1 Boring Old Man

Will Male Breasts Derail A J&J Settlement Over Risperdal Marketing?
Pharmalot
by Ed Silverman
05/10/2013

A much-anticipated settlement of various federal government probes into Johnson & Johnson  marketing of the Risperdal antipsychotic, as well as other medications, is being delayed over language the health care giant fears may cause difficulties for a raft of private lawsuits, The Wall Street Journal reports.

Last year, you may recall, J&J agreed to a $2.2 billion deal that would include a misdemeanor plea and a $600 million criminal penalty [see this]. But J&J wants to avoid admitting to conduct that could negatively affect the outcome of personal-injury lawsuits alleging Risperdal caused increased levels in children of a hormone that stimulates breast development and milk production. Last September, J&J began settling dozens of lawsuits charging Risperdal caused gynecomastia, which is the abnormal development of large mammary glands in males, but product labeling lacked sufficient warnings. The initial Risperdal labeling allegedly downplayed the risk of increased prolactin levels and failed to suggest that a test should be used, according to Stephen Sheller, a plaintiff’s lawyer [back story].

For its part, J&J has argued that Risperdal labeling has noted the pill increases prolactin levels and that side effects seen in a small number of patients include breast development in males. The labeling also notes this was reported in 2.3 percent of the 1,885 children and adolescents given Risperdal in clinical trials, the paper writes [see here].  As part of the settlement, however, the feds want J&J to admit data played down the risks from increased prolactin, while J&J wants the feds to agree not to continue to pursue the allegation, the paper adds. Lawsuits have noted that a study sponsored by J&J, which was published in the Journal of Clinical Psychiatry in 2003, reported “no correlation” between side effects and elevated prolactin levels.

By settling the first such lawsuit last fall, J&J [JNJ] avoided having ceo Alex Gorsky called to the stand. Banks’ lawyers were seeking his testimony because from October 1998 to October 2001, Gorsky was vp of marketing at the J&J Janssen unit that sold the antipyschotic. And from October 2001 to early 2003 he was the Janssen president, during which time he was responsible for selling Risperdal…

Having sat through the TMAP Trial in January 2012, I have a special affinity for JNJ’s antics. He was an integral part of JNJ’s Risperdal’s misadventures from the start – and they were extensive. When things blew up, he transferred to London, then left the company [in my mind, to distance from responsibility for his sins - a guess]. He returned in 2008 and was CEO byn 2012 [shoveling…]:

Last year, he avoided testifying in the Gynecomastia trials by being terminally important. Here are a few reminders about the last time around [shoveling…, when does that go on trial?…, a keynote address…].

A Perfect Storm for Psychiatry
Psychology Today
^{Blog: How Everyone Became Depressed}
by Edward Shorter, Ph.D.
May 8, 2013

What a week! Last week began with the announcement that suicides are up sharply. This means that all the “antidepressants” that people have been gobbling by the handful — one in ten Americans — have been ineffective against the grimmest consequence of depression of all: killing yourself.

Last week ended with NIMH Director Tom Insel’s announcement that the National Institute of Mental Health was cutting loose from the Diagnostic and Statistical Manual of the American Psychiatric Association, the famous “DSM.” Insel charged, “The weakness is its lack of validity.” That means that we here at NIMH in Bethesda, speaking as neuroscientists and fast-lane clinicians, don’t believe that your main diagnoses are valid. Insel didn’t specify which ones he thought invalid, but for years a small group of Nosological Rebels – clinical scientists rebelling against the official disease classification – have been casting doubt on such entities as “major depression.,” “bipolar disorder,” and “schizophrenia.” Depression and psychosis [the core of schizophrenia] exist alright, but not in the forms that the disease-designers of DSM have cast them, and from which the pharmaceutical industry has made so much money.

Now, the DSM crowd has its defenders. Many have stood up in the last 48 hours and said, “Well, how about you, Mr Smarty Pants Insel: If the DSM diagnoses are invalid, tell us which ones you think are valid.” And of course Insel has nothing to respond – at this point. The Research Domain Criteria crowd [RDoC] at NIMH have not yet gotten far enough in their attempts to link basic neural mechanisms to clinical phenomena. They are not yet able to say which are the “valid” phenotypes, which correspond to underlying genetic and biochemical realities. Maybe some day they will, after spending the hundreds of millions of dollars that the Obama Administration is allocating to the brain. Or maybe not. That’s irrelevant at this point. 

