Sunday, April 19, 2015

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.







Sunday, April 12, 2015

Moving Pianos




One of the first legitimate jobs I had was moving furniture with my grandfather.  He had been doing it since the days when it was referred to as a "dray line".  His only truck was a 1933 Diamond T and by the time I was in high school he was on his 6th engine and I think that each engine had gone for 150,000 miles.  I was probably in my senior year in high school when he asked me to show up and help him out on the job.  I usually worked with two other guys - my Uncle Bill and a guy who worked with my grandfather for many years - Elwood.  Bill and Elwood were both in their 50s and usually looked pretty tired.  My grandfather was wiry and in his early 70s but no longer did any heavy lifting.   When he walked he was bent in two different directions.  From behind it looked like his torso was walking next to where his hips and legs were located.  Occasionally we were joined by my Uncle Carl who was in his 20's and very physically fit.  Despite that mix of personnel, we took on jobs that I would never consider at this point in my life, even though at the time it seemed like a job I could get into and make a career of.

My grandfather's dray line was preferred delivery service for a local appliance store.  That means moving stoves, refrigerators, and freezers and making sure that they are delivered and set up in pristine condition.   My grandfather was a perfectionist and always reminded us that he had never paid out an insurance claim for damaged appliances or furniture.  One of my early lessons was just how demanding customers are.  We were delivering a refrigerator freezer that weighed about 300 pounds.  After carrying it up about 20 steps to a long porch and across the threshold and into the kitchen without a glitch, the homeowner told us he wanted it dropped through a 4 x 4 foot hole into the floor and into the basement.  The only way down that hole was a ladder.  It meant that one of us would need to slide the unit through the hole and the two guys in the basement would have to catch it.  Elwood looped a piece of rope around two of the casters and lowered it over a piece of padding.  Bill and I caught it and lowered it to the floor.  Even though the entire process only took about 15 minutes we were covered in sweat and not very happy at the end.  It felt like we were just lucky that nothing bad had happened.  That usually explained all of the swearing along the way.  The volume of the swearing usually indicated which one of us was at the breaking point.

But the real problem for us in those days was pianos.  Everybody thought they wanted their kids to play a piano and it took a few years to discover that was not going to pan out.  At that moment we were called to move the piano to the house of the next child prodigy.  My grandfather saw himself as an expert in moving pianos.  We had specialized equipment for moving pianos like pianos trucks for upright pianos.  The upright piano had to be carefully wrapped to prevent damage to the finish and then we could affix a piano truck to each end, tighten the straps and it was fairly maneuverable until we had to lift it.  In some cases we had to move grand pianos and that would typically involve the local college going up a winding staircase for three or four floors.  During one particularly heavy grand piano lift we recruited about 10 college students to keep a rope taught that was affixed to the piano as we slowly moved it up the stairs.  Their job was to prevent it from falling back on us if we lost control carrying it up.  I came away from those jobs realizing that moving pianos was grueling work.  The first time I heard the term "heavy lifting", I understood it as a metaphor and a physical reality.  But was it more than that?

By my late-twenties,  I already knew that the practice of medicine could be physically exhausting.  I would come home from work as a resident or intern and collapse on the floor.  I had just spent 36 hours in the hospital and for at least the last 12 hours of that time, I was falling asleep while I did documentation.  All of the notes were handwritten in those days.  When I finally snapped out of it,  my handwriting would just slide into an incomprehensible scribble when I fell asleep.  One of the medicine residents I worked with had a novel solution to the problem.  In those days I was writing the equivalent of 10 point font.  He went in the other direction.  He wrote as large as he could possibly write.  I marveled at some of his notes - 4 words per line and 4 lines per page.  Sixteen words per page!  I know that he took a lot of heat from some of the attendings.  But he was doing 15-20 admissions per night in an acute care hospital on an Internal Medicine service.  My first lesson about work in medicine was that sleep deprivation and overwork can be as exhausting as heavy physical labor.   There is no way that my grandfather would have expected  us to work as much as interns and residents in the 1980s.  In fact, if my grandfather would have survived that long I am sure he would have had something to say about the working conditions.  

