I've just been sent a link to a document prepared by the staff of the Committee on Finance United States Senate. It's a staff report on GlaxoSmithKline and their diabetes drug, Avandia and makes very interesting reading indeed.
The Executive Summary reads:
This staff report was developed over the last 2 years by U.S. Senate Committee on Finance investigators who reviewed over 250,000 pages of documents provided by GlaxoSmithKline (GSK/the Company), the Food and Drug Administration (FDA), the University of North Carolina, and others. Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA, and anonymous whistleblowers.
Committee staff began this investigation in May 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.
When an independent scientist sought to publish a study in 2007 pointing out the cardiovascular risk of Avandia, GSK acquired a leaked copy of that study from one of its consultants prior to the study being published. The company’s own experts analyzed the study, found it to be statistically reliable, and then attacked the soundness of that study in press releases and public comments.
GSK also sought to counter the study’s findings by quickly releasing preliminary results from its own study on Avandia, even though the company’s internal communications established that its study was not primarily designed to answer questions about cardiovascular risk.
I've not read through all of it yet as it's 342 pages long... but what I have read, is very damning for GlaxoSmithKline.
The report, a result of a two year investigation, criticizes the FDA and calls for an independent pharmacovigilance unit to be set up.
The report also finds that GlaxoSmithKline failed to warn patients and the FDA of the dangers of Avandia and that it attempted to discredit any research showing Avandia in a negative way. It also highlights how GlaxoSmithKline intimidated [bullied] independent physicians who dared to speak out against Avandia.
**Special thanks to Christina England for giving me access to this document.
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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