Thursday, January 30, 2020

Warren v. Dinter - More Implications Than Malpractice Law

I have few comments about this case that is written about from the perspective of malpractice law and the implications for informal consultation.  In this case, Richard Dinter, MD was a hospitalist employed by one of the main hospital systems in Minnesota.  By way of background, over the past 20 years most hospitals in the United States are now staffed by hospitalists who are generally internal medicine or family medicine trained specialists dedicated to admitting people to hospitals, treating them while they are there, and discharging them. In the overall history of medicine this is a fairly recent movement.  Before hospitalists, this function in most hospitals were covered by rotating assignments of staff from these departments or in the case of some private practices - the practitioners would see anyone from their practice admitted in the AM and see their clinic patients in the afternoon.  The hospitalist movement seems to have developed to create more efficiency in the system but an undoubted byproduct has been less personal care by physicians who don't know the patient as well, more control over physician practice by business entities, and an increase in the amount of care delivered by proxies or physician extenders.

In this case Susan Warren presented to a clinic in Hibbing Minnesota with abdominal pain, fevers, and chills. She had an elevated white blood cell count. The nurse practitioner seeing her called the hospital system where the call was randomly assigned to Dr. Dinter. The question was whether or not the patient should be hospitalized.  Hospitalization was not recommended and the nurse practitioner did not seek the hospitalization on her own. The patient was discharged home and died of sepsis. The family sued both the physician and nurse practitioner.  In Minnesota nurse practitioners can practice independently without physician supervision.  Reversing prior precedents, the Minnesota Supreme Court ruled that a physician-patient relationship was not necessary for a medical malpractice claim. Instead they established a new standard of reasonable foreseeable action. In other words, a malpractice claim could be initiated if harm suffered was a “reasonably foreseeable action” of a physician’s actions.

Amici curiae briefs were filed by the Minnesota Medical Association partnering with the American Medical Association and separately by the Minnesota Hospital Association. The main arguments were that this standard would stifle collaboration and informal consultation and that might possibly lead to patient harm. The most shocking result of this court decision is that a physician can be sued without any formal physician-patient relationship.  On the surface it all seems to be a standard malpractice issue complicated to some degree by new treatment relationships. But are there larger issues here. The fact that the Minnesota Hospital Association filed an amicus brief suggests that there are.

Minnesota has had the highest penetration of managed care organizations of any state for a long time. Practically all of the care the state is managed by three major healthcare companies who dominate the market. They have their own standards organization that sets guidelines and standards for certain practices in the state. A good example would be the Diamond Project that led to the state government adopting a standard that they would collect depression rating scale scores as a proxy for the quality of depression care being delivered in primary care settings in the state.  This was an early form of “collaborative care” that is currently being pushed by several organizations. In collaborative care for psychiatric purposes, a psychiatrist reviews charts, rating scales, case manager notes, and possibly primary care physician notes and makes a recommendation for a specific treatment. The original Diamond Project focused only on depression and antidepressant prescriptions. I attended the APA sponsored course on collaborative care and learned that according to some standards all psychiatric disorders can now be treated remotely without seeing the patient.

Managed-care organizations and every healthcare plan has a vested interest in providing this type of care to their patient-subscribers. For the past 20 years they have been putting “physician extenders” in hospital and clinic settings with varying degrees of supervision. Many of these personnel like nurse practitioners can now practice independently without physician supervision. The only way physician supervision occurs in many cases is because of local rules within the health plan that employs the physician and the physician extender.

I have seen tremendous variation in how physicians work with nurse practitioners and physician assistants. In one case, I saw a physician working with four nurse practitioners in an outpatient clinic and in half a day - they would see 40 to 60 patients. The incentive for that arrangement was the physician would get the “productivity” numbers.  The organizations call this “population-based medicine” for the emphasis on treating large numbers of people rather than individual patients.  Of course for physicians, there is really no such thing. Seeing large numbers of patients, even with nurses, nurse practitioners, or physician assistants - should not reduce the amount of information needed in the time needed to make decisions and recommendations in that person’s best interest on that day. Some organizations have triage systems in place even before patients see anyone. I wrote about one of those systems four years ago that led to the inappropriate care of an 80-year-old man after a fall.

