Avandia Drug Injury Discussed In New Senate Report

In a front-page story, the New York Times (2/20, A1, Harris) reported, “Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports.” A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that “has been brewing for years but has been brought to a head by disagreement over a new clinical trial.”

A similar story also ran in the Wall Street Journal (2/22, Mundy). The Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA’s documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet “with FDA scientists and outside experts to gain a full understanding…of all of the data and issues involved,” a spokeswoman said.