Medicine to Psychiatry to Parking Lot: The Evolution Of Detox Over The Past 30 years

There is probably no better indicator of discriminatory rationing in the business run era of health care than the way substance users, alcoholics, and addicts are treated.  If you think about it - this is the ideal population to discriminate against.  In the severe situations where hospital detoxification is needed most of these folks are isolated and they have burned a lot of bridges.  They don't have a lot of friends and family members advocating for medical resources.  Most are unconcerned about their own health and many have significant medical morbidity associated with the addiction.  With any addiction, the tendency to continue the addicted states governs decision making so they enthusiastically leave medical facilities without addressing the problem as soon as a physician gives them clearance to go.  They are quite happy to keep bed occupancy and length of stay to the very minimum.  That is if they get admitted at all these days.

Back when I was in training as a medical student, I was fortunate to get most of my clinical training in large public facilities like county hospitals or VA hospitals.  In those days, patients with alcoholism or addictions who needed detoxification were admitted to Internal Medicine Services.  This was a great idea for several reasons.  Many people with addictions have significant medical comorbidity either independent of the addiction or due to it.  I saw many cases of acute pneumonia, pneumonia and meningitis, acute hepatitis, cirrhosis, pancreatitis, hepatic encephalopathy, delirium tremens, withdrawal seizures, and Wernicke's encephalopathy.  I don't think there is any better place in a hospital to address those problems than under the care of Internal Medicine specialists.  Until you have seen enough people critically ill and in withdrawal - it is difficult to appreciate the life-threatening aspects of intoxication or withdrawal from an addictive substance.  At some point in the mid to late 1980s, the detoxification landscape changed dramatically.  Suddenly a large number of those patients needing detox were sent to psychiatry services.  Only the obviously ill and delirious could get admitted to Medicine.  After the triage decision in the Emergency Department (ED) it was up to Psychiatry to sort out the problems and treat them as well as doing the detoxification.  There was also the development of county detox units, basically as a safer environment than the street, but offering little to no medical detoxification services.  If a patient went to a county detox unit and had a seizure there or became delirious - they could always be sent back to the ED.

A few years into my inpatient career. utilization reviewers started to deny the cost of care for anyone on my unit getting detox services.  That included people with the highest risk profile - depression, alcoholism, and suicidal ideation or behavior.  The primary rationale of these reviewers was that the patient did not require detoxification on an inpatient unit - even if they were in active withdrawal, taking high doses of detox medications, and had been discovered attempting suicide prior to admission.  The denial was based on an addiction or alcoholism and the fact that managed care companies had mandated that it was no longer an acceptable reason to treat somebody in a hospital.  The year was about 1990 and it was clear that this was a blanket denial of anyone with an addiction.  That had the predictable effect of inpatient psychiatry no longer being a resource for safe medical detoxification.  We are still dealing with the fallout from these business decisions 26 years later.  The fallout takes several forms including:

1.  A loss of infrastructure - there are no longer a significant number of Internists or Psychiatrists who routinely diagnose and treat withdrawal states and the associated addictions.  Most hospitals in any state do not have these services with the exception of the occasional person who is agitated or delirious in the ED and requires intubation and ICU support.  One of the frequent suggestions I hear about the current opioid epidemic is whether or not physicians are adequately trained in addictions.  With the loss of a detoxification infrastructure, I doubt that medical students and residents are seeing anywhere near the number of patients with addictions that they need to see relative to 30 years ago.

2.  A proliferation of inadequate detoxification facilities - a lot of the current facilities are run by counties and there is no medical aspect to treatment.  Decisions to get medical assistance may be made by someone with no medical background.  These facilities do not have environments that are managed to provide a calm and non-threatening atmosphere.  Many people admitted to them are fearful of the other patients and see the detoxification as a penalty.  They leave as soon as possible - even if they are still experiencing withdrawal symptoms.  Some of the facilities will only accept patients with a positive blood alcohol level by breathalyzer, and they discharge people when their estimated blood alcohol content reaches a certain level.  If you need detoxification from a sedative hypnotic or an opioid or several compounds -  you are out of luck.

City and county jails also double as detox facilities, in the same way that they double as psychiatric hospitals.  A common history is a patient on methadone or buprenorphine maintenance who is incarcerated, not given their usual maintenance medications and who is forced to go into acute withdrawal.  People who have been taking sedative hypnotics or using alcohol can also go into acute withdrawal that is potentially more serious.  Correctional facilities need systems in place to assure adequate and safe care for incarcerated individuals to prevent these acute withdrawal syndromes.  There are always a number of people with alcohol and drug use problems who die while they are incarcerated and as far as I can tell - these deaths are never investigated to determine if they received adequate medical and psychiatric care.

3.  A proliferation of "outpatient detox" - I can't really pinpoint when it became acceptable for patients with uncontrolled alcohol or drug use to suddenly manage their own detoxification using addictive drugs, but it is a common scenario these days.  Go into the ED with alcohol withdrawal and leave with a benzodiazepine to take on a scheduled basis.  Nobody should be too surprised if that medication is ingested at a higher than directed rate.  At times the entire bottle is taken on day 1.

4.  A disrupted spectrum of addiction care - apart from preventing life-threatening complications, the main reason for detoxification is to disrupt the cycle of addiction so that the affected person can get past all of the negative reinforcement (cravings, preoccupation, physical withdrawal symptoms) that keep the addiction going.  Without this modality, people are at home trying to cautiously taper off a drug or alcohol.  Many will go on for years without any success and they will be frustrated by the lack of abstinence or sobriety and give up.  Some with leave a clinic or ED with a supply of medication in order to try to detoxify themselves and realize that they are not able to take that medication on the suggested schedule to complete a safe detox.  Many will feel guilty or ashamed about going to AA or NA meetings while they are still using drugs or alcohol and give up.  Adequate detox avoids all of these problems with a rapid and safe approach to the initial stage of recovery from addiction.  

5.  The myth that business managers know what is best - the managerial class in America continues to run medicine without any knowledge of measurement, statistics, or quality.  In this case the logic seems obviously wrong.  Since the need for medical detoxification is an emergency it should be difficult to deny coverage for this condition.  That denial has been more or less routine and the cumulative denial has led to a serious degradation of services available for alcohol and drug use problems.

