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 May 12, 2005
Cox-2 Drugs Take Center Stage at Government Hearings
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By Amanda Gardner, HealthDay Reporter

WEDNESDAY, Feb. 16 (HealthDay News) -- Drug makers and health experts laid out the risks and benefits of cox-2 painkillers Wednesday, during the first of three days of government hearings on the future of these troubled drugs.

In recent months, Vioxx, Celebrex and Bextra, all in the class of medications known as cox-2 inhibitors, have been implicated in clinical studies for causing cardiovascular problems. Only Vioxx has been removed from pharmacy shelves.

The members of two U.S. Food and Drug Administration (FDA) advisory committees, meeting in Washington, D.C., could recommend regulators yank the drugs from the market or simply add new warnings to their labels once the three days of testimony ends.

"The agency will act rapidly in the next several weeks," said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, as the hearings got underway. The FDA is not bound to follow the recommendations of its advisory panels, but it usually does.

The future of cox-2 inhibitors is an issue that has attracted an "unprecedented level of international attention," Galson acknowledged.

"Millions of people around the world are taking the drugs. We must keep the interests of patients front and center," he added. "We are anxious to hear all points of view."

Pointedly, he stated that all FDA staff were free to make any presentation "without fear of retaliation." This appeared to be a reference to the tribulations of David Graham, the FDA whistleblower who has been a longstanding critic of Vioxx. He told HealthDay last month that he had been threatened with "serious consequences" if he published a paper assessing casualties from Vioxx. The paper was eventually published in The Lancet, and Graham kept his job. He is scheduled to speak at the hearings.

The central question being debated is how to weigh the relative risks and benefits of cox-2 inhibitors, drugs that were initially developed to reduce gastrointestinal complications associated with traditional nonsteroidal anti-inflammatory drugs (NSAIDs).

"There is a risk-benefit balance," Galson said. "We cannot lose sight of the reduced morbidity, pain and suffering achieved by the products under discussion, and the real impact on people that changes in regulatory status may entail."

Dr. Alistair Wood, chairman of the joint panel -- one on arthritis and the other on drug safety and risk management -- referred Wednesday to the assembled experts as a "cast of thousands."

Their mandate, Galson added, is the "miraculous job of crystal clarity."

The first day of the hearings made that seem a daunting task.

Dr. Lourdes Villalba, medical officer with the FDA's Center for Drug Evaluation and Research, reviewed for the panel all the available data on cox-2s and then stressed the challenges the agency had faced when reviewing the drugs for approval.

Villalba said that all the data and signals from them had not always been clear, and that the agency could only review what was given to them because "we don't have a legal mandate to ask that certain studies be done."

"How puzzled we were with all the data as it came in," she added.

"NSAIDs are clearly associated with morbidity, mortality and cost worldwide," testified Dr. Byron Cryer of the University of Texas Southwestern Medical School in Dallas. "There is a need for increased gastrointestinal safety." Cryer revealed that he has a relationship with the pharmaceutical sponsors at the hearings, but declared he was not being paid for his involvement Wednesday.

Taking aspirin can nullify the protective effects of cox-2, he said. Aspirin is at issue because many people are prescribed the drug to mitigate the possibility of various cardiovascular problems.

There are, however, alternatives, he said, including adding a protective agent while taking a cox-2 or switching to an older NSAID. "There are other strategies available to reduce the GI effect," he said.

Dr. Garret FitzGerald, head of the pharmacology department at the University of Pennsylvania School of Medicine, testified to the heightened cardiovascular risks of cox-2 drugs, and stressed the need to distinguish between individual effects and population effects.

He also cautioned that any similar new drugs should face tougher testing to get approval.

Dr. Ned Braunstein, director of Merck Research Laboratories, pointed to an apparent class effect, as opposed to an effect specific to Vioxx, which Merck produced, for the heightened cardiovascular risks found in studies.

And Dr. Joseph M. Feczko, vice president of Pfizer Inc., the maker of Celebrex, said reports of increased heart problems needed to be put in context because cox-2s offer an important benefit.

The FDA, long under the gun from its critics on the issue of drug safety, moved on Tuesday to establish an independent Drug Safety Oversight Board, to better monitor approved prescription drugs and resolve disputes over drug safety.

At the same time, the agency received a citizen's petition from a group of doctors and families asking it to strengthen label warnings on products containing the over-the-counter painkiller ibuprofen, the main ingredient in Advil. The group claims ibuprofen can cause rare but life-threatening skin reactions.

More information

Read more about the hearings at the FDA (www.fdaadvisorycommittee.com).

SOURCES: Feb. 16, 2005, U.S. Food and Drug Administration (FDA) advisory panel hearings with Steven Galson, M.D. acting director, Center for Drug Evaluation and Research, FDA; Alistair Wood, M.D., chairman, joint panel; Byron Cryer, M.D., University of Texas Southwestern Medical School, Dallas; Garret FitzGerald, M.D., chairman, department of pharmacology, University of Pennsylvania School of Medicine; Ned Braunstein, M.D., senior director, Merck Research Laboratories; Joseph M. Feczko, M.D., vice presient, Pfizer Inc.; Lourdes Villalba, M.D., medical officer, Center for Drug Evaluation and Research, FDA

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