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Healthy Skepticism Library item: 17335

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Government Document

Baucus M, Grassley C
Staff Report on GlaxoSmithKline and The Diabetes Drug Avandia
Committee on Finanace United States Senate 2010 Jan
http://www.cafepharma.com/boards/showthread.php?t=412204


Abstract:

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.

 

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