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onsdag, 01-12-2021

Jay Amsterdam, Edward Shorter, Donald Klein, Allen Frances and Bernard Carroll – Comment Exchange

Barry Blackwell: Corporate Corruption in the Psychopharmaceutical Industry
Revised
(Prepared by Olaf Fjetland)

 

Jay Amsterdam

Apr 14, 2017, at 2:55 PM

 

            This is a very nice response to Mickey’s note to you (may he RIP). Irrespective of the political climate in Congress, it would be a remarkable feat, in and of itself, if you could get even one brave INHN member (outside of the few who have contributed to your commentary) to take up the cudgels on behalf of this issue. However, don’t hold your breath waiting. There is nothing wrong with the content of your commentary; the problem is with the moral compass of our academic colleagues.

 

Edward Shorter

Apr 14, 2017 9:32PM

 

            I totally agree with Barry's comment, but also I think that Jay has correctly grasped the reality of how difficult change in this area will be.  I am currently going through the back issues of a “boring old man” (am currently at May 2011), as a source for writing the history of psychiatry and psychopharmacology in our era.  And it is clear to me what a sharp and prescient mind Mickey had -- as well as being a gifted polemicist.  He would sometimes post two or three times a day, and with fresh, documentary material, not just diatribes and rants.  Along with Tom Ban's two series of biographies on CINP and ACNP, 1boringoldman will remain one of the main documentary sources in the history of the scientific collapse of American psychiatry.

 

Donald Klein

Apr 15, 2017 2:42 AM

 

            A current calamity well worth documenting. It would be all the more poignant, and historically meaningful, by contrast with the tidal wave of fundamental, serendipitous, clinical discoveries of the 1950s and 1960s that petered out by the 1970s.  A speculative, ironic, note is that the turning point was what was generally viewed as a wonderful legislative advance: the 1962 Kefauver-Harrison Amendment.   It required Pharma to scientifically demonstrate specific therapeutic activity prior to marketing. It was not recognized that this turned Pharma's scientific support from discovery to validation, while its leadership fell into the profit promising hands of salesmen.  Under their guidance, Phase 2 findings re safety and therapeutic promise were truncated, thus eating into market monopoly time. This led to absurdly high Phase 3 failure rates and the eventual withdrawal of Pharma from psychiatric research.  NIMH did not compensate, but pursued normal subject behavior under the guise of   bench-to-bedside therapeutic claims. The understanding of disease processes was supposedly Pharma’s concern, although Pharma had no interest.  Concurrently, the economic promise of managed-care destroyed the clinical hospital's  support of Independent clinical research. The complex context of the calamity is necessary for adequate history.   I am concerned that scientist's autobiographies are often focused on the apparently random vicissitudes of their career.

 

Allen Frances

 April 15, 2017 4:52 AM

 

            All true, but I think the basic underlying factor is that there was precious little low hanging fruit and it was all picked very early. Research efforts since the pioneering days have for sure been frustrated by commercialism, careerism, DSM blind alleys and NIMH strait-jackets, but I think by far the biggest problems are the ineluctable brain and clinical complexities - and no best-case scenario would have solved these in any wholesale way. Despite all the fancy tools now available,  it will be a decades long, bit by tiny bit retail slog, sorting out only tiny pieces of the complexity in a very gradual way. Nature of the beast. The greatest tragedy to me is less the wasted research time, money and talent (although all considerable), but rather the neglect of patient care and health services research that accompanied the quest for the holy neuroscience research grail. Trying to hit neuroscience home runs, we struck out when it comes to minimally decent patient care.

 

Bernard Carroll

April 15, 2017 4:19 PM

 

            Don is correct in what he says about the unintended consequences of the 1962 Kefauver-Harris Amendment. The road to hell is paved with good intentions. But in its historical context that Amendment was necessary. It came at the end of the 1950s when clinical pharmacology in general was ramping up. Serious drug toxicity was being recognized – the thalidomide episode was a proximate stimulus – plus, a premium was placed on efficacy in view of the proliferating number of drugs like antibiotics and steroids. To some extent, psychopharmacology was an afterthought at this time.

            To Allen’s point about low hanging fruit, during the 1940s through the 1960s we did hit the key targets with ECT, lithium, antipsychotic drugs, anxiolytics like meprobamate and benzodiazepines, and antidepressants like the MAOIs and the TCAs. All of that happened against a roiling background of debates in descriptive psychiatric nosology (I won’t even mention the chaff thrown up by the Freudians). Those debates required recalibration by many clinicians and researchers. I recall the late 1960s and early 1970s as a stimulating period of clinician involvement in formulating the key questions, while they collaborated with basic pharmacologists in proposing translational narratives for testing out. Don’s work in that era is as good a model as any.

            The rot set in when commerce entered the picture, as Don outlined. The emphasis shifted from scientific opportunity to market opportunity. I could sense that happening in the late 1970s (ask me sometime about the zometapine fiasco at Parke-Davis) and it was compounded by the Bayh-Dole Act of 1980. It took a while, but that opened the door for the corruption of clinical scientists who brushed off concerns about conflicts of interest with airy reassurances about confluence of interests. Again, the road to hell is paved with good intentions.

 

August 3, 2017