FDA Advisory Panel Rejects Vioxx Successor

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"We don't have the data to know the boundaries of Arcoxia's safety," he said in an interview Thursday before the vote. "There is a difference now that there is awareness of heart risk with these drugs. There was not awareness, in fact, there was denial back in 2001."

"If the drug is approved, it would not be the same as what happened years ago," he added. "But I still am concerned that we don't have the cardiovascular safety issue assured. There can be misrepresentation of the drug when it's marketed."

A top Merck official told the advisory panel that the company has "comprehensively characterized the safety and efficacy profile" of Arcoxia.

"We at Merck believe etoricoxib represents a valuable treatment option for patients with osteoarthritis. We would like to emphasize there is more long-term safety data ... for etoricoxib than any other NSAID," said Peter Kim, president of Merck's research laboratories.

But other experts were not convinced.

In prepared testimony for the panel, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the drug should not approved in the United States and should be pulled from the market in the more than 60 countries where it is now sold.

"How can the approval of etoricoxib and the large numbers of preventable, life-threatening cardiovascular adverse reactions be justified?" Wolfe said in a prepared statement. "Why should the similarly dangerous offspring of Vioxx be approved? The answer is that it should not."

Wolfe noted that trial data presented by Merck on cardiovascular risks compared etoricoxib with the arthritis pain reliever diclofenac (brand name Voltaren), which he said is much more cardio-toxic than older, safer pain relievers.

"It is time to shut the door on further additions to this dangerous class of cox-2 inhibitor drugs," Wolfe said. "The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. In addition, further trials on these cox-2 drugs are unethical and should be stopped."