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September 1, 2010

Statement of Dr. Sidney Wolfe, Director,
Public Citizen’s Health Research Group

It is no surprise that a study published today in the New England Journal of Medicine shows that the weight loss drug Meridia increases the risk of strokes and heart attacks.

In 2002, we petitioned the Food and Drug Administration (FDA) to ban Meridia because: 1) in pre-approval randomized trials, it significantly increased heart rate and blood pressure – both risk factors for heart attacks and strokes, and 2) because the FDA’s 1996 advisory committee voted narrowly against its approval, also opposed by the FDA medical officer reviewing the drug. By 2002, after its 1997 approval, cases of otherwise unexplained heart attacks in young Meridia users had been reported to the FDA.

In its 2005 denial of our petition, the FDA pointed toward the then-ongoing SCOUT trial, which it described as a “landmark” study “examining, for the first time, whether drug-induced weight loss reduces the risk for fatal and nonfatal cardiovascular disease.”

Although SCOUT clearly showed increased risk of heart attack and stroke, and the European Medicines Agency recommended banning the drug in early 2010 based on its overall results, the FDA has unconscionably allowed this drug, which should not have been approved in the first place, to stay on the market.

As is the case with Avandia, Darvon and other drugs, the agency appears immobilized to act against drugs without any unique benefits but unique, serious dangers.

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