When I think about how medical treatment is supposed to work, every health plan should have adequate residential or hospital detox services for quality, safety and continuity of care.  Those facilities need to be more than holding tanks.  The environment has to be respectful, quiet, and comfortable where every patient feels safe and like they are being provided adequate care.  Active psychiatric consultation needs to occur because of the high comorbidity of psychiatric problems with addiction.  The current opioid epidemic has precipitated a discussion of improving the infrastructure to treat addiction.  That would not be too difficult since a large part of that infrastructure has been rationed out of existence in the last 20 years.

This sequence of events also has implications for all of the ideas about mandated physician education about opioid prescribing.  In some states the requirement is extensive and in many at this point it is mandated for licensure.  These mandates are shortsighted without the necessary infrastructure.  Addiction and detox services require administrative support and not administrative rationing.  Mandated education for physicians in not likely to do much good as long as they are sending addicted patients out with a bottle of medications and they end up detoxing in the parking lot.

It is time to drastically improve the treatment of all patients with alcohol and substance use disorders and stop the long-standing discrimination against them.      


George Dawson, MD, DFAPA

Closing In On Retirement

A happy retirement dream:  I am walking along the edge of a canyon that I have walked many times before.  In physical reality this canyon does not exist.  There is a large herd of buffalo stampeding through the canyon and making a lot of noise.  On the opposing ridge there are 5 or 6 wolves trailing the herd.  I see a family to my right and step into their yard to warn them about the wolves.  The father reassures me that everything is under control and there is nothing to worry about.  He has three small children playing behind him.  He introduces me to a friend who I recognize from college and who has not aged well.  I am sure that I remember his name but don't say it just in case I am mistaken.  I realize that I am late and need to take a test, but it is a long way back to town.  I think about asking my brother to pick me up and take me there - but I am already 15 minutes late.....


Closing in on retirement is not what I expected.  I can remember sitting in 8th grade English class and wondering what it would be like to live to the old age of 40.  Now that I am well past that and surprisingly healthy what is the best way to transition?  Many people who retire these days are in a similar position. Chronic illnesses are better managed and most people anticipate a phase of active retirement, before moving on to less activity.  One of the critical questions is how to make that transition as a professional.  Besides feeling fairly healthy and fit, I also feel like I am at the top of my game as a psychiatrist.  At a time when most psychiatrists are over the age of 55, should I try for a more gradual transition from patient care and teaching?  Or should I just walk away?  A lot of people seem to think that they have the answer.  They have observed my work habits that included too many hours and too few compromises and have concluded "You will never retire!"  The psychiatric colleague who I have known the longest has concluded that about herself.  She thinks that she will end up being  carted away some day from the job that she has worked for decades.  I know I could not do that because I walked away from that setting 6 years ago - burned out and fully intending to call it quits.  When you work a job for 22 years, it is easy to lose sight of the fact that there are many more reasonable jobs out there.  Some of us just hunker down in longevity mode and don't see it until a crisis hits.

I put some preliminary communications out there.  I concluded a couple of years ago that the most rewarding and efficient use of my time would be teaching - preferably psychiatric residents.  Residency programs are much different today than when I was a resident.  Business management has basically corrupted them.  Today it is virtually impossible to be teaching clinical faculty anywhere and not have the same productivity expectations as psychiatrists in private practice.  In other words there is the expectation that you can see large numbers of patients and continue be an innovative and creative teacher.  Your salary is "justified" by the amount of billing that is generated.  That has never really worked for me.  I just attached one of my old storage devices to my current network this afternoon.  Sitting there on that drive was a series of 10 PowerPoints on psychopharmacology from 2008.  They were all 2 hour lectures and I came up with them from scratch after meeting with the residency director of a program I was affiliated with.  The residents that year had requested that I teach the psychopharmacology lectures.  I had peripheral involvement with the program until that point - largely due to the administrative restrictions.  She thought it was really important for me to do it and I agreed that I would, but it was a significant time penalty for me.  There was no productivity credit for preparing and delivering the lectures and no additional reimbursement.  It was all done on my own time after taking care of all of the clinical work, billing and documentation.  All done late at night and on the weekends - free gratis.  Despite that, I was confident that I did a good job and the residents appreciated the work.

The point I am at in psychiatry, I am confident that I can teach nearly anything and do a good job of it.  I am not confident at all that I want to transition into retirement seeing 75 - 100 very ill polypharmacy patients and teaching residents how to tweak that polypharmacy.  You really don't need an experienced and knowledgeable psychiatrist to do that.  I know that this is not really psychiatry, but somebody's business model of how to generate revenue and not consider all of the information that merits consideration.  I can't sit by and look at people who have never had a manic episode being misdiagnosed with bipolar disorder, or the endless people with chronic stress in their lives expecting that medication will somehow change that, or the high functioning person with "ADHD" who really wants a prescription for a stimulant so they are not at a competitive disadvantage in college or professional school.  Beyond that - I can't bite my tongue and listen to how they are seeing a therapist who is a "sounding board" and endlessly rehashing either their childhood or what happened last week and how that is supposed to be productive psychotherapy.  I can tell them what they need to do to get better and if necessary do the therapy myself.  And then there are the people with non-epileptic seizures, psychogenic mutism, chronic Lyme's disease, chronic pain, chronic daily headaches, reflex sympathetic dystrophy/complex regional pain syndrome and endless somatic permutations that need psychiatric care but walk in saying they don't: "I am here because my doctor thinks this is all in my head".  There are the people with delirium, dementia, movement disorders, and abnormal MRI scans.  I can see all of those people until my dying day, but it does not make an impact unless what I know can be amplified through current residents.

