was also on the board of CRI, had met with Anthony Fauci and pleaded for him to issue federal guidelines recommending pentamidine use to prevent PCP. When Fauci refused, citing the lack of data on efficacy, Callen returned to New York to tell his fellow board members: "We're going to have to test it ourselves." In San Francisco, the CCC had also launched its own study, a three-armed trial where patients received different doses of pentamidine but no one received a placebo. Denied funding by NIAID, the CCC received money for the trial from Lyphomed and the University of California.
In 1989, after examining study data from both the CCC and CRI, the FDA approved aerosolized pentamidine for prophylactic use against PCP—the first time in its history that the agency approved a drug based solely on data from community-based research. Before accepting the CRI's data, FDA representatives had visited the CRI's offices in New York and gone over their methods and their paperwork. They came away satisfied that "good science" was being done. This was essential for the legitimation of CRI, according to Dr. Bernard Bihari, a member of the board of directors: "Doing good science allowed us to establish our credibility."
Plaudits soon arrived from all quarters. "The Community Research Initiative … offers the possibility to combine the technical expertise of the research community with the outreach potential of community
health clinics and physicians in community practice," wrote the Presidential Commission on the HIV Epidemic in its 1988 report, urging direct federal funding of the community-based research programs. One member of the commission described CRI as "one of the best things to have come out of the AIDS effort." Said Anthony Fauci the following year: "What I see in the community programs is totally compatible with the mission of the NIH."