Jay D. Amsterdam: The Paroxetine 352 Bipolar Study Ethical Conduct
Leemon McHenry’s comment
It has been my pleasure to work with Dr. Jay Amsterdam on exposing the scientific misconduct in the SmithKline Beecham (now GlaxoSmithKline) Paroxetine Study 352 clinical trial, comparing the antidepressant drugs imipramine and paroxetine for the treatment of bipolar type I major depression (or manic depression). During our 10-year collaboration we published two papers on this study, “The Paroxetine 352 Bipolar Trial: A Study in Medical Ghostwriting,” in the International Journal of Risk & Safety in Medicine, 2012, and “The Paroxetine 352 Study Revisited: Deconstruction of Corporate and Academic Misconduct,” in the Journal of Scientific Practice and Integrity, 2019, as well as other articles on the general problem of corrupted industry-sponsored trials.
As a research consultant for the law firm, Baum, Hedlund, Aristei & Goldman of Los Angeles I had collected documents on the 352 trial as part of on-going litigation against SmithKline Beecham for harms done to patients prescribed paroxetine. I was then working on the now-infamous Paroxetine Study 329 with Dr. Jon Jureidini but was well aware that the 352 trial was part of a much larger strategy in SmithKline Beecham’s competition with other SSRI manufacturers to gain market share. The documents from the now-defunct medical communication company, Scientific Therapeutics Information (STI), showed the same pattern of misrepresentation of trial results we found in Study 329 via ghostwriters employed by STI. When Dr. Amsterdam contacted Baum Hedlund, he had no idea of what was coming". His suspicions were completely vindicated by what was revealed in the documents.
The evidence was indisputable that the 352 trial was grotesquely manipulated by SKB and STI aided by academic key opinion leaders named as “authors” on the ghostwritten study. When reality would not cooperate with marketing hype, the results were fudged to publish a “positive” trial in the pages of the American Journal of Psychiatry. The key opinion leaders and the journal editor well understood the commercial value to SKB. What they didn’t count on was the lone voice of Dr. Amsterdam who courageously stood up against the corruption and the law firm, Baum Hedlund, that stood behind him. Once the misconduct was exposed to the light of day, instead of following the path of science and correcting the record, the powers that be circled the wagons, stonewalled and doubled down to silence Dr. Amsterdam. This left an enduring stain on the University of Pennsylvania that partnered with GlaxoSmithKline, Scientific Therapeutics Information that did the ghostwriting, The American Journal of Psychiatry that published the fraudulent paper and the Office of Research Integrity for failure to act on Dr. Amsterdam’s complaint.
As one peruses the pages posted on this INHN site, it is perhaps not surprising that scientific integrity means very little when enormous profits are at stake, but it is disheartening when the government fails to stand up for science.
References:
Amsterdam JD, McHenry LB. The paroxetine 352 bipolar trial: A study in medical ghostwriting. Int J Risk Saf Med 2012;24(4):221-31.
Amsterdam JD, McHenry LB. The Paroxetine 352 Study Revisited: Deconstruction of Corporate and Academic Misconduct. JoSPI 2019;1(1):1-12.
April 28, 2022