only one question…

Posted on Friday 1 June 2012


Senator complains to NIH about UM doctor
Sen. Charles Grassley sent a letter questioning the National Institutes of Health about a grant for a University of Miami doctor.
Miami Herald
By John Dorschner
May 31, 2012

Sen. Charles Grassley, R-Iowa, has sent a letter to the National Institutes of Health demanding to know why the NIH recently gave University of Miami psychiatrist Charles Nemeroff a grant of about $400,000 a year for five years.Grassley pointed out that he had criticized Nemeroff earlier for “failing to fully disclose industry income” when he was publishing papers about the effects of drugs. Those accusations concern events when Nemeroff was at Emory University. Previous investigations by Grassley’s staff concerned allegations from 2008 that Nemeroff failed to disclose $1.2 million in consulting arrangements from GlaxoSmithKline, maker of the antidepressant Paxil, while leading a $9 million NIH grant studying depression.

UM and Nemeroff did not immediately respond to a request for comment, although Nemeroff has previously said he did nothing wrong. He told the Herald previously that news reports had not made clear that his talks were about GSK drugs now on the market, while his research funded by NIH involved basic lab studies of GSK chemical compounds that were years away from market. That work did not promote GSK products, he said…

A commenter noticed that I used the "S" word [Sociopath] in my last post about Dr. Nemeroff. I’m not proud of that. I should have said "crook." I think I must be really mad about all of this and used a diagnostic word as an invective.  But a card laid is a card played and it is what I think. This is the stuff that makes me so angry, "Nemeroff has previously said he did nothing wrong. He told the Herald previously that news reports had not made clear that his talks were about GSK drugs now on the market, while his research funded by NIH involved basic lab studies of GSK chemical compounds that were years away from market." That statement is actually true [except for the did nothing wrong part]:
This application, in response to RFA: MH-03-008 […], proposes the creation of "The Emory-GSK-NIMH Collaborative Mood Disorders Initiative." This unique opportunity to accererate antidepressant drug development brings together expertise of three complementary research groups: the Emory University School of Medicine Department of Psychiatry and Behavioral Sciences, the Mood and Anxiety Disorders Program at NIMH and the Center for Excellence in Drug Discovery in Psychiatry of GlaxoSmithKline, one of the largest multinational pharmaceutical companies. The two major goals of the current application are the development of innovative new models for basic and clinical research in mood disorders and the intensive scrutiny of 5 novel GSK antidepressant candidates in preclinical and clinical paradigms. In addition to an Administrative and Animal/Assay Core, 7 research projects are proposed…
What difference does it make what GSK was paying him for? They were paying him money while he had an NIMH grant with them. And, in addition, he didn’t report the income to Emory. I recall his excuse was that he didn’t know giving talks counted [having been censored previously for the same thing]. And when he was busted for a ghost written textbook, it wasn’t ghost written because he had scrutinized the galleys and added marginalia. And when he published an infomercial for a device he had a financial interest in [as did all the other authors] without declaring it, he said it was a publishing error that omitted the declaration [he was the editor of the journal][it was ghost-written]. And subsequently, another article of his about Risperdal augmentation in depression [also in his journal] had two quick Corregium correcting left out conflicts of interest and a grossly distorted value that changed the outcome, shortly after he was busted for the previous one. So after such a listing of improprieties and lame excuses, the usual practice is to bury the conclusion in innuendo rather than use the implied indictment directly. I didn’t do that. I think it’s because I had just read this NIMH description of his new grant and found it infuriating:
DESCRIPTION (provided by applicant): Post-traumatic Stress Disorder [PTSD] is one of the most highly prevalent psychiatric disorders and its prevalence is likely increasing in the United States and worldwide due to the rising numbers of natural disasters [earthquakes, hurricanes, tsunamis], man-made disasters [oil spills], terrorism and wars, as well as violent crime and automobile accidents.
    I call this the Apocalyptic Public Health Argument, a standard in the writings of such people. It was perfected by his ghost-writer, Sally Laden, years ago, but has now become an industry standard. It’s has been a particular favorite of  people like Tom Insel and Depression researchers creating pseudo-epidemics.
Although the majority of trauma victims experience the cardinal symptoms of re-experiencing, avoidance and hyperarousal, for the large majority of such individuals, these symptoms do not become chronic nor do they develop syndromal PTSD. It is important to identify the large minority of trauma victims with a high likelihood of developing PTSD because of the very significant medical and psychiatric morbidity and mortality associated with this disorder.
    This is a fairly common non-clinician view of PTSD, the fact that not all people in a given situation develop PTSD. Long ago, this definhed bravery or cowardice. A more modern interpretation is that the unafflicted have something called resiliency or that the afflicted have some kind of biological vulnerability. These are tautologies – the invention of attributes with circular definitions [that define themselves].
There is already considerable evidence that the likelihood of developing PTSD after trauma exposure is due to a combination of genetic and environmental factors.
    While there may be factors in an individual that are important, the evidence that they are "genetic" is quite speculative and a particular obsession of Dr. Nemeroff himself who can create a biological/genetic argument for any human experience.
This two-site, linked R-01 application seeks to utilize state-of-the art advances in genomics, transcriptomics and epigenetics, coupled with comprehensive clinical and psychological measures, to address this seminal unanswered question in PTSD clinical service and research.
    Hardly a ‘seminal unanswered question,’ but note the use of big words and ‘state-of-the-art.’ That’s Charlie’s MO – engaging concepts on the front end of science. In what follows, there are more examples: "novel genetic and epigenetic risk factors and most importantly, the primary downstream effects of these genomic and epigenetic findings by the use of conventional and newer statistical modeling methods" being a particularly eloquent example.
To achieve this goal, 500 trauma-exposed subjects will be recruited at the University of Miami Ryder Trauma Center and the Emory University affiliated Grady Memorial Hospital and followed at regular intervals for one year. This focused, hypothesis-driven study will scrutinize previously identified psychological and biological risk factors. Genetic risk factors include polymorphisms of the ADCYAP1R1, FKBP5, DAT, BDNF, COMT, CRFR1, 5HTTLPR, RGS2, GABA2 and 5HT3R genes, novel genetic and epigenetic risk factors and most importantly, the primary downstream effects of these genomic and epigenetic findings by the use of conventional and newer statistical modeling methods.
     The endings are always the same, fantastic and global. They follow the ‘translational’ motif and invariably lead to the creation of more patients to be treated in some as yet undefined way.
These findings should provide the means to identify trauma survivors who will likely develop PTSD and can therefore be referred for appropriate psychotherapeutic and/or psychopharmacologic treatment. Such a strategy has the potential to help redefine psychobiological subtypes of PTSD as well as to reduce the burden of chronic PTSD on our healthcare system. PUBLIC HEALTH RELEVANCE: Exposure to severe trauma is, unfortunately, extraordinarily common in the United States and worldwide, and consequently the prevalence rate of posttraumatic stress disorder [PTSD] is among the most common of the severe major psychiatric disorders. The fundamental unanswered question in the field is how to identify markers in trauma victims that predict who will later develop PTSD. The ability to identify those individuals with a high likelihood of developing PTSD will permit the development of a preventative intervention strategy that can be implemented appropriately and efficiently.
His approach here is similar to the current study he’s signed onto of ‘treatment resistant’ depression [iSpot] – using genotype to select antidepressants based on similar fuzzy logic.

