BLOOD & BIOLOGICS.

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Dr. Tapas Das Gupta, M.D., Ph.D., University of Illinois at Chicago, Chicago, IL, March 9 (CBER-Office of Compliance and Biologics Quality). The agency wrote up the clinical investigator for enrolling four subjects in a study of metastatic malignant melanoma who failed to meet inclusion criteria, including one subject whose computerized axial tomography (CT) scan revealed multiple metastatic lesions described as "large." FDA also hit Gupta for failure to perform tests for cellular immune response and antibody response on four enrolled subjects and noted that the clinical investigator did not inform the institutional review board (IRB) of the deaths of three participants. The letter noted that Gupta possessed two versions of the study protocol and could neither distinguish between the two nor determine which he had sent to the IRB. The letter informed the physician that regulatory action may include initiation of disqualification proceedings. Investigator Jeanne Morris of the Chicago District Office audited Gupta May 9-19, 2000. BiMo

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Dr. Malik Juweid, M.D., University of Iowa Hospitals and Clinics, Iowa City, IA, Feb. 23 (CBER-Office of Compliance and Biologics Quality). FDA's review of the physician's conduct while director of nuclear medicine at the Garden State Cancer Center in Belleville, NJ, disclosed that Juweid administered study drugs to 95 subjects prior to submission of investigational new drug paperwork for the three studies involved. The letter stated further that the physician reviewed pre-therapy radiolabeled antibody scans "in a retrospective manner," recording his interpretation of the scans on case report forms (CRFs) while working on the study's annual report. The agency insisted that eligibility documentation was incomplete for a subject whose baseline CT scan disclosed moderate pericardial effusion and who developed life-threatening cardiac tamponade after therapy requiring surgical drainage of a 1500cc effusion. The letter also noted that a subject who developed grade-3 neutropenia was enrolled despite a white blood cell count lower than the protocol allowed. FDA suggested Juweid undergo training for clinical investigators and informed the physician that the agency's actions may include initiation of disqualification proceedings. The unnamed investigator's audit ended May 25, 2000. BiMo

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Dr. Lloyd Shabazz, M.D., Portsmouth, VA, Feb. 23 (CBER-Office of Compliance and Biologics Quality). FDA stated that the clinical investigator enrolled subjects in a study for non-Hodgkin's lymphoma who met exclusion criteria, including pleural effusion and elevated creatinine levels and failed to perform chest X-rays, electrocardiograms and urinalysis on subjects in a study on non-small cell lung cancer. The letter commented that Shabazz administered incorrect doses of a chemotherapeutic drug in an unspecified study and drew pharmacokinetic samples for one subject after commencement of therapy and not at all for two other subjects. The agency wrote that the investigator did not report adverse events in CRFs, including neuropathy in one subject and, in another subject, rash and redness at the extremities and constipation. Discrepancies between CRFs and source documents were said to include recorded times for plasma collection and data for pharmacokinetic samples recorded on source documents but not on CRFs. FDA informed the clinical investigator that regulatory actions may include initiation of proceedings for disqualification. FDA's audit of Shabazz took place May 25-June 23, 2000. BiMo