The Luck Of The Ethical Researcher

“My point here is that when discussing an actual case, the ideological wars melt and people from multiple sides of a debate can usually agree. "Clinician trumps Ideology." 

From 1BOM March 30, 2015 post.



Not sure that I follow that line of thinking.  That has not been my experience in psychiatry or any other medical specialty.  There is plenty of ideology and a lack of technology across the board.  There is also the dirty little word that nobody likes to see affiliated with medicine and that is politics.  As far as I can tell a lot of the ethical debates in medicine are all politics. I can point out several on this blog.

There is also the question of uncertainty.  I can recall being a grunt in a new drug protocol that I will not name but I will say it is in a therapeutic class almost never prescribed by psychiatrists.  My job was to do the medical and psychiatric evaluations and assure that the patients were medically fit to continue the protocol.  Part of the weekly screening was an ECG. I looked at this patient’s ECG, determined it had been changed and told the monitor that I was stopping the protocol.  The monitor got very angry at me because the patient was 2/3 of the way through the protocol and would not count as a completed patient.  I referred the patient immediately to a medicine clinic and they agreed the ECG was changed.  The patient was advised to come back for routine follow up care.  They could not comment on the study drug and they did not recommend any acute care. The monitor remained angry, but I stood my ground and the patient was taken out of the study and referred back to medicine.

A week later the patient had a major medical complication and ended up in the ICU. The monitor and the chief investigator both thanked me for taking the patient out of the protocol at that time – one week later.  The monitor apologized for getting irate with me.

So the rub is – am I more “ethical” than the monitor (who was not an MD) or am I just lucky? Uncertainty certainly can make you look like a hero or a zero in a hurry in medicine.  In this case an internist did not have any reason for concern even though the ECG was clearly different. Was the ECG change causally connected to the ICU incident?  Was it casually connected to the study medication?  Or was the decision to stop the protocol more related to my blue-collar anti authoritarian roots?  To this day nobody knows (but as I age I am more inclined to credit the roots).

And what if I had no markers and the person had stayed in the protocol and ended up in the ICU on the study medication?  Certainly the company and the FDA would have investigated the study and me and my methods.  Would I have been vilified as just another researcher working in the interest of a pharmaceutical company?  Would it have been good press for somebody trying to benefit at my expense?  My only thoughts at the time were in the interests of the patient.  But that difference in course could have been career changing for me, despite the fact that my only interest then and in the past 30 years has been patient safety.

Situations like this are easily politicized and there is a very porous boundary between politics and ethics.

George Dawson,  MD, DFAPA

Supplementary 1:  For the whole story go to the 1BOM blog and start reading at the link.

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.

WIll Integrity Save Psychiatry?

The answer is - it  depends on how it is applied.

In the last two days, I have seen the integrity argument pulled out.  Allen Frances is still using his bully pulpit on the Huffington Post, where it seems that anything critical of psychiatry is readily posted.  In this case, he used the text of a blogger and the timeline created by this blogger to illustrate how there was no disclosure of a conflict of interest by a group of researchers, one of whom was the chair of the DSM-5 Task Force.  The APA investigated this and acknowledged the non-disclosure of the conflict of interest.  Apparently the acknowledgement in the form of an apology from the research group and the investigation by the APA is not enough for these critics.  The blogger Dr. Nardo suggests that an "outside panel" be appointed to review his findings and the original materials again.  I cannot think of how an "outside panel" could be convened.  I have never really seen an objective analysis by an outside panel and wonder who might be selected.  And yes I am suggesting that any outside panel would naturally have a significant conflict of interest.  There appear to be many critics of psychiatry and only weak defenders.

He refers to a post by an anonymous web professional Neuroskeptic who summarized the state of things in his post as there being "no smoking gun."  He also concludes that the idea of a psychiatric critics benefiting from book sales with the same theme suggests "by which logic, every author in history has had a financial conflict of interest in their own ideas." As a student of conflict of interest that IS a logical conclusion, especially when I see links to two of Dr. Frances' books listed right below the Huffington Post article.  It is also an obvious fact that people routinely deny that applies to all human endeavors.  If I am heavily invested in any subject my "ideas" can be counted upon to be fairly subjective and consistent with my self interest whether that is academic or financial.  That is why I have read thousands of articles in Science, Nature, and medical journals in the past three decades and very few have panned out.  At a larger level it is why Ioannides could declare that most published research is false.  It is why you can count on seeing significant side effects from practically every medication approved by the FDA as safe and effective.  So yes, I am afraid that same standard applies to the critics as well as the people doing the heavy lifting and trying to prove something in the first place.  I would even take it a step further and suggest that the same transparency rules should be applied.  How much money can you make as a critic of psychiatry or the DSM?  My guess is plenty.

