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FDA Spectacularly Inept

Dec 26, 2004 | Toledo Blade

White House Chief of Staff Andrew Card says he believes that the Food and Drug Administration is doing a "spectacular job." That's hard to understand, given the mounting evidence that something is seriously wrong at the agency.

His remarks came after Celebrex, a drug prescribed for arthritis pain, was found to be linked to heart attacks and strokes but before yet more news arrived about another painkiller, the popular Aleve. Add in the Vioxx revelations, and we have one more example of the Bush Administration substituting spin for reality.

The FDA says new evidence shows that Celebrex doubles the chances for heart attacks and strokes. If that sounds familiar, it should; it was less than three months ago that drug maker Merck yanked Vioxx, another popular arthritis pain drug, after it was found to, yes, increase the chance of heart attacks and strokes.

A difference is that Pfizer, the maker of Celebrex, won't take it off the market, even though increased cardiovascular risk was found in a study of its use as a cancer treatment. Federal scientists stopped the study, and the National Institutes of Health ordered a review of COX-2 inhibitor drugs, a class of painkillers. Pfizer insists that because those in the study took higher than normal doses, it won't pull the drug.

By now, Americans may be forgiven if they are totally confused about what's going on at the FDA. The agency is supposed to keep drugs from the market that could lead to other serious health problems. Yet it is under fire not only for its handling of Vioxx and Celebrex, but for concealing evidence that children who take antidepressants may have an increased risk of suicide. Other drugs on the market are also increasingly falling under suspicion, too.

It might sound extreme to compare the FDA to a firm of front men for snake oil salesmen. But that's basically what whistleblower David Graham has done. And Vanderbilt University epidemiologist Wayne Ray, who himself consults for the Food and Drug Administration said, "Structurally, the FDA is flawed."

That's a fair conclusion, considering that funding for the agency is too closely tied to the drug firms asking the agency to approve their products. That puts the FDA under unhealthy pressure to neglect its primary duty: to monitor food and drugs to protect the national health.

And yet, the White House chief of staff, gives the FDA an A+ rating. Perhaps we should be happy that Andy Card isn't in charge of auto safety. He may not have been wrong to use the word "spectacular." Indeed, the FDA is beginning to look like a "spectacular" failure. But Mr. Card's banalities aren't the issue. What matters is that someone recognizes it is time to overhaul the FDA before more people die as a consequence of drugs that our supposed watchdog agency has cleared for marketing.

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