I don’t buy it. We are bombarded by articles making all kind of things out of Dr. Insel’s blog post, Transforming Diagnosis, an announcement that the NIMH will move away from the DSM-5 – coming just a couple of weeks before the DSM-5 even goes on sale. Like everyone else, I’ve joined in on the speculation and commentary on the reasons for this surprising move [old news…, a flair…, groundhog day…, replaces with…, damage control…, our jobs…, said it again…]. When I talk too much about the same thing, it’s because there’s something I’m trying to figure out but I haven’t gotten there yet. So for the last several days, I’ve been going over the history and rereading the articles trying to get the story clear in my mind rather than reacting to the media frenzy. I’ve done that now and here’s the conclusion. I don’t buy it. If you don’t either, and already know why, don’t bother to read further. It’s way too long. I just wanted to write it down so I didn’t have to keep mulling it over in my mind.
Since the release of the DSM-III in 1980, there have always been two versions of the paradigm for the diagnostic manual. The first one was in the DSM-III Manual itself and said:
For most of the DSM-III disorders, however, the etiology is unknown. A variety of theories have been advanced, buttressed by evidence – not always convincing – to explain how these disorders came about. The approach taken in DSM-III is atheoretical with regard to etiology or pathophysiological process except for those disorders for which this is well established and therefore included in the definition of the disorder. Undoubtedly, with time, some of the disorders of unknown etiology will be found to have specific biological etiologies, others to have specific psychological causes, and still others to result mainly from a particular interplay of psychological, social, and biological factors. The major justification for the generally atheoretical approach taken in DSM-III with regard to etiology is that the inclusion of etiological theories would be an obstacle to use of the manual by clinicians of varying theoretical orientations, since it would not be possible to present all reasonable etiologic theories for each disorder.
Robert Spitzer, in the DSM-III, p 6.
The second version, the background version, was from the group centered at Washington University in Saint Louis and was called – neo-Kraepelinian. It professed the same basis for classification [observed symptoms], but had nothing like the neutrality of Dr. Spitzer’s version. Their view has been summarized as the neoKraepelinian Tenets:
1. Psychiatry is a branch of medicine.
2. Psychiatry should utilize modern scientific methodologies and base its practice on scientific knowledge.
3. Psychiatry treats people who are sick and who require treatment.
4. There is a boundary between the normal and the sick.
5. There are discrete mental illnesses. They are not myths, and there are many of them.
6. The focus of psychiatric physicians should be on the biological aspects of illness.
7. There should be an explicit and intentional concern with diagnosis and classification.
8. Diagnostic criteria should be codified, and a legitimate and valued area of research should be to validate them.
9. Statistical techniques should be used to improve reliability and validity.
[1. & 2.] were directed against psychoanalysis and said that psychiatry was a medical enterprise, not involved in matters psychological. The next three [3.-5.] were a counter to the criticisms from Dr. Szasz and others who said that there was no such thing as mental illness and that psychiatry was not a medical specialty. Number 6. said that physicians were only to be involved with the biological aspects of mental illness. It didn’t say that all mental illness was biological, just that biology was the legitimate domain of psychiatric physicians. And the last three [7.-9.] were a call to use scientific methods in classification.
The Spitzer version [atheoretical, descriptive] was the official version, and under that definition, the DSM-III was used by mental health professionals of all disciplines. During the next decades, the other mental health professions became increasingly covered by health insurance as members of approved panels by the various insurers and the DSM-III [IIIR and IV] systems became the standard reporting system for mental health in America [cross referenced to the ICD-9CM, the official system by treaty].
The neoKraepelinian version was the nucleus for a dramatic change in academic psychiatry which became rapidly biomedical and psychpharmacological. Private practitioners in psychiatry increasingly followed suit with more and more doing "medication management" for the clients of practitioners in other disciplines. And over the next twenty years the journals, practice, and focus of American psychiatrists followed the more neoKraepelinian "biological aspects of mental illness" definition.
