The Heuristic is Dead - Long Live The Heuristic

One of the latest non-scandals to rock monolithic psychiatry and psychiatrists everywhere is David Healy's commentary on serotonin and depression (1).  Certainly nothing new there from the Healian perspective - SSRIs don't work, SSRIs don't work for melancholic depression, no evidence that SSRIs raise or lower serotonin levels, SSRIs pushed tricyclic antidepressants out of the market, and SSRIs forced the abandonment of research on biological disturbances in depression like hypercortisolemia.  The only thing I did not see was the idea that SSRIs are somehow addicting because they cause discontinuation symptoms in a subgroup of people who take them.  Feel free to call that a withdrawal syndrome, but withdrawal does not constitute an addiction.  All of these premises allow him to reject serotonin and it's role in depression on the vaguest possible grounds while stating that it is not irrelevant:

"Serotonin is not irrelevant.  Just as with noradrenaline, dopamine, and other neurotransmitters, we can expect some correlation with personality and temperament."

Indeed - but I expect those to be a very weak correlations probably not on par with the mood disorder work.  I was glad to see his reference to the late Marrku Linnoila (2) or more specifically Linnoila and Virkkunen.  Linnoila had done some of the outstanding work in this area and work on serotonin metabolites (CSF HIAA) in alcohol use disorders remains a classic.  He talks about the serotonin based research running into the sand.  I did a Medline search of serotonin and major depression and plotted the papers per year and there does not seem to be any precipitous fall off (the 2015 references are through March).  If anything I would expect the research to increase with the availability of ligands for additional receptors and the further characterization of serotonin transporter (SERT) variants.

But the main problem with Healy's argument is that he is talking about serotonin as if there is a chemical floating around in the brain and that is it.  He is basically describing his own brand of chemical imbalance theory.  So if he is saying there is no serotonin chemical imbalance theory I would of course have to wholeheartedly agree with him.  And in fact, I would tell him the same thing I told the Prozac rep back in the 1980's:  "The brain is far more than a bag of chemicals.  Unless you can say something about brain structure and physiology naming a neurotransmitter is meaningless."  There is no such thing as a chemical imbalance theory and reading through the index of any psychopharmacology text printed in the past 30 years will confirm that.

Healy can't stop himself at that level.  He goes on to describe the impact of his chemical imbalance theory on clinicians:

"This history raises a questions about the weight doctors and others put on biological and epidemiological plausibility.  Does a plausible (but mythical) account of biology and treatment let everyone put aside clinical trial data that show no evidence of lives saved or restored function?"

Things get very tenuous at that point.  As a clinician who has made a career out of treating patients with the most severe problems  I don't care at all about the "biological and epidemiological plausibility" of a theory of a medication.  I got past that in the 1990s when the elegant Nobel laureate mechanism of action of aminophylline was debunked and the former first line drug for asthma and COPD exacerbations was suddenly relegated to tertiary status.  And even then, with the people I was running up on gurneys from the emergency department while calculating the parameters of their aminophylline drip - not a patient of mine was lost.  I suppose you could say it was all an elaborate placebo response, treating all of those people with acute shortness of breath bad enough to be brought in by paramedics.  I was after all using a tertiary treatment with a disproven molecular mechanism.  But really?  And my living, breathing pulmonary patients did not seem to mind.

The only thing that matters to me is if the medication works in my hands, has few side effects, and I am using it exclusively to save lives and restore functioning.  And without keeping anyone in suspense, I do prescribe SSRIs and they do work, and I do fully acknowledge to anyone willing to listen that the mechanism of action is unknown. Not surprisingly many patients want more than that and I can discuss speculative mechanisms as well as the next psychiatrist.  I don't think that makes me a drug company stooge or an idiot, because I am the only person with any accountability in the entire scheme of things.  It really doesn't matter to me what David Healy or anybody else thinks.  I am seeing very ill people and it is my job to get them better and not cause them side effects with the medication and not have the drug interact with one of their underlying medical conditions.  When you get right down to it, I don't need a mechanism of action to use a medication - only the approval of a regulatory body like the FDA.  At some point somebody may say that  SSRIs are no better for depression than aminophylline was for asthma, but so far (apart from Healy and various sympathizers) that has not happened.  I just attended a CME conference last weekend and they were still recommended.  As far as I know the FDA has not sent out any letter to doctors telling them not to prescribe them any more.

Healy also asks the irrelevant question:  "Do clinical trial data marketed as evidence of effectiveness make it easier to adopt a mythical account of biology ?"  Or I guess the real question is do these data make it easier to accept this strawman?  I strongly encourage any psychiatrist to read and reread the FDA approved package insert on any drug they prescribe and any drug their patient happens to be taking.  I encourage reading and rereading those package inserts especially if they are updated and sent out in a mass mailing by the FDA.  These package inserts need to be studied because they are not the final word in safe prescribing.  If you are an experienced psychiatrist you will routinely be called on to decide if a medication (based on all of the available evidence) is safe to prescribe to a patient with cardiac, liver and renal disease.  You will have minimal data to go by in most cases, because people with significant medical illness are typically eliminated from clinical trials.   Any psychiatrist reading those package inserts will recognize that for some time now, the package inserts have contained clinical trials data and that data is very useful.  It's utility has nothing to do with putative biological mechanisms, it has to do with safely monitoring and prescribing the medication.  The other consideration implicit in this question is that clinical psychiatrists are unaware that clinical trials are really a primitive technology.  Given that awareness exists, why would anyone accept clinical trials data as proof of much of anything.  How in the world does a double-blind placebo controlled study with an intent to treat analysis have anything at all to do with my practice of psychiatry?  It is totally irrelevant clinically and even less relevant theoretically.  Its only use is to get a new drug in my hands that my patients and I will accept as useful or reject as too toxic or worthless.

Why are reasonable people interested in serotonin despite Healy's commentary?

The complexity of serotonin or more appropriately serotonergic signaling for one.  Absolute levels of neurotransmitters are rarely the issue in complex disorders.  In the case of serotonin any bare bones discussion needs to consider the fact that there are 14 serotonin (5-HT) receptor subtypes coded by 18 genes.  Those receptors are organized into 7 families, 6 of which are G-protein receptor linked superfamily.  The remaining family is part of the ligand-gated ion channel superfamily.  The combinatorics of these receptor types, their specific locations, and their genetic variants can lead to a dizzying number of signaling variations that can easily be found in psychiatric research (4).  As an example, this is from a 2013 review of serotonin signaling in depression and suicide by Mann (3):

".......Part of the neurobiology observed in recurrent major depression, that is present between episodes as well as during episodes, is a series of abnormalities in the serotonergic system [19]. Cerebrospinal fluid (CSF) levels of the main serotonin metabolite, 5-hydroxyindoleacetic acid (5-HIAA), are low in more lethal suicide attempters, and predict the risk for future suicide with an odds ratio of 4.6 [20].  Convergent evidence comes from some reports of low CSF 5-HIAA in suicide attempters with other diagnoses such as schizophrenia [21,22], bipolar disorder [23] and personality disorders, although there are fewer studies and less consensus in these other disorders [24,25]. Nevertheless, if correct, such findings suggest that less serotonin transmission, as implied by less 5-HIAA, appears to be associated with suicidal behaviour across psychiatric diagnostic boundaries, as would be expected if it were associated with the diathesis for suicidal behaviour instead a specific psychiatric disorder. A review of post-mortem brain studies of suicides has found much the same thing: most studies find suicides have lower levels of serotonin and/or 5-HIAA in the brainstem serotonin neurons compared with psychiatric-matched groups [26–28]."
   
Apart from all of the disputed technical details, what is the importance of the Healy commentary?  It follows the political tradition of other commentaries mentioned on this blog by prominent psychiatrists.  People have sent me e-mails and asked me: "What do you mean by political?"  In the simplest analysis it is taking one end of a polarized position and running with it and bringing everything that you can to support that position.  That is the classic way that politicians work.  They are fueled by ideology.  On the surface, it seems that science operates like that as well, but ongoing scientific arguments don't include comments about marketing or words like "neurobabble".  They don't make assumptions about how clinicians think or whether they are confusing science and hypothesis testing with clinical work.  The best science encompasses complexity and contradictory data and we are past the point where neuroscience can be watered down for the masses in a 2 minute sound bite.

Neurobabble happens when a neuroscience discussion is reduced to a sound bite and debated the way that Democrats and Republicans discuss just about anything.  That is what happens when we are all polled "Serotonin - yes or no?"

If you really want to get your opinion out in the press that way that is one thing.  Let's not pretend that psychiatrists really think this way or that psychiatrists are just flunkies for Big Pharma talking about some crazy chemical imbalance theory or that we based our clinical practice on heuristics or for that matter marketing.

