Does the Insurrection End the Debate on the Goldwater Rule?

 

I think it does and both sides lose.

As a refresher take a look at my earlier comments on the Goldwater Rule at this link.  More briefly, the Goldwater Rule was implemented by the American Psychiatric Association (APA) as ethical guidance to its members following an incident where a 1964 magazine survey of psychiatrists concluded that the Republican candidate Barry Goldwater was “psychologically unfit” to be President of the United States.  As you can see from the ad in this previous post, there was a strong implication by the Lyndon Johnson campaign that a Goldwater presidency would put the country on a path to nuclear war.  Goldwater subsequently sued the magazine and was awarded damages – three years after he lost the election.

In the meantime, the APA included the following section in the Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry.

Section 7.3

On occasion psychiatrists are asked for an opinion about an individual who is in the light of public attention or who has disclosed information about himself/herself through public media. In such circumstances, a psychiatrist may share with the public his or her expertise about psychiatric issues in general. However, it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.

Since I wrote the original post, I have queried many colleagues who are also APA members and as far as I know no member has ever been sanctioned by the APA or any of its district branches for violating the Goldwater Rule.  There has been a lot of intense debate about it and that debate has never been as intense as during the recent Trump administration.  Beyond the debate there are unequivocal examples of psychiatrists ignoring the Goldwater Rule and, in some cases, criticizing the APA about it. The rhetoric extends to the point that the APA invented the rule because it was embarrassed about the original Goldwater incident and it was suppressing the free speech rights of its members who felt an ethical duty to use their skills to either warn or protect the United States from President Trump.  While some have found that rhetoric to be admirable, I do not. First, APA membership is completely voluntary and the obvious way to escape its long reach into First Amendment rights is to not be a member.  The predictable response to that suggestion is that all of the benefits of membership will be not be available and that might put non-members at a disadvantage.  Having been an APA member for over 30 years, I can attest to the fact that there are minimal advantages to being a member primarily as discounts to publications by the organization.  Even then, the American Medical Association (AMA) membership fee is much lower and includes free access to many more publications.

A second consideration is the context of what is happening.  In my previous post, I pointed out that psychiatrists are trained to assess problems in a particular context.  During years of training that comes down to a face-to-face discussion with the patient about problems that were either identified by the patient or someone else.  Collateral information is considered and that can be exhaustive. A diagnosis and problem formulation follows. Until the profiling of political leaders, criminals, and historical figures came into the scene in the past few decades there was no suggestion that psychiatrists could assess people at distance with any degree of accuracy. In fact, criminal profiling is generally done these days by trained law enforcement personnel suggesting that no psychiatric qualifications are necessary at all.  It all seems predicated on a folk psychology model that personality features and patterns of behavior are constant over time and dependent on past behavior. Some of the commentators on this issue have identified themselves as forensic psychiatrists. Forensic psychiatrists are paid to do even more exhaustive interviews and review of collateral information than clinical psychiatrists. They may take 15-20 hours to do an assessment compared with a clinical psychiatrist who probably has 60-90 minutes at the most. The idea that forensic psychiatrists endorse assessments at a distance seems even more incongruous to me.

Focusing only on the conclusory article (1) post insurrection it is clear why psychiatric opinion adds nothing to the political mix.  In the first paragraph, the authors conclude that Trump is “clearly mentally unbalanced and unable to grapple with a reality that threatens his inflated and fragile ego.”  They suggest that only reason that people would not believe their statement is that they ascribe his behavior to “puckish idiosyncrasy or creative disruption”.  That gives their statement way too much explanatory power. How about the obvious political considerations and Trump’s previous behavior as a businessman?  He is clearly a guy who is used to steamrolling over people and often uses the legal system to do it.  He demonstrated that in the primary and the debates.  He demonstrates it on a weekly basis toward anyone who he thinks is being disloyal – irrespective of their track record. He threw his Vice President under the bus for adhering to the Constitution that he was sworn to uphold. Who would describe that behavior as puckish?  Any objective observer would see that President Trump is a negative force and somebody that you do not want to deal with and hopefully would never be employed by. In political terms, he is an autocrat that deals in propaganda and he knows the power of propaganda. By definition, that is dangerous to any democratic republic but once again – it has nothing to do with psychiatry or the special training of psychiatrists.

The preamble in that conclusion: “clearly mentally unbalanced” is also rhetorical.  He has tens of millions of followers who all believe the propaganda. The authors themselves acknowledge that if Trump was a private citizen they would not be concerned and that their concern is only based on the fact that he was the President. This would be the first case of mental illness based on the condition of Presidency. The additional evidence in this article that Trump was “delusional”, “impulsive”, vengeance seeking, or “deranged” is non-existent and it can easily be argued that deficiency occurs as a direct result of not having personally examined him to ask him for direct explanations.   All of the examples cited are consistent with the behavior of a highly self-interested politician or businessman who will do anything to win. In the event that the authors have not noticed there are tens of thousands of these people walking around in American society. Possibly hundreds of thousands and none of them are being treated by psychiatrists.

The authors previous argument that they have an ethical responsibility to warn the public about Trump’s dangerousness based on a presumptive personality disorder falls apart under that scrutiny.  If there is no clear evidence of a diagnosis there seems to be no basis for the authors to base their actions on. Further Trump’s recent statement on the day of the insurrection and even since are no more radical than many of his colleagues or followers. Why are psychiatrists needed when there is nothing to base a professional opinion upon?