The point is that, floating around in nosological cyberspace, there are diagnoses that correspond to what people really have. Some, such as melancholia, possess genuine biological validation: the dexamethasone suppression test [DST], high serum cortisol, and a host of findings from sleep studies that show melancholia is a depressive illness sui generis, a disease of its own in other words. This has been known for centuries! And the DST has been available to psychiatry since Bernard Carroll introduced it for the study of depression in 1968.

Catatonia is another basic disease entity that only now is being detached from “schizophrenia,” a non-disease, and made a disease of its own. DSM-5 goes part way in acknowledging catatonia as a separate illness. And there exist pharmacological verifications and validations of catatonia: the response to benzodiazepines and electroconvulsive therapy. So it’s a real disease too [no other serious disorder in psychiatry responds to benzodiazepines, though many garden-variety illnesses do]. 

And what do we do about chronic psychosis, all forms of which up to now have been called “schizophrenia”? The term embraces many different patterns of illness. One in particular is onset of social isolation and withdrawal in adolescence, first psychotic break, then stabilization with some kind of mental “loss” – or “defect,” just to use the ugly technical term – at a relatively high level of functioning. You can work as a porter; you can get married and be a good husband and family father; but a neuroscientist … ahem … you’ll never be. Let’s call this hebephrenia, core schizophrenia. 

So there we’ve got three diagnoses right off the bat that correspond to what people actually have. We don’t need a lot of cogitation about “negative valence systems” – à la RDoC – to make progress, though fundamental progress in neuroscience is devoutly to be desired.

It’s going to be so exciting: DSM-5 will be launched at the American Psychiatric Association’s annual meeting in San Francisco in a matter of days. And the bleachers will be filled with skeptical fans yelling, “Why are your patients all killing themselves!” and “Give us some diagnoses that really work!” Don’t you wish you were going to be there?

^{"Major Depression doesn’t exist in Nature. A political process in psychiatry created it…"}

Spent yesterday with matters medical, mostly local. When I passed by the television as the day settled down this afternoon, CNN was going strong with coverage of the verdict in the Jodi Arias trial – media frenzy at its highest pitch. Every commentator and quaisi-expert in America has something to say. Later, I finally sat down at my computer, and there it was again on a different topic – a flood of news articles about the DSM-5 close to equaling the barrage from the Phoenix trial. The stories were not quite so histrionic [but they were close enough to make the comparison obvious]. There was a monotony to the stories – a few simple themes. Pathologizing everyday life. Overmedication. No biomarkers or validity. NIMH drops DSM-5 [as in Nike drops Lance Armstrong]. The sheer volume of news articles is impressive.

I did something on the side as I read through the articles. I recurrently put "DSM-5 <kol>" into Google, where <kol> was a name from the list of all the people I could think of that were in the KOL set – Grassley’s list of COI offenders, the people with hundreds of industry funded publications, the psychiatrists working in the academic/pharmaceutical complex, the usual suspects, etc. As you might guess, nothing came up. As I read the articles, there was a fairly high incidence of my own long-suffering rarely mentioned pet peeve – the personification of the word psychiatry. As in "psychiatry thinks …" "psychiatry has been unable to…" etc. Sometimes, it’s "psychiatrists think…" "psychiatrists have been unable to…" – in this latter case implying a unity that I don’t feel a part of, but I’m not outside of either.

I don’t mention my pet peeve [negative categorical comments] much because it is so much a part of the very issue on the table. It’s the kind of simplification people do when they’re angry, and there’s every reason in the world to see the occasion of the DSM-5 release as a cause for anger. Even bigger than that, it’s the down side of a Taxonomy itself. In Medicine, we categorize sick people in order to hone in on the problem, to help figure out the appropriate direction for treatment. But it’s labeling, just like critics say it is. And one charge against the DSM-5 is that the labeling has been manipulated to serve other motives: the use of medications, the access to services, legal status, due process, psychiatric hegemony, insurability, etc. So my whining about being included in the category that "thinks…" something I don’t happen to think would be to miss the whole point of the criticism.

