American Psychiatric Association removed homosexuality from its list of illnesses in 1976. It is from this past experience that AIDS activists of all stripes—from mainstream lobbying organizations to street groups using direct action (demonstrations and civil disobedience)—came to challenge some of the fundamental assumptions of the public health community's response to AIDS: from traditional public health control measures to how research ought to be conducted to determining who should make decisions about access to experimental therapies.1

Decision making regarding early release of dideoxyinosine (ddI), a promising antiretroviral drug that has been seen as a potential replacement for the often highly toxic drug zidovudine (AZT) in the treatment of human immunodeficiency virus (HIV) infection, occurred in a context of more general discussions within the AIDS scientific and activist communities about early access to experimental treatments for persons with AIDS that were to be offered on a "parallel track" with ongoing clinical trials. In effect, ddI became a prototype for early access before a model for implementing the broader parallel track program was developed or approved by the relevant government agencies. The success of the parallel track concept will be closely linked to the improvised approach developed for ddI.

The support for early release of ddI and the general notion of parallel track represented a remarkable shift in attitudes among government researchers and regulators, a change inspired by discussions with and pressure from the AIDS activist community. The endorsement of parallel track by top PHS officials occurred in a context of agency jockeying for support from the AIDS activist community. Parallel track and early release of ddI have also resulted in an unusual confluence of interests among AIDS activists, regulators, drug companies, and some key scientific researchers. Government officials saw early release as a means of showing compassion and responsiveness at a time when existing research and regulatory structures seemed rigid and uncaring. Drug companies and top government regulators saw early access as another step toward the reduced regulation of the pharmaceutical industry that was a hallmark of Frank Young's tenure as FDA commissioner. Finally, activists saw parallel track as providing greater autonomy in decision making for persons with HIV infection.

This paper reviews and describes the decision-making process that led to the early release of ddI. It is not an attempt to judge the merits of early release of ddI or the entire parallel track concept. Rather, it is meant to paint a picture of how and why decisions were made, with the hope that it might provide a basis for better, more rational decision making in the future.

To lay the groundwork for the discussion of early release of ddI, the



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