GAITHERSBURG, Md., April 12 — A panel of federal drug advisers voted 20 to 1 Thursday to reject an application by Merck to sell its pain pill Arcoxia because of concerns that the drug could cause as many as 30,000 heart attacks annually if widely used.
Food and Drug Administration officials were unusually harsh in their criticism of the medicine.
“What you’re talking about is a potential public health disaster” if Arcoxia is approved for sale, Dr. David Graham, an F.D.A. safety officer, told the panel.
Arcoxia is a sister to Vioxx, which Merck withdrew in 2004 after a study showed that it also increased the risks of heart attacks and strokes. Merck sells Arcoxia in 63 countries, and the company underwrote an extensive safety testing program that involved 34,000 arthritis patients.
The studies showed that Arcoxia caused nearly three times as many heart attacks, strokes and deaths as naproxen, a popular pain pill sold as Aleve, but was no more effective in curing pain. Patients taking Arcoxia suffered worrisome increases in blood pressure.
Dr. Peter Kim, Merck’s research chief, told the panel that the nation’s estimated 21 million arthritis patients needed new therapy options. Representatives of his company who followed him said Arcoxia was no more effective than 20 older pain pills already marketed — some for pennies a pill — and just as risky for the heart than all but one of them.
It was a tepid endorsement for a medicine Merck had once hoped would offer arthritis sufferers significantly better and safer pain relief. Indeed, Merck executives insisted for years that the company would seek to sell only medicines that offered substantial benefits over previous therapies.
The F.D.A. forcefully disagreed with the company, and several panel members were withering in their criticism of Merck and its drug.
“There is nothing special about this drug that would warrant giving it to patients and putting them at risk of cardiovascular death,” said Dr. David Felson, a panel member from Boston University.
Dr. Felson said the testing of Arcoxia and similar medicines should be stopped until companies could create drugs with fewer heart risks.
Other panelists said patients needed better arthritis drugs, not more of them.
Much of the day’s discussion centered on how Arcoxia compared with older medicines.
In early studies, Merck compared Arcoxia with naproxen and found that Arcoxia was far more dangerous to the heart. So the company switched to comparing it with diclofenac, a pain medicine that is popular outside the United States and is widely believed to be more dangerous to the heart than naproxen. The company claimed that its trials showed that Arcoxia was no more dangerous than diclofenac.
But Dr. Robert B. Shibuya, an F.D.A. medical officer, said that if a million patients switched to Arcoxia from diclofenac, as many as 2,300 more could experience heart attacks, strokes and death.
The panel discussed whether it was fair to penalize Merck’s drug for having a heart risk when older medicines like diclofenac that continue to be sold seemed to have similar risks.
Dr. John Jenkins, director of the Office of New Drugs at the F.D.A., said the science had changed.
“We didn’t know about these cardiovascular problems back in the ’80s and ’90s” when the older drugs were approved,” Dr. Jenkins said. “Some could question, Should all those other drugs still be out there?”
The F.D.A. and its advisers have become far less tolerant of risks in medicines that offer few life-saving benefits.
Thursday’s vote could signal an end to the possibility of any new medicines similar to Vioxx and Arcoxia being approved in the United States.
Called Cox-2 inhibitors, these drugs, which include Celebrex, were developed in hope that they would be easier on the stomach than ibuprofen and naproxen. But while they safeguarded the stomach, they worsened heart risks. Since heart attacks are far more frequent and deadly than ulcers, the reason for the class of drugs disappeared.
Arthur Levin, a panel member who is director of the Center for Medical Consumers in New York City, said he wondered why the F.D.A. even called the advisory committee together. “Based on the history and based on the evidence, my question is why are we even having this meeting?” Mr. Levin said.
A Merck spokeswoman, Kyra Lindemann, said the company was “disappointed in today’s outcome.”
“We continue to believe that Arcoxia has the potential to become a valuable treatment option,” Ms. Lindemann said, adding that Merck would continue to sell the drug outside the United States.
