Testosterone Study Is Disappointing For More Than The Obvious Reasons

Testosterone

Testosterone replacement has been a controversial issue, despite a large number of physicians who prescribe it, FDA approval of products for mass marketing, and a number of advocates that see it as an anti-aging and performance enhancing drug for aging men.  The science behind is has been surprisingly slow.  In an era where inequities in health care are often argued by race or sex, this seems to be one where the science at least lags far behind what is known for women.  Expert opinion about testosterone replacement has changed very little over the years, despite much popular literature about how this has occurred for years in Europe and there is widespread benefit for physical and emotional well being of men as they age.  From a clinical perspective, psychiatrists are seeing more and more middle-aged men on testosterone replacement.  This treatment modality has significant implications for any medical treatment provided by psychiatrists as well as associated comorbidity.  From a psychiatric perspective it is also important to determine if the testosterone use is more than indicated, is associated with increasing muscle mass and body image changes, and if it occurring in the context of unreasonable expectations like preserving youth , reversing the effects of aging, or athletic performance enhancement.

In the most recent study of men 65 years of age and older the authors examined the effects of treatment with testosterone gel for a period of one year (1).  The total number of subjects was 790 out of a total of 51,085 men who were screened.  In order to qualify for the trial testosterone level had to be sufficiently low (less than 275 ng/dl) on one of two samples and that eliminated 85% of all of the screened men.  The trial was designed to look at physical function, sexual function, and vitality.  The treatment resulted in testosterone levels that were in the mid-normal range for 19 to 40 year old men.  Despite considerable medical comorbidity in the recruited patients there were clear cutoffs for medical comorbidity.  Those cutoffs included a history of prostate cancer or risk of prostate cancer on the Prostate Cancer Risk Calculator, other conditions known to cause hypogonadism, medications known to effect the concentration of testosterone, high cardiovascular and severe depression (PHQ-9 score >20).   The overall results showed that there was moderate benefit on sexual functioning and some benefit with mood and depressive symptoms but no effect on physical functioning or vitality.  A look at these measurements is instructive.

Physical Function was assessed using the 6 minute walk.  Recent normative data has been established for various age cohorts using subjects from several countries.   That data establishes normative curves for age cohort stratified by sex.  The six-minute walk distance (6MWD) ranged from 559 +/- 80 meters in 60-69 year old men to 514 +/- 71 meters in 70-80 year old men.  On two trials subjects usually walked on average 12 meter farther on the second trial.  In the present study, the criterion for a positive effects from testosterone was a walking distance increase of 50 meters.  When compared with controls, the testosterone treated men had significantly more men increasing the distance walked by 50 meters, the percentage of men exceeding this measure, the change from baseline, and the percentage of men with higher scores on the physical function domain test (PF-10) from the Medical Outcomes Study 36-Item Short Form Instrument (SF-36).  One of the concerns I had reading this methodology is the use of testosterone for physical performance enhancement.  Is it effective without using a training program?  Were the subjects in this study advised to extend their walking distances or speed?  Without it I am skeptical that it would have much of an effect.

Vitality was determined by measures on the FACIT-Fatigue score as the primary outcome measure.  Interestingly FACIT stands for Functional Assessment of Cancer Treatment and their web page links to an extensive list of modified rating scales.  I could not tell if the rating scale had been validated in normal 65 year old men without a cancer diagnosis.  No significant differences were noted between testosterone treated men and controls.  On secondary measures testosterone treated men were more likely to report higher energy at the end of the trial, but that measure was unspecified and may have been a line item in the SF-36.

Sexual Function was measured primarily by question 4 of the Psychosexual Daily Questionnaire.  This item is a 12 item yes-no checklist of male sexual behaviors, thoughts, and fantasies.  Greater testosterone levels achieved in treatment correlated with higher testosterone levels.  A secondary measure - the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II) also documented increased sexual desire and it was also used as a screen for participants in the Sexual Function arm of the trial.  The sexual function measures do appear to be more straightforward, but they are all self report measures over considerable time frames.

