The rules of the trials clearly stated that the PIs must record all adverse reactions on their CRFs and report immediately to the FDA. The Boston PIs did neither. The FDA documents showed that the PIs knew very well which patients were on AZT and which on placebo, that they were skewing safety results in AZT’s favor to give advantage to the AZT participants. Researchers began by placing the sickest patients in the placebo group. The researchers then bent over backward to coddle the group that took AZT, giving them more supportive medical services than the placebo subjects. For example,
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