Having spent a large chunk of my adult life treating people with PTSD, I could go off of on a rant about why this is an absurd study based on layers of misunderstanding, but I’m going to resist the temptation. Likewise, having read his previous publications in this area based on patients recruited from the waiting rooms of a large charity hospital, again I’ll pass on an critique. What I’d rather say is that this is a typical Nemeroff production – leading edge topics and science melded with a fanciful hypothesis and guaranteed non-results. As of today, he has 651 articles in PubMed chasing similar ‘breakthroughs’ without a single contribution of note to the scientific body of knowledge. His major contribution has been to bring scandal to every corner of psychiatry and eat up a lion’s share of scarce research resources.

We are as of yet unable to nail the genetic markers for illnesses we know have genetic components – Alzheimers, Schizophrenia, Manic Depression. The time for genetic fishing expeditions looking for ‘maybe genetic factors’ is in a future unlikely ever seen by living scientists. And it will be done by Geneticists, not hobbyists. The funding of this study for this investigator at this time raises only one question: What is wrong with the NIMH funding process?
  1.  
    June 1, 2012 | 1:47 PM
     

    There have been more refugees from environmental disasters than from wars for the better part of this century. I’ve got this crazy idea that most of these people need to have their most basic needs met and need to have reasonable hopes for a better future before they need to be offered drugs. It’s difficult to recover from anything when you’re whole world has been ripped out from under you and everyone you know.

  2.  
    June 1, 2012 | 2:28 PM
     

    I was glad to see your candid use of “sociopath”, frankly he has something wrong with him that could be in the DSM5 IMO that goes beyond greedy and unethical– no more excuses for people who commit crimes and that is what Nemeroff does; he evades the truth, and conveniently ignores what is right or legal. What would Grassley call him? what do we call someone constantly breaking the law? just a “good guy”?

  3.  
    June 1, 2012 | 2:30 PM
     

    PS I could place him on the same “Axis of Evil” with Joseph Biederman I guess.

  4.  
    Joel Hassman, MD
    June 1, 2012 | 10:45 PM
     

    You really think we have just a few colleagues who’s behaviors and actions aren’t directly defined as Narcicistic or Antisocial? Yeah, I would agree sociopath is a bit of a stretch, but if it comes out he played a sizeable role in promoting the use of a medication that had much more harm than benefit, what is the end result that differs from this versus a drug dealer selling heroin or coke?

    I do know this, we have too many whores and cowards that pretend to be physicians allegedly helping people with mental health problems.

