A Reminder That No Drug Is Risk-Free

By ALEX BERENSON and BARNABY FEDER

Published: February 19, 2005

Cost-benefit analyses for drugs are rarely as explicit as they were yesterday.

When a federal panel of doctors and scientists recommended allowing the sale of arthritis medicines from Pfizer and Merck despite acknowledging their heart risks, it did more than just give new life for Celebrex, Bextra and possibly Vioxx - three drugs some analysts had viewed as doomed.

The panel's recommendations backed the pharmaceutical industry's stance that no medicine is risk-free and that patients should sometimes be allowed to choose medicines that have serious risks even for conditions that are not life-threatening.

The panel, which was convened by the Food and Drug Administration to discuss the risks of pain medications, reached its conclusions after three days of hearings in Maryland. The F.D.A. typically adopts the recommendations of its expert panels, particularly in such controversial matters.

Even as a vocal alliance of consumer groups and plaintiffs' lawyers are raising similar questions over other widely used drugs, the panel's analysis offers at least a small dose of good news for the industry. Indeed, drug stocks rallied broadly yesterday, while the industry's critics spoke out against the panel's decision.

Merck shares ended the day up 13 percent, or $3.76, at $32.61. Pfizer rose almost 7 percent, gaining $1.74, to $26.80. Shares in both companies remain sharply lower than they were before Merck withdrew Vioxx from the market in late September.

Now Merck, which makes Vioxx, and Pfizer, which makes Celebrex and Bextra, face their own choices.

Merck stopped selling Vioxx last fall after a clinical trial showed evidence of heart risks in patients who took the drug for more than 18 months. The company can now decide whether to reintroduce it.

A Merck official said in testimony to the panel on Thursday that the company might take that step, if the experts concluded that the risks were characteristic of the entire class of drugs, known as cox-2 inhibitors. Yesterday, after the F.D.A. panel reached just that conclusion, Merck declined to comment further on its plans.

If it does bring back Vioxx, Merck faces the challenge of persuading doctors and their patients to use a medicine that it has already said is unsafe. Pfizer faces a similar though somewhat less serious challenge with its drugs, which have remained on the market, although their sales have fallen sharply.

Merck and Pfizer will also undoubtedly use the panel's conclusions to defend themselves against lawsuits by people who say they had heart problems after taking the drugs. Merck, in particular, faces hundreds of such suits, some of them scheduled to go to trial this spring.

While some lawyers said yesterday that jurors might not be swayed by the F.D.A. panel's analysis, the gains in Merck and Pfizer shares indicated that investors had initially concluded that the F.D.A. recommendations could limit the legal liabilities of the companies.

"Merck can say a panel of experts said this drug was safe enough to be continued to market," said C. J. Sylvester, an analyst at Banc of America Securities who has a neutral rating on the company.

John LaMattina, Pfizer's president for global research and development, said the panel's hearing had given patients new information about the risks and benefits of all pain medications, including over-the-counter drugs like Advil.

A spokeswoman for Merck said the company appreciated the chance to offer data to the committee and looked forward to further discussions with the F.D.A.

Despite yesterday's decision, the drugs will probably never again reach the sales they had last year, analysts said, in part because the panel recommended that the drugs carry so-called black box warnings - the most stringent measure used to warn of potential dangers.

Since they were introduced in 1999, Vioxx and Celebrex have been among the most heavily promoted and most popular drugs, each taken by more than 20 million people. In 2004, Vioxx, Celebrex and Bextra had combined sales of more than $6 billion, almost 10 percent of the total sales of Pfizer and Merck.