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Wednesday, May 12, 2010

Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia


GlaxoSmithKline's Avandia and the way the FDA handled complaints about it have been highlighted at a recent US Congressional hearing.

The report, by Sens Max Baucus and Charles Grassley, concluded that there are "serious health risks associated with Avandia."

Subcommittee chair Rep Rosa DeLauro said: "This report poses several troubling questions for this subcommittee. Most obviously, if Avandia is unsafe, how did it ever get on the market in the first place? For that matter, why is it still on the market, right now? And what does the case of Avandia tell us about the FDA's current ability to conduct its drug safety responsibilities?".

Grassley, Dr Harlan Krumholz [Yale University School of Medicine], and Dr Sidney Wolfe [Public Citizen] told the congressional hearing that the system allows companies to suppress negative clinical data on their drugs.

Summing up Grassley told the hearing that GlaxoSmithKline knew years before Nissen's meta-analysis was published that rosiglitazone [Avandia] may increase the risk of Myocardial infarction, commonly known as a heart attack, but suppressed that information and that safety experts at the FDA had also expressed concerns about the drug, but these were ignored by the leaders at the agency.

GlaxoSmithKline responds

GlaxoSmithKline issued a statement reiterating points the company has made repeatedly in the past, emphasizing that the best evidence to date comes from RECORD, which showed no safety issues with Avandia, and that judgment should be reserved until the FDA-directed TIDE trial has been completed and analyzed.

"In the years since the FDA convened the joint advisory committee meeting to address questions about the cardiovascular safety of Avandia, six large, prospective, randomized, clinical trials have reported results. None of these randomized clinical trials . . . shows a statistically significant association between Avandia and myocardial infarction or other ischemic cardiovascular events," the statement reads.

GlaxoSmithKline also rejects suggestions made in the February Senate report that the company failed to present an accurate, balanced, or complete view of the currently available information on Avandia. "A fair examination of the company's record will show that GlaxoSmithKline has been diligent in its efforts to thoroughly study the safety and effectiveness of rosiglitazone and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians, and others in a variety of ways," it says

Déjà vu anyone?

Full damning report can now be downloaded HERE



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