GlaxoSmithKline emails reveal Avandia concerns

In 2007, GlaxoSmithKline publicly refuted study findings that its diabetes medication, Avandia, increased patients' risk of heart attack by 43 percent, but emails sent between researchers at the pharmaceutical company reveal scientist concerns that the study findings were on target.

After the study came out, sales went way down and GSK came under tougher scrutiny by the FDA. The company added a black-box warning to the medication, warning about the risk of worsened or new congestive heart failure.

Cleveland Clinic cardiologist Steven Nissen authored the 2007 study that the New England Journal of Medicine (NEJM) published. Shortly before its release, a senior consultant for GSK wrote an email saying, "The numbers are the numbers; the analysis is very similar to our own," and added that while the company could not "undermine" the figures, it might be able to find a way to explain them.

Publicly, however, GSK pointed out early results from its study, called Record, and submitted the results to NEJM. The journal questioned the data and did not agree with GSK authors that the findings contradicted Nissen's meta-analysis findings. Still, NEJM published a revised version early that June that said patients on Avandia might have increased heart risks, but that there was no connection to increased risk of heart attack or death.

GSK says it did not disagree with Nissen's findings, but rather disagreed with the conclusions he drew from the data, and also says that it never hid its own meta-analysis findings, which were similar to Nissen's. 

Whether GSK was transparent and forthcoming or not, GSK's Avandia has its share of problems. Approximately 1,000 patients with heart-related problems that developed after taking Avandia are suing the company, and Senator Chuck Grassley continues to implore the FDA to request that GSK withdraw Avandia from the market.

- read the story [1] in the Wall Street Journal

Related Articles:
Study: Avandia linked to higher death risk [2]
Did GSK try to quash docs' Avandia fears? [3]
Journal calls for Avandia restrictions [4]
Nissen questions approval process for diabetes drugs [5]
FDA expert wants Avandia withdrawn [6]

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