a grief observed I…

Posted on Sunday 9 February 2014

Back in March 2012, Lisa Cosgrove and Sheldon Krimsky documented the extensive connections between DSM-5 workgroup members and  the pharmaceutical industry – criticizing the COI policy and suggesting changes:
PLoS Medicine
by Lisa Cosgrove and Sheldon Krimsky
March 13, 2012

Summary Points
  • The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
  • The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
  • Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
  • Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
At the time, I made this chart to illustrate their reported findings:
Then APA President John Oldham issued an immediate Press Release denying the analysis in their paper. Said APA CEO James Scully [lame…]:
In a statement, APA medical director and ceo James Scully says the DSM-5 development process ‘is the most open and transparent of any previous edition of the DSM. We wanted to include a wide variety of scientists and researchers with a range of expertise and viewpoints in the DSM-5 process. Excluding everyone with direct or indirect funding from the industry would unreasonably limit the participation of leading mental health experts in the DSM-5 development process.
The issue on the table at the time was the Task Force plan to eliminate the Bereavement Exclusion from the diagnostic criteria for Major Depressive Disorder. The obvious fear was that this was simply a move to open up the grief market for antidepressants [DSM-5 To The Barricades On Grief, a fundamental flaw…]. Again, APA President Dr. Oldham explained:
"What we know," Dr. Oldham said, "is that any major stress can activate significant depression in people who are at risk for it. It doesn’t make sense to differentiate the loss of a loved one as understandable grief from equally severe stress and sadness after other kinds of loss."
Then in December 2012, the Washington Post had an article about the extensive COI with PHARMA among DSM-5 Task Force and APA Guidelines members [Antidepressants to treat grief? Psychiatry panelists with ties to drug industry say yes], focusing specifically on the proposed elimination of the Bereavement Exclusion and the possibility of overmedication of normal grief. In that article, APA CEO Scully reiterated:
Each work group member was allowed to receive as much as $10,000 a year in income from pharmaceutical companies and hold as much as $50,000 in stock. Members could also receive unlimited amounts of money from pharmaceutical companies to conduct research. Scully said that if no financial ties were permitted, many knowledgeable psychiatrists would be excluded because so many university studies are funded by pharmaceutical companies.
And DSM-5 Task Force Chair David Kupfer responded with a Press Release defending the DSM-5 COI policies [Response to the Washington Post]. In an interview in Medscape, Kupfer added this addressing the footnotes designed to quell the rage:
… The Washington Post article also brought up criticisms about the DSM-5’s removal of the bereavement exclusion from the criteria for major depressive disorder, which would be replaced with cautionary notes for clinicians. But will these notes be enough to help differentiate between normal grieving and a potentially serious problem?

"Yes," Dr. Kupfer told Medscape Medical News. "This change draws clinicians’ attention to the distinctions between grief after a significant loss and depression. The exclusion criteria will be replaced by 2 notations — a footnote at the end of the criteria that cautions clinicians to differentiate between normal grieving associated with a significant loss and a diagnosis of a mental disorder, and a note embedded within the criteria that reminds clinicians that major depression and bereavement can coexist." "This provides greater guidance to clinicians to help make this distinction and ensures that it is understood that sadness, grief, and bereavement are not things that have a time limitation to them, as dictated in DSM-IV’s bereavement exclusion," he said.

He noted in the release that removing the exclusion "helps prevent major depression from being overlooked and facilitates the possibility of appropriate treatment, including therapy or other interventions."
Dr. Kenneth Kendler of the DSM-5 Mood Disorders workgroup had written the justification for removing the Bereavement Exclusion [see depressing ergo-mania…] and Dr. Stanley Zisook had published an article [industry funded and uncontrolled] using Wellbutrin to treat grief [see the what is absurd…]. But other than that, if there was anyone else on the planet who supported this change that wasn’t on the DSM-5 Task Force, I don’t know who they were. The outrage was universal with petitions signed by thousands circulating, particularly among the psychologists and bereavement counselors. In spite of the hue and cry, in December, the APA Board of Trustees approved the DSM-5 as written and it was sent to press for release in May 2013.