Part of the rich tradition of medicine from that era was that at some point - you completed residency training and moved on.  You realized that there was a whole world out there that did not depend on interns and residents staying up all night long taking care of acute medical problems under the dim fluorescent lights of the hospital.  Like everyone else I moved on and one day about 15 years later, sitting in one of my morning team meetings on an acute care psychiatric unit - I realized I was still exhausted.  I had listened to my social worker tell me that she had tried to get a patient out to local facilities and had called 25 of them and they all turned her down.  She spent her whole day on that one task and we had another 19 patients.  I listened to the usual battles with people trying to send us patients that we could never discharge.  I listened to the passive aggressive comments of county social workers and screeners who were also no help.  I listened to the complaints of our own administrators, blaming us for not being able to work faster and get people out faster.  That is difficult to do when you get absolutely no cooperation from anyone.  I looked around the room at staff who were angry, frustrated, tearful, and burned out.  We clearly had to deal with a lot of people who were supposed to be helping us provide care but they were hurting us.  It was 9 AM and we had not talked with any of the patients yet - the people we were really there to help.

And then I realized, this is just like moving pianos.  Well - moving pianos in hell maybe.  But I said it out loud to my team.  I explained the premise.  I asked them to envision me with a piano on my back and the forces tipping me one way or the other.  In the moving business we would say: "Tip er to me, tip er to you." to make the necessary rapid adjustments.  

I think a few people got it.  I looked over at my OT and she was smiling.

And for a few minutes - the mood in the room was lighter.



George Dawson, MD, DFAPA






Supplementary 1:

The implicit second lesson is that the constant warfare against managed care companies, administrators of all sorts, probate courts, and county bureaucrats is more fatiguing than moving pianos and it leads to burnout on a grand scale.  It is why when I ran into one of my mentors in an airport a few years ago and told him that I was quitting inpatient work after 23 years he said: "3 months wasn't long enough?".

If I had to rank the fatigue factors listed here over piano moving I would say they are:

constant warfare against the people that are supposed to "help" us > overwork > sleep deprivation

They are obviously not independent of one another and in fact the order above could also be viewed as a casual chain of events.

Supplementary 2:

Even though I was not moving furniture at the time, furniture movers everywhere must have rejoiced when the electronic keyboard started to appear.






  

Friday, April 10, 2015

Epidemiology and Toxicology of Aircraft Assisted Pilot Suicides





I thought I would add a few facts to the speculation about what is really known about the epidemiology and toxicology involved in aircraft assisted suicides. It turns out that there are substantial studies that have been written.  If you are a bottom-line kind of person and want to avoid further reading, I can tell you that the events are rare especially events involving commercial aircraft where the incident is ruled a suicide by aviation authorities.  The events are so rare that prediction is doubtful.  In many cases the descriptions of suicidal statements and behavior occur on the day of the events and there are further extenuating circumstances like the use of alcohol and other intoxicants.  If you are really interested in these events, there are numerous places where you can see the analysis of what happened and what the ruling was by the National Transportation Safety Board (NTSB). 

The media reaction is similar to what is seen following mass shootings in the United States.  After the initial shock, there is typically a period of speculation about the causes of the disaster of the form: “What motivates a person to do something like this?”  There is the invariable dissection of their life in the media.  Were they bullied?  What was their personality like? What was on their computer?  Were there any clues that were missed that suggested that one day they would start shooting people?  Were psychiatrists involved?  How did they get the firearms?  When all of those familiar touchstones are exhausted (and it does not take long), the analysis starts to take on the characteristics of groups with agendas.  Gun advocates will suggest that this person was not a typical gun owner and therefore tighter gun laws are not needed.  Gun control advocates will provide the counter arguments that usually involve how easy it was for this person to get a gun.  There is a political impasse largely due to the power of the gun lobby and some politicians start to talk about “being in the wrong place at the wrong time.”  Mental health advocates, especially anyone who wants to talk about the real problems of mental illness and violence are as disenfranchised as the gun control advocates.  Nothing ever happens.  The screening advocates step up and suggest that many of these incidents could be prevented if we just “screened” enough people.  Anyone familiar with Bayesian statistics knows why that won’t work and may cause more harm than good. 

