• Tuesday, November 24, 2009
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University Pulls Cardiologist From Human-Subjects Research

The University of Arizona has barred a cardiologist from conducting research on human subjects because of violations of scientific standards during a nationwide study of an experimental pacemaker, according to articles in Wednesday’s Arizona Daily Star and Tucson Citizen. The researcher, Paul Fenster, who is an associate professor of medicine, dismissed the violations as mere “clerical mistakes.” The university uncovered the problems in the course of a routine audit, and turned its suspicions over to the U.S. Food and Drug Administration, which has jurisdiction over medical devices like pacemakers.

The FDA found that the professor had failed to obtain informed consent from patients, among other violations, although it was unclear if any of them had been harmed as a result. The study, which was sponsored by the device’s manufacturer, the Guidant Corporation, concluded that the pacemaker helped lengthen the survival of heart patients. Results of the study. including those patients under Dr. Fenster’s care, were published in The New England Journal of Medicine.