Black Box Backfire

By ACSH Staff — Apr 21, 2007
This piece first appeared in the April 21, 2007 Wall Street Journal.

This piece first appeared in the April 21, 2007 Wall Street Journal.

On her popular blog, Arianna Huffington stopped just short of blaming antidepressant medications for Cho Seung-Hui's lethal rampage at Virginia Tech this week. Anti-pharmaceutical demagogues love to blame drugs for all society's ills. Yet if antidepressants had anything to do with the massacre, it's likelier that it was the premature cessation of medication that led to Cho's violently disturbed state of mind.

That's one conclusion that can be drawn from a new analysis on the benefits and risks of antidepressants for children and adolescents published by the Journal of the American Medical Association. The analysis found that the risks of these medicines are much lower -- by a factor of two or more -- than the FDA previously thought. It had concluded from a previous study that young people had a 2% risk of having aberrant thoughts if they took antidepressants. The rate is only 0.7%. Further, the study found that these drugs are effective in treating depression and other mental illnesses found in children and teens. The new study, by the way, was undertaken by the National Institutes of Health and the Robert Wood Johnson Foundation -- not Big Pharma.

This isn't the what the FDA led us to believe in 2004, when it released an analysis indicating that young people on antidepressants had about a 2% risk, not of suicide, but of "suicidal thoughts." Anti-pharmaceutical activists and some politicians immediately called for major restrictions on antidepressants, simply ignoring that since the introduction of modern SSRI-type medications in the late 1980s, teen suicide rates had steadily fallen. No, the drumbeat from the "no risk allowed" crowd got the attention of the always risk-averse FDA.

The result was a "Black Box" warning -- the strongest possible warning short of an outright ban -- slapped onto the antidepressants. Remember, this was provoked by an alleged increase in thoughts, not deeds. There were no actual suicides -- zero -- in the FDA studies, and none in the latest, more extensive analysis.

Guess what happened next? Parents, naturally as frightened by this new warning as they would be by a skull-and-crossbones, decided to forego giving these medicines to their children. Many family doctors, spooked by the prospect of lawsuits, suddenly found other, less effective treatment options more appealing. Primary-care physicians are the ones who prescribe most treatments for depression, not psychiatrists. Since this warning label was introduced, usage of SSRI medications declined by more than 14% from 2004 to 2006 among patients under 19 years old. And, no surprise, actual suicides, not hypothetical ones, increased 18% among youngsters during the first year of the Black Box warnings -- the first such increase in many years.

When the FDA was quizzed by renowned psychiatrists -- many of whom had disparaged the original warning -- spokespersons for the FDA said, in effect, that the new study wasn't surprising and that they weren't forbidding the drugs, merely asking doctors to warn patients and monitor them.

Really? That's not what parents and treating physicians took away from the Black Box warning. As for monitoring, when I was in medical school, many, many years ago, we learned that the most dangerous time for depressed patients was when therapy was initiated. A previously immobile, depressed person, when treatment got started, might mobilize just enough to become self-destructive. Because of that, doctors already know that careful monitoring of seriously depressed patients is mandatory. Neither parents nor doctors need the FDA to tell them that. They took the new warning to be something more dire.

So why is the FDA stonewalling on modifying or eliminating the Black Box warning in the face of the new data about its effects? Simple: They have painted themselves into a "safety" corner. Calls for more and more safety -- seeing only risks and not benefits from drugs -- make the regulators twist in any direction that allows them to avoid having to backtrack. If they remove the warning and some teen actually does self-destruct, imagine the outcry. But the director of the New York University Child Study Center, Dr. Harold S. Koplewicz, said it best: "What is the risk of your child not taking the medicine?"

When risks and benefits of medications are discussed, this topic never seems to be broached. Drugs have significant benefits, or they wouldn't be developed, approved and marketed. What happens when a beneficial drug is avoided out of needless fears raised by some demagogue or plaintiff's attorney? People die. We shouldn't forget that.

See also: ACSH's full report and brochure on the costs and benefits of medications.

benefits and risks book cover

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