Before business managers ran medicine there was the kind of room I need at the current stage of life.  Senior staff in those days were the people the house staff and attendings consulted.  The absolute best teaching team that I ever worked on was a Nephrology team at Froedtert Hospital in Milwaukee.  It was my last rotation in medical school.  I recall finishing rounds at 10:30PM on the night before graduation and walking across the county hospital grounds to my apartment like it was yesterday.  That team was staffed by two senior Nephrologists in their late 60s.  The remaining team members included a Nephrology Fellow, two internal medicine residents, an intern and me.  There was no myth that these senior staff somehow knew less or were less relevant.  It was quite the opposite.  We rounded twice a day until all of the consults and hospitalized patients were covered and the senior staff were the primary discussants.  That myth is alive and well today, largely as a means to disenfranchise the tested clinical methods in medicine and make future generations of physicians dependent on organizations run by business managers rather than colleagues.  Organizations that have promoted the idea that tests and arbitrary and unvalidated performance metrics are more important than spending enough time with patients and enough time discussing clinical scenarios with a broad range of physicians including the most experienced colleagues.  It is no coincidence that the myth thrives in non-academic hospital environments staffed by generalists working impossible shifts.  Knowledge and academics seems at its leanest point in the past 50 years.  

At this point I am resigned to do what I can.  I have offered my services but there are a significant number of reasons why none of that may come to pass.  The hardest thing about retirement for me comes down to three issues.  First, there are not nearly enough people to take my place.  Psychiatry is possibly the best example of how a field can be decimated by political and business influences even in the midst an obvious shortage of services.  Throughout my entire career there has been a shortage of psychiatrists and nobody has done a thing about it.  Second, the very inefficient transfer of knowledge.  I was personally taken out of the teaching loop for a long time by business practices that made it impossible for me to teach.  What I know is not written down in texts and if I don't pass it along - it dies with me.  That is counter to the evolution of how knowledge is passed from one generation to the next.  Only American politics and business practices can stop evolution in its tracks.  Finally, being an active part of a person's treatment and recovery from mental illness is important to me.  In every case that involves an internal process on the part of the psychiatrist.  In retrospect, I have attributed it to having great teachers and colleagues, a great memory, a particular personality characteristic, scholarship, or just being compulsive.

Despite what the measurement based people say, the validation of that process is totally subjective.  At the end of the day or years/decades later - it is a person saying that you made a difference in their life and knowing that happened because you gave them the best medical advice that you could at the time.  For me personally, it has also meant seeing people who have the most severe problems.

I won't miss any of the productivity based work any more than if I walked off any assembly line.




George Dawson, MD,  DFAPA




Addendum: 

I realized in the last couple of years that this blog factors into the transition as well.  People have always asked me how I know something when I quote research or suggest a particular treatment or method of analysis.  I think that part of what I am doing here on these pages is illustrating how I know something.  Hopefully fellow psychiatrists, but especially medical students and residents will find it useful.


Attribution:

The graphic at the top of this post was downloaded from Shutterstock on July 4, 2016.











               

Modern Medical Management - The Myth of Sharing

Any casual reader of this blog will note that I don't really find any value in the myriad of management practices that have been added to medicine since businessmen and their friends in government have taken over.  The only reasons that these practices have been added is strictly political and rhetorical.  Nothing has been overhyped as much as management adding value to medicine with so few results.  Nothing has done quite as much to detract from the quality of care than these same business practices.  At this point they have become as entrenched as gun legislation and will be every bit as intractable. These problems are very difficult for the typical consumer/patient to see.  The obvious points of contention are insurance company denials either for medication or medical care.  They peaked in the 1990s when managed care companies thought that they would just put specialists out of business and had primary care physicians acting as "gatekeepers".  If you are old enough you may recall having to get a referral from your primary care physician to see specialists, for various services. and in some cases even to go into an emergency department.  It took them a while but these businesses learned that being that transparent in denying care was probably not in their best interest.  It also created a large burden on primary care physicians who were now uncompensated reviewers for the insurance company business practcies.  Eventually that system was scrapped in favor of shifting financial risk around - some to consumers and some to physicians and physician groups.  There are many ways it can happen, I thought I would provide a few examples below.

Managers like to use a shared decision making model in their manipulation of physicians.  I guess they don't consider physicians to be particularly bright people.  I don't know if that happens when you are socialized in the business world and automatically consider your decisions to be the best based on scant data, a lack of measurement standards and perceived quality of a good idea.  Whatever the reason, the approach generally only works because the physicians have no leverage.  Consider the following example.  Ten physicians are in a group providing hospital coverage for admissions to a community hospital.  It can be any specialty.  They are working a 7 days on and 7 days off model and each of them typically admits 10-14 patients per day at work.  They are stretched to the maximum so that anyone requiring emergency leave seriously disrupts the schedule.  Their colleagues are expected to cover.   The administration would like to open an 10% additional bed capacity and meets with all of the physicians about this to problem solve over how that might happen.  The physicians are asked the question: "We are here to all figure out how to increase the number of admissions by 10%.  Do you have any ideas about that?"  That leads to a general discussion of how the physicians are overworked and already spending too much time from home on the electronic health record.  A consensus builds and the physicians say they need more staff and staff to cover unpredicted absences.  At that point the administrator states: "No - I guess I didn't explain myself very well.  We are here to decide how to provide more services without increasing the cost by hiring new people."  The physicians finally get it.  Sharing in this case means, I will ask you for your input, but it is meaningless and I will require that you work harder even though you are probably burned out right now.

Another popular sharing model where physicians share more than anybody else is financial risk sharing.  The first introduction was when RVU productivity units were introduced.  The initial administrative argument seemed to be that not everyone was carrying their own weight.  The RVU system was portrayed as being inherently more advantageous to those people who were really productive.  It would allow them to make more more than the slackers in the department.  That was a good theory to try to appeal to physicians competitive natures, but in most departments - schedules and productivity was already saturated.  There were no slackers.  That point goes to the administrators.  The second risk sharing introduced was the "holdback" model.  This said that 10-15% of everyones' productivity would be held back until it could be assured that the production figures were met and then it would be released to the physicians in the group.  Keep in mind this was money that was already billed and earned.  There was no similar "holdback" from administrators or other personnel.  A take off on this risk sharing was getting physicians in administrative meetings and showing them endless spreadsheets of overhead costs and how much they would have to "produce" in order to get either their holdback or some other form of reimbursement.

