Sunday, December 21, 2014

Psychiatry and Torture



For me - torture has never passed some basic thought experiments.  The first is whether or not there is any information that critical that could be memorized by individuals that would be worth the effort to either conduct torture to get it or resist torture to prevent its disclosure.  Reading Alan Turing's effort  to crack German cryptography  in World War II comes to mind.  Those messages had to do with the deployment of German submarines.  In that case there was a elaborate code that could only be decrypted by a team of geniuses and a computer they invented.  That was 70 years ago.  Is it likely that information in the computer age would be easier and more efficient to hide outside of human memory?  It certainly seems like it to me.  In the case of relationships, wouldn't surveillance be a much more reliable source of information?   The second is the mindset of the person being tortured.  If I knew the information was redundant, carried by multiple sources,  or subject to fail safe why would I not tell any captor what they want to know?  Third, if my captors either did not believe me or decided to proceed for other reasons, why would I not tell them exactly what they want to know or make up any story they wanted to hear to get them to stop?  The cinematic stereotype of resisting any disclosure at all costs while undergoing various forms of torture seems totally irrational to me.  All of these considerations taken to their conclusion would produce information that was accurate but possibly rejected because it was easily obtained or information that was inaccurate but accepted because it was made up under duress.  Either way it seems like a very poor source of information.

The Senate Report on the CIA interrogation and detention methods came out a few days ago and there is the expected media enhanced political furor.  The entire document is 499 pages long.  It is also redacted to remove details that could not be declassified.  I decided to take a look at it because I saw one of Atul Gawande's tweets decrying the involvement of the medical profession that he described as "doctors, psychologists, and others sworn to aid human beings......".  That struck a chord with me because I was aware of this issue and how the American Psychiatric Association reacted to it in 2005.  Then president Steven Sharfstein, MD took the initiative in making it explicit that it is unethical for psychiatrists to participate at any level in torture, enhanced interrogation or even deceptive interview practice.  There was some lag in a similar response from organized psychology but eventually both organizations came out with a joint statement on the issue.

Psychiatry and the CIA have crossed paths on occasion most notably on the notion of being able to profile political leaders.  The original ethical conflict with CIA psychiatrists was the Goldwater Rule (see reference 3). That rule states that it is not ethical to diagnose a person (usually a public figure) without actually interviewing that person and disclosing the information with their consent.  It came about as a result of the 1964 Presidential election.  The candidates were Barry Goldwater and Lyndon Johnson.  One of the more infamous attack ads in political history suggested that Senator Goldwater would put the US at higher risk for involvement in a nuclear war.  A survey of psychiatrists suggest that he was unfit for the office.   That same article points out that even today despite the rule, there appear to be no shortage of psychiatrists willing to offer their opinions about people they have never personally examined.    

I decided to take a course on profiling political figures by one of the original psychiatrists who worked on these methods -  Jerrold Post, MD.  The course was offered at the Door County Summer Institute in August 2003.  He provided a disclaimer at the outset that "psychological interpretation" based on childhood experiences was a scientific fact that could be applied to the analysis of the personality of political leaders.  Over the next 4 days he reviewed personality and its development in political leaders, how personality is a factor in political decisions and decision making in hundreds of different compromised and uncompromised political leaders.   The final day was devoted to a look at terrorism.  He made the argument that terrorists were psychological normal meaning that they had no major psychiatric diagnoses.  He suggested that that there were predominant personality types attracted to terrorism including aggressive sociopaths and angry paranoids and that a common externalizing defense could be observed in both groups.  He discussed theories about personality types that might comprise terrorist groups.  The issue of the Goldwater Rule seemed irrelevant.  Dr. Post presented profiles that were based on actual historical data about the lives of political leaders rather than the self report that typically forms the basis of most psychiatric evaluations.  It was after all his job and he and his cohort of colleagues specializing in the psychology of political leaders developed methods for this work.  It culminated in a text of how this analysis proceeds (see references).  The text provided a fuller appreciation of the limits of this kind of analysis than the PowerPoints:  

"Understanding and predicting the behavior of smart, highly functioning individuals, who are acutely aware of their circumstances and what might be needed to surmount them,  make it a very tricky undertaking.  It is possible that, in spite of their own psychological inclinations, such persons, if not alone, then certainly with the help of many advisers, whose only occupational purpose is to help leaders pursue their own personal and political self-interest."  (p.  300).

Translation: the psychological profiling done by psychiatrists and psychologists with decades of experience is less of a sure thing than the television profilers that you can see on a nightly basis.   At that point I decided that the analysis of the psychology of political figures by the CIA was really not the same as somebody on the local news speculating about the next mass shooter.  In many ways this analysis has much more relevant data than any typical psychiatric evaluation.

The ethics of the psychological profiling of politicians seemed resolved.  What about interrogations and coercion.  It turned out that there was a course the next year  called "A Law Enforcement Approach To Behavior Analysis" taught by Dale Mueller, a 30 year veteran with the FBI.  The course covered crime scene analysis, terrorist personality types and interview strategies, hostage and crisis negotiations,  interviews for deceptive verbal behavior, and interrogation techniques that answer the question: "What does law enforcement do to get a confession?"  That course was an eye opener in terms of the differences between interrogation and a clinical interview.  He described interrogation techniques and the reliability of various observations that suggested a person my be lying.  He described the optimal environments and mindset of the professional conducting the interrogation.  He emphasized good preparation and a non-threatening manner.  Interrogations are not without stress for the person being interrogated because at some point the strategy may become a direct confrontation like:  "Because of A, B, and C you are lying."  The interrogator may stand directly over the the person being interrogated for additional effect.  Some famous interrogations were reviewed and a tape of an interview was shown.  It was a product tampering case.  The suspect had social and possibly psychiatric problems.  The main focus of the interview was to convince her to admit to the crime and she did.  Specific interrogation techniques were discussed for different terrorist personality types.  Interrogation is an alien interaction with people for a clinical psychiatrist like me.  Psychiatrists are clearly not trained in these techniques and generally do not have much interest in who is guilty of crimes or not.  During the actual interrogation of a person who appeared vulnerable, I would probably have veered off to discuss  those problems and solutions rather than focusing on a conviction.  Interrogation seems to be the sole purview of law enforcement and nothing that a psychiatrist would do.

The issue with psychiatrist employees in the CIA or any other organization - even at the contract level is the ever present conflict-of-interest between professional standards and the interest of the organization signing the pay check.  In many cases that is a changing point of reference and it is not always clear.  I have consulted with expert witnesses for example who felt that at some point they were massaged into a position that they really did not want to testify to by the attorney who hired them.  Physicians can clearly be manipulated into doing whatever other entities want them to do and that is why it is imperative that professional organizations take a stand that is unequivocal, based on professional standards and faster than any other response.  In this case, organized psychiatry - specifically former APA President Sharfstein was at the forefront.  I applauded his position then and I applaud it now.  There is always some criticism that this just involved jumping on the bandwagon with everyone else but the public opinion result at the time was far from certain.  After the opinion was public, there was hardly any acknowledgement that anybody cared.  That opinion came out 8 years before the current Senate document.

Searching the document reveals exactly 1 reference to psychiatry/psychiatrist, 56 references to psychologist/psychology, 58 references to medical officer, and 5 references to physician/physician assistant.  The most specific references include this section in the summary about contract psychologists who "devised" the enhanced interrogation techniques.



The political rhetoric is always interesting:

1.  Does torture produce results?  After reviewing the evidence I don't think there is any evidence that it does.  In fact, it is daunting to think about the millions or billions of people who have been tortured at one point or another in human history with this goal in mind.  In retrospect much of the contested information was trivial and meaningless in the course of human history.  I don't recall any major battle or war where the outcome was determined on information produced by torture.  I think there is a stronger argument that terrorism or what used to be called guerilla warfare produces more results than torture.  And let's not forget that a contractor with the National Security Agency probably released more secret data that all of the people tortured since the dawn of time.  And all of that data was accurate.

