open letter to the APA…

Posted on Tuesday 21 January 2014

Open Letter to the Board of Trustees and the Assembly of the
American Psychiatric Association



January 21, 2014

It has been a dark time for psychiatry. Since the investigations of Senator Grassley exposed significant corruption and unseated three chairs of Psychiatry in 2008, there has been a series of disturbing exposures involving widespread ghost writing, guest authoring, and questionable clinical trial reporting; escalating widely publicized settlements by pharmaceutical companies involving psychoactive drugs and implicating prominent psychiatrists; charges of overmedication and entrepreneurialism; the drying up of the pharmaceutical pipeline; recurrent charges of ubiquitous Conflicts of Interest in high places; and an ongoing and divisive process that spanned the DSM-5 Revision process. Besides the gravity and frequency of the problems, their handling by the administrative levels in our specialty have played poorly in the eyes of the public and our currency is at an all time low.

The recent revelations of multiple unreported Conflicts of Interest by the Chair and other members of the DSM-5 Task Force threaten to throw gasoline on an already uncontrolled fire. The public memorandum from the Speaker of the Assembly, Dr. Mindy Young, reads more like a defense attorney’s closing argument than an impartial investigation, and is being viewed as a "whitewash" – threatening to add to our reputation of sweeping things under the rug rather than thoroughly exploring and dealing with charges of impropriety. It focuses on the concrete impact of their actions, but doesn’t address the more cogent issue of conduct unbecoming persons of high responsibility – people we entrust to make important decisions. Our specialty is in a steady decline, much of it our own making, and we don’t need to help it along by ignoring this obvious issue of integrity.

I have prepared below a Timeline of the major events in these revelations, with links to the salient documents involving Dr. Kupfer and his business associates. I have also provided a link to commentary by a respected weblog professional, Neuroskeptic. I ask you to read these materials carefully and appoint an outside panel that can review them independently. The Trustees approaching this issue with integrity, open-mindedness, and thoroughness will go a long way towards restoring our reputation as the ethical medical specialty that we need to be, and set a new precedent that Conflicts of Interest will be thoroughly pursued.


TIMELINE:


  Date Public   Submitted Accepted Published Disclosure

1 07/01/1993 Exactly what does the Hamilton Depression Rating Scale measure?
by Gibbons RD, Clark DC, and Kupfer DJ.
Journal of Psychiatric Research. 1993 27(3):259-273.
"… the HDRS total score is a weak index of depressive syndrome severity. The findings provide a benchmark by which the adequacy of future results may be judged, because the multidimensional IRT model does not suffer from the statistical limitations that arise when applying traditional factor analytic methods to discrete symptom ratings…"
2 2002-2010 COMPUTERIZED ADAPTIVE TESTING – DEPRESSION INVENTORY
NIMH Project MH066302
NIH RePORTER
"Total project funding amount for 9 projects is $4,958,346"
3 2002 A Research Agenda for DSM-V
edited by David J. Kupfer, Michael B. First, and Darrel A. Regier,
"DSM-IV and ICD-10 are both categorical classifications or typologies, and so were all their predecessors. In principle, though, variation in the symptomatology of mental disorder could be represented by a set of dimensions rather than by multiple categories…"
4 11/01/2005 Dimensional Models for Research and Diagnosis: A Current Dilemma
in Toward a Dimensionally Based Taxonomy of Psychopathology
by Kupfer, David
Journal of Abnormal Psychology. 2005 114[4]:557-559.
"Ultimately, new methodological strategies need to be incorporated that address both categorical and dimensional aspects of the overall diagnostic framework. These refinements will be vital in determining the extent and reality of co-occurrence of disorder and the determination of boundaries across specific disorders."
5 04/01/2006 Kupfer appointed chair DSM-5 Task Force
6 04/01/2008 Using Computerized Adaptive Testing to Reduce the Burden of Mental Health Assessment
by Robert D. Gibbons, David J. Weiss, David J. Kupfer, Ellen Frank, et al
Psychiatric Services 2008 59:361–368.
"Instead of using small fixed-length tests, clinicians can create item banks with a large item pool, and a small set of the items most relevant for a given individual can be administered with no loss of information, yielding a dramatic reduction in administration time and patient and clinician burden."
7 03/27/2009 Dr. Jane Costello resigns from the DSM-5 Child and Adolescent Disorders workgroup. In her letter of resignation, she said:
"…The tipping point for me was the memo from David and Darrell on February 18, 2009, stating “Thus, we have decided that one if not the major difference between DSM-IV and DSM-V will be the more prominent use of dimensional measures inDSM-V”, and going on to introduce an Instrument Assessment Study Group that will advise workgroups on the choice of old scale measures or the creation of new ones."
8  unk Drs. Robert Gibbons and Paul Pilkonis appointed as Expert Advisors to the Instrument Assessment Study Group
9 11/29/2011 Psychiatric Assessments Inc. incorporated in Delaware [enter File #5072041].
10 01/23/2012 Psychiatric Assessments Inc. incorporated in Illinois [enter File #68256313].
11 08/31/2012 Yehuda Cohen, a professional management executive, registers Adaptive Testing Technologies website. Mr. Cohen is featured as a principal on the corporate website. .
12 10/23/2012 Privacy Policy posted on the website.
13 11/01/2012 Development of a computerized adaptive test for depression.
by Gibbons, Weiss, Pilkonis, Frank, Moore, Kim, and Kupfer.
Archives of General Psychiatry. 2012 69[11]:1104-12.
"Traditional measurement fixes the number of items administered and allows measurement uncertainty to vary. In contrast, a CAT fixes measurement uncertainty and allows the number of items to vary. The result is a significant reduction in the number of items needed to measure depression and increased precision of measurement."
    Publication [CAT-DI] 08/19/2011 01/04/2012 11/01/2012 no
14 12/01/2012 DSM-5 approved by the APA Trustees.
"Cross-Cutting Dimensions" moved to Section III [Emerging Measures and Models].
15 02/25/2013 The Future Arrived
by David J. Kupfer; Emily A. Kuhl; Darrel A. Regier.
JAMA. 2013 309[16]:1691-1692.
"The next revision of psychiatry’s Diagnostic and Statistical Manual of Mental Disorders [DSM-5] will be published in May 2013 and is the first revision of this psychiatric nomenclature in almost 2 decades…"
    Publication [DSM-5]     02/25/2013 no
16 03/02/2013 Dr. Kupfer’s lecture to ACP Virginia
by David J. Kupfer
Dr. Kupfer’s lecture to ACP Virginia promoting the Dimensional Measures in DSM-5 [see slides 8, 17, 32, 34, & 36]. No disclosure of PAI/ATT.
    Presentation [slides]     03/02/2013 no
17 05/18/2013 DSM-5 Published.
18 07/01/2013 Computerized Adaptive Test–Depression Inventory Not Ready for Prime Time
by Bernard Carroll
JAMA Psychiatry. 2013 70[7]:763.
"The goal of commercial development seems premature; patients risk being “assayed” against a non–gold standard. Though CAT-DI may have been an interesting statistical challenge, it lacks a solid clinimetric grounding. It is not ready for clinical use…"
    Publication [letter] 11/19/2012 11/26/2012 07/01/2013 yes
