Showing posts with label New England Journal of Medicine. Show all posts
Showing posts with label New England Journal of Medicine. Show all posts

Tuesday, March 12, 2024

An Unpublished NEJM Letter

 



 I was notified this morning that a letter I sent in to the New England Journal of Medicine would not be published because they had limited space.  Anyone sending a letter is notified that if the letter does not respond to one of their articles you are limited to 400 words.  If your letter does respond to an article the word limit is 200 words.  I was responding to an essay by Lisa Rosenbaum, MD (1) and whether medicine is a calling or just a vocation and the implications that each of those categories have.   My first attempt at the 400-word mark (374 actual) is below:

 To The Editor:  The essay by Dr. Rosenbaum (1) highlights a critical issue in medical education, research, and practice.  Much of the analysis is dependent on the concept that medicine is either a job or a calling. The critical factor in all settings is the practice environment.  Over the past 30 years we have seen a severe deterioration in that environment and how it impacts physicians. 

Forty years ago – physicians were valued as knowledge workers.  Work quality was emphasized and teaching departments were run by senior physicians who emphasized teaching and research.  They were models for focused lifelong learning and were able to maintain interest and enthusiasm in their departments by balancing clinical demands and those learning tasks. Trainees in the department benefitted from identification with these physicians as well as learning clinical approaches in their specialty.  The department head often had a business administrator in the department, but there was no doubt that the focus was medicine first and business tasks were minimal.

Over the past several decades, business and political interests have changed the physician role to production workers. Physicians are now valued in corporations for productivity and all the administrative time that takes. Department heads are often more focused on business matters than teaching and research.  Meetings take on a business rather than academic orientation.  More time is spent learning about the business environment rather than learning medicine.  The administrative burden alone easily exceeds the time used in the past for teaching rounds and conferences.  This burden has also decreased physician efficiency and added hours per day producing documentation for billing purposes that is repetitive and excessive. It also detracts from the physician patient relationship that is further fragmented by physician extenders.

The modern practice environment is not conducive to producing and motivating physicians.  Rather than an environment where experts can have spirited exchanges about medical care – it is one where experts are second guessed by administrators with no medical training.  It is an environment that does not produce a calling.

Recognition of the severe deterioration in the practice environment is the first step in correcting the problem.  Steps need to be taken to restore practice environments to stimulating settings that can lead to a high level of expertise, quality, and humanistic care.    

 

George Dawson, MD, DFAPA

 

References:

1.  Rosenbaum L.  On calling – from privileged professionals to cogs of capitalism?  N Engl J Med 2024; 390: 471-5.

 

The final 200-word final submitted version is below:

 

Rosenbaum argues doctors' declining job satisfaction stems from corporatization, generational changes, and a shift to production-style management.1 Traditionally, senior physicians oversaw the practice, fostering a learning and research environment. Forty years later, business managers treat doctors as production workers2 in an increasingly inefficient environment. This clashes with physicians’ role as knowledge workers, requiring intellectual stimulation, collegiality, and patient-centered care.

That change is responsible for a marked deterioration in the training and practice environment.  Business practices have been emphasized to the point that there has been an adverse effect on physician time management for professional and personal activities. It is also a direct cause of burnout.3

Physicians function best as knowledge workers consistent with their training. Physicians have been forced into the role of production workers. The solution is not to develop a rhetorical response to being in that role. The solution is not an idealization of the “good old days” – but recreating and restoring the physician knowledge worker environment.  That is the first step toward making physician sacrifice meaningful again.

 

George Dawson, M.D.

 

1.  Rosenbaum L.  On calling – from privileged professionals to cogs of capitalism?  N Engl J Med 2024; 390: 471-5.

2.  Drucker PF. Knowledge worker productivity – the biggest challenge.  California Management Review 1999; 41: 71-94.

3.  Lacy BE, Chan JL. Physician burnout: the hidden health care crisis. Clinical gastroenterology and Hepatology. 2018;16(3):311-7.

 

It took me 5 rewrites to get to progressively less words.  When you tend to use as many words as I do that was a painful process.  If you are a blogger the pain is compounded by the fact that editorial control is lost and you cannot publish your comments anywhere else (including a blog) if you hope to get them published in a journal.  The NEJM has a 3-week deadline for letters based on their articles.  It took them 5 weeks to reject it. They obviously can publish whatever they want and provide whatever rationale that they want – but the space argument seems thin.

Let me suggest why I thought this letter – even pared down to 170 words was important enough for me to send.   A brief review of Dr. Rosenbaum’s essay is necessary and if you have access, I encourage you to read it.  The essay begins with standard blue-collar rhetoric rooted in reality – basically that the working man is subjected to the whims of corporations who rarely have their interests in mind.  A young physician from that family concludes that the idea of medicine as a calling is using that term “weaponized against trainees as a means of subjugation— a way to force them to accept poor working conditions.” 

The problem with that analysis is twofold.  First, trainees do not have a monopoly on subjugation by corporations or the government.  It has been a decades long process directed at practicing physicians.  Second, rhetorical “weaponization” of terms applied to the profession is unnecessary.  That battle has already been lost. The current work and training environment has been deliberately shaped by the managed care business and like-minded governments for the past 30 years. Businesses don’t have to use weaponized rhetoric.  All they have to do is replace physicians with non-physicians, tell them they can work somewhere else, or reduce their compensation or just not pay them if they don’t meet their productivity expectations. They can also use internal committees and business practices to scapegoat and gaslight physicians who they do not like.  There is essentially unlimited leverage to get what they want.  All those measures are far more powerful in getting physician compliance than suggesting they need to make sacrifices in the service of a calling.  Physicians today are expected to make significant sacrifices or else – all in the service of their business masters.  It is evident the young physician in the essay knows nothings about it. The only practice and training environment that he knows is the one that has been severely compromised.

From medicine-as-a-calling, Rosenbaum introduces us to workism.  This term was coined in an Atlantic magazine essay to suggest that somehow work is a central part of life, identity, and meaningfulness is life.  That author goes on to suggest that people born between 1981 and 1996 were encouraged in this attitude and found themselves instead in debt and with no meaningful life work.  That led to demoralization and nihilism about capitalism.  When I read these paragraphs, I had to wonder how naïve this generation could be?  How could they possibly think that American capitalism and the economy was good for anybody?  Don’t they read anything about the environment, pollution, climate change, environmental catastrophes, unnecessary wars, near economic catastrophes – all precipitated by American capitalism?  I don’t think the idealization of work or capitalism explains the lack of medicine-as-a-calling.

There is a glimpse of reality in the next section when we hear how of how a long-time residency director of internal medicine stepped down due to a misalignment of the missions of hospitals and training programs. That is really putting it mildly. In many cases that difference was all it took to destroy training programs.  It is common to hear how residents are just used as inexpensive labor – but that has always been the case. The real problem is that the quality of teaching is adversely affected when faculty are told that they must max out their productivity and at the same time – get no credit at all for teaching.  

Rosenbaum’s essay depends on generational stereotypes and barely touches the root of the problem.  I reference the work of Peter Drucker – widely considered a guru in business management.  He pointed out the differences between production workers and knowledge workers. Basically, knowledge workers are quality focused in areas that they have more expertise than the management does. They are generally felt to be critical to the business and the idea is to retain them and give them adequate resources. Establishing a culture of excellence in their knowledge base adds to the environment. Production workers are engaged in repetitive tasks.  Their supervisors generally have worked their way up from doing the same tasks and therefore know as much about their work.  Early experiments in mass production showed that analysis of the repetitive tasks by so-called efficiency experts could improve the overall production.