2.  Does torture inflame the enemy and lead to more adverse consequences for the torturers?  I heard an interesting discussion of this issue on Fareed Zacaria's Sunday morning show on CNN.  The discussant was an Arab from the Middle East and it was clear that his sympathies did not align with the US.  When asked about the impact of this document on public opinion, he said that he did not think it would have much of an impact because of a baseline issue.  Most people had such a low opinion of the United States that they would expect something like this to happen.  There was after all the Abu Ghraib prison incident in 2003.

3.  Are there qualitative differences in torture?  Certainly these techniques were bad but they pale in comparison to the atrocities described in the middle east and the atrocities inflicted by some of these combatants on their own countrymen.  As one of the consulting psychologists pointed out about 48 hours after the report was leaked there is also the question of what is worse a slap in the face during an interrogation or "sending in a Hellfire missile that kills grandma and the kids."  (ABC news Thursday AM show)

4.  How is the release of this document relevant to the concept of American democracy and American life?  Interestingly one of the critics on the Sunday morning show gave the opinion that self disclosures like this report does seem to distinguish American democracy from other political systems and raises the general awareness  that this is true.

5.  How can I make the most of this story?  Certainly media outlets and bloggers are motivated to whip this story up to attract viewers to their sites.  I saw a very funny comedy sketch by a stand up comedian who ranted against "Cheeto eating bloggers.." who were destroying his comedy act by posting politically incorrect experimental pieces that he was trying out in his routine as though he was serious.  The blogosphere likes to see itself as more innovative and more pious than the press but conflicts of interest remain.  It has gone from a corporate conflict of interest to conflict of interest at an individual level.  At many levels bloggers are more strident, argumentative, and hyperbolic.  It is not too surprising that they attract a like-minded following.  That being said, there have been few psychiatric bloggers that seem to have picked up on the torture issue.  It was an active area of discussion on the APA Listserv with several psychiatrists taking the role of human rights advocates.

Professionals often find it difficult to resist government interventions.  I have criticized the lack of an adequate response from organized psychiatry and organized medicine to any number of government interventions.  In other cases, they have come through with an exceptional response.  On the torture issue, Dr. Sharfstein took an unequivocal position on torture.  I was involved in a discussion of the issue at the time and there was speculation that there would be political pressure from "CIA psychiatrists".   There is always the question of whether a small special interest group within an organization can affect its policy.  In this case, the clinical focus of the membership, the maxim to do not harm and the modern conceptualization of the physician-patient relationship.  In the end there was no commentary that I am aware of from CIA psychiatrists.  I am not sure that there are any CIA psychiatrists.  I applied to be a CIA psychiatrist at about 15 years ago and the focus of the position was on interviewing potential employees rather than terrorists.

I think it is important to clarify any role that psychiatrists were involved in these activities.  They are not trained in interrogation techniques and I think that most psychiatrists would balk at the techniques.  On the other hand, it is clear that programs can be developed within government agencies that have little to do with clinical training and may clash with patient centered ethics.  It is also true that psychiatrists or physicians can abandon their usual clinical roles and use their knowledge for other purposes.  I am very skeptical of the science behind any of these techniques.   That sounds like an absurd statement on the face of it, but keep in mind the references to the program being based on a "learned helplessness model".  That is a scientific model that has been used to study depression.  Any review of that model would show that using it to develop an interrogation program is quite a stretch.  Actual human research would not pass the scrutiny of any Human Subjects Review Committee that I am aware of and it certainly is not associated with any standard of care.  The acceptance of these ideas indicates that there is really nobody in the CIA capable of scientifically reviewing a program like this or they just did not care.  As to the ultimate question of psychiatric involvement, I have a more definitive source on order (reference 5) and will report any differences here.  There is also an online database (reference 6) but it does not have much granularity but some of the linked reports contain a some details that I have not seen anywhere else (reference 7).


George Dawson, MD, DFAPA



References:

1.  Senate Select Committee on Intelligence.  Committee Study of the Central Intelligence Agency's Detention and Interrogation Program.  Foreword by Senate Select Committee on Intelligence Chairman Dianne Feinstein.  Findings and Conclusions.  Executive Summary.  Approved December 13,2012.  Updated For Release April 3, 2014.  Declassification Revisions December 3, 2014.

2.  APA Official Actions.  Position Statement on Psychiatric Participation in Interrogation* of Detainees.  Approved by the Board of Trustees, May 2006.  Approved by the Assembly, May 2006

"The American Psychiatric Association reiterates its position that psychiatrists should not participate in, or otherwise assist or facilitate, the commission of torture of any person. Psychiatrists who become aware that torture has occurred, is occurring, or has been planned must report it promptly to a person or persons in a position to take corrective action........"

3. American Psychiatric Association: Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry. Arlington, VA: American Psychiatric Association, 2013 (p.9):

"...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."

4.  The Psychological Assessment of Political Leaders: With Profiles of Saddam Hussein And Bill Clinton.  Jerrold Post, MD (ed). The University of Michigan Press, Ann Arbor 2003, 462 pp.

5.  Steven H. Miles.  Oath Betrayed: America's Torture Doctors.  University of California Press, 2009, 312 pp.

6.  Doctors Who Torture Accountability Project.  Link.

7.  Physicians for Human Rights.  Doing Harm: Health Professionals’ Central Role in the CIA Torture Program.

This document is interesting because it has the qualifier "physicians (including psychiatrists)" four times in the report even though it is based on the original Senate Report.


Supplementary Info:

Supplementary 1:  Photo credit as suggested on WikiMedia:  Derived from File:911 - FEMA - Areas debris impact (graphic).png by Therese McAllister, Jonathan Barnett, John Gross, Ronald Hamburger, Jon Magnuson of the Federal Emergency Management Agency (FEMA) of the United States Department of Homeland Security. As a work of the United States government, it was released to the public domain.

Supplementary 2:  I sent Physicians for Human Rights an e-mail on December 21, 2014 to clarify the qualifier they use in their analysis of the Senate document  "physicians (including psychiatrists)".  I will post their response here as soon as I get it.



Friday, December 19, 2014

Question For APA Candidates? OK Here It Is.

"Why are there no leaders with vision in the APA who can focus us on the best science and the best psychiatry to provide treatment for individual patients with severe mental illnesses?"


I got a message today that I should craft a question for the American Psychiatric Association (APA) candidates.  It is election season and the LinkedIn forum is apparently the place for political debate.  I can recall asking a question last year along with James Amos, MD (The Practical Psychosomaticist).  The questions had to do with Maintenance of Certification (MOC) and the arduous recertification schedule that was essentially invented by the American Board of Medical Specialties.  Dr. Amos has done more to maintain this issue at a high level of visibility than any other psychiatrist.  That includes looking at the paucity of evidence that it is superior to life-long learning and CME as we all know it.  I  went to LinkedIn to look for my post from a year ago and it wasn't there.  The earliest post is from April 29, 2013.  This is a forum that was suggested to replace the long running member-to-member (M2M) listserv managed by the APA.  It was in M2M that members learned their concern about the MOC issue would be ignored despite overwhelming support on the basis that only 25% of the members voted and a 40% vote was required to pass the measure (see supplementary info below).

The events associated with that vote continue to bother members greatly.   It is seen as a continuing symptom that APA membership does not translate into any support for front line psychiatrists.  We have witnessed decades of increasing rationing and onerous regulations that have been basically brushed off at the level of the APA.  There has been minimal activity in responding to politicians, regulators, and businessmen.  It seems that whatever these special interests want to do - the APA is willing.  We had a billing and coding debacle in the 1990s with the rest of medicine.  Instead of pointing out that this was a purely subjective scheme designed to allow the persecution of any physician, the stance of both the APA and the AMA was "we will give you what you need to be better billers and coders."  We have had three decades of managed care utilization review, prior authorization, and pharmacy benefit managers and the response from the APA has been literature on how to be a better managed care psychiatrist.   There was a lawsuit against some managed care payers for a lack of parity but I don't think there is any evidence that the members who were forced to provide free care have gotten much benefit from that.