One of the most interesting aspects of this trial was an analysis of the side effects.  One of the main concerns in treating men with testosterone is the risk of prostate cancer that is sensitive to testosterone levels.   I have had personal communication with physicians who were treating patients with testosterone who developed widely metastatic prostate cancer.  The significant adverse effects in this trial were all summarized in a table.  There were 394 placebo treated men compared with 394 testosterone treated men.  The events were summarized according to prostate-specific antigen (PSA) level increases, diagnoses of prostate cancer, elevations of hemoglobin, myocardial infarction, stroke, all cause cardiovascular death, death and hospitalization.  Although there were a greater number of PSA elevations in the testosterone treated men, there was only 1 case of prostate cancer (compared to 0 in the controls) during the year of study and 2 cases of prostate cancer in the testosterone group and one in the placebo group in the subsequent year of the study.

The rationale for this study was try to to add to the results of previous trials that showed inconsistent results of testosterone replacement on muscle mass, body fat, sexual function, energy level, and physical function.  It is disappointing to read through all of these details and find out that there was not much of an effect and that the methodology in the 21st century is so weak.  The only good news that I can find in the article is that it is relatively safe to replace testosterone in 65 year old men who are rigorously screened for hypogonadism and prostate cancer risk.  Although selection bias for a project like this is certainly a consideration, I asked myself whether men self-selected for replacement by low testosterone ads would be rejected at the 85% level by their physicians.  Of course the researchers here point out that the risk over the long run can only be determined by larger trials or (my opinion) post marketing surveillance.  But post marketing surveillance as suggested by the FDA is really a blunt instrument compared with any type of organized pharmacosurveillance or screening all new cases of prostate cancer on a particular electronic health record for testosterone prescriptions. At some level,  I wonder if the research questions would have been answered more completely by trials focused solely on each groups, but there were a very large number of investigators.  Many of the investigators have the appearance of conflict of interest through affiliations with pharmaceutical companies and many do not.

The results of this study are consistent with what clinical psychiatrists see in their practice.  It is not uncommon to see men taking supraphysiological doses of testosterone and not wanting to reduce those doses.  It is common to see men on testosterone who stop taking it because there is no clear efficacy and/or because they are concerned that the women and girls in their life will accidentally come into contact with testosterone.  But let's face it - this is really not about hypoandrogenism.  That is not what is fueling the debate.  I am not an advocate of aging gracefully and accepting what happens.  I think if you have been dieting and exercising through the first 65 years of life it would be useful if medical science could provide something to help you maintain an active lifestyle and prevent the kind of morbidity that slows you down, leads to deconditioning and the host of metabolic factors that hasten aging and death.  Preventing that pathway of physical deterioration depends on maintaining attitude, muscle, joints, and bone.  This is another paper documenting that there is no clear solution to that array of problems.

It is unfortunate that medicine does not have a scientific solution at this point - even after hearing all of the unscientific hype about testosterone and growth hormone for the past 30 years.    

                  

George Dawson, MD, DLFAPA



References:

1:  Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119. PubMed PMID: 26886521.

2:  Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, LopezMV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. PubMed PMID: 20525717.

3:  Lee KK, Berman N, Alexander GM, Hull L, Swerdloff RS, Wang C. A simple self-report diary for assessing psychosexual function in hypogonadal men. J Androl. 2003 Sep-Oct;24(5):688-98. PubMed PMID: 12954659.


Brief Video:

The two minute NEJM video summarizing this trial can be found at this link.  Interestingly the video attributes sexual function, vitality, and physical function to testosterone decrease with age and yet full replacement to the point where it is equivalent to levels in much younger men does nothing for physical function or vitality.

