Wednesday, May 8, 2013

Psychiatry in Crisis! Mental Health Director Rejects Psychiatric “Bible” and Replaces with… Nothing - By John Horgan - blogs.scientificamerican.com

Psychiatry in Crisis! Mental Health Director Rejects Psychiatric “Bible” and Replaces with… Nothing

By John Horgan | May 4, 2013

What is mental illness? Schizophrenia? Autism? Bipolar disorder? Depression? Since the 1950s, the profession of psychiatry has attempted to provide definitive answers to these questions in the Diagnostic and Statistical Manual of Mental Disorders. Often called The Bible of psychiatry, the DSM serves as the ultimate authority for diagnosis, treatment and insurance coverage of mental illness.

Now, in a move sure to rock psychiatry, psychology and other fields that address mental illness, the director of the National Institutes of Mental Health has announced that the federal agency–which provides grants for research on mental illness–will be “re-orienting its research away from DSM categories.” Thomas Insel’s statement comes just weeks before the scheduled publication of the DSM-V, the fifth edition of the Diagnostic and Statistical Manual. Insel writes:

“While DSM has been described as a ‘Bible’ for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been ‘reliability’–each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely indicate the best choice of treatment. Patients with mental disorders deserve better.”

Insel said that the NIMH will be replacing the DSM with the “Research Domain Criteria (RDoC),” which define mental disorders based not just on vague symptomology but on more specific genetic, neural and cognitive data. But then, immediately after making this dramatic announcement, Insel added that “we cannot design a system based on biomarkers or cognitive performance because we lack the data.”

Hunh? So the NIMH is replacing the DSM definitions of mental disorders, which virtually everyone agrees are profoundly flawed, with definitions that even he admits don’t exist yet! What more evidence do we need that modern psychiatry is in a profound state of crisis?

Insel’s statement is also an implicit admission that there is no real theoretical basis for drug treatments for mental illness. As I have pointed out previously, drug treatments have surged over the past few decades, while rates of mental illness, far from falling, have risen.

Ironically, some pharmaceutical companies that have enriched themselves by selling psychiatric drugs are now cutting back on further research on mental illness. The “withdrawal” of drug companies from psychiatry, Steven Hyman, a psychiatrist and neuroscientist at Harvard and former NIMH director, wrote last month, “reflects a widely shared view that the underlying science remains immature and that therapeutic development in psychiatry is simply too difficult and too risky.” Funny how this view isn’t incorporated into ads for antidepressants and antipsychotics.

NIMH director Insel doesn’t mention it, but I bet his DSM decision is related to the big new Brain Initiative, to which Obama has pledged $100 million next year. Insel, I suspect, is hoping to form an alliance with neuroscience, which now seems to have more political clout than psychiatry. But as I pointed out in posts here and here on the Brain Initiative, neuroscience still lacks an overarching paradigm; it resembles genetics before the discovery of the double helix.

Since I became a science writer 30 years ago, I have heard countless claims about breakthroughs in our understanding and treatment of mental illness. And yet as the NIMH decision on the DSM indicates, the science of mental illness is still appallingly primitive. Instead of forming fancy new programs and initiatives and alliances, leaders in mental health should perhaps do some humble, honest soul searching before they decide how to proceed. And they should think of what’s best not for their professions or the pharmaceutical industry but for those suffering from mental illness, who deserve better.

Photo: http://www.tumblr.com/tagged/dsm-iv-tr.

About the Author: Every week, hockey-playing science writer John Horgan takes a puckish, provocative look at breaking science. A teacher at Stevens Institute of Technology, Horgan is the author of four books, including The End of Science (Addison Wesley, 1996) and The End of War (McSweeney's, 2012). Follow on Twitter@Horganism.

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The views expressed are those of the author and are not necessarily those of Scientific American.

NIMH | Director’s Blog WED MAY 8TH, 2013 - THOMAS INSEL Transforming Diagnosis

NIMH | Director’s Blog

WED MAY 8^TH, 2013

THOMAS INSEL

Transforming Diagnosis

Director’s Blog

In a few weeks, the American Psychiatric Association will release its new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This volume will tweak several current diagnostic categories, from autism spectrum disorders to mood disorders. While many of these changes have been contentious, the final product involves mostly modest alterations of the previous edition, based on new insights emerging from research since 1990 when DSM-IV was published. Sometimes this research recommended new categories (e.g., mood dysregulation disorder) or that previous categories could be dropped (e.g., Asperger’s syndrome).¹
The goal of this new manual, as with all previous editions, is to provide a common language for describing psychopathology. While DSM has been described as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been “reliability” – each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely indicate the best choice of treatment.
Patients with mental disorders deserve better. NIMH has launched the Research Domain Criteria (RDoC) project to transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system. Through a series of workshops over the past 18 months, we have tried to define several major categories for a new nosology (see below). This approach began with several assumptions:

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.

