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FDA scrutinized by Lawmakers over Avandia Issues

Submitted by jrlaw on Mar 9th, 2009

In one of the latest developments in the Avandia diabetes drug issue, a group of lawmakers sent a letter to FDA asking Commissioner Andrew von Eschenbach to explain the agency's policy on conflicts of interest regarding hiring employees directly from drug companies regulated by the FDA.

FDA spokesman Douglas Arbesfeld, who has worked for several drug companies, is one of the focal members in the controversy. E-mails were sent to journalists against cardiologist Dr Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, who recently waved the red flag about the risks associated with GlaxoSmithKline's Avandia.

Dr Nissen and statistician Kathy Wolski, MPH, evaluated 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug. They found there were 86 myocardial infarctions in the Avandia group and 72 in the control group, and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.