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Study 329 Restored
via: Study329.org SCIENTIFIC INTEGRITY THROUGH DATA BASED MEDICINE:
Band of Intrepid Researchers "Sets the Record Straight" on Ghostwritten Study
an excerpt:
"Toronto (September 16, 2015) — Today the BMJ published Restoring Study 329, a decade-long effort by researchers to uncover the truth about the safety of an antidepressant approved for use by adolescents. Restoring Study 329 is a reanalysis and rebuttal of the original Study 329 ..." more here
Psychiatry’s Thalidomide Moment
an excerpt:
an excerpt:
Study Details and Findings
"The authors of Study 329 began recruiting adolescents for a comparative study of Paxil, imipramine and placebo in 1994 and finished their investigations in 1997. They dropped a large number of their original cohort, so the randomness element in the study must be open to question. Late in 1998, SmithKline Beecham, (henceforth GSK) the marketers of Paxil, acknowledged in an internal document that the study had shown that Paxil didn’t work for adolescents in terms of the two primary and six secondary outcomes they had established at the start of the study. In a nutshell, Study 329 was negative for efficacy and positive for harm, contrary to their succinct upbeat conclusion. Adjudging, of course, that this lack of benefit and presence of risks could not be communicated to an innocent public, the team’s task was now to see how bad news could be transformed into good. They decided then that they would cherry-pick the few positives they might glean from their mass of data and publish these. This, however, required them to abandon nearly all of their original outcome measures and dredge up a few new ones, abandoning the symptoms in the Hamilton Rating Scale for Depression (HAM-D),which they originally invoked and which is the normal scale used in such studies.
"The article had first been rejected by JAMA..." read here
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