Psychiatrists are really bright people, time to stop pretending that we are not.


 George Dawson, MD, DFAPA



References:

1: Healy D. Serotonin and depression. BMJ. 2015 Apr 21;350:h1771. doi: 10.1136/bmj.h1771. PubMed PMID: 25900074.

2:  View my collection, "Marku Linnoila" from NCBI

3: Mann JJ. The serotonergic system in mood disorders and suicidal behaviour. Philos Trans R Soc Lond B Biol Sci. 2013 Feb 25;368(1615):20120537. doi: 10.1098/rstb.2012.0537. Print 2013. Review. PubMed PMID: 23440471

4:  KEGG.  The Serotonergic synapse.

5: Albert PR, Benkelfat C. The neurobiology of depression--revisiting the serotonin hypothesis. II. Genetic, epigenetic and clinical studies. Philos Trans R Soc Lond B Biol Sci. 2013 Feb 25;368(1615):20120535. doi: 10.1098/rstb.2012.0535. Print 2013. PubMed PMID: 23440469

6: Albert PR, Benkelfat C, Descarries L. The neurobiology of depression--revisiting the serotonin hypothesis. I. Cellular and molecular mechanisms. Philos Trans R Soc Lond B Biol Sci. 2012 Sep 5;367(1601):2378-81. doi: 10.1098/rstb.2012.0190. PubMed PMID: 22826338

How Does The IOM Ignore The Single Most Important Conflict of Interest?

Another free 28 minutes of work for corporate America on their prior authorization procedure.  I won't type out the dialogue and arbitrary holds along the way.  This time I was referred by the pharmacy to one of the major Pharmacy Benefit Managers (PBMs) and after negotiating their queue and listening to about 15 minutes of pure nonsense (privacy notifications for veterans, Medicare programs, etc) I reached a human being.  At that point he advised me that the PBM was not responsible for this particular prescription and I had to contact their insurance company.  He gave me the number and connected me, but of course it involved a queue that had similar recorded messages and then had a difficult time understanding my voice saying: "I am a provider."  I eventually spoke with a human being who had to look up the circumstances that would allow her to approve the prior authorization.  She had no apparent medical training and the criteria that she was reading out of a book could have been applied as easily on the front end by a pharmacist to save me from 28 minutes of free work for a PBM.  And keep in mind this was one prescription that the patient had already been taking.

There is really no excuse at all for this ongoing charade.  At the same time professional groups like the AMA are not able to take any action that would alleviate this burden.  Managed care companies have institutionalized these rules in most states for decades at this point.  It was shocking when I first discovered that.  Look at the state statues and realize that rules stacked against you and your patients are the law.  The law mandates that you need to do all of this work for free for a managed care company.

Today,  I came up with a new idea.  Attorney Generals in the State of Minnesota have a record of activism against health care companies and unfair practices.  I decided to send a letter of my most recent experience with a PBM to the Attorney General's Office along with a copy of a letter I wrote as an opinion piece the Minnesota Medicine a few months ago.  That letter details how these practices disproportionately affect psychiatrists and patients with mental illnesses.  The proposed solution to the problem is a very simple one.  Instead of expecting physicians or their surrogates to endure a 28 minute telephone gauntlet in order to speak to a non professional who is unsteadily reading approval instructions out of manual - give that manual directly to the retail pharmacist.  The 28 minute call would evaporate into a 2 minute call or less.  Better yet, take the physician out of the loop entirely.  There is no way that a physician should collude with a business decision to make money for a managed care company.   If the company refuses the physician order, it should clearly be documented and the next choice should be made (if possible) and designated as not the optimal choice by the physician.

That brings me to the all important issue of conflict of interest.  You can read blogs all over the internet that discuss the issue of pharmaceutical company influence ad nauseum.  The Pharmascolds remain preoccupied with this issue and are apparently unable to see that businesses run according to business ethics (whatever that might be),  clinical trials of practically all drugs are imperfect and no matter how many repeat studies the Cochrane Collaboration wants that basic fact will not change,  and that the FDA is a flawed politically biased agency rather than the guarantor of drug safety.  These are some of the common fallacies that I see played out each day across a number of settings.  At any rate,  just based on the frequency of enraged posts any casual reader would think that this is a daily crisis.  The only significant variant is that physicians and psychiatrists in particular are blamed for the ethical shortcomings of both American businesses and government.

But when you get right down to it - what is conflict of interest?  It is probably useful to use existing definitions rather than my direct observations for the purpose of this post.  There is no more respected body than the Institute of Medicine.  They routinely publish books on health care policy that are widely quoted and their definitions carry some weight.  I don't like their entire conflict of interest policy because they equate the appearance of conflict of interest with conflict of interest.  Congress would probably also have an issue with that definition.  Their basic introductory definition from the reference at the bottom of this page is included in the table below:

  
To keep it simple let's consider the primary interest in this case to be the welfare of patients.  The secondary interests in this case are defined as:  ".... financial gain but also the desire for professional advancement, recognition for personal achievement and favors to friends and family or to students and colleagues.." (p. 47).  They qualify this by saying that financial gain is not necessarily bad and that policies reasonably focus on financial gains but:  "When a secondary interest has inappropriate weight in a decision and distorts the pursuit of a primary interest, it is exerting undue influence."  They go on to define the conflict as any set of circumstances that arises that does not necessarily compromise the primary interest of patient welfare but that merely creates a risk for doing so.

How does this apply to prior authorization?  Prior authorization certainly sets up a secondary interest.  In this case the interest is the financial well being of the managed care company or PBM and in the case of publicly held companies - their shareholders.  From the perspective of the physician the secondary interest is maintaining employment which is the worst case scenario of "professional advancement."  Most employers and insurance companies stipulate that in order to stay employed you have to actively participate in all managed care prior authorizations and utilization review.  I am sure that astute politicians will claim that these surrogates are necessary to control runaway health care costs.  That does not explain how one could come up with a new sets of businesses worth tens of billions of dollars that make their money strictly from rationing pharmaceuticals.  These are companies that arise out of thin air based on the questionable theories of politicians and business people.  It does not explain why they are currently in the business of rationing very inexpensive generic drugs.  It certainly does not explain how there is a direct correlation between managed care rationing and an over 300% increase in health care administrators in the industry.  And most importantly it does not explain the complete failure of the managed care industry to contain health care costs.  In short, anyone espousing the need for expensive administrator heavy systems to control runaway prescribing does not have a leg to stand on.  The secondary interest in this case is clear.  Prior authorization is there to make money for companies and make a lot of it and physicians are forced to participate.    

The second issue here is an interesting and important one.  Physicians don't have to be convinced by flashy ads, salespeople, free samples, or financial inducements.  They are simply coerced.  When their patients are standing in a Walgreens or CVS, they don't have the luxury of saying no or even putting it off until the next day.  A patient who they have seen and assessed needs a medication and something has to be done.  They have to jump through a managed care hoop in order to get the medication that they have already prescribed - paid for.  The only question is: "How high is that hoop?"    

When people talk to me about all of the pharmaceutical company influence and evil marketing practices I don't even blink an eye.  I would like to know how the systematic coercion of the professional judgment of physicians by for profit companies on a national scale is not a far bigger problem than trinkets and pizza from the pharmaceutical industry?  There is no bigger risk of compromising the primary interest of patient welfare.  Patient welfare is always secondary to financial interest of the company involved.  The only case where it is not is if the company agrees with the prescriber, but even then they have created strong disincentives (the gauntlet-like telephone queue) to the accomplishment of the primary goal of prescribing what the physician considers the best possible medication.

I would like to know how the Institute of Medicine can ignore this?           


George Dawson, MD, DFAPA

References:

IOM (Institute of Medicine). Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press; 2009.

Supplementary 1:  I consider the quotes from the IOM reference to be fair use under the US Copyright Law.

Serotonin Syndrome at The Tipping Point

I spend a lot of my time trying to prevent Serotonin Syndrome (SSyn) and in recognizing it early enough prevent major complications.  I think that I have a fairly good record of doing this, but the statement is qualified by the fact that the likely incidence of SSyn is very low.  What is even more amazing is that if you look at the graphic, a large number of very common medications are implicated in serotonin (5-HT) turnover, signaling, and metabolism.  It is very common for me to see combinations of an SSRI or SNRI antidepressant and trazodone.  Some patients are also taking serotonergic migraine medications like sumatriptan, rizatriptan, zolmitriptan, frovatriptan, naratriptan, and almotriptan.  These migraine drugs are all 5-HT1 receptor agonists with varying affinities for subtypes of this receptor.  They are commonly encountered in clinical psychiatry in patients with chronic depression, chronic headaches and poorly controlled migraines.  In some cases these patients are also on valproate for migraine prophylaxis.  Any computerized drug interaction search will frequently flag 3 or 4 medication combinations that increase the risk for SSyn.  Reading the literature and practicing psychiatry results in a broad appreciation of SSyn including the broad range of precipitants and presentations.  The syndrome can be triggered by as little as a single dose of an SSRI type antidepressant.  On the other hand millions if not tens of millions of people tolerate combinations of serotonergic medications as suggested in the above diagram and in fact some of these combinations are recommended by experts for treating depression.

