1 Boring Old Man

The DSM-5 Task Force and its antics have dominated and embarrassed psychiatry for several years now, and like the swirling winds in Oklahoma, left a swath of destruction in its wake that will be long remembered. It has certainly been the noisiest DSM Revision effort in history, but is substantively of almost no consequence. While APA President Dr. Jeffery Lieberman calls it a "gold standard," it’s hard to see that it’s very different from the DSM-IV of 1994. The messiness of the Depression and Anxiety categories is, if anything, messier. There are some silly additions like renaming Dr. Biederman’s Bipolar Child as Disruptive Mood Dysregulation Disorder, the invention of Somatic Symptom Disorder, and other made up place holders that won’t lead to any deeper understanding of human experience or biology. So I guess the only "gold" involved that I can see is the $25 M they left along the way.

Looking over the meeting schedule and the daily bulletins, if you subtract all the DSM-5 goings-on, there wasn’t much left. A new CEO I’ve never heard of with a lot of administrative background. A lot of politically correctness – LGBT disaster studies, bullying, gun control, minorities, prevention – things that matter but not much in the way of scientific teeth. There were lots of "advances in…" and "overview of…" and less "neurobiology of…" than usual. Drs. Alan Schatzberg and John Rush were there with an update on iSPOT [without Dr. Nemeroff]. Dr. Nemeroff had only one session on aging, whoops – replaced by the incoming APA President, Dr. Paul Summergrad [right].

There was not much about this meeting that caught my attention one way or another other than following the DSM-5 launch, and even going over the schedule of sessions and symposia, it all seemed pretty bland. Maybe I’m just getting old and hard to engage, but maybe not. Maybe there just wasn’t a lot there. It felt like a wake. On the other hand, all week long I’ve had an odd non-evidenced-based feeling – one that surprised me. The feeling is, "It’s over" – something of a relief feeling. I’m going to have to cogitate on what "It" really means. First shot is that "It" is the strangle-hold that a particular group of highly placed industry-affiliated psychiatrists have had on the specialty for several decades that has finally begun to play itself out. You can all name the ones I’m talking about. Their names fill the posts of this blog [but not the APA program].

DSM-5: Caught between Mental Illness Stigma and Anti-Psychiatry Prejudice
Scientific American: Mind
By Jeffrey A. Lieberman
^{American Psychiatric Association President}
May 20, 2013

Like many psychiatrists, I have been amazed by the debates surrounding the DSM-5, the first major revision of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders in nearly twenty years, which was just released. Never before has a thick medical text of diagnostic nomenclature been the subject of so much attention. Although I was heartened to see more and more people discussing the real-world issues and challenges — for patients, families, clinicians and caregivers – within mental health care, for which the book offers an up-to-the-minute diagnostic GPS, I was also alarmed at the harsh criticism of the field of psychiatry and the APA. Consequently, I believe that as you read and watch this increased coverage, it’s important to understand the difference between thoughtful, legitimate debate, and the inevitable outcry from a small group of critics – made louder by social media and support from dubious sources — who have relentlessly sought to undermine the credibility of psychiatric medicine and question the validity of mental illness.

DSM-5 has ignited a broad dialogue on mental illness and opened up a conversation about the state of psychiatry and mental healthcare in this country. Critiques have ranged in focus from the inclusion of specific disorders in DSM-5, to the concern over a lack of biological measures which define them. Some have even questioned the entire diagnostic system, urging us to look with an eye focused on the impact to patients. These are the kinds of debate that I hope will continue long after DSM-5’s shiny cover becomes worn and wrinkled. Such meaningful discourse only fuels our ability to produce a manual that best serves those touched by mental illness…

^{“There are huge unmet clinical needs in mental disorders and addiction,” said Jeffrey Lieberman, M.D., incoming president-elect of APA and chair of psychiatry at Columbia University, who moderated the morning session. “There should be tremendous interest in this area, but there is not.”}