Early in the course of the Trump presidency, the issues arising with the Goldwater Rule were analyzed by Kroll and Pouncey (2).  After considering all of the variations their conclusion was that the Goldwater Rule was based on the need of the APA to prevent embarrassment to the profession by making statements similar to the statements made by psychiatrists during the original Goldwater controversy. That assumes that the APA as a guild is successful in preserving and promoting the interests of psychiatrists in the USA.  The track record there is very sketchy.  The APA and medicine in general has been completely unsuccessful in preserving a practice environment conducive to quality care.  At many levels it has facilitated that transition most notably by a near complete lack of opposition to managed care tactics and legislation and more recently collaborative care initiatives.  The APA has not been successful in advocating for patients with the most severe forms of mental illness. There has also not been any success in advocating for reasonable infrastructure to help the severely mentally ill avoid homelessness and incarceration. That string of failures is potentially more embarrassing than whether or not a few psychiatrists look foolish on the evening news.  I think there is an ethical basis for the Goldwater Rule that extends far beyond embarrassing the many by the few.

One of the key dimensions that I have not seen anyone comment one is that most psychiatrists are liberal Democrats. Psychiatry is the only medical specialty where that is true.  That is a clear bias when assessing a President from the opposite political party.

The insurrection itself clearly illustrates that psychiatric intervention in a Constitutional crisis is not possible or advisable.  I am basing that on the fact that for 25 years I participated in thousands of civil commitments, guardianships, and conservatorships.  I know all the legal requirements for these proceedings in both Minnesota and Wisconsin.  There is no court in any county in either state that would accept a legal proceeding against the President based on his current public behavior.  A typical argument against my position would say it is a utilitarian argument and therefore limited on those philosophical grounds. I don’t think it is at all.  If you are arguing that psychiatrists need to be involved, the question needs to be asked: “What for?”  The psychiatrists who have been the most vocal that President Trump is dangerous or irrational and, in some cases, claim that they are being stifled by the APA and the Goldwater Rule need to have an endpoint.  Every day psychiatric practice dictates that if you are seeing a dangerous individual you have to enact a plan to protect the patient and others. I don’t think that level of evidence exists – it certainly does not rise to the level of court intervention. The next step would be approaching members of Congress and asking for Impeachment or invoking the 25^th Amendment. They don’t need psychiatrists for that.  So what mysterious psychiatric intervention do the Goldwater Rule deniers want to see happen?  Should psychiatrists sitting in arm chairs call someone in the White House and tell them to remove the President based on his most recent outrageous statements?  That clearly would not work.  The concern that he has access to the nuclear briefcase also does not work. The evidence at this point is very clear, his cabinet had the opportunity to enact the 25^th Amendment and they declined.  Vice President Pence declined even after he was publicly berated by the President. Limits were set by the Department of Justice, the Joint Chiefs of Staff, social media companies, the National Guard and law enforcement on the ground.  President Trump had an unorthodox exit from the White House but he did leave.  Several days later the public was informed that he left a letter for President Biden.

The Republic survived without psychiatric intervention and none was indicated. The Goldwater Rule did not prevent some psychiatrists from making rhetorical statements from both the right and the left.  Nobody was sanctioned because from a practical standpoint it is ethical guidance – and I think it is good ethical guidance.

Is there a role for psychiatrists in these situations apart from making a speculative guess about the mental status of the Commander-in-Chief?  I think there is and that is in an advisory capacity about some of the group dynamics and containment of violence that occurred. It is absolutely critical to notice when propaganda is being used to incite violence or in this case an insurrection. Propaganda is not a “shared delusion” it is emotionally charged speech that can lead to fixed irrational positions.  It has to be recognized and countered in order to prevent the mass level of dysfunction associated with the denial of systemic racism, pandemic denial, mask denial, climate change denial, and the denial that the Presidential election was free and fair.  All of those levels of denial associated with the Trump administration occur in the context of longstanding denial that there is a serious problem with firearms in this country.  If psychiatrists want to be politically involved – those are the hard problems that need to be addressed.

There is much to be said for psychiatrists’ experience with containing violence and aggression.  When I witnessed what happened on January 6, I had many concerns about Inauguration Day.  My primary concerns were whether there would be adequate force to stop a similar attack and minimize the risk of injury to the police or demonstrators.  As I saw the barriers erected my concern was whether they was a plan in place to keep large groups away from the fences and avoid a violent confrontation.  Was there intelligence about the possibility of foreign actors taking advantage of the situation? And most of all – did the police and National Guard have clear rules of engagement to contain escalating violence and aggression and avoid serious injuries.  It turns out that everything except the rules of engagement were handled well. 

My advice about the Goldwater Rule either way is straightforward.  Forget about debating the President’s mental status in public.  The standard for Presidential capacity is a lay standard and not specified by any statute.  Psychiatric opinion is and will be remain unnecessary.  And if an APA member decides they want to bring an ethics complaint based on a violation of the Goldwater Rule – that is a waste of time as well. Stay focused on your own medical professionalism and remember that being a psychiatrist does not necessarily make you immune to emotional reasoning, political rhetoric, or propaganda. There are probably many more friends, neighbors, and relatives that need to get back on track to carry on the more mundane work of democracy.  

