WASHINGTON — Vioxx could go back on sale if the government finds that heart and stroke problems linked to arthritis drug are not unique to the painkiller and that the medication's benefits outweigh the risks, a company executive suggested Thursday.
"When we withdrew the drug it was based on the information available at the time," said Peter S. Kim, president of Merck Research Laboratories.
Vioxx was pulled from the market on Sept. 30. Since then new information has indicated that those medical problems may be associated with an entire class of painkillers known as Cox-2 inhibitors, Kim told a Food and Drug Advisory panel that is assessing the safety of those drugs, which include Vioxx, Celebrex and Bextra.
If the committee and the agency conclude that the benefits of this class of drugs outweigh the risks for some, "then we would have to consider the implications of these new data" for Vioxx, Kim said.
Asked if that meant the company would consider returning the drug to the market, Kim said, "There are unique benefits to Vioxx. The science has progressed and we need to take that science into consideration."
He said that when Vioxx was withdrawn, Merck said it felt it could be possible to market the drug with labeling that included increased safety trial information.
Earlier Thursday, an Army physician argued 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 the FDA advisory committees 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 such as aspirin.
Other witnesses cited the drugs' painkilling value.
"Vioxx gave me my life back," Dimitra Poulos said. "I have 40 Vioxx left, I have 40 days left before my life will be altered."
Poulos, who did not give her home town, said she is ready to sign a risk waiver to get the drug. She asked for that opportunity.
Merck & Co. withdrew Vioxx after a long-term study showed an increase in heart problems and stroke 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.
Also Thursday, an FDA whistleblower who had complained the agency was trying to muzzle him addressed the panel about the painkillers' dangers.
Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research, said Vioxx could cause hundreds to thousands of additional heart attacks. He said he believes there is a heart hazard from using Celebrex at high doses, and the problem may cover the whole class of drugs.
Other speakers at the session included:
—Judith Fogel of Ithaca, N.Y., a longtime arthritis sufferer who started taking Celebrex three years ago. "On most days I feel better than I did 30 years ago," she said.
—Dr. Mark Einstein of New York, a specialist in gynecological cancer who said the Cox-2 drugs show promise for possible treatment of endometrial and cervical cancer. He complained that trials to test the drugs have been stopped.
—Diana Zuckerman of the National Research Center for Women and Families, who said Americans "don't expect to have to weigh the risks and benefits. They expect medications approved by FDA to be safe and effective."
Graham discussed two studies — both preliminary and not officially published — that cast doubts on the safety of Vioxx because they showed an increased risk of heart attack for the drug's users.
"We're talking about small levels of risk that turn out, at the population level, to be enormously important," Graham said.
He said various studies indicate a range of increased heart attack risk that translates to as few as 400 or as many as 10,800 additional heart attacks per million men age 65 to 74 at low doses of the drug, and up to 40,000 at higher doses.
Merck said in a statement that Graham's estimates were speculative and that determining the cause of a patient's heart attack or stroke must be done case by case.
Also Thursday, the European Medicines Agency said it would require stronger warnings about the cardiovascular risks posed by Cox-2 inhibitors.