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Letters to the Editor
Published Online: 15 October 2004

NIMH Guilty Too?

Jonathan Leo, PH.D.Authors Info & Affiliations
Publication: Psychiatric News
Volume 39, Number 20
https://doi.org/10.1176/pn.39.20.0390031
The July 16 article “Clinical Trials Controversy Spotlights Flawed System” discusses several SSRI manufacturers accused of withholding data. However, it appears that it is not only pharmaceutical companies that have withheld data.
In the November 1997 Archives of General Psychiatry, Emslie et al. published the first study responsible for fluoxetine's approval for use in children. The study, which was funded by NIMH, made no mention of any children attempting suicide. In fact, the authors commented on page 1033, “Side effects as a reason for discontinuation were minimal, affecting only four patients who were receiving fluoxetine.”
However, in fall 2003 the Food and Drug Administration posted documents on its Web site that discussed the study, and these documents contained a vague reference to two children who took fluoxetine and attempted suicide.
According to these documents, “Two subjects who attempted suicide may have had their blinded treatment revealed to a nonstudy physician who was not an investigator” (Fluoxetine patients 2051 and 2163; FDA, 2001, p. 19).
I say “vague” because nowhere on the FDA pages is there a full presentation or a discussion of these data. But more important, why is it that an NIMH study never released these data and has still not released them? How can the drug companies be blamed when it appears that NIMH has done the very same thing?

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Psychiatric News
Volume 39 • Number 20 • October 15, 2004
Pages: 31

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Published online: 15 October 2004
Published in print: October 15, 2004

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Jonathan Leo, PH.D.
Parrish, Fla.
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