The most telling event about where the APA and AMA are at is their full scale cooperation with the PPACA (aka Obamacare) and so-called collaborative care.  In many if not most of those models of care, a psychiatrist collaborates with primary care physicians in treating depression or anxiety in their clinics.  In many of the models, the diagnosis hinges on a rating scale determination of depression or anxiety.  The rating scale score is the diagnosis.  The treatment modality is a medication - usually an antidepressant.  In some models the psychiatric consultant never sees the patient.  I just realized it, but this is all eerily similar to managed care reviewers several states away telling attending psychiatrists how to manage their patients.  This is managed care - a business centered model of providing medical care.  A model that many (myself included) do not consider a valid method of providing medical care.  And yet, the President of the APA and several other psychiatrists promote this as a model of care.  What physician would do 4 years of residency training to sit in an office, look at rating scale scores, and recommend antidepressant doses?  Why would you train all of those years and know all of that theory for such a simple task?

That simplistic collaborative care model captures the primary problem in psychiatric leadership today.  Here we stand at a crossroads.  We are studying the most complex organ in the body and we clearly know more about it now than at any point in the past.  The literature in brain science as it applies to psychiatry is growing exponentially.  We have some of the best thinkers in the world in all areas of the field ranging from pure neurobiology to psychopharmacology to imaging to neuropsychiatry to medical psychiatry to community psychiatry to psychotherapy.  There is so much to learn about the brain and psychiatry and what are we doing with it at a global level?

Nothing as far as I can tell.  The leadership of the APA is locked into a mindset from the Clinton administration.  The APA is acting like we have a responsibility as a profession to address bloated mental health statistics and provide population-based psychiatric care to the masses.   We have a responsibility to provide cost-effective care to the masses.  We have a responsibility to fight stigma wherever we find it because this is the real reason why people, governments, and insurance companies discriminate against psychiatrists and their patients.  We have to grin and bear it when some clown attacks the profession despite the fact that thousands of our colleagues go to work everyday and many toil with inadequate resources, impossible conditions, a lack of cooperation and they still get the job done.  Thrown into the breech with no support, front line psychiatrists are still getting the job done.

The APA on the other hand has done very little to support that effort.  APA officials seemed to breathe a sigh of relief about the vote on the MOC issue.  I heard one of them speak about it at a local meeting.  She told us all about how the new certification fees were really not a windfall for the American Board of Psychiatry and Neurology (ABPN).  This was really an expensive process after all.  I finally learned that this was really an initiative by the ABMS and that participating boards did not really have a choice.  If most of the boards voted for recertification all of the boards had to participate even if they voted against it.  I had learned about 10 years ago that the American Board of Obstetrics and Gynecology ( ABO+G) had a robust program that consisted of didactic material every year that was designed to bring all members up to speed.  A test was taken every year on that well defined information.  At the time there was no MOC and to me it seemed like an ideal program to assure that all members of a particular specialty were up to date and studying relevant information about what was important for the specialty.  For a while, I promoted this model as the preferred model for ongoing professional learning.    The APA does provide a similar program called Focus that could naturally fill the same role.  Typical MOC exams are not on a focal body of material and the pass rates are high.  Candidates of all specialities typically take time off of work (an off of vacation) to study for these examinations in addition to paying high examination fees for a test that is designed for the test makers and not the test takers.  A test of random facts for the purpose of recertification is not the same thing as a test for professionals to assure they are all up to the same standard.

The APA has just completed a much criticized multi-year effort of revising the DSM and producing the DSM-5.  I think that has been a good effort and with the associated online material it is a definite advance relative to previous editions.  That does not mean I am in agreement with everything in the book, or think that all of the diagnoses in that text exist.  I do think that it covers all of the major diagnoses and severe mental illnesses that psychiatrists treat.  On an academic and clinical level the APA needs to do much more.  Hospitals and clinics currently are being run by administrators with mixed agendas.  We are seeing business people conduct psychiatric care.  The APA used to provide comprehensive guidelines for the treatment of aggression in inpatient settings.  It used to have timely treatment guidelines describing the role of psychiatry and what the standards of care are.  By abdicating that role, we now have business organizations and nonprofessionals dictating care for people with severe mental illnesses.  We have psychiatrists who have to defend their care against those nonprofessional guidelines every day.   That is hardly the expected behavior of a professional organization.

Any psychiatrist should be concerned about the fact that their professional organization does not seem to support the members doing the work of psychiatry.  Any psychiatrist should be concerned that the APA does not vigorously defend the profession and that it seems to have adapted the pseudoscientific methods of governments and managed care organizations.  Any psychiatrist should be concerned that the APA has adopted the questionably valid ABMS preparatory school model of professional education that is unfocused and a waste of time and money.  Any psychiatrist should be concerned about the fact that we have some of the greatest minds in American medicine in our medical institutions and our professional organization is lurching back to the Clinton administration of the early 1990s.  Back to the time when a few political insiders thought that managed care was a good idea.  All of these things considered the question I will post to the candidates is:  

"Why are there no leaders with vision in the APA who can focus us on the best science and the best psychiatry to provide treatment for individual patients with severe mental illnesses?"
 
That is how I was trained and how every psychiatrist I know was trained.  It is time our professional organization consistently gives us what we really need.


George Dawson, MD, DFAPA



Supplementary 1:  This was the APA 2011 election report I got on the following referendum to basically eliminate patient feedback and maintain a cognitive exam very 10 years.  Although the APA maintains that it requires a vote of 40% of the voting members, the vote to support these measures exceeded the votes for the President Elect and the Secretary (both national candidates) by 1373 and 1388 votes respectively. (Reported February 18, 2011)


The APA was petitioned by members to hold a referendum on the issue of informing the ABPN as follows regarding its proposed maintenance of certification requirements.

1) The patient feedback requirements for the purpose of reporting to the Board is unacceptable, as it creates ethical conflicts, and has the potential to damage treatment.
2) The requirements other than a  cognitive knowledge examination once in 10 years, regular participation in continuing medical education, and maintenance of licensure, pose undue and unnecessary burden on psychiatrists.
Member Referendum
Support
5,525 (80%)
Do not support
1,418 (20%)


The referendum did not pass. APA received ballots from 25% of the voting members.
The APA Operation Manual states the following regarding member referendums: “The adoption of a referendum shall require (a) valid ballot from at least 40 percent of the voting members, (b) the affirmative vote of at least one-third of all the voting members of the Association, and (c) the affirmative vote of a majority of those members who return a valid ballot.

Supplementary 2:  Another one of the sorry miscalculations made by the APA and its officers is the image it projects to potential trainees.  Applying the dynamic I point out in this post, any potential resident ends up asking themselves:  "Why would I want to join a speciality that seems to want its members to have less expertise than they used to rather than more?  What other speciality does that?"  I tried to address that as a response to a current resident written on his blog and for some reason the response was never posted.  You can read his original post here and my response below:


The most significant reasons why psychiatry has the image problem that you discuss is that the profession is politically inept and our largest professional organization is not addressing the problems that psychiatrists face on a day-to-day basis on the front lines. The biggest front line problem is that practically all systems where psychiatrists work have mercilessly slashed resources for treating the mentally ill. We also seem to attract a number of ideas from critics that are not helpful. The example you posted about a prescriber with watered down qualifications is a case in point. In what other specialty does anyone suggest that the practitioners of the future should be less qualified?

That type of nonsense only happens in psychiatry and it is completely inconsistent with current research. In this weeks’s Neuron there is a perspective on Computational Neuropsychiatry. As neuroscience becomes more relevant to daily practice psychiatrists need that level of training in addition to medical and psychotherapy skills. We seem to have a lack of visionaries right now who can put all of that together.

I would encourage psychiatrists of the future to be thinking more along these lines, than the rationed managed care model of care that is currently being promoted. It turns out that “cost-effective” psychiatric care is frequently the same as no care at all.


