a clinical trial…

Posted on Wednesday 7 December 2011

Says Jamzo:
    The APA Nominating Committee reports the following slate of candidates for the 2012 Election. Please note that this slate is considered public, but not official, until the Board approves it at their December 2011 meeting:
    President-Elect
    • Renee L. Binder, MD
    • Mary Helen Davis, MD
    • Jeffrey Lieberman, MD
When I read these nominations, I had an immediate reaction. Whenever I see Dr. Jeffrey Lieberman‘s name, my thoughts go immediately to 2006 when I learned of Dr. Nemeroff’s article in the Journal he edited [Neuropsychopharmacology] praising a product he had a financial stake in without acknowledging that interest. Shortly thereafter, this letter appeared in the Wall Street Journal supporting Nemeroff. I knew most of the signers of that letter from the Emory faculty. But there were others from elsewhere, including Dr. Lieberman [non-Emory signers at the end of the letter below]. Here’s what the AHRP had to say at the time:
… letters in The Wall Street Journal [below] raise serious questions — including the propriety of a letter signed by 45 signatories — of who 38 are junior level faculty [Assistant Professors] at Emory where Dr. Nemeroff is “the boss of bosses.”  They wrote: ““Dr. Nemeroff’s extremely productive and successful career as a leader in academic psychiatry, we have the utmost respect for his science and ethics.” If 38 of Emory’s faculty have “utmost respect for his science and ethics” — which have earned him considerable criticism, one must wonder about the scientific and ethical culture at Emory!  Additionally, questions surely arise about how easy it might be for subordinates to refuse to show solidarity with “the boss of bosses.” The other seven signatories hold positions of authority and have almost as much of a financial stake in the business of psychiatry as does Dr. Nemeroff. [Alliance for Human Research Protection]
The Wall Street Journal
Letters to the Editor
Needless Furor Harms Outstanding Psychiatrist
19 September 2006

The furor arising from your article about the absence of a potential conflict of information statement in a scientific paper on vagal nerve stimulation therapy for depression ["Medical Journal Editor Nemeroff Steps Down Over Undisclosed Ties," Aug. 28] has potentially harmed the fields of medicine and psychiatry.

Dr. Nemeroff was the lead author of the article in question, and all of the required individual conflicts were submitted to the journal, of which he was the editor, but they weren’t included due to a regrettable oversight at the level of administrative publication. Thus, the concern about this is much overdone, as Dr. Nemeroff has reported his collaboration with the maker of vagal nerve stimulators in numerous other publications, as well as public and academic presentations. Dr. Nemeroff’s decision not to pursue another appointment as editor of Neuropsychopharmacology is highly unfortunate, as this journal is more focused on the biological mechanisms of psychiatric diseases and their treatments than any other, and Dr. Nemeroff is extremely well-qualified to lead it.

Due to Dr. Nemeroff’s extremely productive and successful career as a leader in academic psychiatry, he and others like him are asked to be on the boards of many pharmaceutical firms specializing in central nervous system agents. Through such collaborations, the development and testing of novel treatments are greatly enhanced and the safety of research subjects strengthened. Yes, these companies must make profits, but they also share with researchers a desire to find scientific truth, which usually isn’t as clear-cut as many believe. The overwhelming majority of academic researchers are proud of their independence and are dedicated to advancing their fields through quality research. At a time of diminishing funding, does it not make sense for industry-sponsored support to provide a viable alternative, especially if available in a no-strings-attached way with sufficient academic research oversight?

We are academic psychiatrists and researchers who are colleagues of Charles Nemeroff, and we have the utmost respect for his science and ethics. Some of us receive research support from pharmaceutical companies, some from federal agencies, some from both and some from neither. All of us want the best for the fields of science, medicine and psychiatry in their endeavors to better humanity.