The ultimate form of risk sharing today seems to be the contract that comes in and puts everyone at risk by not even recognizing the physician billing.  In this case the insurer comes in and says - this is how much we will pay you on a per diem basis to cover these patients for various problems.  You agree not to charge use anymore than than - no matter how much care each one of those patients needs.  This last model is the most insidious.  It caps any insurance payments (losses) and puts any physicians and their clinic at complete risk for catastrophic loss but more importantly it is a war of attrition.  With this model as the only source of funding, it allows administrators to view physicians as "costs" rather than resources and eliminate them, underfund them, overwork them, and burn them out.  It is a tried and true pathway for how managed care organizations using this model can adversely impact the quality of care in every organization they contract with, but especially the ones that don't understand corporate doublespeak.

Too many of my colleagues tolerate corporate doublespeak in management systems.  They don't seem to understand that risk sharing does not really mean that anything is shared.  It means that they are left holding the bag.  These same systems tell us how "younger physicians" are more accepting of these models.  Medical professional organizations and specialty boards are talking the talk.  We have the American Psychiatric Association talking about various collaborative care models where psychiatrists don't need to see patients any more.  The speciality boards have designed a number of expensive and complicated performance metrics that have no basis in reality and CMS (Centers for Medicare and Medicaid Services) has done the same.  It is hard to imagine that when I started out in Medicine we did not have to deal with all of this administrative fantasy.  We went to work each day and it centered on the facts, patient care, and the medical science of the day -

Not what somebody forced us to believe for a few months at a time while they were wasting our time, energy, and money.

  

George Dawson, MD, DFAPA

The Demise of the "5th Vital Sign"

The American Medical Association came out two days ago and said that they were dropping the pain as the fifth vital sign movement because it encouraged opioid overprescribing.  Even more interesting is that I did not get the news from the AMA (I am a 30 year member) but from the Pain News Network.  The only stories that I could Google the next day was about the AMA defending its position against attacks from pain societies and organizations who want to maintain what I would describe as a liberal approach to opioid prescribing as the best way to approach pain.  My term liberal is meant to connote a political position with no basis in science and the lack of science started in 1998 with the pain as a 5th vital sign approach.  In 1996, the President of the American Pain Society declared pain as the Fifth Vital Sign.  In the year 2000, the Joint Commission (then JCAHO) launched a pain initiative that described the 10 point pain scale as a "quantitative approach to pain."

I don't know if quantitative analysis is still a prerequisite for medical school, but this is a reason why it still should be.  In quantitative analysis, the task is to measure chemical concentrations accurately and reproducibly.  To use a quote from my old analytical chemistry text (1): "Qualitative analysis is concerned with what is present, quantitative analysis with how much is present."  The ability to do this is often a major part of the grade for that course.  Since the chemical composition in the samples are known - they should be determinable with precision.  In some cases, a lack of accuracy can reflect problems with the analytical technique if there are widespread variations in the results.  This is a true quantitative approach.  Asking a person to rate their pain on a 10-point scale is not.  Pain is a subjective experience influenced by a number of variables including whether the pain is acute or chronic, emotional state, the presence of an addiction, and personal biology affecting pain perception.  It is not a quantitative assessment.  It is as obvious as asking someone where they are on the 10-point  scale and being told they are a "14".  There are a lot of potential messages with that statement, but none of them involve an accurate measurement of pain.  A quantitative scale has no implicit meaning - it is supposed to be a known measurable quantity no matter what.

From a medical perspective, there is also no better example of the adverse consequences of widespread screening for a problem.  Chronic pain varies with age and other demographic factors.  Epidemiological surveys show widely variable numbers of people with chronic pain, but some suggest an average is about 25% of the population and 10% of the population with pain that has some secondary disability.  While there are no good ways to estimate the optimal amount of opioid needed to treat pain in a population, current data suggests that the US is the largest consumer of prescription opioid drugs in the world.  For example, the US has 5% of the world's population and Americans use 55% of the world's supply morphine and 37% of the world supply of fentanyl.  By contrast 80% of the world population uses 9.9% of the morphine and 19.7% of the world's fentanyl.    The United States is clearly at the top in terms of opioid consumption.

Clinical trials have also shown that opioids are moderately effective for some forms of chronic pain and no more effective than non-opioid medications.  The screening approach to chronic pain is clearly associated with overexposure to opioids, widespread availability of illicit sources of opioids, and an epidemic of overdose deaths.  The idea that rapid assessments can be made with rapid qualitative screening by anyone also eliminated pain specialists as gatekeepers in the decisions about who would receive treatment with opioids for chronic noncancer pain.

In the opening days since the AMA statement, it appears that political forces are lining up to maintain the status quo.  The idea that the AMA has to defend their position seems like pure rhetoric to me.  How about the American Pain Society defending the original statement in the context of everything that has happened since?  Despite defensive statements about how opioid prescribing was increasing before the position was adopted - the hard data suggests that it was associated with a major inflection point in opioid consumption in the USA.

The policy debate on this simple statement has far reaching effects for health policy in the United States.  At every level in today's health care system there are groups of managers/administrators who have set themselves up to monitor various measurements and hold somebody accountable.  I doubt that they know the difference between quantitative or qualitative measurements any more than the people who proposed that a subjective pain scale was somehow a quantitative measure.

I doubt that any one of them ever took a class in Quantitative Analytical Chemistry.



George Dawson, MD, DFAPA



References:

1:  James S. Fritz and George H. Schenk.  Quantitative Analytical Chemistry. Second Edition.  Copyright 1969 by Allyn and Bacon, Boston, p 3.



Attribution:

Pain scale graphic downloaded from Shutterstock per their standard license on June 29. 2016.

Free Lunch and Odds Ratios - The Rest Of The Story

JAMA Internal Medicine came out with an article this week that has been heavily covered by most media outlets.  The Wall Street Journal headline was: "Even Cheap Meals Influence Doctor's Drug Prescriptions, Study Suggests".   Time concludes: "Why Doctors and Drug Companies Can't Be Friends".  Even public radio got into the act with "Crestor Prescriptions Rise After Doctors Get Free Meals."  It is pretty clear that in the court of public media that Big Pharma is at it again, bribing doctors into using their drugs and the most expensive drugs at that.  But is that really what the article suggests?

