Stronger Child-Suicide Warning Advised
Antidepressants May Put Some Kids at Risk, FDA Panel Says
Patient Advocates on Both Sides
Patient advocates are arguing both for and against antidepressants for children. The National Mental Health Association is strongly urging the FDA to approve the drugs. The Center for Science in the Public Interest is demanding that the FDA remove three panel members because of financial support from the pharmaceutical industry. And the Alliance for Human Research Protection says the FDA has "stacked the deck" by denying independent scientists sufficient opportunity to present crucial research findings.
The FDA's Laughren offers the panel a way out. He's asked a Columbia University group to act as an independent consultant to review the drug company data. This solution may get the FDA panel off the hook -- but it won't make everybody happy.
At the heart of the problem is the nature of depression and its treatment. Depression can be deadly. Suicide is much more common in depressed people than in others.
Clinical trials don't conclusively show that antidepressant drugs work. That's because the studies compare the drug to inactive placebo. And depressed patients who enroll in clinical trials, have interactions with medical staff, and receive realistic-looking sugar pills tend to get better. This so-called "placebo effect" can be a nightmare for drug trials.
University of Connecticut psychologist Irving Kirsch, PhD, says that 75% of the effect of SSRI antidepressants -- and 97% of the effect of the older, tricyclic antidepressants -- is due to the placebo effect.
Children react differently to antidepressants than adults. And there's reason to think that antidepressants may, in some people, lead to changes in brain chemistry that make suicidal behavior more likely.
Psychotherapy can help depression. But different clinicians do different kinds of psychotherapy, making this very difficult to measure in clinical trials. One kind of therapy -- cognitive-behavioral therapy -- is standardized. And clinical trials do show it to be effective -- but far from a cure-all.
On the other hand, untreated depression can lead to suicide, too. Advocates of antidepressants warn that the FDA should not take one of the few treatments for depression out of the hands of doctors.
The FDA advisory panel will meet again this summer. Then the heat will be on. They'll have to recommend which course the FDA should take.
SOURCES: Susan Cruzan, FDA. Laughren, T. Memorandum: Background comments for Feb. 2, 2004 Meeting of Psychopharmacological Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, Jan. 5, 2004. News release, National Mental Health Association. News release, Center for Science in the Public Interest. News release, Alliance for Human Research Protection. FDA Testimony of Dr. Irving Kirsch and Dr. David Antonuccio on the Efficacy of Antidepressants With Children, Alliance for Human Research Protection, Feb. 2, 2004. FDA.