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Center for Special Immunology

Executive Summary

Florida-based clinical research subsidiary of Health Professionals, Inc. receives Aug. 12 FDA warning letter for record-keeping inadequacies and altering admission criteria in two studies: a Roche-sponsored trial comparing ddC (Hivid) and AZT (Burroughs Welcome's Retrovir) monotherapy; and a trial of Adria's Mycobutin (rifabutin) for mycobacterium avium complex. The warning letter directed to CSI Principal Investor and CEO William Reiter, MD, resulted from a 14 month FDA investigation and presents affidavits of former CSI employees that allege Reiter requested alterations of patient entry T4 cell count results to allow patients to enroll into the studies who otherwise would not have qualified. The allegations contradict previous affidavits, from some of the same employees, submitted to FDA at the beginning of the investigation by attorneys for CSI. While the warning letter states that CSI could be subject to future enforcement action, CSI said Aug. 30 the agency told the organization that "the FDA findings did not warrant any official action and that the FDA has no present intention of pursuing any administrative or other enforcement action." CSI notes that it has added a quality assurance group and requires that all records are accurately maintained...

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