PAXIL study and Charles Nemeroff et al under fire: Nature International weekly journal of science

VIA Nature


Paxil Study Under Fire

Trial researcher alleges paper exaggerated antidepressant benefits.:

"The contentious issue of drug-industry influence over medical-research writing erupted on the campus of the University of Pennsylvania in Philadelphia this week. A professor of psychiatry has alleged that several colleagues — including the chair of his department — allowed their names to be added to a manuscript while ceding control to the global pharmaceutical giant GlaxoSmithKline (GSK). The professor, Jay Amsterdam, also claims that the manuscript, written with an unacknowledged contractor paid by GSK, unduly promotes the company's antidepressant drug Paxil (paroxetine), the subject of the study.

"The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam's lawyer wrote in an 8 July letter to the Office of Research Integrity (ORI), the body responsible for investigating research misconduct in US Public Health Service agencies and its grant recipients.

The letter accuses the study's academic authors of engaging in scientific misconduct by allowing their names to be attached to the manuscript (C. Nemeroff et al. Am. J. Psychiatr. 158, 906–912; 2001), which has been cited more than 250 times. Documents accompanying Amsterdam's complaint are offered as evidence that "most if not all" of the authors were handpicked by GSK, working in conjunction with the medical-communications company Scientific Therapeutics Information (STI) in Springfield, New Jersey, to lend credibility to a result that Amsterdam says places Paxil in an overly favourable light."

Continue reading Nature article HERE.


The Study in Question

Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression

Charles B. Nemeroff, M.D., Ph.D., Dwight L. Evans, M.D., Laszlo Gyulai, M.D., Gary S. Sachs, M.D., Charles L. Bowden, M.D., Ivan P. Gergel, M.D., M.B.A., Rosemary Oakes, M.S., and Cornelius D. Pitts, R.Ph.

OBJECTIVE: This study compared the efficacy and safety of paroxetine and imipramine with that of placebo in the treatment of bipolar depression in adult outpatients stabilized on a regimen of lithium.

METHOD: In a double-blind, placebo-controlled study, 117 outpatients with DSM-III-R bipolar disorder, depressive phase, were randomly assigned to treatment with paroxetine (N=35), imipramine (N=39), or placebo (N=43) for 10 weeks. In addition to lithium monotherapy, patients may have received either carbamazepine or valproate in combination with lithium for control of manic symptoms.


Further reading about another conflicted study-- the PAXIL 329 study scandal-- in the labels listed on this post.