FDA’s drug-monitoring process flunks another test

Remember when you were a kid in school and the teacher asked a question that no one in class knew the answer to? The teacher would give clues until finally the answer would become blatantly obvious, and everyone at once would raise their hand with the teacher’s desired answer. Somehow this news story reminded me of that:

Avandia side effect reports tripled in the month after a controversial study linked the blockbuster diabetes drug to increased risks of heart disease, reports the Associated Press. In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped …

Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet. The reports — obtained from the FDA through a Freedom of Information Act Request — suggest that doctors, previously unfamiliar with Avandia’s side effects, started to report problems that they once thought unrelated to the drug.

However, it’s not possible to infer any conclusion more complete than that, because the FDA’s reporting system is completely voluntary. It has value as an early-warning system, but that’s about it — and it’s the foundation of the FDA’s post-approval drug monitoring process. The jump in Avandia side effect reports might not say much about the drug, but it certainly says a lot about the need to reform the FDA.

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