Even a casual reader could hone in on the discussion session of the article and read the following about cross sectional data and disclaimers about causation versus correlation:

"Our data are cross-sectional. The findings reflect an association, and not necessarily causality. Because we linked 5 months of Open Payments data with 1 year of Medicare Part D prescription data, we also could not determine whether high prescription rates for brand-name drugs were preceded, followed, or temporally unrelated to the receipt of industry-sponsored meals.  The policy implications of our findings thus depend on further clarification of the mechanism of the association between the receipt of industry-sponsored meals and physician prescribing behavior..."

Two additional paragraphs of study limitations follow that clearly show that this initial look at this data has significant limitations.

Various blogs and sites have picked up on this paper as well many of the physician sites also seem to favor the narrow interpretation as seen in the press.  In some cases there is a nod to the theoretical issue of causality but a discussion of the result as though it is proof of something.  I can think of a number of competing theories that should be tested instead of the meal equals causality theory but do we even have to go there?  Bear with me on the analysis here.

Looking at the basic design of this study, the authors looked at a database of 533, 919 prescribers in the Medicare Part D database.  252,250 of these prescribers were eliminated for administrative reasons that can be examined in the Supplemental section of this paper.  From there the authors determined which of these physicians wrote 20 more more prescriptions for the four study drugs of interest -  statins, cardioselective beta blockers, ACEI or ARB antihypertensive prescriptions, or SSRI or SNRI antidepressant prescriptions.  Table 2 in the final paper shows the total prescribers and their characteristics in each group.  The total number of physicians receiving financial reimbursement varies from 2-12%.  That reimbursement totaled 63,524 payments totaling $1.4 million - 95% of which was meals and 5% in the form of other promotions.  The meals averaged $12-18.  The authors proceed to show that the sample selected for reimbursement were more likely to prescribe the promoted drug.  They do this by calculating the odds ratio of prescribing versus the non-reimbursed physicians.  They also calculate the odds ratio across a number of variables including the number of day (0 -> 4+) in order to demonstrate a dose response effect of the promotions on prescribing and conclude that industry sponsored meals was associated with an increased rate of prescribing the name brand drug in each class that is being promoted.

The standard response to this study seems to be: "Aha - no news there.  We knew that Big Pharma corrupts physicians and even the slightest gift sways prescribing practices."  I will let the reader pull up the article and read the authors concerns about causality.  I don't think that predictable corruption or an esoteric statistical argument about causality is the most interesting part of this paper.  I think the most interesting part of this paper has apparently been lost on the majority of people reading it.  Let me put it another way.  Would it shock anyone that a small (2-12%) proportion of physicians, carefully selected for whether or not they accept promotions from pharmaceutical companies end up prescribing the promoted drugs more frequently than physicians who don't?  I don't think that it should.

The good news in this article is that 88-98% of the physicians studied apparently do not accept these promotions and by the authors definition do not prescribe the promoted drug at anywhere near the frequency of the studied group.  The majority of physicians do prescribe promoted drugs, even without receiving any incentive from the pharmaceutical company and that should also not come as a shock to anyone.  As a former member of two Pharmacy and Therapeutics (P&T) Committees, I can say unequivocally that all members of a generic class are not equivalent when applied to any population of human beings.  Response and tolerability vary significantly from person to person.  In the case of generic antidepressants - SSRI/SNRI are all commonly used as first line drugs primarily to avoid prior authorization harassment of the prescribing physician.  There are many patients who fail several and many patients who cannot tolerate any of these medications.  In those cases non-generic medications are often the next choices.

Any time I see a statistic like an odds ratio, I tend to interpret it like percentages.  Those numbers seldom stand on their own.  There needs to be some additional data.  In the table below, I show the number of prescribers in each category across all 4 classes of research drugs and the Target Drug used to calculate the odds rations.  It is clear that the vast number of prescribers in each class are in the No Meal (NM) category.  It is also clear that the prescribers in the Meal (M) category prescribe the drug class at a much higher rate than their NM colleagues.  Even if the prescribing rates in the M category are relatively high, it is easy to speculate that the total prescriptions for the target drugs may actually be higher in the NM category despite the odds ratios indicating that the M physicians are more likely to prescribe them.  I sent an e-mail to the corresponding author on this issue and asked for the raw data as rates of target drug prescribing in each group or the raw numbers for all of the target and non-target drug prescriptions in each class.  I will post those results here if I receive them.

Class/ Target Drug	Meal =M No Meal =NM	Average Rx Volume Per Prescriber	Total Prescribers
statin/ rosuvastatin	M	742.2	15,941
	NM	470.1	115,266
beta blocker/ nebivolol	M	410.0	3843
	NM	299.8	122,291
ACEI/ARB/ olmesartan	M	562.7	9483
	NM	394.8	121,860
SSRI/SNRI/ desvenlafaxine	M	437.6	1926
	NM	289.5	121,392

Just looking at total prescriptions in any class the NM physicians prescribe roughly 5 times the total of the 4 general classes of medications as those who are designated as M prescribers.  Pharmaceutical companies are clearly selling these medications without the suggested promotion.    This is a better measure of the impact of pharmaceutical promotions and it illustrates the fact that there are other significant forces at play than a free lunch.

Overall I thought this paper was useful because it provided confirmation of one of my previous observations on pharmaceutical pricing.  In that post I made the statement that even when physicians are taken out of the promotion loop by one force or another, the United States still has by far the most expensive pharmaceuticals.  This paper provides proof that the vast majority of physicians are not getting the free lunch promotions and contrary to most of the headlines don't base their prescribing on an inexpensive meal.  Although we currently do not have a good characterization of what the real difference in target drug prescriptions is between N/NM groups it is safe to say that there is more at play here than an $18-20 meal.

That fact alone suggests causation is more complex than it seems in the papers.



George Dawson, MD, DFAPA


Reference:

1:  DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries. JAMA Intern Med. 2016 Jun 20. doi: 10.1001/jamainternmed.2016.2765. [Epub ahead of print] PubMed PMID: 27322350. (free full text online).

