Drugs nearing approval for mysterious pain condition
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Although not all doctors are convinced that the pain and fatigue condition diagnosed as fibromyalgia is a distinct condition, drug companies are racing to win U.S. regulatory approval to serve this potentially lucrative market.
The debilitating disorder is thought to affect an estimated 2 percent to 4 percent of Americans, mainly women. Diagnosing fibromyalgia is not easy because its cause is unknown and its symptoms, which include depression, can overlap with other conditions.
With no test to confirm fibromyalgia, doctors rely on patient complaints of symptoms and subjective responses to physical exams. As a result, some physicians are wary of viewing it as a distinct ailment.
Still, several large pharmaceutical companies, including Pfizer Inc., Eli Lilly & Co., Forest Laboratories Inc. and Wyeth, hope to seize on a market now dominated by older antidepressants as well as painkillers and other drugs.
The companies each want to be the first to receive clearance by the U.S. Food and Drug Administration for a fibromyalgia treatment, which could occur as soon as 2008.
Doctors can prescribe medicines for fibromyalgia even though the drugs are not cleared specifically for it. However, without FDA approval, companies cannot promote the drugs as treatments for that condition.
An FDA approval could also settle doubts about the disorder’s legitimacy, while paving the way for companies to promote medicines specifically for fibromyalgia. “If the FDA approved a drug for fibromyalgia, that would really give the field validity,” said Richard Harris, investigator at the University of Michigan who recently published a data review of fibromyalgia.
As classified by the American College of Rheumatology in 1990, a fibromyalgia diagnosis involves a patient feeling muscle tenderness in at least 11 of 18 predetermined sites on the body, with the pain spread throughout the body.
Fibromyalgia patients also tend to tire easily, struggle to sleep and have trouble remembering things, a problem referred to as “fibro fog.”
Lynne Matallana, founder and president of the Orange, California-based National Fibromyalgia Association, was an advertising executive and avid skier and bicyclist in the early 1990s until she began experiencing widespread pain and fatigue that left her bedridden.
She said she had seen 37 doctors and received diagnoses of lupus, rheumatoid arthritis and depression before a physician finally identified her condition as fibromyalgia.
“It’s devastating because it is totally life-altering, and many, many, many people find themselves in this situation,” Matallana said. She gradually improved through exercise, meditation and medication.
In their review, Harris and a colleague at the University of Michigan reported evidence of increased neurological responses to pain, indicating that the central nervous system of a fibromyalgia patient processes pain differently.
Traumatic events—such as a car accident—may trigger the condition. Matallana said her fibromyalgia flared up after she underwent surgery for another ailment.
“I think that some physicians do believe that fibromyalgia isn’t a real condition, and our job to spread the word that there are objective findings that these people are in pain,” Harris said.
But Dr. Scott Zashin, a rheumatologist in private practice in Dallas, says fibromyalgia is one of the more common conditions he sees, and usually tries to get fibromyalgia patients to exercise more or get more rest before turning to medication.
“These patients seem to have an increased sensitivity to pain,” Zashin said. “Something in their makeup makes them experience pain differently.”
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