The presentation of SSyn will vary on who you ask.  If you are asking acute care internists or hospitalists, they are likely to say that it is an acute mental status change - usually delirium accompanying a toxic reaction to a drug.  If you ask movement disorder experts (1, 2), they may describe it as confusion, myoclonus, rigidity, and restlessness and list it in the differential diagnosis of those movement disorders and ataxia.  Psychiatrists should have the lowest threshold since we are prescribing more serotonergic medications, using augmentation strategies, and generally follow patients more closely.  I have seen it develop very gradually with onset of muscle pain secondary to hypertonia.  At that point the patient describes clear cut muscle pain and may have difficulty walking or with balance.  In consult settings, I have seen people with acute delirium completely unresponsive with ataxic breathing to the point I had to suggest an ICU setting and mechanical ventilation.

Harvey Sternbach is credited with coming up with the first diagnostic criteria for SSyn (3).  At the time his article was published in 1991, there were many descriptions of syndromes that were thought to be due to serotonergic hyperstimulation, both in humans and animals.  He analyzed 12 case reports covering 38 patients.  In the majority of these patients, the manifestations lasted for a period of 6 hours to 4 days.  There was one fatality in this case series,  where the patient developed seizures, hypotension, and disseminated intravascular coagulation.  Sternbach also discusses a second death from the literature where the patient presented with probably SSyn that was mistaken for Neuroleptic Malignant Syndrome (NMS).  As the patient was treated for NMS she developed disseminated intravascular coagulation, renal failure, hepatic failure and died.  In both of those cases, the patients were taking monoamine oxidase inhibitors with tryptophan and fluoxetine or lithium.  This was about the time that tryptophan was removed as a supplement from the American market and the author comments that this might reduce future risk.  Sternbach laid out his Suggested Diagnostic Criteria for Serotonin Syndrome based on that analysis:  

"A. Coincident with the addition of or increase in a known serotonergic agent to an established medication regimen, at least three of the following clinical features are present: 1) mental status changes (confusion, hypomania) 2) agitation 3) myoclonus 4) hyperreflexia 5) diaphoresis 6) shivering 7) tremor 8) diarrhea 9) incoordination 10) fever 
B. Other etiologies (e.g., infectious, metabolic, substance abuse or withdrawal) have been ruled out. C. A neuroleptic had not been started or increased in dosage prior to the onset of the signs and symptoms listed" (from reference 3, p. 713)

SSyn appears to be a major omission in DSM-5 (6).  The manual contains a cursory description of NMS in the section Medication-Induced Movement Disorders and Other Adverse Effects of Medication (pp. 709-714) but the only reference is in the differential diagnosis of NMS:

"Neuroleptic malignant syndrome also must be distinguished from similar syndromes resulting from the use of other substances or medications, such as serotonin syndrome; parkinsonian hyperthermia syndrome following abrupt discontinuation of dopamine agonists; alcohol or sedative withdrawal; malignant hyperthermia occurring during anesthesia; hyperthermia associated with abuse of stimulants and hallucinogens; and atropine poisoning from anticholinergics." (p. 711).

A syndrome this important needs at least equal time in the DSM-5.  In average clinical practice serotonergic medications and the flagged side effects in electronic databases probably far exceeds the concerns about medications for Parkinson's Disease and antipsychotic medications causing NMS.  The role of antidepressants in movement disorders especially myoclonus and akathisia should not be underestimated.

The most recent approach to diagnosis of SSyn has been the application of the Hunter Criteria (4).  In their original paper the authors point out that the diagnosis was typically made on the basis of recognizing 3/10 of Sternbach's criteria, but those features had low specificity and were present in other toxidromes.  The Hunter Criteria were developed by a toxicology service observing people with overdoses of serotonergic agents and were therefore more specific.  A single feature like spontaneous clonus or combinations of features like tremor and hyperreflexia or inducible clonus and diaphoresis leads to a diagnosis of serotonin toxicity (see the paper for all of the variations).

As a practicing and teaching clinical psychiatrist who has worked across a number of settings, it is critical that all psychiatrists known about SSyn and familiarize themselves with the diagnosis and acute treatment.  I have listed some of my preferred strategies in the table below on prevention and early recognition.  It is safe to say that the earlier the recognition, the better the outcome.  That is another reason why I don't suggest to anyone that they need to "get used to" a medication or even take an antidepressant if they tell me that they can't tolerate one.  It is also why the toxicity of the medications needs to be carefully explained to anyone taking them, and as a physician I have to believe that either that person or their representative will call me if there are problems.  There also needs to be a high level of vigilance for new agents that can potentially precipitate SSyn.  I recently investigated Suboxone and found a case report that when it was added to tricyclic antidepressants it precipitated the syndrome (5).
 

George Dawson, MD, DFAPA



1:  Stanley Fahn,  Joseph Jancovic.  Principles and Practice of Movement Disorders.  Churchill Livingstone Elsevier.  Philadelphia, PA, 2007.

2:  Mark Forrest Gordon,  Adena Leder.  Serotonin Syndrome.  in Movement Disorder Emergencies; Steven J Frucht, Stanley Fahn (eds).  Humana Press, Inc; Totawa, New Jersey 2005: pp 175-193.

3:  Sternbach H. The serotonin syndrome. Am J Psychiatry. 1991 Jun;148(6):705-13. Review. PubMed PMID: 2035713.

4:  Isbister GK, Buckley NA, Whyte IM. Serotonin toxicity: a practical approach to diagnosis and treatment. Med J Aust. 2007 Sep 17;187(6):361-5. Review. PubMed PMID: 17874986.

5:  Isenberg D, Wong SC, Curtis JA. Serotonin syndrome triggered by a single dose of suboxone. Am J Emerg Med. 2008 Sep;26(7):840.e3-5. doi: 10.1016/j.ajem.2008.01.039. PubMed PMID: 18774063.

6:  American Psychiatric Association.  DSM-5  Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.  Arlington, VA, American Psychiatric Association, 2013.


Supplementary 1:

For an additional graphic of Serotonin Syndrome with a glossary of the abbreviations take a look at this link.

Interviewing 101

Interviewing seminars are a big part of the first year of psychiatric training.  I am not sure how it goes these days, but I can recall having to record interviews and being critiqued by the instructor and all of my peers in seminars.  I can remember not always agreeing with the critiques.  Every psychiatrist goes on to develop their own interview style around the basics.  Just about every interview is unique because it also depends on the person you are talking with.  The flow of information in the interview has always been fascinating to me.  At times you can cover all of the essential elements in 30 minutes.  At other time you can talk for 90 minutes and end up with 25% of the information.  Facilitating and directing that flow of information is one of the key elements of interviewing.  Against that backdrop I found this commentary on an interview of Robert Downey, Jr. somewhat interesting.  It seems surprisingly linear.  It reminded me of some of my media interview experiences where the predominate advice seemed to be: "No dead air.  Either I am talking over you or you are talking over me.  Got it?".  This clip has been widely broadcast for the past several days.  In it, the interview takes a bad turn and Downey politely gets up and walks out.  The discussion near the end of this brief clip suggests that there were probably just a few minutes left.







In the critique of this interview, Kathleen Kelley Reardon focuses on what is described as the human chemistry between the participants and how that potentially involves features like attractiveness, mood, timing and other features.  Reardon speculates that Downey may not have been up for the interview and the transition to personal questions may have been premature. She sees it as an excellent case study in what can go wrong with interviews.  I think that there are some good examples of what might go wrong but there are also some unknowns.  From my vantage point as a psychiatrist I have a few other observations and I have never had to worry about the tone of the interview, but then again I am never working on an interview as an infomercial.

1.  The introduction is very important, but we may have missed it.  Even though this is supposed to be the entire interview, it begins with Downey speaking.  This is an old Oral Boards style point - if you don't introduce yourself and set the context of the interview - come back and try it again next year because you have just failed the exam this year.  The interviewer could have saved himself a lot of problems by discussing the interview context ahead of time and setting ground rules for what the actor is or is not willing to discuss.  You don't have time to discover that in an 8 minute interview.