Why Psychiatry’s Seismic Shift Will Happen Slowly
Forbes
by Matthew Herper
5/08/2013

… The reaction from the blogosphere was swift and loud as journalists and bloggers interpreted the decision as a swipe against the fifth edition of the DSM [called the DSM-5] and the American Psychiatric Association, which compiles it. Mindhacks wrote that the NIMH was “abandoning the DSM” and called the move “potentially seismic.” New Scientist called it a “bombshell” and said the DSM was being “denounced.” The Verge also went with the headline that the NIMH was abandoning the “controversial bible” of psychiatry.  John Horgan at Scientific American wrote that psychiatry was in crisis as Insel rejected its Bible and replaced it with nothing.

There were also some more nuanced comments, from Neurocritic and 1 Boring Old Man, noting that this was not a shift so much as a continuation of the line of thinking that had been presented previously by both Insel and the APA itself. But the DSM-5 has been beset by controversy, partly because Allen Frances, a prominent psychiatrist who worked on previous editions, has been publicly decrying the way the new edition of the manual was put together. And a fight between the country’s largest psychiatric organization and the institute that decides which psychiatric projects get government money was too good to pass up.

The real story is more complex, and it is driven by the huge disappointments of the past two decades in psychiatric research, which have failed to lead to new drugs and have led to most large drug companies backing away from or abandoning the psychiatric field. Changing how patients with mental illness are diagnosed is going to take a lot longer than many people seem to think. The DSM is not being abandoned — psychiatry is finally growing up.

I called the NIMH, and was put on the phone with Bruce Cuthbert, the director of the division of adult translational research. I had a pretty simple question. If the NIMH were really rejecting or abandoning the DSM, that would mean the agency wouldn’t accept studies that use DSM-5 criteria. For instance, if you wanted to test a new schizophrenia drug in schizophrenics, you’d have to find some new RDoC way of describing the disease. Cuthbert said repeatedly that would not be the case. It’s not so much that studies that use the DSM-5 will be excluded and abandoned, but that researchers would now be allowed to apply for grants that would not use the manual’s diagnostic criteria, or subdivided them in new, creative ways.

“Using DSM diagnoses for research has become a de facto standard ever since the DSM-III came out in 1980,” Cuthbert said. “What we are trying to do is to study neural systems directly because they cut across lots of the dsm disorders.” I asked the question again. “We are moving in a new direction. That doesn’t mean that next month we’ll stop accepting DSM diagnoses. It rather is a shift in emphasis. New studies can still include DSM diagnoses, but their boundaries should not be limited by what’s in the DSM. The new NIMH policy gives scientists the choice of going much broader, or being far more narrow.

In practice, grants at the NIMH are given out by a peer review scoring system in which anonymous experts critique proposals. At the end of the day, which grants get funded will depend on how they do in that system. So this change in focus will happen slowly, and will depend on the exact experiment being done. The DSM-5 will still be the manual used by psychiatrists diagnosing patients, and it will still be used by insurance companies, and the government programs Medicare and Medicaid to decide what to pay doctors and hospitals for treating mentally ill patients. Cuthbert says that the NIMH is already working on ways to build “crosswalks” between the DSM-V and its new RdoC diagnosis system, which is still barely sketched out.

Why change at all? Cuthbert gives the example of one symptom of depression called anhedonia, the scientific name for inability to find pleasure in normally enjoyable activities. On the one hand, this condition occurs in lots of psychiatric illnesses, including anxiety and eating disorders. We don’t know if it is neurologically similar in all of them or not. On the other hand, there are different types of anhedonia, Cuthbert says. Some people might go out to dinner with friends and not enjoy it. Others might be so down as to lack the energy to get to the restaurant in the first place, even though they would enjoy it once they arrived.

The NIMH’s strategy with the RDoC approach is to dis-entangle a diagnosis like this. If there were a protein or blood test or brain scan that fit with one type of anhedonia (people with eating disorders who are too tired to go out for instance), but not with the others, it doesn’t want to miss it. But this means taking the DSM-5 apart and re-assembling it through arduous experimental work. “It’s going to take a decade or more for results to bear fruit,” Cuthbert says.

