CardioExchange Archive

The Avandia Saga Comes to an End — or Does It?

The FDA advisory panel wound up its two-day marathon meeting with a decisive mixed vote. Of the 33 voting members,

• 12 voted for rosiglitazone to be withdrawn from the marketplace,
• 10 voted to keep the drug on the marketplace but with severe new restrictions,
• 7 voted to keep the drug on the marketplace with a stronger warning, and
• 3 voted to keep the drug on the marketplace with no changes to the label.

There was one abstention. There were no votes for the option that would have lightened the warnings on the label.

The vote prompted a number of different interpretations. The New York Times headline, “FDA Panel Votes to Restrict Avandia,” contrasts sharply with the Wall Street Journal headline, “FDA Panel Backs Keeping Avandia on the Market.” On the one hand, it seems clear that the opponents of rosiglitazone didn’t achieve their goal of having the drug removed from the market. On the other hand, 22 out of 33 advisors voted to either withdraw the drug or impose severe restrictions on its use, which can hardly be taken as a strong endorsement. The FDA will have to find the right balance between these views. GlaxoSmithKline issued a press release in response to the panel vote.

Dick Cheney Receives an LVAD: Former Vice President Dick Cheney received a left ventricular assist device (LVAD) last week, according to reports in USA Today, the Wall Street Journal, and MSNBC. “A few weeks ago, it became clear that I was entering a new phase of the disease when I began to experience increasing congestive heart failure. After a series of recent tests and discussions with my doctors, I decided to take advantage of one of the new technologies available,” Cheney said in a statement to the media.