Fibromyalgia: Does it Exist?
Can 11 million Google hits on "fibromyalgia" be believed? Pfizer, thanks to FDA approval last year is now advertising Lyrica©, an anti-epileptic drug also used for nerve damage, as the new miracle treatment for what they call (with a wink?), a "real disease," fibromyalgia. In the first nine months of 2007, Pfizer spent over $46 million in advertising, and prescriptions for the drug are approaching 1 million a month. But is fibromyalgia, whose very existence is now questioned by a large number of physicians, a disease, a collection of symptoms (a syndrome), or simply another name for plain old "aches and pains"? The doctor who wrote the now classic 1990 paper defined it as widespread pain, mostly of middle-aged women, of unknown origin, without definite physical or laboratory findings. He now claims he was wrong, that the disease does not exist. He accurately predicted that Lyrica and the other drugs taken to relieve sufferers will be consumed by millions of people who do not need them. Yet advocacy groups, many partly supported by drug companies, and tens of thousands of physicians who treat fibromyalgia estimate that 6-12 million Americans suffer from the disorder.
Dr. Nortin Hadler, a rheumatologist and professor of medicine at the University of North Carlolina who has written extensively on fibromyalgia, stated, "These people live under a cloud. And the more they seem to be around the medical establishment, the sicker they get." Dr. Frederick Wolfe, the lead author of the original paper referred to above, and Director of the National Databank for Rheumatic Diseases, referred to by the New York Times (Jan.14, 2008), says he has become cynical and discouraged about the diagnosis, and now considers the condition a physical response to stress, depression, and economic and social anxiety.
Most interesting, Lyrica, its mode of action on the brain and nervous system unclear, was originally developed as an anti-depressant, since it raises levels of serotonin, like the SSRI drug class to which Prozac©, Paxil©, Zoloft©, Effexor©, Cymbalta©, etc. belong. Moreover, Lyrica has been used off-label (unapproved, but legal use) by many physicians as an anti-depressant. Yet the drug is not without problems of toxicity, such as widespread swelling or edema, dizziness, blurring of vision, acute allergic reactions, and especially common, severe weight gain.
The argument over the existence of fibromyalgia brings up many perplexing questions, I have previous written about giving names to complaints or collections of complaints. (Newsletters 17 and 18) on the medicalization of America, "somatization," and "disease mongering." As I wrote, a diagnosis, disorder, or disease is officially defined by an ICD-9 code, the International Classification of Disease used for decades throughout the world. "Yet no coding scheme for medical diagnosis or treatment can be all-inclusive or unambiguous." Words like "anemia" and "intersex" challenge any classification. Yet if we are not careful we can create a disease, give it an existential reality, simply by giving a condition or disorder a name.
But wait, Fibromyalgia does have a code: according to ICD-9, it is 729.1, including "Other disorders of soft tissues, myalgia and myositis, unspecified." Does that make it real? In one sense, certainly, since it allows doctors and hospitals to bill for it. Are there other (questionable?) conditions whose existence is validated by an ICD-9 or ICD-10 code? Of course. Sometimes this can present problems, especially when a syndrome is fictitious or invented. Am I simply begging the question? A slippery place to end up.
Reduced to the ultimate choice for the medical establishment, if not the public: Do we ignore millions of patients by depriving them of their disease and possible treatment, or do we save them from exposure to another potentially risky drug and billions of dollars in needless medical attention?
Martin F. Sturman, MD, FACP
Copyright 2008, Mathemedics, Inc.
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