- The Washington Times - Wednesday, November 24, 2004

Many arthritis sufferers who took the drug Vioxx for severe pain are having trouble finding effective treatment alternatives since the drug was taken off the market by its manufacturer, doctors say.

“A surprising number of people say Vioxx was the only thing that gave them relief,” said Dr. Hayes Wilson, chief of rheumatology at the Piedmont Hospital in Atlanta and a national medical adviser for the Arthritis Foundation.

Dr. David Borenstein, clinical professor of medicine at the George Washington University Medical Center, said: “It’s fair to say some people came to Vioxx through a process that evolved over time,” in which they had found other arthritis medications to be ineffective.

“Now a large group of patients are suffering, because an arthritis drug that was effective and caused no side effects [in most patients] is no longer available,” said Dr. Borenstein, also a rheumatologist at Arthritis and Rheumatism Associates.

Drug manufacturer Merck & Co. withdrew Vioxx on Sept. 30, after ending clinical trials that showed it doubled the risk for heart attacks and strokes when taken daily for more than 18 months.

Vioxx, like two other popular arthritis drugs — Celebrex and Bextra, both made by Pfizer Inc., are in a category of relatively new drugs known as Cox-2 inhibitors. The drugs were developed as alternatives for treatments using nonsteroidal anti-inflammatory drugs, or NSAIDs. Drugs in that class, such as aspirin, sodium naproxen and ibuprofen, were blamed for causing stomach damage, acid reflux and heartburn in some patients.

Catherine O’Connell, a research scientist at the National Institute of Standards and Technologies in Gaithersburg, said she’s been hurting since she stopped taking Vioxx two months ago. She had been taking the drug for two years.

Ms. O’Connell, 53, has an arthritic condition known as nonspecific connective tissue disease.

“Before I went on Vioxx, I had exhausted all other arthritis medications. None had worked. But from the first day on Vioxx, I felt freedom. Vioxx was like a miracle for me. There was no pain, no swelling, no stiffness” in joints.

Today, Ms. O’Connell said she is back to taking nonsteroidal anti-inflammatory drugs and another drug to “prevent stomach damage.”

She said she is angry that Vioxx has been taken off the market.

“My knuckles and knees are swollen, and I live with pain. … I can move pretty well, but I’m still achy and stiff,” she said.

Dr. Kenneth Saag , an associate professor of medicine and a rheumatologist at the University of Alabama at Birmingham, observed: “There are some people who believe Merck [instead] might have asked for a warning on the drug” for those at risk of cardiovascular disease and stroke.

Dr. Wilson said he would have liked Merck to use a warning instead of pulling the drug.

“Merck did the honorable thing. But it’s unfortunate since so many people were benefiting from Vioxx,” he said.

What’s more, Dr. Wilson said: “A disproportionate number of people are experiencing pain today [because Vioxx is gone], compared to the number of people in the trials who had cardiovascular events. If pain is yours, it’s all-consuming.”

He said Merck indicated that the overall risk for serious complications from Vioxx is no more than 1 percent or 2 percent.

“It could be as low as 0.75 percent.”

To replace Vioxx, doctors are prescribing either Celebrex or Bextra, both Cox-2 inhibitors, or NSAIDs in combination with medicines to protect the stomach.

Meanwhile, Ms. O’Connell said she hopes Merck will be compelled by public pressure to start selling Vioxx again.

But neither Dr. Wilson or Merck spokesman Tony Plohoros foresee the return of the drug.

“We made a decision (to withdraw), knowing we could have left the drug in place with a different label,” Mr. Plohoros said. “I don’t anticipate [Merck officials] will be changing their minds.”

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