go often askew…

Posted on Monday 30 November 2015

    this is the way the world ends  
    this is the way the world ends  
    this is the way the world ends  
    not with a bang but a whimper
                        T.S.Eliot 1922

… A national search for a new NIMH Director will be launched, but in the meanwhile Dr. Collins has issued an official statement appointing Dr. Bruce Cuthbert as Acting Director. Bruce has held a number of leadership positions at NIMH, including leading our RDoC initiative as well as the NIMH Division of Adult Translational Research. He is an internationally recognized researcher. I greatly appreciate his willingness to lead the Institute during this transition period. I know with Bruce at the helm and the leadership team in place at NIMH, I leave the Institute in strong, capable hands.
Back at the turn of the century, the dominant forces in psychiatry had big plans. Steven Hyman, then NIMH Director had funded a series of mega-drug trials to test the new drugs, and had gone in with the American Psychiatric Association to fund an extended series of symposiums in anticipation of a new revision of the psychiatric classification. The DSM Task Force published its research agenda – planning to add biological and longitudinal data to the next DSM bringing psychiatry closer to mainstream bio-medicine. And a surprise choice, Dr. Tom Insel who directed a Translational Center in Atlanta, was appointed to succeed Hyman at the NIMH. Within a few years, Insel’s agenda to turn psychiatry into Clinical Neuroscience was on the table fitting well with the directions of the DSM Task Force and the exciting technologies of the day – neuroimaging and advances in genomic research. And it fit well with industry as well. In the real world of patient care, the new drugs were flowing from the pharmaceutical pipelines in a steady stream competing for an ever expanding market. Psychiatrists were well paid to prescribe as consultants. Psychologists, Social Workers, and other disciplines were paid for counseling, all tightly controlled by Managed Care panels. And the psychoactive drugs were increasingly being prescribed by primary care physicians.

The post  millennial honeymoon didn’t last as long as many hoped. We know about the negative stuff – the drugs’ exaggerated efficacy, the sometimes dire side effects, the exposed corruption of the academic-pharmaceutical alliances, and the accompanying rampant conflict of interest problems among key opinion leaders in high places. It seemed as if the once venerated position of department chairman had become a stepping stone to political and financial gain. And while these revelations of tarnished power became increasingly apparent, there was a much bigger problem in the background. The research was flat as a pancake – producing little to none of the kind of neuroscience breakthroughs assumed to be just around the corner. And the drugs which were selling like hotcakes were little more than clones of two basic themes – SSRIs and Atypical Antipsychotics.

So by the end of the first decade of our new century, the DSM-5 Task Force had to abandon its grand plan for a neuroscience-based DSM and fell into a much-ado-about-nothing mode. And speaking of abandonment, the pharmaceutical industry was pulling out of CNS drug research and development altogether for lack of results – and busied itself dealing with the multiple civil and criminal suits coming their way. Insel’s NIMH apparently concluded that its lackluster results were due to a faulty clinical diagnostic system. Abandoning the DSM-5, they embarked on creating one of their own – the RDoC [Research Domain Criteria] – envisioned as a dimensional system based on… neurobiology? or something like that. [see Dr. Carroll’s Clinical science and biomarkers: against RDoC and Dr. Insel’s parting comments in Brain expert: Why I jumped ship to Google].

There’s another thread on the way to my point. Dr. Insel wrote an odd blog post in early 2012, Balancing Immediate Needs with Future Innovation. He had apparently been challenged in an advisory committee meeting about leaning so heavily in the neuroscience direction with there being so many unmet clinical needs in our society. He made his usual pitch for investing in the neuroscience future, but defended the NIMH by bringing up the RAISE studies [for the future…] – two programs for treating First Episode Psychosis patients. They had been financed outside the NIMH budget using ARA funds [economic stimulus], in my opinion skirting the challenge made by the committee. Flash Forward to May 2014 [a fabrication?…]. One of the RAISE studies evaporated, and the second was not completed, but Dr. Insel was talking about giving the RAISE program to SAMHSA who was approving block grants for First Episode patients. Insel called it "translation." I balk at that. I call it "opportunism" [ARA, SAMHSA Block Grants] since RAISE wasn’t even completed yet. Then RAISE was recently sort of reported [raising a dilemma…], but there’s a lot missing. RAISE remains on the fastest of tracks…
Coordinated specialty care may become more readily available