2.  Too many people in the room is never a good thing.  Because I am teacher, I still have people observing my interviews for teaching purposes and I never like it.  I have to be completely focused on the other person and how they are affecting me.  I did not see Downey as distracted or disinterested; I saw him look to his advisor several times until it got to the point he was overtly looking for advice.  I saw him make a clear announcement at one point: "Are we promoting a movie?" where he was clearly dissatisfied in the direction things were headed and that comment was directed to other people in the room.  The best way to maintain focus is to make sure that there are only two people in the room.

3.  What is the purpose of the interview?  There has to be a focus on that point and the interviewer needs to be aware of it.  In a psychiatric or medical interview the overriding agenda is that there is a mutual focus on a problem that needs to be solved for the patient.  Everything is as confidential as possible.  I heard a prominent psychiatrist and researcher say at a psychotherapy conference that some of the primary goals are: "Be nice to the patient and say something useful to them."  In a celebrity interview there are really dual agendas - publicity for both the interviewee and the interviewer.  Being a celebrity interviewer can lead to celebrity status on its own.  The interviewer is probably aware of how they want to come across to the viewers.  Where do they want to be along the famously provocative to famously uncontroversial spectrum?  Do they aspire to be a celebrity interviewer?  How focused are they on entertainment versus journalism?  I personally cannot think of a greater intrusion into the interview process.

4.  Contrary to the author's point, I don't think that the reporter (Krishnan Guru-Murthy) had a problem with transitioning or failing to read the cues of Downey. He seemed anxious to me. Downey came across as authoritative when talking about American cultural influences but then somewhat oppositional and defensive when talking about a past opinion that he gave during an embarrassing period in his life. He was aggressive when commenting on the interviewer's motor behavior and suggesting that he was running out of time to ask (what was probably going to be) a controversial question.  This would have been an entirely different interview if the focus had been maintained on superhero culture and the actors theories of where the film fits into that genre. He had a pretty good interpretation of some of the Stan Lee origins in Vietnam era America.  Just the time line of those developments and the further implications for the film would have filled the time.

5.  Sometimes the person being interviewed drops a gift at your feet and you have to go with it. As an example, if I am interviewing a person who has been incarcerated I rarely go directly after that information.  I can probably get the historical details elsewhere and it is a threat to the interview process.  I don't want the interviewee to develop the "cop transference" and start to experience it as a police interrogation.  And I usually have an hour compared to this less than 10 minutes session.  The  interviewer needs to be aware of the fact that he is not doing psychoanalysis and that all of those Barbara Walters interviews where there was a key emotional disclosure occurred after hours of interviewing and heavy editing.  In this case Downey talks about how he portrays the character and how his interpretation of the character had changed over time.  That leaves him talking to a small part of the audience for this interview - the people interested in art and acting but that would have ended a lot better.

6.  As I watched the interview, I had the question about whether there were any journalistic biases operating.  It becomes clear that Guru-Murthy wants Downey to answer questions that have nothing to do with the movie and were from a very difficult time in the actor's career.  It is clear that the reporter's anxiety level is building as he tries to force those questions.  And, it is clear that he is trying to force them into the smallest possible window in this interview - the final minutes.  It was anxiety provoking for me to watch that section of the interview.

7.  There is often a lot of focus on the process aspects of the interview.  It seems that the emphasis on the communication aspects of the interview are very linear - pick up this cue and make this intervention.  Interviews (at least the way I see them) are non-linear,  There are a lot of parallel processes going on and interviewers tend to elicit much different information based on their biases and techniques.   There may be times where I slow the interview way down to get at specifics and at other times I am looking for global markers and whether they are present or not.  

8.  Based on my past experience,  I also had to wonder if the gotcha dynamic was operative.  I have been called in for media interviews where the reporter has some preconceived notion of how the world works.  A good example is the fallacy that the Christmas Holiday season is the peak time of the year for suicides.  After I had spent some time explaining to the reporter over the phone that this is really not true, during the interview I was pummeled with comments and anecdotes about how people naturally get depressed and kill themselves more often during Christmas.  This has happened to me more than once and it is a good reason to avoid reporters.

The way this interview ended seemed quite civil to me.  It is not surprising to me that the media is making a big deal of it in spite of the fact that really catastrophic interview endings tend to occur with people who are accusatory, demanding, threatening and/or aggressive.  In an interview with an actor that is not likely to happen.

Despite all of our focus on interviewing in psychiatry, we seem to be loathe to look into the science of it all.  For the past 30 years we have been operating under the illusion that in order to make a DSM diagnosis, all it takes is getting the answers to the right questions.  Those questions were typically structured interviews using DSM or the precursor RDC criteria.  It gave way to the Diagnostic Interview Schedule (DIS) for early epidemiological work followed by the Schedule for Affective Disorders and Schizophrenia (SADS).  This work seems to have led to brief diagnostic checklists based on  the DSM criteria.   I read an article in the Journal of Clinical Psychiatry once that suggested if all of the clinicians in a clinic used the SADS as their diagnostic interview they would have better outcomes.  The idea that a structured interview or checklist elicits better or more useful information than an experienced psychiatrist interviewing the patient is another great fallacy in the field.  I would actually put that at the top of the list and rate it higher than needing a head to head comparison of antipsychotics based on time to discontinuation or whatever the Cochrane Collaboration has to say about "limitations of methodology / need more study" for practically any drug trial.  The evidence that I am right is replicated tens of thousands of times every day by psychiatrists out there doing the same work.  If you interview the same patient twice it is very unlikely that they will give  you the same history.  I have a standard flashcard that lists about 100 medications of all classes and they will not consistently endorse the same medications on this list.  We interview people about their subjective experience and that experience is always plastic.  That is much more interesting than storing the encyclopedia on computer chips.

In some cases we might put a metric like test-retest reliability on an interview metric or the global result of a structured interview.  Given that we are measuring something that reflects the functioning of a highly plastic organ, I don't know why we would expect reliability to be high.

That brings me back to this interview.  Our interview technology is a holdover from the 1950s.  We have evolved subtle modifications over the years but currently we are constrained to a small fraction of the conscious state and we do not know how to optimize the flow of relevant information.  This is a major limitation.  There have been some theorists who have looked at mapping diagrams of the interview process but none have gained any widespread acceptance.

The only good news for psychiatrists now is that we are not operating at the level of reporters.


George Dawson, MD, DFAPA

Cycling Tips From A Psychiatrist

I have been a serious cyclist for longer than I have been a psychiatrist.  At midnight on Labor Day in 1972, two friends and I took off on a trip that we hoped to accomplish the same day.  I was riding a CCM 10-speed bike built around Reynolds chromoly tubing.  We were traveling to a town 164 miles away.  My first friend dropped out at 57 miles.  The second made it all the way but for the last third of the trip he was falling asleep on his bike.  That trip and several others taught me valuable lessons about cycling.  The picture at the top of this post is me stepping off the bike after my initial test cruise yesterday.  When I was slightly younger, I would have been out biking as soon as the snow melted.  Less than 5 years ago I was out biking down the Gateway Trail on a mountain bike and I hit a patch of ice and went down hard.

As I was dusting myself off, I recalled a story from a gastroenterology colleague of mine who is about 10 years older than me.  He would always ride in the Minnesota Ironman,  a spring ride that is designed to be a century (100 mile) ride but also can be broken up to shorter rides.  It is scheduled this year for April 26th, with options to ride 14, 27, 29, 60, and 100 miles.  The problem in Minnesota at this time of the year is the weather.  My GI colleague told me he was sitting there waiting for the ride to start.  It started to rain and sleet.  By starting time, he was soaked, cold and his shoes were full of ice cold water.  He got off the bike, walked over to the van that would be at the finish line with T-shirts, picked up his T-shirt, and went home.  I guess the lesson there is that at some point, you realize that you can enjoy cycling and not be miserable doing it.  It is a lot easier to ignore misery when you are younger.

When you are younger, your physiology is also a lot better.  I was doing pretty well until about 7 years ago when I had an episode of atrial fibrillation.  By pretty well, I mean essentially unlimited exercise potential.  I could go as hard as I wanted for as long as I wanted up until that point and even after that point for a while.  But eventually I realized that even exercise induced tachycardia predisposes a person to atrial fibrillation.  I had to tone my very high heart rates down into a more conservative range in order to prevent episodes of atrial fibrillation and the conditions that predispose to atrial fibrillation.  Now when I am out in the country, I am always watching a heart rate monitor instead of my speed.  That is somewhat depressing and it has an impact on self image when you have to go from unlimited exercise capacity to somewhere on the deterioration spectrum.  My goals have varied over the past 30 years from biking 200-250 miles per week to doing more speedwork for racing.  My fastest race time occurred when I would do 2 - 50 mile rides on the weekend and 4-18 miles rides during the week.  For half of the 18 milers I would try to ride as fast as I could.  These days my goals are a lot more conservative and these are my modest goals for 2015.