This court decision is really a managed-care friendly decision in that it affirms a system where physicians have no direct contact with patients but are responsible for the outcomes. Like managed care health systems, the court is basically saying that physicians can direct healthcare provided by nonphysicians remotely. The implication here is that the quality will be the same. A further implication is that the healthcare company does not end up appearing to be a two-tier system, staffed at one level by physicians and at another level by nonphysicians. That would not allow for the indiscriminate draping of quality banners over all the buildings in a certain organization.

Some people see this court decision as a “guild issue” or scope of practice issue.  I have already seen arguments about physician extenders replacing physicians and healthcare organizations and the implications of those maneuvers. Since nurse practitioners can practice independently - this is about physician supervision or collaboration available in health care settings that assume physicians can operate that way.

From a strategic standpoint, this decision points out that you may not be able to ration physician expertise on the one hand and avoid negative clinical or legal outcomes on the other. The average patient does not appreciate this effort until they realize that significant medical care has been denied and the physicians treating them are powerless to advocate for them. Although this case has not been litigated in a civil hearing - the ground rules have been suggested. In this case we have a nurse practitioner who according to Minnesota state law is licensed to practice independently without physician supervision. That nurse practitioner contacts a physician to discuss the case and the physician is implicated in the outcome. Managed-care organizations have successfully used this dynamic for years. The clearest example is the imposition of case managers in hospital settings telling physicians when they must discharge patients based on business rules rather than medical indications.  Another common example is the “physician reviewer” who reviews medical care remotely without any direct knowledge of the patient and makes a decision on whether they should be discharged from the hospital or not. In that situation physician reviewers are immune from liability according to federal law. Warren v. Dinter shows that there may be no such exemption for physicians working in healthcare organizations who provide consultation about medical care and hospital utilization.

Once physicians were sufficiently undermined so that their opinion carried no more weight than nonmedical business personnel, healthcare businesses were able to dictate medical care they way they wanted to. That direction is generally to make a profit and in the case of publicly held companies - to make as large profit as possible to satisfy their shareholders.  

This decision suggests that there may be no protection from civil litigation similar to the federal immunity for business physician reviewers for any working physician making recommendations on the basis of the same limited data.

George Dawson, MD, DFAPA 

Saturday, January 25, 2020

Medical Journals Continue To Support The Business Intrusion Into The Profession

Ran across an article that was posted to Twitter today entitled “The medical profession is breaking its psychological contract with medical students and trainees.”  It was not posted on Medline yet so I am concluding that this is a blog post on the British Medical Journal website. As far as I can tell none of the authors are physicians. The qualifications listed suggest they are all business school professors. Rather than accept my brief summation of the article, I encourage anyone reading this post to read the article in full at this link.

The authors develop their argument from a business concept called the psychological contract. They link to it in their post.  It is from a 1995 book written by Denise Rousseau called Psychological Contracts in Organizations - Understanding Written and Unwritten Agreements.  Searching the author shows that she is a University Professor at Carnegie Mellon University in Organizational Behavior and Public Policy.  The closest definition I could find in this section of pages occurred on pages 9 and 10:

“When two people work interdependently, such as a worker and a supervisor, agree on terms of a contract, performance should be satisfactory from both parties’ perspectives. As individuals work through their understandings of each other’s commitments over time, a degree of mutual predictability becomes possible: ‘I know what I want from you and you know what you want from me’. Commitments understood on both sides may be understood based on communications, customs, and past practices.”  

By the second paragraph the authors have concluded that a violation of the subjective psychological contract has led to the well-known morbidity and mortality within the medical profession although they are focused primarily on trainees for the purpose of their argument. They provide links to burnout, stress, and depression. They suggest that this provides direct evidence that violation of the psychological contract has occurred.  They go on to point out how training environments or “cultures” have a neagtive effect as a number of vaguely defined and poorly quantitated negative outcomes. They never really comment on how widespread the abusive culture is or the total number of people affected. One of their stunning conclusory statements is:

“A cursory examination of the first interactions that physician trainees have with medical schools and residency or specialty training programmes suggests that from day one, the relationships begin somewhat adversarially, suspiciously, and with potentially lower levels of trust between the parties.” 