The idea that psychiatry needs to become more focused on biological causes of disease, not associations of symptoms, is not new, either for Insel, who gave a TEDex talk on the topic, or to psychiatry as a whole. A recent paper in The Lancet, a medical journal, found that schizophrenia, bipolar disorder, autism, major depression and attention deficit hyperactivity disorder all shared common genetic glitches as potential causes.

Behind all this talk about biology is a commercial reality: psychiatric drug development has become a dead-end. GlaxoSmithKline, Novartis, and AstraZeneca have stopped trying to invent new psychiatric drugs. Pfizer, Merck, and Sanofi have de-emphasized them. There are just 303 psychiatric drugs in development, compared to 3,436 cancer medicines and 1,247 drugs for other neurological disorders, according to the Analysis Group in a study commissioned by PhRMA, the drug industry trade group.

The introduction of the DSM-III in 1980 created a standardized language for psychiatry, and this did lead to big advances in psychiatric medicine. The next decade would see the introduction of anti-depressants like Prozac, Paxil and Wellbutrin and antipsychotic drugs like Zyprexa, Risperdal, and Abilify. In the 2000s, the NIMH funded big, independent clinical trials testing how well these medicines compared and how well to use them. A big study of the antidepressants found that a third of patients became symptom-free on taking them, but that switching those who were not helped to other drugs yielded diminishing results. A study of the schizophrenia drugs showed that, for just about all of them, patients and doctors chose to switch to another treatment three-quarters of the time, showing how difficult to use these medicines are.

But the strategy of conducting studies of existing drugs in thousands of patients fails when new drugs are not being invented. So Cuthbert says that the NIMH is very consciously focusing on small studies of new experimental drugs that drug companies have not embraced. The idea is to follow the “de-risking” model that has been successful for disease charities. The best example is Kalydeco, a drug for cystic fibrosis originally developed at Vertex Pharmaceuticals with funding from the Cystic Fibrosis Foundation. Eventually the drug became Vertex’s most important product, demanding lots of resources and generating a high price. The idea is to try to get industry interested in psychiatry again. Changing the diagnostic system, seen as one reason that drugs are failing, is part of the job.

The part in red is why this article was picked from the many available, and I appreciate Richard Noll pointing me to it. In the time of Drs. Hyman [1996-2002] and Insel [2002-present] at the NIMH, the agency funded huge clinical studies of the drugs PHARMA was bringing onto the market: STAR*D, CATIE, TADS, CO_MED, TORDIA, COBY, STEP-BD, etc.  Some were better than others, but the point is that the NIMH spent its money reacting to what PHARMA was doing. The APA, Academic Psychiatry, and the NIMH basked in the shadow of their successes [in the marketplace]. The APA and its burgeoning DSM-5 Task Force was the leading edge of the march into the future. When PHARMA ran out of targets for new drugs, Organized, Academic, and Government psychiatry was unable to help – they had been followers, supporters, even critics occasionally, but had no scientific direction to offer.

The real task of the DSM-5 was to revise and refine the diagnostic system to more accurately describe patients with mental illness. That’s why Drs. Robert Spitzer and Allen Frances got steamed up because they could see that it was on another trajectory. When it became obvious that it failed to bear fruit, the real agenda had been ignored too long, and their predecessors began to warn them to change gears. But the warnings were ignored and the resulting DSM-5 Manual is essentially unrevised. It has the same problems it had before they started, but they added some new ones of their own following the yellow brick road they hoped to be on rather than the one they were assigned:

Jeffrey Lieberman, the chairman of psychiatry at Columbia University’s College of Physicians and Surgeons, ran the NIMH’s big schizophrenia trial. He is also a defender of the DSM in its current form. But he is also a big believer that psychiatry needs to base its decisions more on biology, and less on behavior.

“The DSM is the past and, for the time being, the present,” says Lieberman. “But it won’t be the future. [In] the future it will be either improved or replace by a more physiologically based set of diagnostic criteria. That may change the whole landscape for diagnosis.”