Attribution:

Pizza graphic is from https://commons.wikimedia.org/wiki/File%3APizza_(25).jpg
By Miansari66 (Own work) [CC0], via Wikimedia Commons.

Significantly Lower Mortality With Antipsychotic Use

It is always an interesting phenomenon to see the headline grabbing news about how toxic psychiatric medications are killing people.  At first it was just  cult news, but these days it seems that some people can make a fairly good living at it.  A knowledge of psychiatry or clinical experience is never a prerequisite.  It always requires the reader to suspend their sense of reality and what they know happens in real life.  That reality is that a family member, neighbor, or friend was having some very serious problems - saw a psychiatrist and got better.  It also requires a suspension of belief in the tremendous history of what happens with untreated psychotic disorders both in terms of morbidity and mortality.  Finally it requires suspension of a belief in the usual regulatory mechanisms.  If so many people were dying from treatment - it would be obvious and somebody would be held accountable.  Every state has medical boards that basically solicit complaints against physicians.  Surely any group of physicians prescribing an inordinately toxic medication would come to light.  You have to suspend all of these realities of course because none of it has occurred.  Despite those reality factors there are any number of antipsychiatrists or people claiming to be critics who are basically using the same rhetoric warning people about the toxicities and how many people are killed by these medications each year.  Some of their estimates are astronomical and suggest a clear and biased agenda.  Actual community surveillance reveals an accurate picture and the medications with the highest complication rates are easily recognized by any psychiatrist or primary care physician.

That is not to say that the medications prescribed by psychiatrists are perfectly safe.  As I just posted - no medical decision including one that involves taking a common medication is risk free.  I spend a good deal - if not over half of my time warning people about side effects that will never happen, warning people about severe but rare side effects, managing side effects that do happen, and screening for potential side effects that might go unnoticed by the patient like electrocardiogram abnormalities or blood tests for a specific bodily systems.  In 30 years of practice, I have diagnosed the most severe problems including serotonin syndrome, neuroleptic malignant syndrome, prolonged QTc interval, various degrees of heart block, arrhythmias, myocardial infarctions, strokes, drug-induced liver disease, agranulocytosis, diabetes mellitus, diabetes insipidus, hypo/hyperthyroidism and many other that were either caused by a medication or picked up as a result of my screening for a medical complication or pre-screening for safe use.  But relative to primary care, the number of diagnoses in psychiatric practice for this reason is smaller.  The most significant cause of mortality in psychiatric populations is cigarette smoke.  The most significant number of medical conditions are pre-existing and if the psychiatric disorder is caused by an underlying medical condition - it is not common.

All of the factors in the first two paragraphs led me to read an article on the epidemiology of antipsychotics, antidepressants, and benzodiazepines in a well determined population and the effects on mortality in the June American Journal of Psychiatry.  The authors have a number of studies that appear to use a similar epidemiological approach.  For this study they identified cohort participants from national health care registers of all people 17-65 living in Sweden in 2005.  They identified anyone receiving health care for schizophrenia or psychosis (by ICD-10 codes) and anyone on disability for schizophrenia.  They also  determined all of the antipsychotics, antidepressants and benzodiazepines dispensed from 2006-2010.  They were classified by Anatomical Therapeutic Chemical Codes (ATC codes).  They calculated cumulative exposures using the WHO defined daily dose (DDD) methodology.  The WHO web site has a search engine that will let you search for the defined daily dose of medications.  Examples for antipsychotic medications would include 10 mg for olanzapine and 5 mg for risperidone.  The researchers summed the follow up days minus any hospitalization days and divided this into the sum of the dispensed medication.  That allowed the subjects with schizophrenia to be broken into four DDD groups: 1) no antipsychotics, antidepressants or benzodiazepines during the follow-up, 2) low dose -  small or occasional medications (0-0.5 DDD/day), 3) moderate doses (0.5-1.5 DDD/day, inclusive), and 4) high doses (>1.5 DDD/day).  Using the olanzapine example that would mean a dose range from 0 - >15 mg/day cross all 4 groups.  

A total of 1,591/21,492 or 7.4% of the cohort died in follow-up.  That was 4.8 times higher than a control group of age and gender matched patients.  The commonest causes of death were cardiovascular disease, neoplasms, respiratory diseases, and suicide in that order.  No interactions were noted at the level of demographic variables.  Mortality rates and hazard ratios for antipsychotic, antidepressant, and benzodiazepine use were calculated and the following observations were noted:

1.  Any exposure to antipsychotics or antidepressants was associated with a lower rate of mortality (15-40% lower) compared to no use.          

2.  High exposure to benzodiazepines was associated with a 74% higher risk of death than no exposure.  Benzodiazepine users had the highest mortality, highest risk of suicide, and more frequent visits to health care services.  

3.  In terms of cardiovascular mortality, only high dose antipsychotic use showed an equal mortality to no exposure to antipsychotics with low and moderate dose showing decreased mortality.

4.  A sensitivity analysis of first episode patients showed that there was a decreased risk of mortality with exposure to low and moderate exposure to antipsychotics and increased mortality with exposure to moderate to high dose benzodiazepines.  More striking is the fact that during the follow up period this was a cohort of 1,230 patients and 45 (4%) of them died.  Most of the patients with first episode psychosis who I treated were otherwise healthy 20 year olds, illustrating the significance of this problem.

This is an excellent study from a number of perspectives.  It looks at well defined data across a population that is generally possible only in Scandinavian populations.  By contrast studies done in the US typically look at either incomplete retail pharmacy data designed originally for pharmaceutical sales or detailed health interview data that is based entirely on self report using long and detailed questionnaires.  The study uses WHO methodology suggested for pharmacoepidemiological research.  The follow-up period is during a times when most atypical antipsychotic medications are widely available.  These are the drugs that are suggested as a source of higher cardiovascular mortality in psychiatric patients.  The authors findings are discussed in light of several other studies that show similar effects.

