Thursday, January 17, 2008

Questionable Diagnosis, FDA-Endorsed Treatment

The New York Times ran an interesting article the other day about the use of Lyrica for fibromyalgia. Lyrica was recently approved by the FDA to treat the condition in addition to existing approvals for nerve pain and seizure disorders.

The question on the minds of a lot of medical professionals is whether or not we now have an approved treatment for a disease that may not exist.

Fibromyalgia is kind of weird. My clinical assessment professor, an emergency department doctor specializing in internal medicine, expressed the opinion that fibromyalgia was essentially a BS diagnosis that drug-seeking patients rode as far as they could to get their hands on painkillers to abuse. He seems to have overlooked the fact that most fibromyalgia sufferers say they don't get relief from opiates. In any case, I wouldn't go that far, myself, but as I understand it, the literature on fibromyalgia is iffy.

Most theories suggest that fibromyalgia is a chronic pain disorder characterized by abnormalities in nervous conduction that result in a lower pain threshold in affected patients. However, fibromyalgia has also been used as a "blanket diagnosis" of sorts for patients with non-specific aches and pains, fatigue, or other symptoms that are difficult to pin to a particular disorder.

Fibromyalgia might be a real disease with a clear cause. It might not. I don't have data on hand to form an opinion one way or the other. But I would be willing to bet very large amounts of money that only a fraction of patients "diagnosed" with fibromyalgia are actually ill in any medically identifiable way. Fibromyalgia, like "chronic fatigue syndrome," is essentially a diagnosis that your poor, stressed doctor can make when he's at the end of his rope and ready to give up.

I say this because no MD in his right mind is going to jump to fibromyalgia as a first diagnosis. For example, acute trauma, infection, and diabetes are all going to be considered first as sources of weakness, tiredness, or pain. All of these can be screened for or quickly ruled out by physical exam. Psychogenic illness--in essence, the idea that faulty brain chemistry is responsible for your problem--will probably be proposed at some point. Sufferers of depression, for example, frequently present with fatigue or difficult-to-explain aches and pains. You will try SSRIs, tricyclics, Wellbutrin, SNRIs, lithium, and electroconvulsive therapy before you get tired of treatments that aren't helping.

A dozen lab tests, MRIs, and lumbar punctures later, your poor doctor will conclude that it's not Lupus and be forced to diagnose you with fibromyalgia for lack of any better ideas.

In any case, studies demonstrated that patients diagnosed with fibromyalgia improved more when given Lyrica than when given a placebo. So you could make a case that Lyrica isn't a sham treatment; it's not like using homeopathy for fibro, but I'm sure people have tried it--and felt better afterward.

So it all comes back to placebophilia. What's worse, giving patients with non-specific symptoms of a questionable disease a drug with potentially inconvenient side effects or the same patients treating themselves with fake medicine? Ethically, I'm opposed to "therapeutic placebo usage," but the question is still there. We don't want to give patients medication that they don't really need. Are we doing that here?

Only time and research will tell. Maybe someday we'll get a handle on fibromyalgia. Maybe not.

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