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DRUG DOESN'T RESOLVE DEBATE

The FDA's approval of Lyrica to ease the pain of fibromyalgia seemed to validate the illness' reality, but skeptics continue to wonder just what is being treated.

Fibromyalgia is a real disease. Or so says Pfizer in commercials for Lyrica, the first medicine approved to treat the pain condition.

But its very existence is questioned by some doctors - including the one who wrote the 1990 paper that defined fibromyalgia but who has since changed his mind. These doctors say that Lyrica, and other drugs expected to gain FDA approval, will be taken by millions who don't need them.

As diagnosed, fibromyalgia primarily affects middle-age women and is characterized by chronic, widespread pain of unknown origin.

Because fibromyalgia patients typically do not respond to conventional painkillers such as aspirin, drug companies are focusing on medicines, including Lyrica, that affect the brain and the perception of pain.

Advocacy groups and doctors who treat fibromyalgia estimate that perhaps as many as 10-million Americans suffer from the disorder.

Those figures are sharply disputed by doctors who do not consider fibromyalgia a medically recognizable illness. Further, they warn that Lyrica's side effects, which include severe weight gain, dizziness and edema, are very real, even if fibromyalgia is not.

Despite the controversy, the American College of Rheumatology, the Food and Drug Administration and insurers recognize fibromyalgia as a diagnosable disease.

Doctors who specialize in treating fibromyalgia say its sufferers have been stigmatized as chronic complainers.

Lynne Matallana, president of the National Fibromyalgia Association, a patients' advocacy group that receives some of its financing from drug companies, said the new drugs would help people accept fibromyalgia. "The day that the FDA approved a drug and we had a public service announcement, my pain became real to people," Matallana said.

She said she has suffered from fibromyalgia since 1993. At one point, Matallana said, the pain kept her bedridden for two years.

She still has pain, but a mix of drug and nondrug treatments has enabled her to improve her health, she said. She declined to say whether she takes Lyrica.

"I just got to a point where I felt, I have pain, but I'm going to have to figure out how to live with it," she said. "I absolutely still have fibromyalgia."

But doctors who are skeptical of fibromyalgia say that vague complaints of chronic pain do not add up to a disease. No biological tests to diagnose fibromyalgia exist, and the condition cannot be linked to any environmental or biological causes.

Frederick Wolfe, the director of the National Databank for Rheumatic Diseases and the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia, says he has become cynical and discouraged about the diagnosis.

He now considers the condition a psychosomatic response to stress, depression and even economic anxiety.

"Some of us in those days thought that we had actually identified a disease, which this clearly is not," Wolfe said. "To make people ill - to give them an illness - was the wrong thing."

In general, fibromyalgia patients complain not just of chronic pain but of many other symptoms, Wolfe said. A survey of 2,500 fibromyalgia patients published in 2007 by the National Fibromyalgia Association indicated that 63 percent reported suffering from back pain, 40 percent from chronic fatigue syndrome, and 30 percent from ringing in the ears, among other conditions.

Most people "manage to get through life with some vicissitudes, but we adapt," said George Ehrlich, a rheumatologist and an adjunct professor at the University of Pennsylvania. "People with fibromyalgia do not adapt."

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