 

George Dawson, MD, DFAPA

 

References:

1:  Leonard L. Glass,  Edwin B. Fisher, Bandy X. Lee.  Trump’s Danger is now Undeniable.  He is clearly mentally unbalanced and unable to grapple with a reality that threatens his inflated and fragile ego.  Boston Globe January 7, 2021.

2:  Kroll J, Pouncey C. The Ethics of APA's Goldwater Rule. J Am Acad Psychiatry Law. 2016 Jun;44(2):226-35. PMID: 27236179.

Graphics Credit:

1:  Donald J Trump official portrait By Shealah Craighead - White House, Public Domain, https://commons.wikimedia.org/w/index.php?curid=63769676  Downloaded from Wikimedia Commons on 1/29/2021

2:  Barry Goldwater 1960 portrait By United States Senate - https://www.senate.gov/artandhistory/history/common/generic/Featured_Bio_GoldwaterBarry.htm  Public Domain, https://commons.wikimedia.org/w/index.php?curid=79152516

Downloaded from Wikimedia Commons on 1/29/2021

 

Disclosure 1:

Jerome Kroll, MD was one of my professors when I was a resident at the University of Minnesota.  He is a brilliant psychiatrist and wrote one of the best books ever The Challenge of the Borderline Patient.  He was also one of many professors who taught me that you can argue with colleagues and nobody has to take it personally - a good lesson in politics as well. 

Disclosure 2:

In my previous post I pointed out that for the past several decades I have been a small "i" independent.  That has changed with recent events.  I would find it very difficult to vote for a Republican based on their collective behavior and inability to respond to President Trump for the good of the American people.  But I still  do not think that psychiatrists have anything to offer in that area.

Supplementary:

I decided to attach the next several paragraphs based on what I have encountered over the Goldwater Rule into arguments I have heard from deniers and supporters of the rule. The last section are my personal observations (from above) - admittedly not independent of the others

Goldwater Rule Deniers:

1: Psychiatric or mental health experience is necessary in the case where a President may be incapacitated and unable to perform their duties.

2: Psychiatrists are ethically bound to publicly speak out if the President is incapacitated and a potential danger to the country.

3: The only reason the Goldwater Rule exists is to prevent embarrassment of the psychiatric profession.

4:  There may be an element of financial conflict of interest if the Goldwater Rule was recently modified over concerns that the APA may receive less money/tax benefit because of criticism of the President.

4: The APA suppresses the free speech rights of psychiatrists who speak out on the basis of their public assessment of the President.

5.  At least some deniers of the Rule believe that there should be a lower standard for capacity or mental illness if it is applied to the President. In other words, psychiatric opinion is conditional on whether or not the person being observed is the elected President at the time.

6.  The personal interview is not reliable and all of the information necessary to make a diagnosis is already out there in the public domain.

7.  The President's personality or alleged mental illness is the primary problem in what appear to be poorly thought out decisions.

 

Goldwater Rule Supporters:

1:  The Rule is the rule and direct examination of the patient is required to get the assessment out of a purely speculative mode where observations potentially have multiple possible meanings.

2:  The politicization of psychiatry is inevitable with experts for either party.

3:  The politicization of psychiatry potentially impacts patients’ willingness to see psychiatrists for help.

4:  Competency versus capacity – competency requires legal definition, capacity may be informal but that is unlikely in a contested procedure.

5:  Scientific accuracy of predictions of dangerous behavior are not good (Estelle v. Barefoot and APA amicus brief)

6:  Psychiatrists are not immune to rhetoric, propaganda or emotionally charged speech. The original treatment of Goldwater is a good example.

7:  If the issue is dangerousness and we are talking about President Trump there were many more dangerous presidents based on total war casualties that occurred during their terms – including Lyndon Johnson who was elected in part on the alleged dangerousness of his opponent Barry Goldwater.

8:  The President's personality or alleged mental illness is difficult to separate from purely political tactics like intentional misinformation or propaganda that are designed to disrupt and manipulate the electorate. 

 

GD:

1:  The Rule is ethical guidance that has never been enforced.

2:   The Rule is obviously ignored – nobody has ever been sanctioned by the APA or a District Branch in the 50 years it has been in effect

3:   The Rule only applies to APA members so people outside of the APA should not be concerned about it.  If you are really concerned about it don’t be an APA member and comment as much as you like.

4:   Presidential capacity is a lay standard that is not specified in any legal statute. In other words, there are no judicial descriptions of a standard for Presidential incapacity, no standard of proof.

5:  There is no mechanism to remove the President from office based on psychiatric opinion.  There are however political and legal mechanisms (25^th Amendment, Impeachment) to remove the President based on the opinion of his cabinet and in the case of repeated impeachments disqualify from further election eligibility.  A non-psychiatric standard is defined in the 25^th Amendment.

6:  In retrospect, some of the original campaign against Goldwater was propaganda (see ad on nuclear war) and that was reflected in some of the psychiatric opinion at the time.

7:  Psychiatrists potentially have a more significant role at the level of the group dynamics of violence, aggression, misinformation, propaganda, and the containment of violence and aggression.

8:  Several polls have characterized psychiatry as the most liberal medical specialty and the only one where a majority of members are Democrats.  That conflict of interest should be disclosed when commenting on opposition party politicians.