^{But there’s another type of critique that does not contribute to this goal. These are the groups who are actually proud to identify themselves as “anti-psychiatry.” These are real people who don’t want to improve mental healthcare, unlike the dozens of psychiatrists, psychologists, social workers and patient advocates who have labored for years to revise the DSM, rigorously and responsibly. Instead, they are against the diagnosis and treatment of mental illnesses — which improves, and in some cases saves, millions of lives every year — and “against” the very idea of psychiatry, and its practices of psychotherapy and psychopharmacology. They are, to my mind, misguided and misleading ideologues and self-promoters who are spreading scientific anarchy…}

^{"While some of the criticism has come from small groups who would criticize anything we might do, that’s to be expected. More troubling is the criticism from our colleagues in psychiatry, other mental health specialties, and particularly patients. They worry about inappropriate labeling; about influences from industry and other conflicts of interest in recommending medication treatment, minimizing side effects and maximizing drug efficacy; about psychiatrists not spending enough time with patients to understand the context of their lives; about being overly enthusiastic about the exciting but distant frontiers of neuroscience; about over-diagnosing and over-medicating; and more." The traditional role of psychiatrists is listening, and I’ve heard those messages. In my coming year as President, I intend to lay the groundwork for seriously looking into each of these complaints and can assure you that they will be thoroughly and fairly studied. While many of those criticisms can be traced to outside forces, that’s no excuse for psychiatry to avoid taking a long genuine look in the mirror. And I intend for us to do just that."}

^{[Lieberman, Frances, Horowitz]}

^[Greenberg]

DSM-5: A Manual Run Amok
^{It’s time for psychiatry to drop its field guide and try to learn about mental ills}
Wall Street Journal
By PAUL MCHUGH
May 17, 2013

… With its third edition [DSM-III], the manual [which had existed since 1952] underwent a transformation. Its editors focused on codifying symptoms that seemed to distinguish one mental disorder from another. If psychiatrists would use these criteria consistently, they suggested, then perhaps researchers would be able to explain and differentiate disorders in terms of psychobiology. This prescription for diagnostic peacemaking radically changed the psychiatric scene. No longer was it an unruly market of claims, counterclaims and "orientations." Psychiatric practices became centered on using the manual to identify disorders, much as a naturalist uses a field guide to identify birds or trees. The treatments derived from these diagnoses had no particular theory behind them. They were efforts, mostly pharmacological and rule-of-thumb, to provide relief from symptoms. Psychiatric thinking about patients and their disorders withered.

Today the public complains that psychiatrists seem ready to call every state of mental distress an illness. They see that any restless boy can receive a diagnosis of attention deficit disorder, that troubled veterans—whether exposed to combat or not—are routinely said to suffer from post-traumatic stress disorder, and that enormous numbers of discouraged, demoralized people are labeled victims of depression and have medications pressed upon them. The public is not far wrong. A recent nationwide diagnostic census based on DSM claimed that the majority of Americans have or have had a mental disorder. As a result, an appalling number of young adults in schools and colleges are on one form or another of psychiatric medication.

The problem, though, is not only that psychiatrists have gone too far in naming mental states — they surely have — but that they have gone on too long with their field-guide checklists. They seem unable to do better. DSM-5 will be more of the same — a way to "know of" disorders without "knowing about" them, to draw a distinction made by William James. With its new manual, the APA might instead have started taking steps toward a system of classification that, as in medicine, organizes disorders according to what we know about their natures and causes. Such knowledge, rather than checklists of symptoms, would then direct treatment and research.

Psychiatrists know, for instance, that depression and anxiety can derive from a number of different sources: cerebral diseases such as schizophrenia and bipolar disorder; alcoholism or drug addiction; experiences of loss, deprivation or trauma; and, more generally, a vulnerable temperament, characterized by introversion, shyness and emotional intensity. Deciding which of these sources, alone or in combination, applies to a particular patient requires hours of evaluation. Prescribing an appropriate treatment involves not checking symptoms but determining who the patient is and what he or she has experienced and done.

DSM-5 displays none of this thinking. It remains a field guide organized by symptoms, clustered in categories that can expand without limit. Official, APA-approved psychiatry seems to lack the will to change. It justifies its stagnation not only by reminding its members of the chaos of the 1970s but by claiming that the U.S. health system would not pay psychiatrists if they tried to know their patients the way that they could and should.