GD







Wednesday, December 17, 2014

Survey-Centric Versus Customer-Centric Versus Patient-Centric




Over the past decades of managed care we have evolved from a medical model that mandated specific behaviors toward the patient to a business model that is supposedly based on customer satisfaction.  After all, the business theory is basically that satisfied customers are more likely to come back and do additional business. As any customer knows that model does break down in a number of ways.  My recent post illustrates a marked difference in the level of customer assistance available through many Internet companies over the past 15-20 years.  And yet, large managed care companies and other health care companies continue to adopt the customer satisfaction approach even when it can be demonstrated that this approach can result in increased mortality and morbidity for the satisfied patients.

It recently came to my attention that there is another variable in play that would have never been an issue in the days of patient centric care.  The best way to point it out is with the example.   Two separate people recently talked with me about their experience buying new cars.  I am going to maintain their anonymity because it could be traced back to the salesperson and have repercussions as you will see in a few lines.  New cars are high tech vehicles with an impressive array of electronics.  All of these electronics require more than a manual or a DVD.  The salesperson generally gives you an orientation to the vehicle and helps you with the preliminary setup.   In both cases that occurred taking about an hour each time.  At the end of the hour the salesperson approached with the customer satisfaction survey and said something like this:

"This is the customer satisfaction survey.  It is rated on a scale of 1 to 10.  1 is the worst and 10 is the best.  I have  to tell you that if you liked my service I would really appreciate it if you could rate me a 10.  If you rate me a 9 or lower I am out of here!  They will replace me in a month."

The first time I heard that, I thought "Incredible - this is just like the scripting that occurs at major hospitals and clinics."  Scripting is basically an exit interview set up to capture the elements of the customer satisfaction survey and inflate the scores.  The best way to get a high rating on a question about whether or not your nurse provided you with information on how to take your medication, is to have that nurse go through a standardized protocol about that right before he or she hands you the satisfaction survey.  What can you do at that point?  It just happened and it matches the survey question.  In compiling that kind of information, it should not surprise anyone when you find that all of the facilities in your area are in the 90th percentile.

I had a second thought.  I remembered the times that a patient was clearly satisfied with my work and said so right during the appointment.  Having been "scripted" about the importance of customer satisfaction at a recent staff meeting I had the thought: "Well if you really feel that way, it would greatly help me if you said that on the survey that they will send out to you on your satisfaction with my care."  I admit to thinking about it, but never said it.   I would never say it because I consider it to be a boundary violation.  Since when is it proper to suggest to a patient that they do something to advance your interests?  To my way of thinking (and the thinking of psychiatrists who preceded me) - never.  It is such a natural thought that it would not surprise me if it happens.  I think it is more likely to happen with clinicians schooled in business model of medicine.  If it was ever disclosed I can imagine that there are any number of administrators waiting to jump on it.  I can recall a physician telling me that his administrator insisted that he tell all patients coming in to see him that they need to bring in their insurance card.  He was actually reprimanded for not doing it a few times.  It only took a couple of complaints about that physician being too focused on the insurance card to get him fired by the same administrator who insisted that he should ask about it in the first place.

It is internally consistent that the MBAs who currently run America's healthcare system with seemingly little input from physicians would force the customer satisfaction issue.   They consider it a tool even though I would question its validity these days.  It seems like customer service is just common sense - why shouldn't it be rated?  There are a number of reasons.  Many ratings appear to have an unusual level of complexity.  Does it really take 10 or 20 different Likert scales or is a simple "yes" or "no" global rating better?  Clinical trials technology would suggest that there is an important role for both.  What about the manner in which the data was collected?  Should a rating that was coached by the subject who is being rating have the same validity as the rating that was not coached?  I would say no - again based on clinical trials technology.  Data needs to be collected in the same way to be comparable.  Either everybody uses scripting or nobody uses it.  There could also be a correction factor for ratings where scripting occurs.  It may result in a more realistic look at health care resources in local communities.  We also know that the way health care companies are managed has nothing to do with customer satisfaction.  One of the leading texts in how MBAs are taught shows very clearly that profitability counts and mental health services are considered the "dog" quadrant.   Are you really going to pay much attention to ratings of providers in the "dog" quadrant?  Only if you need it for leverage with those providers.  And finally does everything have to be rated?  If I am desperately searching for a way to fix my computer so that I can complete a document for a deadline, are pop-ups asking me to rate whether or not suggested fixes that did not work were helpful?  Probably not.   On the clinic or hospital rating from those questions focus on services that are peripheral to the provision of care.  How does the lack of parking or an ATM machine affect a patient's attitude toward their doctor when it comes to those ratings?

The most important consideration that nobody seems interested at all in - what is lost when we apply business ratings to physicians.  It allows us to consider that physicians are just like any other group of hucksters bound only by their ability to separate you from your money.  Caveat emptor right?  It neglects an entire system of checks and balances that have evolved over centuries from the professional relationship between patients and their physicians.  It also neglects a massive bureaucratic structure that regulates physicians and demands certain behaviors and concessions when they engage in certain types of business transactions.  Rating physicians, even with multiple Likert scales seems to put them on the same plane as the pizza delivery guy.

With the current business emphasis in medicine,  it may be that some day physicians will have the same level of responsibility as the pizza delivery guy especially if governments and business interests succeed in their efforts to erode professionalism.  Until then, I think it pays to remember that your physician is obligated to treat you in a certain way - irrespective of any rating systems.

That includes not requesting a certain rating.  



George Dawson, MD, DFAPA


Supplementary 1:  No offense to pizza delivery guys everywhere and I hope you don't have to hand out customer satisfaction surveys with the pizza.




Thursday, December 11, 2014

More On Violence And Aggression In Minnesota Hospitals

There was a recent incident (see link within that article) that occurred in a Minnesota hospital a few weeks ago that resulted in serious injuries to nursing staff.  There are various sites on the Internet where you can view the videotapes that were obtained from the hospital's security cameras.   It shows an out of control man chasing and striking nursing staff with a metal bar or pipe, in some cases repeatedly.  The patient in this case was eventually apprehended outside of the hospital and died suddenly after he was tasered, taken to the ground, and handcuffed.   Preliminary information suggested that the patient involved in this situation was probably experiencing an acute change in his conscious state because it was a total departure from his personality and he had no previous episodes of aggression or violence.  Nursing staff sustained serious injuries including a pneumothorax.  Autopsy results have not been released at this time.

Many people were shocked by this activity and yet is is a fairly common occurrence.  People may expect this kind of agitated and aggressive behavior to occur only on psychiatric units, but the reality there is that is happens only on a few psychiatric units.  Most psychiatric units are managed to limit the admission of patients with a high potential for violence.  It happens on medical-surgical units for a number of reasons and the effects are more dangerous at times because of the availability of objects that can be used as weapons.  I have seen stands used for hanging intravenous solutions being swung in a wide circle through an intensive care unit.  These stands have heavy bases that can inflict serious injuries and destroy a lot of equipment in an ICU.  There are many possible reasons for this kind of aggressive behavior ranging from delirium and psychosis on one end of the spectrum to antisocial behavior and wanting to intimidate medical staff on the other.  Although it seems incongruent with a controlled hospital environment, many families have an experience with a family member who suddenly loses control.  The proscription on aggression and violence and the moral interpretation of this behavior often makes it difficult for families to comprehend what is happening.  Families and medical professionals alike often lack the vocabulary for describing this behavior and can just lump it together as "bad" behavior.

I saw the preliminary description of this incident and the video clips and decided not to comment on it until after the results of the autopsy and investigation were known.  The idea that  this problem would be approached by making this behavior illegal made me change my mind for a couple of reasons.  First, there is a very high probability that this behavior was precipitated by a medical problem that led to a change in consciousness to the point that this individual had no control over his behavior.  Anyone who has been delirious has experienced this at one point or another.  In my own family one of the male relatives who was a well driller was apparently "blown up" in a well one day and the resulting brain injury led to permanent and extreme changes in his behavior.  From that day on he was extremely aggressive and the aggression was directed toward property.  He continuously overturned furniture and smashed dishes until the entire house was trashed.  In those days before any care or containment was available, the expectation was that the family would care for him and they did until he died.  The home environment was constantly disrupted by rage attacks until that day.  In my capacity as an inpatient psychiatrist, I would routinely see people brought to the hospital after they suddenly became aggressive at home.  When their relatives arrived they were always shocked to find that the patient had been admitted to a psychiatric unit.

