First published in the June 2005 issue of the American Journal of Psychiatry
In October the Food and Drug Administration (FDA) officially announced it would require manufacturers of the SSRI and tricyclic antidepressants to add a black box warning label to the drugs' package information. This action closes the latest chapter on a decade long controversy involving the SSRIs. I attended both the February and September 2004 FDA hearings on the SSRIs and children's depression. During the meetings I was struck repeatedly by a message I heard from psychiatrists both on the expert panel and those testifying during the open public hearing section. Again and again I heard them say, "Don't take away the only thing we have to offer these kids."
Following the official FDA announcement on the black box warning, the American Psychiatric Association said it had "deep concern" over the black box warning and its potential "chilling effect" on treatment. "We believe the biggest threat to a depressed child's well-being is to receive no care at all."
Of course all quotes can be taken out of context but I'm left feeling disappointed and distressed. First, as a front-line practitioner I've been asked over and over to practice evidence based medicine. However, when the evidence in 4600 children simply isn't there for SSRI effectiveness in pediatric depression, I am now asked to believe, once again, in "professional experience." Even data from the recent TADS study, which was meant to bolster the case for fluoxetine in adolescent depression, at the hearings, ironically led panel experts to further question the drug's effectiveness and safety (including higher rates of suicidality in the treated vs. placebo group).
Most disturbing is the implied role for today's child psychiatrist or behavioral/developmental pediatrician in the treatment of childhood depression. If the SSRI medications are ineffective for large numbers of youth, have we no other care to offer them? The testimony and response of organized psychiatry to the SSRI controversy suggests just how far the field has moved from the biopsychosocial to medical model of disease and intervention. A survey of recently trained child psychiatrists found that only one in ten children in their practices does not receive a medication (Stubbe et al, 2002). I must say I missed a voice like Robert Coles representing the profession at the FDA hearings.
The training, experience, prestige and power of the child psychiatry seem wasted when all of practice is reduced to diagnosis and medication. The role of the child psychiatrist in influencing children, parents, schools and communities is paramount. Why does it seem we are more ready to intervene in the environment of the synapse than in the environment of the child? The controversy over the SSRIs and children's depression should give us pause to consider "effective" treatments and our own roles in providing them.
Harris G. "FDA toughens warning on antidepressant drugs." New York Times, Oct 16, 2004 p A8
American Psychiatric Association News Release, "APA responds to FDA's new warning on antidepressants." October 15, 2004, http://www.psych.org/news_room/press_releases/04-55apaonfdablackboxwarning.pdf
March J, Silva S, Petrycki S, et al. "Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial." JAMA 2004; 292:807-20.
Stubbe DE, Thomas WJ), "A survey of early-career child and adolescent psychiatrists: professional activities and perceptions." J Am Acad Child Adolesc Psychiatry 2002; 41:123-130.
Coles R. The Mind's Fate: A Psychiatrist Looks at His Profession: Thirty Years of Writings (Boston, Little, Brown and Co.) 1995.