Both Dr. Frances and Dr. Nardo seem to be suggesting that all of the conflict of interest issues of academic psychiatrists and the way the APA handles them is sending psychiatry to hell in a handbasket.  This is a historically incorrect view of the dismantling of psychiatry in the United States.  Every day people in this country are getting inadequate psychiatric care.  It has nothing to do with the ethical behavior of academic psychiatrists.  It has a lot to do with the fact that the APA is not a very politically savvy organization and there are massive conflicts of interest interfering with the delivery of psychiatric care.  Here are a few scenarios:

1.  A depressed or psychotic but nonfunctional person is discharged from the emergency department because of a lack of "acute dangerousness" criteria.  The family is outraged but they are told: "Look there is nothing we can do because he/she is not imminently dangerous to themselves.  Upon further investigation the state has a "gravely disabled" criterion in the commitment statutes but it is practically never used.  They find that local hospitals and courts never use that criteria because the patients admitted are too difficult to treat and place.

2.  A person with acute alcohol and benzodiazepine withdrawal is sent home from the ER with a bottle of lorazepam and advised how to detoxify themselves.  They go home and take the entire bottle to get high.

3.  A person with alcoholism and depression is admitted for suicidal behavior.  She was intoxicated, depressed and staring at a handgun.  The next day the attending physician is contacted by a psychiatrist/utilization reviewer from the insurance company who has concluded the patient is no longer suicidal and they can be discharged.  He will no longer authorize payment for inpatient treatment. 

4.  A pharmacy benefit manager refused to refill a 2 week prescription by a patient's psychiatrist.  They have the pharmacist faxes a form to the psychiatrists office saying that they will only accept a 3 month prescription.  The psychiatrist takes time to explain first to the pharmacists and then 2 different people at the PBM (total time 30 minutes) the rationale for not giving a large supply of medication to a chronically suicidal patient.  The PBM refuses to change their position.

5.  A managed care company refuses to cover psychotherapy provided by a psychiatrist.  The psychiatrist explains that he is an expert in this type of therapy and the patient has been referred to him by the patient's primary psychiatrist.  The managed care company authorizes 3 "crisis sessions".  

6.  A person completes a PHQ-9 scale in their primary care clinic and they score an 18.  They see their primary care physician and say they would like to see a therapist.  They are told to take an antidepressant and to come back in two weeks to fill out another PHQ-9.  Total time of the visit is 5 minutes.

7.  A person is seen in their primary care clinic and in 20 minutes is told by their nonpsychiatric physician that they have bipolar disorder.  They are prescribed quetiapine, citalopram, and divalproex.  Within several days they are too sedated to function at work.

The are just a few examples of thousands of people everyday who are receiving grossly inadequate care based on a specific ethical principle of physician behavior.  That is the physician makes an assessment and prescribes care in what he or she believes is the best interest of the patient.  That is the contract.  There is no insurance company or government bureaucrat involved.  There is no restricted access to mental health care or pretending that primary care physicians are psychiatrists.  There is no remote "assessment" by a physician employed by a managed care company that prioritizes the financial well being of that insurance company or pharmacy benefit manager over the patient.  In fact,  I do not understand how that is ethical behavior at all.

That is the basis of the decline of psychiatry in this country.  It has taken a proportionately larger hit than any other specialty.  It is documented in detail on this blog and in E. Fuller Torrey's recent book.  The adventures or misadventures of academic psychiatrists are relevant only insofar as the APA seems to use the President of the APA as a position that academics cycle in and out of.  The idea that "psychiatrists in the trenches" are poorly represented by such a system is accurate with two possible exceptions that I can think of.  Psychiatrists in the trenches are also poorly represented by criticism of academic psychiatrists and their conflict of interest agreements and personal employment contracts.  It does nothing to address the central problems of the specialty, provides no tools that front line psychiatrist can use against all of the real conflicts of interest they face on a day by day basis, and is generally demoralizing.  Before any critics suggest that I am supporting a "whitewash" - put yourself in the position of a psychiatrist who has just put in a 12 hour day taking care of 20 inpatients and putting up with passive aggressive and aggressive MCO and PBM reviewers who have been wasting your time and interfering with your care.  You go home to read the paper and suddenly there is a major story of how unethical psychiatrists are - based on the appearance of conflict of interest.  You try to remember that last time you saw a CME event that was sponsored by a pharmaceutical company.  Then you check your files to make sure you have enough CME credits for relicensure.  As an added piece of information that same psychiatrist doesn't really care about Section 3 in the DSM-5 or the issue of dimensional versus categorical diagnoses.  They have not blinked an eye with the release of DSM-5 and won't in the future.

That is how the psychiatrist in the trenches experiences this academic exercise in conflict of interest.  I say if you want to pull out an ethical argument and use that to help front line psychiatrists, it needs to be focused on the obvious targets in managed care and the government bureaucracies that support them.

You know - the real forces dismantling psychiatry (very effectively I might add) over the past three decades.

George Dawson, MD, DFAPA