DSM-5 is a missed opportunity to advance the discipline, instruct the public and encourage financial support for needed psychiatric services. Its editors seem willing to waste another decade before dispersing the mysteries of psychiatry and bringing practitioners and patients together in understanding what they are doing and why.

This WSJ article starts with a critique of the version of psychoanalysis that dominated psychiatry in the pre-1980 days and why things needed to change. In spite of being an analyst myself, most of what he had to say are things I generally agree with, but I thought Dr. McHugh’s description of the post-1980 state of play was exceptional [above]. While critical, he’s fleshed out the essential elements in a clear and concise  way and points to a rational alternative.

^{DSM-5 is a missed opportunity to advance the discipline, instruct the public and encourage financial support for needed psychiatric services. Its editors seem willing to waste another decade before dispersing the mysteries of psychiatry and bringing practitioners and patients together in understanding what they are doing and why.}

Expert Sets Record Straight on Antidepressant Myths
Psychiatric News
May 19, 2013

Anthony Rothschild, M.D.Antidepressants do “really work” and do not “cause suicide,” said Anthony Rothschild, M.D., at APA’s 2013 annual meeting today during a discussion of his second book in the Evidence-Based Guides series, the evidence-based guide to antidepressant medications [American Psychiatric Publishing, 2012]. Rothschild is the Irving S. and Betty Brudnick Endowed Chair and Professor of Psychiatry at the University of Massachusetts Medical School.

Rothschild said that although clinicians have successfully used antidepressants to treat millions of patients suffering from depression for 50 years, Kirsch et al. published in 2008 a paper claiming that although antidepressants are statistically superior to placebo, the magnitude of the drug-placebo difference is small and that these differences were clinically relevant only in patients with severe depression. Surprisingly, he said, the paper received considerable attention in the media, including radio, front-page newspaper coverage, and “60 Minutes.” Rothschild said that the focus on questions about whether antidepressants really worked needlessly upset patients and their families. He pointed out that many experts in the field have argued that the analysis by Kirsch and colleagues was seriously flawed because it relied upon unusual statistical techniques biased against antidepressants.

Rothschild also discussed the fact that some have questioned whether treatment with the SSRIs and other antidepressants can induce suicidal ideation and whether they worsen existing suicidal ideation. Although the totality of the reliable scientific evidence indicates that SSRIs and other antidepressants do not cause suicide, the FDA has required that all antidepressants contain a black-box warning that they are associated with “suicidality” in children, adolescents, and young adults up to age 24. Rothschild said that clinicians should be aware of two important points: [1] the FDA’s black-box warning does not indicate that antidepressants increase the risk of suicide in anyone or that they increase the risk of suicidal thinking or behavior in patients ages 25 and older; and [2] although the FDA used the concept of “suicidality” as a proxy for completed suicide, they are not the same thing. The term “suicidality” has been criticized as grossly overestimating the risk of suicide and as not being as clinically useful as more specific terminology such as ideation, behavior, attempts, and suicide.

The workshop included discussions regarding the fact that antidepressants are prescribed for many patients in addition to those who have major depressive disorder, including patients with bipolar disorder, posttraumatic stress disorder, schizophrenia, and personality disorders, as well as those with medical illnesses. The workshop reviewed the use of antidepressants for so-called off-label use—to treat illnesses for which the medications do not have U.S. Food and Drug Administration approval—and emphasized that practicing clinicians need to understand the use of antidepressants among several special populations, including children and adolescents, geriatric patients, and pregnant and lactating women.

I find this article infuriating. First, he takes on the efficacy of antidepressants. As we all know, the efficacy of the modern antidepressants is much lower and variable than we’ve been lead to believe. Most practitioners already know that from usage if they follow people closely. Dr. Rothschild takes the most extreme critic, Dr. Kirsch, and talks as if the fact that Kirsch’s methodology has been questioned as proof that the complaint has no validity. Rothschild’s bias is clear – similar to Robert Gibbons discussions. Anyone can easily find multiple other studies that confirm the complaint that the newer antidepressants operate in the range of "Lite."

