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

6. Attachments H and I (Letter to the Office of Research Integrity – Lawyer’s letter excerpt)

       Moreover, according to a report on ghostwriting by Senator Charles Grassley (dated June 24, 2010), the University of Pennsylvania considers ghostwriting to be equivalent to plagiarism.

       While this incident took place some time ago (i.e., 2001), the manuscript has been cited hundreds of times up through 2011 according to an internet search on Google Scholar. (Attachment B.) In fact, Dr. Gyulai cited the paper again in a study he published in 2007 in the New England Journal of Medicine (Attachment H) and Dr. Sachs cited the paper in 2011 in the Journal of Clinical Psychiatry. (See Attachment C, Record 1.)

       Moreover, the purported "findings" of Study 352 and the published results from other studies and articles that have cited this study have been used to support the design and implementation of at least two other NIMH-funded grants to study the efficacy and safety of antidepressant drugs (like Paxil) in bipolar depression. See, e.g., MH080097, Prevention of Relapse and Recurrence of Bipolar Depression and MH060353, Treatment of Bipolar Type II Major Depression.

       Dr. Amsterdam submits this complaint in the hopes that ORI will conduct an investigation, impose appropriate penalties to correct the past publication of Study 352' s results, to prevent similar conduct from happening again, and hopefully prevent further use of this paper to support the dangerous prescription of Paxil to patients diagnosed with bipolar depression.

       Pursuant to 42 C.F.R. Part 50.103(d)(13), Dr. Amsterdam should receive full and complete protection from retaliation and/ or defamation by either the University of Pennsylvania or any other parties involved in the production and publication of Study 352. Dr. Amsterdam requests the protections described in ORr's "Handling Misconduct - Whistleblowers." (Attachment I.)

       To ensure that this complaint is taken seriously, and to alert interested parties, we are providing copies of this correspondence to Senator Charles Grassley, Senator Herb Kohl, and the Chairman and Ranking members of the House Energy and Commerce, and the House Committee on Oversight and Government Reform.

ATTACHMENT H

Sachs GS,  Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, Friedman ES, Bowden CL, Fossey MD, Ostacher MJ, Ketter TA, Patel J, Hauser P, Rapport D, Martinez JM, Allen MH, Miklowitz DJ, Otto MW, Dennehy EB, Thase ME.  Effectiveness of Adjunctive Antidepressant Treatment for Bipolar Depression. N Engl J Med 2007;356(17):1711-22.

ATTACHMENT I

Office of Research Integrity. Handling Misconduct – Whistleblowers. ORI Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research. November 20, 1995.

//ori.hhs.gov/misconduct/Guidelines_Whistleblower.shtml.

September 9, 2021