Barry Blackwell’s Pioneers and Controversies in Psychopharmacology. Chapter 19. The End of the Beginning: The Beginning of the End? Corporate Corruption in the Psychopharmaceutical Industry - Revised
Max Fink’s comments
Thank you for a concise history of the rise and fall of the methodologies for the evaluation of psychoactive drugs. The story is saddened by the politicization of medicine during the administration of Ronald Reaganwith the watering down the rules for the FDA licensing the marketing of new entities, theencouraging ofadvertising of medicines to the publicand creating a culture in which unproven and often ineffective medicines were and continue to be marketed.
I was a member of the NIMH Clinical Committee,created by Jonathan Cole and chaired by Henry Brill, that established the Early Clinical Drug Evaluation Units(ECDEU) system. I wasa grantee from 1959 to 1985. Grantees organized twice-yearly meetings at members' clinical sites to discuss clinical experiences and the changing methodologies. ECDEU was a collaboration of 15 sites, each led by a clinician-scientist, at academic hospital centers. Besides clinical trials, each center sought to develop an aspect of neuroscience. Grants supported my clinical trials of novel compoundsand those of Turan Itil to develop and apply the pharmaco-EEG methodology. We developed digital computer methods of EEG analysis using IBM 1710 and later the larger IBM 1800 digital computer systems. In our clinical assessments of hospitalized patients we reported some compounds that became clinically established, some that were evaluated as placebos, and some that were clinically rejected.
At first, the attendees to ECDEU meetings were restricted to grantees and NIMH personnel. As ECDEU money became tight, NIMH personnel coordinated the meetings and allowed, then encouraged, industry attendees. By the 1990s, the meetings became markets forthe coordination and hiring of industry supported non-hospital based evaluation centers fully funded by industry with subjects recruited by newspaper advertising and effects evaluated by college students, nurses, and social workers trained to assess symptoms by rating scales with only nominal direct physician evaluation.
Concurrently, the meetings of American College of Neuropsychopharmacology (ACNP), the Collegium InternationaleNeuro-psychopharmacologicum (CINP), andthe Society of Biological Psychiatry(SBP) where drug studies were initially discussed by clinicians interested in the changes in symptoms increasingly enthused about laboratory studies, about the “neuroscience” of the putative compounds.
Studies of ECT are not invited. In 1984 at the Florence, Italy CINP meetings at a plenary session I discussed ECT as a form of psychopharmacology, with similar, often more potent, more immediate changes in brain and body physiology than feeding patients pills or injecting chemical substances.I called for ECT to be included within the pharmacologic science interests and meetings, to "bring it into the tent," that there was much to be learned about brain changes induced by thesetreatments that were valuable for clinical psychopharmacology. Alas, nothing came of my call. The pharmacology of induced seizures is not reported at psychopharmacology society meetings.
And, the ECT folk have lost scientific interest in the brain changes induced by seizures, the interactions of chemicals and seizures, and the mechanismsof the effects of seizures on behaviour or brain chemistry. The annual meetings of the International Society for ECT and Neurostimulation(ISEN) and parallel regional ECT societies highlighttechnical issues of inducing seizures (electrodes, dosage, currents),side-effects mainly on memory and cognition, and the technologies of non-seizure applications of electricity or magnetism byrTMS, VNS, tDCS, and DBS methods. These non-seizure treatments use the clickity-clack of the devices as substitutes for the technical tricks used by hypnotists. Sadly, ECT is no longerdiscussed at sessions of the epilepsy, psychopharmacology, or neuroscience societies. Neuroscience and society have lost much by the ending of the ECDEU collaborations, by the end of interest in the pharmaco-EEG science,and by the academic rejection of induced seizures as a pariah of neuroscience.
September 13, 2018