Event Timeline of the Paroxetine 352 Research Misconduct Complaint
2010 to 2012 – Scientific misconduct complaints in the paroxetine 352 trial were filed with the
Department of Health and Human services (DHHS) Office of Research Integrity (ORI).
2010 to 2011 – The University of Pennsylvania Perelman School of Medicine (Penn) convened
an ORI-mandated Inquiry Committee that performed an incomplete investigation of the
whistleblower allegations of academic and research misconduct by their own (and other)
university research professors pertaining to the paroxetine 352 study and its publication.
2013 – The Penn Inquiry committee found that no scientific misconduct had occurred in the
352 study by either their own research professors (or the professors of other universities) who
were all listed as authors on the published paroxetine 352 report). As a result, the ORI
subsequently closed the 352 misconduct case.
2013 – 2018 – Despite the outcome resulting from Penn’s incomplete examination of certain
inculpatory documents related to the 352 case, repeated attempts were made to provide Penn
and the ORI with these documents indicating that the 352 study results had been wholly
produced by Glaxo-Smith-Kline (GSK) and the medical ghostwriting firm of Scientific
Therapeutics Information, Inc (STI). The research misconduct complaint alleged that the STI
documents contained vital evidence of wrongdoing by the research professors. However, Penn
repeatedly refused to examine these documents.
2019 – The 352 STI documents become publicly available on the internet.
2019 – A peer-reviewed research article was published entitled “The paroxetine 352 bipolar study revisited: Deconstruction of corporate and academic misconduct,” in the Journal of Scientific Practice and Integrity. This article provided detailed evidence of misconduct by the named research professors during the 352 study. The article was subsequently reprinted in its entirety in 2020 in several highly respected on-line venues: http//inhn.org/controversies/jay-d-amsterdam-and-leemon-b-mchenry-the-paroxetine-352-bipolar-study-revisited-deconstruction-of-corporate-and-academic-misconduct.html.
2019 – Lawyers for the Complainant submitted to Elizabeth Handley (Director, Office of
Research Integrity, Department of Health and Human Services), a letter describing the newly
available STI documents of the 352 misconduct case (that Penn had previously refused to
examine as part of their 2010-2011 ORI Inquiry investigation. The newly available STI evidence
supported the original 2010 scientific misconduct allegations against the university research
professors and requested that the DHHS ORI reopen the scientific misconduct case to include
the newly available STI evidence.
2019 – A summation of the 352 study detailing alleged academic misconduct, data
manipulation and academic plagiarism (including information from the STI documents)
appeared on the Madd in America website: https//www.madinamerica.com/2019/12/the-
whistleblower-and-penn-a-final-accounting-of-study-352/
2020 – Penn’s lawyer wrote a letter to Elizabeth Handley at the DHHS ORI suggesting that the
previously unexamined STI documents provided no new factual information to support the
contention that the 352 misconduct case should be reopened and requested that the
Complainant’s request to reopen the 352 case be denied.
The Complainant’s lawyer responded by providing a point-by-point rebuttal raised by the Penn
lawyer and requested that the 352 scientific misconduct case be reopened.
September 22, 2022