BACKGROUND
On November 20, JAMA Psychiatry (formerly Archives of General Psychiatry) published an interesting letter. It was headed: Failure to Report Financial Disclosure Information, and was signed by Robert D. Gibbons PhD, David J Weiss PhD, Paul A. Pilkonis PhD, Ellen Frank, PhD , and David J. Kupfer MD.
The letter is an apology for failing to disclose a financial interest in an article, Development of a Computerized Adaptive Test for Depression, that had appeared in Archives of General Psychiatry a year earlier (November 2012). The article described a computerized questionnaire for depression (the CAT-DI) and was generally positive with regards to the potential usefulness of the test in clinical settings. In the article, the authors had clearly stated that they had no conflicts of interest, but that:
“The CAT-DI will ultimately be made available for routine administration, and its development as a commercial product is under consideration.” (p 1)
But they did not disclose that they had already formed a company, Psychiatric Assessments, Inc. (PAI), the apparent purpose of which was to market the test. According to the Delaware Division of Corporations, PAI was incorporated on November 29, 2011. The Gibbons et al article was accepted for publication on Jan 4, 2012, and was published in November 2012. So there was certainly plenty of time for the authors to disclose their financial interest.
The matter came to light earlier this year. Bernard Carroll, MD, PhD, who incidentally blogs on Health Care Renewal, wrote a letter to JAMA Psychiatry critiquing the Gibbons et al article, and challenging the validity, usefulness, and need for the CAT-DI. Dr. Carroll’s letter is dated July 2013, and contains a clear conflict of interest disclosure to the effect that he himself receives royalties from depression scales that he has developed.
Dr. Gibbons et al responded to Dr. Carroll’s letter in the same issue. Dr. Carroll was not convinced by this response, did some investigating, and uncovered the existence of PAI and the conflict of interest. He has documented this matter in a post When Is Disclosure Not Disclosure? on Health Care Renewal.
We’ve seen so many conflicts of interest scandals in this field in recent years, that it might be tempting to shrug this off as just more of the same. But, there’s a bigger issue.
DSM-5 AND DIMENSIONAL ASSESSMENT
First a little history. In the Introduction to DSM-IV (1994) it states:
“It was suggested that the DSM-IV Classification be organized following a dimensional model rather than the categorical model used in DSM-III-R. A dimensional system classifies clinical presentations based on quantification of attributes rather than the assignment of categories and works best in describing phenomena that are distributed continuously and that do not have clear boundaries. Although dimensional systems increase reliability and communicate more clinical information (because they report clinical attributes that might be subthreshold in a categorical system), they also have serious limitations and thus far have been less useful than categorical systems in clinical practice and in stimulating research. Numerical dimensional descriptions are much less familiar and vivid than are the categorical names for mental disorders. Moreover, there is as yet no agreement on the choice of the optimal dimensions to be used for classification purposes. Nonetheless, it is possible that the increasing research on, and familiarity with, dimensional systems may eventually result in their greater acceptance both as a method of conveying clinical information and as a research tool.” (p xxii)
Under a dimensional system a person might be described as having a certain score on an anxiety scale, rather than having generalized anxiety disorder, or a certain score on a depression scale rather than having major depressive disorder, and so on. When this notion was floated in 1994, it seemed to me that it would be a big improvement over the traditional DSM “diagnoses,” but in the intervening years I’ve come to the conclusion that psychiatry could compromise and exploit a dimensional diagnosis just as readily as a categorical diagnosis. But that’s a separate subject.
The central issue here is that one of the authors of the original Gibbons et al study is David J. Kupfer, MD, chairperson of the DSM-5 Task Force. Given that DSM-IV had floated the notion of dimensional assessment, it was entirely reasonable that the DSM-5 Task Force should give the matter some consideration. And they did. Here are some quotes from their Introduction to DSM-5 under the heading Dimensional Approach to Diagnosis (p 12-13)
“Indeed, the once plausible goal of identifying homogeneous populations for treatment and research resulted in narrow diagnostic categories that did not capture clinical reality… (p 12)
This is a somewhat elaborate way of saying that the “diagnoses,” collected and set out in successive revisions of the manual, have no validity – they don’t “capture” reality! This is a truly amazing admission, given that it is precisely the alleged ontological reality of these “diagnoses” that has constituted the conceptual underpinning of psychiatry and the legitimization of the drugging for the past 60 years. The current edition of psychiatry’s diagnostic manual has the unique distinction of denying the validity of its subject matter in its own introduction. But that’s also a separate subject.
“The historical aspiration of achieving diagnostic homogeneity by progressive subtyping within disorder categories no longer is sensible…” (p 12)
(Just in case there was any doubt as to the meaning of the previous quote.)
