Avandia (text link) made headlines two weeks ago when The New England Journal of Medicine published research by Dr Steven Nissen at the Cleveland Clinic. Nissen calculated that the medicine, taken by one million diabetics nationwide to reduce glucose levels in the blood, at the same time increases the risk of a heart attack by 43%. NBC's Tom Costello noted that the FDA has responded to Nissen's study by ordering a stronger warning label while GlaxoSmithKline, Avandia's manufacturer, responded by taking out full-page ads claiming to have found "no increased risk of heart attacks."
Since Avandia has been approved as safe and effective since 1999, the House Oversight Committee asked the FDA who was right. "The FDA still does not know," replied ABC's Lisa Stark (subscription required). "It is still pouring over reams of complicated evidence." CBS' Wyatt Andrews called the hearings "unusually raucous" with Republicans questioning Nissen's "political motives." Rep Chris Cannon (R-UT) accused him of causing a 20% slump in the price of GlaxoSmithKline's stock on financial markets. CBS' Nancy Cordes noted that Nissen, a cardiologist, had already identified heart problems from using another FDA-approved prescription drug, the now-withdrawn pain reliever Vioxx: "It is not that I go looking for trouble," Nissen assured her. "In science, it is always better to have information out in the public domain so that it can be evaluated by everybody."
ABC's in-house physician Timothy Johnson (no link) argued for a dual FDA system for approving medicines: one standard of safety for "desperate patients who, quite literally, have nothing to lose;" and a higher standard for medication like Avandia that competes with already available treatments and "that will be taken by millions of people."
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