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FDA – cautious on food safety, reckless with prescription drug safety

The new guard at 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 recently of products containing hydrolyzed vegetable protein in which the FDA stated that although “no illnesses are known to be associated with this problem of [bacterial] contamination,” the agency was “taking steps to protect the public.”

Three cheers for that. New FDA Commissioner Peggy Hamburg and Principal Deputy Commissioner Joshua Sharfstein are rightly giving muscle to an agency that for too long has let industry call the shots.

However, in contrast to becoming more active in enhancing food safety by removing potentially dangerous products before they have caused harm, though, 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, including hundreds of deaths, outweigh their health benefits.

This evidence is so clear that two of the drugs – the pain killer propoxyphene (Darvocet) and the diet drug sibutramine (Meridia) – have been removed or are in the process of being removed 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 a total of approximately 23 million prescriptions filled for these three drugs in the U.S.

In deciding to ban propoxyphene in mid-2009, the European Medicines Agency (EMA) stated that “the available evidence suggests that the combination of propoxyphene and acetaminophen [as in Tylenol] is no more effective than acetaminophen on its own” and that “the benefits of all medicines containing propoxyphene, either on its own or in combination, do not outweigh their risks.”

An earlier announcement of the eventual ban in the U.K. has resulted in “a major reduction in deaths involving coproxamol [propoxyphene and acetaminophen] compared with the expected number of deaths (an estimated 295 fewer suicides and 349 fewer deaths including accidental poisonings), but no statistical evidence for an increase in deaths involving either other analgesics or other drugs.”

In announcing the UK withdrawal, the government stated: “It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive.”

Last year, the FDA ignored the recommendation of one of its own advisory committees to ban propoxyphene, deciding instead to merely increase the warnings. Former FDA Commissioner Dr. Donald Kennedy and former Bureau of Drugs Director Dr. Richard Crout, both at the FDA when it rejected our earlier petition to ban propoxyphene in 1978, now support our petition to ban this drug.

When they recommended the ban of Meridia in January, the EMA stated that its benefits don’t outweigh its risks, based on a 10,000-person study showing significantly increased heart attacks, strokes or cardiovascular deaths in people taking the drug compared with those who took a placebo. The FDA, in contrast, said that it had not yet analyzed the data from this study but will strengthen warning label and have an advisory committee meeting in the fall.

A Canadian study last year found that for every million people using Avandia, instead of a similar but safer diabetes drug, Actos, there would be an excess of 8,300 cases of heart failure and 3,500 excess deaths. These needless cardiac deaths were the reason that the American and European Diabetes Associations concluded that “given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone [Avandia].”

Why the stark difference between the approach to food safety and drug safety?

Doctors Hamburg and Sharfstein have clearly made a decision to take the lead and insist that the agency does a much better job to protect consumers from dangerous food.

Unfortunately, they have deferred to the existing, dangerously flawed leadership in FDA’s Center for Drug Evaluation and Research, on drug safety. They apparently are unwilling to challenge the decisions to leave these three dangerous drugs on the market.

If the agency is to act on the statements Hamburg and Sharfstein made in an editorial in June 2009, that the “overriding purpose [of the FDA is] protecting the public health” and that “[s]ome benefits are not worth the risk,” they will insist on the ban of these three drugs and the replacement of the current top drug officials with those more intent on protecting the public health.

Dr. Sidney M. Wolfe is the director of Public Citizen’s Health Research Group.