 

Admit What You Don't Know - An Unmentioned Organizing Principle

Everybody has ideas about medical ethics.  Often that is their own version.  There are medical ethicists who routinely comment on it in the media. There is endless speculation about what is ethical and what is not.  That speculation frequently focuses on financial compensation and reimbursement for physicians from outside services like pharmaceutical companies. Every physician in the United States is monitored by their state medical practice board who have varying ideas about what is ethical and what is not. Those ideas can even change over time. When I started out, it was common for physicians to prescribe various medications for friends and family members. At some point that was determined to not be a good practice for several reasons and it became a general rule adopted by most medical practice boards.

Ethics debates frequently are political debates and other common areas have to do with abortion, resuscitation, and unnecessary prolongation of life. Many of these debates played out in public arenas and resulted in legislation, court rulings, and practical applications like living wills and advanced directives in the event that the decision-maker is compromised and decision-making is limited.

I am constantly thinking about my training and how it relates to what I do every day. That means that from time to time I revisit what happened to me during that time frame and what it means today. I always seem to come up with something new even though I have thought about it many times before. Just yesterday I was contemplating the scenario where President Trump talked about disinfectants and ultraviolet light being used to kill coronavirus in humans. There are many places where you can view that videotape as well as the responses to it. In a politically charged partisan atmosphere many of those responses are predictable. The President and his allies are certainly in a spin control mode since this happened. They are contemplating having less frequent news conferences which I would agree with. Political opponents have seized the opportunity to characterize this as a lack of leadership and irresponsible statements. One of the physicians working with the president has suggested that he was simply “problem-solving” and “thinking out loud”with physicians in the Department of Human Services.

I think there is a more parsimonious explanation that will take me back to the third year in medical school. It should be fairly apparent to any trained physician that the President does not really know much about medicine. The clearest example would be his quote that we don’t really know much about nature of the coronavirus pathogen, when of course we do. There has never been a better time to study viruses and their molecular biology than right now. The President has made many other errors when talking about the pandemic and the associated medical problems. He approaches it like he does political rhetoric. He makes contradictory statements to gain some time and then sweeps in at the end with the correct position even though it is often in opposition to what he said in the first place. In medical school that would not get you past the third year.

Third-year medical school is an exciting time. Everyone is starting intense clinical rotations. You are scaling up in your ability to see more patients per day. You are getting more efficient in conducting the elements of the patient evaluation, differential diagnosis, and treatment planning. You are learning more about relevant laboratory and imaging testing. But there is also important ethical element that you need to discover right away or you rapidly get into very deep trouble. Simply stated that element is - know what you know and what you don’t know and clearly state whether you know something or not. The corollary is that time is of the essence and there is no time for equivocating. If you are asked directly by an attending physician or a senior member of the team and you draw blank - the correct answer is “I don’t know”. There is no room for guesswork or rhetoric.

During my training I saw some relatively brutal enforcement of that rule. One conversation went like this:

Attending: “Do you know this patient’s calcium level?”

Intern: “I think it was 10.8…”

Attending: “Do you know or not? Are you just guessing?”

Intern: “No I am pretty sure it was 10.8.”

In this brief scenario, the correct answer was “I don’t know”. It turns out the calcium level was not 10.8. That led to a fairly intense private conversation between the attending and the intern about his expectations of patient care and how they were not being met. The intern was subsequently asked to leave the program.

I witnessed several scenarios like this and they are tense situations. The expectation of course is that individual team members will know everything about the patient particularly all the relevant evaluation and testing that occurs in the hospital and that they will be able to synthesize that for the attending during rounds. It is a high-pressure situation because all eyes are on the person being questioned. I can still recall being in ICU with a fairly intense pulmonary medicine staff person who decided he wanted to question my favorite Internal Medicine intern on pulmonary function testing in various lung disorders. For anyone not familiar with this testing there are a set of esoteric terms and concepts that vary across lung diseases and the attending in this case wanted an extemporaneous summation. He provided no structure whatsoever for the intern. The other four members the team took a deep breath and focused on the intern. In his southern drawl he provided a perfect description of pulmonary function testing and how it varied in the pulmonary conditions of interest. It was pretty amazing.

Similar high-pressure situations don’t go that well. I had just started out on a cardiology team in the same hospital and rounded on a patient and went to present to one of the cardiologists. It seemed to be going pretty well until he asked me to show him the chest x-ray. In those days, we had to go to Radiology and collect all of the films we needed, check them out, carry them around all day and then return them. I did not have a chest x-ray and for the next several minutes fielded a few sarcastic comments like “You didn’t think a chest x-ray was important in a cardiology patient?” In similar situations it was always better to say “I don’t know” rather than trying to bluff your way through a barrage of questions from an attending physician. Not having a chest x-ray is relatively easy one.  It is harder if it is a question about specific history or data or information that you are expected to know.

An important part of the lesson is that even though it may be emotionally painful to say “I don’t know.” it must be said if you really don’t know. There is no spin after the fact in medicine. The patient and everyone else on your team depends on you being able to make that statement. When you complete your training - it is equally important to make that statement to your coworkers and the patients you treat.  I have never really heard much comment about it in the media or by the ethicists but for me it is a central organizing value. There is a ripple effect. If you don't want to end up with that statement - you do everything possible to prevent it.  But most importantly you recognize the vast information base of medicine and you recognize the uncertainty of the day to day decisions.

This post is not supposed to be a lesson for politicians. It is not a suggestion that politicians should adopt ethics that are useful to physicians. It is a simple observation that being able to admit that you don’t know something even when it seems like you should is transformative. It is better to be brutally honest with yourself upfront than having to do it later to deal with the complications. All medical decision-making and professionalism hinges on this ethic. 