NIMH • Science Update
October 29, 2015

NIMH is the world’s leader in mental health research, yet it’s rare for that research to have an immediate impact on clinical practice. However, the NIMH-funded RAISE initiative is an exception. On October 16, 2015, the Centers for Medicare & Medicaid Services posted an informational bulletin to State Medicaid Directors about covering treatment for first episode psychosis. The bulletin represents a joint effort by several agencies: NIMH, CMS’ Center for Medicaid and Children’s Health Insurance Program, and the Substance Abuse and Mental Health Services Administration. A key feature of this bulletin is CMS’ support for coordinated specialty care [CSC], the evidence-based treatment approach tested in the Recovery After an Initial Schizophrenia Episode [RAISE] initiative.

The bulletin says that the two RAISE studies, as well as the Specialized Treatment in Early Psychosis [STEP] study from Yale University, “demonstrate convincingly [1] the feasibility of first episode psychosis specialty care programs in U.S. community mental health settings, [2] that young people with psychosis and their family members accept these services, and [3] that CSC results in better clinical and functional outcomes than typical treatment.”

The rest of the bulletin goes on to explain how states can use the federal Medicaid program to pay for evidence-based first episode psychosis services, such as those tested in RAISE…

Robert Burns     English Translation
But Mousie, thou art no thy lane, But little Mouse, you are not alone,
In proving foresight may be vain: In proving foresight may be vain:
The best-laid schemes o’ mice an’ men The best laid schemes of mice and men
Gang aft agley, Go often askew,
An’ lea’e us nought but grief an’ pain, And leave us nothing but grief and pain,
For promis’d joy! For promised joy!

Not that it matters so much anymore, but I don’t buy the narratives of the hour. By any parameter, both the NIMH’s Clinical Neuroscience and the APA’s Biomedical DSM-5 have been colossal failures. So my guess is that Dr. Insel was no longer able to bring off the argument he advanced in Balancing Immediate Needs with Future Innovation back in 2012:

Finally, we have an unprecedented opportunity for progress, real progress, in understanding mental disorders. The answers are likely to be more difficult and more complex than cancer or many single gene disorders, but the tools are now becoming available. High throughput sequencing for DNA and RNA, whole genome epigenomics, high resolution imaging of the human brain, connectomics—all of these tools are giving us a first opportunity to understand mental disorders at many levels beyond the reported symptoms or the observed signs. What the EKG did for cardiology, the bacterial culture did for infectious disease, and molecular biology did for oncology, neuroscience should provide for the study of mental disorders.

Some think the technology is just not yet up to the task. Others think that locating mental illness in the brain was off the mark from the start. And there are infinite gradations in-between. But there’s not much argument with the fact that we haven’t gotten anywhere. Whether Insel’s exodus was fueled by his own frustration or the frustration of others with his results is likely something we’ll never know. Parenthetically, I don’t see RAISE as a product of Insel’s NIMH. They jumped on available ARA funds and it became a future policy before it was even completed. That RAISE program could use some liberal tweaking, but I  gather  hope it’s more template than injunction. Whatever the case, increasing funding and attention directed towards the first episode of psychosis has to be a good idea.

But we’re left with a problem. What will come of the NIIMH now? The shadows of Tom Insel’s Clinical Neuroscience fall heavily on every corner of the campus. Currently, even NIMH Grant Applications are contingent on furthering the RDoC [whatever that means]. But if we’ve learned anything from all of this, it’s that an agenda-driven, top-down National Institute of Mental Health just didn’t work. And the only thing that’s crystal clear right now is that it’s past time for a big change [whether by bang or by whimper]…

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