FDA Panel Mulls Vioxx Risk

Medical experts spent Wednesday trying to digest both the risks and rewards of blockbuster painkillers already swallowed by millions of patients across the country.

As a three-day hearing kicked off, the Food and Drug Administration began weighing testimony about the safety of drugs that it approved for widespread use more than five years ago. The so-called superaspirins once promised safe pain relief without stomach problems but have since been linked to heart problems.

Merck (MRK Quote - Cramer on MRK - Stock Picks) voluntarily withdrew one of the drugs, Vioxx, last year following a study that exposed significant cardiac risks after extended use. But this week's session could help decide whether the entire class of drugs, known as Cox-2 inhibitors, should carry harsher warnings or perhaps even follow Vioxx off of pharmacy shelves.

Ned Braunstein, senior director of Merck Research Laboratories, said that recent data "strongly suggest" that the class as a whole may be posing risks.

"Long-term comparative studies are needed," he said. "More work needs to be done."

Originally, Merck adopted a different stand when pulling Vioxx from the market. The company said that it chose to withdraw Vioxx because patients could choose alternative treatments with no proven links to heart problems. Merck's biggest rival, Pfizer (PFE Quote - Cramer on PFE - Stock Picks), manufactures two Cox-2 inhibitors -- Bextra and Celebrex -- that remain on the market. Similar drugs, including one by Merck, still await FDA approval.

One physician complained Wednesday about Merck's shift in attitude. He noted that the company had always portrayed Vioxx as the sole drug in its class clearly labeled to reduce stomach problems. Thus, he questioned why the company suddenly decided that alternatives existed when Vioxx presented heart problems.

"It sounds like you're trying to have your cake and eat it, too," he declared.

Shares of Merck fell 1.5% to $28.91 Wednesday afternoon. Pfizer slid 1.7% to $27.48.

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