NEJM and the Neurobiology of Addiction

[Original Graphic removed due to license expiration]


There are numerous articles in the popular press that attack the disease concept of addiction as well as many that attack the idea that addiction may be a biological based problem,  Volkow, Koob and McLellan have an interesting article in a recent edition of the New England Journal of Medicine that discusses both the neurobiology and some of the biases involved in stating that addiction is neither neurobiologically based or a neurobiologically based disease.  The article is relatively low in the details that reductionists like myself like to read but it is well referenced and a good overview of what is known about the neurobiology of addiction.  It is also a discussion of failed theories and what is currently known.  There is only one graphic and it is the basic one shown at the top of this post.  It shows a basic mapping of typical behaviors associated with addiction and is an elaboration of George Koob's previous all-encompassing one liner that sought to capture the behavioral pharmacology of addiction in one sentence:

"Addiction is a chronic relapsing syndrome that moves from an impulse control disorder involving positive reinforcement to a compulsive disorder involving negative reinforcement."

In this review the authors describe three stages of addiction; binge and intoxication, withdrawal and negative affect, and preoccupation and anticipation.  They are located in the table immediately below the brain graphic in the above infographic.  They break it down at a neurobiological level.  For the binge and intoxication stage increased dopamine release at the reward centers occurs.  With repeated stimulation the dopamine release is attenuated in response to the reward and shifts to anticipation of the reward.  Most authors discuss the initial phase of this process as occurring on the ventral striatum, in dopaminergic neurons from the ventral tegmental area innervating the nucleus accumbens.  I had some initial difficulty seeing the nucleus accumbens but it is there.  The larger message  is that plastic or experience dependent changes occur in not only the nucleus accumbens but also the dorsal striatum, hippocampus, amygdala, and prefrontal cortex.  I also liked the authors' inclusion of the word salience defined as a property of the prefrontal cortex in assigning relative value to a stimulus.  It is common to attend addiction conferences and hear the term being bantered about without any clear reference to the prefrontal cortex attributing salience to a particular stimulus.

Their description of withdrawal and negative affect discusses how with repeated stimulation reward and motivational systems are focused on the more potent effects of addictive drugs rather than the usual correlates including food and fluids, social affiliation, sexual behavior, and even good decision making.  This used to be referred to as the Hijacked Brain Hypothesis which basically stated the same thing.  Any physician working in a large acute care hospital will see a significant number of patients admitted largely because they have been using intoxicants on a chronic basis and ignoring their basic need for food and fluids.  This behavior is consistent with a new set of priorities for the reward and motivational systems, that biases the system heavily in the direction of continued substance use.  The previous theory of increased sensitivity to dopamine and higher levels of dopamine in the dorsal and ventral striatum in persons with addiction was proven to be wrong.  In fact dopamine release is attenuated and the reward system becomes less sensitive to all activating stimuli.  This results in both the loss of drug-induced euphoria and the lack of reward effects for previous enjoyable and preferred activities.  Recovery of this effect takes a prolonged period of abstinence and a sustained effort to get back into previous activity patterns.  At the same time, the stress response mediated by corticotropin releasing factor and dynorphin are involved in further attenuation of reward system dopaminergic cells.  Combined with changes in the extended amygdala this results in a dysphoric state and decreased stress tolerance.  It is captured in the second part of Koob's sentence - addiction becomes "a compulsive disorder involving negative reinforcement."  At this point the person with an addiction is self administering a drug to "feel normal and function" rather than get high.

The preoccupation and  anticipation stage impaired dopaminergic and glutamatergic signalling in the prefrontal cortex inhibits more typical decision making and creates a bias in the direction of continued use.  Self monitoring processes that evaluate the decision, whether or not it was successful and whether or not it was adaptive are similarly affected by these systems.  The value of the reward is depicted in the graphic below from Fuster's text The Prefrontal Cortex:

           

 The authors clarify their use of the term addiction relative to the more commonly used DSM-5 terms. With the advent of DSM-5 the familiar definitions of use and abuse disappeared and there is a single use category.  Severe use disorder requires 6 or more of the 11 symptoms of the use disorder.  The authors equate severe use disorder with their use of the term addiction.  Thinking about the demographics of people with one or more severe use disorders fits their description of addiction.  It is also much more likely that this group of patients will have markers and behaviors that cannot be dismissed by those who criticize a neurobiological approach to addiction.

