Friday, March 02, 2012

1 Boring Old Man » coming soon?…

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]:

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?…

Posted via email from Jack's posterous

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