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Internal Emails Reveal Glaxo Scientists’ Avandia Concerns

Back in 2007, GlaxoSmithKline (GSK) was quick to deny a study that proposed that their diabetes medication, Avandia, was causing increased heart-attack risk in patients taking the drugs. New information leaked from several Glaxo scientists’ emails, however, reveals that the pharmaceutical company’s own scientists were concerned about the same problem.

In an email written several days before the study results were released in the New England Journal of Medicine, Glaxo’s senior consultant noted, “The numbers are the numbers, the analysis is very similar to our own.” While the consultant admitted that Glaxo would have difficulty undermining the study, he did suggest that they could try to find a way to explain the results.

The study’s results simply couldn’t be ignored. It found a 43% higher risk of cardiovascular problems for Avandia users. These frightening numbers caused Glaxo’s sales figures to plummet and also prompted a congressional investigation into the way in which Glaxo marketed the FDA’s response to the health concern. While Janet Woodcock, FDA drug-review division director, claims that Avandia has been wrongly “convicted without a trial,” many others think differently.

Senator Chuck Grassley of Iowa has been calling for the FDA to force Glaxo to withdraw the drug; however, his efforts have gotten no results so far. He is currently preparing reports that will outline the specific dangers of the drug and address the liability of the company for releasing dangerous drugs.

The man responsible for conducting the initial study, Dr. Nissen, claims to have been approached by Glaxo scientists just days before the publication was released. According to Dr. Nissen, the scientists wanted him to reconsider his concerns. Glaxo representatives say that GSK doesn’t disagree with Dr. Nissen’s data; however, the company does disagree with the conclusions drawn from the data. Glaxo is quoted as stating, “GSK believes that a full and scientific evaluation of all the data does not confirm the safety questions originally raised.”

Glaxo isn’t the only one facing questions, however. The FDA is facing hearings for the way that they have handled Avandia. FDA representatives say that they are completing their own analysis and sent out a press release that they had recently received Glaxo’s analysis of 2005, which they are reviewing. This is contrary to information revealed in an internal email from Glaxo, which stated that the FDA had possession of their analysis the year before the study in the New England Journal was released.

For more information about the dangers of Avandia, contact the Avandia lawyers of Williams Hart at (800) 220-9341.

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