1 Boring Old Man

DSM 5 – ‘Living Document’ or ‘Dead on Arrival’
^{untested ‘scientific hypotheses’ must be dropped}
Psychology Today
by Allen J. Frances, M.D.
November 11, 2011

^{News flash From Medscape Medical News – ‘APA Answers DSM-5 Critics,’ a defense of DSM 5 offered by Darrel A. Regier, MD, vice-chair of the DSM-5 Task Force. Wonderful news that APA is attempting to address the fact that DSM 5 alarms many of its potential users- it is long past time for an open dialog. Unfortunately, however, Dr Regier dodges the concerns that must be addressed if DSM 5 is to become a safe and credible document. Five simple questions were previously posed to APA with a request for five straight answers:}

[1] Why is APA not willing to have an independent scientific review of questionable DSM 5 proposals- especially since its own internal and confidential review process has been so badly discredited?
[2] Since the DSM 5 suggestions will all broaden the definition of mental disorder, why should we not worry about diagnostic inflation and the massive mislabeling of normal people as mentally ill?
[3] Won’t this diagnostic inflation exacerbate the already rampant over prescription of psychotropic medications [especially by primary care doctors, especially antipsychotics, especially to kids]?
[4] Why should we not worry about the unintended forensic complications of a sloppily written DSM 5 containing suggestions that are obvious targets for forensic misuse?
[6] Won’t the many small, needless, and arbitrary changes in DSM 5 complicate future research efforts and make impossible the interpretation of data collected before vs after DSM 5?

^{None of the five questions gets anything approaching a real answer. Instead Dr Regier tells us that:}

[1] "We hear your concerns and are aware of those from others in the mental health field, and take them under serious consideration in our deliberations". But if APA really heard our concerns, there would be an immediate independent scientific review to allay them. What possible excuse is there for not taking the one obvious step that will make DSM 5 credible?
[2] Dr Regier assures us not to worry about the radical DSM 5 suggestions, promising "a rigorous test-retest design to assess the reliability and clinical utility of proposed criteria … in 11 academic field trial centers." "The full range of disorders will be assessed in this field trial and the findings will contribute to the final decisions about the diagnoses." But, simply stated, the field trials are completely useless for DSM 5 decision making. They failed to ask and therefore cannot begin to answer the only really important question- what will be the effect of DSM 5 on the rates of mental disorder? Will DSM 5 mislabel as mentally ill millions of people who have problems that are just part of the human condition. And experience teaches us that results generated in academic centers often have nothing at all to do with how DSM is actually used (and often misused) in the real world. 
[3] Dr. Regier goes on to admit the obvious- that the new DSM 5 proposals are not based on anything resembling adequate research: "However, a lot of this has not been tested as well as we would like." "Some of these fixes are not as well studied as others and we recognize that. But we can’t move forward without some of these put into practice. So we think this is a much more testable set of scientific hypotheses." "And that’s what the DSM is – a set of scientific hypotheses that are intended to be tested and disproved if the evidence isn’t found to support them." There could not possibly be any more eloquent testimony to exactly where DSM 5 has gone badly and dangerously off the tracks. DSM 5 most definitely should not harbor the ambition of providing a set of ‘scientific hypotheses’ created by and for researchers to encourage further testing of their pet ideas. DSM 5 is not at all meant to be a program setting forth ‘scientific hypotheses’ to guide future research. Instead, DSM 5 is a guide to current clinical practice that will have a crucial impact on the lives of the people misdiagnosed- they will often be hurt, sometimes badly hurt, by receiving unnecessary medicine and unnecessary stigma. Recent experience proves that children will be particularly vulnerable to the mislabeling that will follow this exercise in DSM 5 ‘hypotheses testing.’ To say nothing of the misallocation of resources away from the truly ill (who desperately need them) and toward the worried well (who often will be more harmed than helped). There is no conceivable excuse for conducting what amounts to an uncontrolled public health experiment just so the DSM 5 researchers can further the testing of their pet ideas.
[4] Dr Regier is fond of calling DSM 5 a "living document that can be revised regularly." "We’re thinking of having a DSM-5.1, DSM-5.2, etc". The implication of this ‘living document’ concept is chillingly out of touch with the perils of clinical reality. Although he doesn’t come right out and say it, Dr Regier seems to be reassuring us with something like – Don’t you worry if our untested hypotheses get it wrong now, we can always fix it up later. This blithely ignores the needless and sometimes dangerous medication side effects and stigma to be endured by those who are mislabeled by the premature and untested DSM 5 ‘scientific hypotheses’. The makers of DSM 5 have forgotten the most important injunction in medicine – the Hippocratic First Do No Harm. What needs to be done? In the short term, APA has only two choices- submit DSM 5 to external review or drop the most dangerous suggestions. Otherwise DSM 5 risks not being trusted and not being used by mental health clinicians.

