Today the New York Times has another installment in its excellent Evidence Gap medical series (here is previous Evidence Soup coverage). In For Widely Used Drug, Question of Usefulness Is Still Lingering, Alex Berenson writes about the cholesterol drug ezetimibe; it's sold as Zetia, and also as the Vytorin combo hypertension-cholesterol drug (I've seen several Vytorin TV ads).
The triumph of marketing over evidence. Berenson writes that "sales of the medicines reached $5.2 billion last year, making them among the best-selling drugs in the world. More than three million people worldwide take either drug every day. But there is still no proof that the drugs help patients live longer or avoid heart attacks. This year Vytorin has failed two clinical trials meant to show its benefits. Worse, scientists are debating whether there is a link between the drugs and cancer.... Now some prominent cardiologists say that the evidence has swung so decisively against the drugs that they should not be sold."
Sell now, study later? The Evidence Gap continues: "About the only point on which both sides agree is that no one can judge ezetimibe’s safety and benefits for certain without more data, ideally from a clinical trial covering more than 10,000 patients and lasting several years, long enough to show that the drug actually helps patients live longer or avoid heart attacks." But a satisfactory trial did not begin until late 2005, three years *after* FDA had approved the drug. Get it together, FDA: This sounds like unacceptable public policy, and inadequate evidence-based medicine. FDA must start following a guideline that establishes more stringent rules for agency decision-making based on medical evidence.
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