After that impasse, a second wave of speculation starts driven largely by people who ascribe to the theory that psychiatric medications and psychiatric treatment can cause homicidal behavior.  There are a couple of schools of thought on that one.  The first has to do with medications and the idea that specific medications like SSRIs can lead to homicidal behavior.  The other has to do with the fact that seeing a psychiatrist is associated with homicidal behavior and therefore psychiatric treatment must at some level cause homicidal behavior or at the very least the psychiatrist is responsible for not stopping it.  As I explored in a previous posts – there is not a shred of evidence that any of that is true.  There is however more evidence about pilot safety, pilot use of antidepressants, and incidents ruled pilot suicide than I have seen discussed in the media.  Here are a few bits of solid data to ponder during the expected swell of speculation about causes, who is to blame, and possible solutions.

1.  The denominator is huge:  

When the FAA or NTSB looks at all certified pilots in the US that includes a total of roughly 620,000 people per year including classifications for student, recreational, sport, private and commercial.  Roughly 1/3 of the FAA certified pilots are classified as commercial.  The US government also collects detailed statistics on the total number of passengers flown per year (815.3 million), the total number of flights per year (9.821 million) and a host of associated statistics on the Bureau of Transportation Statistics web site. 

2.  The numerator is very small:  

A quick glance at the table below on either antidepressant use by pilots or the total incidents rules as suicide shows that a small proportion of the total deaths are associated with either suicide or antidepressant use.  The proportions of the total pilots in the data base is much smaller and the rates of both suicide and antidepressant use are much lower than expected on a population wide basis.  Data from the Aviation Safety Network suggests that there were 8 to 10 incidents involving commercial aircraft and pilots since 1976 or about 9 in the last 40 years.

3.  The data on pilot use of antidepressants in fatal crashes: 

 Until about 2006, the FAA prohibited the use of antidepressants by commercial pilots.  They have since modified their stance to allow for specific antidepressants.  The European Aviation Safety Administration has publicly posted information of the safety of pilots and necessary screening for psychiatric disorders as well as prohibitions on certain diagnoses.  There have been studies that look at positive toxicology for antidepressants in the cases of fatally injured pilots.  These studies have looked for the presence of tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) in in fatal crashes.  Tricyclic antidepressants were the predominant antidepressants prescribed before the approval and release of fluoxetine in 1987.  One study by Dulkadir, et al looked at fatal crashes between 1990 and 2012.  In this study the researchers received biological samples from 7,037 fatally injured pilots out of a total of 8,429 fatal accidents.  2,664 were positive for drugs on toxicological analysis.  Of those positive samples TCAs were found in 31 samples, TCAs alone in 9 and TCAs with other drugs in 22.  None of the pilots involved reported TCA use during their aviation medical exam.  The authors point out that at the time covered in this study that TCAs were not approved for pilot use and that selective serotonin reuptake inhibitor antidepressants or SSRIs were approved on a case by case basis.  That is a prevalence of TCA use in this database is less than 0.5% ( 31/7,037 aviators).  That number is much lower than estimates of population wide use of antidepressants.

Where the blood levels were determined they clearly indicate that some overdoses had occurred (see Table II and III).  Blood concentrations greater that 1,000 ng/ml are usually very consistent with overdoses and that is the case with nortriptyline and imipramine/desipramine in these tables.  The authors were able to determine that the TCAs were prescribed for depression in three cases, pain in two cases, and chronic insomnia in one case.  Other antidepressants were listed along with opioids, anticonvulsants, cold medications, antihypertensives, benzodiazepines, muscle relaxants, diabetes medications and ethanol were detected but the epidemiology was not reported.  In both the studies by Akin and Dulkadir “drugs and alcohol and/or a medical condition” was given as “a probable cause or contributing factor in about 1/3 of the accidents where antidepressants were detected.

There was an earlier study of the epidemiology of SSRIs in pilot fatalities from 1990-2001 (Akin, et al) that showed they were involved in 61/4,128 pilot fatalities or a total of 1.48%.

The available data suggests that pilot suicide by aircraft is very rare and much lower than the pilot suicide rate by all methods.  There is also a suggestion that the suicide rate in pilots has actually decreased.  Searching the NTSB database yielded 74 fatal accidents using the search term "suicide" dating back to 1966. 



Explanations given in the article for the fewer pilots taking TCAs was that they are more toxic and less preferred agents.  Certainly in the 1990s SSRIs were heavily promoted along with the medical treatment of depression.