 

There must be two sides to every story.
And who’s to say, who’s right and who is wrong?…

Glaxo And Its Transparency Effort Finally Moves Forward
Pharmalot
by Ed Silverman
05/07/2013

Witty A: Report to the President
by David Healy
07 May 2013

I say, "Looks like every time you go to the doctor, somebody starts another drug." They say "yes" as if that’s normal. They often know about the "withdrawals" from personal experience, running out of money for medications. I’ve been there for a while, and I’m beginning to notice that if I can get them off of the compendium of drugs, and later start one in what I consider to be the right way – low dose first, minimal expectations, they [and I] are often surprised at the response. There are always things in their lives that need attending to, and I find myself often sayingt, "These medications aren’t for life, and they’re only minimally effective when they work. The point is to feel better so you can ___." Fill in clean up your life, marriage, etc. etc. I’ve come to realize that they basically don’t know in any useful way that their symptoms have something to do with their lives.

An outrageous number have been told, "you’re bipolar," and they incorporate it in what seems at first like a useful way, as if it legitimizes their depression, but in the long run it becomes something of a "fate neurosis" – a life sentence. I have had to learn that in addressing that, I am taking something away from them if I challenge that diagnosis, so I have to walk softly, but it pays off in the end. There are some people with genuine Bipolar Disorders, but it’s obvious who they are [and they are in the minority]. When I first started, a lot of drug-seeking character disordered people wandered through. I must’ve done something right, because I rarely see such patients any more.

About once every clinic morning, some patient shows up with the kinds of problems I treated in practice. Today, it was an attractive talented girl who is almost home-bound because of a malignant envy problem. I’ve seen her occasionally over the last several years, and she’s finally begun to hear that her intense feelings are not truth, but the problem themselves. Today, she brought her mother to apologize to her for "being a jerk." "I thought it was your fault." They talked about her getting a job to practice being among people and planned her starting college in the Fall. If you had asked me if you could treat show-stopping envy by a few sessions in which you mainly just explained that her feelings were a bad compass, I would’ve scoffed. But I would have been wrong, as I saw this morning.

Actually, that little clinic in a couple of old trailers run by a bunch of do-gooder retirees has been sustaining in writing this blog. It’s so easy to get cynical and discouraged reading the APA, PHARMA, DSM, NIMH goings on. In the clinic, I rarely think of such things. Back when I directed a residency program, I used to tell a story to graduating residents when they were nervously planning their next step. When I finished my Internal Medicine Residency, I was the smartest person on the planet. I could roll off differential diagnoses, treatment algorithms, quote journal articles. I was a giant. Then I started practicing, and was humbled by the experience. When I finished psychiatry, I felt like an idiot who knew nothing. It wasn’t until I practiced that I realized how much I’d learned. So I suggested they take a clinic job where they knew what they were doing already, and only gradually build a practice. Most did that, but within a year or so were too busy to stay in the clinic.

Psychiatry’s Guide Is Out of Touch With Science, Experts Say
New York Times
By PAM BELLUCK and BENEDICT CAREY
May 6, 2013

^{Just weeks before the long-awaited publication of a new edition of the so-called bible of mental disorders, the federal government’s most prominent psychiatric expert has said the book suffers from a scientific “lack of validity.” The expert, Dr. Thomas R. Insel, director of the National Institute of Mental Health, said in an interview Monday that his goal was to reshape the direction of psychiatric research to focus on biology, genetics and neuroscience so that scientists can define disorders by their causes, rather than their symptoms. While the Diagnostic and Statistical Manual of Mental Disorders, or DSM, is the best tool now available for clinicians treating patients and should not be tossed out, he said, it does not reflect the complexity of many disorders, and its way of categorizing mental illnesses should not guide research. “As long as the research community takes the DSM to be a bible, we’ll never make progress,” Dr. Insel said, adding, “People think that everything has to match DSM criteria, but you know what? Biology never read that book.”}

Biology may have never read the book, but we saw the movie. In the classic, Groundhog Day, Bill Murray lives the same day over and over again. Each morning, he wakes up into the same day, but after a number of iterations, he started learning from the repetition and began to change things around about himself in each new version of the day. I’m not sure we’ve figured that out yet in psychiatry. We just keep repeating the same thing and [to quote the old definition of insanity] expecting different results. Picking up the story in 1970 [after the publication of the DSM-II in 1968]:

Establishment of Diagnostic Validity in Psychiatric Illness: Its Application to Schizophrenia
^{BY ELI ROBINS. M.D.AND SAMUEL B. GUZE, M.D.}
American Journal of Psychiatry. 1970 126[7]:107-111.

