Rochester Panel Members Weigh In on Avandia Recommendation to FDA
Wednesday, July 21, 2010
On July 13 and 14, 2010 the FDA convened a special scientific advisory panel to provide recommendations on the controversial diabetes drug Avandia, which some studies have shown increases cardiac risks for patients. University of Rochester Medical Center faculty Arthur Moss, M.D., director of the Heart Research Follow-up Program, and David Oakes, Ph.D., professor of Biostatistics, participated on the panel and recommended that Avandia remain on the market as an option for physicians treating patients with Type 2 diabetes.
Moss and Oakes agree that the data presented throughout the two-day advisory committee meeting was weak and inconclusive, and that a head-to-head trial directly comparing Avandia with rival Actos and older diabetes drugs is needed to determine if one drug is superior to the other in terms of safety and efficacy.