4.  Intoxicants are found in toxicology specimens –

The study by Canfield, et al identified a greater percentage of specimens that were positive for cannabinoids (relative to antidepressants) and additional performance impairing drugs in 38% of the individuals who tested positive to cannabinoids.  They also looked at the mean THC concentration in the blood and concluded that during 1997-2001 it was 2.7 ng/ml and for 2002-2006 it was 7.2 ng/ml.  The rate of increase in THC levels over those years exceeded the increase in cannabis potency as reported by the National Institute of Drug Use (NIDA) over the same years (2.7 fold as opposed to 1.5 fold).  Some authors have concluded that THC levels between 2 and 5 ng/ml represent the lower and upper ranges of significant impairment from cannabis use on performance tests measuring driving skill (see Ramaekers, et al) in recreational cannabis users.

The study by Bills, et al looked at the toxicology in a cohort of 36 pilots who committed suicide by aircraft during a 21 year period from 1983 and 2003.  Each suicide case was matched against 2 randomly selected control accidents.  In this study, the pilot characteristics included positive toxicology for alcohol, prescription drugs, and illegal drugs in 24.3%, 21.6%, and 13.5% of cases respectively.  An exhaustive list of drugs found was not available in the paper.  The authors were also not able to compare the toxicology of the cases to controls because 84% of the controls survived and their toxicology was unknown.  

5.  The baseline rate of pilot suicide is low or is it? -

Bialik looked at the issue of workplace suicide, the data quality estimates for pilots in the US.  One of the key references was a paper by Tiesman, et al that looked at the issue of workers who suicide in the workplace.  It used databases from the CDC (National Occupational Mortality Surveillance (NOMS)) and  Bureau of Labor Statistics (Census of Fatal Occupational Injury (CFOI)).  The NOMS database has no granularity and does given intentional self harm as a search parameter.  Unfortunately only "transportation occupations"  can be searched grouped by age, race, and sex.  I did not find the number of deaths or the PMR (Proportionate Mortality Ratio) to be useful.  The NOMS did have granularity with specific occupations and there was a homicide definition but none for suicide or intentional self harm.  Bialik concludes that pilots in general may have a slightly higher rate of suicide than the population in general but there are problems with that estimate and he was able to consult with an epidemiologist from the CDC.

Another approach to looking at this issue to to find a study with a very well characterized database that looks at the occupational issue.   Roberts, et al meets that criterion in a 2013 study of high-risk occupations for suicide.  The researchers looked at the numbers of suicides and numbers in all occupations in England and Wales for specific time intervals.  They determined the 30 occupations with the highest suicide rates (generally greater than 20/100,000).  In comparing the time intervals (1979–80, 1982–83) to  (2001–2005) they determined shift in the ranking and discussed possible causes of those changes.  Pilots were not listed in the top 30 occupations by suicide rate.  The only transportation workers listed were "rail transport operating staff".  They noted that suicide rates for professional occupations decreased over the time interval studied while there were sharp increases in the suicide rates for manual occupations.  As a comparison the 2013 suicide rate in the US was 12.6 per 100,000.

6.   The accident rate due to suicide attempts in commercial aviation is lower than that found in general aviation - 

These incidents are tracked  by the Aviation Safety Network and their web site currently lists intentional incidents and accidents caused by pilots dating back to 1976 in commercial flights.   There is a separate list of aircraft accidents caused by pilot suicide and that lists 9 suicides in the same time period but proportionally more associated fatalities. 

7.  Pilots can already self report substance use problems - 

There have been some suggestions that screening would be enhanced if pilots could self report problems without the fear of recrimination - the same way that licensed health care professionals are allowed to do in many states.  The focus would be on treatment rather than punishment.  The health care professional experience demonstrates that this leads to significantly more self reports and that is consistent with the goal of public safety.  Since pilot certification occurs at the federal level and health care professional licensing occurs at the state level - there is an opportunity to develop a more standardized approach to the potentially compromised pilot that depends more on self-report than screening.  There is currently an "occupational substance abuse treatment program" called HIMS that states at least part of their goal is to preserve careers.  A broader focus to include voluntary self- report of psychiatric conditions and suicidal thinking would result in more referrals for treatment and potentially impact the suicide rate.

