Monday, May 6, 2013

NIMH Delivers a Kill shot to DSM-5

Science.Com
By Hank Campbell
May 3rd 2013


( NIMH is replacing the DSM http://www.nimh.nih.gov/research-funding/rdoc/index.shtml )

The National Institute of Mental Health (NIMH) is distancing itself from the the American Psychiatric Association and its upcoming Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

While they acknowledge that the goal of DSM "is to provide a common language for describing psychopathology" they are no longer convinced that approach has value if we are going to solve 21st century neuroscience problems.  It is, paraphrasing the statement  of Thomas R. Insel, M.D., Director of the National Institute of Mental Health, more of a dictionary than a manual.  He uses the term "Bible" instead of 'manual' but I would have used 'glossary' rather than 'dictionary'.

Insel pulls no punches in his statement on why they are not going to fund things based on DSM criteria any more.

"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."

This is a charge leveled at psychology as well, and the field in general, but psychiatry takes the biggest hits, because they are supposed to be the most evidence-based. Unlike psychology, psychiatrists have to be M.D.s first. Writing in The New Yorker, Gary Greenberg tries to tackle why neuroscience hasn't kept pace with medicine, much less science, writing rather nicely that "it’s not entirely clear that psychiatrists want a solution to the problem."

Insel is more blunt. "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."

Basically, he says DSM is stuck in the past.

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 is leaving the past behind. In the past, Insel notes, they would reject a biomarker that did not match a DSM category. Now they instead want to collect how all data - genetic, imaging, physiologic and cognitive - cluster, and not just how symptoms do.  They call it the Research Domain Criteria (RDoC) project.

"That is why NIMH will be re-orienting its research away from DSM categories.," he wrote, and that means funding applicants are going to have to adjust to the 21st century.

The APA may be outraged, and certainly some DSM defenders, but I predict people in neuroscience who want to really do science and get NIMH funding are relieved that they are not going to have to cater to a document everyone seems to know was always flawed.

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Thursday, March 25, 2010

Top US psychiatrist calls for ethics cleanup

The Boston Globe
By Carla K. Johnson
AP Medical Writer
March 23, 2010


FILE Photo- In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a 'culture of influence' created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. FILE - In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. (AP Photo/Dennis Cook, File)



CHICAGO—American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, the head of the National Institute of Mental Health said in a leading medical journal.

Dr. Thomas Insel stops short of calling researchers corrupt or asking them to stop taking money from drug companies. But he highlights a "bias in prescribing practices" that favors brand names drugs over cheaper generics and non-drug treatments. And he says the situation must change with new standards for transparency and full disclosure of psychiatry's collaborations with industry.

"We can show the rest of medicine how to clean up our act," Insel told The Associated Press. His commentary appears in Wednesday's Journal of the American Medical Association.

His efforts got a boost Tuesday with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the "sunshine" provision because it also requires a database the public can search for their own doctors' ties to industry.

"Transparency is the first step toward giving patients and the public the tools they need to evaluate those relationships," said Allan Coukell, director of the Pew Prescription Project, a consumer health project of the nonprofit Pew Charitable Trusts.

Current National Institutes of Health rules on financial disclosure are confusing, Insel said. They allow researchers seeking federal funds to make their own judgments about what constitutes a significant financial interest, which they must report to their academic or research institutions. The rules also exempt disclosures of anything below $10,000 annually or 5 percent equity interest in a company. Insel is helping oversee a revision of the NIH's rules, which date back to 1995.

Industry pays for much of the medical research in the United States and many scientists have financial relationships with drug and device makers. Researchers at many institutions are expected to fully disclose those ties to their universities, to the NIH and to the medical journals that publish their research.

Beginning in 2008, an inquiry by Sen. Chuck Grassley, R-Iowa, uncovered millions of dollars in unreported fees paid by drug industry to prominent researchers. The investigation prompted universities and NIH to reassess their conflict-of-interest policies.

When the Grassley inquiry accused seven psychiatrists of failing to report payments they received from drug companies, Insel, himself a psychiatrist, said he tried to determine whether psychiatrists were being targeted unfairly.

He found, instead, evidence that psychiatry may have more drug ties than other medical specialties. In Vermont, for example, which requires public disclosure of industry payments to doctors, psychiatrists receive more money from drug companies than do other types of doctors.

Psychiatric journals report slightly higher rates of industry funding of published studies than other medical journals. And one study found that 90 percent of the advisers who help write American Psychiatric Association guidelines had undisclosed financial ties to industry, Insel writes in JAMA.

Meanwhile, antidepressants and other drug treatments rack up multibillion-dollar annual sales while non-drug treatments such as therapy are "woefully underused," Insel writes.

Insel said he has no financial ties with the drug industry.

Dr. Alan Schatzberg, president of the American Psychiatric Association, told the AP that future leaders of guidelines work groups "will have zero financial relationships with industry during their terms."

Insel's commentary will be influential, said Dr. Emil Coccaro, psychiatry department chairman at the University of Chicago and a recipient of NIH grants.

"It's important that our potential patients and their family members know we're above reproach in terms of undue influence by Big Pharma," Coccaro said.

That's why he threw away all the coffee mugs and pens given to him by drug companies and is careful to report any payments he receives as a board member of a startup biomedical company, he said.

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On the Net:

JAMA: http://jama.ama-assn.org

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