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

3. Attachments A, B, C and D (Letter to the Office of Research Integrity – Lawyer’s letter excerpt)

Dr. Amsterdam believes the individuals named above engaged in scientific misconduct by allowing their names to be appended to a manuscript that was drafted by a "medical communications company" (Scientific Therapeutics Information, "STI") hired by SmithKline Beecham (now known as GlaxoSmithKline, "GSK"), and which Dr. Amsterdam contends misrepresented information from a scientific research study (Paroxetine Study 352), which was funded by GSK and NIH. The manuscript (hereinafter "Study 352") was eventually published in the American Journal of Psychiatry (158:906-912; June 2001) suggesting that Paxil may be beneficial in the treatment of bipolar depression, without acknowledging the medical communication company's contribution or the extent of GSK's involvement. The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil. (Attachment A.) Since its publication, study 352 has been cited in hundreds of medical journal articles, textbooks and practice guidelines up to 2011. (See, e.g., Attachment B and C.) Although Dr. Amsterdam was a Co-Principal Investigator of the study and possibly enrolled the largest number of patients, he was excluded from the final data review, analysis and publication. (See Attachment D.)

Attachment A

Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. American Journal of Psychiatry 2001;158(6):906-12.

Attachment B

Google scholar search of citations for Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. American Journal of Psychiatry 2001;158(6):906-12.

Attachment C

ICI Website of knowledge. 2 pages, 183 references for Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. American Journal of Psychiatry 2001;158(6):906-12.

Attachment D

Final ghostwritten draft of Nemeroff et al. manuscript for publication in the Am. J. Psychiatry.

August 19, 2021