The DSM-III-R  and DSM-IV  revisions made changes in the Manual, but stayed with the Spitzer version [atheoretical, descriptive]. Meanwhile, academic and organized psychiatry continued along their biomedical neoKraepelinian path. The Decade of the Brain at the NIMH spanned the 1990s and there was a stream of new drugs – antidepressants and atypical antipsychotics. The Spitzer version was in the books and used by non-psychiatrists. The neoKraepelinian version was the stuff of clinical drug trials, the explosion of psychopharmacology, and psychiatry.
But in mainstream psychiatry, something subtle had happened. The distinction between the two versions was becoming anachronistic. It was no secret that the upper levels of psychiatry were almost universally biological. I don’t think in 2000 that most of us were aware of the extensive connections between academic and organized psychiatry with PHARMA, particularly the back room connections. In this next document written in 2002 in preparation for the next DSM Revision, there is no distinction. The descriptive approach is now called neoKraepelinian. The atheoretical aspect is nowhere seen. It looks to me as if they felt that they could finally stop equivocating and create the biologically based DSM they’d always wanted:
The DSM-III diagnostic system adopted a so-called neo-Kraepelinian approach to diagnosis. This approach avoided organizing a diagnostic system around hypothetical but unproven theories about etiology in favor of a descriptive approach, in which disorders were characterized in terms of symptoms that could be elicited by patient report, direct observation, and measurement. The major advantage of adopting a descriptive classification was its improved reliability over prior classification systems using nonoperationalized definitions of disorders based on unproved etiological assumptions. From the outset, however, it was recognized that the primary strength of a descriptive approach was its ability to improve communication among clinicians and researchers, not its established validity.
Dr. Spitzer’s compromise in 1980 was to settle for inter-rater reliability and let validity go [since we have no way to determine validity anyway, it was no loss]. They go on to say that the hope had been that the DSM-III groupings would lead to etiology, but since no biomarkers were yet defined, it hadn’t worked out. Notice that biomarkers and etiology are now connected. The atheoretical is gone for good. The problem at hand was that the expected biomarkers had not been found – as in not yet found. The conclusion was that the biological bases of mental illness were not revealed by the clinical categories of the DSM-III+, and by the way, the clinical disorders not only didn’t map to biological findings, but they didn’t map to the drug treatments either. As a matter of fact, they thought the DSM categories may even be hampering research in some way.
Disorders in DSM-III were identified in terms of syndromes, symptoms that are observed in clinical populations to covary together in individuals. It was presumed that, as in general medicine, the phenomenon of symptom covariation could be explained by a common underlying etiology. As described by Robins and Guze, the validity of these identified syndromes could be incrementally improved through increasingly precise clinical description, laboratory studies, delimitation of disorders, follow-up studies of outcome, and family studies. Once fully validated, these syndromes would form the basis for the identification of standard, etiologically homogeneous groups that would respond to specific treatments uniformly.
In the more than 30 years since the introduction of the Feighner criteria by Robins and Guze, which eventually led to DSM-III, the goal of val- idating these syndromes and discovering common etiologies has remained elusive. Despite many proposed candidates, not one laboratory marker has been found to be specific in identifying any of the DSM-defined syndromes. Epidemiologic and clinical studies have shown extremely high rates of comorbidities among the disorders, undermining the hypothesis that the syndromes represent distinct etiologies. Furthermore, epidemiologic studies have shown a high degree of short-term diagnostic instability for many disorders. With regard to treatment, lack of treatment specificity is the rule rather than the exception…
Concerns have also been raised that researchers’ slavish adoption of DSM-IV definitions may have hindered research in the etiology of mental disorders. Few question the value of having a well-described, well-operationalized, and universally accepted diagnostic system to facilitate diagnostic comparisons across studies and to improve diagnostic reliability. However, reification of DSM-IV entities, to the point that they are considered to be equivalent to diseases, is more likely to obscure than to elucidate research findings.
