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.

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