In 2001 the "Journal of the Academy of Child and Adolescent
Psychiatry" published a research study on the treatment of depression
in adolescents, randomized control trial (RCT) which had groups
that received paroxetine, imipramine, or placebo -- this study
is also known as "Study 329". In that article it was claimed that
paroxetine was effective and safe to use with adolescents. At that
time there were those who questioned the research design and
the results but the marketing of paroxetine (by the company now
known as GlaxoSmithKline or GSK) made it widely used.
Critics of the Study 329 were able to get the original data and
documents and they completed and published a re-analysis of
the data which was just published in the British Medical Journal
or BMJ. The main conclusion: one the primary measure of
depression, the three groups did not differ after 8 weeks of
treatment (i.e., paroxetine vs imipramine vs placebo). No
effect at all. However, the paroxetine group showed increased
suicidal ideation and behavior while the imipramine group showed
cardiovascular problems. As you might imagine, all hell has
broken loose as a result. The popular media has picked up
on this story and one source is (you guessed it) the New York
Times; see:
http://www.nytimes.com/2015/09/17/health/antidepressant-paxil-is-unsafe-for-teenagers-new-analysis-says.html?_r=0
The re-analysis is available on the BMJ website; see:
http://www.bmj.com/content/351/bmj.h4320
The BMJ also has an editorial that highlights some of the research
and ethical problems associated with the research and those
who were involved in the origin study; see:
http://www.bmj.com/content/351/bmj.h4629
The title of the editorial is:
No correction, no retraction, no apology, no comment: paroxetine
trial reanalysis raises questions about institutional responsibility
I think this study beats Milgram and Zimbardo in the unethical
department.
-Mike Palij
New York University
[email protected]
P.S. I find the following sentence from the editorial both frightening
and hilarious:
|The first draft of the manuscript ultimately published in the
|Journal of the American Academy of Child and Adolescent
|Psychiatry (JAACAP) was not written by any of the 22 named
|authors but by an outside medical writer hired by GSK. .
There were 22 authors and the paper was originally written
by a medical writer who probably didn't even get an authorship
credit.
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