foolish, naive, incompetent, … biased
not written with complete integrity and accuracy given the data [they] had
disregarding [of his] responsibility to the proper scientific method, to the public, children and families
Evaluation of suicidal thoughts and behaviors in children and adolescents taking paroxetine.
by Apter A, Lipschitz A, Fong R, Carpenter DJ, Krulewicz S, Davies JT, Wilkinson C, Perera P, and Metz A.
Journal of Child and Adolescent Psychopharmacology. 2006 16[1-2]:77-90.
OBJECTIVE: The aim of this study was to summarize results of a blinded review of potential suicidal events and analyses comparing incidence rates between paroxetine- and placebo-treated pediatric patients.METHOD: One thousand one hundred ninety-one (1191) children and adolescents received paroxetine (n = 642) or placebo (n = 549) during placebo-controlled portions of all acute double-blind trials of paroxetine (n = 5). An expert panel blindly reviewed and categorized all identified cases detected by electronic and manual search of adverse events (AEs), serious AEs, and selected cases as suicidal or non-suicidal behavior. Incidence rates were calculated for suicide-related events and for rating scale items assessing suicidality.RESULTS: Suicide-related events occurred more often in paroxetine (22 of 642, 3.4%) than placebo groups (5 of 549, 0.9%); odds ratio (OR) 3.86 (95% CI 1.45, 10.26; p = 0.003). All suicide-related events occurred in adolescents of at least 12 years, except for 1 of 156 paroxetine-treated children. All suicide attempts occurred in major depressive disorder (MDD); few suicide-related events occurred in patients with a primary anxiety disorder. Suicide item analyses did not reveal significant differences between paroxetine and placebo.CONCLUSIONS: Adolescents treated with paroxetine showed an increased risk of suicide-related events. Suicidality rating scales did not show this risk difference. The presence of uncontrolled suicide risk factors, the relatively low incidence of these events, and their predominance in adolescents with MDD make it difficult to identify a single cause for suicidality in these pediatric patients.
I should add that the people I contacted at the American Academy of Child and Adolescent Psychiatry [incoming and outgoing presidents, the ethics committee] were cordial and responsive. Besides the blog series above, I sent them copies of Alison Bass’s book Side Effects, still a classic [used copies, sorry Alison]. I expect that Editor Andres Martin was the decider and under a lot of pressure not to retract this article – whether from GSK, from the authors of the paper, from the editor who accepted the article originally, or from other elements within the Academy. But that said, I find it impossible to accept his comment as the truth about his decision, "the Journal editors found no basis for retraction or other editorial action." The evidence is just too strong and too widely available. I don’t think I’m being a sore loser here. The loser in this story is the American Academy of Child and Adolescent Psychiatry, and ultimately psychiatry itself…