“The adjacent placement of ‘internalizing disorders’ characterized by depressed mood, anxiety, and related physiological and cognitive symptoms, should aid in developing new diagnostic approaches, including dimensional approaches, while facilitating the identification of biological markers.” [emphasis added] (p 13)
In other words, we’re introducing a dimensional approach through a back door. “Internalizing” will become the dimension underlying the various diagnoses in that category.
“…the…dimensional DSM-5 approach and organization structure can facilitate research across current diagnostic categories by encouraging broad investigations within the proposed chapters and across adjacent chapters. Such a reformulation of research goals should also keep DSM-5 central to the development of dimensional approaches to diagnosis that will likely supplement or supersede current categorical approaches in coming years.” [emphasis added] (p 13)
It doesn’t take too much reading between the lines here to see that there was clearly some momentum within the Task Force to adopt a dimensional approach. The categorical approach of the past is subjected to considerable criticism (in fact, I would suggest, total repudiation), and although DSM-5 didn’t adopt the dimensional approach whole-heartedly, it’s clear that the alterations in the manual’s layout and structure were adopted with a view to encouraging a dimensional approach in the future.
“The organizational structure [of the manual] is meant to serve as a bridge to new diagnostic approaches without disrupting current clinical practice or research.” [emphasis added] (p 13)
All of which leads us to wonder where within the DSM-5 Task Force was the momentum towards a dimensional framework centered, and in this regard it is clear that Dr. Kupfer has been a big fan of the dimensional approach.
In an April 2013 article in Nature, Mental health: On the spectrum, writer David Adam stated:
“The problem is that biologists have been unable to find any genetic or neuroscientific evidence to support the breakdown of complex mental disorders into separate categories. Many psychiatrists, meanwhile, already think outside the category boxes, because they see so many patients whose symptoms do not fit neatly into them. Kupfer and others wanted the latest DSM to move away from the category approach and towards one called ‘dimensionality’, in which mental illnesses overlap. According to this view, the disorders are the product of shared risk factors that lead to abnormalities in intersecting drives such as motivation and reward anticipation, which can be measured (hence ‘dimension’) and used to place people on one of several spectra. But the attempt to introduce this approach foundered, as other psychiatrists and psychologists protested that it was premature.” (p 2)
and
” When Kupfer and his DSM-5 task force began work in 2007, they were bullish that they would be able to make the switch to dimensional psychiatry. ‘I thought that if we did not use younger, more-basic science to push as hard as we could, then we would find it very difficult to move beyond the present state,’ Kupfer recalls.” (p 5)
and
” In the middle of 2011, the DSM-5 task force admitted defeat. In an article in the American Journal of Psychiatry, Kupfer and Darrel Regier, vice-chair of the DSM-5 task force and the APA’s research director, conceded that they had been too optimistic. “We anticipated that these emerging diagnostic and treatment advances would impact the diagnosis and classification of mental disorders faster than what has actually occurred.” The controversial personality-disorder dimensions were voted down by the APA’s board of trustees at the final planning meeting in December 2012.” (p 5)
and
“On the question of dimensionality, most outsiders see it as largely the same as DSM-IV. Kupfer and Regier say that much of the work on dimensionality that did not make the final cut is included in the section of the manual intended to provoke further discussion and research.” (p 6)
and
“Once the evidence base strengthens, he says, perhaps as a direct result of the NIMH project, dimensional approaches can be included in a DSM-5.1 or DSM-5.2” (p 6)
In December 2011, Emily Kuhl, PhD (the Senior Science Writer on the DSM-5 Task Force), Darrell Regier, MD (Task Force Vice-Chair), and Dr. Kupfer co-authored an article for the AMA’s Virtual Mentor. The article is called Patient-Centered Revisions to the DSM-5. The word “dimensional” occurs ten times in this article. Here are some quotes:
“Supplementing binary diagnostic categories (in which the diagnosis is either present or absent) with dimensional quantitative rating scales (in which symptoms are measured along a continuum) will better capture the nuances of mental illnesses, including co-occurring conditions and disease severity, and could result in earlier, more accurate identification of psychiatric illness and provision of care.”
“Theoretically, this would allow psychiatrists to document limitless variations in personality by providing dimensional ratings of personality traits, domains, and facets; this level of specificity should make a designation of personality disorder trait specified more clinically meaningful than the DSM-IV’s personality disorder NOS in terms of better understanding patients’ symptom presentations and treatment needs.”
There is also a reference to the use of scales and questionnaires to implement dimensional assessment:
“A patient who indicates that she has been experiencing moderately depressed mood for the past 2 weeks, for instance, would be given a corresponding assessment for depression…”
“Many of the proposed dimensional assessments for the DSM-5 are drawn from existing tools…”
And, incidentally, Ellen Frank, PhD, one of the co-authors of Gibbons et al, served on the DSM-5 Task Force as Text Coordinator for mood disorders.
