Forbes.com: Doctors Back Bextra Ban

Apparently the divide in the FDA panel came down to doctors who would benefit from prescribing Bextra and “…drug safety experts and cardiologists…” who recommended against Bextra. This interesting article points out the often-overlooked financial considerations that may factor into the drug approval process.

Analysts and doctors agreed that since Bextra is being pulled Merck’s (nyse: MRK – news – people ) similar Vioxx, which was withdrawn in September, is unlikely to ever return to the market. At first glance, the FDA’s decision seems to contradict the advice of a 32-person advisory panel that the agency convened in February.

“My first reaction is surprise, since the FDA panel advised that Bextra be kept on the market,” says Antonio Gotto, dean of the Weill Cornell Medical College. “I think the FDA is being extremely cautious–they’re taking the position that there are alternative drugs.”

The FDA has apparently decided to side with the drug safety experts and cardiologists, who comprised only half the panel, and not with doctors who treat arthritis and would more frequently prescribe Bextra. Additionally, some panelists say, the up or down vote on Bextra obscured more broad concerns about the drug’s safety.

“I think the FDA made a decision about the overall safety of this drug and felt that there were alternatives,” says Steve Abramson, chairman of rheumatology at New York University’s Hospital for Joint Diseases. He was on the panel and voted that Bextra should be kept on the market. But he says he feels the FDA’s decision takes into account the totality of discussion on Bextra. Many panelists worried that Bextra, like many other arthritis drugs, might pose a risk. Worse, he says, studies on the drug were not extensive enough to provide clear answers.

Byron Cryer, an expert in gastrointestinal side effects who was a nonvoting adviser to the FDA panel, says that he does not view the decision as being counter to the panel’s advice. The vote for Bextra (17 for, 13 against, two abstaining) was very close to the 17-15 vote for Vioxx. Eric Topol, chairman of cardiology at the Cleveland Clinic and one of the most vocal critics of Bextra and Vioxx, says that he saw the FDA panel split mostly between arthritis doctors and others.

Read the rest of the article at Forbes.com: Forbes.com: Doctors Back Bextra Ban