What has occurred in the past 30 years has been the mass conversion of physicians from knowledge workers to production workers. The associated practice and academic environments have suffered drastic changes. Academic physicians have found that a major part of their work – teaching and research has been devalued in many cases to nothing.  In the meantime, they are expected to see many more patients, often to the point that they find themselves in new clinics – just to increase the overall billing.  The electronic health record (EHR), billing, and coding, and maintenance of certification are all added time penalties with no associated productivity credit. They have little say about how they see patients or how many patients they see.

I will cite one of many examples to highlight these points.  Just 5 years ago,  an internist I know was audited by his managers who had him tracked from 8AM to 4PM by an efficiency expert. That time frame encompassed 90% of his patient contacts, but only 66% of his workload.  Every day when the efficiency expert left – he would ask: “Where are you going? I am here for another 4 hours.”  The managers wanted to use the efficiency expert report to suggest that he was not efficient enough in seeing patients – but the real problem was the lack of clerical support and the EHR. The exercise was enough for the internist to realize he was working in a hostile environment and he moved on.  A clear loss of a knowledge worker.  The corporate myth that everyone is replaceable missed again in this case. This internist had experience and skills that could not be duplicated by anyone else in that clinic. This cycle of corporate flexing repeats itself thousands of times per day.

There can be no calling to work in such an environment where your work is routinely denigrated and devalued.  It plays out as a personal attack. You will necessarily feel like a production worker and start to work on the goals of production workers like standardized working conditions, hours, and benefits.  When you come home at night – you will leave the job behind you and no longer think about the patients who have problems with no solutions or what you need to know to do a better job. There is no esprit de corps of cohesion, support, and invigoration necessary for a stimulating knowledge worker environment.

That is the recent attitude and it correlates directly with the business takeover of medicine – not the newest generations.  It also correlates with prominent editorials in the top journals of our field like the New England Journal of Medicine.  These editorials illustrate on almost a weekly basis that there is no end to the businessmen, politicians, and lawyers who want to run and ruin our profession.  To date – they have been tremendously successful.  There is also no lack of evidence that the medical profession has been completely inadequate advocating for a reasonable practice and training environment.

Medicine will never be a calling again until the work and practice environment has been repaired and removed from the complete control of businesses and governments.

And yes – it is that simple.

George Dawson, MD, DFAPA

 

References:

1:  Rosenbaum L.  On calling – from privileged professionals to cogs of capitalism?  N Engl J Med 2024; 390: 471-5.

2:  Drucker PF. Knowledge worker productivity – the biggest challenge.  California Management Review 1999; 41: 71-94.

Graphic Credit:

All details at this link.  Coming from 4 generations of railroad workers it was a natural choice:  
https://commons.wikimedia.org/wiki/File:Group_of_laborers_digging_through_dirt_pile_along_railway_bed_LCCN2016647134.jpg

Saturday, November 2, 2019

There Is No Identity Crisis in Psychiatry





The New England Journal of Medicine published an opinion in their October 31, 2019 edition titled “Medicine and the Mind-The Consequences of Psychiatry’s Identity Crisis” (1).  Claiming that psychiatry (meaning organized psychiatry and all psychiatrists) has some sort of an identity crisis is a favorite editorial topic these days. It lacks face validity considering over 40,000 psychiatrists go to work every day, have working alliances with their patients, treat problems that no other doctors want to treat, and get results. Furthermore, most psychiatrists are working in toxic practice environments that were designed by business administrators and politicians. As a result, psychiatrists are expected to see large numbers of patients for limited periods of time and spend additional hours performing tasks that are basically designed by business administrators and politicians and have no clinical value.

The authors in this case fail to see that problem. In their first paragraph they critique “checklist amalgamations of symptoms” as if that is psychiatric practice or what psychiatrists are trained to do in their residency programs. I happen to be an expert in these checklists because I have been critiquing them from the outset. The state of Minnesota mandates that all patients being treated for depression in primary care settings have to be rated on these checklists over time, and that data is supposedly analyzed as a quality marker. Anyone familiar with the analysis of longitudinal data will realize that cross-sectional data points on different patients at different points in time are meaningless. But that doesn’t prevent politicians in Minnesota from dictating psychiatric practice and it doesn’t prevent these authors from blaming psychiatry for it.

Their additional opening critique on “medication management” ignores the fact that this procedure was invented by the federal government. This procedure and all the associated billing codes did not exist in psychiatry until HCFA thought it was a good idea to assign these codes to psychiatrists and call them “medication management”. It was only recently that psychiatry could use the same E & M codes that the rest of medicine uses for the provision of complicated care including psychotherapy. Instead of just stating that the authors say “We are facing the stark limitations of biological treatments, while finding less and less time to work with patients on difficult problems”.  Apart from the rhetoric I don’t know what that means. If I have a patient with a difficult problem - I make the time to work on it.  If there were any stark limitations in psychiatry – they occurred before the invention of biological treatments. In those days, people died from severe psychiatric disorders and the associated effects of severe hyperactivity, starvation, and dehydration.  Many people also had their lives disrupted when they were sent to state mental hospitals for years or in some cases decades.  Those were the historic limitations in psychiatry.

They move onto a critique about diagnosis and their opinion that “the solution to psychological problems involves matching the “right” diagnosis with the “right” medication". I don’t know where the authors went to psychiatry school but that is a new one on me.  At a different point in their opinion piece they critique the current diagnostic manual. If they read that manual they would notice there are conditions with strictly psychological and social etiologies that do not require medical treatment. They also minimize the role of tertiary consultants like myself. I see thousands of people who were started on psychiatric medications by non-psychiatrists. There is clearly a lack of expertise prescribing those medications and I make the necessary adjustments including stopping medications that were inappropriately prescribed. I also prescribe the indicated treatment when it was never provided in the first place. That all happens in the context of a therapeutic relationship and providing necessary psychotherapy.

Somehow the authors conclude that a lack of “scientific and intellectual integrity” does a disservice to patients, practicing psychiatrists, and medical colleagues. They suggest that medical colleagues are striving to provide the best possible and “most humane care to people with medically and psychologically complicated conditions”. I don’t know who the authors think is holding up the psychiatric and psychological end of that treatment. I worked in a multidisciplinary clinic with every imaginable consultant for 22 years. Nobody hesitated to refer patients to me for psychiatric care. They knew it would be comprehensive, that the assessment would be exhaustive, and that the treatment plan would be beneficial. We also had an active consultation-liaison team that provided active ongoing consultation to a large medical-surgical hospital. Without those psychiatric services there is no “humane care” to the medically complex psychiatric patient. This psychiatric function is widely known and these treatment plans can be read directly from the pages of the NEJM.

