June 06,2007

Grassley, Baucus ask for details of effort to muzzle a doctor’s concern about Avandia risks

WASHINGTON — In response to testimony given today to a House committee reviewing the safety of the diabetes drug Avandia, Sens. Chuck Grassley and Max Baucus today asked GlaxoSmithKline and the University of North Carolina to account for intimidation of a medical researcher who suggested the drug may carry risks beyond those contained in the FDA label on the drug.

“Today’s testimony reveals a repeat in the pattern we’ve seen unfold during the last three years, starting with Vioxx, where extraordinary efforts are taken to protect drug sales at the expense of public safety. It’s the FDA’s job to overcome these efforts and make certain that science and safety prevail,” Grassley said.

“I’ve become convinced that the FDA’s current structure doesn’t give the post-market surveillance of drugs the voice and power that’s necessary to protect the public, and I’m committed to do everything possible to strengthen the FDA’s monitoring of drugs once they are the market.”

“If pharmaceutical executives tried to silence a researcher who found safety issues with Avandia, then we’ve found a whole new level of culpability here. If credible research exposes the risk of death for patients taking a drug, then any drug company attempt to squelch that information would be morally reprehensible,” said Chairman Baucus. “The Finance Committee has a responsibility to root out the facts and take whatever action is appropriate to protect Medicare and Medicaid beneficiaries.”

Baucus is Chairman and Grassley is Ranking Member of the Senate Committee on Finance. The text of their letters to the drug maker and the university follows here.