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 May 12, 2005
Health Experts Wary After FDA Panel's Cox-2 Recommendations
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By Amanda Gardner, HealthDay Reporter

SATURDAY, Feb. 19 (HealthDay News) -- Even though a government advisory panel decided to keep Cox-2 inhibitors on the market, health experts who followed the three-day proceedings feel that the fundamental problems with the popular painkillers remain.

"The news is not good news," said Dr. Mark Fendrick, professor of internal medicine at the University of Michigan School of Medicine in Ann Arbor. "Cox-2 users who started to scrutinize this class of drugs after [last] September 30 [when Vioxx was pulled from the market] should under no means flock back to them."

Fendrick, among others, maintained that continued use of this particular class of pain relievers should be judicious.

"Given that the FDA panel has stated the potential for all Cox-2 inhibitors to increase the risk of adverse cardiovascular events, their use should be limited to only those individuals who are at risk for stomach injury, which is the darn thing they were developed for in the first place, and those who are at low risk for cardiac problems," he said.

"There's politics mixed with science mixed with consumer demand," added Dr. Jason Theodosakis, assistant professor at the University of Arizona College of Medicine and author of The Arthritis Cure. "These drugs should be used as the last line of therapy in the treatment of osteoarthritis, and people want to use them as the first line."

Members of the U.S. Food and Drug Administration advisory panel Friday voted to recommend keeping Bextra and Celebrex on the market. The Celebrex vote was an overwhelming 30-1. But the vote on Bextra was much closer, 17-13. And even more narrowly, 17-15, the advisory panel concluded that "current data supports the marketing in the U.S." of Vioxx, the drug that had been under the darkest cloud. Vioxx was voluntarily withdrawn from the market last September by its manufacturer after company trials showed increased heart problems. A majority of the panel members also recommended against direct-to-consumer advertising for the drugs.

And those who voted "yes," following almost three days of intense public testimony from scientists, government representatives, pharmaceutical companies and members of the public, did so with much reservation.

At one point, panel chairman Dr. Alastair Wood reminded the assembled experts that "the committee needs to act in a way that limits hazard to patients, and the public has a right to expect us to do that."

Whether or not this actually happened remains unclear.

The votes themselves were quick and matter-of-fact, in stark contrast to the lengthy and sometimes poignant testimony and the concerns raised by individual panel members.

At one point, Wood himself said, "Vioxx is worse than the others, and I can't see any reason to keep it on the market."

In the end, the conclusions were only as good as the data that was presented. And various participants expressed reservations about the quality of that data.

In their final determinations, the panel members issued numerous caveats about duration and dosage of the drugs. They also recommended that the drugs not be advertised directly to the consumer.

A majority of the panel suggested, in aaddition, that the drugs carry strong black-box warnings on their labels.

And, in the case of Vioxx, many of the "yes" votes came with the phrase "with restrictions."

Dr. Steven Shafer, a professor of anesthesiology at Stanford University, said during the hearings that the use of Vioxx in adults should be only for reasons of compassion.

And even the much-touted black box warning may not achieve much, others noted.

Oftentimes patients don't look at black box warnings, Theodosakis pointed out. "The checks and balances they feel are already taken care of," he said. "The FDA has allowed it to be on the market."

The warnings may, however, have an indirect effect via direct-to-consumer advertising, however. Although these warnings do not mean companies can't advertise, they do mean that it's less attractive to advertise because the ugly warts of the medication have to be aired.

The decision was good news for Pfizer and Merck on the New York Stock exchange. At the end of the trading day Friday,Medrck's price was up by nine percent, Pfizer's by six percent.

"If you have a big laundry list of things in there like you'll look like a mushroom, that's going to turn off people," Theodosakis said.

Theodosakis also said that there is some evidence of cartilage loss with these drugs, something that is rarely mentioned.

"These drugs are used for osteoarthritis," he said. "If it is true, this is like cholesterol-lowering drugs causing more heart attacks or birth control pills raising fertility."

Some doctors said they have not, and will not, turn to Cox-2s first.

"Usually, the Cox-2s are not my first choice in medication for arthritis," said Dr. Khanh Tuong Ho, a rheumatologist with the Ochsner Clinic Foundation in Baton Rouge. "I think there are bigger issues at hand, meaning that our country overall is more and more unhealthy. We smoke. Obesity is rampant and cholesterol and diabetes are rampant. Those issues need to be addressed. Certainly there are bigger risk factors for coronary disease, for having strokes than taking a pill."

More information

The FDA's advisory on limiting use of cox-2s is available at its Web site (www.fda.gov ).

SOURCES: Mark Fendrick, M.D., professor of internal medicine, University of Michigan School of Medicine, and professor of health management and policy, University of Michigan School of Public Health, Ann Arbor; Khanh Tuong Ho, M.D., rheumatologist, Ochsner Clinic Foundation, Baton Rouge, La.; Jason Theodosakis, M.D., assistant professor, University of Arizona College of Medicine, Tucson, and author, The Arthritis Cure; Feb. 16-18, 2005, U.S. Food and Drug Administration hearings

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