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Debate among experts about NEMJ article and Avandia

May 24th, 2007

The Avandia affair is now moving to Capitol Hill. Senator Charles Grassley has penned a letter to the Food and Drug Administration which says that “tens of thousands of excess heart attacks may have occurred.” He has also written to GlaxoSmithKline, maker of Avandia. In it, he mentions “reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.” The company refutes any such suggestions.

Representative Henry Waxman has announced plans for a hearing in early June which he hopes will include the FDA commissioner, GSK executives and Dr. Steven Nissen, main author of the meta-analysis on Avandia that was published recently in the New England Journal of Medicine.

Other Avandia-related media coverage has focused on Dr. Nissen himself. The Wall Street Journal noted that Dr. Nissen’s attention was first drawn to Avandia after he learned of cardiovascular side effects with a related drug. After he had published these findings, a diabetes expert wrote to Dr. Nissen suggesting that Avandia could have similar issues.

In 2006, after seeing signs of heart problems in the DREAM and ADOPT studies, he sought more data, finding a treasure trove on the FDA and GSK websites. His Cleveland Clinic colleague, Dr. Kathy Wolski, describes him in the WSJ article as “a dog with a bone” regarding Avandia and its side effects. Since Dr. Nissen was also involved in the downfall of Vioxx, he has earned a reputation as a drug watchdog of sorts.

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