^{For the future, the lesson couldn’t be clearer- never again allow researchers the freedom to turn DSM into a plaything for their pet ‘scientific hypotheses’. The DSM’s are not meant to be a casually undertaken experiment. They have become far too important an influence on clinical practice and public health policy. DSM 5’s radical ambitions have failed- it attempted to fly too high and now must come back to earth.If you agree we me that the APA defense of DSM 5 is much more troubling than reassuring, consider signing the petition requesting reform at: http://www.ipetitions.com/petition/dsm5/}

Dr. Regier goes on to admit the obvious- that the new DSM 5 proposals are not based on anything resembling adequate research: "However, a lot of this has not been tested as well as we would like." "Some of these fixes are not as well studied as others and we recognize that. But we can’t move forward without some of these put into practice. So we think this is a much more testable set of scientific hypotheses." "And that’s what the DSM is – a set of scientific hypotheses that are intended to be tested and disproved if the evidence isn’t found to support them." There could not possibly be any more eloquent testimony to exactly where DSM 5 has gone badly and dangerously off the tracks. DSM 5 most definitely should not harbor the ambition of providing a set of ‘scientific hypotheses’ created by and for researchers to encourage further testing of their pet ideas. DSM 5 is not at all meant to be a program setting forth ‘scientific hypotheses’ to guide future research. Instead, DSM 5 is a guide to current clinical practice that will have a crucial impact on the lives of the people misdiagnosed- they will often be hurt, sometimes badly hurt, by receiving unnecessary medicine and unnecessary stigma…

Unfortunately, it’s not something limited to the mind of Dr. Regier, but rather a macabre version of a widely held way of thinking. In the early 1980s when I was first exposed to this breed of psychiatrist, I recall spending a lot of time feeling confused. I had left a research oriented career in Immunology before coming into psychiatry, and I thought that I understood the place of research in medicine. I’d done it for a few years myself – in tandem with clinical medicine. I was an Internal Medicine Resident for half the day and on call at night. And my other half time was in a research lab. Occasionally, I’d run across an intersenting clinical case that we studied with the extensive technology availabe, but for the most part, there was a firewall between the two parts of my life – doctor, researcher. Beside the laboratory studies, we had a clinical project and the subjects were recruited, transferred to a research ward, and heavily informed about what we were doing.

In psychiatry, the new breed talked mostly about research, even on clinical rounds. Grand rounds became almost exclusively about new drugs or new thoughts about old drugs. At the time, I was teaching the 2nd year medical student’s course, and when I had the new people as guests, they talked about the future – not behavioral science. I stopped inviting them because the students were confused by what they said. It was as if psychiatry hadn’t existed before, and everything was new, future-oriented. The only place I felt comfortable was my office seeing patients, so I left and did just that until I retired. I taught a lot, but what I taught were things I knew about, not what I or someone else might know at some later date. I shied away from psychiatry as-a-whole and stuck to psychotherapy because I really didn’t get what was going on in the rest of psychiatry. I now think I was confused because it was confusing, but back then, I felt sort of inadequate. I couldn’t separate out what was known from what was speculation. I’m bitter about that, because I lost something that I valued – a kind of mastery of clinical psychiatry that had been important to me.

So what I now think is that the blurring of a clear boundary between research and clinical medicine, between what’s known and what’s not yet known was a gargantuan mistake. When I went to a psychiatric meeting and attended a talk, I didn’t feel like I was listening to seasoned clinicians who were speaking from experience – the kind of people I’d become accustomed to listening to and learning from. It was more like the brown-bag seminars of research fellows from my fellowship where we talked about hyotheses yet to be confirmed. Clinical doctors find such things interesting, but what we really want to know is how to approach the patients we will see tomorrow.

So Dr. Regier’s notion, "… that’s what the DSM is – a set of scientific hypotheses that are intended to be tested and disproved if the evidence isn’t found to support them" feels like an extrapolation of that blurring of boundaries between research and clinical medicine that I saw twenty-five years ago carried to a sick extreme. He must have no idea how far out in left field his statement really is. If he did, he wouldn’t say it. It explains why they would consider Attenuated Psychosis Syndrome or Disruptive Mood Dysregulation Disorder and not understand why we might object. Frankly, I think the same can be said of the current versions of Major Depressive Disorder on some of the extensions of the Bipolar Disorder diagnoses.