  5.  
    June 2, 2012 | 3:02 PM
     

    Not wanting to diagnose a person makes some sense, but I see no reason that a psychiatrist should not be able to call out sociopathic, abusive and dehumanizing behavior and beliefs. Psychiatrists are also capable of being grandiose and lacking insight— even as they practice psychiatry. T

    The continued refusal of other psychiatric professionals to keep each other in check has led to the exercise of pathology to the point that the whole institution is corrupt. This, of course, is a problem with many professions; but psychiatry relies so much on professional faith that it allows itself to abuse vulnerable and trusting people in order to prop up it’s unproven and misguided notions as law..

  6.  
    June 2, 2012 | 4:11 PM
     

    Well, the vote is in. Sociopath it is…

  7.  
    medulla
    June 3, 2012 | 10:23 PM
     

    The use of innuendo may be the “usual practice”, and maintenance of decorum certainly has its time and place, but isn’t it the very (protracted and pervasive and comfortable) “practice of the usual” that got us all – as a profession, culture, society, a nation even, into all sorts of pathologies that we are confronting/confronted by these days?
    So, Sir, I would like to encourage you to please continue to be vivisectionally frank – with both us, the audience, and yourself, as the “1 boring old man”: it’s much more therapeutic for all, I believe. And we need that – the therapeutic, right now in a very bad way. (Sunshine remains the best disinfectant from both a personal and public health perspective, no?)
    But, then again, it’s easy for one to talk the talk under the cloak of (relative) anonymity…
    At any rate, I admire you and your motives – both the overt and not so overt ones, very much indeed. Thank you.

  8.  
    Carl
    June 6, 2012 | 7:37 AM
     

    And a vote for “vivisectionally frank” as “Best Use of English Language Phrasing in Non-Fiction”.

  9.  
    June 7, 2012 | 7:52 AM
     

    Hi Mickey,

    I occasionally read your blog and generally appreciate what you have to say.

    In this particular instance, while I do completely agree with your overall sense of what Dr. Nemeroff is doing, I would not call him “sociopathic”; for, I’m not into pathologizing human behaviors – because, to pathologize is, “to view or characterize as medically or psychologically abnormal” (at least, it is according to Merriam-Webster’s Dictionary); and, so, there’s a very fine line (and slippery slope) which stands between ‘pathologizing’ and ‘medicalizing’ ones behaviors.

    And, I do not wish the medicalization of behaviors, upon anyone who might not choose that, of his/her own accord – not even were s/he to qualify as the proverbial ‘worst enemy.’

    Being one who, many years ago, as a young man, had his behaviors forcibly medicalized (and then, repeatedly, forcibly medicalized, because those medicalized behaviors were given a pathologizing label), I’ve come to reject all labels which pathologize human behaviors.

    Indeed, in my being now, nearly a quarter of a century, happily free of psych-meds (which top psychiatrists had insisted were absolutely necessary for my survival), my observation, time and again, has been, that: psychiatry has designed most of its ‘diagnostic’ labels, mainly to ‘justify’ drugging people – often against their will.

    Of course, there are real/tangible physical diseases (e.g., Alzheimer’s) which can lead to genuinely problematic behaviors, which may be ameliorated, at least temporarily, by psychopharmacology.

    But, you write, “We are as of yet unable to nail the genetic markers for illnesses we know have genetic components – Alzheimers, Schizophrenia, Manic Depression,” so you seem to lump these three (what you call “illnesses”) together; and, I wonder: why do you conflate the three? And, why do you even call all three “illnesses”??

    And, do you really mean to suggest, that it’s your belief, genetic markers will eventually be found for all three???

    You may or may not be meaning to imply such a belief.

    But, if you do really put all three in the same category and think of all three as “illnesses” being somehow derived from equally tangible/bio-physical/genetic causes, then I believe you are terribly mistaken.

    First of all, I believe, in fact, there is no clear separation between most of what is called “schizophrenia” and most of what is called “manic depression”; so, the causes of most effects, which lead to application of these two, seemingly separate labels, may be (in many instances – or most) largely identical.

    But, moreover, in my view, it’s ‘fuzzy thinking’ which leads people to presume genetic markers shall eventually be found for so-called “schizophrenia” and/or so-called “manic depression” (or, so-called “bipolar 1,” which is generally considered to be synonymous with “manic depression”).

    These are not “illness,” after all (at least, not before psychiatry makes them into iatrogenic conditions); at their outset, these are, for the most part, variable sets of behavioral and emotional effects – born of more or less clearly evident environmental stressors.

    And, while, yes, some people may be genetically inclined to develop a greater ‘sensitivity’ to certain environmental stressors, nonetheless, anyone, given the ‘right’ mix of excessively stressful circumstances (including, perhaps, certain long-brewing, underlying interpersonal and/or relational conflicts) could be led to develop a condition ‘diagnosable’ as either “schizophrenia” or “manic depression”/“bipolar 1”.

    As I get, from reading your blog, that you are a genuinely intelligent/observant psychiatrist (or, retired psychiatrist), who is really an adept analytical thinker, I wonder: can you not imagine that I might be right about some or all of what I’m saying here???

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