^{… One of the reasons that diagnostic classification has fallen into disrepute among some psychiatrists is that diagnostic schemes have been largely based upon a priori principles rather than upon systematic studies. Such systematic studies are necessary, although they may be based upon different approaches. We have found that the approach described here facilitates the development of a valid classification in psychiatry…}

Dr. Spitzer’s compromises, reliability for validity and atheoretical/descriptive for etiology produced a very long day. The diagnostic system had several revisions, refinements of the DSM-III, and the DSM-IV set a record, lasting 19 years [1994-2013]. In 2002, the future chairs of the DSM-V [as it was then called] announced that Spitzer’s compromise had outlived its usefulness and proposed to move the diagnostic system closer to mainstream medicine by including the biological findings with the diagnoses – a biomedical diagnostic system for psychiatry was on the way. And so we started our day over once again. That same year, Tom Insel took over the NIMH and became a cheerleader for Clinical Neuroscience, his renaming of psychiatry.

We all know what happened. The psychopharmacology bubble burst and clay feet were exposed far and wide – in industry, in academia, just about anywhere anybody looked. The DSM-5 [as it had become] Task Force had to announce that its plans biomedical had been premature, and everything else went equally badly. They were amply warned by their predecessors [Drs. Robert Spitzer and Allen Frances] that they were headed for big trouble, but instead of listening, they resorted to Ad Hominem defenses. It has been a bad version of that same old day, the one that lasted from 2002 until this week. No question about that.

NIMH Won’t Follow Psychiatry ‘Bible’ Anymore
by Emily Underwood
ScienceInsider
6 May 2013

^{Although Insel’s blog was reported as a bombshell and potentially seismic, NIMH’s decision to scrap the DSM criteria has been public for several years, says Bruce Cuthbert, director of NIMH’s Division of Adult Translational Research and Treatment Development. In 2010, the agency began to steer researchers away from the traditional categories of DSM by posting new guidance for grant proposals in five broad areas. Rather than grouping disorders such as schizophrenia and depression by symptom, the new categories focus on basic neural circuits and cognitive functions, such as those for reward, arousal, and attachment…}

The first time I wrote about Insel’s blog on this, I called it old news…. That was an overstatement, it’s not any kind of news at all. It’s political positioning. Dr. Insel hears a great sucking sound over at the APA offices and he’s trying to get out of its way before it sucks him down with it. His NIMH was a major partner with the APA in the DSM-5 conferences and planning. His RDoC was born in that failure as a way to keep the dream alive when the APA failed. He’s aiming to replay that same day with the same theme over one more time. In the movie, there came a time when Bill Murray woke up and it wasn’t the same day he’d been reliving over and over. It was a new day for real. We could use one of those in psychiatry about now rather than Dr. Insel leading us on the same old charge to nowhere…

A long time ago, I took that paragraph at face value, at least the first part. I don’t specifically recall my reaction, but I expect that the second part felt like a rationalization to me. It sure feels that way to me now. While my own focus was primarily in the psychological and social domains, I was interested in the biological too. I  don’t recall feeling that there were competitions. Obviously oblivious is how I now think of my naivety in those days. It only gradually dawned on me that people were talking like all mental illness had a biological basis. Back then, they didn’t often say it ["that all mental illness is biologic"], they just talked as if that were true – hardware rather than software. And there was a lot of all going around back then. The behaviorists saw it as all due to faulty learning. Many of the analysts were close to all with their theories. From my perspective, the DSM-III had unmasked deep fault lines in the psychiatry of the time, but miraculously, it cooled off the public crisis. And there was something else unmasked, a rage against psychoanalysis that I didn’t know was there. It’s still pretty easy to find it if you peek just under the surface.

