The controversy over fibromyalgia

   It has been decades since we have observed a medical controversy of the magnitude we see currently with fibromyalgia.  Knowledgeable and compassionate experts in orthopaedics and pain management seem to fall resolutely at both ends of the spectrum with regard to the propriety of this diagnosis.

  Fibromyalgia was defined in a 1990 medical paper as a condition, primarily affecting middle-aged women, characterized by chronic, widespread pain of unknown origin.  It frequently occurs concomitantly with other conditions such as depression and irritable bowel syndrome.  The lead author of that paper which "recognized" and defined fibromyalgia, Dr. Frederick Wolfe, director of the national databank for Rheumatic Diseases, has since changed his mind and concluded that appending this diagnosis on the pertinent symptoms is actually counter-productive for the patient.  Dr. Wolfe now believes that rather than a separate disease process, fibromyalgia instead represents a physical response to stress, depression and anxiety.  Whether a separate medical condition, or a negative reaction to other conditions, advocacy groups argue that between 2 and 4 percent of Americans demonstrate the symptoms.

The large drug companies have entered into the fray, now, however, with drugs approved for the treatment of this controversial disease.  Pfizer, for example, secured approval to sell Lyrica as a treatment for fibromyalgia, despite very very modest evidence of effectiveness in treatment.   Eli Lilly and Forest Laboratories have also sought approval from the FDA for drugs intended to treat fibromyalgia.

  Dr. Dan Clauw of the University of Michigan, who has consulted with Pfizer, thinks that the recognition of fibromyalgia as a separate disease construct will help to achieve better understanding of the condition and end the longstanding undertreatment of the disease symptoms.

  There is no test to diagnose fibromyalgia.  A survey performed by an advocacy association documented that 63 percent of patients suffered from back pain, 40 percent suffered from chronic fatigue syndrome, and 30 percent from tinnitus or ringing in the ears.  Many other symptoms, affecting fewer patients, were also identified.

  In clinical trials, Lyrica did not perform well and it caused significant side-effects.  Patients suffering from fibromyalgia, diabetic neuropathy or shingles described a 2-point drop on a ten-point pain scale, compared with a one-point drop for patients receiving a placebo.  Since many patients suffered weight gain (9 percent experienced a 7 percent weight gain in 12 weeks--a gain that appears to continue after the 12 weeks), edema, dizziness and sleepiness, FDA reviewers did not recommend approval of the drug.  They were especially concerned about weight gain with fibromyalgia, since in the 2007 survey, the average patient diagnosed with fibromyalgia stood 5 foot 4 and weighted 180 pounds. 

   Nevertheless, senior FDA officials in the Bush Administration overruled the reviewers and Lyrica was approved.  The company then ramped up its advertising, spending 79 million dollars in the next 19 months to hype the drug.  According to Dr. Wolfe, even the modest improvement in pain levels documented for Lyrica during the first 12 weeks are not sustained.   The drugs nearing approval by the other manufacturers have taken a different approach to the fibromyalgia problem:  they were developed as anti-depressants, originally, designed to increase levels of serotonin and norepinephrine.  The Lilly drug, Cymbalta, has demonstrated treatment efficacy similar to that documented with Lyrica.