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Saturday, 29.04.2017

Barry Blackwell: Corporate Corruption in the Psychopharmaceutical Industry

Barry Blackwell’s reply to Mark S. Kramer

1.      Provenance of Mark Kramer’s current Commentary

The provenance of Mark Kramer’s voluminous and emphatic response to my essay requires elucidation. Shortly after my essay was posted INHN received a rapid and earlier (unpublished) 50 page commentary by Mark to which I made a brief affirmative reply (posted below). This was shared with Mark who responded in kind, “I treasure Barry Blackwell’s response to my long-winded commentary.” After the kindest of comments he took brief issue (7 pages and 2 references) with a few of my assertions including the integrity of biological psychiatry as a discrete discipline as well as specific legislative actions to halt corruption. These included NIMH launching a new National Drug Evaluation Unit for which I suggested Mark might be an appropriate Director. Mark demurred; “I am neither sufficiently bright nor sly to navigate the service.”

These three unpublished, mutually shared documents, (Mark’s 50 page Commentary, my reply and his response) all awaited posting on INHN and I believed the matter settled. But events proved otherwise. My original essay had been unknowingly posted on other networks and perhaps, influenced by other feedback, Mark had gazed deeper into Nietzsche’s abyss, retracted the commentary awaiting posting and replaced it with the current 64 page magnum opus supported by 92 references.

This document demands respect for the depth of passion, integrity and experience with which it speaks, full throated.

After much reflection I decided to share my initial response, still awaiting posting, to Mark’s original 50 page Commentary plus a brief Addendum that highlights a few essential similarities and differences in our approaches to corruption and the quagmire we both lament.

2.      Barry Blackwell’s Reply to Mark’s earlier (unpublished) Commentary

It was a delight to read Mark Kramer’s informative and inspiring 50 page long commentary on matters relevant to the corruption essay. Both of us share similar academic credentials and each of us has worked in the pharmaceutical industry but at significantly different times. My own tenure (1968-1970) as Director of Psychotropic Drug Research for Merrell Corporation in the wake of the thalidomide disaster was mercifully brief, at a time when drug development was still driven more by science than commerce. Mark spent 13 years (1989-2002) as Head of Clinical Pharmacology at Merck and Co., during an era when the dominance of commerce over science was consummated, to which he responds passionately and constructively.

      Mark Kramer’s contributions both scientifically and philosophically are substantial and ongoing, whereas mine are trivial and overshadowed by a career devoted to medical education and diverse areas of scientific interest. This may explain a significant difference in our basic approaches to “biological psychiatry”. Mark defends its integrity as a discrete discipline, is somewhat dismissive of psychosocial approaches and is concerned about disparagement by the anti-psychiatry movement. While I share this latter concern, I view biological psychiatry as part of a biopsychosocial matrix in the understanding and treatment of psychiatric disorders that is consistent with first person accounts by the pioneers (Ayd & Blackwell 1971), lengthy biographies of their lives (Blackwell 2013-2015 on INHN.org) including Thudichum, Elkes, Berger, Calloway, Charalampous, Delay, Delgado, Lehmann, Lewis, Rickels, Smythies and Varga as well as 50 short Dramatis Personae in Volumes 4, 7 and 9 of the Oral History of Psychopharmacology (Ban 2011).

      We may agree that there is a need to cutback “20 fold” the use of mood altering drugs with the false hopes they engender but not that innovation might produce “non-addictive drugs for demoralization.” Mark likens this to SOMA in Aldous Huxley’s Brave New World, in which one character declares, “Hug me honey, drug me honey; half a gram of soma, hug me honey, drug me honey, till I’m in a coma.” This is hardly different from the street recreational drugs that Mark speculates might have triggered a decline in SSRI prescriptions. Frank Berger, discoverer of meprobamate, the first anxiolytic, believed emphatically that medication was not a substitute for philosophical or psychotherapeutic interventions in treating the troubles of daily living. (See the review of his book, published posthumously in INHN Biographies.)

       One understands that Mark “feels frustrated, embarrassed and hopping mad with the constant barrage on the science of biological psychiatry” (p.26, Open Hunting Season on Biological Psychiatry”). This may be why he alleges I endorsed Whitaker’s claim that psychiatric drugs inflict brain damage, creating chronicity. In p.3 of the essay (The Problem at Large), I provide a brief synopsis of each of the 7 books on which the essay is based, so as to provide readers with an idea of the author’s potential biases. In Whitaker’s case, I was sufficiently concerned to seek a second opinion and cited Fuller Torrey’s review of the book; he “refutes as unsubstantiated the claim there is any evidence of brain damage”, while he also acknowledges Whitaker “got many things right” and they agree that polypharmacy and over prescribing are in play. Conclusions with which I agree but Mark still claims I was “seduced and became a publicist” for Whitaker.

       That said, Mark’s intricate dissection of how biological psychiatry lost its way, how and why innovation failed to demonstrate meaningful efficacy is elegant, contributed to by lack of interest in the phenotype of disorders and DSM-oriented symptomatic diagnoses. Nor does he believe Research Domain Criteria (RDoC) are an adequate substitute for reasons he provides.

