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POLICY WATCH //

Tracking Adverse Drug Reactions

Medicare data would allow the FDA to identify dangerous side effects.

Fall 2005
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Last year the pharmaceutical manufacturer Merck withdrew Vioxx after studies showed patients who had used the painkiller for prolonged periods were at increased risk for heart attacks and strokes. That recall reignited criticism of the Food and Drug Administration's system for tracking drug safety. The voluntary system relies largely on physicians and pharmacists to report adverse drug reactions. But drug side effects are notoriously difficult to detect, and studies have shown that fewer than 10% of adverse reactions are ever reported.

In June the Centers for Medicare and Medicaid Services proposed making information from the Medicare prescription drug program available to the FDA. The plan, backed by the FDA and with support in Congress, would expand existing databases to link drug data with Medicare billing records. With patients’ identities protected, researchers could scan the resulting database for worrisome patterns involving particular drugs.

The Medicare program, expected to cover as many as 43 million people in 2006, would give researchers a massive array of data, allowing them to identify side effects that did not occur during clinical trials and to compare the effectiveness of competing drugs—without data from pharmaceutical companies.

“The FDA has only been able to tell us whether a drug is more effective than a placebo, and safe when thousands of people take it,” says John Santa of the Center for Evidence-Based Policy at Oregon Health & Sciences University. “We should really ask whether a drug is better than what we already have, and safe when millions take it.”

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