The authors provide a one sentence sketch of brain function and how the external world affects our “brain-minds”. They grudgingly acknowledge that basic science may be a necessity. They bemoan the fact that advances in neuroscience “are still far from offering real help to real people in hospital, clinic, and consulting room”.  That is not what I observed in 35 years of practice. There has been a steady improvement in psychopharmacology both in terms of safety and selectivity. There have been major advances in neuromodulation -both electroconvulsive therapy and transcranial magnetic stimulation. There have been pharmacological advances in addiction psychiatry with more medication assisted treatments. There have been advances in specific conditions like severe psychiatric disorders associated with pregnancy and various forms of catatonia. The diagnostic advances related to basic science research have been stunning. When I first started consulting in nursing homes 35 years ago - every diagnosis was either “senility”, “senile dementia”, or “atherosclerosis”. There were no science-based diagnoses of dementia in those days. We currently have a comprehensive approach to detailed dementia diagnoses as well as a comprehensive approach to diagnosing 127 different conditions associated with substance use disorders all neatly detailed in the diagnostic manual that they seem to have a problem with. Hopefully there is no more “senility” in nursing homes.


The authors attack neuroscience in the usual ways. They state they agree that discoveries in neuroscience are exciting but on the other hand “are still far from offering real help to real people in the hospital, clinic, and consulting room.” They restate that twice in the space of this brief essay. Is that true?  Some reading in the area of translational psychiatry might be in order. Every week I assess many patients for anxiety disorders. A significant number of them have been anxious their entire life. There are currently no good conceptualizations and indicated treatments that separate this group from people who develop anxiety later in life. From the work of Kalin and others (3,4), the biological basis of anxious temperament and potential solutions to lifelong anxiety is now becoming a possibility. Progress in neuroscience has gone from receptors and neuroendocrinology in the 1980s to genetics and multiomics in the 21st century. Now there is more than speculation and empirical trials. Entire mechanisms that include genetics, transcription, anatomic substrate and the impact of the environment on brain systems are determined.

There is in fact a group dedicated to bringing neuroscience into the clinical realm – The National Neuroscience Curriculum Initiative. It is possible to think of a neuroscience-based formulation as easily as one might think of a psychodynamic formulation.  The point of neuroscience research in psychiatry is the same as it is in any other specialty with one exception - the organ being studied is more complex and generates a conscious state. The basic science of practically every other field has been studied more intensely and with more resources than brain science has been studied. Many other fields have not produced miracle cures when it comes to chronic illnesses and the basic treatments of these illnesses have been static for decades. The cures or disease altering interventions often occur after much more time has been spent studying them then we have spent studying the brain. In that context, basic science brain research is as on track as any other field

The most erroneous opinion advanced by these authors is that psychiatry has somehow abandoned the social and psychological elements of care. They cite an author who is a historian and who suggests that psychiatrists should limit their scope to “severe, mostly psychotic disorders”. There are many authors with similar irrelevant opinions about psychiatry but they generally aren’t quoted in an opinion piece for the NEJM. Nothing that author says is realistic or accurate in this article, but that is typical of the so-called critics of psychiatry. The authors own proposals for change in psychiatry are similarly irrelevant because it is apparent that they have a limited understanding of what is going on in the field or what psychiatrists do on a day-to-day basis.

The next section of their opinion piece is about funding and how biological funding has “replaced all other forms of psychiatric research”. They provide no evidence in terms of actual numbers. I expended some effort to try to do that.  I asked NIH, NIMH, SAMHSA, one of my US Senators and I tweeted the director of the NIMH to get an answer to the question about the proportion of funding for basic science versus psychosocial mental health research. I also searched the AAAS research reports to see if anything was listed there. What I got back was largely devoid of any useful data.  The above links were sent to me by a public affairs specialist at the NIH.   

I remembered reading about an analysis in American Psychologist suggesting that 30% of the $1.6B NIMH budget goes to psychosocial research. I was able to find the article (2) and it was not straightforward as most advocates of increased psychosocial research think. That 30% figure comes from a graphic generated by a review of research abstracts of 15% (2,028) of all funded studies from 1997-2015. They were coded on a 1 - 5 scale by doctoral level students where 1 = entirely focused on biomedical topics to 5 = entirely focused on psychosocial topics.  There was a positive trend in favor of biomedical research but the authors point out several limitations in the data and areas for further study. And they make this important comment:

“A test of the differences in regression slopes indicated that there was, however, no difference in the increase in award size for R01 grants, F(1,475) = 3.97, p = ns, suggesting that the proportion of biomedical grants awarded increased, but they did not receive disproportionately larger awards than psychosocial grants. This is notable given that biomedical research is often more costly because of expensive procedures and larger research teams.” (p. 417-418)

This reference provides a very balanced look at the issue including a discussion of the significant limitations of psychosocial treatments - something that you do not see in the NEJM piece or from the people claiming that basic science research is clinically worthless. 

Although the authors are critical of neuroscience results, they don’t seem to mention the lack of innovation in psychotherapy and other psychosocial therapies. More significantly they ignore the fact that these therapies are routinely not funded by managed-care companies, government insurers, and responsible counties. They blame psychiatry for the “abandonment and incarceration of people with chronic, severe mental illness” when in fact the necessary psychiatric beds and inpatient facilities as well as community housing for these patients has been actively shut down by businesses and governments over the past 30 years.  It seems that counties have adapted managed-care practices that includes rationing services for the chronically mentally ill to the point that they end up in jail. The authors seem to conveniently blame psychiatry for that. Once again they could read about what psychiatry really does in the pages of the NEJM and how these very patients are served by ACT teams. The treatment approach was invented to improve the quality of life of people with chronic mental illness and support them in independent living. It does not work in a vacuum and there has to be a funding source.

The authors suggest that psychiatry needs to be “rebuilt”. From their suggestions about training programs I wonder if they participate in training programs, teach residents, and work on resident curricula.  And if they do - I wonder what that training program looks like. I say that because all the suggestions they have seem to have been in place for decades. In fact, their entire argument is reminiscent of the old "biological psychiatry versus the therapists" argument from about 1984. That argument should stay firmly planted in the "old history" folder.

Their concluding paragraph is a extension of earlier rhetoric.  They talk about psychiatry having an exclusive focus on “biological structure” rather than meeting the needs of real people. I go to work every day and talk to real people all day long. I know quite a lot about the biological structure the brain and its function. I must because I don’t want to be treating a stroke, brain tumor, a traumatic brain injury, or multiple sclerosis like a purely psychiatric problem. I also realize that if I conceptualize the psychiatric disorder as a specific brain area or network - that is still occurring in a unique conscious state. That conscious state is generated by the most complex organ in the body. It is an organ with tremendous computational power. All psychiatrists are treating people with unique conscious states and there is no specialty more aware of that. And in that complex setting psychiatrists are focused on helping the people they are seeing. They are the only ones accountable.

There is no “identity crisis” in psychiatry. Making that claim requires a suspension of the reality about how psychiatrists are trained and the grim practice environments that many of us face. Those grim practice environments are the direct result of governments and businesses actively discriminating against psychiatrists and their patients. That has resulted in discrimination that is so gross that county jails are now regarded as the largest psychiatric hospitals in the USA.  Pretending that these problems are the result some flaw in psychiatrists one of the greatest medical myths of the 21st century.  These authors and the New England Journal of Medicine are promoting it.  This opinion piece is so poorly done it makes me wonder what the editorial staff at NEJM are doing. It is as bad as another opinion piece that should never have been published in the psychiatric literature.   

The real message from the profession that should be out there is:

“Give us a practice environment where we can do what we are trained to do! Get out of the way and let us do our work! Give us the resources that every other medical specialist has!”