Apart from the neurobiology update, the other interesting aspect of this paper was the authors taking on critics of a neurobiological model of addiction.  They are generally the same crowd who is critical of the disease model of addiction.  This paper defines a more specific model of addiction and its features than the disease model, even though popular surveys illustrate that most people see addiction alcoholism, and severe psychiatric illnesses as diseases.  At some level the popular and medical definitions of disease encompass a diverse group of conditions and arbitrary definitions can be adopted to support and argument.  A favorite is always that there is no known observable lesion or pathology in conditions that are not diseases.  I have examined several of these arguments about addiction in a previous post.  The authors here include their examination of 7 arguments entitled:  Criticisms of the Brain Disease Model of Addiction and Counter‐ Arguments.  The only substantial way their differ from my examination of the criticisms of addiction being modulated by a distinct set of pathological neurobiological features is that they include two points about public policy specifically how research is funded and how patients have benefitted.  One of the most common misconceptions about psychiatric illness and addictions when they are approached from a neurobiological perspective is that critics seem to think that this is tantamount to the "medicalization" of a problem and that this means only a medical intervention or medication can be used to treat the disorder.  In the field of addiction, excellent work has been done showing a number of unique paths to recovery that may depend on speculative neurobiological mechanisms, but do not depend on the use of medications or contact with physicians.  Critics of neurobiology seem to see the brain as a turf war rather than a need for a deeper understanding of the most intricate organ in the body.

I encourage a careful reading of this paper, by anyone who wants a brief overview of how addiction may affect the brain.  This is not a comprehensive review by any means and at some point I will come back and point out some of the shortcomings.  If you are a psychiatrist or psychiatric resident - you need to know what is in this paper at the minimum.  That is true if you are involved in the diagnosis and treatment of addiction or not.  The systems discussed in this paper are involved in cognition and complex decision making.  Contrary to popular belief there are no decisions made that are devoid of an emotional component.  That fact does not come alive until you know the relationship between limbic structures and reward/motivational systems.  Thirty years ago, some of the free literature from pharmaceutical companies contained graphics highlighting some of these systems and how they may be affected in schizophrenia and psychosis.  In the intervening time period, the bulk of useful research in the area came from scientists and physicians doing research in addiction.

As the knowledge in this area increases, this neurobiology will have wider applicability across the entire spectrum of psychiatric disorders.  


George Dawson, MD, DLFAPA

References:

1: Volkow ND, Koob GF, McLellan AT. Neurobiologic Advances from the Brain DiseaseModel of Addiction. N Engl J Med. 2016 Jan 28;374(4):363-71. doi: 10.1056/NEJMra1511480. PubMed PMID: 26816013.

Attribution:

Graphic at the top is from reference 1, with permission from the Massachusetts Medical Society.  License date is Feb 1, 2016 - license number is 3801731329358 for 12 months from the date of the license.  According to the publisher I am classified as a free-lancer (not-for-profit publisher) and hence the change in my LinkedIn status to free-lance writer at Real Psychiatry.

A Real Case Of Psychosis And What Can Happen

Public radio continues to be a rich source of information when it comes to real life psychiatric problems.  In this case the NY Times was also involved.  Considering the date the story was filed the usual critics have not chimed in yet.  They may not be able to since no psychiatrist or psychiatric medication was involved in the care of this patient - and it shows.  There is no more compelling story that psychiatric disorders exist, are severe, and for various reasons can end catastrophically.  I won't  belabor the point that I have treated hundreds of people with very similar problems.  For 22 years, I treated people with severe psychiatric disorders and most of them had psychotic disorders.  The episode of psychosis described in this story is the kind of psychosis that psychiatrists treat, not the vague symptoms described in a recent paper that suggested that some symptoms of psychosis are a normal experience.

