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The Social Impact of Aids in the United States
Both the American Foundation for AIDS Research and the National Institute of Allergy and Infectious Diseases have established a formal network of community-based trials (and some sites receive funding from both sources). In addition to sponsorship of clinical trials, the network's program will include establishment of an observational database to collect information gathered during the routine care of patients by their primary physicians. It is hoped that the database will provide information that will be useful in studying the natural history of HIV disease, in assessing the use of particular therapies by people with HIV disease, and perhaps, in projecting those patients' resource needs. Such databases have been developed to a lesser extent for other diseases and have been suggested as a means of creating an accurate historical group and thereby lessening the need for randomized trials.
It will be important to monitor the types of community studies done and their success in improving patient participation and retention and to delineate any drawbacks to the approach, such as decreased ability to monitor or respond to drug toxicities. It will also be important to determine whether a national system can retain the flexibility of a more grass-roots structure while providing the capability to mount large trials.
Almost from the beginning of the AIDS epidemic, patient advocacy groups took on the role of medical advisers through the creation of patient information newsletters (Steinbrook and Lo, 1990; Bishop, 1991). In San Francisco, AIDS Treatment News began appearing in May 1986 and grew from a biweekly column in a local gay newspaper to a newsletter with a circulation of about 5,000 (James, 1989). Also in 1986 in New York City, the Gay Men's Health Crisis began to publish Treatment Issues, an update on research in progress, complete with extensive references to the medical literature. The American Foundation for AIDS Research publishes the AIDS/HIV Experimental Treatment Directory . Buyers' clubs were also formed to import and distribute drugs that were not approved for use in the United States or approved drugs that were available more cheaply in other countries. Such groups were instrumental in educating patients about therapeutic options and creating in many areas a climate of debate on AIDS care and research. These developments reflected a new "consultant" ethos among potential and actual research subjects.
Such advocacy took on a whole new dimension, however, when one such group, San Francisco's Project Inform, under the direction of Martin Delaney, carried on its own study of compound Q, a cucumber derivative that had been used as an abortifacient in China and was reported to have significant in vitro activity against HIV. This study was conducted without oversight by FDA or an institutional review board, which sparked criticism from a number of lawyers and bioethicists. Project Inform argued that this was an ethical trial because patients were already taking the drug on their own, and the trial afforded at least some oversight by a participating physician.