Patients accept painkiller risk

Arthritis sufferers from across the United States have pleaded with American advisers to keep their pain medicines, saying they are willing to risk heart problems for joint pain relief.

Judy Fogel, an arthritis patient who has been taking Pfizer's Celebrex for three years, said she had tried 10 other drugs to fight the swelling pain in her arms and hands.

"I feel like Celebrex was made for me," she told a panel of experts. "Most days I feel better than I did 30 years ago. "

More than 40 people, including physicians and patient advocates, spoke before the panel called by the Food and Drug Administration (FDA) after Merck & Co withdrew its popular arthritis drug Vioxx in September when a study showed an increased risk of heart attack and stroke.

Since then, other studies have shown similar heart risks in Celebrex and Bextra.

The medicines are part of a class of drugs called Cox-2 inhibitors. They are thought to be less corrosive on the stomach than other non-steroidal anti-inflammatory drugs, such as aspirin, that can cause ulcers and dangerous bleeding.

The FDA is asking two outside advisory committees if Cox-2 drugs offer enough benefits to stay on the market, if they need stronger warnings and what further research is required.

Several arthritis sufferers said they were willing to sign a waiver or otherwise assume responsibility for any cardiovascular problems.

Amy Leong, who said she had tried more than 35 arthritis drugs, said patients could weigh the benefits themselves.

"I'm a standing benefit in front of you. It is my choice to work with my physician to determine what is a high risk for me," she told the panel.

Several patients taking Vioxx lamented that the pill was pulled from the market too soon.

Gloria Barthelmes said she had suffered from severe arthritis but found relief with Vioxx.

"When they took the Vioxx away, I panicked," she said.

Her rheumatologist then prescribed Bextra.

"I hope you people can help me and not take these medications away," said Barthelmes.

American Chronic Pain Association board member Nicole Kelly said other patients had told the group that they had stopped taking their pain medicines for fear of a heart attack or stroke.

But most wanted immediate relief, she said.

They would rather live 10 years with manageable pain than 20 years without relief.

* …and another risky one

GAITHERSBURG - A painkiller called Mobic has shown a higher risk of heart attacks than found with Merck & Co's withdrawn Vioxx, says a veteran US Food and Drug Administration scientist.

The drug, made by Boehringer Ingelheim Pharmaceuticals, showed the effect in a yet-to-be published study, said David Graham, of the FDA's Office of Drug Safety.

Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx, and any possible heart attack risk is important as more patients take the drug.

"You now have a shift in the marketplace," Graham told an FDA panel of outside experts meeting to discuss whether pain drugs such as Pfizer's Celebrex and Bextra should remain on the market.

Graham, along with other scientists outside the FDA, analysed data culled from California's Medicaid programme of more than 15,000 heart-attack patients, making it the largest study to date on such risks.

They found the statistical risk of heart attack was 1.37 for Mobic, 1.32 with Vioxx and 1.09 with Celebrex.

The FDA approved Mobic in 2000 to treat osteo-arthritis, and last year for rheumatoid arthritis.

- REUTERS