It became immediately clear that we cannot design a system based on biomarkers or cognitive performance because we lack the data. In this sense, RDoC is a framework for collecting the data needed for a new nosology. But it is critical to realize that we cannot succeed if we use DSM categories as the “gold standard.”² The diagnostic system has to be based on the emerging research data, not on the current symptom-based categories. Imagine deciding that EKGs were not useful because many patients with chest pain did not have EKG changes. That is what we have been doing for decades when we reject a biomarker because it does not detect a DSM category. We need to begin collecting the genetic, imaging, physiologic, and cognitive data to see how all the data – not just the symptoms – cluster and how these clusters relate to treatment response.
That is why NIMH will be re-orienting its research away from DSM categories. Going forward, we will be supporting research projects that look across current categories – or sub-divide current categories – to begin to develop a better system. What does this mean for applicants? Clinical trials might study all patients in a mood clinic rather than those meeting strict major depressive disorder criteria. Studies of biomarkers for “depression” might begin by looking across many disorders with anhedonia or emotional appraisal bias or psychomotor retardation to understand the circuitry underlying these symptoms. What does this mean for patients? We are committed to new and better treatments, but we feel this will only happen by developing a more precise diagnostic system. The best reason to develop RDoC is to seek better outcomes.
RDoC, for now, is a research framework, not a clinical tool. This is a decade-long project that is just beginning. Many NIMH researchers, already stressed by budget cuts and tough competition for research funding, will not welcome this change. Some will see RDoC as an academic exercise divorced from clinical practice. But patients and families should welcome this change as a first step towards "precision medicine,” the movement that has transformed cancer diagnosis and treatment. RDoC is nothing less than a plan to transform clinical practice by bringing a new generation of research to inform how we diagnose and treat mental disorders. As two eminent psychiatric geneticists recently concluded, “At the end of the 19th century, it was logical to use a simple diagnostic approach that offered reasonable prognostic validity. At the beginning of the 21st century, we must set our sights higher.”³
The major RDoC research domains:
Negative Valence Systems
Positive Valence Systems
Cognitive Systems
Systems for Social Processes
Arousal/Modulatory Systems

References

¹Mental health: On the spectrum. Adam D. Nature. 2013 Apr 25;496(7446):416-8. doi: 10.1038/496416a. No abstract available. PMID: 23619674
²Why has it taken so long for biological psychiatry to develop clinical tests and what to do about it? Kapur S, Phillips AG, Insel TR. Mol Psychiatry. 2012 Dec;17(12):1174-9. doi: 10.1038/mp.2012.105. Epub 2012 Aug 7.PMID:22869033
³The Kraepelinian dichotomy - going, going... but still not gone. Craddock N, Owen MJ. Br J Psychiatry. 2010 Feb;196(2):92-5. doi: 10.1192/bjp.bp.109.073429. PMID: 20118450

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Forbes - Pharma & Healthcare

WED MAY 8^TH, 2013

MATTHEW HERPER

Why Psychiatry's Seismic Shift Will Happen Slowly

Changing how patients with mental illness are diagnosed is going to take a lot longer than many people seem to think.

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Why Psychiatry's Seismic Shift Will Happen Slowly - 5/8/2013 - Forbes - Business

Why Psychiatry's Seismic Shift Will Happen Slowly - 5/8/2013 - Forbes - Business

» Why Psychiatry's Seismic Shift Will Happen Slowly
08/05/13 08:43 from Forbes - Tech
Last week, Thomas Insel, Director of the National Institute of Mental Health, published a blog post that outlined a new approach for deciding what psychiatry research the U.S. government would fund. No longer, he wrote, would the NIMH rely ..

Matthew Herper, Forbes Staff

I cover science and medicine, and believe this is biology's century.

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Why Psychiatry's Seismic Shift Will Happen Slowly

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English: official picture of Thomas R. Insel, ...

Thomas R. Insel, Director, National Institute of Mental Health. (Photo credit: Wikipedia)

Last week, Thomas Insel, Director of the National Institute of Mental Health, published a blog post that outlined a new approach for deciding what psychiatry research the U.S. government would fund. No longer, he wrote, would the NIMH rely on the Diagnostic and Statistical Manual of Mental Disorders, the collection of symptoms used by psychiatrists to diagnose depression, bipolar disorder, schizophrenia, and other ailments, as its “gold standard” for categorizing patients in research studies. He wrote:

While DSM has been described as a “Bible” for the field, it is, at best, a dictionary, creating a set of labels and defining each. The strength of each of the editions of DSM has been “reliability” – each edition has ensured that clinicians use the same terms in the same ways. The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever. Indeed, symptom-based diagnosis, once common in other areas of medicine, has been largely replaced in the past half century as we have understood that symptoms alone rarely indicate the best choice of treatment.

As a result of this, he wrote, the NIMH “will be re-orienting its research away from DSM categories.” Instead, it would be encouraging medical researchers to frame their studies using a still nascent classification system being developed by the NIMH, called RDoC.

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.

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. The future it will be either improved or replaced by a more physiologically based set of diagnostic criteria. That may change the whole landscape for diagnosis.”