But Goodman voted to extend the black box warning for patients up to age 25. He and 5 others voted for that warning to be in the form of a black box. Two of the 8 members of the PDAC voted against that step. In the context of rewriting the current black box warning, Goodman suggested, and a majority agreed, that the FDA should be urged to accompany the warning with a reference to the fact that the risk of suicidality in untreated depression is higher than the risk observed in clinical trials among those given placebo.
The current black box warning, which was written before the new data on suicide became available, makes no mention of the benefits of antidepressants to untreated patients, or even the importance of getting treatment for depressive disorders. Its first 2 sentences read: Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Insert established name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need.
The reference to the need to balance the risk of suicide with “the clinical need” is the only allusion in the warning, or in any of the other key sections of the labeling, to the fact that antidepressants can alleviate depression. The PDAC apparently wants to provide physicians with a much stronger recognition of that fact in whatever new labeling the agency asks antidepressant manufacturers to adopt.
That desire was based on information on suicides recently released by the CDC and a group of academics who published an article in the November 2006 issue of the American Journal of Psychiatry titled “The Relationship Between Antidepressant Prescription Rates and Rate of Early Adolescent Suicide.” The lead author was Robert D. Gibbons, director, Center for Health Statistics and professor of biostatistics and psychiatry, University of Illinois at Chicago.
Gibbons and coauthors found that suicide rates among children aged 5 to 14 years during the period 1996 to 1998 were lower in counties with higher SSRI prescriptions. The CDC data were more recent (its numbers were from 2004). Gibbons said that although the FDA asked companies to put black box warnings on antidepressants in 2005, the CDC statistics for 2004 are still valid because SSRI prescriptions were already nose-diving in 2003 and 2004 because of media attention to a possible link between that category and increased risk of suicide.
Goodman believes that it is critically important to alert families and patients that it is dangerous to accept the arguments of scientologists and other anti-psychiatry groups who argue that clinical trial data show that placebo groups do almost as well as treated groups—the implication being that antidepressants aren't worth much. Goodman argued that it is misguided to extrapolate results for patients treated with placebo inside clinical trials, where they benefit from a medical safety net and all sorts of care advantages, to the results that can be expected for untreated patients outside clinical trials, who of course are most of the people in the United States with major depressive disorder.