When I looked at that sentence - as I hope any physician reading this will do - I asked myself if these were the kinds of relationships I had with attending physicians on day one of my residency training. I also asked myself if I had these kinds of relationships with my medical school professors and the residents and medical students that I was teaching. The answer was a resounding “No!”. Medical training is of necessity intense and prolonged but it is not focused on “book smarts” and "high-stakes”.  The authors lack an understanding of why medical training requires this approach and that has to do with pattern matching. Medicine is not learned by “book smarts”. Medicine is learned by seeing as many possible patterns of illness as you can during residency training. In the case of surgical training, that involves as many supervised surgical procedures as possible. Only when this pattern matching has occurred will a physician be safe to see patients and practice medicine independently. If there is any expectation at all on the part of trainees it should be that their training program provides them with these experiences and adequate time with attending physicians so that they might also benefit from the experience of those physicians. 

Every good training program provides that experience as well as the necessary relationships with attending physicians. All through medical school and residency training, a training physician has direct contact with senior residents, attending physicians, and various consultants. They all have varied skills and motivations for teaching, but it is hard to imagine that the training in the United States one cannot find several outstanding teachers and role models in any residency program. I have role models and residents that I trained who I am in contact with to this day. We are still all focused on patient care and united by the goal of quality care and being able to take care of patients with complex problems.

I also have first-hand experience with what directly interferes with the teaching experience. Without a doubt it is the intrusion of business practices into academic settings. Pharmaceutical sales and detailing has been the usual focus but that is completely benign compared with managed care. I have highlighted a few major problems with managed-care and academic medicine in the table below and will elaborate on some of those points.

Business Practices Adversely Affecting Medical Education

1. Lack of quality - before the intrusion of business practices there were medical standards of quality. Those of been replaced by business standards of “value” that have essentially no meaning in the practice of medicine.  The role of physician as a "steward of resources" is a business idea and not a medical one.

2. Unrealistic productivity standards - any academic practice that requires RVU production and awards no credit for teaching productivity necessarily detracts from medical education.

3. Unscientific metrics - medical students and residents can observe attending physicians being ordered around by nonphysicians based on business metrics such as length of stay that have nothing to do with patient care.

4. An unscientific environment - is there adequate time in a managed-care teaching setting to discuss something other than rationing techniques? Is there time on rounding to discuss the latest scientific research? In most cases it is seriously eroded.

5. Documentation burden - it is currently immense relative to before businesses took over the field and that necessarily leads to less direct contact with teachers and mentors and less academic discussion.  This is an artifact of a very low quality information technology environment both in terms of records and security that is the direct result of business based standards in medicine.

6. Less disagreement and controversy - one of the key concepts that every medical trainee must learn is that medical science is an active dialogue and critical papers and concepts change over time. The business influence on teaching environments suggest otherwise and make it seem as though completely unscientific ideas like utilization review and prior authorization represent some sort of immutable standard - the criteria for which never seem to be completely available.  Science is secondary to the proprietary business environment.  Physicians on the faculty who disagree with that are frequently scapegoated and fall into disfavor. Managed-care companies cull the ranks of trainees looking for “managed-care friendly physicians” to maintain the business-based practice.

7. Revolving door policies - there is probably nothing more demoralizing for an intern than to have to readmit a patient who has been discharged because they were in the hospital too long and who returns because they were not stable at the time of discharge. Those discharges are generally based on business metrics.  These policies also eliminate the possibility of residents seeing their patients recover and verifying that their diagnosis and treatment plan was correct.

8.  Unnecessary bureaucratic burden - I was fortunate enough to be an intern at the time managed care was just starting to take off. At that time I had a critically ill patient in an intensive care unit and I was contacted and told that they needed to be transferred to another hospital because of their insurance contract.  Today practically all physicians routinely encounter the managed-care intrusion into their patient care on a daily basis. With physicians in training it is no different. They are still subjected to the review processes and spending far too much time getting medications approved that are clearly indicated. All of this detracts from teaching and learning time.