Robert N. Golden, M.D.  Dean, School of Medicine, U. Wisconsin Madison… 

Ned H. Kalin, M.D. Chairman, Dept. Psychiatry, University of Wisconsin… 

Martin B. Keller, M.D.  Chairman, Dept. Psychiatry, Brown University…

Jeffrey A. Lieberman, M.D.: Chairman Department of Psychiatry, Columbia University College of Physicians and Surgeons…

Thomas Schlaepfer, MD: Assistant Professor Dept. of Psychiatry, Johns Hopkins…

Michael E. Thase, M.D: Professor of Psychiatry, University of Pittsburgh Medical Center and the Western Psychiatric Institute and Clinic, Pittsburgh, PA…

By 2006, Dr. Nemeroff was completely out of control. I didn’t know how far out back then, but I knew enough to feel glad that someone had finally called his hand. The list of people signing from Emory made me sad. I knew most of them, and with some exceptions, they were decent people captured in the Nemeroff spell. But those outside people? They weren’t spellbound. I suspected that they were in the game too [even though back then I had no clue what the game really was, or how corrupt it had become]. Since then, that list has been branded on my mind.

Is it fair to say that by signing that letter, Dr. Lieberman disqualified himself forever as being President of the American Psychiatric Association? After all, he’s a Chairman at Columbia and he directed CATIE, a clarifying study of the Atypical Antipsychotics. He wasn’t on Grassley’s 2008 list. Maybe he was just one of Nemeroff’s personal friends, like pals or something like that. Since then, Lieberman’s articles always say that he accepts no payment for being an advisor to drug companies. So I decided to do a study to decide if he has been a party to the dark side of psychiatry. I would go to PubMed and put this into a search – lieberman j[Author]) AND nemeroff c[Author]. It would be like a clinical trial – I’d declare my outcome parameter before hand. And the envelope please…
From clinical research to clinical practice: a 4-year review of ziprasidone.
by Nemeroff CB, Lieberman JA, Weiden PJ, Harvey PD, Newcomer JW, Schatzberg AF, Kilts CD, and Daniel DG
CNS Spectrums. 2005 10(11 Suppl 17):1-20.
[full text on-line]

Ziprasidone is a second-generation antipsychotic that received Food and Drug Administration approval in February 2001. It has a unique receptor profile that includes high-affinity antagonist activity at dopamine D2 receptors, inverse agonist activity at serotonin (5-HT)2A receptors, agonist activity at 5-HTlA receptors, and a relatively high affinity for the serotonin and norepinephrine transporters. The 5-HTIA affinity, together with the inhibitory effect on mono-amine reuptake, may underlie the hypothesized beneficial effects on comorbid affective and cognitive abnormalities in schizophrenia and schizoaffective disorder. The short-term efficacy of ziprasidone for core positive symptoms of schizophrenia appears to be comparable to other conventional and atypical antipsychotics. The short-term efficacy of ziprasidone in acute mania has been established based on two 3-week, double-blind, placebo-controlled trials.Open-label treatment for up to 52 weeks confirms the sustained efficacy and safety of ziprasidone in bipolar disorder. Maintenance studies in schizophrenia and schizoaffective disorder indicate that long-term ziprasidone therapy is effective in preventing relapse, while maintaining cognitive and psychosocial benefits. The safety database suggests that the overall cardiovascular and cerebrovascular risk associated with ziprasidone is lower than with other atypicals, with notably lower risk of drug-related increases in weight, glucose, or lipids. The data also suggest a modestly increased risk of QTc prolongation that is not dose related or linked to torsades de pointes. Switching to ziprasidone from other atypicals appears to improve both clinical symptoms and metabolic parameters, though more studies are needed to fully characterize these benefits. This monograph summarizes the efficacy, tolerability, and safety of oral ziprasidone in the treatment of schizophrenia, schizoaffective disorder, and bipolar mania.
This, from the article:

This Clinical Information Monograph is based in part on an expert consensus roundtable entitled “From Clinical Research to Clinical Practice: A 4-Year Review of Ziprasidone,” held in New York City on June 27-28, 2004. The meeting was moderated by Prakash S. Masand, MD, and contributors included David G. Daniel, MD, Philip D. Harvey, PhD, Clinton D. Kilts, MD, Jeffrey A. Lieberman, MD, Charles B. Nemeroff, MD, PhD, John W. Newcomer, MD, Alan F. Schatzberg, MD, and Peter J. Weiden, MD.