There was something else about that DSM-5 COI policy that we all noticed, but I for one didn’t foresee as being what it is turning out to be. Frankly, by January of 2012, I was exhausted with ranting about the DSM-5, exhausted and maybe disgusted. I’m a psychiatrist, and although I haven’t been an APA member for decades, I felt ashamed that the APA had behaved so badly along the way. So I focused my attention on other things [there are plenty to choose from]. I think it’s called scandal fatigue. But others saw the writing on the wall more clearly. Here’s what David Allen had to say at the time:
Family Dysfunction and Mental Health Blog
by David M. Allen MD
January 10, 2013

… David Kupfer, MD, chair of the DSM-5 Task Force, said in a news release"While speculation is bound to occur, we think it is important to stay focused on the fact that APA has gone to great lengths to ensure that DSM-5 and APA’s clinical practice guidelines are free from bias."

In his news release, in which he defended the policies regarding conflict of interest in the members of the different groups that were working on the DSM -5, published in the Psychiatric Times, he stated“… all individuals agreed that, starting in 2007 and continuing for the duration of each individual member’s work on DSM-5, that individual’s total annual income derived from industry sources [excluding unrestricted research grants] [italics mine] would not exceed $10,000 in any calendar year, and he or she would not hold stock or shares of a pharmaceutical or device company valued at more than $50,000."

So nothing to worry about?  No conflict of interest here? Unfortunately, that part I highlighted in the above quote is big enough to drive the proverbial truck through. As the article in the Washington Post of 12/26/12, pointed out, “Members [of the various task forces creating the new DSM] could also receive unlimited amounts of money from pharmaceutical companies to conduct research.”

If the drug companies are supporting the research of an "expert," how is that not financial influence?  Most of these experts are academics; if they do not get funding, they often cannot keep their jobs! Depending on Pharma for your income is hazardous to your objectivity. This very sly loophole in disclosure and conflict-of-interest rules has also been exploited by some Pharma-funded researchers who label themselves as “unpaid consultants” in the “disclosures” attached to journal articles…
and more
So what? you ask. What if there are ongoing trials with DSM-5 workgroup members as Primary Investigators. Aren’t all the antidepressants finally going off patent? Can’t we finally breathe a sigh of relief?
  1.  
    February 9, 2014 | 1:34 PM
     

    So which of the grief experts on the DSM-5 committee got grants from Eli Lilly?

    See Newsweek article saying the Cymbalta manufacturer is exploiting the DSM-5 redefinition of grief to get a patent extension on the blockbuster antidepressant for “bereavement-related depression” http://mag.newsweek.com/2014/02/07/pill-ill.html

  2.  
    February 9, 2014 | 1:36 PM
     

    I’m getting there. I’m writing as fast as I can!

  3.  
    February 9, 2014 | 2:29 PM
     

    The suspense!

  4.  
    February 9, 2014 | 11:02 PM
     

    Hi,

    I just wanted to mention that the APA did a “neuroimaging markers” report in 2012 where they tried to essentially throw a bunch of math at fMRI in order to generate a method that can reveal psychiatric illness.

    of course, this is a very challenging problem (it was rumored to be pursued by the great Sir Isaac Newton as an application for his laws) and they failed miserably. see here: http://www.psych.org/File%20Library/Learn/Archives/rd2012_Neuroimaging.pdf

    they have, since, tried to hold me down. i have had experiences with a few doctors at NYU langone who have been nothing short of amazing (dr michael milham especially, and a few of his colleagues).

    in short, if you look at my thesis on my webpage in the future work, i allude to the underpinnings of the method that produces 80% on 3 different disorders using a consistent experimental design inspired by the greats from the 1960s (David Ingvar, Goran Franzen and Niels Lassen). If you google their study (ingvar franzen 1974) you’ll see essentially the approach that this mathematical method allows (it’s very powerful).

    you can contact me at the listed email for any other questions.

    i’m delighted i found your blog. again, check the future work section of my thesis, ingvar & franzen’s 1974 study, and the neuromarker report from the APA given above.

    put 2 and 2 together. i am being held down by these very same beaurocrats. there is a very promising medical tool on the horizon that is being short shrift because it’s my intellectual property (and thus the drug companies are the mercy of the scientific community, as the research must demonstrate causation between brain regions and the disorder).

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