Very few of those environments exist.  They have been rationed out of existence by politicians, bureaucrats and administrators.  People who know nothing about the field seem to be totally unaware of that problem and like these authors they never comment on it. Only people lacking that awareness would believe an article like this - or write it.


George Dawson, MD, DFAPA


References:

1: Gardner C, Kleinman A. Medicine and the Mind - The Consequences of Psychiatry's Identity Crisis. N Engl J Med. 2019 Oct 31;381(18):1697-1699. doi:10.1056/NEJMp1910603. PubMed PMID: 31665576.

2: Teachman BA, McKay D, Barch DM, Prinstein MJ, Hollon SD, Chambless DL. How psychosocial research can help the National Institute of Mental Health achieve its grand challenge to reduce the burden of mental illnesses and psychological disorders. Am Psychol. 2019 May-Jun;74(4):415-431. doi: 10.1037/amp0000361. Epub 2018 Sep 27. PubMed PMID: 30265019.  

I thank these authors for making this paper available on ResearchGate.


3: Kalin NH. Mechanisms underlying the early risk to develop anxiety and depression: A translational approach. Eur Neuropsychopharmacol. 2017 Jun;27(6):543-553. Doi: 10.1016/j.euroneuro.2017.03.004. Epub 2017 May 11. Review. PubMed PMID: 28502529; PubMed Central PMCID: PMC5482756.


4: Fox AS, Kalin NH. A translational neuroscience approach to understanding the development of social anxiety disorder and its pathophysiology. Am J Psychiatry. 2014 Nov 1;171(11):1162-73. doi: 10.1176/appi.ajp.2014.14040449. Review. PubMed PMID: 25157566; PubMed Central PMCID: PMC4342310.



Supplementary:

The Psychiatry Milestone Project: an indication of what psychiatry residents are evaluated on in their training programs. Link.



Graphic Credit: 

The graphic was downloaded from Shutterstock per their standard user agreement.



Thursday, September 15, 2016

Hospitalists.....





I was a hospitalist before the word was fashionable.  It was July 1988 and I had just completed a 3 year post residency stint at a community mental health center as part of a public health service scholarship payback.  For one of those years I commuted another 300 miles to keep a community hospital psychiatric unit open.   I headed for the hospital where I did my rotating internship in Internal Medicine, Pediatrics and Neurology.  It was the only real metropolitan inpatient treatment setting I had known at that point.  In my residency program, the interns were split up into two groups and each group worked at one of the major county hospitals in the Twin Cities.  It was a unique setting at that time because psychiatrists provided almost all of the medical coverage.  They had to be able to diagnose and treat a lot of common medical problems, write for all of the patient's medications, attend to acute medical problems and do the appropriate diagnosis and triage.  I had a wide range of medical problems admitted directly to me ranging from gunshot wounds to delirium.  Any psychiatrist working in these conditions realizes that the term "medically stable" is a relative one.  I had many patients admitted to my service with severe medical problems only because they also had a severe psychiatric disorder and were symptomatic at the time.  In many cases I had to rapidly assess them and transfer to medicine or an intensive care setting.

I had excellent back up by consultants and many of them to this day are some of the best physicians I have ever seen.  But they really did not want to hear from me unless I had a very specific probable diagnosis and most of the evaluation was done.  There are not too many places in psychiatry where jobs like that exist anymore.  If anyone asks me about similar positions - I actively discourage them from accepting a similar job.  With this arrangement the work is far too long and all of the medical care is provided for free - psychiatrists do not get any extra credit for it.

In those days there were six of us covering 3- 20 bed wards, five days a week.  The ads for psychiatrists these days often speak of "psychiatric hospitalists" - but every one of them specified no medical coverage.  They also tend to leave out the part that it is basically a rapid triage and discharge position and the job is to either maintain or cooperate with high discharge rates.  The only thing they have in common with the Internists and Family Physicians who have come to be designated as hospitalists is that they work 7 days on and 7 days off.  A schedule that very few people question.

I naturally picked up this week's copy of the New England Journal of Medicine to see what the two perspective pieces on hospitalists (1,2) had to say.  I was also interested because my brother is an Internist and over the years we have discussed the issue at length.  The initial essay by Wachter and Goldman documents the rapid rise of hospitalist care as a medical specialty.  Since 2003 the number of hospitalists has increased 5-fold to 50,000.  That makes hospitalists the largest speciality within Internal Medicine.  They cite the growth of managed care, Medicare DRG payments, and possible evidence as reasons for the growth of the field.  I am always skeptical of the term efficiency especially when it is combined with the term quality.  I guess it is difficult for some people to accept the fact that managed care and Medicare DRG payments are rationing mechanisms that are tied to quality only by the tenuous thread of government and healthcare company rhetoric and advertising.  The other critical question is efficiency for who?  It certainly is more efficient to administer a group of physicians who work 7 days on and 7 days off and happen to all be in the same chain of command.  It is a lot easier to get them to accept the role of rationing care in the interest of the hospital or health care group than the patient's personal physician who may see their part of their role as patient advocacy.

The authors have an interesting take on the deficiencies of the model.  They talk about the 7- days-on, 7-day-off model as implying that during the off period the physician is literally off and suggests that time might be better spent contributing to key institutional programs.  To me - this schedule seems more conducive to burnout and anyone who works it needs the off time to fully recover.  I have never seen a study on the cognitive efficiency during the 7-days-on, but my conversations with hospitalists suggests that by day 6 it starts to plummet.  With hospitalists supplanting specialists and subspecialists as inpatient attendings they suggest that trainees have less exposure to basic and translational science.  Although not stated in the article, the model involves eliminating whole blocks of specialty care.  I worked at a hospital where an entire Neurology service was eliminated by hospitalist care.  When I questioned that decision I was told: "We have an Internist who is interested in strokes."  Changing neurologists from attendings to consultants with hospitalists as the primary physicians for neurological problems changes the entire nature of care.  It also changes the associated nursing care when staff have no ongoing interest in the care of complex neurology patients.  The authors also note that hospitalists do not seem to have focused on investigating common inpatient illnesses.  They suggest possible remedies - but these seem like major problems that will only get worse with the increasing business rather than academic emphasis in medicine.

Gunderman points out that as opposed to the usual delineators of speciality care - patient age, physician skillset and body system hospitalists are delineated only by patient location.  He doesn't make it explicit but what is the relationship between location and his list of putative benefits? Looking at length of stay for example - that could logically follow as a concentrated effort in the location, but is that a clinical effort or an administrative one?  He points out that the increasing number of hospitalists per se,  cannot be taken as evidence of benefit and that perverse incentives exist.  I agree with the most perverse being the low reimbursement incentive for high volume practice. Seeing complex inpatients with a high frequency of initial and discharge assessments may reduce the volume necessary for productivity demands.  When I was a psychiatric hospitalist, this dimension was manipulated in a number of ways.  I was initially told, I was responsible for a set number of inpatient beds.  At some point there was a great deal of pressure for me to start running outpatient clinics because they would be more "interesting" than just seeing inpatients.  I resisted that and had significant leverage because nobody else wanted to do my job.  I eventually did run a Geriatric Psychiatry and Memory Disorder Clinic for many years while continuing inpatient work.  That clinic was eventually closed by administrators because they claimed our productivity was not high enough to work with a nurse.  The neurologist and I needed all of the collateral data that she collected to do our work.  The expectation was that we would see complex dementia patients and do everything that the nurse in our clinic did - so we closed.  In over two decades of political wrangling around inpatient productivity the current consensus is that covering 10-12 inpatient beds is a reasonable approach.  At one point I was covering 20 beds with the help of an excellent physician assistant but at the cost of doing no teaching.

