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The Painkiller Panic
Wall Street Journal, 12-23-04

The Journal editorial today is a clarion call for sanity in the midst of what is shaping up to be a very irresponsible debate on drug safety: “One of the most frustrating things about the latest news on painkillers is that almost none of the people reporting it understand the concept of relative risk – i.e. that a doubling of adverse events like heart attacks still doesn’t mean that event is very likely. A doubled risk might well be a chance worth taking, especially if the baseline risk is low to begin with and the drug’s benefits are significant for the patient in question.”

The key phrase is “patient in question.” Regulators (and certainly not industry critics) are in no position to substitute their judgments for that of physicians and their patients, who can best determine for themselves the relative benefits and risks of a given treatment.

Public hysteria over small incremental risks will, in the long run, create a very large threat to public safety if the FDA retrenches and makes it even harder than it already is for industry to create vital new medicines.

Project FDA.
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