But his discussion of suicidality and the Black Box warning is where Rothschild’s bias shines. It’s hard for me to imagine anyone that prescribes SSRIs hasn’t seen akathisia – agitation with aggression. It’s not common, but it’s not rare either. He does what most people do, get lost in semantics, but basically is lobbying against our knowing about something that is very real. They could easily say the truth. It is an unusual reaction that is quite frightening to patients and can lead to lethality. But Rothschild takes the it-doesn’t-happen road. That seems so un-medical to me, particularly in an official, "evidence-based" guideline book. This whole presentation reeks of drug promotion don’t-worry-about-it rhetoric instead of responsible information giving.

Vortioxetine clinical phase III data show significant improvement in symptoms of major depression
NASDAQ OMX
May 18, 2013

Vortioxetine clinical phase III data show significant improvement in symptoms of major depression

• Takeda and Lundbeck present results from pivotal phase III clinical trials with vortioxetine, an investigational compound for major depression
• First presentation of results from four pivotal clinical studies of doses of up to 20 mg/day
• Clinical studies demonstrate efficacy at doses of 15 mg and 20 mg per day including an improvement of overall functioning
• The safety profile was shown to be consistent with previously completed studies at lower doses

Valby, Denmark, 18 May 2013 – H. Lundbeck A/S [Lundbeck] and partner Takeda Pharmaceutical Company Limited [Takeda] today announced that the companies will be presenting new data on four pivotal studies on vortioxetine, a novel investigational drug under review by the U.S. Food and Drug Administration [FDA] and the European Medicines Agency [EMA] for the treatment of major depression. The phase III data will be presented at the 2013 Annual Meeting of the American Psychiatric Association [APA] in San Francisco, USA.

The objective of these four studies was to evaluate the efficacy and safety profile of vortioxetine in doses ranging from 10-20 mg per day, complementing other studies in the New Drug Application [NDA] submission package that included dose ranges of 5-20 mg per day. Three of the four pivotal studies met the primary efficacy endpoint as measured by the change from baseline of the Montgomery-Åsberg Depression Rating Scale [MADRS] total score at week 8. Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Results of all four studies provided additional information regarding the safety profile of vortioxetine.

"It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic," said Madhukar Trivedi, M.D., professor of psychiatry, UT Southwestern Medical Center. "As a clinician, I’m encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients with MDD."

Dr. Trivedi … serves as scientific advisor for Lundbeck and Takeda.

^{SAN FRANCISCO — The American Psychiatric Association officially kicked off its annual meeting this weekend with the release of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. To mark the occasion, incoming APA president Jeffrey A. Lieberman, MD, announced during the opening session that the profession of psychiatry has come of age. "This is the time for us to seize the moment, for mental illnesses to step out of the shadows, for mental health care to be made accessible and fairly reimbursed, and for psychiatry to take its rightful role in the field of medicine," he said… Despite some of the challenges, psychiatric medicine has grown by leaps and bounds, Lieberman said. He gave examples of the emergence of psychopharmacology, neuroimaging, molecular genetics and biology, which have propelled psychiatry to the forefront of modern medicine…}

^{We’re all mad here by DR. ALLEN FRANCES – Human nature doesn’t change that fast, but the labels used to describe it can follow fickle fashions. The vehicle of today’s fashion shift is the publication yesterday of the fifth edition of the “Diagnostic and Statistical Manual of Mental Disorders,” the official compendium of psychiatric diagnoses. DSM 5 has added many new mental disorders that include many symptoms and behaviors previously accepted as simply part of the human condition. The resulting overdiagnosis of mental disorder will have many harmful unintended consequences — the misuse of medication, unnecessary stigma, high costs, misallocated resources, narrowed expectations, a reduced sense of personal responsibility, and the misapprehension that we are all becoming sick individuals living in an increasingly sick society…}

^{Psychiatry faces another crisis of confidence – Psychotherapist Gary Greenberg is more blunt. “Even at its best … psychiatric diagnosis is fiction sold to the public as fact,” Greenberg writes in his new book, The Book of Woe: The DSM and the Unmaking of Psychiatry. “There is a huge disconnect between what psychiatry claims for itself, and what it can actually do,” he says… In other words, 200 years after psychiatry was recognized as a medical discipline, a stark question persists: Is psychiatry credible?…}

