a magnificent omission…

Posted on Thursday 21 July 2011

A few months back when I was retracing the TMAP story, I was horrified at all the "Guidelines" and "Algorithms" for treatment in Psychiatry. I scoured the Internet looking for ones that were free of conflict of interest contamination, and found nothing – nothing. When I recently ran across the Guidelines for the Treatment of Childhood Bipolar Disorder, I was equally appalled at the conflict of interest megaload among the experts. It reminded me of an article I ran across along the way earlier, which I relocated and scheduled for your enjoyment while I’m off adventuring:
One Size Fits None? Treatment Algorithms and Guidelines in Psychiatry and Neurology
by Andrew A. Nierenberg, MD
CNS Spectrums 2010 15(4):210-1.


A hypothetical algorithm of treatment algorithms or a guideline to treatment guidelines would be of little use to practitioners of psychiatry or neurology because they would become obsolete as soon as their creators disseminated them. New knowledge simply comes too fast to be integrated into these fanciful compendiums of compendiums. And such knowledge is invariably incomplete. Nevertheless, treatment guidelines proliferate at an impressive rate. If only we had more data; if only the guidelines were more detailed, then we would be more certain about what to do for our patients. A marvelous short story, ”On Exactitude in Science” by Jorges Luis Borges may be instructive….
    “……the Cartographers Guilds struck a Map of the Empire whose size was that of the Empire, and which coincided point for point with it……The following Generations, who were not so fond of the Study of Cartography as their Forebears had been, saw that that vast Map was Useless, and not without some Pitilessness was it, that they delivered it up to the Inclemencies of Sun and Winters. In the Deserts of the West, still today, there are Tattered Ruins of that Map, inhabited by Animals and Beggars;….”
    —Suarez Miranda, Viajes de varones prudentes, Libro IV, Cap. XLV, Lerida, 1658
Perhaps I am being too harsh, cynical, or pessimistic. After all, algorithms and guidelines can serve a useful purpose, ie, they can serve as an introduction to the sequence of evidence-based steps that can inform clinicians about potential options for the most straightforward and uncomplicated of clinical scenarios for the average patient. If these are to be useful, how can clinicians use them? Do clinicians routinely or regularly consult these to inform their clinical decisions? Should health care organizations require that their clinicians use these and justify deviations from them? And couldn’t these be implemented by less experienced and less trained technicians? After all, how difficult could it be to follow a treatment algorithm or guideline?

Forgive me for falling back into being critical, but policy makers are suggesting such things. Look at “The Innovator’s Prescription” by Christiansen and colleagues. They make a cogent argument that the medical field would benefit from moving from intuitive medicine to precision medicine, using infectious diseases and cancer as examples. Precision medicine has a well-defined method of diagnosis with a treatment to match. A penicillin responsive bacterial infection should be treated by penicillin. Makes sense, a “no brainer”. In fact, one does not need advanced training to implement a prescription of penicillin. One does, however, need advanced training to manage the complications that could result, eg, if the patient takes less penicillin than prescribed and ends up with a penicillin resistant infection or if serious adverse effects occur. For psychiatry and neurology (and their interface), perhaps we will eventually get closer to precision medicine with the current push for personalized medicine and appropriate biomarkers.

Should we be moving towards technicians implementing precision medicine? Would you want you or your loved ones to be treated in such a way? As a clinician, would you want to be constrained by such a system? Would it serve your patients well? As Klein wrote, “Algorithms are brittle and often don’t work well in the shadows, whereas skilled decision makers are more resilient and sensitive to context and nuance…. In addition, algorithms can get in the way when we need people to develop and sustain skill and expertise”. Perhaps algorithms would be appropriate for the simplest of problems. In one of our conversations, my colleague Gary Sachs told me that the problem is physicians do not like these because one size does not fit all. What we really need are decision support systems, not decision replacement systems. We need systems that augment and enhance our judgment and provide us with information that helps us make better decisions. What we need are well-trained doctors, nurses, and physician assistants who are capable of “adaptive decision making”. What will happen when these algorithms and guidelines become automated and embedded within electronic medical record systems? Will outcomes improve? Will physicians accept them? Many will develop such systems and companies will spring up to disseminate them. We will need to assess if these systems yield better outcomes than what Christensen and colleagues refer to as “intuitive medicine”. I can only imagine that their utility (or lack thereof) will become clearer in time. Perhaps in 10 or 20 years, practices will be dominated by these. Or perhaps we will find their remnants when we go walking in the “Deserts of the West….”.
An erudite discussion this. It just leaves out one little detail – the motives and the financial arrangements of the Guideline/Algorithm framers. Seems like he might of at least mentioned that Guidelines and Algorithms have been a perfect conduit for pharmaceutical companies to hawk their wares via kol expert opinions – like is so criminally evident in the case of TMAP [or for that matter, all the ones I could find]. I wonder why Doctor Nierenberg left that possibility out of his reflections? At any rate, here’s the rest of the page:
Dr. Nierenberg is professor of psychiatry at Harvard Medical School, co-director of the Bipolar Clinic and Research Program, and associate director of the Depression Clinical and Research Program at Massachusetts General Hospital (MGH) in Boston.