8.  Aviation regulators and the aviation industry collect data that the healthcare industry can only marvel at - 

Reading through the sheer amount of data and how it is acquired it is evident that anyone involved in aviation has a single-minded focus on safety.  The methods of data acquisition through flight recorders and the checks and balances on the ground are far superior to any safety standards in the health care industry in the United States.  As a basic thought experiment, can you imagine recording similar outcome data from patients rapidly discharged from hospitals in the US?  I am talking about real data and not the survey that the nurse hands a patient after they have coached them on what to check off. 

I don't have to imagine what that data would look like.  I know what that data looks like and it is quite ugly.  It is more than a little ironic that health care experts, especially in this case psychiatrists and other behavioral experts are going to rush in and correct what is wrong with the aviation industry.  By comparison, health care measurement and incident analysis is all smoke and mirrors.  They don't know how to collect relevant data and many of the outcome measures are strictly political and meaningless.  If anything we should be bringing in aviation safety experts to run hospitals instead of MBAs.

With what I have read, I doubt that there is any possible improvement beyond voluntary reporting and making sure that there is always a second crew member in the cabin on commercial airliners.  In some of the commercial aircraft crashes the planes were stolen by staff who were not pilots and crashed.  But in the case of air disasters that resulted in multiple passenger deaths a second person in the cabin is a clear safeguard.  I am not an expert on how many people are in air crews, but I know that there is also a flight engineer in the cabin in some cases.  Given that these incidents are rare by any combination of numerators and denominators that are chosen and the fact that screening for rare events is generally not successful, screening for these rare events is not likely to work.  Flight crews currently undergo random urine toxicology to prevent the use of intoxicants that can impair the ability of a pilot.  Anecdotal evidence would suggest that is useful, but in the case of addictions there are often attempts to circumvent this intervention or use a drug that is not detectable.  The experience of health care professional screening programs would suggest that voluntary reporting can both improve public safety and preserve careers.  That seems like a useful approach for pilots.

Most importantly, the aviation industry is a model for safety assurance and the investigation of incidents where there were lapses.  It holds many lessons for the health care industry.        




George Dawson, MD, DFAPA



Akin A, Chaturvedi AK. Selective serotonin reuptake inhibitors in pilot fatalities of civil aviation accidents, 1990-2001. Aviat Space Environ Med 2003; 74(11):1169–76

Canfield DV, Dubowski KM, Whinnery JE, Lewis RJ, Ritter RM, Rogers PB.  Increased cannabinoids concentrations found in specimens from fatal aviation accidents between 1997 and 2006. Forensic Sci Int. 2010 Apr 15;197(1-3):85-8. doi: 10.1016/j.forsciint.2009.12.060. Epub 2010 Jan 13. PubMed PMID: 20074884.

Zeki Dulkadir,  Gülhane, Arvind K. Chaturvedi, Kristi J. Craft, Jeffery S. Hickerson, Kacey D. Cliburn. Antidepressants Found in Pilots Fatally Injured in Civil Aviation Accidents.  Federal Aviation Administration, Office of Aerospace Medicine, Nov 2014.

Lewis RJ, Johnson RD, Whinnery JE, Forster EM. Aircraft-assisted pilot suicides in the United States, 1993-2002. Arch Suicide Res. 2007;11(2):149-61. PubMed PMID: 17453693.


Russell J. Lewis, Estrella M. Forster, James E. Whinnery, Nicholas L.  Webster.  Aircraft-Assisted Pilot Suicides
in the United States, 2003-2012  Civil Aerospace Medical InstituteFederal Aviation Administration. Oklahoma City, OK 73125
February 2014

Ungs TJ. Suicide by use of aircraft in the United States, 1979-1989. Aviat Space Environ Med. 1994 Oct;65(10 Pt 1):953-6. PubMed PMID: 7832739.

Bills CB, Grabowski JG, Li G.  Suicide by aircraft: a comparative analysis.  Aviat Space Environ Med. 2005 Aug;76(8):715-9. PubMed PMID: 16110685.


Ramaekers JG, Moeller MR, van Ruitenbeek P, Theunissen EL, Schneider E, Kauert G. Cognition and motor control as a function of Delta9-THC concentration in serum and oral fluid: limits of impairment.  Drug Alcohol Depend. 2006 Nov 8;85(2):114-22. Epub 2006 May 24. PubMed PMID: 16723194.