Remember, this is a document from 2002 written by the APA psychiatrists charged with revising the DSM-IV. What they are saying is that the DSM-III, -IIIR, -IV paradigm didn’t pan out. The descriptive
atheoretical system did not reveal any disease specific biological markers and so we should change the way we do diagnosis in order to find them. These biological illnesses have yet to reveal their secrets.
All these limitations in the current diagnostic paradigm suggest that research exclusively focused on refining the DSM-defined syndromes may never be successful in uncovering their underlying etiologies. For that to happen, an as yet unknown paradigm shift may need to occur. Therefore, another important goal of this volume is to transcend the limitations of the current DSM paradigm and to encourage a research agenda that goes beyond our current ways of thinking to attempt to integrate information from a wide variety of sources and technologies…
The atheoretical part of the system just quietly evaporated. This 2002 book is all about biology and neuroscience. The possibility that the biomarkers hadn’t been found because the Manual was faulty [eg absent Melancholia, etc] wasn’t considered. Even odder, there’s no mention of the possibility that many of the mental illnesses were not biological in the first place, ergo had no biomarkers hidden or otherwise. But that’s an obvious point. More cogent for the moment is that I couldn’t find where anyone considered that the major users of this diagnostic system by actual count are not psychiatrists, not people who would be involved with biological diseases or disorders. They are psychologists, social workers, counselors, etc. The content of this Research Agenda for the DSM-V was written from the perspective of biological psychiatrists frustrated that the confirmation of biomedical psychiatry had not been forthcoming, and it was being reevaluated to find a more biological-friendly system. The fact that this tack was incompatible with the practices of the majority of mental health workers in America who use the DSM doesn’t seem to have been on the radar. In my way of thinking about this, the quiet compromise of the two paradigm versions, Spitzer vs neoKraepelinian, had been erased. So from 2004-2008, the DSM-5 Task Force held 13 planning conferences in conjunction with the NIMH, NIAAA, and NIDA before starting to work on the DSM itself, looking in to going biological. And then, starting in 2009, the NIMH introduced their RDoC:
Current versions of the DSM and ICD have facilitated reliable clinical diagnosis and research. However, problems have increasingly been documented over the past several years, both in clinical and research arenas. Diagnostic categories based on clinical consensus fail to align with findings emerging from clinical neuroscience and genetics. The boundaries of these categories have not been predictive of treatment response. And, perhaps most important, these categories, based upon presenting signs and symptoms, may not capture fundamental underlying mechanisms of dysfunction. One consequence has been to slow the development of new treatments targeted to underlying pathophysiological mechanisms…
NIMH plans to maintain liaison with the American Psychiatric Association and the World Health Organization regarding mutual interests in psychiatric classification. As an initial step, representatives of the APA, WHO, and NIMH met in July 2009 to map out common ground. These organizations have also articulated the importance of adding molecular and neurobiological parameters to future diagnostic systems, but at our current state of knowledge this step seems more appropriate for research than for immediate clinical use. NIMH views RDoC as the beginning of a transformative effort that needs to succeed over the next decade and beyond to implement neuroscience-based psychiatric classification.…
Notice that the APA was there from the start of the RDoC, just like the NIMH has been there through the whole DSM-5 process. Notice that the opening argument is the same one made by the DSM-5 Task Force in 2002, and the one we’re reading in 2013 in these last couple of weeks. Finally, in 2011, the DSM-5 Task Force announced that they couldn’t bring off a biological DSM-5 after all, and they, themselves, discussed the NIMH RDoC:
In the initial stages of development of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders,we expected that some of the limitations of the current psychiatric diagnostic criteria and taxonomy would be mitigated by the integration of validators derived from scientific advances in the last few decades. Throughout the last 25 years of psychiatric research, findings from genetics, neuroimaging, cognitive science, and pathophysiology have yielded important insights into diagnosis and treatment approaches for some debilitating mental disorders, including depression, schizophrenia, and bipolar disorder. In A Research Agenda for DSM-V, we anticipated that these emerging diagnostic and treatment advances would impact the diagnosis and classification of mental disorders faster than what has actually occurred…