Faculty Disclosures: Dr. Nierenberg consulted to or served on the advisory boards of Abbott, Appliance Computing, Inc., Brain Cells, Inc., Bristol-Myers Squibb, Eli Lilly, EpiQ, Forest, GlaxoSmithKline, Janssen, Jazz, Merck, Novartis, Pamlab, Pfizer, PGx Health, Pharmaceutica, Schering-Plough, Sepracor, Shire, Somerset, Takeda, and Targacept; he has received research support from Cederroth, Cyberonics, Forest, Medtronics, NARSAD, the NIMH, Ortho-McNeil-Janssen, Pamlab, Pfizer, Shire, and the Stanley Foundation through the Broad Institute; he has received past support from Bristol-Myers Squibb, Cederroth, Eli Lilly, Forest, GlaxoSmithKline, Janssen, Pfizer, Lictwer Pharma, and Wyeth; he has received honoraria from the MGH Psychiatry Academy (MGHPA activities are supported through Independent Medical Education grants from AstraZeneca, Eli Lilly, and Janssen; he earns fees for editorial functions for CNS Spectrums through MBL Communications, Inc., and Psychiatric Annals through Slack, Inc.; he receives honoraria as a CME Executive Director for the Journal of Clinical Psychiatry through Physicians Postgraduate Press; he has been on the speaker’s bureaus of Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest, GlaxoSmithKline, and Wyeth; he has received royalties from Cambridge University Press and Belvoir Publishing; he owns stock options in Appliance Computing, Inc.; and owns the copyrights to the Clinical Positive Affect Scale and the MGH Structured Clinical Interview for the Montgomery Asberg Depression Scale, exclusively licensed to the MGH Clinical Trials Network and Institute.
  1.  
    July 21, 2011 | 11:43 AM
     

    That’s quite a financial disclosure list! par for the course for so-called experts! (self-appointed KOL’s w egos fueled by pharma income)

  2.  
    Ivan the Terrible
    July 21, 2011 | 12:16 PM
     

    This is an image management technique known as hiding in plain sight. Some KOLs are very good at it. To pull it off, it helps to be able to compartmentalize information in one’s own head.

  3.  
    aek
    July 21, 2011 | 2:41 PM
     

    So what’s a patient/subject/victim to do?

  4.  
    July 21, 2011 | 9:59 PM
     

    […] Hat tip to 1 boring old man […]

  5.  
    Nancy Wilson
    July 21, 2011 | 10:49 PM
     

    I appreciate Nierenberg’s point about “no-brainer” interventions, such as penicillin for penicillin responsive bacterial infection. I had the same thought when I read about the DATE study, which is being conducted at Shelton School in Dallas, Texas. The researchers want to find out if exercise is good for adolescents with depression. Seems like a no-brainer to me. See

    http://tinyurl.com/3sxqbab

    In any case, DATE non-responders and partial responders are then good candidates for other intervention studies, including drug studies. Dr. Carroll Hughes is Principal Investigator of the DATE study and Director of Research at Shelton.

    Remember Dr. Hughes? He was a “key player” in CMAP. See

    http://tinyurl.com/4528yqb

  6.  
    Nancy Wilson
    July 22, 2011 | 1:07 AM
     

    I found a 2009 DATE study publication here:

    http://tinyurl.com/3sx4rcf

    Dr. Hughes is first author and consults with the company BioBehavioral Diagnostics, which makes testing equipment for ADHD. Guess who second author is.

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