cost accounting…

Posted on Sunday 18 November 2012

I started medical school naively thinking of medicine and science as a somewhat linear march towards the truth, and woke up this morning thinking about fads in medicine, how they come and go much as in popular culture, and how many I’ve seen in the intervening half century. Last week, I was writing about Tom Insel’s NIMH Director’s Blog [the monocle…], and I said:
So Insel’s NIMH has been a directed research agency, jumping on the Translational Medicine ideas of the NIH – research focused on a speedy move to clinical application. And it was more focused than that. There were any number of programs that announced topics of interest. My fantasy is that instead of sitting under an apple tree waiting for an inspiring bump on the head, researchers spend their time surfing through the NIMH web-site looking for what’s getting funded this cycle. Besides directed research, there was much ado about partnering with industry. And waves of Clinical Drug Trials – STAR*D, CO-MED, CATIE, TADS, TORDIA, etc. Rather than a funding source for creative scientists, NIMH has been pointing the way. And Insel’s NIMH has been fad-driven. Something that fits comes along, and he’s talking about it in his next blog. Pretty soon, it’s a new direction, a new program.
Then today, I got a link to Dr. Insel’s most recent posting:
From Practice to Research
NIMH Director’s Blog
By Thomas Insel
November 15, 2012

…Recently, there has been a lot of hand wringing about the low efficiency of clinical trials, especially in mental health. They can be slow and expensive, and may not even produce actionable findings. Even when successful, there is a distressing delay in moving an important research finding from the research clinic into practice. In fact, we usually hear that there is a 17-year lag from research to practice. That is not always the case. The polio vaccine was implemented within days of the first report of success, and new AIDS medicines have been disseminated quickly. But for mental disorders and other chronic diseases like hypertension, there does seem to be a persistent gap between what we know from research and what we do in practice. At a meeting last week at NIMH, I heard how one group is working to close this gap. Greg Simon and his colleagues in the Mental Health Research Network [MHRN] presented a new approach – we need to stop thinking about moving research to practice and start thinking about moving practice to research. That’s what MHRN does. MHRN is a network of 11 research organizations affiliated with non-profit health care systems serving 12 million patients. It is the largest research network for people with mental disorders in the nation. The idea is simple: understand what works in the real world of practice by using scientific methods, like randomization and statistical comparisons, to create a learning health care system. By linking health information databases and creating an efficient process for assessing outcomes, MHRN is working to transform the world of health care practice into a laboratory for research…

