It was just over ten years ago that a respected British medical journal stated that fibromyalgia was considered at the “extreme end of the spectrum of poly-symptomatic distress,” and overlapped with chronic fatigue syndrome, which was considered another “distress” syndrome. The authors expressed their disbelief and opinion of fibromyalgia syndrome by equating it with “virtually every other medically unexplained syndrome, including tension headache, chemical sensitivity, irritable bowel syndrome, atypical chest pain, gynecological syndromes, and temporomandibular disorders.” Certainly not a very flattering association.
In 2002, the British Medical Journal, which is the equivalent here in the U.S. of the Journal of the American Medical Association still characterized fibromyalgia as a “non-disease.” In 2001, 400 British general practitioners were questioned about fibromyalgia by being described patients with “medically unexplained symptoms,” which was the way the surveyors asked about conditions that anyone with fibromyalgia would immediately say, “Those aren’t unexplained, those mean you have fibromyalgia!” Their response – 64% of those doctors felt patients had psychiatric illnesses and 84% thought they had personality problems. Although this was eight and nine years ago, something to bear in mind is that these physicians are now approaching the peak of their careers and were responsible for training and educating many of the doctors who are now in practice.
As of 2011, things have softened a bit in England as well as in Europe. It is estimated that fibromyalgia syndrome affects about 14 million people in England and Europe, or about 3 million more than in the United States. The symptoms are just the same – chronic pain and stiffness, fatigue, sleep disturbances, an inability to think clearly, and the other conditions that patients with fibromyalgia know so well. As in the U.S. the level of disability caused by fibromyalgia is exceptionally high costing their societies approximately $110 billion dollars.
A multidisciplinary task force was formed in 2007 representing 11 European countries to generate recommendations for the treatment of fibromyalgia. After a review of almost 150 studies the 20 physicians came up with 9 recommendations. What was their most important recommendation?
“A full understanding of fibromyalgia requires comprehensive assessment of pain, function and psychosocial context.”
They stated this was based on an expert opinion. Pain was given the first priority. They went on to describe treatments such as heated pool treatments, exercise, rehabilitation approaches, and psychological support. The pain medicine tramadol, or Ultracet, was recommended, but not opioid medications. Both the older and newer medications were also recommended such as amitriptyline (Elavil), duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica).
In 2007, the U.S. FDA approved pregabalin as the first drug indicated for the management of fibromyalgia. Within 18 months, the agency also approved duloxetine and milnacipran. Each of these drugs were already being used in Europe for other medical conditions. You would think that given all of this information it would be a sure bet that the equivalent of the FDA in Europe, an agency called EMEA, the European Medicines Agency, would follow suit and likewise approve these medications for fibromyalgia but unfortunately you would be wrong – EMEA did not. EMEA rejected every one of these drugs – pregabalin, duloxetine and milnacipran, when each was separately presented to be used for fibromyalgia. The issues were not safety, that was well demonstrated. There seemed to have been two other reasons.
One reason has already mentioned – fibromyalgia is still not fully accepted as a disease. It was not until 2008, after considerable lobbying from the European Network of Fibromyalgia Association, that the European Parliament issued a declaration requesting the European Union, specifically an organization called the European Commission, recognize fibromyalgia as a disease. However, so far, they still haven’t done what they have been asked.
Another factor is money. The European countries watch their health care dollars more closely as most of their health care systems are funded by their governments. In the U.S., sales of fibromyalgia drugs will exceed $2 billion dollars by 2015. The European health care administrators consider this expense something their health care systems are not able to handle, even though the long term savings to society would far exceed this expenditure. The bottom line – these drugs are an expensive addition to treat a poorly defined medical condition which is not yet perceived as a major health problem. So, if you have FMS and you live in England or Europe, you would not be getting any of these medications.
Be thankful you live in the United States.