That may be a little optimistic but for comparison I watched Fabian Cancellara lead the peleton at what appeared to be a leisurely pace into a small French town a few years ago.  They were doing 30 mph on the flat and his heart rate was 130 bpm.

I thought that I would share a few observations here about some other things I have learned over the years about cycling that might be useful.

1.  Use good gear and keep it in good working order:

The kind of bike you ride is highly subjective.  When I first started cycling, high end bikes could only be assembled from components.  I used to ride Vitus frames that were aluminum tubes that were glued together.  The mechanical components were made by Campagnolo, Shimano, and SunTour in various prices ranges.  My all time favorite components were SunTour Superbe Pro.  They seemed so light and effortless.  I just liked the way the gears changed.  It seemed like there was just a lot less rolling resistance.  But SunTour just went out of business one day.  I currently ride a Trek bike with a carbon fiber frame after riding aluminum frames for over 20 years.  Bikes today are so much better in just about every way than they used to.  If you bike a lot, it pays to ride the best bike that you can afford and go to a shop where people can explain it to you and fit you to the bike.  Don't ride a bike that gives you consistent pain in any part of your body.  You should always feel stretched out and ready to go.  Don't hesitate to buy a bike that you think looks cool.  Don't hesitate to buy as many bikes as you want.  These are both strong motivators for riding.

2.  Be safe and stay alive: 

Biking is in many ways like getting into an open Land Rover and driving out into the Serengeti among the predators and large animals.  Anything can happen and you have minimal protection.  Just pulling out of my driveway I always double check the air pressure (it should always be at the max) and I make sure my front wheel is not ready to fall off by pounding on it with my fist.  I am riding high pressure tires with tire liners to prevent a blowout.  I don't have time to fix flats out on the road.

And then I become hypervigilant......

I was screaming down a hill in Duluth one day and all it took was a split second for a large black Labrador to run out of a bush and right under my front tire.  Hitting that dog was like hitting a tree stump at that speed and I went right over the handle bars and onto the shoulder.  I personally know too many cyclists who were killed or became quadriplegic in accidents like this.  It is the main reason I continue to do a lot of upper body strength training to provide some elasticity in the event of a crash.

In another close call,  I was heading south on Cty Hwy 15 from Square Lake Trail just north fo Stillwater, Minnesota.  Washington County has the highest per capita income of any county in Minnesota and that is reflected in the state of their roads and what happens to the roads at the county line (they get worse).  It is the ultimate biking territory because most of the roads have 5 - 10 feet of pavement  to the right side of the white line.  That is a lot of biking space compared to most county highways.  Coming north in the other lane was a truck pulling a boat on a trailer.  I heard some scraping and saw some sparks.  Suddenly the boat and trailer reared up, disengaged from the back of the truck and was headed right at me.  It cut in front of me by about 5 feet.  I think I was saved by the ultra-wide shoulders in Washington County.

I always stay to the right hand side of the while line by as wide a margin as I can.  All it takes is this little experiment to prove to yourself that this is the best place to ride.  Count the number of cars out a hundred that you see crossing that line in proximity to you when you are riding.  The number I get is about 6% and that is when they see that you happen to be riding next to them.  Hopefully the new car designs with lane deviation alerts will train people to stay in the driving lane.  But it is going to be a long time before everybody has them and let's face it some of those drivers may be intoxicated even in the light of day.

3.  Stay as competitive as you want to be:

I was never a big time racer.  I rode only in an annual unsanctioned 40 mile event.  It was kind of a free-for-all and it was pretty dangerous.  It was a pack style race but in the end, some of the riders were using aero handlebars (ouch) and there was always a massive crash at about the ten mile mark.  Some of the riders were Cat 2 and rode in it for practice.

 I can recall reading Greg Lemond's book about the attitude to have as you get older - basically that you have more responsibilities and more time commitments away from cycling.  That is also true.  Ever since I left Madison, Wisconsin in 1986 - I have been a solo biker.  The only exception was a play date that my wife arranged.   He was a tri-athlete and the husband of one of her health club friends.  The plan was to do a 60 miler from Mahtomedi to the Chemolite plant in Hastings back up to Square Lake Park via Stillwater and back to Mahtomedi.  This guy took off like he was time trialling and I did not catch him until the 20 mile mark.  By then he had hit a wall and his speed started to fall of precipitously.  The last third of the way he was down into the 10 mph range and eventually fell off his bike and fractured his wrist.  The last few miles into Stillwater I was riding next to him trying convince him to stop so that I could call his wife and get him picked up.

That incident captures some of the problems of biking with other people.  What are the mutual expectations?  If it is some kind of competition is it at least a benign competition?  The skill level has to be in the same ballpark as well as the overall expectations of the ride.

What about people that you encounter along the way?  During my time of unlimited exercise, my rule was not to be passed (within reason).  I  would also try to catch anyone on the horizon, but to do it in the most unassuming manner possible.  As aging has taken its toll I have to pick my battles.  Two years ago I was out biking towards an average sized hill when I noticed a pack of about 8 guys quite a bit younger than me closing fast.  I naturally assumed that their social brain worked like mine and they were trying to trounce the old man going up the hill.  By this time I was trying to stick to my heart rate rule of not exceeding 130 bpm and I looked down and I was already at 120 bpm.  I increased my speed to match their figuring that some of them were maxed out trying to close the distance.  At the bottom of the hill I shifted to a bigger gear and hit it as hard as I could.  The group caught me halfway up the hill and then seriously faded.  I was the first guy up and over the top.  I won't tell you what my heart rate was at the time.  I was somewhat elated, especially when the last rider in that group looked over at me and said sarcastically: "Nice work Lance".

Some people view competitiveness as either a character flaw or the most desired personality characteristic.  I see it as neither.  To me it is the embodiment of training and study in the field as well as the third dimension of how long you can put off the ultimate deterioration of your body.  When I win these little competitions that I devise for myself, it is not about the anonymous opponents who I will never know.  It is a battle against my own death anxiety and mortality and a good way to stay physically fit in the process.

4.  Drivers are either not paying attention or they are trying to kill you:  

If you bike long enough or even pay attention to the newspapers, cyclists are always getting killed.  Seven hundred and thirty two cyclists are killed every year and 49,000 injured, but it is possible that the police only record about 10% of the injuries.  In my town it is about 1-2 people per year.  That suggests to me that the fatality estimate is also too low.  I personally know both experienced and inexperienced cyclists who were killed and seriously injured.  In one of the most noted cases a driver mowed down three cyclists while trying to adjust her CD player.  The only defense against the inattentive and/or drunk driver is to be as far to the right of the lane marker as possible and try to avoid sharing the actual traffic lane whenever possible.  There are some additional helpful approaches.

Avoid riding in traffic until you know what you are doing.  The basic skill requirement is to be able to bike in a straight line and not veer all over the road.  That seems easy but it is not.  Any type of distraction including talking with your fellow riders and looking over your left shoulder can cause you to drift into the traffic lane.  Don't ride in traffic if you are drifting all over the road for any reason.  Don't ride in traffic until you can glance over your left shoulder and not drift into the traffic lane.  If you know you can't do that - stop the bike completely, put your feet on the ground and look behind you.

Bike with people you know and trust.  If you are biking distances at speed you have to know that the person in front of you is not going to pull up all of a sudden without warning and cause a crash or lead you to veer into the traffic lane.  Ride single file most of the time,  except where you have enough shoulder surface to comfortably ride side by side.  You should have enough confidence in your fellow riders that you know they will not make any contact with you.

In some cases, the nature of the ride is just plain dangerous.  I can recall riding out of Aspen to Independence Pass.  The shoulder on that road gets down to 6 inches wide as it winds up to the pass.  The day that I did it, there was constant Airstream trailer traffic.  The vehicles pulling those trailers were all outfitted with very long side view mirrors to see around the trailers and they were dangerously close.  To make matters worse,  I was aware of a cyclist who was hit from behind by one of these mirrors.  That image of a mirror imprint on my back made the ride up a lot less enjoyable than it should have been.  Sometimes your cycling goals take you into dangerous territory in spite of everything you know about safety.