In bygone days, analysts had interpreted that anger as representing many things other than being justified without looking in the mirror to see what was right about it. So by 1980, there weren’t near enough cheeks to turn and the analysts were slammed. I’m mentioning this, because it was part of my attempt at understanding why so many psychiatrists acted as if all mental illness had a biological basis. I thought that might be because they were bound and determined to close the door on anything that smelled slightly Freudian. I went about my business and never had to directly address this all mental illness is biologic question. But there are ample comments in prominent places that suggest that it remains a central belief. They don’t all say all, but they come mighty close:

It’s a pretty strange story line if they want to sell their DSM-5 to anyone other than like-minded psychiatrists. And it leaves them high and dry as they’ve based their raison d’être on new biological treatments [drugs]. The reaction of other mental health professionals was civil, but hardly supportive. They’re the ones poised to boycott the DSM-5.

The reason this came to mind [other than Insel's RDoC assumptions] was my recent reading about Emil Kraepelin [all ears…, an open question…]. I won’t rehash all of his comments, they’re there to read. But I think he would’ve eliminated the patients we might have considered neurotic or personality disordered from the domain of mental illness altogether – seeing them as more constitutionally defective, particularly in his 1919 paper entitled ‘Psychiatric observations on contemporary issues.’ It was an extremist right-wing view of the kind still debated on our Capital steps today – only Kraepelin’s version had rough the edge that dominated the German Nationalism of that era: Jews, women, soldiers on disability, criminals, neurotics? It’s a common enough attitude even today, but doesn’t have so open an expression as it did 100 years ago in Germany. Kraepelin certainly had nothing to say good about Freud.

Basing his stand on his extensive experience of institutional psychiatry, he expressed himself forcibly on the prevention of alcoholism and syphilis, two of the indisputable causes of severe psychosis. In 1895 he advocated total abstinence from alcohol and thenceforward was a tireless, even a fanatical supporter of anti-alcohol campaigns…

"Attention must be focused above all on the fight against all those influences threatening to destroy future generations, in particular hereditary degeneration and genetic influences resulting from alcohol and syphilis"…

That a biologic cause was a requirement to be classified as having a mental disorder helps make sense out of things I haven’t understood. PTSD is the paradigm for an acquired mental illness, yet the literature is full of studies looking for a biological predisposition, some genetic flaw. They were traumatized because they didn’t have something called resiliency. Now, they can’t even leave grief alone. It’s about to be pulled into the world of Major Depression. And if there’s no fit between the biology and the taxonomy, then they’ll go find another taxonomy [the RDoC] – bring  the diagnosis to the biomarker rather than the other way around.

I ended an open question… with: "But did Kraepelin’s notion of constitutional inferiority impact his legacy? our current nosology? I don’t know the answer to that and it’s the worst of things for idle speculation. It is an open question." The more I read about Kraepelin, the Social Darwinism of that period, the Eugenics Movement, etc., the more I think his sociopolitical view of people did color his taxonomy and his view of neurotic illness as constitutional weakness. Whether that has transferred up the historical chain is unclear, even if the opinion has stayed the same. But I do wonder how widespread that view is today?

Paradigms lost: NIMH, McGorry & DSM-5’s failure
Left Flank
by Dr_Tad
May 4, 2013

… Last week the National Institute of Mental Health — the peak US mental health research body — delivered a body blow to the authority of the DSM by announcing that it was abandoning the manual in favour of its own Research Domain Criteria [RDoC].

This is a new phase of the controversy that has dogged the DSM-5 at every turn. Petitions opposing the project have garnered the signatures of thousands of clinicians. The revision process has been attacked for being kept behind closed doors, and for favouring the pet research areas of expert committee members. The corporate media — usually uncritical of mainstream psychiatry — has reported substantial criticisms of proposed changes. The taint of academic psychiatry’s incestuous relationship with Big Pharma has fed accusations of financial influence. And the psychiatrists who headed DSM-III and DSM-IV — Robert Spitzer and Allen Frances — have attacked the DSM-5.

Even on the aims its creators set, the DSM-5 is a failure; an incoherent compromise and a mess. Significantly, its contents will reflect the impasse of the diagnostic paradigm that became hegemonic with the DSM-III in 1980, following a “revolution” in diagnosis designed to save US psychiatry from its profound crisis in the 1970s. It will be a further sign of the failure to create a “scientific” basis for psychiatry through symptom-based diagnoses, as NIMH director Thomas Insel has argued on his blog.