This clinical information monograph is supported by Pfizer, Inc. Support of this monograph does not imply the commercial supporters’ agreement with the views expressed herein. Although every effort has been made to ensure that the information is presented accurately in this publication, the ultimate responsibility rests with the prescribing physician. Neither the publisher, the sponsor, nor the participants can be held responsible for errors or for any consequences arising from the use of information contained herein. Readers are strongly urged to consult any relevant primary literature. No claims or endorsements are made for any drug or compound at present under clinical investigation.

The article itself is an advertisement for Geodon [Ziprasidone] with lots of slick slides and tables. I would personally bet a reasonable sum that this round-table never occurred. There’s nothing in the article that suggested it did. If they met at all, it was to hear what Pfizer had put together. Maybe they talked about golf. Who knows? But if you doubt my cynicism, read it yourself and see if I’m being unreasonable [and anyway, I declared my outcome variable in advance].

So, in 2004, Dr. Lieberman signed on to an infomercial for Pfizer’s Geodon with Dr. Charlie Nemeroff and Emory’s research director [Clinton D. Kilts, MD]. Nemeroff pal Alan Schatzberg was in the house. That was before CATIE was published, before Nemeroff’s fall, before Alan Schatzberg’s "stepping down" at Stanford. There are plenty of other signs that Dr. Lieberman is in the game, though he is much more careful these days. This article itself is enough for me to see a morality that is seriously flawed. This is a time when the APA is going to have to deal with a DSM-5 Revision that is both troubling and troubled. We don’t need an APA President who was/is in the game and then tried to play it clean after the hammer fell. Signing on to that letter defending Dr. Nemeroff’s ethics? Signing on as a "guest author" to Pfizer’s Geodon Infomercial? Pathognomonic symptoms that can’t be ignored…
  1.  
    December 7, 2011 | 11:28 PM
     

    Re: the “boss of bosses” (and difficulty refusing to show solidarity)…

    Is this medicine or is this the mob?!

    Duane

  2.  
    December 7, 2011 | 11:33 PM
     

    Duane,
    Yes.

  3.  
    December 7, 2011 | 11:41 PM
     

    Mickey,

    Well then, if I were you, I’d give the brakes in your car a good check every morning… You never know when a brake can go out in the middle of the night…

    On a more serious note, I’m not alone when I say, “Thank-you, sir” for all you’re doing to get the word out, including the countless hours you obviously put into sorting through the science, presenting the facts, and to the getting to heart of the matter.

    My best,

    Duane

  4.  
    Peggi
    December 8, 2011 | 8:28 AM
     

    Amen Duane. Thank you sir. Power corrupts and absolute power corrupts absolutely and all that jazz.

  5.  
    December 8, 2011 | 10:13 PM
     

    How is it that Alan Schatzberg shows up in every single pharma-psychiatry scheme? He is the evil Zelig of psychiatry.

    Clearly, it’s a club. Whenever you see a psychiatry “expert consensus” and pharma sponsorship, you’ll see the same rotating cast of the usual suspects.

  6.  
    December 8, 2011 | 11:17 PM
     

    Altostrata,

    And the meaning of “the usual suspects” has become increasingly clear. My premise is that Jeffrey Lieberman’s presence in the company of “the usual suspects” brands him, particularly in one of those made-up roundtable, PHARMA-generated, infomercials. You don’t get there just by happenstance. You went to that neighborhood knowing the story. And if you went there once, you can go again. Lieberman’s been there lots of times [the CAFE study for example]. It’s a testimony to the level of denial in the high places of psychiatry that he was even nominated. Wasn’t one of those guys as president [Alan Schatzberg] enough for this century?

  7.  
    December 17, 2011 | 9:42 AM
     

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