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Painkiller Decision Suggests Shift In FDA's Risk-Benefit Equation

By Marc Kaufman
Washington Post Staff Writer
Monday, April 11, 2005; Page A03

The Food and Drug Administration's dramatic decision Thursday to rein in the use of a wide array of popular painkillers reflects a broader shift at the powerful agency, which has been battered by six months of controversy over its handling of drug safety issues, say observers in academia and industry and public health advocates.

Certain drug risks that used to be acceptable to the agency have become unacceptable, and benefits that usually guaranteed approval of a new drug are no longer a sure bet -- but whether that is good or bad depends on an observer's viewpoint.

The FDA told the maker of Bextra to withdraw it last week due to risks. (Tannen Maury--Bloomberg News)

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"I would say this is a major decision, with the FDA taking a welcome stand for public health," said Curt Furberg of Wake Forest University, a member of the FDA advisory panel that met in February to assess arthritis drugs and an advocate of greater emphasis on drug safety.

"Will they continue like this when the pressure is gone and the next unsafe drug comes along?" he asked. "I'll hold judgment. But for now, I'm surprised and pleased."

Sam Kazman, chief counsel of the Competitive Enterprise Institute, also said the decision was significant -- but not a good one. He said it was surprising that the decision was made by a business-friendly Republican administration closely aligned with the drug industry, but not shocking, given the FDA's history.

"The traditional FDA response to criticism is to revert to deadly overcaution," Kazman said. "When the agency is criticized about a drug, its natural reaction is to withdraw it and become more cautious about approving others in the future. . . . It seems pretty clear now that the pendulum has swung pretty far to the risk-averse side."

The agency's biggest decision last week was to tell Pfizer Inc. to withdraw its arthritis drug Bextra because of concern that it caused increased heart attacks, strokes and a potentially fatal skin disease. The agency also said it would require tougher safety warnings on all anti-inflammatory drugs in the broad class that includes such popular medications as Celebrex, Mobic, Aleve and Motrin.

Bextra is in the same narrower class of drugs as Merck & Co's Vioxx, the blockbuster COX-2 inhibitor pain reliever whose withdrawal from the market in September started the past six months of FDA turmoil. Legislators and others have accused the agency of being too slow in responding to signals that Vioxx could, like Bextra, cause increased rates of heart attacks and strokes.

Although Merck initiated its Vioxx withdrawal, Pfizer withdrew its drug only reluctantly last week and voiced concern that the FDA was changing how it judges the value of medications.

"What worries me a little bit is that because of the public concern over safety, which I'm not saying is misplaced but is sometimes misdirected, they will raise the hurdles on safety much higher than they will on efficacy advantages," Pfizer chief medical officer Joseph Feczko told the Wall Street Journal on Thursday. "The balance may tip too far on risk and away from benefit."

That balance between the risks of a drug or medical device and its benefits is the central question before the FDA.

Drug companies, public health advocates and financial analysts are looking for signals to suggest which way the agency is leaning, reading tea leaves that would show a slight tipping of the balance in favor of emphasizing drug risks or benefits. All drugs have both, and a billion-dollar drug approval (or withdrawal) can turn on which tendency is in ascendance.

In the late 1990s, the agency responded to safety concerns by withdrawing 10 drugs within three years. But until the Vioxx withdrawal, only one other drug had been pulled since the Bush administration began, leading some to conclude that the agency had made a quiet policy change that emphasized "benefit" and sought to manage "risk" less intrusively.

But last week's decision did not require intense scrutiny to understand -- the FDA plainly said that the potential benefits to patients from Bextra carried less weight than the potential risks, especially because a similar drug with fewer risks (Pfizer's Celebrex) was still on the market.

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