Aggressive drivers are an entirely different problem.  They come in several classes that I would described as the appropriately angry driver,  the enraged driver and the personality disordered driver.  There is a significant overlap between the personality disordered driver and the enraged driver and that depends on the assumption that a person can have defects in emotional reasoning in the absence of major character pathology.  As far as I know that study has not been done.  Prevention is always the best initial approach and by that I mean not doing anything to piss drivers off.  It does not take much.  After all they are in a two ton vehicle obligated to adhere to the rules of the road or risk legal penalties and suddenly the cyclist in the oncoming lane buzzes right through a stop sign.  That action is enough to cause the mild-mannered banker who you personally know to start pounding his steering wheel with both hands while screaming epithets out the window (Don't ask me how I know that).  Simply put you will anger fewer drivers by adhering to the same rules that they have to.  That will not prevent all angry encounters because there remains some ignorance about traffic laws.  For several weeks I encountered an angry young woman cycling toward me in the wrong direction on my side of the road.  She was riding against the traffic.  She was aggressively swearing at me and telling me I was going the wrong way until I politely told her to read the drivers manual.

But obeying all of the traffic laws will not keep you out of the cross hairs of our various personality disordered citizens.  I was biking up Myrtle Street in Stillwater, MN one day.  It is quite a haul and most road bikes don't come with small enough chainrings to make it up that hill very comfortably.  I was 2/3 of the way up when suddenly a young man in a large 4WD pick up truck (not that there is anything wrong with that) pulled up next to me and started to harass me all of the way to the top.  His basic heckle with the expletives removed was: "Yeah you're not so tough now are you?"  Wait a minute, I am the 55 year old guy riding up this hill on a bike and you are the thirty something guy sitting in a 400 horsepower truck going up the same hill and I'm not so tough?  Harassment like that can be disorienting, I flipped into my mindfulness mode and thought about all of the times I have biked this hill - while keeping an eye on how close the truck was to me.

In a previous incident, I was at the bottom of this hill when an elderly driver decided to turn right into me as we came up to the third or fourth cross street.  Luckily she was going at a low rate of speed and I was at the right place where I could slam my hand down on the roof of her car and spin myself and the bike out of the way.  She was oblivious to the whole situation and kept driving.

One of the worst things that you can do with the enraged or personality disordered driver is to escalate the encounter.  It took me a while to figure this out.  The best example I can think of involves being harassed by a motorcycle club on day toward the end of my ride.  I doubt that they were 1%ers, but they were all young very muscly guys wearing sleeveless motorcycle jackets and seeming quite intoxicated.  As I rode by one of them had climbed the cyclone fence that surrounded this establishment and started to shout "Wheelie! Wheelie! Wheelie!......" as I pulled up to a stop sign.  Several of his peers caught wind of this and started to do the same thing.  It was a scene out of a biker film from the 1970s.  Clearly they were expecting a response from me.  In the old days, I might have said something and it would have been off to the races.  Today the exchange went something like this:

Me:  "I can't do a wheelie."
Intoxicated Biker: "Why not?" (angry tone)
Me:  "Because I am too old!"
Intoxicated Bikers: Explode into laughter.  As I ride away they are reassuring me that I am not too old to do wheelies.

So the bottom line is that some of these ugly confrontations can be defused with humor.

5.  Fantasize your brains out:

Psychiatrists don't talk about fantasies any more.  I think that an active fantasy life can be very adaptive.  I have fantasies that I can pull up in any terrain.  In the hills or mountains I can imagine myself riding between the Schleck brothers in the Alps.  On level ground or into the wind, I can see Miguel Indurain time trialling in front of me and I am just trying to maintain the correct spacing between us until I can pull out and pass him.  The weeks of the Tour de France are generally the times of peak fantasy for me.  There is always the case of a solo rider who breaks away from the best cyclists in the world and stays away.  I can't think of anything as exciting in all of sports.  I am waiting to watch that clip and incorporate it into my fantasy world.  I can hear Phil Liggett calling out my name.....

6.  The cognitive versus the emotional aspects of life:

I have decades worth of meticulously detailed training information - all handwritten.  Distances and times, routes, intervals, heart rates, etc.   In the 21st century, none of that stuff is necessary.  You can automatically record all of that data and download it to your computer after the ride.  You can study whatever parameters that you want.  But don't get too lost in the details.  I live for the time during the year when I am cruising along in a fairly steep gear and can put my foot down and go.  Bam!  I am sure that any coronal section of my brain on fMRI at that point would show my nucleus accumbens lighting up, but the subjective experience is most pleasurable.  It can occur only with the right distribution of power and weight and I notice that it is advanced on in the season.  If it ever disappears, I know that I will miss it.    

7.  Wear the most radical clothing you feel comfortable with:

Most non-cyclists don't understand the utilitarian nature of cycling clothing.  I was speedskating one night and came off the ice with some biking gear on.  One of the hockey dads decided to give me a rough time and commented how I must think that I was pretty cool because I had special speedskating clothing on.  Keeping in mind that he had several kids with about a thousand dollars worth of hockey gear on,  I said:  "Well no, this is my cycling clothing."  On top of thermal underwear of course.

I have been in pursuit of the perfect biking shorts and saddle for the past 30 years.  When I find a pair that seems to meet the criteria, it doesn't take long for the manufacturer to change the design or the chamois.  It is a basic fact that you cannot expect to bike every day if your perineum is trashed or you develop saddle sores.  The best way to do that is to think that you are going to ride more than 10 miles in a pair of cotton Bermuda shorts over boxers.  I am currently trying out some very high tech shorts.  They were so high tech that I had to send an e-mail to the company.  I was concerned about what kind of chamois lubricant to use, because of all of the high tech materials used in the short.  Their reply was totally unexpected.  Don't use anything.  Wear these trunks dry.  So for the first time in 30 years I don't have some kind of lubricant between my ischial tuberosities and my bike saddle.

Live and learn.

8.  Inclement weather:

I don't bike in the rain or snow anymore.  I will also not be biking up to Independence Pass again unless they ban Airstream trailers.  I have an ergometer in my basement and I try to match the outdoor conditions.  I know that at many levels that is an illusion.  I do however always bike in extremely hot weather and in the wind.  It takes a certain mindset to overcome those conditions.  You have to be able to feel that you are going with the wind and benefitting from the temperature at some level.

This is a long post and that's all I can think of for now.  So the next time you see some old dude out on the road biking - he may be a narcissist wrapped in Lycra, but it is more likely he has a lot on his mind and he is trying to live the best way that he can.


George Dawson, MD, DFAPA




Supplementary 1:     

Disclaimer:  I am not a cycling coach or expert.  The point of this post was to look at some of the unspoken psychological aspects of biking from the standpoint of individual consciousness.  Don't take any of this as advice on how to cycle or live your life.  Follow the advice of your personal physician on all matters related to exercise especially if you have decided to start a new program or alter your intensity.


Supplementary 2:

I am a guy so this is written from a male perspective.  I know that women are as dedicated and serious about biking as I am, but I can't speak to their conscious state.  If you are a female cyclist feel free to comment about your conscious state in the comment section below.  Or better yet, send me an essay and I will post it as an invited commentary by a distinguished guest.  I am very interested in your motivations, cycling fantasies, and daydreams about cycling and any insights that you have developed as a result.  Not everyone can keep riding and I am very interested in the ways that people do.

The Ethical Climate

I thought that I would comment on the recent Legislative Auditor's Report (LAR) entitled "A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case Special Review".   This review focused primarily on ethical and conflict-of-interest requirements in laws, policies, and guidelines rather than the clinical care given.

I felt compelled to comment on this report for several reasons.  First and foremost I am a Minnesota psychiatrist and I practice psychiatry.  That gives me first hand knowledge and experience in several nuances of the report that will be obvious in my commentary.  Second, I have an interest in quality psychiatric care and research.  Third, I have no conflicts of interest to report in this matter.  I have an appointment in the University of Minnesota Department of Psychiatry largely through my teaching of medical students and residents at a peripheral campus.  My primary affiliation in terms of residency training was the Hennepin-Regions program not affiliated with the University.  The last resident I was involved in supervising was from that program and over one year ago.  Teaching has always been considered to be a requirement of my work without any additional compensation.  Like practically all physicians my actual source of income was productivity-based defined as the number of patients I see.  I have not received a check from the University of Minnesota since I was a resident there in 1984.  I have no conflicts of interest with regard to any industry and encourage anyone to try to find me on the Big Pharma database.

My 23 years of working in an acute care setting in this state uniquely qualifies me to address issues involving civil commitment, stays of commitment, and competency to consent.  There are literally a handful of people with those qualifications in the state and I know most of them. I have also been a Peer Review Organization Reviewer in both Minnesota and Wisconsin and have experience on Human Subjects Committees, Institutional Review Boards, and Pharmacy and Therapeutic Committees for both hospitals and major healthcare organizations.  As far as I know,  I may be the only psychiatrist in the state with that combination of experience.  I list these qualifications for two reasons: they are immediately relevant to this review and they also speak to the comment from the Board of Medical Practice about how they retain their consultants.  I have offered to be their consultant on two occasions and they did not even acknowledge that I had applied.

