Congress Holds Hearing Concerning Avandia Risk

Over 6 million people take the type 2 diabetes drug Avandia®, which is being compared to Vioxx due to its heightened cardiac risk and the parallels between the two in terms of being public health debacles. The U.S. House Committee on Oversight and Government Reform held a hearing June 6, 2007 to investigate allegations that both the FDA and Avandia manufacturer GlaxoSmithKline (GSK) may have been aware of the increased risk of heart problems as far back as late 2005.

In May of 2007 Cleveland Clinic cardiologist Dr. Steven Nissen (one of the experts who identified the Vioxx cardiac risk) and his colleague Kathy Wolski evaluated 42 studies that compared patients taking Avandia with patients not using the drug. The studies included nearly 28,000 patients, 15,560 of whom were taking Avandia.

They found that the risk of heart attack increased 43 percent among patients taking Avandia. They also determined that there is a 64 percent increased risk of dying from cardiovascular causes while taking Avandia. These findings will be published in the June 14 issue of the New England Journal of Medicine.

Hours after Dr. Nissen's study was made public, the Food and Drug Administration (FDA) issued an alert on May 21, 2007 based on clinical trial data provided by GSK showing a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.

Dr. Nissen discovered the Avandia drug data by reviewing GSK’s clinical trial results posted on the web, after it agreed to post such findings as part of a settlement agreement with then New York Attorney General Eliot Spitzer. Spitzer had sued GSK alleging that, starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning Paxil's safety and efficacy when prescribed for depression in children and adolescents.

For more information, see: