Jay D. Amsterdam: The Paroxetine 352 Bipolar Study Ethical Conduct


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


The Paroxetine 352 Bipolar Depression Study

        The paroxetine 352 article was published in the American Journal of Psychiatry in June 2001 under the authorship of Nemeroff et al. It was completely ghost written by hired medical writers and employees of SmithKline Beecham, now GlaxoSmithKline (GSK), without these facts being acknowledged in the journal. The so-called academic ‘authors’ (who had financial ties to GSK), had little or no direct involvement in the design, conduct, data analysis, or publication of the study results. In fact, the ‘authors’ on the published article never reviewed or saw preliminary drafts of the manuscript, and only saw the final GSK-written manuscript prior to publication.

        Beyond the duplicity of ghost writing the study results in the form of a scientific article published in a prestigious journal under the imprimatur of so-called academic authors, GSK was able to take a noninformative trial with insufficient statistical power and inconclusive results, and spin it into a glitzy marketing advertisement for the off-label use of paroxetine in bipolar depression. In fact, there was no evidence of paroxetine efficacy, and safety data were suppressed that hid the presence of paroxetine-induced manic symptoms.

        The American Journal of Psychiatry article posted herein shows the originally published, ghost written and plagiarized article.




October 27, 2022