 The finding of this study will come as no surprise to acute care psychiatrists across the US.  It is the reason why psychiatrists cover these settings despite the hardships involved.  They know they are treating very difficult problems with very little assistance and that even in the absence of a continuum of care they can be successful.  These psychiatrists are also aware of the medication toxicity and more importantly as this article points out - they can identify high risk patients and safely treat them.  Despite the concerns about the metabolic effects of atypical antipsychotic medication there is an implication that other factors (like smoking) may be more significant in the development of cardiovascular disease (3).  The risk of antidepressant and antipsychotic medication can be seen in an appropriate context in this study and that is lowering mortality rather than causing it.

The study also provides very useful guidance on benzodiazepine use.  In my opinion, benzodiazepines should be used only briefly for the treatment of catatonia and acute agitation in patients with psychotic disorders.  They should not be used on a long terms basis.  I agree with the authors' idea that tolerance is a problem.  When dose escalation fails or results in withdrawal and panic attacks or protracted insomnia, the risk for impulsive behavior and increasing depression is much greater.  More frequent primary care visits can also occur due to tolerance and the need for dose escalation and more discussions of appropriate use.  Treating this population in the United States is problematic because at a certain point, people can be safely detoxified from benzodiazepines only in an inpatient unit, and those services are widely unavailable.   This study is a blueprint for quality assurance projects using the same methodology on electronic health records (EHR) across the country.   Every clinical population should be examined using the authors' techniques and followed for outcomes and active interventions.

The reference provides an opportunity to see the realistic risk and benefits of treatment in people with high risk psychiatric illness.  It also presents an opportunity to use this methodology to provide better treatment to people with the same illness and prescription profiles everywhere.  Instead of using the EHR to catalogue useless full text information and track physicians, the authors methods can be used with much finer tracking of details like BMI, blood pressure, smoking status and other relevant lifestyle factors.  Apart from the aspects of polypharmacy, the overall difference in mortality due to a diagnosis of a psychotic disorder needs to be addressed, and it needs the level of detail available in an EHR.  Psychiatrists in major health plans using large databases could get active feedback in a very similar manner.  The EHR could finally be used the way they advertised it a decade ago.         

George Dawson, MD, DFAPA

1: Tiihonen J, Mittendorfer-Rutz E, Torniainen M, Alexanderson K, Tanskanen A. Mortality and Cumulative Exposure to Antipsychotics, Antidepressants, and Benzodiazepines in Patients With Schizophrenia: An Observational Follow-Up Study. Am J Psychiatry. 2016 Jun 1;173(6):600-6. doi: 10.1176/appi.ajp.2015.15050618. Epub 2015 Dec 7. PubMed PMID: 26651392.

2: Robinson DG. Early Mortality Among People With Schizophrenia. Am J Psychiatry.2016 Jun 1;173(6):554-5. doi: 10.1176/appi.ajp.2016.16030334. PubMed PMID: 27245185.

3:  Newcomer JW, Hennekens CH. Severe mental illness and risk of cardiovascular disease. JAMA. 2007 Oct 17;298(15):1794-6. PubMed PMID: 17940236.

Being Suicidal - The Conscious State

The assessment of potential for suicide is a large part of a psychiatrist's work.  Within the past decade these footnotes have popped up even in algorithms that are designed to guide decisions about psychopharmacology.  They have always been present in treatment guidelines for most major psychiatric disorders.  They are a major cause of anxiety for practitioners, because we all know that our predictive capacity is low, but more importantly we know that unlike Internists and Surgeons we have limited access to the resources necessary to address the problem.

Considering for a moment a typical outpatient crisis, for a person known in the practice with depression who is now clinically changed in an office assessment with suicidal thoughts, the options are very limited.  In the case of an assessment of extreme risk, inpatient treatment may be offered.  If the patient has any inpatient experience at all, he or she knows that inpatient units are generally miserable places where very little active care happens and where they are enclosed with a number of very ill patients.  They may also know that there are an arbitrary number of hoops that must be jumped through in order to be discharged and that as a result they may be in that environment much longer than they need to be.  They may also have had a typical experience of the inpatient psychiatrist not talking with their outpatient psychiatrist and making a number of abrupt medication changes that are neither necessary or indicated based on their brief familiarity with the case.  For those reasons and also because most people are averse to sitting in hospitals - people will balk at the suggestion of inpatient care.

The suggestion of inpatient care also assumes there is the availability of that option in the community.  Most hospitals in any given state do not offer inpatient psychiatric care.  That level of care has been discriminated against at a political and financial level for 30 years and as a result hospital services and inpatient psychiatric beds have contracted in an expected manner.  Patients are often transferred hundreds of miles within states to reach these beds.  A related issue is the availability of electroconvulsive therapy (ECT) for severe depressions.  In the case of high risk depression it may be the only effective option.  Many states have no availability of this option for patients who need it.

The suggestion of emergency department (ED) care is an even bigger dead end.  The vast majority of ED care is provided by mental health professionals who are not psychiatrists and who are making triage decisions that ED physicians can sign off on.  The wait is hours and if a high risk determination is made it might be days in the ED before any disposition can be made.  Patients are often discharged on the basis of whether their suicidal ideation is chronic or not and whether they are saying that they have a suicidal thought and an intent to harm themselves right at the time of the assessment.

All of the above factors generally place the burden of care back on the original treating psychiatrist, even when the risk is higher that he or she would want.  Most psychiatrists recognize that if they are treating very ill patients, there needs to be an element of acceptable risk in order to provide treatment and the hope of recovery.  Psychiatrists realize that resources are severely rationed, that their patient needs acute treatment, that the patient will only accept certain treatment, and that there is a societal expectation of medical paternalism if the patient in not able to remain safe.   The psychiatrist and the patient are frequently operating in this zone of acceptable risk that is perceived very differently by others.  Family members are the clearest case in point.  Like society in general, many family members have their biases when it comes to psychiatry.  Many have been instrumental in discouraging their family member from getting treatment.  In some cases they have interfered with treatment and suggested that the family member discontinue treatment or throw away any medications that they have been taking.  At the same time, family members generally favor a zero risk treatment environment.  They would prefer that the patient's suicidal thinking resolve completely so that there is no risk that they will attempt suicide.  They see suicidal thoughts as controllable and the product of a series of correctable decisions.  They don't understand why the thoughts just can't be turned off by the patient, their psychiatrist, or in some cases - the medication the patient is taking.  In extreme cases, they may threaten litigation if the patient suicides or makes a suicide attempt implying a volitional and controllable basis for suicidal thinking.