DISCUSSION
So we have three main themes:
1. Dr. Kupfer, during his tenure as DSM-5 Task Force Chair, was heavily invested in the promotion of dimensional assessment, initially as a replacement for the traditional categorical system, and later, when it became clear that this was not achievable, as an ancillary component of the categorical system. It is also clear that he conceptualizes DSM-5 as a bridge between the categorical “diagnoses” of the past and the dimensional ratings that he visualizes for the future.
2. At the same time, Dr. Kupfer was a major shareholder in a private company that was designing a computerized assessment tool that would plausibly be much in demand if the dimensional system were implemented.
3. Dr. Kupfer, along with his co-authors, failed to disclose their conflict of interest in the November 2012 JAMA article, and in fact only did so later when the conflict was exposed by Dr. Carroll. This, incidentally, was about the same time that Dr. Kupfer was issuing assurances that the ties of 70% of Task Force members to Pharma did not sway their judgment.
NIMH FUNDING
The CAT-DI research that was written up in the original Gibbons et al article was funded by a grant from the National Institute of Mental Health (a department of the NIH). The article cites the following grant number: R01-MH 66302. On the NIH’s RePORTER website there are 23 entries under Robert Gibbons’ name since 1990. Nine (9) of these entries are linked to the 66302 number:
Project | Year | Total Cost |
---|---|---|
MH066302 | 2002 | $380,713 |
MH066302 | 2003 | $381,740 |
MH066302 | 2004 | $375,025 |
MH066302 | 2006 | $634,030 |
MH066302 | 2007 | $581,084 |
MH066302 | 2008 | $554,052 |
MH066302 | 2009 | $555,007 |
MH066302 | 2009 | $368,885 |
MH066302 | 2010 | $1,127,810 |
Total | $4,958,346 |
So since 2002, Dr. Gibbons and his colleagues have drawn down a total of almost $5 million in public money to develop a psychiatric assessment instrument that they now plan to promote for private profit. This has prompted Dr. Carroll to write:
“…where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel [Director of NIMH] on top of this?”
INTERPRETATION
It is difficult to put a benign interpretation on Dr. Kupfer’s role in this matter. It is clear that he believed in the merits of the dimensional system, and that, in his role as DSM-5 Task Force Chair, he promoted this system with as much vigor as he could muster. Even when the APA Board of Trustees voted in December 2012 to retain the categorical approach, he laid the structural groundwork for the introduction of dimensional assessment at a later time, and crafted a numbering system (5.1; 5.2; etc.) whereby the manual can be updated easily and at frequent intervals.
During the DSM-5 deliberations, it was obvious to anyone that if the APA replaced the categorical model with a dimensional model, then there would be a vastly increased market for dimensional rating scales, and that the profit potential was enormous.
Given all of this, and given the lack of transparency in the Gibbons et al article, it is difficult to avoid the conclusion that Dr. Kupfer’s motivation was at least partly financial, and that he used his position as DSM-5 Task Force Chair to further his own financial agenda.
If a more benign interpretation can be put on these events, I would be interested in hearing it. But it’s clear that psychiatric credibility has taken yet another hit. Dr. Kupfer is a graduate of Yale’s medical school. He joined the University of Pittsburgh in 1973, and became chairman of the psychiatry department in 1983. He continued as department chair until 2009, and is now a professor of psychiatry at that establishment. He has published more than 800 articles, books, and book chapters, and has served on the editorial boards of various journals. And, of course, as mentioned earlier, he served in the prestigious position as chair of the DSM-5 Task Force. He is, in every sense of the term, an eminent psychiatrist.
So I am left with two questions: Firstly, 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. Secondly, why are we not hearing widespread expressions of concern from psychiatry about this matter? To the best of my knowledge, the only psychiatrists who have spoken out on this are Bernard Carroll, who exposed the matter in the first place, and Mickey Nardo, who has been retired for ten years.
This kind of silence in these kinds of situations has become characteristic of psychiatry, through scandal after scandal, in recent years. It is very difficult to avoid the impression that neither psychiatry’s leadership nor its general body has any interest in ethical matters.
There is only one agenda item in modern American psychiatry: the relentless expansion of psychiatric turf and drug sales. They’ve promoted categorical diagnoses and chemical imbalances strenuously for the past five decades. Now that these spurious notions are on the point of expiration, psychiatry is developing dimensional diagnoses and neurocircuitry malfunctions as the rallying points of the “new and improved” psychiatry.
But the bottom line is always the same: turf and money. Something is truly rotten in the state of psychiatry.