Roberts SE, Jaremin B, Lloyd K. High-risk occupations for suicide. Psychol Med. 2013 Jun;43(6):1231-40. doi: 10.1017/S0033291712002024. Epub 2012 Oct 26. PubMed PMID: 23098158; PubMed Central PMCID: PMC3642721.

Total FAA Certified Pilots:  http://www.aopa.org/About-AOPA/General-Aviation-Statistics/FAA-Certificated-Pilots

Aviation x Antidepressant Medline Search April 2015:  http://www.ncbi.nlm.nih.gov/sites/myncbi/1-MAvBcofi/collections/47791909/public/

Carl Bialik. We Don't Know How Often Pilots Commit Suicide.  FiveThirtyEight (a very sophisticated blog)




Wednesday, April 1, 2015

I Don't Need Your Vote






Apple’s CEO Tim Cook came up with quote last week and I thought it was a good one:

“I’m not running for office.  I don’t need your vote.  I have to feel myself doing what’s right. If I’m the arbiter of that instead of letting the guy on TV be that or someone who doesn’t know me at all, then I think that’s a much better way to live.”

The original article began with an introduction about how Steve Jobs took a lot of heat and a lot of praise to protect the executives focused on Apple’s business and products.  Observers also note the activities of so-called “activist investors” trying to influence the management of the company into buying back stock for a quick short-term gain.  Cook is clear that he is all about long-term results and he is accountable for those results.  The same logic applies to what I do and have done for the past 30 years.  On the financial message boards there is constant noise with news and analysis of whether the stock price is going up or down.  After watching those trends it is clear that nobody knows the trends and that far fewer people know anything about the technology.  Many of those posts are placed there to manipulate opinion.  The critics don't know Tim Cook and the critics don't know me and clearly seem to have never met the psychiatrists that I know and work with.  Let’s take a look at how the so-called critics of psychiatry compare with the critics that Cook is addressing.  They can be broken down into several classes:

1.  The professional critic – criticism generally takes the form that I have special knowledge that no other psychiatrist has.  That knowledge can vary from the totally absurd (there is no such thing as mental illness or I am the only person to keep psychiatry honest) to more plausible exaggerations (I am the only person who can do this therapy, detect this side effect, prescribe this medication, etc.).  There is some legitimate criticism but it tends to be very rare.  I think the sheer number of internet articles by the same author saying the same thing may be an indication of volume substituting for quality.  The obvious message in many of these articles is that I am unique and everyone else is either ignorant, crooked, or stupid.   There are varying levels of conflict of interest (books, speaking engagements, the hero worship of various hate groups).  These critics are magnets for the haters of psychiatry who see them as modern day heroes and generally ignore the conflict of interest issues that their heroes use to criticize others.

2.  The journalist looking for an angle – the overall bias of journalism against psychiatry is well documented and wide spread.  Looking to sell papers or in these days mouse clicks is an obvious motivator.  In some cases the journalists just jump to books and web sites as sources of revenues and fame.  Even the most charitable interpretation of their work will note the obvious flaws.  Considering the DSM-5 a treatment manual or overestimating the impact of the DSM-5 when in fact most primary care physicians never use it are good examples.   While telling psychiatrists what their problems are when they have completely ignored the biggest stories in mental health for the past three decades that really have nothing to do with psychiatrists.  Those stories are how managed care companies and state and local governments have decimated the care for people with severe mental illnesses and addictions.  They have only recently picked up on stories related to incarcerating the mentally ill and trying to provide them psychiatric services in jail.  Not a stellar job of mental health reporting over the past 30 years.  As in the first category, some rare legitimate criticism exists.   

3.  The injured patient – certainly the treatment of psychiatric patients has the potential to cause injury like any other medical treatment and injuries do occur.  As I have posted several times on this blog, anyone who takes a medication that is FDA approved is at risk for side effects up to and including death.   As I have pointed out here (where you will not see in many other places) – the FDA decision can be purely political rather than scientific.  As a result, any medical or psychiatric treatment should be entered into very cautiously.   I have also posted here (and you will not see this in many places) that nobody wants to take a non-addictive medication and that people are generally hopeful that it will provide relief from a miserable condition.  I do not believe that people take any medications, especially psychiatric medications lightly.  I have outlined my clinical method to minimize side effects and adverse events.  Even with that high level of caution, side effects and adverse events will occur.  There are no shortage of remedies that can be pursued at multiple levels.  Most people resolve the problem immediately with their physician.   In the case where medical organizations are involved there can be direct complaints to the medical administration, hospital authority, or patient advocates.  At the state and licensing level complaints to the state medical boards and in some cases complaints to a mental health ombudsman can be made.  There are obviously malpractice attorneys.  Injuries caused by medical treatment are legitimate reasons for complaints and criticism but at some point I would hope that it would lead to a solution to a real problem.  I would also hope that nobody is compelled to sacrifice their medical confidentiality for the purpose of a complaint.

