"This was preliminary and unpublished data that was presented, and we have no way to address it," Yonsky said. "All I can say is that more than 10 million people have taken Mobic in 100 countries, and we've seen no trends towards excess risk of cardiovascular events."
Graham almost did not present his new data about Mobic and other nonsteroidal anti-inflammatory drugs yesterday because of opposition from his FDA supervisors. Because of last-minute changes, copies of his presentation were not available to the large crowd at the Gaithersburg meeting until after the session began.
A drug safety officer for 20 years, Graham has emerged as a powerful voice for change at the FDA. Lionized by some and attacked by others, he has become undeniably influential. In the past 10 years, he has identified 11 drugs as unsafe, and nine were ultimately removed from the market.
At the beginning of his talk, Graham thanked Lester Crawford, recently nominated to be permanent commissioner of the agency, for allowing him to present the new data, which were drawn from an ongoing study of prescribing and disease databases collected by the California Medicaid program. It is unusual for such research to be presented publicly before it has been peer-reviewed and published, but Graham pushed hard to do so. In recognition of the unusual circumstance, he said that he was presenting his views on Mobic, and some other drugs, as an individual, not as an FDA official.
Some panel members and speakers said they objected to the presentation. John H. Klippel, president of the Arthritis Foundation, said the information about Mobic could cause panic and despair among arthritis sufferers.
"I don't think showing slides of data and hearing a person present their opinion is equivalent to a scientific vetting of a study," Klippel said. "The public and interested parties have to scrutinize this data before people start acting on it."
Klippel echoed the complaint of some arthritis patients who testified. "We've lost touch with the benefits of these drugs, which are considerable," he said.
An Army physician testified yesterday that COX-2 drugs "are essential to the global war on terrorism" and should be kept on the market despite their risks. Christopher Grubb said that without the drugs, the military cannot keep as many soldiers functioning on the battlefield. He said the military is concerned about the bleeding that can come with drugs such as aspirin.
But other speakers argued for dramatic action by the FDA.
"Unfortunately, drugs that are studied on a few hundred or few thousand people for a few weeks or months are then taken by millions of people for many years," said Diana Zuckerman, president of the public-interest group National Research Center for Women & Families. "If you're not sure that a product is safe or likely to be used safely, get it off the market."
Also yesterday, Merck Research Labs President Peter Kim said his company will consider returning Vioxx to the market if the panel concludes that its risk-benefit ratio is similar to that of other COX-2 drugs.
