The controversy over fibromyalgia

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Two classic questions that confront medical science are how to define disease and how to measure and treat pain. Both questions are brought into sharp relief by the controversy over fibromyalgia.The term was invented to describe a set of symptoms put into non-technical language by the Mayo Clinic's Web site: "You hurt all over, and you frequently feel exhausted. Even after numerous tests, your doctor can't find anything specifically wrong with you. If this sounds familiar, you may have fibromyalgia."A cynic might reply, "If this sounds familiar, you may merely be getting old, but you can be sure drug companies are developing products to help you manage your new 'disease.' "Sure enough, the pharmaceutical giant Pfizer has just gained FDA approval for Lyrica, a drug that appears to lessen the pain associated with fibromyalgia, although why it does so remains unclear, as indeed does the more fundamental question of whether fibromyalgia even exists.Remarkably, Frederick Wolfe, the lead author of the 1990 paper that first defined how to diagnose the newly identified disease, no longer believes it does. In his view, fibromyalgia isn't a disease at all, but rather a physical reaction brought on by stress, depression and economic and social anxiety."Some of us in those days thought that we had actually identified a disease, which this clearly is not," he told The New York Times. Wolfe went on to make a thought-provoking claim. "To make people ill, to give them an illness, was the wrong thing."Wolfe's words can be interpreted in various ways. He could be understood to be saying it's a bad thing to "give" people an illness because it's bad to classify people as diseased who really aren't. Or he could be saying that the very act of classifying people as ill who weren't really ill before the misdiagnosis produces the perverse outcome of causing them to then actually become ill as a result of being told they are.There is some evidence that this is precisely what is happening with fibromyalgia. Nortin Hadler, a professor of medicine at the University of North Carolina, claims as much: "These people live under a cloud," he told the Times. "And the more they seem to be around the medical establishment, the sicker they get."Others disagree vehemently, arguing that fibromyalgia is both real and undertreated, and that, as in the case of depression and Prozac, approval of Lyrica will help doctors recognize that, in the words of Dan Clauw, a professor of medicine at the University of Michigan, such illnesses "are legitimate problems that need treatment."The financial stakes are enormous. Sales for Lyrica reached $1.8 billion in 2007, even though the drug was approved for the treatment of fibromyalgia only in June. And other pharmaceutical companies are already pushing their competing products through the regulatory pipeline.It's difficult to know what to make of all this. On the one hand, pain is notoriously difficult to measure, and the group most likely to be diagnosed with fibromyalgia -- middle-aged women -- is made up of people who have a history of having their complaints dismissed as "whining" by doctors.On the other, the controversy over fibromyalgia has some suspicious parallels with controversies over several other recently discovered "diseases," such as chronic fatigue syndrome, erectile dysfunction and obesity.More than half a century ago, the newly established World Health Organization defined "health" as "a state of complete physical, mental and social well-being." As critics have pointed out, this seems more like a definition of happiness than of health.The irony is that an unrealistically extreme definition of health may be making many of us both less healthy and less happy. It is, however, making a few of us much richer.(Paul F. Campos is a law professor at the University of Colorado and can be reached at Paul.Campos(at)Colorado.edu.)