19 07/01/2013 Computerized Adaptive Test–Depression Inventory Not Ready for Prime Time: In Reply
by Gibbons, Weiss, Pilkonis, Frank, Moore, Kim, and Kupfer
JAMA Psychiatry. 2013 70[7]:763-765
"In this case, it is Carroll who has the overwhelming conflict of interest.As developer,owner,and marketer of the Carroll Depression Scale–Revised, a traditional fixed-length test, it is not surprising that the paradigm shift described in our article would be of serious concern to him."
    Publication [reply]     07/01/2013 no
20 07/01/2013 The Computerized Adaptive Diagnostic Test for Major Depressive Disorder [CAD-MDD]: A Screening Tool for Depression
by Gibbons, Hooker, Finkelman, Weiss, Pilkonis, Frank, Moore, and Kupfer.
Journal of Clinical Psychiatry. 2013 74[7]:669–674.
"Inexpensive [relative to clinical assessment], efficient, and accurate screening of depression in the settings of primary care, psychiatric epidemiology, molecular genetics, and global health are all direct applications of the current system."
    Publication [CAD-MDD] 12/20/2012 04/05/2013 07/01/2013 yes
21 08/09/2013 Development of the CAT-ANX: A Computerized Adaptive Test for Anxiety
by Gibbons, Weiss, Pilkonis, Frank, Moore, Kim, and Kupfer.
American Journal of Psychiatry. published on-line Aug 9, 2013
"Potential applications for inexpensive, efficient, and accurate screening of anxiety in primary care settings, clinical trials, psychiatric epidemiology, molecular genetics, children, and other cultures are discussed."
    Publication [CAT-ANX] 02/08/2013 05/06/2013 08/09/2013 yes
22 08/20/2013 Dr. Carroll’s letter to JAMA Psychiatry
This letter was provided by Dr. Carroll at my request – 1boringoldman
    [letter] 08/20/2013 rejected unpublished yes
23 10/09/2013 The Future of Mental Health Diagnostic Screening [click on page 4]
PsychsTalk Blog: CME Institute
by Robert Gibbons, Ellen Frank, and David Kupfer.
"… The CAD-MDD and related CAT-DI and CAT-ANX share goals similar to those of the new version of DSM: they seek to improve screening and assessment of mental health disorders in a number of ways for patients, clinicians, and caregivers, including decreasing clinician and patient burden. The third section of DSM-5 is aimed at providing tools for cross-cutting and dimensional assessment, often involving patient-reported outcomes. The electronic version of the DSM-5 will allow for the development and application of many more scales and certainly better possibilities for tracking change and the effectiveness of treatment. Another objective of DSM-5 is to improve the interface with the rest of medicine, especially primary care…"
    Publication [CME]     10/09/2013 yes
24 11/20/2013 Failure to Report Financial Disclosure Information
by Gibbons, Weiss, Pilkonis, Frank, and Kupfer.
JAMA Psychiatry. 2013 71[1]:95.
"To the Editor We apologize to the editors and readers of JAMA Psychiatry for our failure to fully disclose our financial interests in an article that reported a diagnostic tool, the Computerized Adaptive Test for Depression [CAT-DI]… Lead author Robert D. Gibbons, PhD, is the president and founder of PAI, which was incorporated in Delaware in late 2011, then registered to do business in Illinois in January 2012. Dr Gibbons awarded “founder’s shares in PAI” to us, yet all 5 of us failed to report our financial interests in connection with our article and again in a Reply to Letters to the Editor regarding the article… Our submitted disclosure lacked transparency, and we regret our omission."
25 11/21/2013 When is Disclosure Not Disclosure?
Healthcare Renewal
by Bernard Carroll
"Here is a case study in conflict of interest [COI]. A remarkable confession has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh…"
26 12/23/2013 DSM-5 – Dimensional Diagnoses – More Conflicts of Interest?
Behaviorism and Mental Health
by Phil Hickey
"… why hasn’t Dr. Kupfer issued some kind of explanation for the lack of transparency? The JAMA Psychiatry letter of apology was just a stark statement of fact, which leaves a huge cloud of doubt not only over Dr. Kupfer, but also over DSM-5 and psychiatry generally…"
27 01/14/2014 Mindy Young, MD, Speaker
Memo to APA Assembly members
APA Newsroom
"Dr. Kupfer should have disclosed to APA his interest in PAI in 2012. Dr. Kupfer’s interest in PAI, which came after the decision had been made to include dimensional measures in DSM-5, did not influence DSM-5’s inclusion of dimensional measures for further study in Section 3. Interest in inclusion of these measures in DSM-5 began with conferences starting in 2003. If and when PAI develops a commercial product with CAT, it will not have any greater advantage than the dozens of dimensional measures currently being marketed by others."
  1.  
    January 21, 2014 | 4:39 PM
     

    The NYTimes has all these mental health op-ed pieces that are supposed to stimulate controversial feedback. Have you considered submitting this for publication? I think it deserves a larger audience.

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