Friday, April 13, 2007

F.D.A. Rejects Merck’s New Pain Medication - New York Times

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.

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