When it comes to medicine - you can't just make something up or think you know something - when you don't.

George Dawson, MD, DFAPA





Full Disclosure:

I am a small "i" independent.  Yes - I am one of those guys who does not hesitate to "waste" his vote on a non-major party candidate, but at times have voted for those candidates.

The Charlie Gard Case - Why Political Rhetoric Can Never Be Ignored...

  Charlie Gard died three days ago after his life support was withdrawn.  He was a British infant born less than a year ago with infantile onset encephalomyopathic mitochondrial DNA depletion syndrome.  There are three genetic subtypes listed on OMIM and I those linked in the Supplementary material below.  Note that the capital letters in the titles is a convention of OMIM and not my addition.  The medical details as well as the basis for the legal decision is available online.  In this case the court sides with the Great Ormond Street Hospital in deciding to withdraw life support because of Charlie Gard's terminal medical condition.  In the summary an American physician is mentioned who apparently suggested that nucleoside therapy might be tried even though it has never been tested for this condition in humans and it has never been tested in a mouse model of the human disease.  The judge refers to the culture around these issues in the USA as being "slightly different" in that anything might be tried.  This court document was apparently written before Charlie Gard was examined by the American physician Michio Hirano, MD who offered Nucleoside Bypass Therapy an experimental treatment for mitochondrial diseases.  The parents of Charlie Gard ended their legal case to bring him to the United States for experimental treatment on July 24, 2017 - four days before he died.  In the language of contested court cases - their attorney said that new tests confirmed that the experimental treatment would not help.  In fact, there was no real evidence that the experimental treatment would have ever helped.

The conflict between Charlie Gard's parents and the Hospital began after they successfully raised enough money to take him to the USA for treatment in January.  The Hospital's argument at the time was that it was not in the best interests of their patient and subsequently that the treatment being offered was unlikely to be of benefit.  The court documents describe their opinions included the opinion of an expert in mitochondrial diseases who had authored 140 scientific papers and book chapters. He is described as a person with grave neurological disease who is maintained by life support and the in the opinion of the Hospital staff the life support should be removed and he should be allowed to die.

From a political standpoint, the right wing in the United States picked up on the case as a case of a socialist health service against the rights of the parents or as Brook Gladstone (On The Media) said: "a martyr to statist tyranny."  On that same show, Melanie Phillips a conservative blogger and writer for the Times of London described the conservative commentators position in the US as "ignorant and ideological".  She describes their writing about the case as something that could be used in the fight to repeal of Obamacare.  She points out that conservative commentators in the UK are not invested in portraying the National Health Service as a killer.  She points out that right to life activists and that agenda only exist in the US.  It is part of a long succession of political rhetoric that suggests that the risk of a more openly government run system is that it puts the government between the patient and the doctor and the decisions are more likely to be consistent with what the state wants.

I decided to read and footnote one of the articles from the right (5) on this dilemma. In her article on Fox News Health, Penny Young Nance makes the case that the problem is really big government and socialized medicine and that no government can take away God given rights.  The counterpoint to this opening premise is that the political right generally does not view health care as a human right.  They view it a a business and something that must be earned based on merit.  Her second premise is that American healthcare is cutting edge and driven by cure as opposed to National Institute for Health and Care Excellence in the UK that is driven by profit.  Both elements of that second premise are erroneous.  I don't think that there is any evidence that the UK uses less technology and irrespective of how they use it their outcomes are better at a fraction of the cost than the most expensive medical system in the world in the USA.  I also don't know how socialized medicine is making profits (and for who) by denying unnecessary care.  The third premise is that technological advances like the eradication of smallpox requires a free market approach to innovation so that mistakes can be made.  In actual fact, smallpox eradication was a long effort of physicians, academics, public health departments, some private industry, and the World Health Organization.  That is hardly a free market effort. It could easily be argued that it would not be profitable enough for American companies to enter.  She goes on to critique the Independent Payment Advisory Board (IPAB) under ObamaCare as being similar to NICE as a health care rationing body.  NICE is not a rationing body and this opinion leads me to question if she ever viewed their extensive web site of some of the best medical evidence collected in the world.  She conflates IPABs ability to control prices as "shoving us in the direction of single payer health insurance." Every more successful and far less expensive health care system in the world has cost control mechanisms.  Her summary statement connects the Charlie Gard case and IPAB:

"We should heed Charlie’s case as an example of gross government overreach and repeal IPAB immediately."

Only the political right wing in America can draw such a connection.

The rhetoric of the political right, is basically rhetoric that is thinly disguised as concern about individual rights.  It requires a complete suspension of the current reality in health care. Those realities include the following.

1.  Medicine is best practiced by physicians especially the ones taking care of you: 

In Charlie Gard's case he was assessed and treated by experts from multiple specialities in the UK.  No reasonable American physician would doubt that he received expert care and care that is probably available in a small minority of medical centers in the United States.

2.  Medical ethics can easily be politicized but their foundation is more sound than politics: 

There are two relevant concepts here - futile care and experimental treatment.  In this case the best summary appears to be that there was really no evidence that the experimental care would do anything to alter the course of Charlie Gard's terminal neurological illness.