My second reason for concern is the involvement of politicians in what is a misunderstood medical problem.   An acute medical problem causing aggressive behavior in not a criminal act - it is a medical problem.  Attempting to incarcerate or fine a person for aggression that occurs in that circumstance does not make any sense at all.  It may be a way to secure political capital from a special interest groups, but criminalizing a medical problem is not a reasonable approach.  Even suggesting that this is something that should be debated in a court of law is questionable.  I base that on the known track record of the not-guilty-by-reason-of-mental-illness defense.  It is widely known that there is a low probability of that defense succeeding.  It is also widely known that people who have committed criminal acts and who clearly have severe mental illness  are typically convicted.  All it usually takes is a expert testimony suggesting that despite any mental illness diagnosis, the defendant appeared to be taking planned steps to achieve a goal.  In the case of aggression those steps would involve assaultive behavior and destruction of property rather than random activity.  I can say that in every case of aggressive behavior that I have witnessed in a hospital, even in cases where the patient had no subsequent recall of the incident that their behavior appeared to be planned and the assaults were directed.

On the non-medical side of the spectrum, there are people whose conscious state is not altered at all and they have directed violence as part of their personality structure.  Threatening and assaulting people are a way of life.  They frequently have criminal backgrounds or an arrest record.  They often give a history of fighting and may have harmed someone when they were defenseless or felt no remorse if their aggressive behavior resulted in injury or disability.  In my experience the majority of these persons can control themselves in medical settings with a few exceptions.  Any drug or alcohol intoxication state makes them more unpredictable.  Seeking prescriptions for controlled substances like opiates or stimulants can also create confrontations if they don't get the prescription that they are seeking.  There may be a question about whether any special legislature penalizing what is essentially criminal assaultive behavior would be useful.  My guess is that it would not for the same reason that civil commitments fail to work - the laws are not utilized.  Hospital administrators and courts tend to ignore aggression toward medical and nursing staff from patients who are willfully directing violence toward them as a product of their usual conscious state.  Administrators always explained it to me as an occupational hazard, especially on the part of the nursing staff.  That casual attitude often leads to inadequate safeguards at every step.  There should be a zero tolerance attitude for personality disordered violence and that should include prosecutions for assault.

The key to protecting medical and surgical staff and their patients from aggression associated with acute changes in consciousness is to have a heightened level of awareness.   The patient's history prior to admission is critical.  Prompt recognition of delirium from many causes and acute drug and alcohol intoxication and withdrawal states is necessary.  Adequate staffing is critical.  There needs to be a definite team approach, all of the staff on the unit need to be aware of the potential for violence, and the priority needs to be on protecting the nursing staff delivering direct care to the patient.  Medical staff and nursing have to be on the same page and there can be no factors present that lead to split treatment.  Enlightened administrators may be helpful in preventing that dynamic, but in my experience I have not found any.

One of the common problems is that staffing on some of these cases involves 1:1 observation preferably by a trained psychiatric technician or nursing assistant who knows how to help patients de-escalate.   Just having a reassuring person in the room can often have the same effect.  There are protocols that address the physical environment to reduce the likelihood of post operative delirium.  Where necessary it is useful to have experienced staff treat acute agitation in hospital settings with medications.  Some large hospitals have psychiatric consultation 24/7 to address the problem and in some cases where the patient is medically stable transfer them to a more secure psychiatric environment for assessment and treatment.  Medical and nursing staff need to be in close contact 24/7 in order to make rapid adjustments in the treatment plan.

Making the aggressive behavior associated with explainable medical problems a crime is the wrong approach.

When I see legislators talking about what medical professionals do or do not know about containing violence and aggression my typical response is to cringe.  I put it on the long list of all of the other things that legislators think they needed to train physicians in - like how to prescribe opiates (in the year 2000) and then how not to prescribe too many opiates (in the year 2010).  There are plenty of people who come out of training who known how to assess and treat aggression.

They are called psychiatrists and psychiatric nurses.




George Dawson, MD, DFAPA            

Tuesday, December 9, 2014

Minnesota Continues A Flawed Approach To Serious Mental Illness And Aggression








I was shocked to see this article posted on a CBS web site.  I was shocked because I was completely unaware  that such a law existed.  I was shocked because Minnesota has fairly well documented problems in their state hospital system.  The state security hospital has had numerous problems with containing violence and aggression and there is no evidence that situation has been resolved.  There are very few specialized units in hospitals in the state that could potentially deal with the problems of violence and aggressive patients.  There has been no effort to modify the limited infrastructure in the state that has been the result of managed care-like rationing over the past 20 years.

The story is a lot more involved than suggested by the news article.  When I read it I contacted my state legislators and asked for clarification primarily by pointing me to where the "12 hour rule" existed in the State Statutes.  The Minnesota State Statutes are generally easy to search but I could not find it.  My state Senator got back to me and suggested that this is the rule in 253B.10 PROCEDURES UPON COMMITMENT.  Chapter 253 is the civil commitment statute and reading through this chapter suggests that transfers from jail to state mental hospitals have to be adjudicated as mentally ill by civil commitment.  Other pathways include being found not guilty by reason of mental illness, and for examination or determination of competency to proceed to trial.  Apart from the time constraint, that part of the statute does not materially alter patient flow to state hospitals.  The statute gets more interesting with the following subdivision:


Subd. 4. Private treatment.

Patients or other responsible persons are required to pay the necessary charges for patients committed or transferred to private treatment facilities. Private treatment facilities may not refuse to accept a committed person solely based on the person's court-ordered status. Insurers must provide treatment and services as ordered by the court under section 253B.045, subdivision 6, or as required under chapter 62M. 


Private facilities refuse to accept court ordered and committed patients all of the time just based on the fact that severe mental illness cannot be treated on an 8 day DRG payment that in reality is treated like a 4 or 5 day length of stay.

The article itself focuses on Anoka Metro Regional Treatment Center.  That is a state operated psychiatric facility just north of the Minneapolis-St. Paul area.  If the intent of the legislature is to alleviate crowding in jails, the writing of a statute will not do that.  If I had to estimate, the majority of inmates in county jails with significant mental illness and addiction problems are not committed and do not meet the forensic criteria suggested in the statute.  The article also illustrates the ambivalence that the state government has toward state run hospitals.  Not too long ago, the legislature wanted to close this hospital down.  Many states have adopted the managed care rationing model to mental illness.  They reasoned that the best way to "save" money is to close down state-run hospitals and clinics.  I have no doubt that the state would close it down if possible but it occupies too central a role in the civil commitment process.  There is instead a detailed political process to manage the hospital (see first reference).  That document is current, 114 pages long with 41 references to "jail" and 37 references to "aggression".  It acknowledges the role of the state in treating aggressive patients with mental illnesses. 

I have no way of knowing if any of the patients mentioned in this article requested transfer to a private hospital.  I would consider any hospital in the state that is outside of the state hospital system to be a private hospital because at this point they are all parts of private health care systems.  Only a fraction of community hospitals in the state have psychiatric units and a smaller portion of those are equipped to treat violent or aggressive patients.

I have tried to elaborate on this blog the type of structure necessary to treat people who are violent and aggressive as a result of mental illness. Any time that correctional populations are considered, the problem is more complicated than mental illness or not.  There are many individuals with sociopathy or personalities that are anti-authoritarian and with a tendency to criminal behavior.  At the extreme end a variant of psychopathy has been described where criminal tendencies, combined with a lack of empathy leads to an individual who is potentially more dangerous.  Those individuals often have a history of repeated violence against others and a pattern of planned violence as way of life.  The associated issues are that patients who are predominately personality disordered criminals are better taken care of within the correctional system.  Patients with primary mental illness who are incarcerated for non-violent crimes or violent crimes that occur only an episode of discrete mental illness are probably better treated in a mental health setting - especially if that is a continuation of their ongoing care.  Those statements are generally true because the personality disordered mentally ill will demonstrate a pattern of threatening other patients and staff with physical violence.  They may also exploit more vulnerable patients and try to intimidate them into giving them money, information, or personal favors that they can use to their advantage.  Those behaviors are goal driven, reinforced by a life of crime, and not likely to change as a result of any psychiatric intervention.