The critical aspect of Gunderman's thesis is his emphasis on the physician-patient relationship exemplified by this sentence:

"The true core of good medicine is not an institution but a relationship - a relationship between two human beings."

He points out that physicians being affiliated with institutions creates significant conflicts of interest,  isolates hospital staff from the rest of the medical community and that naturally leads to less expertise in the entire community.  It also creates the illusion that an institution rather than the relationship is the core of medical care and it is not.  Government-business constructs like Accountable Care Organizations have a similar effect.  I have experienced this first hand many times as I dealt with the iterations of hospitalists consulting on my patients.  In one case I talked with a young hospitalist about a patient with Type 2 diabetes mellitus.  The patient had a trace of renal insufficiency and was on metformin - a medication that is risky in that context.  The hospitalist advised me to call the primary care Internist taking care of the patient because "He has been doing it a long time and probably knows more about it than I do."  In addition to the relationship - there is clear expertise associated with caring for people with multiple complex medical problems for years in an outpatient setting - compared to a few days as an inpatient.  The medical industrial complex does not adequately value that expertise.                             

I think that there is room for hospitalists and psychiatric hospitalists.  They have to be focused on the needs of both the patient and the patient's outpatient physician.  There have to be clear goals for the hospitalization and one of those goals is what the patient's personal physician would like to see accomplished.  Since making the transition to strictly outpatient care - it is clear that the hospitalists no matter who they might be don't have much control over who gets admitted to the hospital and what happens there.  They are having less to say about when a person is discharged.  This is probably more true for psychiatry than medicine and it results in a large number of psychiatric outpatients not being able to access needed care.

And I can't help but notice that inpatient hospital medicine is still a far better resource than inpatient hospital psychiatry.



George Dawson, MD, DFAPA




References:

1:  Wachter RM, Goldman L. Zero to 50,000 - The 20th Anniversary of the Hospitalist. N Engl J Med. 2016 Aug 10. [Epub ahead of print] PubMed PMID:27508924.

2:  Gunderman R. Hospitalists and the Decline of Comprehensive Care. N Engl J Med. 2016 Aug 10. [Epub ahead of print] PubMed PMID: 27509007.




Friday, January 1, 2016

New England Journal of Medicine Discovers Assertive Community Treatment




I have been a reader and subscriber to the New England Journal of Medicine (NEJM) every year since medical school.  One of the first courses they taught us in those days was Biochemistry and being an undergrad chem major I had a natural affiliation with many of the biochem professors.  The format in those days was lectures focused on the major topics and seminars to take a more detailed look at the experimental and theoretical aspects of the field.  They were fairly intensive discussions and critiques of research papers selected by the professors.  The department head was the mastermind behind this technique and one days he discussed his rationale for it.  He hoped that every medical student coming through that course would continue to read current research.  He strongly recommended subscribing to and reading the NEJM not just in Medical School but for years to come.  In my case it worked.

One of the sections that you don't hear too much about is the clinicopathological exercise that comes out each week.  It is basically a publication of formal case records of Massachusetts General Hospital and the associated findings and discussions.  These case reports are interesting for a couple of reasons - they show patterns of illness that clinicians can familiarize themselves with and they show at least some of the diagnostic thinking of experts.  During the time I have been reading them, they also discuss psychiatric comorbidity of physical illness and medical etiologies of psychiatric symptoms.  At one point I was a member of an informatics group and was very interested in studying this section of the NEJM from a psychiatric perspective.  At that time it seemed that I was the only psychiatrist with that interest.  With modern technology a study like this is more possible than ever.  For example, searching the case records feature of the NEJM from December 1989 to December 2015 yields a total of 31 cases of psychosis.  The etiologies of these cases range from purely medical etiologies, to delirium associated with the medical condition to pure psychiatric disorders with no specific medical etiology.  I have never seen this referred to as a teaching source for psychiatric residents admitting patients to acute care hospitals or consultation liaison services, but I could see it serving that function.  Instead of the usual lectures on medical psychiatry that typically contain PowerPoint slides of the "240 medical etiologies of psychosis" - a discussion of common mechanisms noted in these cases might be more instructive and be a better source for acquiring pattern matching capacity to broaden diagnostic capabilities.  It also put the DSM approach to psychiatry in proper perspective.  Knowing the lists and definitions of psychosis is nowhere enough to be a psychiatrist in a medical setting.  A seminar including this material can make these points and teach valuable skills.

That brings me to the case this week A Homeless Woman with Headache, Hypertension, and Psychosis.  Two of the authors are psychiatrists and the third is an internist.  The authors describe a 40 year old homeless woman with a diagnosis of schizophrenia and severe hypertension and how they established care over a number of years using the Assertive Community Treatment (ACT) model of care.  The patient's history was remarkable for a 12 year history of psychosis characterized primarily by paranoid and grandiose delusions.  She was homeless sleeping in public buildings for about 4 years and that seemed to be due to the thought that she needed to stay outside to watch over people.  She had a brief episode of treatment with olanzapine during a hospitalization about 5 years prior to the initiation of care by the authors, but did not follow up with the medication or outpatient treatment.  She was also briefly treated with hydrochlorothiazide 4 years earlier with no follow up care or medication.   She was admitted for treatment of a severe headache and a blood pressure of 212 systolic.  At the time of the admission physical BP were noted to be 208/118 and 240/130 with a pulse of 95 bpm.  She had bilateral pitting edema to the knees and bilateral stasis dermatitis.  She had auditory hallucinations consisting of voice of God and Satan and grandiose delusions.  Lab data showed a microcytic anemia.  She had standard labs to rule out myocardial infarction and vitamin deficiency states.  Blood pressure was acutely stabilized and she was discharged on lisinopril, thiamine, multivitamin, omeprazole, and ferrous sulfate.  The final diagnoses include schizophrenia, cognitive impairment associated with schizophrenia, hypertension, and homelessness.

The authors provide a good discussion of diagnosis of primary and secondary psychotic disorders and provide some guidance on timely medical testing for metabolic, intoxicant, and neurological abnormalities.  Delirium is identified as more of a medical emergency and necessitating more scrutiny.  The idea that delirium can be mistaken for psychosis is a valuable point that is often missed during emergency assessment especially if the patient has a pre-existing psychiatric diagnosis on their medical record.  The authors sum up screening tests that are necessary for all patient with psychosis and the tests that  are reserved for specific clinical concerns like encephalitis, seizures, structural brain disease, and inflammatory conditions.  They also suggest screening for treatable conditions and inflammatory conditions.

There is a good section on the follow up care that this patient received.  She was seen in a clinic for the homeless, where problems were gradually noted and worked on with her full cooperation.  This is not the typical approach in medicine where it is assumed that the patient will tolerate a complete history and physical exam and then cooperate with any suggested medical testing and treatment.  In this case, the practical problems of foot care were addressed.  She was eventually seen in 60 visits over two years.  By visit 19 she described concerns about cognitive symptoms and by visit 33 she was accepting treatment for psychosis with olanzapine.  She eventually allowed a more complete treatment of here associated physical symptoms including an MRI scan of the brain and treatment for migraine headaches.  The authors point out that tolerating medical and psychiatric uncertainty is a critical skill in treating people who need to habituate to medical systems of care.  A more direct approach is alienating.  It does tend to create anxiety in physicians about what is being missed and not addressed in a timely manner.  There is always a trade off in engaging people for long term care in more stable social settings and pushing to maximize diagnosis and treatment in a way that they might not be able to tolerate.  The ACT model stresses the former.           

