Thursday, February 17, 2005


An Army physician argued yesterday that some popular pain relievers “are essential to the global war on terrorism” and should be kept on the market despite their potentially dangerous side effects. Without them, he said, the military cannot keep as many soldiers functioning on the battlefield.

Dr. Christopher Grubb told a joint meeting of Food and Drug Administration advisory committees studying the risks of a group of drugs known as Cox-2 inhibitors ” including Vioxx, Celebrex and Bextra ” that the military carries Cox-2 drugs into battle. They are needed, he said, because of concerns about excess bleeding that can be caused by more traditional pain relievers like aspirin.

Others in the string of witnesses cited the drugs’ painkilling value as they pleaded for them to be left on the market.

“Vioxx gave me my life back,” Dimitra Poulos told the panels. “I have 40 Vioxx left, I have 40 days left before my life will be altered.”

Miss Poulos, who did not give her hometown, said she is ready to sign a risk waiver to get the drug and asked for that opportunity.

Merck & Co. pulled Vioxx from the market Sept. 30 after a long-term study showed an increase in heart problems and strokes in patients taking it more than 18 months. Since then, similar reports have raised questions about Pfizer Inc.’s Celebrex and Bextra, which remain on the market.

In London yesterday, the European Medicines Agency issued a new warning that people who have had heart disease or a stroke should not take any Cox-2 arthritis painkillers, but stopped short of calling for the drugs to be taken off the market.

The agency’s scientific experts said the Cox-2 medicines, used to alleviate the symptoms of rheumatoid arthritis, carry “an increased risk of cardiovascular adverse events.”

Earlier in the day, an FDA whistleblower, who had complained the agency was trying to muzzle him, was allowed to go before the panel to warn of dangers with painkillers.

Dr. David Graham, a medical officer at the FDA’s Center for Drug Evaluation and Research, said Vioxx posed a hazard of hundreds to thousands of additional heart attacks. He believes there is also a heart hazard from using Celebrex at high doses, and that the problem may cover the whole class of drugs, which includes Bextra.

Other speakers at the session included:

• Judith Fogel of Ithaca, N.Y., who said, “I feel like Celebrex was created for me.” After suffering for years with arthritis, she started on Celebrex three years ago and now, she said, “On most days I feel better than I did 30 years ago.”

• Dr. Mark Einstein, a Bronx, N.Y., specialist in gynecological cancer, said the Cox-2 drugs show promise for potential treatment of endometrial and cervical cancer. He complained that trials to test the drugs have been stopped.

On the other hand, Diana Zuckerman of the National Research Center for Women and Families, said, “When Americans take medicine, they don’t expect to have to read the studies that have been done … they don’t expect to have to weigh the risks and benefits. They expect medications approved by FDA to be safe and effective.”

Previously, Dr. Graham had complained that the FDA ordered him not to discuss a pair of studies that cast doubts on the safety of Vioxx because the reports were preliminary and had not been officially published.

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