The article states that 146 inmates have been transferred from Minnesota jails to state hospitals since July 2013.  There is an eye witness account of what has occurred and a description of some of the injuries to staff including facial fractures and a torn shoulder tendon as the direct result of assaults on staff.  There is also the following statement from the affected staff person:

 And though she agrees there are other factors behind the rise in workplace injuries — a hesitance to use force against potentially abusive patients chief among them — she said she and her co-workers believe the 48-hour rule is largely responsible.

The issue of the use of physical force in psychiatric hospitals was also the primary cause of the upheaval in the previously cited problems at the Minnesota Security Hospital. A change in administration occurred to address the issue of patient injuries due to physical interventions. According to news reports that and the associated administrative measures were associated with an increase in staff injuries. We are left with the impression that there have been no effective interventions to prevent patient and staff injuries in state hospitals and the problem of aggression in these facilities has been poorly addressed. Organized psychiatry in the state has been silent on these issues.

The bottom line in this article is that it illustrates that Minnesota politicians and bureaucrats have no understanding of what is required to treat people with mental illness and aggressive behavior.  Their misunderstanding is significant and it occurs at multiple levels.  First, they have no understanding that the current system of mental health care is based on a system of rationing designed to provide minimal to no mental health care.  That all starts with hospital systems that have been rationed to the point that there are often no detectable changes in the mental health of the people admitted compared with the people discharged.  Psychiatric care in rationed hospitals is designed to limit treatment to a brief period or reimbursement.  Second, they have a track record of using mental health jargon to come up with their own diagnostic category of "sexual psychopaths" that can be used for indefinite confinement of sex offenders.  This categorization allows for diversion away from a correctional system that is apparently unable to confine sex offenders to the satisfaction of politicians and their constituents.  Third, the state managed security hospital has had a number of problems in the past few years including the mass resignation of psychiatry staff and an increasing number of injuries to hospital staff.  Fourth, Deputy Human Services Commissioner Anne Barry is quoted in the article. She was also quoted in previous articles about the Security Hospital. She attributes the problem to unintended consequences. To me that suggests a complete misunderstanding of psychiatric services in the state of Minnesota. Any psychiatrist in this state, especially if they work on an inpatient unit would be able to predict this problem. Commissioner Barry has also been quoted in the articles about the Security Hospital (see below)  Fifth, the direct quote by State Sen. Kathy Sheran also illustrates a misunderstanding of the problem. The idea that state hospitals are holding large numbers of people who don't need to be there is longstanding political rhetoric. In the absence of environments that can assist severely disabled individuals the default environments are hospitals. It is glib to say that people should no longer be a hospital when they have no safe place to live outside the of the hospital. As a reviewer of hospital admissions and lengths of stay, the presence of acute symptoms is typically used to mark who should be in a hospital. Chronic severe psychiatric disorders have a number of problems with cognition and functional capacity that lead to an inability to care for self independently of acute symptoms.  The associated political problem is a lack of funding for community based programs to resolve the problem.  As I have previously posted in many cases these community based programs that are inadequately equipped to contain aggression place both patients and staff at higher risk.

I qualify this post with the same qualifications I have put on previous posts on the topic on state run facilities.  The only source of information I have on this issue has been the press and legislative reports on mental health services in correctional facilities and at Anoka.  Media reporting of psychiatric issues and services leaves a lot to be desired and typically vacillates between blaming psychiatrists for all of the problems and tragic cases that result from a lack of services.  The only corroboration in this article seems to be the reaction of state politicians to it.  We have seen similar reactions to these issues in the press.  Unless there are some outright denials about the scope of the problem, something needs to be done.  The last thing we need is a state run Task Force or Commission investigating  itself.  The second to last thing we need is consultants hired by the state to write another report.  At this point, I don't even think that a review of the incidents is possible.

Any hospital in the state should be required to prospectively flag records based on violence, aggression and whether they were transferred from the correctional system.  All of the staff in those cases should make a recording of their perceptions of the antecedents, intervention and why it failed or succeeded, and the outcome.  Those cases should be reviewed on a weekly or monthly basis by psychiatrists with experience in treating severe mental illnesses and aggression.  That panel of psychiatrists should be carefully screened for conflict of interests, especially any financial conflicts of interest with the State or any other entities responsible for providing the treatment in question.

It is time to solve this problem.  Having the problems analyzed time after time by the same people who do not understand the problem and who can not possibly come up with a solution has not worked in the past 5 years and it will not work in the future.  Instead we have a state official charged with solving the problem saying that fewer psychiatrists makes sense and psychiatric expertise at the systems level is not needed as the system continues to collapse.  The system of state hospital care for patients with serious mental illnesses and aggression may not be salvageable at this point without realistic backing by the state.

A key part of the miscalculation appears to be casting psychiatrists in the role of generic technicians.  Of course these technicians would not have any understanding of patient centered care or a therapeutic alliance despite the fact that they have been writing about it for over a 50 years.  This accomplishes two goals at least at the rhetorical level.  It makes it seem like untrained administrators can address systemic issues of violence and aggression.  It also makes it seem like the only thing psychiatrists can do it prescribe medications - often to "stable" people.  Far too many errors have been made and public statements on the issues are consistent with a lack of appreciation of the problem and a complete lack of appreciation that psychiatrists are the only people professionally trained to provide this level of care.  This is by no means only limited to state systems.  These attitudes are prevalent in any hospital or clinic that is under the direction of a managed care system.

Will the problem of aggression in people with severe mental illness be addressed by arbitrary rules on patient flow and a treatment program that is flowing down from politicians and bureaucrats?  Will the problem be solved by a consensus of stakeholders?  Will the problem be addressed by new age jargon and philosophy?

I don't think so.


George Dawson, MD, DFAPA

Refs:

Minnesota Department of Human Services - Direct Care and Treatment. Plan for the Anoka Metro Regional Treatment Center. Direct Care and Treatment and Chemical and Mental Health Services Administrations. February 18, 2014

From the above document:  "Jails also count on AMRTC to take people whose criminal behavior is determined to be the result of mental illness (a new law requires that AMRTC accept referrals from jails within 48 hours of referral). Because of insufficient capacity in the service system, there are lengthy waiting lists for AMRTC beds"  (p 61).



Supplementary 1:  A previous quote from Commissioner Barry: "DHS officials say the facility no longer needs as many psychiatrists because many of the patients are stable and only require psychiatric visits once every three months. In addition, Barry said, the importance of psychiatrists at the facility has lessened over the years. Psychiatrists are just one part of the treatment team, she said. Nurses and psychologists also play an important role in patient care, and in many cases, advanced practice nurses can handle many of the tasks that used to be the responsibility of the psychiatrists, she said."

Supplementary 2:  I was unable to find any statute that described this 48 hr transfer rule.  I have asked my state representatives for assistance since it may not be a statute.  Corrected as of 12/9/2014 with the statute posted above.

Supplementary 3:  If you currently work in a non-state funded psychiatric unit and have received these transfers from correctional facilities please post your experience in the comments section below.  Feel free to post them anonymously and in a way that does not indirectly identify you or the facility that you work at.





Thursday, December 4, 2014

Marketing, Advertising, and Safeguarding Objectivity

blame (third-person singular simple present blamespresent participle blamingsimple past and past participle blamed)
1.     To censure (someone or something); to criticize.  [quotations ▼]
2.     (obsolete) To bring into disrepute.  [quotations ▼]
3.     (transitive, usually followed by "for") To assert or consider that someone is the cause of something negative; to place blame, to attribute responsibility (for something negative or for doing something negative).


