Jay D. Amsterdam and Leemon B. McHenry : The Paroxetine 352 Bipolar Study Revisited : Desconstruction of Corporate and Academic  Misconduct 

Barry Blackwell’s comment

        This painstaking deconstruction of corporate and academic misconduct by Jay and Leemon, a psychiatrist and legal collaborator, is both instructive and frustratingly inconclusive. It is meticulously dissected, documented and analyzed, including the egregious behavior of well-known academic ghost writers and industry KOLs, orchestrated by employees of a large corrupt pharmaceutical company and published by a compliant and indolent editor of a major psychiatric journal.

        Details apart, the authors’ first paragraph in their concluding discussion tells it all: “The Paroxetine 352 study was a non-informative trial with insufficient statistical power to show anything but inconclusive results. There was no evidence of any paroxetine (or imipramine) efficacy relative to placebo in bipolar major depression and the suppression of safety data hid the presence of paroxetine-induced harm.”

       A decade after their evaluation  was complete and published a complaint of Scientific Misconduct was filed  with the Office of Research Integrity (ORI) of the Department of Health and Human Services which passed it to a Mid-Western University that, in turn, appointed its own ORI, composed of  three professors of medicine. In its wisdom the University appointed no psychiatrist, no statistician and no legal expert. So the outcome was hardly surprising.

       They reached the astonishing conclusion that “each and every allegation lacked substance and credibility.”

       Academic institutions and professional organizations increasingly collaborate with industry in for-profit and educational ventures and may become indebted or dependent on industry in ways that diminish their ability and willingness to identify, discourage or sanction conflicts of interest among their physician members (Blackwell 2016).

       In an even wider way, contemporary culture is becoming inured to corruption bred by income disparity, extreme wealth, greed and addiction to money that erodes the boundary between politics and justice, commerce and science, business and profession (Blackwell 2020). Uncontaminated sources of adjudication to investigate conflicts of interest, assist personal choices or resolve existential predicaments are becoming difficult to find.  Paroxetine 352 is a bell weather tale.

References:

Blackwell B. Corporate Corruption in the Psychopharmaceutical Industry. inhn.org.controversies. September 1, 2016.

Blackwell B. Treating the Brain; An Odyssey. 2020. In press, INHN Publications.

April 2, 2020