A drug for fibromyalgia?

Yesterday’s New York Times runs an article that paints a very complicated picture of Lyrica, the first drug approved by the U.S. Food and Drug Administration to treat fibromyalgia. The drug is already available in the United States, Canada, and other countries as a prescription antidepressant, but it is not being approved for this other purpose. Two other large pharmaceutical companies are seeking government approval for their own fibromyalgia-treating drugs. I see three main troubling things about this development:

1. Fibromyalgia may not really exist. Its symptoms, which seem to vary from person to person but often include chronic pain, fatigue, and ringing in the ears, may in fact be attributable to various factors such as stress, age, depression, and others. There are no standard diagnoses and no established causes, it is not communicable or linkable to any external factors, and, as the article reports, ‘doctors who are skeptical of fibromyalgia say vague complaints of chronic pain do not add up to a disease.’ The article further reports that some skeptical doctors ’say that diagnosing the condition actually worsens suffering by causing patients to obsess over aches that other people simply tolerate. Further, they warn that Lyrica’s side effects, which include severe weight gain, dizziness and edema, are very real, even if fibromyalgia is not.’
2. The drug in question, which goes by the generic name pregabalin, is, as previously mentioned, already marketed as an antidepressant. The problem is nobody really seems to know how it specifically works. It apparently has some effect on the central nervous system that may desensitize it to pain on some level, but using this drug to essentially blot out a person’s ability to feel some kind of nebulous pain strikes me as a rather cavalier way to approach medicine. Now, as a matter of course, painkillers and antidepressants alike act upon the nervous system, but when an antidepressant appears to have an effect on chronic pain, might it not be possible that it’s actually treating an underlying depression?
3. The marketing itself is scary. What’s being marketed is not so much the drug as the disease: the pharmaceutical industry is hoping that by saturating the market with the message that fibromyalgia is real, they’ll get people to buy their drug.

It is the third of these that really bothers me. By legitimizing the disease, or at least appearing to by putting out lots of advertising, they’re going to make a huge profit selling drugs to millions of people who may not really need them. Again, the article paints a fairly bleak picture: ‘In November, Pfizer began a television ad campaign for Lyrica that features a middle-aged woman who appears to be reading from her diary. “Today I struggled with my fibromyalgia; I had pain all over,” she says, before turning to the camera and adding, “Fibromyalgia is a real, widespread pain condition.”‘ And at the end, after speculating that this drug will probably be prescribed in conjunction with others—thus enabling multiple drugs to be sold to the same patient for the same ‘problem’—the article gives us the kicker:

But physicians who are opposed to the fibromyalgia diagnosis say the new drugs will probably do little for patients. Over time, fibromyalgia patients tend to cycle among many different painkillers, sleep medicines and antidepressants, using each for a while until its benefit fades, Dr. Wolfe said.

“The fundamental problem is that the improvement that you see, which is not really great in clinical trials, is not maintained,” Dr. Wolfe said.

Still, Dr. Wolfe expects the drugs will be widely used. The companies, he said, are “going to make a fortune.”

And that’s really the problem, isn’t it? It reminds me of the episode of Dilbert in which Dogbert invents a ‘disease’ called ‘chronic cubicle syndrome’, publishing a book full of made-up information and anecdotal evidence. The book’s tagline is ‘If you think you’ve got it, you’ve got it’. Dogbert proceeds to flood the airwaves with this message, but Dilbert remains skeptical. He convinces his company to engage in some research to determine whether ‘chronic cubicle syndrome’ actually exists, but runs up against the common reaction: ‘Of course it’s real, I saw it on TV!’ (You can find this episode in three parts on YouTube beginning here, at least until some overzealous authority removes the files.)

Whether or not fibromyalgia actually exists, the fact remains that once you’ve created the perception of a problem, the door is open for you to sell people things to alleviate that problem.