To provide context for this post, I refer any interested readers to the previous post and the comment by Steven Reidbord, MD.  I started typing up a response and decided to just continue it into this post.  I like to post things in regular blog format, because the comment section is uneditable and I make frequent spelling and grammatical errors.  My intent is to provide my perspective rather than disprove any of Dr. Reidbord’s points which are basically critical points about assigning blame, the standard of proof that physicians are affected by marketing and advertising, assertions about the connection between all of the marketing components and the profits of pharmaceutical companies and the need for physicians to “safeguard” their objectivity.

On the issue of blaming Big Pharma, of course they have done all of those things.  I would expect them to because that is typical behavior of corporations.   There are some people that believe this indicates that all corporations are evil.  There is also a blanket level of condemnation of the industry independent of any specific legal charge or incident.  You can certainly find rhetoric against all industrial sectors.  Nobody seems to acknowledge that governments have developed this landscape, including a regulatory landscape that encourages individuals to take risks without worrying about any personal or criminal penalty.  Litigation for large corporations is seen as the cost of doing business.   It seems that if anything, the law is written to incur legal activity and legal fees.  It is probably no accident that most lawmakers are attorneys.   I am no more outraged about Big Pharma corporate behavior than I am about any other industry. 

Before anyone tells me that medical industries are somehow different because they deal with peoples’ lives, if you think about it numerous industries deal with peoples’ lives.  Some are actually toxic to peoples’ lives.  Others  (like medicine) have affiliated professionals with professional responsibilities but unlike physicians those professionals (who also work with industry and receive benefits from the industry) are seldom scapegoated because of it. 

On the issue of marketing, I have made the same arguments that Dr. Reidbord makes to Big Pharma critics for at least a decade.  I am usually met with the response that physicians have a higher calling and that we must somehow place ourselves above advertising so that we are not commercially influenced.  The corollary is all of the “proof” that advertising and marketing influences purchasing and therefore prescribing behavior.  There are many problems with the analogy and that argument.  First, the proof generally refers to a fairly loose body of literature with poorly stated hypotheses and experimental designs that are either nonexistent or inferior to any clinical trial designed by Big Pharma.  I am happy to entertain any evidence for this connection in the event that I have missed something.   Apart from lack of the experimental evidence, it defies common sense.  I am unaware of any multi-billion dollar product-based industry that thrives on advertising an inferior product and not backing it up with anything.  To use the automotive example, if I unwittingly purchase a Toyota based solely on a flashy ad and discover it is a lemon, I may conclude that this is an aberrancy or that all Toyotas are lemons.  Either way they are unlikely to find me as a future customer.   That is not a sustainable business model.  The general assumption about pharmaceuticals is that physicians don’t seem to be able to self-correct by noting deficiencies including a lack of efficacy during hundreds or thousands of prescriptions.  I find that to be much more likely that noting your car is a lemon.  With prescriptions physicians are professionally accountable to purchasers.  That is a higher standard than losing time or money on a car.  Second, if I respond to marketing and go down to my car dealer for a $500 cash rebate, 0% financing, or some other incentive, I will not be placed in some national database that can be used to suggest that I am morally inferior to physicians who are not in that database.  Oh sure,  there will always be the usual disclaimers that being listed in the database is really an appearance of conflict of interest rather than actual conflict of interest, but the implication of wrongdoing is palpable and usually evident by what is being written about this list.  Third, the reality of a general lack of effective medications is never really acknowledged.  I have never seen a study about marketing pharmaceuticals that takes that into account.  It is common in clinical practice even before the advent of DTC advertising to see patients who were desperate to try the next new drug on the market.  In many cases we are still looking for a reliable car in a field of Yugos.  We are not looking for a Corvette.  Does that mean we have been influenced by advertising?  Does that mean that the patient/consumer has been influenced by DTC advertising?  It may simply mean that we are faced with a large number of drugs with a lack of uniform efficacy and significant toxicities.  Fourth, there is an overgeneralization of an imaginary boundary problem between pharmaceutical companies and physicians that seems to flow from the marketing rhetoric.  Suddenly companies are not only marketing drugs, they are selling medical diagnoses and treatment guidelines.  Managed care companies and PBMs get a complete pass on this issue and the idea is that the Big Pharma-Physician alliance is in lock step to sell as many drugs as possible.  That is a rather pathetic characterization of the problem and the pat solution of cutting all industry ties is an equally pathetic pseudosolution.   I do consider the business end of Big Pharma to be marketing and advertising.  I think the effect of that marketing and advertising is a vastly overstated political argument.  I think it is hubris to imagine that physicians can’t self correct in the way that any consumer self corrects when purchasing any advertised product.

With regard to what is necessary – like most criticism of Big Pharma nobody is ever really explicit about their meaning.  Practically all articles written about Big Pharma marketing/advertising tactics especially those that involve physicians imply that everyone in that chain of events is working to enhance the bottom line of the pharmaceutical company.  Working for the monied interest of a pharmaceutical company is the conflict in conflict of interest. If you are asking the question: “Who said this was necessary?” I guess my answer would be; “Just about everybody.”

The last question that I hope to address is the idea of “safeguarding” one’s objectivity.  In the previous response the idea was that the physician psyche is so frail and easily persuaded that we need to avoid all contact with Big Pharma advertising.  If that is the case there are many other sources of discordant special interest information that we should avoid like the plague including less competent attending physicians and colleagues, less dynamic medical school lecturers, all forms of managed care, most hospital and clinic administrators, most media outlets and most federal regulations on billing, coding, and documentation.  Off the top of my head I could add previous standard medical practices like the Swan Ganz catheter,  massive back surgeries for back and neck pain, chronic high dose prednisone for COPD,  and meperidine injections for migraines.  The list is endless.

If my objectivity was that tenuous I would be sitting in a dark room somewhere practicing psychiatry the way it is described in the New York Times.   I would be depending on a blog or pious journal editors to keep me honest!  
   
I have no conflict of interest to declare.  I have rigorously avoided Big Pharma advertising and detailing long before it was fashionable to do so.  My interest in avoiding Big Pharma advertising was that I found it to be disruptive, annoying, and demeaning - largely to the reps seen lugging food up and down hospital and clinic hallways.  I will probably never consider myself too stupid to figure out advertising even at the purported mind-control levels.  If anyone reading this disclosure doubts this statement – feel free to look for my name in the database of corrupted (or not) physicians.
 
As a further point of disclosure, I drive a Toyota.  I have a general policy of driving a car until the 150,000-200,000 mile mark and then buying a new one.   I find that by that time most cars have multiple systems that start to fail and it becomes a long series of expensive repairs and safety problems.   I have been driving Toyotas for 10 years and that follows a long line of Chevrolet, AMC, Plymouth, and Pontiac products.  Irrespective of the advertising, my personal experience is that it is the most reliable and cost effective ride for the money. 

Those are my only interests in both Toyotas and new pharmaceuticals. 

  
George Dawson, MD, DFAPA


Supplementary 1:  Posted definition at the top is from Wiktionary per their open access agreement. I intended to use it here more as a graphic than text as a lead in to the article.  

Supplementary 2:  For anyone considering a post here as a comment - please consider composing your comment in a word processor and cutting and pasting it in here.  The comment section on Blogger is not a reliable area to compose and edit comments.  I have lost several myself and the text may be too small to edit.  If the comment appears to have been posted but it does not appear - please send me an e-mail.  It occasionally gets diverted to a spam folder and I can still retrieve and post. 



    

Monday, December 1, 2014

The Increasing High Cost of Generic Drugs

















With all of the drama about high pharmaceutical drug prices, the marketing behavior of the Big Pharma biz, and the medicalization of American society - there has been very little said about the generic drug business.  I discussed it in this piece about the DSM-5 and an absurdly high anti-depressant profit attributed to the pharmaceutical industry.  One of the highlights was how inexpensive some of the most well researched and recommended  antidepressant drugs were.  Then just this weekend I got a call from a friend who was taking an antidepressant who told me that his cost went up by 25% on the medication he was taking on the same insurance plan.  As any psychiatrist knows it is practically impossible to advise a patient on what they will end up paying for an extended release version of venlafaxine, even though it has been generic for a while.  Any attempt to find out online results in a confusing blend of American and Canadian prices.  Some of the Canadian prices on the same list exceed what would be paid in the US.

