Monday, March 09, 2009

Fibromyalgia and new medications

I learned by accident today that on March 7 there were demonstrations in European capitals to make visible the presence of people with fibromyalgia, a condition that is not yet universally recognized without stigma or skepticism, much as was the case with rheumatoid arthritis 30-40 years ago.

I just read about a new drug that has been approved for the management of fibromyalgia symptoms by the FDA; Savella (milnacipran) like Cymbalta, has an effect on both serotonin and norepinephrin reuptake (two neurotransmittors), and has been shown in clinical trial to provide significant relief for some people with fibromyalgia symptoms.

Like Cymbalta, milnacipran was first approved for treating depression and has already been marketed in Europe for that, but was seen to have beneficial effects in relieving fibro symptoms. Clinical trials now demonstrate that fibro symptom relief (pain, fatigue, quality of life) is significant for a large enough number of patients that the FDA has approved it specifically for treatment for fibromyalgia. Because the two drugs function in more or less the same manner, it's likely that they will not (should not) be taken together, but rather will function as alternatives to each other. It's important to remember that while a number of medications have been helpful for treating fibromyalgia symptoms to some degree, they are notoriously NOT helpful for all, and many have intolerable side effects. I first was prescribed a very low dose of amitryptalin (Elavil) many years ago. It led to some immediate improvement in my sleep disorder and pain levels. The down side was that it gave me hideous dry mouth and left me feeling stupid until noon every day. This clearly was not compatible with functioning at work, so I had to stop taking it. Cymbalta and Savella seem to be "cleaner" drugs in that they do not cause as many debilitating side effects, at least for some.

No drug is a magic bullet for fibromyalgia; both patient anecdotes and newer research show that an approach that combines attention to nutrition, gentle aerobic exercise, stress reduction and cognitive therapy give the best results long term. What medications can do is provide enough relief so that these behavioral strategies can even be started. They can be the difference for some people between living on disability and managing the symptoms well enough to continue to work. It turns out that there seems to be some delay in Savella's availability due to a complaint about the integrity of the trials. Knowing what I know about how clinical trails are conducted and managed in this country, I want to take a wait-and-see approach before getting all excited about this news. Unfortunately, the money the drug companies are spending on promoting and marketing these potentially very lucrative drugs is not just questionable because the drugs may not be as effective as claimed; the backlash to their shady tactics is actually causing some people to question the very existence of fibromyalgia as a syndrome. This pisses me off no end because even as more medical evidence is documenting the physiological abnormalities present with fibromyalgia, there is still a segment of the medical community and the press that talk about it as a "murky" condition, a "garbage can diagnosis" that is suspect precisely because it primarily affects women. Here is an article that breaks down these doubts point by point.

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