My FDA Hero Blows the Whistle on Another Vioxx-Like Drug

When I posted news of Arcoxia, I wondered if there was any reason to believe Merck's newest painkiller was any safer than their toxic Vioxx. Apparently not, based on an editorial written by FDA whistle-blower Dr. David Graham for the Journal of the American Medical Association.

The problem: A shell-game strategy by Merck regarding the Multinational Etoricoxib and Diclofenac Arthritis Long-Term Program (MEDAL) program, Graham says, that allowed them to claim the risks for cardiovascular events were no different for Arcoxia and Voltaren (diclofenac), and implying both drugs were safe.

Merck could get away with that, Graham says, because the MEDAL program used a study design "well-known to be especially poor at identifying safety risks between drugs, thereby stacking the deck in favor of its drug." In fact, the MEDAL report compared Arcoxia favorably to Voltaren, a painkiller known to increase a patient's risk of acute heart attack.

Based on the way these misleading study results were framed, however, both drugs were deemed safe. Those results might've been far different and more obvious, Graham says, had Arcoxia been compared to naproxen.

Will the FDA, Graham says, forsake common sense and approve Arcoxia by willingly accepting misdirection and disinformation in the guise of science? Here's hoping rational thinking -- sparked by an avalanche of Vioxx lawsuits being fought in the courts -- will prevail.

Journal of the American Medical Association September 12, 2006 Free Full Text Article

USA Today September 12, 2006

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