Sunday, January 13, 2008

Did Avandia Contribute to Thousands of Heart Attacks?

According to a November 2007 report by the Senate Finance Committee, an analysis by FDA scientists presented at a July 30, 2007, safety panel meeting estimates that Avandia has caused approximately 83,000 excess heart attacks since coming on the market.

The report summarizes the Committee’s findings regarding GlaxoSmithKline’s intimidation of Dr Buse, an independent scientist who first voiced concerns about Avandia back in 1999, in a report found here.

In November 2007, the FDA added a black box warning to GlaxoSmithKline’s diabetes drugs Avandia, Avandamet, and Avandaryl about an increased risk of heart attacks, and a boxed warning about an increased risk of heart failure was added in August 2007.

On October 26, 2007, Senator Chuck Grassley (R-Iowa), ranking member of the Finance Committee, sent a letter to FDA Commissioner Andrew von Eschenbach asking him to respond to reports that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin while considering whether to add a second warning.

According to the Senate Committee report, if the drug maker had considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, instead of trying to limit an independent medical opinion, some of the 83,000 heart attacks may have been avoided.

Buse was said to have written to the maker of Avandia: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat." Source.

Source here.