Which comes first, the drug or the disease?

Today's NYT reports that Pfizer has begun direct-to-consumer advertising for their drug, Lyrica. It's not a new medication, having been approved for some time for the treatment of nerve pain (as experienced by some people with diabetes or shingles).

What's news is that the advertisements are for a new indication: fibromyalgia. Fibromyalgia is a condition for which no definitive diagnosis exists, and its cause and mechanisms are not understood by medical science. People who have it, most of whom are middle-aged women, complain of chronic, widespread pain and tenderness, as well as extreme exhaustion.

But whether fibromyalgia really exists is a contentious issue. Those who suffer from fibromyalgia insist that it is a real, and debilitating, problem. Numerous advocacy and support groups exist online and offer individuals the chance to compare notes with fellow sufferers. Skeptics charge that it is essentially a psychosomatic complaint--i.e., "it's all in their heads."

A few features of this story are worth comment (in my view, anyway). One is that we should be aware of the long-standing tendency of the medical establishment to minimize symptoms it can't explain by saying they are psychological--i.e., not "really real," and outside the purview of "real medicine." Many of these conditions (like irritable bowel syndrome, multiple chemical sensitivity, and chronic fatigue syndrome) tend to affect middle-aged women more than other groups. Coincidence? Maybe. But maybe not. Either way, it's worth thinking about whether these issues are being too easily dismissed.

Another is the influence that pharmaceutical companies have in our society over what "counts as" illness or disease. On one view, if there's a drug for it, then it's a disease. Thus shy people may actually suffer from social anxiety disorder and require Paxil; short people might have idiopathic short stature and need human growth hormone; and the list goes on. Is this trend toward medicalization a good thing? What does it mean, in practical terms, when we move a condition from the "some people are like this" (normal human variation) column into the "people who are like this have a disease" (illness) column? Who benefits from those effects?

One more thing to consider: the challenge of pain. As a subjectively experienced phenomenon, it's tough for medicine to deal with. Most medical problems are objectively measurable in one way or another, but pain is particularly tough to pin down. People have different pain thresholds, experiencing more or less pain in response to the same stimulus. It's been the standard view for a while now that women experience pain differently from men, though whether these differences are biological or social (or both) is still unclear. And the data source for pain? We mainly have to rely on self-report--and as a general rule, science doesn't like self-reported data. But the flip side could mean denying needed relief to people who are suffering ... and who wants to do that?

Jumping Rope with Abe Lincoln and a Groundhog

We've all seen the commercials and print ads for Rozerem, and you must admit how clever you think they are. Also, we've probably all encountered difficulty with sleeping, sometimes days-sometimes a few weeks at a time. I would be hard pressed to ever consider taking any sort of sleeping aid, prescription or OTC (with the exception of an occasional dose of Nyquil), but I have definetely experienced those bouts of poor sleeping. As our lives become increasingly busy and hectic, I think perhaps cutting back on caffeine and engaging in more physical activity (two things which are beneficial in more ways than just as sleep aids) are more healthy and desirable alternatives to help get to sleep at night.

But I did appreciate how some may feel inclined to take a sleep aid. Until now. The New Times published an article this week reporting that sleeping pills are really just mildly effective, that the newer drugs tested cut the time it took to fall asleep by only 12.8 minutes, and increased total sleep time by only 11.4 minutes. Is taking a prescription and ingesting more chemicals worth that? I don't think so.

And that is not all. The same article also reports that older prescription sleep aids such as Halcion and Restoril accounted for signicantly better results than the newer drugs. Yet another case of unneccessary "Me-too" drugs being overly marketed and preying on people who may be in a vulnerable state, in this case, sleep-deprived. As I mentioned above, most people find the Rozerem ads charming; they may march into the doctor's office and specifically request Rozerem. Note the Times article reports Americans spent $4.5 billion dollars on sleep aids last year.

Basically, sleeping pills don't really work, or rather, just aren't as effective as the American consumer is led to believe, according to the analysis. Pharmaceutical companies are latching onto our weaknesses and trying to tell us once again that it can all be solved in a little pill. And if Americans are spending that much money every year on sleeping pills, then it appears physicians are also throwing in the proverbial tower by prescribing these pills. Too bad these physicians can't be like the doctor in Fight Club who tells Tyler Durdan to "get more exercise and chew some valerium root, " instead of prescribing sleeping pills.