Doc Says Military Needs Pain Pills

[David]

AP


An Army physician argued Thursday 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 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 parade 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."

Poulos, who did not give her home town, 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 stroke in patients taking it more than 18 months. Since then, similar reports have raised questions about Celebrex and Bextra, which remain on the market.

Earlier in the day, a Food and Drug Administration 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 said he believes there is also a heart hazard from using Celebrex at high doses, and 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 possible treatment of endometrial and cervical cancer. He complained that trials to test the drugs have been stopped.


Amy Leong, a health care consultant who said she has suffered from arthritis for many years, told the committees that when looking at these drugs, "we have to consider risks and benefits. I am a standing benefit, in front of you." Leong did not give her home town.

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, 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 yet been officially published.

But he included information from those studies in his talk to the advisory committees, which are holding a three-day meeting to assess the safety of this type of drugs. Opening his speech, Graham thanked Acting FDA Director Lester Crawford for allowing him to speak.

Both studies, called Ingenix and Medi-Cal, showed an increased risk of heart attack for users of Vioxx, Graham noted.

"We're talking about small levels of risk that turn out, at the population level, to be enormously important," he said.

He said various studies indicate a range of increased heart attack risk which translates to as few as 400 or as many as 10,800 additional heart attacks per million men aged 65 to 74 at low doses of the drug, and up to 40,000 at higher doses.

Responding to Graham, Merck released a statement calling his estimates speculative.

Determination of what caused any patient's heart attack or stroke can only be made on a case by case basis, the company said.

Graham said, "Patients enrolled in clinical trials are generally healthier than patients in the real world, so models underestimate the actual population impact."

The typical user of this type of painkiller is someone in their 60s, not only men, with other health problems, Graham said. That person already had a one-in-50 risk of heart attack, he said.

As Graham finished, meeting chairman Alistair J.J. Wood of the Vanderbilt University Medical Center asked if he had given the panel the whole picture or was leaving anything out.

"I've been able to present what I thought it was important to present," Graham said.