An understanding of human consciousness provides a way to analyze this situation and the misperceptions about suicidal thinking and behavior.  The predominant model of risk assessment for both suicidal ideation and aggressive potential is risk factor analysis.  It generally proceeds from an elaboration of the specific thoughts to past history of attempts, availability of lethal means, diagnostic risk factors, past history and analysis of attempts, and specific demographic risk factors associated with suicide attempts.  Many texts like the Harvard Medical School Guide To Suicide Assessment and Intervention have detailed approaches to the problem and further conceptualizations like proximate and distal risk factors.  In an earlier post, I discovered a checklist of risk factors that looked at the issue of Increased Reasons or Decreased Barriers to suicide called the Convergent Functional Information for Suicide Scale (CFI-S).   Many institutions these days prefer the Columbia Suicide Severity Rating Scale (C-SSRS).  All of these methods are essentially based on risk factor analysis.  Some are more elaborate than others.  There all estimate risk to one degree or another and in some cases factors that mitigate risk.  I won't debate the merits of these methods here.  All that I want to say about them is that after the risk has been estimated, the psychiatrist may still be working with a high risk patient who is unpredictable in both an inpatient and an outpatient setting.  Interventions can be initiated to reduce the risk, but there is no assurance that they will be effective fast enough to prevent a suicide attempt.  In many clinics where a standardized approach like this is used with an electronic health record and a cutoff score is used to determine risk, a psychiatrist may find the patient visits being flagged for months or longer based on these numbers.

Is there another model that might supplement or improve upon the risk factor analysis models?  For about 15 years now, I have been looking at a model that considers the basic question of what happens when a human conscious state shifts from one that would never contemplate suicide to one that does or in the extreme state proceeds rapidly to suicide.  The usual psychiatric model considers the development of an illness state like depression, bipolar disorder, borderline personality disorder, or alcoholism as a precursor state.  The cognitive changes, like depressogenic thinking seen in the precursor states are seen as the basis for suicidal thinking.  The intervention is generally directed at reversing the precursor state, acutely structuring the environment as necessary for safety, and direct verbal interventions to address the suicidal thinking.

It is possible to explore with people the transition of their conscious state from a person without suicidal thinking to a person who develops suicidal thinking and consider a broad array of associated factors.  Just being able to recognize that this transition has occurred is an important part of any evaluation and intervention.  Some people are so severely depressed that it seems like the suicidal thinking has been there forever.  They can barely recognize a time when they felt better or were not suicidal.  In many cases they are preoccupied with existential factors such as meaningfulness of their life, personal freedom, and of course life and death - factors that they were only peripherally focused on during their daily life.  In some cases they are important psychodynamic factors such as the death of a family member or friend from suicide.  I speculate that many psychiatrists have heard of or been involved in situations like this.  These events are also described in some of the psychoanalytic literature but not necessarily the risk factor analysis literature.  John Bowlby described some examples in his book Loss:

"From many examples from Cain and Fast we select two: one eighteen year old girl who drowned herself alone at night in much the same fashion as had her mother many years earlier;  the other a thirty-two-year old man who drove his car over the same cliff that his father had driven over twenty-one years earlier.  Some of these individuals, it seems, had lived for many years with a deep belief, amounting to a conviction, that they will one day die by suicide.  Some quietly resign themselves to their fate.  Others seek help." (p. 389)

Of course the complexity of this situation is much greater than Bowlby can capture in his brief explanation.  Just at the psychodynamic level there is the issue of identification with the parent and their suicidal actions.  Do they believe that they have a deeper understanding of the parent's action and consider them to be logical?  Have they incorporated this into their worldview and consider it to be their fate?  At the neurobiological end of the spectrum, is it a case of straight genetic vulnerability to suicide or were there epigenetic factors related to a severe disruption of the home environment that the suicide of a parent can cause?  Do they remember an event or series of events during childhood when the affected parent seemed to transmit a tendency to anxiety or depression directly to them?  All of these are relevant considerations when examining what is going one at the conscious level in an individual who has become suicidal.

Elementary risk factor analysis also benefits from the broader perspective of considering other conscious factors.  It allows for an exploration of additional degrees of freedom.  For example, the issue of firearms possession and the elaboration of risk often depends on possession and risky behavior with that gun.  But what constitutes risky behavior and what needs to be asked?  Have you had the gun in your hand when you were thinking about suicide?  Was the gun loaded?  Did you actually point the loaded gun at yourself? What were you thinking about at that time?  The questions and responses cannot be anticipated in a linear risk factor analysis or algorithm.

A nonlinear consciousness approach can also incorporate an informed consent approach to provide active feedback to the patient on the current risk and the limitations of treatment.   This often opens a window into the dynamics of how the patient conceptualizes risk and their ability to work with the psychiatrist in minimizing it.  A more linear assessment often takes on the structure of the psychiatrist trying to guess whether or not the patient is going to kill themselves and leaves the patient as a relatively passive participant.  A consciousness based approach recognizes that the patient has entered at least partially into a conscious state that is foreign to them, less predictable, and represents some degree of risk to them.  They need to hear very clearly that they and the psychiatrist need to work together to restore their baseline conscious state and reduce risk in the meantime.  The process encourages them to not leave the interview leaving something that is potentially important - unsaid.  


George Dawson, MD, DFAPA      


References:

1:  John Bowlby.  Attachment and Loss - Volume III: Loss - Sadness and Depression.  Basic Books. New York.  Copyright by the Tavistock Institute of Human Relations.  1980, p 389.

2:  Douglas G. Jacobs (ed).  The Harvard Medical School Guide to Suicide Assessment and Intervention.  Jossey-Bass Publishers; San Francisco.  Copyright by the President and Fellows of Harvard College. 1999.