We realized from our Research Agenda conference series that we would not be able to accomplish by DSM-5′s deadline all of the things we set out to and, in fact, that portions of that agenda related to advances in neuroscience were already being addressed in other arenas. A logical extension of those discussions, as detailed in our Research Agenda articles, is the Research Domain Criteria [RDoC] initiative recently launched by the National Institute of Mental Health [NIMH]. A commentary by Insel and colleagues introduced readers to the working principles behind the RDoC, whose proposed reclassification of mental disorders for research purposes is predicated on a neuroscience-based framework that can contribute to a nosology in which disorders are grouped by underlying pathophysiological similarities rather than phenomenological observations…
So what do I make of this timeline? Well, first, there’s a piece that’s not yet on it – what happened in the gap between the Research Agenda of 2002 and the creation of the RDoC in 2009 – and it was a lot!:
2002 was at the peak of the psychopharmacology era. The drugs were coming at a steady rate and business was booming. That year, Dr. Insel was a surprise pick to head the NIMH. It was a time of great enthusiasm, the dawn of a new millenium.
While it probably should’ve started in 1996 when the Chairman of Psychiatry at Georgia [Dr. Richard Borison] was convicted, the realization that there was corruption afoot in psychiatry came later. In the mid-2000s, problems with conflicts of interest, unreported PHARMA income, and ghost writing increasingly came to the fore culminating in a U.S. Senate Investigation with several psychiatry chairmen "stepping down" and others in high places censured.
Around the same time, the corruption in PHARMA reached the public eye. Allen Jones blew the whistle on TMAP, and elsewhere the civil suits began to pile up. In discovery, boxes of internal documents revealed the extensive connections between psychiatric authors a PHARMA, and the ubiquitous deceit in the publication of scientific data, along with a lot of shady drug promotion practices.
People like Dr. David Healy and others began to report unmmentioned adverse effects like suicidality. The "black box" warning was added to the antidepressants. The reports of adverse effects were joined by charges of inflated efficacy.
This was the era of large NIMH funded drug trials, and they were pretty disappointing. The new drugs hardly dazzled anyone.
In that period, we learned the term "pipeline" [drugs headed for approval], and then that there weren’t any more "me too" drugs on the way or anything to replace them
After a time of fretting over the "empty pipeline," the drug companies began to shut down their CNS drug development facilities – no candidates to work on.
This was a remarkably non-productive time in research. Lots of new technology and hype, but little in the way of results.
[just for starters]… And so the heyday of 2002 slid into a time with one piece of bad news after the other.
My own read on this narrative is cynical. First, I don’t accept that the American Psychiatric Association, Academic Psychiatry, the DSM-5 Task Force, and the Director’s office of the National Institute of Mental Health are separate entities. I see then as a consortium of people in high places who see the future of psychiatry and mental health as a function of new CNS drug development. That means that the entity we call PHARMA is part of the consortium, whether officially or unofficially – it’s a big part of the mix.
What I think happened is that the consensus around the turn of the century was that they could make the move to a solid biological psychiatry that took its place among the medical professions as a solid member. The DSM-III had opened the door, and the DSM-5 was going to complete the process. But as time moved on and the bad news began to accumulate, things weren’t going as planned, their DSM-5 conferences were going nowhere [I read them so trust me on this point], and they had to do something. The vision of their Research Agenda was handed over to the NIMH who launched the RDoC. Once that was in place and launched, they made their announcement that they couldn’t bring it off. In the meantime, they’d ignored the real business of the revision they’d been assigned, so they got involved in a lot of add-ons [Attenuated Psychosis, Mixed Anxiety Depression, etc]. The original impetus [the future is psychopharmacology] showed in the loosened criteria for any number of diagnoses the dropped bereavement exclusion. It was a lackluster showing at best, because it wasn’t what they were really aiming for in the first place. Why did Insel jump in at the 11th hour? My guess is that it lets the DSM-5 Task Force off the hook, changing their failed attempt at a biological system into something else – a noble try, but the clinical syndromes are just not a good-enough basis for drug development or biological discovery.
