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FDA Reckless on Drug Safety

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FDA Cautious on Food Safety, Reckless on Drug Safety

April 2010

Sidney M. Wolfe, M.D.

The Food and Drug Administration (FDA) has brought welcome, increased focus and action to protect people from unsafe or possibly unsafe foods. The most recent example is the massive recall of products containing hydrolyzed vegetable protein, in which the FDA stated that although “no illnesses are known to be associated with this problem of [salmonella bacterial] contamination,” the agency was “taking steps to protect the public.”

In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless. By deciding not to ban three drugs in particular, the FDA has endangered the lives and health of hundreds of thousands of people. For each of these drugs there is unequivocal evidence that their dangers, resulting collectively in hundreds of deaths each year, clearly outweigh their health benefits.

This evidence is so clear that two of the drugs – the pain killer propoxyphene (included in Darvocet) and the diet drug sibutramine (Meridia) – have already been removed (propoxyphene) or removal has been recommended (sibutramine) from the market in the U.K. and in Europe. The American and European diabetes associations recommended a year ago that the third drug, the diabetes drug Avandia, should not be used. In 2009, there were approximately 23 million prescriptions filled for these three drugs in the U.S.

Why is the FDA cautious on food safety but reckless on prescription drug safety? The agency has clearly made a decision to take the lead and insist on a more public health protective effort in the food area. But it has deferred to the existing, dangerously flawed leadership in FDA’s Center for Drug Evaluation and Research (CDER). For foods with possible harm but no evidence yet, there have been recalls, but for these three drugs with thecertainty of harm already having been established and other countries acting accordingly for two of them, the FDA seems incapable of protecting the public.

The top leaders in the FDA, Commissioner Margaret Hamburg and Principal Deputy Commissioner Joshua Sharfstein, stated last year that the “overriding purpose [of the FDA is] protecting the public health,” and that “some benefits are not worth the risk.” Unless this statement is empty rhetoric with regard to drugs, Hamburg and Sharfstein must insist on the ban of these three drugs, as we have previously petitioned the agency to do. Until this is done, they will be complicit, as leaders of the FDA, in the needless, preventable deaths of hundreds or more people a year from drugs with no unique benefits, only unique, life-threatening risks.