At the risk of being labeled obsessed myself, I’m still on the Gibbons et al article [Suicidal Thoughts and Behavior With Antidepressant Treatment] published on-line this month in the Archives of General Psychiatry about treatment emergent suicidality with the SSRIs. They said of their data sources for this meta-analysis, "we obtained complete longitudinal data for RCTs of fluoxetine hydrochloride conducted by Eli Lilly and Co, the Treatment for Adolescents With Depression Study of fluoxetine in children by the National Institute of Mental Health, and adult studies for venlafaxine hydrochloride conducted by Wyeth." In the abstract, they say, "Data Sources: All intent-to-treat person-level longitudinal data of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride." I wasn’t interested in the adult data, but went looking for the mentioned studies for children and adolescents other than TADS. There are four studies listed and reviewed in the FDA Medical Review for Prozac’s approval for MDD and OCD for children and adolescents in January 2003 and also in the FDA Hammonds Review in August 2004 prior to the black box warning [published full text on-line]:
STUDY DX SPONSOR YEAR N PBO FLX DURATION HCCJ MDD Lilly 1984 40 19 21 6 weeks X065 MDD NIMH? 1991 96 48 48 8 weeks HCJE MDD Lilly 1998 219 110 109 13 weeks HCJW OCD Lilly 1999 103 71 32 9 weeks subtotal 458 248 210 TADS MDD NIMH 2000 433 206 227 36 weeks total 891 454 437
… subtotal 458 248 210 TADS MDD NIMH 2000 439 216 223 12 weeks total 897 464 433
Feels like an orchestrated campaign to me. A biostatistics driven article with no data? full text on-line? data coming soon? a Medscape piece titled No Link Between Antidepressant and Suicide in Kids? with commentary and glossy photos?…
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