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FDA Critic Blasts Merck's Vioxx Replacement

September 14, 2006

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With its once profitable Vioxx banned from the marketplace, Merck & Co. has developed a new painkiller to compete with the arthritis drug Celebrex. But David Graham, a Food and Drug Administration insider, claims the new drug, Arcoxia, may be as risky for the heart as Vioxx.

Graham aired his concerns in an editorial posted on the Journal of the American Medical Association's website. In characteristically blunt language, Graham accused the pharmaceutical giant of engaging in "misdirection and disinformation presented in the guise of science."

An editor's note on the site says the FDA gave its permission for Graham to write the editorial, but only as a private citizen, not as an agency employee. The editorial and the two studies it accompanies will run in the Oct. 4 JAMA, the editors said.

Graham, who is a doctor and works in the FDA's Office of Drug Safety, created headlines in 2004 when he told a Senate committee that the agency was "virtually defenseless" in preventing a "tragedy and profound regulatory failure" such as Vioxx.

Vioxx, a COX-2 inhibitor, was withdrawn from the market two years ago after it was shown to increase the risk of heart attach and stroke. At the time, it was the nation's best selling prescription arthritis medications, taken by millions of consumers. It has since become the object of thousands of liability lawsuits.

Merck's new drug, Arcoxia, is also a COX-2 inhibitor, but the company says it presents a lower risk of dangerous side effects that other non-steroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen.

The FDA, however, has still not made a final decision about Arcoxia. It has asked Merck for more data about its safety and effectiveness. Merck is currently selling Arcoxia in 62 other countries.

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