3.  Political opinions on ethics don't have to be consistent:

There are striking inconsistencies in the positions offered by the political right.  At the level of personal choice they make it seem like there is a panel that will be taking healthcare choices away from Americans.  In fact, the panel will be addressing prices and cost containment.  The political right also seems to have completely ignored how health care is rationed by health care companies and subject to racial and socioeconomic disparities. We are currently in the midst of a very inadequate system of mental health and addiction care based on 30 years of rationing by private American companies.  If you are elderly and have a significant illness in an American hospital managed by an American company, you or your family is likely to be approached about the idea of palliative care or hospice care.  It might be recommended that you forgo certain diagnostic tests or procedures because of your illness and transfer to a hospice setting. Nobody discusses the fact that these recommendations are aligned with the financial interest of the hospital.  If you stay there too long or use too many resources - they lose money.  This is the current system of care in the United States. As most people know - you don't have to worry about the government.

You do have to worry about the the corporations making profits by charging you plenty of premiums and copays and deciding how they will not have to pay that out in services.  That is the rationing that occurs millions of times a day in the US.  

4.  How is a market system that appoints private businesses as proxies for rationing services and  that ignores the health of tens of millions of people ethical?

As noted above - as millions of people are uncovered, tens of thousands die and more suffer.  If your ethical priority is choice - these people do not have a choice.  If your ethical priority is the sacred nature of life - these people have immediately been devalued.  Unless I missed it - these seem to be the main ethical arguments of the political right.

On the whole idea of the government getting between you and your doctor - there are currently two people standing between you and your doctor in the United States.  The first is your health care company.  The second is the company that manages your pharmacy benefits.  If either of these companies does not want to act on your preferences or your doctors orders - they can make life miserable for both of you.  The level of misery can extend from a flat denial of service or medication to saying that you don't meet their medical necessity criteria for a service.

The only logical conclusion here is that American healthcare is highly flawed from an ethical perspective and right wing opinion clearly wants their constituents to believe that it is something that it is not.  We are certainly technically competent to provide care.

The political right has elaborate rhetoric to cover the flawed ethics and the balance tipped in favor of corporations rather than people.  That keeps Americans from getting to the same level of performance as the other, less expensive systems in the world.  That includes the National Health Service in the UK as evidenced by the life expectancy graph at the top of this post.


George Dawson, MD, DFAPA




References:

1:  Melanie Phillips.  Why America Got the Charlie Gard Tragedy So Wrong, July 29, 2017.  http://www.melaniephillips.com

2:  On The Media. July 27, 2017. WNYC studios - The Charlie Gard story is near the end of this podcast.  

3:  Lori Robertson.  Dying from a lack of insurance. The Wire. September 24, 2009.

4:  Truog RD. The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard. JAMA. 2017 Jul 20. doi: 10.1001/jama.2017.10410. PMID: 28727879

5:   Penny Young Nance.  Charlie Gard: Why his struggle may soon be ours.  Fox News Health. July 10, 2017

Supplementary:

MITOCHONDRIAL DNA DEPLETION SYNDROME 9 (ENCEPHALOMYOPATHIC TYPE WITH METHYLMALONIC ACIDURIA); MTDPS9

MITOCHONDRIAL DNA DEPLETION SYNDROME 5 (ENCEPHALOMYOPATHIC WITH OR WITHOUT METHYLMALONIC ACIDURIA); MTDPS5

MITOCHONDRIAL DNA DEPLETION SYNDROME 13 (ENCEPHALOMYOPATHIC TYPE); MTDPS13

RIBONUCLEOTIDE REDUCTASE, M2 B; RRM2B

A Circular Ethics Argument About Psychiatric Services

I attended the Minnesota Psychiatric Society MPS spring meeting yesterday.  The current American Psychiatric Association (APA) President  Anita Everett, MD was there and gave a presentation on ethics.  The title of her presentation was Ethical Issue Management in Team Care.  The conference was focused on collaborative care and innovative ways to extend psychiatric practice out into areas where there is little to no coverage.  The afternoon was dedicated to an APA sanctioned presentation called Applying the Integrated Care Approach: Practical Skills for the Consulting Psychiatrist.

The central theme in Dr. Everett's presentation involved streamlining the 9 dimensions of the AMA code of ethics annotated for psychiatry to 4 dimensions from Principle of Biomedical Ethics.  Those dimensions include beneficence, non-maleficence ("do no harm"), autonomy and justice.  There was not a good 1:1 translation largely because in her formulation autonomy seemed to apply to patients but there was a question mark regarding physician autonomy.  Some of the AMA/APA dimensions applied to two of the 4.  For example, commitment to medical education was seen as applying to both beneficence and non-maleficence.

Dr. Everett is a community psychiatrist and has studied various community mental health centers.  She makes the distinction between simple and complex systems and how applying ethical principles to complex system. She gave some examples of how this might apply like integrated care in a medical shared ACO and meeting a patient in a coffee shop as part of an ACT team intervention.  She  poses the the ethical analysis as a series of questions pertaining to the 4 dimensions.