Recently, the NIH Common Fund launched a broad version of this approach through its Healthcare Systems Collaboratory project with practical trials on hypertension, dialysis, cancer, and suicide prevention. This project is catching the interest of large providers and payers who need answers about what works in the real world. There is a well-described "voltage drop," or decrease in efficacy, when we move treatments from the research setting to real world practice. But efforts like MHRN and the Collaboratory, which are bringing real- world practice to research, should help to reduce this problem. These large research-based practice settings can also serve as a dashboard for monitoring the changing needs of the population or the effects of changes in health policy. For mental health, as we face an historic confluence of insurance parity and health care reform, the questions facing patients and providers are urgent. How should we deal with complex, comorbid health conditions? How can we reduce early mortality? How can we ensure fidelity of the best psychosocial treatments? What is the best strategy to personalize care? These are all pressing questions that can be answered rigorously in large practice networks with a solid infrastructure for conducting research…
So I thought, here we go again – another technology, this time using electronic medical records in HMOs to do research on unsuspecting Plan Members. I thought of the warnings of MediGuard, to do clinical  trials on the Internet, and of the implication in recent books [eg  Pharmageddon] that rather than using clinical trials to inform medical practice, we were modelling medical practice to fit the clinical trial motif. So I read through Insel’s blog and started to move on, but then I clicked the Mental Health Research Network [MHRN] link, almost by habit:
MHRN is based in the HMO Research Network, a consortium of 19 public-domain research centers based in not-for-profit health care systems… MHRN centers have a greater chance of efficiently answering questions that involve real-world patients and providers through joining forces and combining resources. Initial funding for the MHRN is through a 3-year cooperative agreement with the National Institute of Mental Health [U19 MH092201 “Mental Health Research Network: A Population-Based Approach to Transform Research” with total costs of $8,999,198] and through a supplement from NIMH to the existing Cancer Research Network funded by the National Cancer Institute [with total costs of $1,499,873]. This initial funding cycle supports development of a core infrastructure for collaborative research as well as four developmental research projects to test and leverage that infrastructure in specific clinical areas.
$10 M? four developmental research projects? What developmental research projects?
  • Practice Variation in high- and low-value care for mood disorders – At five sites, electronic records will be used to examine how patient, provider, and health system factors influence use of both proven effective treatments and treatments that increase costs without improving outcomes. This work will advance knowledge regarding variation in mental health care and develop methods for future effectiveness studies.
  • Feasibility of behavioral activation therapy for perinatal depression – Across four sites, 200 pregnant women with depression detected by screening will be randomly assigned to receive structured Behavioral Activation therapy [delivered via telephone and in-person] or care as usual. This project will both evaluate feasibility of an innovative intervention and test new methods to increase the efficiency of future effectiveness trials.
  • A geographically and ethnically diverse autism registry for effectiveness studies – At five sites, computerized records will be used to create a population-based registry of children with autism spectrum diagnoses. Methodologic research will examine accuracy of records-based diagnoses. A sample of affected families will be surveyed regarding costs and perceived effectiveness of treatments and will be asked to contribute biospecimens for future research. This project will both advance knowledge regarding diagnosis and treatment of autism and establish a registry and specimen repository to support effectiveness research.
  • Longitudinal analysis of SSRI warnings and suicide in youth – At eleven sites, computerized records will be used to examine the effect of the FDA advisory regarding suicidality during antidepressant treatment on rates of antidepressant use and suicide attempts. This study will both help clarify the relationship between antidepressant use and suicide risk and develop methods for future policy and implementation research.
structured Behavioral Activation therapy [delivered via telephone and in-person]? And what is Behavior Activation Therapy? It’s Cognitive Behavior Therapy with the cognitive parts removed – which is behavior therapy? that you can do on a telephone? Most of the reference papers listed aren’t in journals I can access. So best I can tell, the NIMH is giving $10 M to some HMO consortium to do population research finding ways to save money by delivering generic treatments. And now the HMOs have taken on the cause of treating depressed adolescents with antidepressants by attempting to discredit the Black Box Warning. So, the last one [Longitudinal analysis of SSRI warnings and suicide in youth] was the most upsetting, but number two wasn’t far behind [Feasibility of behavioral activation therapy for perinatal depression]. I looked in the NIMH RePORTER at the SSRI proposal:
Here’s a more readable version, "Our objective in this study is to evaluate the possible unintended consequences of the FDA decision to issue a warning regarding the prescribing of SSRIs to children and adolescents and require a BBW on antidepressant labels. Depression is prevalent among youth in the US and is a risk factor for suicide. Thus, it is of critical importance that the public health implications of possible decreases in antidepressant treatment rates be fully understood. While much research has been conducted in this area, suboptimal study design, absence of long-term trend data, and/or lack of statistical power have left important questions about the effects of the warnings on suicidality unanswered. Below we review the important studies to date and highlight how our proposed research will fill gaps in our understanding of the relationships among FDA warnings [and associated media reports], antidepressant treatment in youth, and risk of suicidal behavior."

