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Balancing Medical Risks; The FDA needs more authority to monitor drugs following their approval
Washington Post, 6-4-07

The Post argues, correctly we think, that the rush to judgment over Avandia is actually evidence that the FDA needs more resources to conduct a careful analysis of the postmarket risks and benefits of medicines.

FOR YEARS, there have been rumblings that GlaxoSmithKline's diabetes drug, Avandia, might be associated with an increased risk of heart attack or other cardiovascular events. Also for years, the drug's labels have noted the risk. Then last month, the New England Journal of Medicine published a review of the available studies on Avandia's side effects that concluded that taking the medication can significantly boost patients' chances of experiencing heart trouble.

Washington responded with a familiar fit of hypertension. In the space of a few days, congressional hearings had been scheduled, the Food and Drug Administration was under attack for being sloppy and slow, and the advocacy group Public Citizen was calling for the FDA to ban Avandia. Sen. Charles E. Grassley (R-Iowa) used the study's publication to push his proposal to reorganize the FDA's drug monitoring division. Meanwhile, Avandia users were no doubt staving off their own elevated blood pressure.

But there is good reason for the FDA to act cautiously. In an editorial after the review's publication, the Lancet, a respected British medical journal, pointed out that the two most significant studies considered did not produce many conclusions of statistical significance. The authors of the analysis admit that it suffers from significant weaknesses, among them that they did not have access to patients' medical histories. Further, the FDA has said that it has other data that contradict the analysis. A large trial is underway, the results of which will help to clarify the medication's dangers. In other words, the analysis is far from conclusive, and the FDA should not be in the business of regulating by suspicion. It always must balance potential dangers against potential usefulness of a drug.

If anything, the episode makes the case for a bill that Sens. Edward M. Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) recently shepherded through the Senate. The most potent criticism of the FDA's behavior in the Avandia case is that it hasn't moved fast enough to quantify the drug's dangers. The legislation would give the FDA clear authority to order post-approval studies if the regulator got a whiff of undocumented risks. The bill would also promote the pooling of public and private data on prescription drugs so that possible side effects can be discovered earlier and appropriate studies commissioned more rapidly. The House should embrace the Senate's approach.

Project FDA.
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