I have directly observed all the above items taking its toll on teaching and learning medicine but I have a couple of anecdotes that bring together many of these areas. The first was my experience on a neurosurgery rotation as a medical student. I did two neurosurgery rotations with the same residents and attendings and at one point hoped to be a neurosurgeon. There is no more rigorous course of training. All of the senior residents were essentially on-call 24/7 all year long. In those days we were rounding on about 35 patients 10 of which were in the neurosurgery intensive care unit. We would typically be done with rounds in two hours and the documentation would be done at about the same time. Our documentation would include the postoperative day number, patient’s subjective status, what the surgical wound looked like, and review of their vital signs, labs, and physical exam. A typical note was no longer than five lines and we could complete it as we were moving from patient to patient. Over the years the federal government developed documentation guidelines that were turned over to the managed-care industry so that every medical encounter these days takes an excessive amount of documentation. If we were doing the same rounding procedure today it would take us additional 2 to 3 hours just to complete the documentation. That 2-3 hours would detract from time in the operating room where residents were learning how to perform neurosurgery and medical students were learning by observing those procedures. That 2-3 hours would detract from time where the senior neurosurgeons would teach imaging rounds and review all of the brain and spine imaging from all of our patients that week.  In short, business practices would have essentially cancelled out most of the teaching on neurosurgery.

My other anecdote has to do with materials available for teaching. At my last teaching position I enjoyed presenting an annual review for psychiatric residents taking the annual “in training” exam. This examination includes questions about neurology, neuropsychiatry, and brain imaging. As an attending physician focused on neuropsychiatry I always had plenty of brain images that were relevant to the practice of psychiatry. With the electronic health record implementation it was relatively easy to download and de-identify those images for teaching purposes. When I sought permission to do that from the medical director at our clinic she stated: “Why would we let you use our images?”  I was stunned because prior to the takeover by businesses, reviewing films even if they were not de-identified was standard teaching practice.

The final anecdote is probably the best. Back in the early days of the business takeover of medicine, the FBI was actually engaged in investigating medical billing and making sure physicians completed the correct documentation template. If they didn’t they could be charged with a crime up to and including a RICO violation. Of course these templates were completely subjective but that is not the way the FBI was treating them. There were several well-known prosecutions of large medical clinics based on the fact that attending physicians were not documenting enough when they supervised residents.  There were no guidelines at the time about what might be involved and so my business people were telling me that I had to document the standard note whether I was working with a resident or not. You can imagine the demoralizing effect that has on a resident when they notice their attending is putting in a separate note every day and their note seems to be irrelevant. When I noticed that happening I suspended all of my teaching of residents because I did not want to insult them just because business and government bureaucrats were telling me what to do. Eventually that guideline was relaxed so that I could go back to documenting that I had discussed the case with the resident but not until considerable damage had been done.

Based on these experiences and more, the opinion piece in BMJ strikes me as another effort to exert top-down control by business interests on the field of medicine.  It is an extension of three decades of failed business initiatives that nonetheless still dominate the practice of medicine in the United States.  Businesses and governments alike are still using the failed strategies. As I pointed out, the same failed strategies have already taken a toll on medical education. And yet these authors suggest that another vague business concept should be applied to medical education.

When I think about my mentors, my colleagues, the residents I have mentored, and what we have all accomplished - we need to keep business concepts out of medical education. We also need to look at the overall strategy and why business authors keep appearing in the pages of our journals. It all seems to be based on the premise that is business managers are experts at everything. 

That is clearly not true in medicine.  They have introduced chaos and stress into the clinical field.  They have already seriously stressed medical education and this opinion piece provides another non-solution that can only be suggested in the context of having wrested control of the clinical practice of medicine away from physicians. 

George Dawson, MD, DFAPA


I have seen recent psychiatric treatment that may illustrate what happens when business managed settings limit patient contact.  In my current employment, I see a lot of people who are treated with antipsychotic medication, antidepressants, and mood stabilizers for a presumed psychiatric diagnosis.  The medications are started and titrated rapidly.  By the time they see me they are experiencing clear side effects, taking too much medicine, and the diagnosis is not clear.  Hospitalizations today are so short and so focused on doing something in a short period of time that physicians in training have limited exposure to the concept of substance induced psychiatric disorders and how they can be best treated.  That also includes the appropriate detoxification of these patients - many of whom are sent out to social detoxification units unless they worsen and are sent back.  All of this decision making should be part of the knowledge base of psychiatrists and primary care physicians.

Thursday, January 9, 2020

The Era of Blockbuster Drugs In Psychiatry Is Almost Over

Four years ago, I commented on a prediction that the era of “blockbuster drugs” in psychiatry would soon be over. That designation is used for medications that generate $1 billion in sales per year. Even at the time of my original comment, most of the drugs prescribed by psychiatrists were generic drugs that were often very inexpensive. The example that I frequently refer to is the antidepressant citalopram that was available for four dollars per month.

