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The activism of the gay community and the technological savvy of many of its organizations were instrumental in reforming the FDA's approval process and policies on clinical trials. Doctors, AIDS patients, and supporters in the 1980s had regarded the long and slow approval process of the FDA, which averaged eight years in the early 1980s, with increasing frustration. The few drug treatments that were available were limited to clinical trials, in which scientific principles demanded doubleblind studies in which half the participants in a trial were given placebos. Additionally, policies designed to protect trial participants severely limited the eligibility of many AIDS patients. Because of the rapid progression of the disease, many doctors and patients felt that the only hope lay in access to experimental drugs. AIDS activist organizations became increasingly vocal about the need to speed both drug development and the approval process, and networks of activists, scientists, doctors, and AIDS patients began to work through alternative channels, exchanging drugs, expertise, and anecdotal evidence about new treatment possibilities.

Activists vocally challenged drug companies and scientists to explore new therapies and means of testing and distributing them while applying increased pressure on the FDA to take charge of the response to the epidemic. Agitation against the FDA sparked congressional hearings in 1987. In 1988, when the FDA commissioner announced that only two drugs could be approved before 1991, networks of AIDS activist amassed enough information to challenge that assertion. A protest at the FDA headquarters by twelve hundred demonstrators received extensive media coverage and initiated a substantial loosening of FDA regulations, including approval of the importation of unapproved drugs for those with life-threatening illnesses.

From the beginning drug prices were exceedingly high and generated a great deal of concern among activists, which was exacerbated by secrecy surrounding development costs. The first antiviral drug to be approved by the FDA, Zidovudine (AZT), cost between $8,000 and $10,000 per patient per year, a price that seemed exorbitant to many, particularly in light of the fact that AZT originally had been developed as a cancer therapy with federal funding. Activists protested against the drug's maker, Burroughs-Wellcome, on Wall Street, and the company was lobbied by a large coalition of activists and legislators. In response, the company reduced its pricing by 20 percent.

Drug companies were criticized for inflating prices and restricting the access of poorer countries to cheaper generic drugs. International pressure and global health initiatives led to significantly decreased drug pricing and wider access to drug therapy in developing nations, though most researchers continued to believe that the price of drugs was far too high to allow widespread access in poorer countries.

References:

Arno, Peter S., and Karyn L. Feiden. 1992. Against the Odds: The Story of AIDS Drug Development, Politics, and Profits. New York: HarperCollins.

Farber, Celia. 2006. Serious Adverse Events: An Uncensored History of AIDS. Hoboken, NJ: Melville House.

Shilts, Randy. 1988. And the Band Played On: Politics, People, and the AIDS Epidemic. New York: Penguin.

Treichler, Paula A. 1999. How to Have Theory in an Epidemic: Cultural Chronicles of AIDS. Durham, NC: Duke University Press.

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