Gosh, I Didn't See That Elephant In The Room

In the December issue of Pharmacotherapy (1), a group of researchers pointed out the obvious, which was that "widely prescribed medications" are "most urgently in need of additional study to determine how effective and safe they are for their off-label uses." Naturally, 9 of those 14 drugs are "antidepressants and antipsychotics," which "have high levels of off-label use without good scientific backing."

Ranking number 1 in terms of off-label use is our good friend quetiapine (Seroquel), which is used to sooth all that ails you. To be honest, I thought olanzapine (Zyprexa) would have at least broke the top 5, but since olanzapine is about as healthy as being exposed to asbestos (2, 3), perhaps landing at unlucky number 13 is appropriate.

Explaining why quetiapine was number 1, one researcher said, "this drug lead all others in its high rate of off-label uses with limited evidence (76 percent of all uses of the drug), it also had features that raised additional concerns, including its high cost at $207 per prescription, heavy marketing and the presence of a 'black-box' warning from the FDA." Personally, I don't think black-box warnings mean anything anymore. They're all the rage now. They're happenin'. A drug truly hasn't made it until it has its own black-box warning. It's the pharmacological equivalent of the iphone.

In the highly ambiguous field of mental health, there are many fads (e.g., Premenstrual Dysphoric Disorder, brought to you by Prozac; Social Anxiety Disorder, brought to you by Paxil). So what's all the rage these days? Bipolar disorder of course, "the most common off-label use for six of the 14 drugs on the list was for bipolar disorder." The principal cause of these fads is another elephant in the room, "when the volume of off-label use of any drug reaches the magnitude that we're documenting, it suggests a role of the pharmaceutical industry in facilitating these types of uses." (Plot twist).

"Although companies are largely prohibited from marketing off-label uses to physicians and consumers, they make use of exceptions or may market drugs illegally...several recent lawsuits have identified systematic plans on the part of some companies to market their products for off-label uses." This has been well-documented at clinpsych (4).

There is, however, one elephant in the room that these researchers neglected to mention. Namely, that much of the research for the uses of these drugs is abysmal (5, 6, 7, 8, 9, 10). The current system is broke. We are just circling the drain at this point. These people can call for all the new research they want, but when the only thing that is produced is garbage, then that's all you're going to get. Garbage in, garbage out.

Update (01/07/09): I like his article more than mine (Last Psychiatrist).