The 1986 Phase II trial that preceded the FDAs unprecedented rapid approval of AZT was presented as a double-blind, placebo-controlled study, though it was anything but that. As became clear afterward through the efforts of a few journalists, as well as the testimony of participants, the trial was unblinded almost immediately because of the severe toxicity of the drug. Members of the control group began to acquire AZT independently or from other study participants, and eventually the study was aborted and everyone was put on the drug. |