Last week PharmaCompass, a drug industry analytic and service company came out with a list of the top 100 drugs by sales in that industry. They listed the top 30 drugs by sales and their website lists the top 500 drugs with additional metrics such as whether or not sales are increasing or decreasing and by the percentage. There were no psychiatric drugs in the top 30. Lyrica or pregabalin, a drug used primarily for neuropathic pain and fibromyalgia came in at number 16 and generated $4.6 billion in sales. Some consider it to have a tertiary indication for anxiety but I would not consider it to be a drug primarily for psychiatric applications.

Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2018 Revenue in US$ billion
AbbVie Inc., Eisai
Autoimmune Disorder
Bristol Myers Squibb, Pfizer
Cardiovascular Diseases
Bristol Myers Squibb, Ono Pharmaceuticals
Amgen, Pfizer, Takeda
Merck & Co.
Mabthera/ Rituxan
Oncology, Immunology
Bayer, Johnson & Johnson
Cardiovascular Diseases
Bayer, Regeneron
Johnson & Johnson, Merck & Co., Mitsubishi Tanabe
Autoimmune Disorders
AbbVie, Johnson & Johnson
Prevnar 13/ Prevenar 13
Pneumococcal 7-Valent Conjugate
Johnson & Johnson, Mitsubishi Tanabe
Immunology, Dermatology

Medications for neurological and mental disorders had a total market share of $55.8 billion or 10.2% of the entire market. There were only three medications that would qualify as blockbuster drugs and being used by significant numbers of psychiatrists and they included Latuda (lurasidone), Chantix (varenicline), and Abilify Maintena (aripiprazole).  The blockbuster drugs listed are all concentrated in a few specialties. Several are from the same class.  For example both Eliquis and Xarelto are novel oral anticoagulants (NOACs).  The total market share of the top 15 drugs greatly surpasses any amounts every attained by psychiatric medications. That makes sense because many are treating conditions that have a high prevalence and these medications generally represent an advance in pharmacotherapy.

I posted this mostly to note the trends over time. Journalists and other commentators tend to get carried away with market snapshots. I have not really noticed any negative commentary about the fact that the current blockbuster drugs that have nothing to do with psychiatric disorders are generating much more pharmaceutical company income. I also have not heard any commentary on how there is a natural fluctuation in this market based on drug discovery and the current rules on patent exclusivity. Many of the previous psychiatric “blockbusters” are obviously rapidly losing market share now that there are generic versions. I would argue that the current data also may indicate that restrictions on current medications may be limiting their market share.

The issue of direct to consumer advertising has typically not been discussed in these opinion pieces.  I have seen Rexulti frequently in television ads.  The application is generally antidepressant augmentation - accompanied by a very fast and diluted compilation of symptoms of both tardive dyskinesia and neuroleptic malignant syndrome. How much do those ads contribute to the market growth of Rexulti? My speculation is quite a lot. It would not take much for a person taking an antidepressant and not experiencing adequate relief to call their primary care physician for the addition of Rexulti.  I have seen similar ads for Vraylar.

Looking only at market share and pharmaceutical revenue only provides a look at one cost of this market. There is a huge pharmaceutical benefit manager component that generates revenue primarily by requiring their authorization for specific medications and also packaging deals for managed-care organizations. There is definite cost what they do but they currently are allowed to force physicians to work for them for free.

I hope that this information allows people take a more skeptical look at political and journalistic pieces that use pharmaceutical sales numbers and specialty sales for one rhetorical purpose for another. I am specifically referring to the recent good old days of the psychiatric drug “blockbusters” where much of what was written was an indictment against psychiatry and those psychiatrists who either worked directly for pharmaceutical companies or received some minor perk. There was the conspiracy theory that pharmaceutical companies had influenced the DSM-5.  That is both unrealistic and it greatly exaggerates the importance of that book. The data illustrates that no amount of physician manipulation can maintain a pharmaceutical product as a “blockbuster” independent of market forces.  

Those market forces also have a significant political and regulatory component where the real conflict of interest lies.  Allow me to translate that to Congress and the FDA.

George Dawson, MD, DFAPA

Graphics Credit

The top table from PharmaCompass was posted with their permission. 


I had to identify and hand count the psychiatric drugs on the PharmaCompass web site from their graphic interface.  It is possible that I missed some or the count is off (they were not numbered).  Let me know if you detect any errors.