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

4. Attachments  E and F (Letter to the Office of Research Integrity – Lawyer’s letter excerpt)

       Dr. Amsterdam only recently became aware that two of the lead authors of Study 352, including his direct supervisor, were linked to ghostwriting through a letter from the Project On Government Oversight (POGO) to NIH Director Francis Collins in November 2010, posted on POGO's website at www.pogo.org/pogofileslletters/public-health/ph-iis-20101129.html. Like the examples contained in POGO's letter to NIH, Dr. Amsterdam believes the manuscript published in the American Journal of Psychiatry was ghostwritten by STI, which was hired by GSK and paid with GSK funds, and that the individuals above lent their names as "authors" to the manuscript. 

       Based upon evidence presented in this complaint and the documents attached hereto, it appears that most, if not all, of the" guest authors" were determined by GSK in conjunction with the "medical communications" firm, STI. STI has had a longstanding history of ghostwriting scientific and medical articles and textbooks which have been attributed to prominently known academics - a practice that has been the subject of mounting criticism. See, for example, an editorial in the Journal of the American Medical Association regarding ghostwriting in relation to Merck's promotion and sales of VIOXX. (Attachment E.) 

       The acknowledgement section of the published manuscript states that Study 352 was conducted and published with support from NIMH grant MH-51761. (Attachment A.) According to a recent search of the NIH Reporter database, NIMH grant MH-51761 was part of an "infrastructure support" and "core-patient recruitment and assessment" project for NIH-funded clinical research trials. (Attachment F.) In this case, it was used to support the recruitment and assessment of research subjects for participation in this GSK-sponsored and GSK-funded clinical trial of Paxil for the treatment of patients with bipolar type I major depression.

Attachment  E

Catherine D. DeAngelis and Phil B. Fontanarosa: Impugning the integrity of medical science. The adverse effect of industry interest. Editorial. JAMA 2008;299:1833-5.

Attachment F

NIH RePORTER - NIH Portfolio Online Search Results. 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. Am J Psychiatry 2001;158(6):906-12.

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August 26, 2021