which, within months, thousands of patients had enrolled in an expanded access program, but the number of participants in the formal trial was significantly less than initial projections.
Many observers have cautioned that the ddI experience may be unique and cannot be used to determine the likely success of the parallel track mechanism. Indeed, debate continues as to what the exact purpose of the parallel track should be. Some argue that through such an approach valuable data could be obtained concerning safety and efficacy, data of sufficient quality even for the purposes of drug licensing. Others have argued that such data would be flawed and that expending the resources required to collect and analyze the data would be counterproductive to the central goal of increasing access.
Although the intention of the parallel track concept was that drugs would be supplied free to participants, no consideration was given to how the costs of laboratory monitoring and physician visits would be handled. Thus, those costs, traditionally covered by sponsors of research in formal clinical trials, have fallen on the patients themselves and, in some cases, third-party payers. This situation has led to the virtual exclusion of poor people from the expanded access program, despite the fact that one of the goals of the parallel track concept was to increase access. Lack of access for poor people has played an important part in recent demands by activists groups for very early licensing of drugs—immediately after phase I trials if any efficacy is demonstrated.
In July 1991, an advisory committee of the FDA recommended the approval of ddI (Kolata, 1991), and the FDA commissioner completed the final steps for approval. Thus, in the space of a very few years, radical changes in drug regulation have occurred, and for the first time, they have been due not to public reaction to a fatal drug toxicity, but to strong consumer activism by a group of affected patients and their advocates.
As activists achieved success in altering the regulation of drugs from 1987 to 1989, they began to turn their attention to the actual design and conduct of clinical trials, criticizing what they perceived as the failure of the AIDS Clinical Trials Group to test and deliver effective therapies rapidly. Although the group did not control many of the clinical trials being conducted in the United States, it had a critical mass of investigators, and its budget had grown considerably. Thus, it offered an identifiable and powerful target against which activists could organize their efforts to reform clinical trials. Over the next 3 years, activism exerted an unprecedented influence over the clinical trials process. The fifth annual International AIDS Conference, which met in Montreal in June 1989, proved to be