I caught an article by Hirst, reproduced in my local paper this weekend.  She describes a patient who was taking generic carbamazepine.  Carbamazepine has been generic for years.  I can recall prescribing the generic 15 - 20 years ago for patients with bipolar disorder.  This patient had been taking the medication for epilepsy and getting the drug through Walgreen's Prescription Savings Club.  He was paying $20 for a three month supply, but recently the price increased to $100.  That forced him to buy it on a month to month basis.  My drug information suggests at least 5 generic manufacturers and the original name brand along with a sustained release patented version are all on the current market.  Senator Bernie Sanders (I-Vt) is quoted:  "....We wanted to know if there was a rational economic reason as to why patients saw these price increases or whether it was simply a question of greed?"  The federal government tightly regulates health care with special attention from the Department of Justice - how could dramatic price increases in the face of ample competition be a matter of greed?  Wouldn't there need to be a cooperative effort on the part of all competitors to drive up the prices that fast?  The article cites "raw material shortages, consolidation in the industry and medical advances that make replicating brand name drugs more expensive".  I don't accept that explanation any more than greed.  One of the most expensive medications to manufacture in recent times was atorvastatin.  When it first came out, I spoke to a scientists involved in the production and he told me what it cost per pill to manufacture.  That cost was a small fraction of the overall prescription price.  That leads me to believe that even a $4/month prescription for ranitidine can lead to profits for a generic manufacturer.

The Hirst article quotes a pharmacy benefit manager as saying that average cost of a generic drug prescription has increased from $14.21 in 2005 to $41.88 in 2009 and that 1/3 of available generics cost more than $100 per prescription.  Another consultant suggested that acquisition costs of pharmacies have increased 17,700% in the past year.

A more academic article is available from the New England Journal of Medicine by Alpern, et al.  Those authors look at the specific example of albendazole, a broad spectrum anti-parasitic with a long expired patent.  In 2010, the average wholesale price (AWP) for a single day dose was $5.92.  By 2013 it was $119.58.  The authors look at the National Drug Acquisition Costs file and cite a number of significant price increases in widely known generic drugs including captopril, clomipramine, digoxin, and doxycyline.  They have produced an excellent graphic that looks at the number of prescriptions and global Medicaid budget for mobendazole and albendazole and the factors that led to the significant price increases for the latter.  In this case it seems like a lack of competition as being the limiting factor and the authors cite that "drug shortages, supply disruptions, and consolidations within the generic drug industry" are all factors that decrease competition and therefore may increase prices.  They also described the generic drug approval process as slowing down competition especially in a market where a delay in implementation of the generic can cost additional tens to hundreds of millions of dollars.

Both the NEJM article and the Chicago tribune article have a supply side emphasis.  Adequate competition and innovation in a free market increasing supply and driving prices lower while maintaining high value to the consumers.  But there is another story.  Demand for pharmaceuticals is relatively inelastic.  That means that if there are price increases buyers cannot postpone their purchases for a better day without the risk of significant and in some cases life-threatening consequences.  That inelasticity is compounded by several recent factors that lead the further complications.   The first is the advent of high deductible health insurance plans.  The majority of employers use these plans largely because managed care has failed to contain costs and costs to their employees are generally shifted to that risk pool in the subsequent year.  This puts anyone with high deductibles at significant risk for out-of-pocket costs until that deductible is satisfied.  Any drug manufacturer can expect to receive significant out-of-pocket payments while the deductible applies.  The second is the advent of "tiered' coverage based on the insurance plan.  This usually involves a steeper copay for an insurance plan that covers less.  The real risk is that the patient may decide to simply forgo the prescription, but until that point is reached there is a good chance that they will pay significantly more than the lowest generic price in the drug class.  The current system of government sanctioned managed care and inelastic pharmaceutical demand places all Americans at financial risk since it is essentially a tax and in many ways an entitlement to health care companies including generic drug manufacturers.

The other obvious factor that none of the authors comment on is that some pharmaceuticals remain top selling drugs despite the fact that they are now generics.  In some cases like Advair Diskus, the drug is in a unique delivery system that is also patented.  Anyone using Advair is very likely to want to continue to use this delivery system whether or not it is a generic drug or not and the price remains high.  In another example from asthma care, numerous metered dose inhalers underwent a regulatory change in propellants from chlorofluorcarbons (CFCs) to hydrofluoralkanes (HFAs).  That was accompanies by a patent and an immediate and significant price hike to anyone using these inhalers.

I think that this trend is instructive for a number of reasons.  First, it illustrates that when it come to pricing of any pharmaceutical product it is more complex than just monopoly power.   There are clearly market forces in play that will escalate the prices of drugs that have been around well past the patent expiration date.  Conversely, there are many medications that have no pricing power and to the concern of patients and physicians they are just no longer manufactured.  It is easy to understand why generic drug manufacturers are unwilling to maintain a large inventory just so Wal-Mart and Walgreens can have a $4 per month formulary.  Second, it shows that there is a potential for significant distortion of markets being introduced by managed care  companies and their government counterparts.  Rather than the idealized "cost effectiveness" some of the arrangements out there are anything but cost effective and my example of how saving pharmacy costs can explode the cost of care in another direction is a case in point.

Most significantly, we have gone through a period of blaming the name brand pharmaceutical industry (otherwise known as Big Pharma) for a number of problems.  They have been blamed inadequate disclosure of clinical trials data, distortion of clinical trials data, ghost writing articles for physicians, and misleading marketing practices.  Critics also have the usual complaints about efficacy and side effects but seem to miss the regulatory goal of getting a relatively safe and effective (but not perfect) drug into the market for use.  They seem to get a pass  on their influence at the FDA and in fact, some critics seem to think that they can create an idealized regulatory agency that is free from political influence.  These critics seem to suspend the reality that pharmaceutical companies are businesses and that the people on the science end of those businesses in all likelihood have no idea about what is going on at the business end.  The explicit motivation according to the critics is money - the fuel of all businesses.  The generic drug industry (Little Pharma?) has a much smaller marketing infrastructure.  Research and development costs are much less.   They aren't detailing physicians. Until recently they were viewed as the saviors of the patient with little resources and a definite positive for every managed care company looking to enhance their bottom line by lower pharmacy costs.  They were the antidote to Big Pharma.  Despite all of the positive spin there has been a 300% price increase in 5 years for generic drugs.  I don't think I am going too far out on a limb here to say that generic albendazole may be one of the most profitable medications ever made.  Politicians are starting to make noise.  Can physicians be implicated like they were in the Big Pharma scandals? I don't see how, but nothing coming out of Washington would surprise me.

But the real silence here seems to be all of the Big Pharma critics.  We have a generic drug industry with no real explanation for huge price increases at least nothing we can easily attribute it to.  Instead of saying that Big Pharma unconsciously influences physicians into prescribing their expensive drugs, we have hundreds of thousands of physicians consciously trying to prescribe the least expensive drugs for their patients and they are now failing to do that on a regular basis.  Maybe the appearance of conflict of interest isn't quite the theory it was cracked up to be?

Where are the Pharmascolds with their theories?    


George Dawson, MD, DFAPA

Refs:

1.  Ellen Jean Hirst.  Generic drug prices skyrocket in past year:  They were supposed top be cheaper but market forces have intervened.  Chicago Tribune  11, 30, 2014.

2.  Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs--implicationsfor patients and policymakers. N Engl J Med. 2014 Nov 13;371(20):1859-62. doi: 10.1056/NEJMp1408376. PubMed PMID: 25390739.

3.  National Drug Acquisition Costs.  Page with multiple files.  This is a large document with over 600 pages and 20,000 medications listed by NDC number.  For a sample click on the graphic below and discover why aripiprazole (Abilify) is such an expensive medication.