Merck Withdraws Arthritis Medication

By Marc Kaufman
Washington Post Staff Writer
Friday, October 1, 2004

The blockbuster arthritis drug Vioxx was taken off the market yesterday by Merck & Co. after a study confirmed simmering concerns that it significantly raises the risk of heart attack and stroke. More than 2 million people take Vioxx worldwide, making this the largest voluntary drug recall in history.

Merck said that it received new information last week showing that people who used the drug for more than 18 months had nearly twice as many serious cardiovascular problems as those on a placebo. By Tuesday, the company had told the Food and Drug Administration that it planned to withdraw the drug.

"We believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data," said Merck President Raymond V. Gilmartin. "However, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."

FDA officials said they would begin an additional study of three other painkillers in the class called COX-2 inhibitors, which were hailed as near-miracle drugs when they came on the market in the late 1990s. The officials said the other COX-2 inhibitors have not been associated with the same dangers of stroke and heart attack but acknowledged that no patients using them have been followed for 18 months, as was the case with Vioxx.

The drug generated $2.5 billion in worldwide sales last year, and its withdrawal slashed the company's stock price by more than $12 a share, reducing the company's market valuation by more than a quarter.

Although Vioxx was aggressively marketed after it won FDA approval in 1999 and has been used widely -- with more than 84 million prescriptions written -- serious health concerns were reported soon after it became available. The FDA required additional warnings on the drug's label in 2002, and several months ago, it received the abstract of another report describing heightened cardiac and stroke risks with Vioxx. FDA officials said they were studying those results when Merck contacted them earlier this week.

Patients who said they have been harmed by Vioxx had filed more than 200 lawsuits before yesterday's announcement. Many of the cases have been consolidated into two major lawsuits in Los Angeles and New Jersey.

Merck officials stressed that, in the new study, there were no more than the expected number of deaths among the patients taking Vioxx, and that they knew of no deaths that should be attributed to the drug. But the company, long one of the biggest and most respected in the industry, was clearly concerned about a potential onslaught of lawsuits.

"We have substantial defenses in these cases and will defend them vigorously," said Kenneth Frazier, Merck's general counsel.

Vioxx is the first prescription drug to be withdrawn since 2001, when the cholesterol-lowering drug Baycol was taken off the market. In the four years preceding that, 11 drugs were withdrawn for safety reasons.

Yesterday's announcement rekindled the debate over whether the FDA has been sufficiently aggressive in monitoring drug safety. The clinical trial that found the increased danger of cardiovascular disease in patients taking the painkiller was designed not to assess the drug's safety, but to determine whether Vioxx protects against the recurrence of potentially cancerous intestinal polyps.

An independent panel monitoring the study advised the company on Sept. 23 to stop the trial because the drug appeared to be increasing the risk of heart attacks and strokes. Patients taking the drug for more than 18 months appeared to face about double the risk of major cardiovascular events, primarily heart attacks and strokes, compared with those taking a dummy pill.

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