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FDA Votes to Keep Avandia on the Market -- Despite Known Heart Attack Risk
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 Earlier this year, it came out in The New England Journal of Medicine that the widely used diabetes drug Avandia increases the risk of heart attack and possibly death.
Now, even though a federal drug advisory committee, assembled by the Food and Drug Administration (FDA), voted 20 to 3 that Avandia does raise the risk of heart attacks, it voted 22 to 1 that the drug should remain on the market.
Their reasoning? Studies involving Avandia were “too murky to merit drastic regulatory action” and other diabetes drugs may have similar risks.
Apparently, causing hundreds of thousands of heart attacks, strokes, and death does not warrant regulatory action in the eyes of the FDA.
FDA drug safety officer Dr. David Graham -- one of my heroes -- may have been the lone voice calling for Avandia’s withdrawal from the market. He reportedly voiced that the drug had caused as many as 205,000 heart attacks, strokes, and death from 1999 to 2006.
He went on to say that for every month Avandia is sold, another 1,600 to 2,200 patients are likely to suffer from potentially fatal heart attacks and strokes.
Yet, once again, the FDA is clearly not faltering in their duty to protect the drug companies. Already, a senior FDA scientist was removed for voicing concerns about Avandia.
Further, it has been revealed that Avandia’s maker, GlaxoSmithKline, told the FDA about the heart risks nearly two years ago, but no warnings were made because of internal FDA disagreements about what to do with the drug.
When you consider that last year Avandia brought in $3.4 billion in sales worldwide, it’s fairly clear what the decision-makers are up against: deciding whether to sacrifice billions of dollars in profits to save a hundred thousand or so lives.
Please, if you or someone you love has type 2 diabetes, review How to Finally Make Diabetes Disappear. This is a condition that is completely preventable and curable without taking a dangerous drug.
New York Times July 30, 2007 RD
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