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Vioxx Alternative Risky, Official Says

Feb 18, 2005 | Washington Post

David Graham, a veteran Food and Drug Administration safety officer and recent whistleblower, on Thursday told a conference reviewing the risks of arthritis painkillers that Mobic, the medication that hundreds of thousands turned to after Vioxx and other COX-2 inhibitors came under a cloud, is potentially just as dangerous.

Graham said a large new study he and a colleague had just completed, which FDA officials initially did not want him to present because it was preliminary, indicates that the anti-inflammatory drug is a "bad actor."

Mobic is now the top-selling prescription arthritis painkiller, and the manufacturer strongly defended its safety record Thursday.

Graham, who was the star witness at an earlier Senate hearing into the withdrawal of Vioxx and the FDA's monitoring of drug safety, again delivered dramatic and controversial testimony Thursday.

In addition to strongly questioning the safety of Mobic, Graham said the cardiovascular risks of taking higher doses of COX-2 inhibitors are comparable to the dangers posed by smoking, high blood pressure and diabetes.

He said he did not see any good reason for consumers to use drugs in the class now that evidence is becoming more convincing that they all increase the risk of heart attacks and strokes and may not provide better pain relief than older analgesics such as ibuprofen, naproxen or aspirin.

Graham's conclusions about COX-2 drugs were supported by many other speakers at the FDA-convened conference, including some who studied COX-2 drugs that are still under development.

At the end of the unusual three-day session today, the expert panel is scheduled to recommend to the FDA whether it should issue warnings about COX-2 drugs or possibly restrict their use.

The difficult decisions facing the panel became increasingly clear with Graham's critique of Mobic and impassioned pleas from arthritis sufferers not to deprive them of drugs that relieve their pain.

Many said the experts are focusing too narrowly on drug risks and minimizing their benefits.

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