The open discussion was instructive.  There was a psychiatric administrator present who talked about the ethical issue of emergency department congestion.  In his hospital there are 80 ED beds.  There has a chronic problem with psychiatric patients stranded in the ED sometimes for days.  The problem is basically a systems problem because most Minnesota acute care hospitals do not have psychiatric units, and very few (2 or 3) in the Metro area are equipped to treat patients with aggressive behavior.  As a result practically all of the police and paramedic related acute admissions in a 5-county area are brought to this hospital.  At the same time acute care beds in Minnesota are rationed to the point that there are fewer beds available than in practically all OECD countries including Mexico.  One of the other attendees at the conference also made a statement consistent with what I have put on this blog many times: the state of Minnesota has systematically dismantled the state hospital system and came up with an inadequate secondary system that they no longer use.  That participant was an expert in the state hospital system.  In the meantime, individual counties have essentially eliminated supervised housing for people with severe mental illnesses.  I really don't know what people expect when all of the resources to treat severe mental illnesses are rationed away and emergencies continue to happen.  What occurs is a large steady state population of mentally ill people who are rooted partially on the street or in very suboptimal housing, inpatient units, the ED, or (worse case scenario) jail.  In what was probably the most illogical approach to a solution, the ED reported the Psychiatry Department to the ethics committee for not solving the problem of ED congestion with psychiatric patients!

The ethical conflict in this situation was discussed from the perspective of turf (ED physicians versus psychiatrists) and patient autonomy.  Physician autonomy was touched on only so far as the question of whether physicians need to sacrifice autonomy for the greater good. Does the sacrifice of autonomy lead to resources to treat more people in the long run?  That argument was advanced by a managed care physician-administrator.

Any reader of this blog knows that I view ethics as basically political arguments.  Most ethics seem relative to the political arguments that carry the day.  For example if you think doctors aren't paying enough attention to costs and you are a health care administrator - make cost effective care the new definition of professionalism.  In this case, it comes down to blaming psychiatrists for severely rationed services.  The technical argument basically transfers blame directly away from the rationers to psychiatrists who are left with a huge problem.  That ethical argument carries the compounding problem negatively impacting all of the ethical elements as outlined by Dr. Everett and leaving the psychiatrists in a totally untenable situation.  It also illustrates how a dissection of a complex system - in this case the entire universe of mental health care in Minnesota - results in a ethical argument that only applies to one environment - in this case the emergency department.  Even there it should be painfully obvious that these problems selectively apply to psychiatric patients.  There is no backlog of patients with chest pain waiting for 2 or 3 days in the ED or being transferred to a remote hospital 200 miles away.  All of the illogical approaches to psychiatric care that apply in the ED can be traced back to decisions by politicians - not the least of which is to hire managed care proxies to ration access to care.  It is obvious that sacrifices in physician autonomy to managed care administrators has only made the problem far worse and not better.

In the state of Minnesota. there is no justice for psychiatric patients.


George Dawson, MD, DFAPA


References:

Anita Everett, MD, DFAPA.  Ethics in complex systems of care.  Minnesota Psychiatric Society Spring Scientific Meeting.  June 16. 2017.      





               

Ethics, Law, and Politics In Psychiatry

I just spent yesterday at the 2016 Minnesota Psychiatric Society Ethical Issues In Mental Health for 2016.  It was a long day, especially for a guy who wants lectures and information.  About 1 1/2 hours was dedicated to a group discussion of cases.  I am always more interested in what the experts have to say - that is my comfort zone at CME courses and meetings.  The first lecturer was Rebecca Weintraub Brendel, MD, JD from the Harvard Medical School Center for Bioethics.  She was also the Chairperson for the Ad Hoc Work Group for the American Psychiatric Association on Revising the Ethics Annotations.  That resulted in the document APA Commentary on Ethics In Practice from December 2015.  A complete listing of the members of that working group is available in the document.  She started out by talking about the Trolley problem and reviewing the various approaches to this issue.  The ethical theories that applied were briefly reviewed including deontology, consequentialism (utilitarianism), virtue ethics, and principalism.  She said that the field has evolved to the point where principalism is the dominant paradigm.  Principalism includes the broad areas of autonomy, beneficence, non-maleficence, and justice.  At this time any search on bookselling websites will pull up a number of references on principalism, including critiques of the concept.  I will probably pick up a copy of one of these books to see just how heavily  the justice component in medicine includes social justice and concepts like global warming.  I have always been amazed at why physicians would expend valuable energy on these issues when they have been unable to protect the integrity of their profession.

A lot of time was spent discussing professional boundaries with some focus on electronic media and communicating with patients.  The afternoon cases discussion focused on two psychiatrists with multiple ethical problems some of which included clear ethical issues involving both social media and electronic communication.  In Minnesota, the consensus is that e-mail communication with patients using typical insecure e-mail is not a good idea, but many psychiatrists are employed by organizations that use secure e-mail through a health system portal.  One of the hypothetical case examples given was membership on Facebook of group therapy members and all of the problems that involves.  One of the key aspects of treating patients like psychiatrists involves not just interpersonal boundaries but also boundaries around the therapy like contact and phone calls outside of the sessions.  Online contact with either frequent e-mail or social media creates the illusion that the psychiatrist is always online and available.  That every comment will be noted, analyzed and responded to.  This is not only unrealistic availability, but also unrealistic analysis.  Psychiatrists more than any other physician should know that typed statements online are very poor substitutes for analyzing the emotional content of communication especially where aggression, suicide, and other critical aspects of judgment are the focus.

