FDA Panel Opens Door For Return Of Vioxx

Chairman Alastair J.J. Wood, right, and other members of the advisory committee listen to testimony. Wood said issues surrounding the drugs are "extremely complex." (Mark Wilson -- Getty Images)

For Pfizer Inc.'s Celebrex, the vote was overwhelmingly in favor of keeping it available. A third arthritis medication, Pfizer's Bextra, also won the support of the panel, but by a small majority.

The restrictions proposed by the panel, if adopted by the FDA, will make COX-2 drugs much harder for manufacturers to sell and for patients to obtain. Once the FDA gives a drug a black-box warning, certain kinds of advertising are no longer allowed and doctors tend not to prescribe it widely.

Still, the Vioxx vote in particular was a vindication of sorts for Merck, which withdrew its product in September because of safety concerns. At the time, the company said it believed Vioxx could remain on the market with restrictions, but it decided not to do so because there were alternatives with fewer safety concerns.

The drug's possible path back to the market remains difficult. FDA officials told the panel that if Merck wants to return Vioxx to the market, the company must win new approval for revised label information about safety and how the drug should be used.

Merck officials said that they are open to returning the drug to the market and that "we look forward to discussions with the FDA" regarding Vioxx and other COX-2 products in the pipeline.

On Thursday, Merck Research Labs President Peter S. Kim said his company will reexamine its decision to withdraw Vioxx if the panel concludes that all COX-2 drugs pose cardiovascular risks. He reasoned that if all are potentially harmful, it is appropriate to measure each in terms of both its relative benefit and its risk. Vioxx is the only COX-2 drug that the FDA has found to protect against gastrointestinal damage, the most common side effect of aspirin and the older nonsteroidal inflammatory drugs.

Sen. Charles E. Grassley (R-Iowa), who has been highly critical of the FDA's handling of Vioxx, commended the panel for its "respect for the scientific process."

But he also said: "I remain troubled by the FDA's reluctance to be fully transparent. . . . Specifically, the FDA should value the science of its own employees at least as much as the science presented by drug companies."

In its recommendations on restrictions, the panel made it clear that it thought they should be tightest on Vioxx -- which showed the most significant cardiovascular problems in recently stopped clinical trials.

The FDA convened the extraordinary three-day meeting to solicit recommendations from some of the top experts in the nation on arthritis treatment and overall drug safety. The meeting was called because of the Vioxx withdrawal and similar health concerns linked to Celebrex and Bextra.

Although the panel members were convinced that the COX-2 drugs carry increased risks of heart attacks and strokes, they voiced differing views on how much the drugs benefit patients and whether they are significantly safer than older anti-inflammatory drugs, such as ibuprofen and aspirin. Also weighing on the panel was public testimony Thursday, when many arthritis sufferers pleaded to be allowed to continue using COX-2 drugs.

In a news conference after the votes, John Jenkins, director of the FDA's Office of New Drugs, said the agency will give great weight to the recommendations and comments of the panel. But he said the narrow margins of some votes mean the agency must look carefully at the members' comments.

"Close votes are very challenging to interpret," he said.

Merck shares surged $3.76, or 13 percent, to close at $32.61 yesterday on the New York Stock Exchange. Pfizer shares gained $1.74, or 6.9 percent, to finish at $26.80.