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AZT


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             In January of 1987 a panel of 11 AIDS doctors were asked to approve the drug by the FDA based upon this research. Several of the doctors on the panel felt uneasy about approving the drug for use among AIDS patients. As one panel member, Ithzak Brooks, said, "The data is just too premature, and the statistics are not really well done. The drug could actually be detrimental" (Farber 2). The study, which was supposed to be conducted for 11 months, was stopped after just six months (Burkett 5). No long term side effects of the drug were known. Furthermore, three months after the study ended, thirteen more of the placebo patients died after being put on the AZT drug, and seven deaths occurred among those who had been taking AZT for the entire time (5). Moreover, the research was supposed to be conducted in a double blind manner (5). In other words, neither the patient nor the doctor was supposed to know whether an individual was receiving the placebo or the actual drug. However, doctors and patients alike were aware of which group the patient belonged to--this occurred for two reasons. First, AZT causes severe damage to bone marrow cells, which means that patients taking the drug must undergo blood transfusions in order to stay healthy (Farber 8). Patients taking the placebo would not have to undergo the same treatment because no damage was being done to their bone marrow cells. In addition, a routine blood count, known as CMV, clearly shows who is on the drug, and this information was never whited out on the patients" charts given to the doctors conducting the research (8). .
             Despite these flaws, and after much debate, the drug was approved by the panel faster than any other drug in FDA history, under certain restrictions and promises agreed to by Burroughs-Wellcome. The drug was to be given only to very sick AIDS patients, and a two-year follow up study was to be done (p. 8). However, these restrictions were not heeded, and the promises were not kept.


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