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Judgment Day For The FDA, Pfizer


Matthew Herper, 02.07.05, 11:10 AM ET

NEW YORK - Next Wednesday, Feb. 16, painkillers go on trial. The big question: Will the jury be tough enough?

A panel of academic scientists--who have not yet been publicly named--will meet to advise the U.S. Food and Drug Administration on the safety of Cox-2 inhibitors such as Celebrex, Bextra and the withdrawn Vioxx. They will also delve into the safety of older anti-inflammatory medicines such as Aleve and Motrin. The task is so difficult that the FDA has allotted three days for the work, a clear sign of controversy. The last similar meeting was on the safety of breast implants. The three-day discussion will provide a climax to a debate about drug safety that began when Vioxx was pulled from the market for doubling the risk of heart attacks and strokes at high doses over long-term use.

It will be an especially important meeting for Pfizer, which makes Celebrex and Bextra. The meeting is likely to determine the future of those drugs--including whether they have a future at all. The discussion may also have an impact on Pfizer's potential liability.

Even if Celebrex and Bextra don't make it through the meeting, Pfizer could look like a winner to investors as long as it doesn't face a massive liability cloud like the ever-ballooning diet-drug litigation that has weighed on smaller rival Wyeth for years.

But for the meeting to save Pfizer--or to settle the public's fears about Celebrex, Bextra, or Aleve--it needs to be credible. That means that the FDA advisory panel needs to be composed of people who are not merely unbiased, but even a little critical of the drugs. There is a real risk that the FDA could field a weak team and fail to settle the considerable public safety arguments about these drugs.

Here's a worst-case scenario: The data are analyzed by the FDA's standing arthritis advisory committee, composed of well-intentioned doctors who desperately need painkillers to give their patients. They don't worry enough about the side effects, and after the meeting, drug safety experts and cardiologists go back into an uproar. Instead of starting to cool, the drug safety firestorm becomes blinding.

To prevent this from happening, the FDA actually needs to put together the toughest panel it can. Drug safety experts--who understand how even a small increase in risk for a common problem like heart attacks can have massive effects--need to be there. So do cardiologists, who will be as focused on the heart as rheumatologists are on the joints.

Even harder for the agency: The panel must contain people who saw the Vioxx risk early on, and it must also contain researchers who have been critical of the FDA's handling of the matter. It is the presence of such critics that will make the panel's judgments stick in the minds of the skeptical. It's not as if it will be hard to find them. Cox-2 skeptics such as Wayne Ray of Vanderbilt University, Steven Nissen of the Cleveland Clinic and Curt Furberg of Wake Forest University have served honorably on FDA panels in the past, as have drug safety experts such as Vanderbilt's Alastair Wood, who was at one time mentioned as a potential FDA head.

On Friday, briefing documents prepared by FDA staff for the panel were made public on the FDA Web site. So far, they are critical, seeing potential for heart risk in unapproved Cox-2 drugs developed by Novartis and Merck. One of the panel's toughest decisions will be to say what is causing such heart risks. One possibility is that it is due to the fact that many of these drugs raise blood pressure slightly, a theory that might exculpate Celebrex, which seems to have less of an effect on blood pressure.

But another theory, put forth by University of Pennsylvania pharmacologist Garret FitzGerald six years ago, argues that all the Cox-2 drugs make blood more likely to clot, thereby increasing the risk of heart attack and stroke. If this second theory wins the day, Pfizer will be in the position of trying to use its vast database of Celebrex data to prove that Celebrex is a very special case. The entire drug industry will be watching with bated breath.

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