must be crazy…

Posted on Thursday 15 March 2012


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.
Conclusion:

The DSM-5 will be published in about 14 months, enough time for the APA to institute important changes that would allow the organization to achieve its stated goal of a “… transparent process of development for the DSM, and …an unbiased, evidence-based DSM, free from any conflicts of interest” [emphasis added]. Toward that goal we believe it is essential that:

  1. As an eventual gold standard and because of their actual and perceived influence, all DSM task force members should be free of FCOIs.
  2. Individuals who have participated on pharmaceutical companies’ Speakers Bureaus should be prohibited from DSM panel membership.
  3. There should be a rebuttable presumption of prohibiting FCOIs among the DSM work groups. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the DSM panels, but they would not have decision-making authority on revisions or inclusion of new disorders.

These changes would accommodate the participation of needed experts as well as provide more stringent safeguards to protect the revision process from either the reality of or the perception of undue industry influence.

I re-sorted their DSM-5 Workgroup data to illustrate this point from their article:
Three-fourths of the work groups … continue to have a majority of their members with financial ties to the pharmaceutical industry. It is also noteworthy that, as with the DSM-IV, the most conflicted panels are those for which pharmacological treatment is the first-line intervention. For example, 67% (N = 12) of the panel for Mood Disorders, 83% (N = 12) of the panel for Psychotic Disorders, and 100% (N = 7) of the Sleep/Wake Disorders (which now includes “Restless Leg Syndrome”) have ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry.
Pharmalot has a good summary. It includes this statement:
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.”
I wonder how many times Scully, Kupfer, and Regier think they can say things like this without creating a global boycott of their beloved DSM-5? That graph up there is absurd. And his comment "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" is exactly the point everyone is making over and over. Reminds me of that wonderful movie title – The Gods Must Be Crazy
  1.  
    March 16, 2012 | 8:27 AM
     

    Mickey, you’ll probably hear from the APA, too, but hours after I published a recent post on my blog about DSM-5 I received this email from the APA Communications Office:

    http://www.scribd.com/doc/85601147/APAresponse031512

    Basically, it contains APA President John Oldham’s rejection of Cosgrove & Krimsky’s conclusion, and his “strong” statement that 72% of the DSM-5 task force and work group members report NO relationships with the pharmaceutical industry during the past year.

    To quote the kids today: “just sayin’.”

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