Experts review FDA decision over the drugs’ safety

The disappearance of Bextra will have an immediate financial impact on New York-based Pfizer, which just Tuesday included Bextra sales as part of its forecast that it would return to double-digit growth by 2006.

“It’s going to make it more difficult for them to achieve the numbers they implied they were going to achieve,” said Jon Fisher, a health-care analyst and portfolio manager with Fifth Third Bank in Cincinnati.

As part of its financial forecast, Pfizer said it planned to cut $4 billion in annual costs by 2008, including cutting jobs and closing plants. Thursday’s news could accelerate those efforts.

The shares took a 5 percent jolt in the morning after the company suspended sales of its Bextra painkiller at the request of the Food and Drug Administration.

But they gradually recovered in heavy trading throughout the day, closing up 4 cents at $26.90.

Many experts said the FDA had made the right choice in asking Pfizer Inc. to pull Bextra. But patients and physicians alike struggled to make sense of a blanket warning that covered 19 drugs, sold under dozens of brand names, but provided no guidance on which ones to take.

“The entire world of prescribing non-steroidal anti-inflammatory has now been turned on its head,” said Dr. Thomas Lansdale, an internist and chair of medicine at Greater Baltimore Medical Center.

The FDA advised patients to seek their doctors’ advice and emphasized that short-term use of over-the-counter strength versions of the medicines does not appear to pose the same risks.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said the agency asked Pfizer to withdraw Bextra because it appeared to be associated more frequently with potentially life-threatening skin reactions than its competitors without showing additional benefits.

Yesterday’s action isn’t likely to end the debate over the drugs’ safety. The discussion has raised broader issues of the FDA’s effectiveness, sparked a movement for better after-market monitoring, and led to congressional hearings.

Yesterday, the FDA said that in addition to requiring new warnings, it has asked manufacturers to review data from previous clinical trials and submit it for FDA analysis. It is not requiring new trials, although Pfizer has agreed to a further study of Celebrex.

Some experts praised the FDA for responding quickly to the recommendations of its advisory committee, which met in late February. Some were surprised that the FDA’s actions seemed more aggressive than the panel had asked for.

“This is an unprecedented action. To get the recommendations out six weeks after the meeting tells me they’ve been working very hard,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a member of the panel. He noted that when the panel made recommendations about Vioxx in 2001, the agency did not act for more than a year.

Some critics were even more harsh. Dr. Sidney Wolfe, director of health research for the advocacy group Public Citizen, said Celebrex is also unsafe and should be withdrawn.

But most experts agreed with the FDA ruling. Of the Cox-2 drugs sold in the United States, it appears to be the safest, they said, noting the safety panel voted 31-1 in favor of it at the February meeting.

Securities lawsuits accuse Pfizer executives of damaging investors by making false and misleading statements about the safety of Celebrex and Bextra.

“It’s an industrywide problem now. It’s not just one company and one drug,” said Daniel Becnel, a Louisiana lawyer whose office is handling many lawsuits filed for people allegedly injured by Bextra, Celebrex or Vioxx. “This is almost as bad as the cigarette industry.”

Becnel said yesterday he planned to ask the federal Judicial Panel on Multidistrict Litigation to consolidate all Bextra and Celebrex lawsuits with a single federal judge.

The company, which at $52.5 billion in revenue last year ranks as the world’s largest drug maker, reported $1.3 billion in global Bextra sales last year, although analysts were projecting much lower sales for this year.

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