I also need to preface my remarks to say that I have no knowledge of this case other than what is reported in the documents that I am commenting on.  There is a lack of original documents such as the FDA report that was mentioned in the LAR report.  A search on the FDA web site revealed only a PowerPoint document that ended with a description of different types of competency.  I know none of the people involved and have no working relationships with them.  I have no relatives or business associates with those relationships.

Finally, I want to acknowledge the reason for this report and investigations and that is the death of Dan Markingson.  Of all physicians, psychiatrists have the lowest threshold for the prevention of patient death.  Nobody is supposed to ever die while they are under our care.  We are the only physicians who are supposed to make an assessment of patient risk every time we see that person.  I am reviewing reports and conclusions that are far removed from the original event.  I am acutely aware of the shock to the family that occurs with these events and the effort that it takes to try to prevent them.  I want to be very clear that I am not trying to second guess or offend anybody in this report.  After reviewing hundreds or thousands of hospital records, I am fully aware of the fact that records are an inadequate substitute for the events as they actually occurred and that reviewing events in a retroscope generally changes everything.  I am also acutely aware of the fact that in the case of severe mental illness, you may only get one chance to do things correctly and the right way may be very unclear.


1.  The facts of the case are the facts of the case:

The concerns about "transparency" don't make any sense to me.  I don't think that the material facts of this case have changed since the outset.  Any time a suicide occurs in the state of Minnesota that triggers a coroner's investigation.  That coroner or investigators from the coroner's office get in contact with the doctors involved in treating the patient.  In this case there was also a malpractice case that was settled out of court, but prior to settlement this would have produced an exhaustive amount of information and detail and in a malpractice proceeding, details and opinions are gathered that are most unfavorable to the treating physicians.  The only persistent arguments in this case involves what was disclosed and when and the manner in which it was disclosed.  Many of the disclosures themselves were far from the original events and did not involve the principle parties.  It is clear from the Legislative Auditor's Report (LAR), that for the bulk of their report they read existing reports and made determinations about the adequacy of those reports and whether or not they agreed with the authors of those reports.  In some cases they submitted questions to the treating psychiatrist and interviewed the head of the Institutional Review Board.  The bulk of the report is focused on the University's Board of Regents and responses from the two past Presidents of the University in this matter.  They are basically accused of being : "...defensive, insular, and unwilling to accept criticism about the Markingson case either from within or outside the University."

2.  The Board of Medical Practice:

There should be no doubt at all that the Board of Medical Practice (BMP) is the supreme authority for physician investigation and discipline in the state.  There should be no doubt that it also has the lowest threshold for proceeding with action against any physician in the state.  The notion that in this case they were unduly influenced by a consultant with conflicts of interest is problematic.  The Executive Director of the BMP at the time of this investigation was an attorney and the remaining staff are state employees who have been investigating physicians for decades.

The process of how those investigations typically go is also instructive.  Any person in the state can make a complaint against a physician for any reason.  That triggers a letter from the BMP to that physician demanding that they personally respond and send all of the relevant records in 2 weeks or risk disciplinary action.  Once the physician response and records are obtained the BMP looks at all of the available data and determines whether any action is taken on the complaint.  They do not assess the merit of the complaint or screen complaints. They provide no safeguards for the privacy of the physician being investigated.  As a result there are thousands of complaints that are thoroughly investigated but never acted on.  Complaints are technically dismissed without action but all of the data is collected and kept on file in case there are future complaints.  The physician is notified about whether or not they are in violation of the Medical Practice Act or not.  The BMP is also insulated from political influence.   Board Members are appointed by the Governor but after that are not accountable to any politicians.

Dismissing a BMP investigation because a consultant has a conflict of interest seems to miss the mark to me.  Any physician in the state knows that of all of the possible investigations the BMP is the most rigorous and certainly carries more real weight and consequences for their career than any other professional investigation in the state.  The threshold here should be does the BMP have a conflict of interest?


3.  The Legislative Auditor's Report represents a point of view:

The document strikes me as being less than neutral.  The lack of neutrality starts with the description of a medication as a "powerful drug".  Where does a statement like that come from in a document put together by nonphysicians?  I have prescribed as much risperidone as anyone and don't consider it to be a "powerful drug".  In fact, most descriptions of a psychiatric medication that start like that are written by people who either don't know much about medication or are going to start talking about psychiatric medications or psychiatrists from a particular point of view and generally one that is not favorable.  The news media picked up on a letter from former Governor Arne Carlson and this report and in both cases characterized them as "blasting" various elements of the University.  Gov. Carlson's letter is mentioned in this report.

In the discussions of the issue of competency to consent to research, the opinion of the Ombudsman for Mental Health and Mental Retardation figures prominently as well as the efforts of the Minnesota Legislature to ban committed patients from pharmaceutical research.  They also apparently tried to ban patients under a stay of commitment (similar to this specific case) but did not because:

"......National Alliance on Mental Illness Minnesota objected. According to a press account, the organization contended that “mentally ill patients benefit from experimental drugs or treatments when traditional therapy fails them.”

I think that a lot of people reading the report, might miss that important fact in the fine print.  In other words, the premier advocacy organization for patients and families with severe mental illnesses, did not want patients on stays of commitment to be banned from research.

It seems fairly clear to me that the LAR, doubts anything that Dr. Olsen has to say about the lack of financial incentives for him to enroll patients into the study.  They suggest that there may be more to it, but it should be easy to investigate.  I would think that the salaries of University employees are public record.  There does not seem to be a similar level of skepticism applied to anything that supports their main contentions.    

4.  This is an adversarial proceeding:

That should be evident but the various critics and commentators write like they are unaware of it.  When you take that perspective you grant yourself the tone of an ultimate moral authority.  There is no reason for considering any facts that contradict your facts.  There is no reason for considering any other point of view.  An attorney who was representing the University at the time was quoted and then criticized for omissions.  I thought that was standard and accepted behavior of attorneys.  Moreover in any adversarial process in the US,  I would expect one party to make the other party look as bad as possible and the party on the defensive to try to make themselves look as good as possible.  I would further speculate that at some point before the malpractice lawsuit that lawyers were telling just about everyone involved what to say or more probably not to say anything.  To criticize those comments as being "misleading" or the fact that people on the defensive in a legal case are "unwilling to discuss it" seems more than a little disingenuous to me.  All semblance of honest exchange generally evaporates with civil legal involvement and the decision to decide things on the "facts" of the case - potentially in a courtroom proceeding.  Saying that somehow those attitudes will drastically change after a lawsuit has been settled would also be disingenuous.  I know that are new approaches suggested in how these emotionally charged situations can be handled including acknowledging that mistakes had been made.  I wonder if any of the authors of those articles have ever been in a situation where there has been an unexpected death of their patient, where the expectation is that patient should not die even though they are in a much higher mortality group than their peers, and where at various points in their career they will be in contact with peers who can claim that they have never lost a patient?  Can you make any adequate decision at all in that state of mind?  I would suggest that you cannot and you will not be able to as long as the emotional turmoil continues.


5.  The issue of competency in the State of Minnesota:

One of the main points of contention in the articles in this case is whether Mr. Markingson was competent to consent to participate in a research project and whether that consent and his continuing cooperation was coerced rather than voluntary consent.  Numerous authors in the documents do not seem to recognize who is considered competent to consent in the State of Minnesota.  From the Minnesota Statute 253B.23 Subd 2:


"Subd. 2.Legal results of commitment status. (a) Except as otherwise provided in this chapter and in sections 246.15 and 246.16, no person by reason of commitment or treatment pursuant to this chapter shall be deprived of any legal right, including but not limited to the right to dispose of property, sue and be sued, execute instruments, make purchases, enter into contractual relationships, vote, and hold a driver's license. Commitment or treatment of any patient pursuant to this chapter is not a judicial determination of legal incompetency except to the extent provided in section 253B.03, subdivision 6."

In the interest of space considerations, I would invite any reader to click on the link to 253B.03.Subd 6. to read about the exceptions for medical care.  It should be clear from reading that statute that committed patients are competent consenters and that there is a hierarchy of substituted consent. There also seems to be confusion about the issue of civil commitment and court ordered antipsychotic medication with competency.  This is a common problem in acute care psychiatric settings when a committed patient needs an acute medical treatment.  These patients are considered to be competent to make these decisions.  In the case where their opinion agrees with the medical or surgical consultant there are no problems.  In the case where there is an acute life threatening problem like bleeding and they disagree the issue of competency comes into play.  In the State of Minnesota the hierarchy of substituted consent is problematic in practice.  Absent interested family members it requires an additional and separate hearing from the civil commitment hearings.  It also generally requires that the patient or family retain private legal representation for that purpose.  That creates a hurdle significant enough in most cases to prevent the timely provision of acute medical and surgical care.

