GlaxoSmithKline Denies Avandia Allegations

Washington, DCGlaxoSmithKline (GSK), maker of diabetes drug Avandia, is now defending itself against accusations that it failed to adequately warn the public about known risks associated with Avandia. The company responded that the allegations, which were released in a Senate finance committee report, were based on information that was inaccurate and taken out of context.

The Senate finance committee report, issued in February 2009, alleges that GSK waited years to alert the public to the risk of serious cardiovascular side effects linked to Avandia. The report further alleges that GSK executives attempted to intimidate physicians and tried to find ways to misrepresent findings that Avandia may increase cardiovascular risks to patients. If concerns about Avandia's potential to increase cardiovascular risk been taken seriously when the issue was initially raised in 1999, the report concludes, some of the approximately 83,000 heart attacks associated with Avandia might have been avoided.

The same report argued that the US Food and Drug Administration (FDA) ignored safety concerns its staff raised regarding Avandia.

GSK issued a 30-page response to those allegations. According to Reuters on 2/24/10, the Senate finance committee report was not "accurate, balanced or complete." There were "glaring omissions" in the Senate report, including a lack of discussion about clinical trials that the FDA analyzed, including the ADOPT, DREAM, and RECORD trials. The FDA has so far voted to keep Avandia on the market.

"Further, the Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline LLC ("GSK") took to continue to monitor the safety and efficacy of its diabetes medication," states the response. "The Staff Report repeatedly cites documents out of context; thereby, crafting a misleading narrative that fails to acknowledge that there is important, relevant safety information pertinent to the understanding of Avandia and its role in helping physicians and patients treat the devastating disease of diabetes."

GSK argues that the Senate report is "neither comprehensive nor detailed in its analysis of safety issues concerning Avandia." It concludes: "GSK respectfully disagrees with the Committee's decision to publish a Staff Report with such errors of fact, omission, and inference."

According to CNN on 2/20/10, the Senate investigation included a review of more than 250,000 pages of public and internal documents provided by GSK, the FDA and research institutes.

GSK says that it not only studied Avandia's safety but also communicated its findings to regulators.