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When the good guys are doing us wrong


Detective Robert Goren said it to Nichole Wallace on Law & Order: Criminal Intent. Sara Sidle said a version of it Gil Grissom on C.S.I. And Herman Meville probably would have said it to Sigmund Freud.

"Sometimes, a whale is just a whale."

I am as big a fan as anyone of tough regulation of pharmaceutical companies, but it seems in recent months that the Food and Drug Administration has continue the drive off the cliff of logic that they leap a few weeks back and have landed in the gorge of patient destruction - at least when it comes to mental health medications.

In May 2007, the F.D.A. ordered a "black box warning" be placed on the packaging of all antidepressants to warn people of an increased risk of suicide related to the medications. Earlier this year, the F.D.A. reversed itself and ordered a "black box warning" be placed on anticonvulants, including those used to treat depression and mania in bipolar disorder and mood swings in other psychiatric illnesses.

The F.D.A. argument seems to make sense on its face. People on these drugs commit suicide at a higher rate than the general population. But, unlike the formal logic that development experts say is grasped by 8 year olds, the F.D.A.'s conclusions forget that correlation does not, indeed, equal causation, especially when three is a much more likely reason for people on antidepressants and mood stablizers to commit suicide. The illnesses they have, both mental illnesses and neurological illnesses, have a higher than average rate of suicide than the general population, especially when not treated with psychoactive medications.

Yet, as a result of litigation, politics and factors, people who most need psychoactive drugs are warned away from them because of the high rate of suicide associated with the drugs. If I could have a quarter for person who has come to me this year with a prescription from their doctor for an anti-depressant who has told me that they do not want to take it because of the rate risk for suicide - "Look right here, Jayson!!!!! It says so on the box."

I pull out a paperback copy Kay Redfield Jamison's "Night Falls Fast," a scholarly and narrative book on suicide, and, then, I explain to them how the F.D.A. concluded that the drug they now don't want to take has a high risk of suicide.

It's goes a bit like this (and I am making up the numbers):

People taking antidepressants commit suicide at a greater rate than the general population, so, the black box logic goes, that antidepressants cause suicide.

It's predicated on that a person who is taking antidepressants is more likely to commit suicide than a person who is not. Really, Sherlock? Could it be because they are depressed.

What's next? More people who take antidepressants have depression, therefore antidepressants cause depression.

The logic for mood stabilizers is even scarier and takes off from the bad conclusion of the previous decision, but I'll spare you.

It would be easy to laugh at the F.D.A.'s logic and "black box warnings" if the labels did not have an impact on people whose lives are at risk and who are already unlikely to comply with taking medications because of their real side effects.

An article in The Journal of Psychiatry points out that "FDA warnings have contributed to the increase in the number of youth suicides" and that if the "recent expansion of the FDA black box warning to young adults decreases overall SSRI prescriptions by 20%, there would be an additional 3,040 suicides in the United States over a 1-year period. Its a shame that their logic is much better than the F.D.A. black box approval process. It has also had an impact on the prescription of more heavy duty drugs with even more serious short-term and long-term side effects, such as antitypical antipsychotics.

The F.D.A.'s black-box warnings on suicide are about as logical as one of my favorites that Detective Goren delivered in explaining the thought process of a schizophrenic witness who would not take his medication: Sick people take meds; I'm not sick, so, therefore, I don't take my meds because meds make people sick.

They make about as much sense as the Consumer Product Safety Commission warning against airbags because more people get killed when airbags are deployed than when they are not. Airbags are deployed when people are at serious risk, and so are anti-depressants.

We all know that's silly. But before we get there or somewhere equally dangerous, the F.D.A. should consider a different set of standards, one that respects the difference between a relationship with something -- or a correlation -- and the cause of something. In these cases, the whale was just a whale but the F.D.A. has turned them into Moby Dick.

I'm the first to admit that pure logic would be a dangerous thing; but a little would be nice.
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