The second lecture was given by Colleen M. Coyle, JD General Counsel for the APA and it was titled When Law And Ethics Collide....   Privacy rules, informed consent and substituted consent were the early issues.  A suggested authorization form that covers all of the contingencies was suggested.  I can recall signing several including the standard recredentialing forms that authorizes multiple unknown parties complete access to any and all information about me.  The coercive nature of these forms was not discussed.  I see even the most standard consent to treatment form as fairly coercive these days, especially the sections that cover requirements for disclosure by state laws.  A comparison of attorney-client privilege vs. physician-patient privilege would have been instructive.  I think it would point out the obvious - once again that physicians have done a poor job of protecting their profession and that lawyers have succeeded in making legal decisions (Tarasoff) part of the psychiatric code of ethics.  Some of the vague situations of disclosure under the more liberal HIPAA versus the more restrictive CFR42 were discussed.

The discussion ended on prescription drug monitoring programs, the ethics and the current legal landscape.  The legal landscape was most interesting in terms of who inputs the data and whether mandatory accessing of the database exists.  Thirty one states require that prescribers access the database and 11 of those also require a query.  Nineteen states do not require mandatory access.  There are criminal and civil penalties for not reporting controlled substance prescriptions in the database.  Twenty six states and D.C. provide some immunity from civil liability for not accessing and using the database.  Minnesota has a very reasonable approach.  Pharmacy data populates the database and accessing the database is not mandatory.  As a physician I can't imagine having to treat patients, do all of the necessary documentation and orders/prescriptions and then access a separate database and re-enter the prescriptions.  If that is happening to any extent in other states that is another serious abuse of physician time.  It is also part of the general trend of dictating how physicians practice medicine.  Learning what rules apply to you in your particular state is critical irrespective of how rational the process may or may not be.

Ruth Martinez, MA Executive Director of the Minnesota Board of Medical Practice was the third presenter.  Her emphasis was on documentation, boundary issues, informed consent, and response or lack of response to the treatment plan.  An important concept that I have always used is documentation of the informed consent process.  A written and signed document is not needed (with the exception of ECT and antipsychotic medications in the state of Minnesota), but documentation of the discussion is useful.  In situations where the discussion covers a lot of contingencies, it is useful to come back to that part of the document in terms of treatment planning and what the next step might be.  The only potential problem is that when everyone has access to your thinking, suddenly everyone is an expert as in: "I noticed in your note that if this antidepressant was not effective your plan was to change to antidepressant B.  I discussed this with the patient and he wants to try B now."

The part of the presentation that I was in disagreement with was the discussion of the power differential in the physician-patient relationship.  The rhetoric of power is an interesting one that I hear discussed much more frequently outside of medicine than inside.  In my experience social workers tend to discuss power in relationships.  To me,  power is a nonspecific word.  When I am obsessing about making the right decisions in very uncertain situations - being some sort of omnipotent authority figure is the farthest thing from my mind.  All of the psychiatrists I know operate from a therapeutic alliance model and that can be captured by two sentences:  "The therapeutic alliance means that you and I are working to solve your problems.  In that context it is my job to give you the best possible medical advice on how to do that and your job to decide about whether you want to use that advice or not."  Even in the cases where substitute consent is required like civil commitments or guardianships, the physician involved basically brings the problem to the attention of a judge who makes the determination.  Physicians do not want to run patients' lives.

Steve Miles, MD from the University of Minnesota Center for Bioethics gave the scientific part of the program on the epidemiology of gun violence.  It had striking similarities to some of the positions I have posted here on how to approach this problem that I plan to discuss that as a separate post.  He also reviewed the political timeline on how research into gun violence was eventually defunded courtesy of heavy lobbying by the pro-gun forces in Washington.  

I thought that politics was the important word that was left out of the ethics discussions.  As an example, the issue of torture was discussed and how the American Psychiatric Association came to the position that psychiatrists should not participate in torture.  That was a lengthy discussion that eventually came down to a line in the sand - psychiatrists should never participate in torture.  That is not true for two other ethical dilemmas discussed in this conference - managed care utilization review and collaborative care.  Instead hypotheticals were discussed.  If you were this managed care reviewer and your company wanted you to deny specific care that you knew was indicated - what would you do?  Similarly - if you were in this collaborative care arrangement and your salary and bonuses depended on what you were using to fund the "at risk" population that you were seeing - what would you do?   So basically being a military psychiatrist asked to perform torture there is a clear ethical guideline and in the managed care and collaborative care situations you are on your own.  You can call me concrete, but if I was king, the latter two situations would also be forbidden by the ethical code of psychiatrists.  In the case of collaborative care the APA recently announced (1) it received a federal grant to "train 3,500 psychiatrists in the clinical and leadership skills needed to support primary care practices that are implementing integrated behavioral health programs."  Instead of questioning the ethics of a practice that limits the direct assessment of patients by psychiatrists and potentially creates financial conflicts of interest - at the organizational level the APA celebrates this grant and making the practice it more broadly available to all psychiatrists!

Calling the APA Ethics Committee with your ethical dilemmas was encouraged and they clearly take it seriously, but I think these inconsistencies do not make the organization popular among clinicians who deal with these problems on a day by day basis.  They are as easily solved as the questions about physician participation in torture and executions.


George Dawson, MD, DFAPA


References:

1:  Mark Moran.  APA Receives Federal Grant to Train Psychiatrists In Integrated Care.  Psychiatric News - November 6, 2015.  v50(21): p.1.

The grant to train 3,500 psychiatrists was $2.9 million over 4 years or about $828 per psychiatrist.  Each psychiatrist is expected to support up to 50 primary care providers and consult on the care of 400 patients per year.  The ultimate goal is to support 150,000 primary care providers and consult on the care of a million patients a year.  Does anyone see the problems here?     



                     

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.

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.