Psychiatric News October 15, 2004
Volume 39 Number 20
© 2004 American Psychiatric Association
p. 31
NIMH Guilty Too?
Jonathan Leo, PH.D.
Parrish, Fla.
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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