But the authors of DSM-5 also wanted the kind of quantum leap Insel advocates. When they started work over a decade ago they saw their task as going beyond simply describing disorders in terms of the symptoms and behaviours [the DSM is currently silent as to the “aetiology”, or cause, of almost all the disorders it defines]. Instead they would align diagnoses to the “underlying” genetics and neurobiology. Yet as they proceeded it became increasingly obvious that there was insufficient evidence for this shift. More importantly, the biomedical model was increasingly being challenged from a number of directions: A series of major scandals involving kickbacks from drug companies to psychiatric “thought leaders”, mounting public concern about the over-diagnosis and gross overmedication of adults and children, and the growing evidence that many top-selling psychiatric medications [especially anti-depressants] worked little or perhaps no better than placebo.

It is no wonder that DSM-5 “innovations” like removing bereavement as an exclusion criterion for Major Depression are widely opposed. It feeds into a suspicion that psychiatrists and drug companies are cynically expanding potential markets for the expensive services and products they are selling. The finished DSM-5 will have most of its original raison d’etre missing, some of the rewriting [e.g. personality disorders] relegated to an appendix, and a pall of controversy, mistrust and confusion surrounding it. The APA has suffered financially in recent years from a stagnant membership base and growing regulation of its financial ties with industry. Sales of the manual [not cheap at US$199] and its various guides to use form a major part of the APA’s annual revenue and seems to have been a driver for getting a new edition out for sale. In the end politics hobbled the DSM-5 because the “objective” scientific advances its developers saw as being just around the corner proved to be a mirage…

While this is a setback for the DSM, it is far from being a defeat for the dominant neurobiological model of mental health and illness. As blogger 1 Boring Old Man points out, Insel is simply taking the established NIMH position to its logical conclusion by formally breaking with DSM-5. And the last half-century is proof of how profoundly that model shapes psychiatric research and practice. No matter how lean the pickings they deliver, biologically based approaches remain powerful and those who question them tend to be sidelined. You can see this in Insel’s alternative program for devising new diagnostic boundaries:

• A diagnostic approach based on the biology as well as the symptoms must not be constrained by the current DSM categories,
• Mental disorders are biological disorders involving brain circuits that implicate specific domains of cognition, emotion, or behavior,
• Each level of analysis needs to be understood across a dimension of function,
• Mapping the cognitive, circuit, and genetic aspects of mental disorders will yield new and better targets for treatment.

Such assumptions are little more than speculative, yet they are presented as conclusive. They serve to close off avenues of research that fall outside their boundaries rather than open them up. They point to the imperviousness of the dominant biological paradigm to evidence that contradicts it. In the words of Samuel Beckett, “Try again. Fail again. Fail better.”

I know I thought those things when I read about the RDoC, but why didn’t I say them? I think I’ve been a Straw Man in too many conversations where people want to unload their contempt for psychological or psychoanalytic thinking. So I’ve limited myself to only questioning scientific misbehavior, not basic assumptions. Having been on the other side of contempt, I don’t want to be it’s agent. But in this case, I should have started my blog pointing out that Dr. Insel’s RDoC assumptions have skipped way too many steps, or said, as Dr_Tad did, "Such assumptions are little more than speculative, yet they are presented as conclusive," which is perfect – perfectly said and perfectly true.

The real problem afflicting all these attempts to find a way out of the current impasse is that they have failed to accurately diagnose the sources of the crisis. Because psychiatry, like the rest of medicine, is deeply imbued with scientific positivism [that real science is free of social values] and methodological individualism [that social processes are merely the aggregate outcome of individual behaviours], it cannot fully grasp that all health and illness — mental and physical — is both socially embedded and socially constructed. Therefore it cannot critically reflect on its own social nature, its own ideologies and practices that are inextricably bound up with wider social conflicts in their historical contexts.

The reaction to the 1970s crisis of American psychiatry was to use claims about the “reliability” of diagnosis to strengthen the profession’s “scientificity” in appearance but not reality. That model served powerful interests in the psychiatric profession, academia, government bureaucracies, and the pharmaceutical industry, but has unraveled when so many of its claims to help those with mental health problems have been exposed as hollow. A new paradigm that doesn’t simply repeat those flaws cannot be built from above, not by DSM committees nor NIMH directors. It can only be built through the struggles of patients and clinicians for a mental health system driven by quite different social priorities.