There are some very relevant ACT concepts illustrated in this article.  First and foremost the rate at which medical interventions are prescribed depends almost entirely on the patient's ability to accept them.  This is at odds with the timeliness of medical interventions that most physicians are taught.  I say "almost entirely" in this case because the authors were very fortunate that the patient cooperated with treatment of extreme hypertension.  One of the common hospital consultations for psychiatric is a person with a mental illness and life-threatening illness who is not able to recognize it.  Even on the subacute side of care there are many tragedies due to patient with mental illness not being able to make decisions that could have saved their life.

I think that there are also some very practical applications for psychiatry on an outpatient basis.  Most patients with severe mental illnesses are never going to see a primary care provider 60 times before starting treatment.  It only happens in a subsidized setting with physicians who are highly motivated to see a certain approach work.  The care model described in the paper is certainly not the collaborative care model that some authors, the American Psychiatric Association (APA), and the managed care industry keeps talking about.  There is also the obvious point that people don't go into primary care because they like talking with people who have severe mental illnesses.  Psychiatrists need to see these people either in ACT teams or community mental health centers.  It won't work in a standard managed care clinic seeing a patient who is this ill - 2- 4 times a year for 10 - 15 minutes. ACT psychiatrists need to know about primary care providers who work better with the chronically mentally ill or people with addictions and make the appropriate referrals.  All psychiatrists should be focused on blood pressure measurements and work on getting reliable data.  Funding for psychiatric treatment often precludes ancillary staff present in all other medical settings to make these determinations.  Existing collaborative care models in primary care clinics can get blood pressure measurements on the chart but restrict patient access to psychiatrists.  

This Case Report is a good example of what can happen with a real collaborative care model that focuses on the needs of a person with severe chronic mental illness.  It is a model of care that I learned 30 years ago from one of the originators and it is more relevant today than ever.  It is also a model of care that is currently rationed and provided in the states where it is available to a small minority of patients.  It is not the method of collaborative care that you hear about from the APA, the managed care industry, or government officials.  It should be widely available to all psychiatric patients with complex problems.


George Dawson, MD, DFAPA


References:

1: Shtasel DL, Freudenreich O, Baggett TP. CASE RECORDS of the MASSACHUSETTS GENERAL HOSPITAL. Case 40-2015. A 40-Year-Old Homeless Woman with Headache, Hypertension, and Psychosis. N Engl J Med. 2015 Dec 24;373(26):2563-70. doi: 10.1056/NEJMcpc1405204. PubMed PMID: 26699172.

2:  New England Journal of Medicine Case Records of MGH x psychosis (on Medline).  Shows 101 references as opposed to 31 on NEJM search engine and 10 on basic Medline search.

3:  Marx AJ, Test MA, Stein LI. Extrohospital management of severe mental illness.Feasibility and effects of social functioning. Arch Gen Psychiatry. 1973 Oct;29(4):505-11. PubMed PMID: 4748311.

4:  Stein LI, Test MA, Marx AJ. Alternative to the hospital: a controlled study.Am J Psychiatry. 1975 May;132(5):517-22. PubMed PMID: 164129.

5:  Test MA, Stein LI. Alternative to mental hospital treatment. III. Social cost.  Arch Gen Psychiatry. 1980 Apr;37(4):409-12. PubMed PMID: 7362426.

6:  Stein LI, Test MA. Alternative to mental hospital treatment. I. Conceptualmodel, treatment program, and clinical evaluation. Arch Gen Psychiatry. 1980 Apr;37(4):392-7. PubMed PMID: 7362425.

7:  Weisbrod BA, Test MA, Stein LI. Alternative to mental hospital treatment. II.   Economic benefit-cost analysis. Arch Gen Psychiatry. 1980 Apr;37(4):400-5. PubMed PMID: 6767462.


Attribution: 

Photo at the top of this post is by Jonathan McIntosh (Own work) [CC BY 2.5 (http://creativecommons.org/licenses/by/2.5)], via Wikimedia Commons.  Original photo at https://commons.wikimedia.org/wiki/File%3ARNC_04_protest_77.jpg




Sunday, November 22, 2015

NEJM Review of Generalized Anxiety Disorder




















There was a review of Generalized Anxiety Disorder (GAD) in this week's New England Journal of Medicine by Stein and Sareen (1).  I just did a bit of a critical review of the concept here and thought I would look at what these authors had to say.  

They start the review with a clinical vignette of a 46 year old married woman with insomnia, headaches, back pain, and excessive worry about a number of daily stressors.  She is also drinking alcohol on a daily basis to "self-medicate".  She is described as a person who comes in frequently for appointments.  After reviewing the phenomenology,  comorbidity, and differential diagnosis - the authors come back to this case and apply what is in the review.

Their review of the diagnosis does highlight a few things that are problematic about the diagnosis.  The key diagnostic feature is chronic excessive worry.  The worry has to be there for at least 6 months.  In their review of other psychiatric causes of anxiety they omit diagnoses that can cause short term worry or anxiety - the adjustment disorders.  They point out that GAD is more common in primary care clinics where it usually presents with a chief compliant of somatic problems rather than excessive worry.  They discuss major depression as a common co-occuring condition and suggest that anhedonia may be a distinguishing symptom for depression.  They also describe anxious depression as episodic depression superimposed on chronic anxiety.  There is no mention of the low diagnostic reliability of the disorder and why that might occur.  I think that any psychiatrist who sees GAD over time experiences the same problem that occurred in the DSM-5 field trials, the diagnosis can seem to change between visits from GAD to major depression, even in the absence of any new stressful life events.  Critics of psychiatry frequently cite this as a problem with DSM-5.  I think that DSM-5 does a good job with the symptom descriptors, but we don't know why this change occurs and I have not heard anyone talk about it like it is a real phenomenon.

Alcohol use is described as a common co-morbidity with 35% of people with GAD "self-medicating."  I put that term in quotes because it suggests that alcohol can actually be used for the purpose of medication.  What really occurs is that over time the person becomes more anxious and sleep deprived because of the negative effects of alcohol on sleep, baseline anxiety, and baseline mood.  Practically everyone I talk with who has an alcohol use disorder can recognize this pattern and modify any remarks about self-medication to "feel better for a few hours" or "knock myself out and forget about my problems".  There is also the issue of alcohol use being the cause of an anxiety disorder rather than temporary relief.  While I am on the topic of substance use and GAD, at one point the authors make the statement: "Data are also lacking on the use, usefulness, and safety of medicinal marijuana for generalized anxiety disorder" (p. 2066).  Many if not most anxious people are averse to the use of marijuana for anxiety.  Initial use of marijuana typically causes a drop in blood pressure with a compensatory tachycardia.  Tachycardia especially if there is a noticeable accentuation of heart beats is not tolerated well by patients with anxiety.  Many have had panic attacks.  Others have cardiac awareness and are sensitive to any changes in heart rate or intensity.  Many people tell me they thought that marijuana was effective for anxiety, but over time it seemed to make them more and more anxious, they developed panic attacks, and they had to stop using it.  These features combined with a tendency of patients to stop talking to their primary care physicians about substance use are good reasons to heavily educate them about these problems at the earliest possible time.