I have heard the argument that the University was concerned about being "right" rather than doing the right thing.  That seems rhetorical to me.  As a physician you have no choice but to follow the laws in the state.  The issue was also commented on the LAR report by judges on pages 5, 8 , and 28 (specific judges in the case were not named).  The judges in all cases described Mr. Markingson as competent or stating that there was no evidence that he was not competent.  I really cannot think of more compelling evidence in favor of competency to make decisions than a decision by a judge hearing the actual case.

On the issue of the consent form.  I have not seen the consent form.  I have only seen a form that was a checklist of sorts to determine competency.  The LAR report includes highlights of reports from two different psychologists that may have implications for competency.  Psychiatrists are trained to assess patients for general and specific competence.  General competency has to do with the ability to function and handle one's affairs on a day to day basis.  Gutheil and Appelbaum suggest that this includes a mix of current awareness, an ability to assess the current facts of a situation, an ability to adequately process risk/benefit information, and day-to-day functioning (3).  Specific competence is more focused and the person needs to be able to elaborate their thought process and demonstrate that they are reasoning in a logical manner.  The same authors have an action guide (p. 255) about what needs to be down to complete either type of competency evaluation.  The bottom line is that it takes time and I doubt that any antipsychotic trial would use that standard.  If they did there would be two problems.  The first would be reliability problems between psychiatrists doing those evaluations.  The second would be that there would be a significant number of people screened who would not pass the evaluation.  I was not able to find any literature looking at this issue (that is rigorous competency evaluations in patients with psychosis who were research candidates).   A more objective evaluation of general competency could be done, and the approach to specific competency for consent to research needs a lot more work.  These competency issues are really no different for patient enrolled in research projects outside of the field of psychiatry.  A good general validated approach to the issue of specific competency to consent to pharmaceutical research would benefit that entire field.

That said, as an investigator I cannot recall any consent form that did not clearly say that the research subject could quit at any time and that their decision to quit would not in any way affect current or future medical care that they would receive in the health care system.  That is all part of a standard research consent.  


6.  Pharmaceutical research and "evidence-based" medicine in general:  

The mechanics of the project are familiar to me from my participation on research projects as an investigator.  Practically all studies have research coordinators that do not have any medical credentials.  They are necessary because of the sheer amount of paperwork involved in drug trials. The research coordinators are the representatives of the study to families and on the other end of the spectrum they are responsible for the protocol paperwork that is submitted to the FDA.  There appears to be no uniform qualification for these research coordinators and it does not appear to be career path work.

Research now appears to reflect clinical practice and that is not a good thing,  In some of the research that I participated in in the 1980s, the initial phase of antipsychotic trials were done for a specified period of time in an inpatient unit.  The thinking was that disrupting a patient's maintenance medication could lead to acute exacerbations of psychosis.  It certainly did that in the research that I was involved with.  Even in the case of known medications, dose equivalency is always an issue when changing from one medication to another.

In this case the study involved a trial of medications (quetiapine, risperidone, and olanzapine) that had already been approved by the FDA.  The question of whether that study was even necessary could have been answered by any acute care inpatient psychiatrist.  By the time of the original study I had already treated hundreds of patients with all of the study medications in acute care inpatient settings.  Looking at one of the publications, the authors describe a sample size of 400 patients (4).  Like most acute care psychiatrists I have treated multiples of that number and there were no surprising results from this study.  At some level the idea that all of these double blind studies using human subjects needs to be challenged.  It comes from the highest levels of so-called "evidence-based" medicine.  Reading thorough the Cochrane Collaboration about any antipsychotic drug (or practically any medications for any indication) - you will see the same conclusions - inadequate methodology and further study is necessary.  That is not true and at this point I would see those conclusions as approaching the level of a fallacy.  Do I really need a large multi-center study to tell me that people who do not respond to a medication or don't tolerate it may not want to take it?  That information is not only useless to me, but I have already made the necessary changes a lot faster than any research protocol can change during day to day clinical care.  Today's so-called "evidence based" world doesn't give clinicians on the front lines nearly enough credit.  If I had to wait for the blessing of the Cochrane Collaboration I would be incapable of doing my work.

Given the effort required to design and run these trials and the difficulty in recruiting patients is the research question in this study that important?  I would suggest that it is not as evidenced by the fact that physicians like me in clinical practice already know the answers and we are a lot faster on our feet than "evidence-based medicine".  This is currently problem at the national level and it is not just a local problem in Minnesota.  It also has significant political implications.

I pointed out this issue in an e-mail to one of the top epidemiologists in the world a few months ago - so far no response.


7.  The care of people with severe mental illnesses in general:

The outline that I provided on the elements of good psychiatric care as advice to residents still applies here.  There are some additional considerations that can only be honed by years of experience in these settings.  Foremost among then is recognizing the life threatening nature of severe mental illness.  A lot of people with no direct responsibility and concern for the patient's well being do not have this concern or deal with it in the abstract.  We live in a culture where there is not only a bias against this idea but even the idea that mental illnesses exist.  It should not be surprising that people find it difficult to accept the idea that severe mental illnesses exist,  but also that they represent a high level of risk to the individual.  Even people who should know better have a hard time keeping that latter concept in clear focus.  When I do an assessment, I am looking for anything possible that will allow me to look at future risk and what I can do to minimize it.  But even then, we currently lack a technology that can produce the degree of certainty that most of us would like.  The most important aspect of this kind of care is open communication with the patient and as many friends and family as possible.  It is not a 9 to 4 job.  The lines of communication with the clinician or physicians covering for them need to be open at all times.  Any acute changes need to be carefully assessed.  In this age where people with severe problems are dismissed from emergency departments, there has to be a plan for respite care or emergency hospitalization that will work.   In the ideal settings those places need to be hospitable and supportive.  

The ethical climate:

Blackburn describes some characteristics of ethical climates:

"Human beings are ethical animals.  I do not mean that we naturally behave particularly well nor that we are endlessly telling each other what to do.  But we grade and evaluate, and compare and admire, and claim and justify.  We do not just "prefer" this or that, in isolation.  We prefer that our preferences are shared; we turn them into demands on each other.  Events endlessly adjust our sense of responsibility, our guilt and shame and our sense of worth of our own and that of others.  We hope for lives whose story leaves us looking admirable; we like our weaknesses to be hidden and deniable....." (p. 5)

Ethical climates are interesting.  An ethical climate can lead to the establishment of a totalitarian regime or a rich humanitarian culture.  They basically generate their own reality.  The most read post on this blog was about the issue of conflict of interest and it basically has to do with an attempt to construct or continue a certain ethical climate.  Various ethical environments are applied more selectively to psychiatry than any other medical speciality.   In this investigation I can easily argue selective attention to some of the elements in my above commentary and ignoring other elements creates a particular ethical environment despite the fact that the authors seem to agree with the main points of some of the investigations and reports that they attempt to discredit.

In that process a lot is lost in the translation - not the least of which is that we have a report that seeks to establish the Office of the Ombudsman for Mental Health and Developmental Disabilities as a monitor for drug studies in the Department of Psychiatry when there is no evidence that they are equipped to do the job.  This is apparently being done because of the way the administrations reacted to and disclosed various investigations into the original incident.  Further, the same report has disenfranchised the state's primary agency in charge of investigating and disciplining physicians based on a conflict of interest that was fully disclosed to the BMP before the consultant was hired.

It all comes down to the question: "Is this a fair analysis of the problem or is this a case of an ethical environment being engineered to produce a certain result?"

This is more than a moot question given the concrete recommendations of the report.


George Dawson, MD, DFAPA




1:  Legislative Auditor's Report entitled "A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case Special Review".  March 29, 2015.

2:  Simon Blackburn.  Being Good - A Short Introduction to Ethics.  Oxford University Press, New York, 2001.

3:  Thomas G. Gutheil, Paul S. Appelbaum.  Clinical Handbook of Psychiatry and The Law, 3rd ed.  Lippincott Williams and Wilkins, Philadelphia, 2000.

4:  Perkins DO, Gu H, Weiden PJ, McEvoy JP, Hamer RM, Lieberman JA. Comparison of Atypicals in First Episode study group. Predictors of treatment discontinuation and medication nonadherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: a randomized, double-blind, flexible-dose, multicenter study. J Clin Psychiatry. 2008 Jan;69(1):106-13. PubMed PMID: 18312044.