^{Time present and time past
Are both perhaps present in time future,
And time future contained in time past.
If all time is eternally present
All time is unredeemable.
What might have been is an abstraction
Remaining a perpetual possibility
Only in a world of speculation.
What might have been and what has been
Point to one end, which is always present…}
^{T. S. Eliot, Burnt Norton}

APA Leaders Defend New Diagnostic Guide
MedPage Today
By John Gever
May 18, 2013

The fifth edition of the "psychiatrist’s bible" was officially released here in all its 947-page glory, with its developers offering a spirited rebuttal to their critics. Known as DSM-5, the new version of the American Psychiatric Association’s [APA] Diagnostic and Statistical Manual of Mental Disorders was launched at a press briefing to kick off the organization’s annual meeting. Most of the changes from the previous edition had already been made public, at least in general outline.

At the briefing, DSM-5 Task Force chairman David Kupfer, MD, of the University of Pittsburgh, defended several of the most heavily criticized revisions from DSM-IV, as the last edition was called. Other top APA leaders, including current president Dilip Jeste, MD, of the University of California San Diego, and president-elect Jeffrey Lieberman, MD, of Columbia University in New York City, addressed another, more recent controversy over DSM-5, which was sparked by a blog post from National Institute of Mental Health [NIMH] Director Thomas Insel, MD. In his blog, Insel criticized the DSM classification system’s scientific validity, and his remarks were then reported in consumer media as suggesting DSM-5 is "out of touch with science," as a New York Times headline put it.

Kupfer identified several specific changes from DSM-IV in the new edition that had drawn the most heat from others in the mental health community and patient advocacy groups…

• Autism Spectrum: …
• Bereavement Exclusion in Major Depression: …
  APA fact sheet distributed at the briefing pointed to several features that "usually" distinguish depressive illness from normal grief in patients experiencing recent losses. They include continuous unrelieved negative mood and feelings of worthlessness and self-loathing. In normal grief, extreme sadness is typically intermittent and self-esteem is unaffected, the fact sheet said.

• Disruptive Mood Dysregulation Disorder (DMDD]: …
  The diagnosis "is intended, in part, to address issues about potential overdiagnosis and overtreatment of bipolar disorder," Kupfer said.

• Mild Neurocognitive Disorder:
  In a critique of DSM-5 published on the eve of its launch, the head of DSM-IV’s development in the 1980s, Allen Frances, MD, of Duke University in Durham, N.C., singled out the new edition’s inclusion of mild neurocognitive disorder as another example of medicalizing normal function… "There has been concern that we may have added a disorder that may not be important enough to merit clinical attention," Kupfer said… "Clinicians have lacked a reliable diagnosis to assess such [impairments] and to understand what might be the most appropriate treatment or services," Kupfer said. Including mild neurocognitive disorders in DSM-5 "serves two essential needs," he said. One is that it provides "an opportunity for early detection," while another is that it "encourages the development of an effective treatment plan before deficits become more pronounced and progress to dementia."

• Insel’s Comments: …
  Apparently without meaning to, Insel set off a firestorm with an April 29 "director’s blog" post on the NIMH website, in which he lamented that the DSM – not just the new edition but its predecessors as well – is not grounded solidly in biology. Rather, he said, "the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure.

At the press briefing here, APA officials reiterated that there is, in fact, no disagreement with Insel. "We support what he’s trying to do," said John Scully, MD, the APA’s chief executive officer. "We want him to get biomarkers for us." Added Lieberman, "He [Insel] was trying to exhort the biomedical research community to try to break new ground that will lead to more dynamic and fundamental changes in psychiatric diagnosis." Yet, Kupfer suggested, the flaws in DSM-IV for daily clinical practice needed to be addressed in the short term, and an extension of the symptom-based approach remained the only alternative. "While we don’t yet have the biomarkers that we are hoping are on the edge of discovery, patients can’t keep waiting, and we can’t keep waiting," he said.

• Other Criticisms …

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