AMA Calls Glaxo Avandia Study Inappropriate, Wants Rules Reviewed
By Jim Greene
Published on April 23, 2010
A study by drug giant GlaxoSmithKlein (GSK) on the side effects of its own diabetes drug Avandia® is a "disturbing example" of what's wrong with some industry-sponsored drug research, according to a recent editorial in the Journal of the American Medical Association (JAMA). The editorial called for analysis of such reports by scientists without ties to the companies involved.
JAMA editors said academic researchers should have full access to all study data, and that medical journal editors should not publish company-funded research results without an independent review. The editors said their journal already follows that standard.
Editorial Follows Senate Allegation Glaxo Rushed Report
The editorial was spurred by a February report by U.S. Senators Max Baucus and Charles Grassley alleging that GSK used heavy-handed tactics in a 2007 attempt to shortcut normal procedures in publishing a company-funded report on the safety of Avandia® and failed to include information about potential heart health risks known to the company.
Along with the editorial, the journal published comments by Steven Nissen, chairman of cardiology at the Cleveland Clinic, whose separate 2007 study linked Avandia to a 43 percent increase in heart attack risk. Nissen wrote that independent review is needed to protect study results from undue influence by the drug industry.
Nissen said many drug companies consider the results of their own studies to be proprietary information and do not feel obligation to share it.
GSK Says Research Was Independently Verified
A GSK spokesperson said analyses of the Avandia® research results were independently verified by the London School of Hygiene and Tropical Medicine and that the JAMA criticism unfairly questioned the motives of the physician scientists who conducted the research.
Avandia® is the subject of numerous personal injury lawsuits alleging that the drug, intended to regulate blood sugar levels in type 2 diabetes patients, contributes to heart attacks and heart failure. The root problem is said to be weakening of the muscles of the heart wall.
If you or someone you know has suffered heart ailments after taking Avandia®, contact an experienced personal injury attorney. You may be eligible for financial compensation to help you deal with medical expenses, loss of income, and pain and suffering.
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