       Speculating on his own and the future of biological psychiatry, Mark balances his frustrations with the clinical needs of seriously ill psychiatric patients who “deserve so much more than a teardown of the field”. For this “lack of humanity,” he indicts “individuals now in our ranks who have betrayed their professional oaths of integrity”. In  my memoir, Bits and Pieces of a Psychiatrist’s Life, I have a bit on Mammon and Modern Medicine that deals with this topic and the lip service and disregard paid to the professional oaths medical students still swear from Hippocrates and Maimonides to a modern version devised by Lou Lasagna, father of clinical pharmacology. Each, in its own way, abjures against greed while the faculty looking on may worship Mammon and Midas (the M&M twins).

       In a concluding table on potential solutions, Mark concentrates primarily on Academia and Industry, proposing expulsion for professional societies, loss of academic standing and jail time for corrupt titans of industry. Although he lists all branches of government, he does not provide a strategy or goals, the area in which ideas and plans are most needed.

I believe we should analyze the legislative actions that led to the current situation and advocate for steps to reverse them particularly if the forthcoming elections create a Democratic President and majority in the Congress. Here is a list of possibilities:

1.      Revoke the Bay-Dole Act to end “technology transfer”, restore the integrity of academic programs and restrict the ability of industry to co-opt and control research while preserving its ability to finance development.

2.      Revise the Hatch Waxman Act to restrict monopoly rights on patented drugs and limit the capacity to extend patents for trivial modifications.

3.      Revoke the Prescriber Drug Use Fee Act and divert funds paid to FDA by industry to NIMH ($360 million annually).

4.      Use the money diverted to NIMH to restore one or more federally funded National Drug Evaluation units (Modelled on the NCDEU). Industry would be allowed to fund studies but not control design, data collection, statistical analysis or publication.

5.      Congress would require FDA to revise the IND process, including the mandatory inclusion of effective generic prototype compounds in Phase 2 and Post-marketing effectiveness studies.  Members of FDA advisory panels would be prohibited from receiving any compensation by Industry.

6.      Following the results of the November Election, all Democratic legislators will be provided with detailed evidence of corruption by industry and suggestions for corrective legislative action.

         If, in the wildest of dreams, such changes came to pass, I hope Mark would be offered and accept the leadership of a new National Drug Evaluation Unit.

         I shall look forward to and respond to comments from colleagues on INHN.

 

References

Ayd FJ, Blackwell B. Discoveries in Biological Psychiatry. Philadelphia: Lippincott, 1971

Ban TA. (Series Editor) An Oral History of Neuropsychopharmacology. Brentwood, Tennessee: ACNP, 2011.

Blackwell B. Bits and Pieces of a Psychiatrist’s Life Xlibris 2012 (review in INHN Biographies 8. 21. 2013).

Blackwell B. Jose Manuel Delgado: A distinguished but controversial career. in INHN Biographies; 5.30.2013.

Blackwell B. Review of A biography of Jean Delay by Driss Moussaoui in INHN Biographies; 2. 27.2014.

Blackwell B. Review of Asylum: A Mid-Century Mad House and its Lessons about our mentally ill today. in INHN Biographies; 4.10.2014.

Blackwell B. Review of Karl Rickels: A  Serendipitous Life: From German POW to American Psychiatrist. in INHN Biographies; 5.24.2014.

Blackwell B. Review of Frank M Berger: A Man of Understanding; a Noted Scientist’s Guide to Happiness. in INHN Biographies; 8.21.2014

Blackwell B., Goldberg DP. Sir Aubrey Lewis in INHN Biographies 1.29.2015

Blackwell B. Review of John and Vanna Smythies: Two Coins in the Fountain in INHN Biographies 4.16.2015.

Blackwell B. Joel Elkes: An Integrative Life. in INHN Biographies; 8.20.2015.

Blackwell B. Heinz Edgar Lehmann in INHN Biographies; 11.5 2015

Blackwell B. Comment on David Healy’s Shipwreck of the Singular on INHN.org in Controversies 04.21.2016.

Blackwell B, Charalampous K. Kanellos Charalampous: Confronting the Zeitgeist. in INHN Biographies; 12.24.2015.

Blackwell B. Ervin Varga: Family, Culture, Persona and Career. in INHN Biographies; 3.24. 2016.

3.      Addendum to 2

I agree that the problem extends beyond the bounds of psychopharmacology but, like Mark, decided to stick to what each of us knows best. The influence of money and greed over corporate integrity is ubiquitous in medicine and America today. We are congruent in believing that the various contributors to corruption share a common absence of moral integrity that legal recourse will not resolve. Thomas Jefferson had it right that corruption of the legislature is “fatal to every honest hope.” Mark may differ from my own opinion that our legislature is the primary source of corporate corruption and remains the only hope of remediation, but only if and when the three branches of government unite to stifle commercial dominance over moral integrity. Until that occurs the best we can do is to lay our concerns before the legislature and appeal to the public that elects its representatives. 

If we have a major disagreement it may lie in the meaning of “biological psychiatry”, the source of which is explored in my response to David Healy’s INHN essay, Shipwreck of the Singular. (Blackwell, 2016). Sadly this debate is hanging in the air awaiting the author’s response to several thoughtful commentaries. My own essay focusses on the manner in which medical education, physician roles and public expectations have corrupted the practice of medicine by placing biological and pharmaceutical interventions ahead of a balanced biopsychosocial perspective to address etiology and management of disease, sickness and suffering.

Barry Blackwell

November 3, 2016