From my perspective, the deeper I looked, the worse it got. I’m not really the person to evaluate something like treating depressed pregnant women with a token-based behavior-mod regimen. My negative reaction is visceral rather than rational. But I’m a little better placed to look at treating depressed adolescents with SSRIs, because I treat them and have given a few of them SSRIs [with big time warnings]. I’ve seen occasional suicidal akithisia. I’ve had some successes. But mostly I’ve seen no effect. I spent a long session Friday with a 15 year old girl I’ve known for a while whose boyfriend had been put on an SSRI by his primary care physician recently. The kids had all watched him withdraw and become hostile in the days before he shot himself in the head several weeks ago. His friends all say, "It was the antidepressant" [recall that I live in rural Appalachia and they aren't reading that in our weekly paper]. My patient was wearing the boyfriend’s sweater the day I saw her, and had intrusive thoughts of joining him. She has taken ADD medicine for about two years [for good reason with good results], but she stopped after her boyfriend killed himself. She wants nothing to do with medication. So that story may be a little too fresh in my mind for me to claim objectivity – but I’ll continue with that as my conflict of interest statement.

Using population statistics to study the suicidal reactions of some people on SSRIs is futile – shown over and over again. But the drugs are cost effective, so they’re still at it even after the drug companies have exhausted their patents and moved on. They want the Black Box Warning removed so their doctors won’t read it and tell their patients [or not prescribe]. But I’m underwhelmed by this whole enterprise because the goal in each instance is clearly fiscal and population based – and wonder what the NIMH was thinking. Since I see clinical medicine as a one patient at a time endeavor, I’m pretty sure I want my own family members seen by doctors who are focusing on them and not simply their superficial groupings. But beyond that, is this what the NIMH is for? funding cost-effectiveness studies for HMOs using electronic medical records? Is this an exciting new technology deserving Dr. Insel’s enthusiasm? deserving our $10 M? Not from where I sit. It feels more like government financed cost accounting for a private enterprise than mental health research…
  1.  
    Bernard Carroll
    November 18, 2012 | 11:44 PM
     

    The notion of a federal agency like NIMH shaping research in the field is more than scary… but that is the bureaucratic imperative: We know best… we will set directions… we will declare priorities… we will fine tune our portfolios of funded projects… Then, human nature being what it is, gaming the system becomes the dominant mode, displacing original science. The net result looks like regulatory capture – a lot like Wall Street and Pharma operate.

    Giovanni Fava has written perceptively about self-interested power elites within academic psychiatry. See PubMed ID 22817334. In these circles, the name of the game is to keep the game going. That is how dubious or even worthless projects soak up the public NIMH dollar. Need examples? Check out the foolish Emory-GSK-Mount Sinai School of Medicine-NIMH Collaborative Mood Disorders Initiative (5U19MH069056), once headed up by Charles Nemeroff. See if anyone from Emory is willing to defend it today. NIMH kissed goodbye to over $5 million on that one. Hey! Those are our dollars!

    So, the current chatter from Director Insel about the Mental Health Research Network is in line with his recent history. Remember the saying: the name of the game is to keep the game going. Quality? What’s that?

  2.  
    Annonymous
    November 19, 2012 | 2:14 AM
     

    Dr. Carroll, thank you very much for bringing up this Fava paper. By any chance would you consider writing a post about it on HCR? 1BOM, is it enough up your alley to write a post about it? As clinicians I would be curious to hear what you each think of its strengths and weaknesses.

  3.  
    Annonymous
    November 19, 2012 | 2:30 AM
     

    OK, that’s strange. I just saw a new post and posted a comment. Then both the post and the comment disappear. Either I’m imagining things or my comment was taken to heart (but at 2AM?). Strange. If I’m not imagining things then I still recommend the advice I gave. And, stand by my second point. If I am imagining things then my current post is completely unintelligible.

  4.  
    November 19, 2012 | 6:23 AM
     

    BURNT NORTON
    T.S. Eliot

    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…

  5.  
    November 19, 2012 | 9:22 PM
     

    Especially on the InterWeb.

  6.  
    annonymous
    November 20, 2012 | 9:52 AM
     

    1BOM, I love this blog.

    Did you just randomly happen to know a strikingly on-point poem, or do you have familiarity with a large number of poems?

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