4.  The severely personality disordered – there is no good way to say it, but there are people who are very hostile to other people.  In many cases they aggregate around psychiatrists because that is where everyone else tends to send them when they cannot be dealt with.  Like any group of people in contact with psychiatrists, the vast majority of people with personality disorders are able to work on their problems in a productive way and do not turn treatment into a series of personal attacks.  But there are also the small fraction that do.  In many cases they target psychiatrists (and others) and their anonymous criticism is frequently irrational, heated and in some cases threatening.  They can attract like-minded people.

5.  The professional critic who is not a psychiatrist.  I posted my earliest experience of an irrational response by an attending physician when he learned that I was going into psychiatry.  In today’s politically correct landscape it would be classified as harassment and abuse.  Practically all of the psychiatrists I know have similar stories.  In fact, I personally have several more.  The unexamined irrational hatred of psychiatrists is just a fact that any psychiatrist has to deal with.  But when I hear a medical professional come up with some blanket statement about psychiatrists that is what it is all about.  I have examined in a previous post the basis for these generalizations.  Most physicians are at least are circumspect about why they did not go into psychiatry.  Most of them tell me they don’t want to deal with lethal violence or deal with the severely personality disordered.  Unless somebody points out this unexamined irrational thought pattern for what it is – it will never be corrected.  See my previous comment about it.  Or as the kids say these days haters be hatin' and leave it at that.

6.  The people who bristle when psychiatrists speak out against irrational criticism or even offer an alternate explanation are an interesting lot.  Some blogs seems to attract a lot of them, but I don’t frequent the more hateful blogs.  They are a self- righteous lot that looks as far as their own information.  They generally ignore any contradictory information and stick to their story or accusations.  They will attempt to bury any psychiatrist pointing that out with righteous indignation and sophistry usually by invoking victimhood  ("Noooo we are not antipsychiatrists – stop calling us that name!"),  hero worship ("You just aren’t as good as the psychiatrists who we agree with!") or the usual appeals to emotion ("It is so pathetic that these psychiatrists are just so (ignorant, evil, etc) and they just can’t accept our “facts”").  You can apparently say anything and really believe it is true.  Just so nobody forgets – it is true that psychiatrists are bogeymen.

Boo!

I am an experienced psychiatrist with 30 years of experience.   I have specialized in treating the toughest problems and the problem of lethal violence and severe mental disorders, often with significant medical comorbidity.  Like a neurosurgeon said to me at a serious point: “You guys treat the toughest problems that nobody else in medicine wants to treat.”  I have treated many more people than are mentioned in “case reports” and at this point in entire clinical trials.  I have as much experience as anyone in the safe and effective treatment of these disorders.  I encourage people to not tolerate side effects, use psychotherapy, and to be comfortable with the idea that I should be able to answer any questions they might have about my assessment or treatment recommendations.  Like all physicians I have much higher levels of accountability than most other professionals.  Like all physicians there is a rare day where I am not being harassed by someone who thinks they know how to do my job better than I do usually because it suits their business interests.  And I am the one with no conflicts of interest.  This is a non-commercial blog.  I have no books to sell.  I have no financial connections to any industry.   I couldn't care less if anybody ever paid me for my opinion.  So it should not be too surprising when I say:

I don’t need your vote.  I know what I am doing and that has been substantiated time after time – tens of thousands of times.  Further, I know how to read research and interpret the findings as opposed to the general lack of scholarship from those who assume they know more about my job than I do.  There are a handful of psychiatric experts that I consider to be authoritative and none of them are the usual media critics.  In fact, some of the media critics aren’t even psychiatrists and it shows.  But the best part is I am no different from my other colleagues that I consult and collaborate with every day.

They don’t need your vote either.


George Dawson, MD, DFAPA