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FDA Rejects New Vioxx Clone

Despite some concerns about its objectivity, a FDA advisory panel voted by an overwhelming 20-1 margin to reject Merck's application to approve Arcoxia, a COX-2 inhibitor already sold in 63 other countries that's been called by some the son of Vioxx.

An approval by the advisory panel of Arcoxia would've been one more public health disaster in the making, says FDA whistleblower Dr. David Graham. Just as damning were the comments by Arthur Levin, director of the Center for Medical Consumer in New York, who asked, rhetorically, why the panel was convened at all, based on all the grave concerns about the Merck drug.

Graham also debated two of his agency peers about the inherent risks of older pain drugs already in the consumer pipeline, assertions the director of the FDA's office of new drugs called "simply false." Of course, Merck researchers like Dr.  Scott Korn would have you believe the overall risk-benefit profile for Arcoxia is enough to support its approval. The truth speaks louder, however, than any false assumptions about a painkiller's alleged safety.

This isn't the only recent misstep by Merck. The New Jersey drugmaker and a Danish partner (Lundbeck) abandoned plans to develop an experimental insomnia drug last month, no doubt attempting to invade the sleep aid arena already dominated by Ambien.

New York Times April 12, 2007 Registration Required

San Francisco Chronicle April 12, 2007

CNNMoney.com March 28, 2007

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