Emails Reveal Glaxo Scientists are Concerned about Avandia

GlaxoSmithKline (GSK) has some explaining to do after internal emails between Glaxo scientists revealed that they are concerned about the health risks caused by their diabetes treatment, Avandia. Back in 2007, Glaxo representatives were adamant in denouncing the findings of a study released in the New England Journal of Medicine. The study linked the medication to causing increased heart-attack risk in patients taking the drug.

An internal email written by Glaxo’s senior consultant just days before the study results were released in the New England Journal of Medicine stated that “the numbers are the numbers, the analysis is very similar to our own." The consultant also noted that Glaxo couldn’t undermine the findings; however, they could attempt to explain the results in an effort to offset the damaging effects of the findings.

The study found a 43% higher risk of cardiovascular issues for patients using Avandia. As a result, Glaxo’s sales figures plummeted and a congressional investigation was initiated to look into the way that Glaxo has been marketing the FDA’s response to the health concern. The director of the FDA drug-review division, Janet Woodcock, has been defending Glaxo, stating that Avandia has been wrongly “convicted without a trial.” Others strongly disagree.

Senator Chuck Grassley of Iowa has been pressing the FDA to force Glaxo to withdraw the drug; however, his efforts have gone unnoticed so far. He is currently preparing reports that will address the liability of the company for releasing dangerous drugs and outline the specific dangers of the drug.

The man responsible for conducting the initial study, Dr. Nissen, has commented that he was approached by Glaxo scientists days before the publication was released. According to Dr. Nissen, the scientists wanted him to reconsider making his analysis public. Glaxo representatives state that GSK didn’t disagree with Dr. Nissen’s data; however, the pharmaceutical giant disagrees with Dr. Nissen’s conclusions drawn from the data. According to Glaxo representatives, "GSK believes that a full and scientific evaluation of all the data does not confirm the safety questions originally raised."

The FDA is also facing questions about the safety of Avandia. FDA representatives say that they are in the process of completing their own analysis and are reviewing Glaxo’s analysis of 2005, which they recently received. Information revealed in an internal email from Glaxo, however, implies that the FDA had possession of the GSK analysis one year before the New England Journal’s study was released.

For more information about the dangers of Avandia, contact the Avandia attorneys of Williams Kherkher at 800-220-9341.