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

Samuel Gershon’s additional comment

       The material presented by Jay Amsterdam and Leemon McHenry (2020) goes to confirm patterns of behavior of some of our colleagues that has been going on for some time now. The sordid affair on which they report became involved in congressional hearings and the findings were pretty clear cut - senior members of our profession were acting improperly.

       Months of evidence was collected in these hearings. As far as we know these documents have not been made public nor were any other actions to correct these behaviors. Barry Blackwell has recently published a book, Treating the Brain: An Odyssey, available on Amazon (Blackwell 2020). This book deals with many of these issues in an evolutionary process as presented historically, along with his own professional training. In my opinion this book should be required reading for medical students and practitioners. Further, I wonder whether the ACNP should become involved in distributing such educational material.

       My other source of unreliable Pharma psychiatric information is elegant TV advertisements. They clinch the deal, on drugs to stop the dementing process. Tacrine, on which we did much of the initial pharmacology, did clearly show it had alerting properties in many situations (one example: morphinized dogs would be restored to full active function after one IV injection) (Shaw, Gershon and Bentley 1957). Some years later it was marketed in the US and the rest of the consumer world for the action of improving memory function in Alzheimer’s dementia, i.e., improvement above baseline.

       The evidence for this indication did not seem to hold up in practice. Now, hold on for the next step: the developers went back to the FDA to claim that it would instead slow the rate of decay of mental functions, resulting in approval by the FDA for a different application. Now it is in the trash can.

       These issues have dogged our field at least since the examples in Blackwell’s book through the senate hearings, etc. I think we should try a full-fledged push on education and I think Blackwell’s book could be a first step – a little hope is still left.

References:

Amsterdam JD, McHenry LB. The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct. inhn.org.controversies. March 19, 2020. 

Blackwell B. Treating the Brain: An Odyssey. INHN Publishers, Cordoba; 2020. 

Shaw FH, Gershon S, Bentley GA. Morphine antagonism. Journal of Pharmacy and Pharmacology 1957;9(1):666-71.

July 8, 2021