I think that all these people really do believe that the only avenue to follow is psychopharmacology and new drug development. What I object to is all the behind the scenes wheeling and dealing, presented to us in carefully prepared sound bytes. I object that they haven’t listened to Dr. Robert Spitzer, Dr. Allen Frances, and the rest of us who are trying to tell them that their monocular vision is obscuring everything. The roar of criticism about the DSM-5 has all said the same thing, "You’re supposed to be revising our clinical diagnostic manual! And you’re doing something else!" Everything has been wrapped around new drug development. It’s not even about biology because they’ve ignored repeated calls to reinstate our best candidate – Melancholia. It’s just about drug development, finding new targets to entice PHARMA back into the game. They say that outright.
So I believe there is a real they composed of the groups above, with a fixed goal in mind to the exclusion of any other. They really liked the years leading up to 2002, and they just can’t let go of where they thought they were headed. In 5 days they‘re going to publish a book that will enshrine their folly…
Press Release • May 13, 2013
Thomas R. Insel, M.D., director, NIMH
Jeffrey A. Lieberman, M.D., president-elect, APA
NIMH and APA have a shared interest in ensuring that patients and health providers have the best available tools and information today to identify and treat mental health issues, while we continue to invest in improving and advancing mental disorder diagnostics for the future.
Today, the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM), along with the International Classification of Diseases (ICD) represents the best information currently available for clinical diagnosis of mental disorders Patients, families, and insurers can be confident that effective treatments are available and that the DSM is the key resource for delivering the best available care. The National Institute of Mental Health (NIMH) has not changed its position on DSM-5. As NIMH’s Research Domain Criteria (RDoC) project website states, “The diagnostic categories represented in the DSM-IV and the International Classification of Diseases-10 (ICD-10, containing virtually identical disorder codes) remain the contemporary consensus standard for how mental disorders are diagnosed and treated.”
Yet, what may be realistically feasible today for practitioners is no longer sufficient for researchers. Looking forward, laying the groundwork for a future diagnostic system that more directly reflects modern brain science will require openness to rethinking traditional categories. It is increasingly evident that mental illness will be best understood as disorders of brain structure and function that implicate specific domains of cognition, emotion, and behavior. This is the focus of the NIMH’s Research Domain Criteria (RDoC) project. RDoC is an attempt to create a new kind of taxonomy for mental disorders by bringing the power of modern research approaches in genetics, neuroscience, and behavioral science to the problem of mental illness.
The evolution of diagnosis does not mean that mental disorders are any less real and serious than other illnesses. Indeed, the science of diagnosis has been evolving throughout medicine. For example, subtypes of cancers once defined by where they occurred in the body are now classified on the basis of their underlying genetic and molecular causes.
All medical disciplines advance through research progress in characterizing diseases and disorders. DSM-5 and RDoC represent complementary, not competing, frameworks for this goal. DSM-5, which will be released May 18, reflects the scientific progress seen since the manual’s last edition was published in 1994. RDoC is a new, comprehensive effort to redefine the research agenda for mental illness. As research findings begin to emerge from the RDoC effort, these findings may be incorporated into future DSM revisions and clinical practice guidelines. But this is a long-term undertaking. It will take years to fulfill the promise that this research effort represents for transforming the diagnosis and treatment of mental disorders.
By continuing to work together, our two organizations are committed to improving outcomes for people with some of the most disabling disorders in all of medicine.