The authors take a risk factor analysis approach to looking at historical features that can also be associated with the diagnosis.  They point out that they are nonspecific and amy be associated with other psychiatric diagnoses.  I would encourage a more developmental approach, looking back at the first recollection of anxiety - usually at some point in childhood and how that developed in the childhood environment.  It is fairly common for the patient to describe one or both parents being anxious and how that was transmitted to them  eg. ) "I started to worry about the same things my  mother worried about" or "I started to worry about my mother because she was worried all of the time - I worried that something was going to happen to her."  Those learning patterns associated with adult anxiety are fairly common and may explain the low heritability (15-20%) of the disorder.  The authors do discuss one feature that is important in this context and that is intolerance of uncertainty.  Clinically that translates to excessive and at times catastrophic worry about uncertain situations.  They are unsure about the biological or experiential origins of the symptom.  I think the important part is that with a careful enough history and sometimes collateral information the learning aspects of this bias can be examined and it can be unlearned in therapy.

The authors advocate for a stepped approach to treatment and I certainly agree.  This approach would include an initial medical assessment to look for common medical conditions that can cause anxiety followed by education about anxiety and lifestyle changes to address sleep, exercise, caffeine intake and alcohol use with monitoring response to those interventions.  Those first two phases could be accomplished at the initial visit.  If those initial interventions don't help moving on to "low intensity psychological interventions" like self-help books, computer-assisted psychotherapy, and support groups.  The next step up is more intensive psychological interventions like individualized cognitive behavioral therapy (CBT) or pharmacological management based on the patient's preference.  The highest level of care would include pharmacotherapy and more intensive CBT alone or in combination with other therapies (psychodynamic or acceptance and commitment therapy (ACT)).  The practical issue with this 4 step algorithmic approach to care is that it is generally not available in primary care settings.  In many of those settings, the patient is screened with the Generalized Anxiety Disorder 7-item questionnaire (GAD-7) and the patient is treated with a medication.  This is viewed as "cost-effective" care by managed care systems because an inexpensive prescription and a 20 minute appointment with a physician is apparently much more "cost effective" to the organization than maintaining computerized psychotherapy or educational and monitoring systems.  There is also the largely undetermined effect of the patient taking a completely passive role in their care.  There is a significant difference between a patient who is actively engaged in lifestyle changes and self education and one who expects a complete cure from a pill.  The actively participating patient has better outcomes.   

The authors include a table of 16 medications used to treat GAD.  They point out that the effects of medication are modest at best and no single medication has better efficacy.  They discuss vilazodone as a promising medication in clinical trials and do not include it in the list.  My current prescribing information says that it is FDA approved only for major depression, but only 4 of the 16 drugs on the list are approved for GAD: paroxetine, venlafaxine XR, duloxetine, and buspirone.   The authors comment on the practice of using hydroxyzine for GAD and suggest not to use it.  I am in complete agreement with that recommendation and think that any anti-anxiety effect comes from the non-specific sedating effect of antihistamines.  The side effect profile is also not very favorable.  They point out the benzodiazepine paradox with GAD - they are recommended for short term (3-6 month) use but the condition is chronic.  There is even more subtlety there.  Some early studies of GAD treated with antidepressants suggests that patients needed to take the medication only 30% of the time over ten years of treatment.  I don't think you will see a similar study with benzodiazepines and I think it has to do with the behavioral pharmacology of the drug.  The single-most important issue when it comes to benzodiazepines is the informed consent and letting the patient know that they are taking a potentially addictive drug.  

The  authors are silent about the fact that GAD may be the most heterogenous of all of the DSM-5 categories.  In October and November of this year, I went to three excellent conferences.  One of the central themes was phenotypic diversity in DSM-5 categories and what it implies for biology and genetics.  GAD seems to offer some of the best clinical features for distinguishing intermediate phenotypes and I outline a few in my previous post.  There are problems with a diagnostic category that says "excessive worry" is a discriminating feature and ignores real physiological markers like persistent tachycardia, hypertension, body mass index, and hyperarousal at the time of sleep.   This also points out how basic science can drive clinical diagnoses in psychiatry and hopefully at some point in the near future we will see this kind of research.
    
I think that we have gotten as much as we can out of the GAD diagnosis at this point and it is time to break it down into what can be more reliably observed. 


George Dawson, MD, DFAPA


References:

1: Stein MB, Sareen J. Generalized Anxiety Disorder. N Engl J Med. 2015 Nov 19;373(21):2059-68. doi: 10.1056/NEJMcp1502514. PubMed PMID: 26580998.

Wednesday, October 29, 2014

The Antidepressant Black Box Warning - A Better Solution

There were two opinion pieces in the New England Journal of Medicine this week on the antidepressant black box warning.  Richard A. Friedman, MD contends that the warning had an adverse effect on antidepressant prescriptions, a decreased rates of new depression diagnoses, increase in psychotropic drug poisoning (as a proxy measure for suicide attempts)  and that is reflected in an increase in the rate of completed suicides in people from 10-34 years of age between 1999 and 2010.  He argues for removing the warning entirely.  Marc B. Stone, MD points out that there is contradictory data showing that an increase in suicide rates and no good correlation with an increase in rate and the year of the boxed warning.   He discusses other factors that can result in fluctuating levels of depression diagnosis and treatment, including a change in antidepressant marketing because many antidepressant were becoming generic at the time and how that may have affected the prescription rates.  He cites CDC data on the rate of intentional versus non-intentional overdose as a more appropriate metric and points out that rate was lower both before and after the warning.  He concludes that despite many efforts there is no real correlation between the warning and suicide rates.  Disclosure forms will be available when the article becomes available online but for now Dr. Friedman appears to be affiliated with the Department of Psychiatry, Weill Medical College of Cornell University and Dr. Stone is affiliated with the FDA.

One of the central problems with the debate is the problem of looking at statistical significance in low rates on a longitudinal basis.  In all of the studies I have seen and in these debates, the longitudinal data is almost always interpreted as correlational (we seem to never be able to determine causality) and there appear to be endless number of correlations - and none of them are mathematical.  In these articles alone the authors looked at drug company marketing and sales strategies, the impact of the original warning, the impact of the revised warning,  the impact of the discussion in the media as opposed to the warning, the diagnostic patterns of physician, the impact of managed care and pharmacy benefit managers, and the prescribing patterns of physician (broad versus narrow) as possible correlates.  All of this is analyzed at a qualitative level and apparently not by anyone who is an expert in the analysis of longitudinal data.  The debate becomes a series of true or false statements based on snapshots.  That to me is essentially a political analysis of the data and it seems to lead nowhere.  It can be a question of "my data being better than your data" but it is not the kind a probabilistic analysis that physicians are trained to do.  The central question here is whether the original FDA meta-analysis of clinical trials showing a 4% to 2% ratio of "suicidality" in the treated versus placebo group is valid and what should be done about it, keeping in mind that suicidality did not confer any increased risk of completed suicide.  In this case Dr. Friedman agreed that something should be done based on that meta-analysis so both authors would agree that finding is significant.

