Federal Drug Advisory Committee Recommends That FDA Keep Diabetes Drug on the Market, Despite Heart Attacks and Strokes

The good news is, the FDA and its drug advisory committee are airing their dirty laundry in public. But that’s the only good news.

Before a near-unanimous vote to recommend keeping the controversial diabetes drug Avandia on the market, advisers and officials of the Food and Drug Administration openly debated the merits and dangers of the drug, at several points disagreeing vehemently about both the credibility of research and the prudent course of action. (http://www.nytimes.com/2007/07/31)

A majority of panel members said that the research on Avandia was too “murky” to prompt drastic regulatory action. And besides, they said, there are other diabetes medicines that pose similar dangers.

A drug safety officer at the FDA, Dr. David Graham, begged to differ. He claims that the drug has caused more than 200,000 heart attacks and strokes, some of them fatal. Dr. Sidney Wolfe of Public Citizen (http://www.citizen.org/) pointed out Avandia’s record of problems beyond heart attacks, including risks of fractures and liver failure. But Dr. Robert Meyer, director of the FDA office that originally approved Avandia, pooh-poohed these concerns on the grounds that doctors and patients need to have a range of drug choices.

If you have diabetes – joining the 20.8 million Americans who do – it’s hard to believe that in order to control your disease, you must choose from a menu of heart attack, stroke, broken bones and liver failure. Once again, a Federal agency is putting us between a rock and a hard place when it comes to quality health care options . . . and we should be outraged.