Retrovir: The Challenge of Postmarketing Surveillance
This chapter discusses the wide spectrum of the social, political, regulatory, and medical aspects of the Acquired Immunodeficiency Syndrome (AIDS) epidemic and shows the uniqueness of Retrovir development, testing, and surveillance. It provides a quick recap of AIDS followed by a review of the clinical trials, then describe the innovative, open-label trial. The disease spread rapidly among the homosexual population, and gradual reports of cases among hemophiliacs and intravenous drug abusers narrowed the search for an etiology toward an infectious agent transmittable sexually or by blood or other body products. In March 1987 the drug was approved by the Food and Drug Administration (FDA) as the result of a unique collaboration between industry and public health agencies. The FDA specified that patients who met certain criteria would be eligible for enrollment in Treatment IND 29,025. First, patients had to have a history of one or more episodes of histologically confirmed Pneumocystis carinii pneumonia and no current AIDS-defining conditions requiring chemotherapy.