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.
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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.
My daughter who has a medical PHD, works for a lab in MA, sent me the a report about Avandia safety with graphs showing a group of patient studies of those taking Avandia for a period of 6 months whose cholesterol levels had almost tripled! And that is exactly what mine had done. My doctor switched me to another diabetic drug but I've been struggling with those high levels ever since.
I can't locate that 2004 report. I had saved a copy on my pc. I printed a copy for my records, then lent it to a friend who was also taking the drug, she no longer has it so I printed off another 24 pg one recently and discovered it has been changed! How they could do that is a mystery! The page with that study graph was pg 18.
I'm still struggling with high cholesterol and triglycerides.