They differ on what existing data mean and what should be done.  As a clinical psychiatrist  who deals with side effects at least as much as symptoms of depression and anxiety, I think a lot could be done to improve the awareness of side effects and improve treatment.  The solution is a lot less drastic but more comprehensive than a Black Box Warning.   After all, it is highly likely that most people are going to encounter more common and potentially problematic side effects than intrusive suicidal thoughts  or suicide attempts.   That is probably as true for medications without a black box warning as medications with a black box warning.  Even considering another class of medications with a warning about suicidal ideation - anticonvulsants, says nothing about whether a patient is more likely to experience those thoughts with the anticonvulsant or the antidepressant.  Depression is a common problem in people with epilepsy, what about people needing to take both an anticonvulsant and an antidepressant?

My recommended approach to the problem would resolve a couple of issues.  It would emphasize to the public that a choice to take a medication is not without risk and is not a guarantee of a cure.  That one cannot assume that an FDA approved medication is totally benign and will be completely effective for their problems.  The FDA is unique in terms of the efficacy, side effects, and pharmacosurveillance data that they collect.  They are also not transparent with it.  In that context they expect physicians to make sense out of what is presented to patients in the risk-benefit discussion of whether or not to take a medication.  That leaves the benefit discussion full of unnecessary guesswork about what does and what does not need to be discussed.  In that context a black box warning is just another rare cloud on the horizon.  Using the Back Box warning as a standard, a doubling of suicidality from 2% to 4% with no completed suicides with antidepressants is on par with a 1-6/10,000 chance of Stevens-Johnson's syndrome from carbamazepine.

The solution here is an FDA attachment to the package insert of what needs to be discussed with the patient to give them a better idea of the risks and benefits of a particular medication.  It makes no sense at all to feel forced into a discussion of suicidality from taking a medication when far more patients will experience fatigue, headaches, diarrhea, and discontinuation symptoms.  I have attached a sample of a general outline of what needs to be covered.  I think that Medline plus medication handouts could also be considered.  The FDA can specify what these points are for every medication.  If the psychiatric profession has not set a standard, it is time for the regulators to do more than issue confusing black box warnings and back it up with all of the data in an accessible format on their very confusing web site.  You can bet that the managed care industry does not want their psychiatrists spending an extra few minutes with a patient to have this discussion.  The regulator in this case has a unique opportunity to set a uniform standard for side effect discussions based on the priorities they establish from both clinical trials and pharmacosurveillance.   The solution to the debate of the toxic or non-toxic black box warning is as simple as that.

Most importantly the physicians having the discussion with the patient can document "The FDA recommended risk/benefit discussion for this medication was completed with the patient."



George Dawson, MD, DFAPA    


Friedman RA.  Antidepressants' black box warning 10 years later.  N. Engl J Med 2014;317;18: 1666-1668.

Stone MA.  The FDA warning on antidepressants and suicidality - why the controversy?   N. Engl J Med 2014;317;18: 1666-1668.

Peter Diggle, Patrick Heagerty, Kung-Yee Liang, Scott L. Zeger.  Analysis of Longitudinal Data.  Oxford University Press.  Oxford.  Second Edition 2002.

Monday, May 21, 2012

DSM5 - NEJM Commentaries


I highly recommend the two commentaries in the New England Journal of Medicine this week.  The first was written by McHugh and Slavney and the second by  Friedman.  Like Allen Frances they are experienced psychiatrists and researchers and they are likely to have unique insights.  I may have missed it, but I am not aware of any of these authors using the popular press to make typical political remarks about the DSM.  Those remarks can be seen on an almost weekly basis in any major American newspaper.

McHugh and Slavney focus interestingly enough is the issue of comprehensive diagnosis and opposed to checklist diagnoses.  It reminded me immediately that the public really does not have the historical context of the DSM or how it is used.  It also reminded me of the corrosive effect that managed care and the government has had on psychiatric practice with the use of "templates" to meet coding and billing criteria in the shortest amount of time.   Finally it reminded me of the bizarre situation where we have managed care companies and governments combining to validate the concept of a checklist as a psychiatric diagnosis and court testimony by experts suggesting that it is negligent to not use a checklist in the diagnostic process.

McHugh and Slavney summed up in the following three sentences: “Checklist diagnoses cost less in time and money but fail woefully to correspond with diagnoses derived from comprehensive assessments. They deprive psychiatrists of the sense that they know their patients thoroughly. Moreover, a diagnostic category based on checklists can be promoted by industries or persons seeking to profit from marketing its recognition; indeed, pharmaceutical companies have notoriously promoted several DSM diagnoses in the categories of anxiety and depression.” (p. 1854)

In my home state, the PHQ-9 is mandated by the state of Minnesota to screen all primary care patients being treated for depression and follow their progress despite the fact that this was not the intended purpose of this scale and it is not validated as an outcome measure.  The PHQ-9  is copyrighted by Pfizer pharmaceuticals.

The authors go on to talk about the severe limitations of this approach but at some point they seem to have eliminated the psychiatrist from the equation. I would have concerns if psychiatrists were only taught checklist diagnoses and thought that was the best approach, but I really have never seen that. Politicians, managed care companies, and bureaucrats from both are all enamored with checklists but not psychiatrists. They also talk about the issue of causality and how that could add some additional perspective. They give examples of diagnoses clustered by biological, personality, life encounter, and psychological perspectives. Despite its purported atheoretical basis, the DSM comments on many if not all of these etiologies.

Friedman's essay is focused only on the issue of grief and whether or not DSM5 would allow clinicians to characterize bereavement as a depressive disorder. That is currently prevented by a bereavement exclusion and DSM-IV and apparently there was some discussion of removing it. He discusses the consideration that some bereavement is complicated such as in the situation of a bereaved person with a prior episode of major depression and whether the rates of undertreatment in primary care may place those people at risk of no treatment.

There can be no doubt that reducing a psychiatric diagnosis to a checklist loses a lot of information and probably does not produce the same diagnoses. There is also no doubt that the great majority of grieving persons will recover on their own without any mental health intervention. Both essays seem to minimize the role of psychiatrists who should after all be trained experts in comprehensive diagnoses (the kind without checklists). They should be able to come up with a diagnostic and treatment formulation that is independent of the DSM checklists. They should also be trained in the phenomenology of grief and the psychiatric studies of grief and realize that it is not a psychiatric disorder.  If they were fortunate enough to be trained in Interpersonal Psychotherapy they know the therapeutic goals and treatment strategies of grief counseling and they probably know good resources for the patient.

The critiques by all three authors are legitimate but they are also strong statements for continued comprehensive training of psychiatrists. There really should be no psychiatrist out there using a DSM as a "field guide" for prescribing therapy of any sort based on a checklist diagnosis. Primary care physicians in some states and health plans have been mandated to produce checklist diagnoses.  The public should not accept the idea that a checklist diagnosis is the same as a comprehensive diagnostic interview by psychiatrist.

That is the real issue - not whether or not there is a new DSM.

George Dawson, MD DFAPA



McHugh PR, Slavney PR. Mental illness--comprehensive evaluation or checklist?
N Engl J Med. 2012 May 17;366(20):1853-5.

Friedman RA. Grief, depression, and the DSM-5. N Engl J Med. 2012 May
17;366(20):1855-7.
http://www.nejm.org/doi/full/10.1056/NEJMp1201794?query=TOC