Before I get into a brief discussion of the scenario, I would like to acknowledge the patient Alan Pean for sharing his story.  I heard his story on This American Life and the host Ira Glass was explicit that Mr. Pean  had signed a release of information so that the hospital records and a 50 page report of the incident could be used to construct what had happened. His family members were also available for the interview.  In this age where health care companies view patient information as proprietary corporate information I applaud Mr. Pean's decision to make this very personal private information public.   There are numerous lessons to be learned from this incident that I hope to make explicit  at the end of this post.

For anyone interested in listening to the audio version of this story go to the This American Life web site and look up episode 579 My Damn Mind.  This amazing story begins after Mr. Pean has been shot in the chest and is bleeding to death on the floor of his hospital room.  There is blood  everywhere on the floor and people entering the room have to put on shoe covers.  Later in the story we learn that he lost about 1/3 of his total blood volume.  A trauma surgeon is demanding that the police take the handcuffs of Mr. Pean because even though he is shot and immobile, he is handcuffed lying on the floor.  According to the Centers For Medicaid and Medicare (CMS) report he was trying to get up after he was shot and saying that he was "Superman". From there,  Ira Glass starts to interview Mr.  Pean about the 20 hours prior to this incident.  He describes being anxious and at times panicky.  He was sleeping 4 hours per night and recognized he was manic from his past experiences in 2008 and 2009.  He was diagnosed with possible bipolar disorder treated with medication and had no further episodes in 6 years.  He was trying to unwind by playing a video game online with his friends.  He started to think that the video game controller had been reprogrammed by the enemy and was switching on a processor inside of him.  He could not logon to the game because he knew that drones would triangulate on him if he did and destroy his apartment.  He called his brother for advice.  His brother told him to lay down and put cold water on his face.  He concluded that his circuits were overheating like a robot and his brother knew this.  At one point he knew he had to escape from his third floor apartment balcony because snipers were closing in on him.   As he looked down he thought remember your training - you are trained for this.  At that point Ira Glass jokes with him about that point and they both laugh.  He of course had no training and it was apparent to me that Glass had not talked with many delusional people.  Pean executes a perfect drop to the second floor balcony and grabs the railing.  From there he notices two air conditioning units on the ground swings past then and jumps.  He hits the ground running for his car because he has called in a drone strike in his apartment building using Google Maps.  He jumps in his car and heads out of the parking lot.  When the gate doesn't open he rams it until it opens.  At this point he is thinking that his rendezvous point is the hospital.  In a moment of clarity he also realizes that he needs Geodon, the medication that he takes for psychosis.  He feels like he is a bionic person or a cyborg driving the car at a high rate of speed toward the hospital.  As he approaches, he loses control and hits several autos and the hospital building totaling out his car.  An EMT sees the crash. puts him on a gurney and wheels him into the Emergency Department.

This entire sequence of events was driven by delusions.  In the narrative Pean described an intense fear for his life and the fact that his "adrenaline was pumping" at times.  That combination of emotion, especially high anxiety and delusional thinking can lead to impulsive behavior and a lack of typically rational decision-making.  It is an example of "dangerousness" or the emergency criteria that governs whether a patient with psychiatric problems is offered inpatient treatment or not.  The problem is that Pean's actions are all internally consistent with his delusional state.  He talks with his brother on the phone and does not mention that he thinks he is delusional.  In this state of mind, it is very likely that anyone assessing him for "dangerousness" would seriously underestimate what he was capable of.  A lot of his acts are also environmentally determined.  His delusional biases interpret the information as he sees it.  When he was speeding toward the hospital, he was convinced that some of the buildings he was passing were going to explode at any minute.  Despite the non-psychiatric interview, I think the emotion driving the delusionally based decisions is apparent.  Ira Glass points out that the narrative though irrational is internally consistent like a movie and not what he expected.

Pean is eventually admitted to the trauma surgery service for further observation of injuries from the car crash.  There was ample information that he had a significant psychiatric disorder including direct statements from his father who is a physician.  He is noted to be disoriented and believes that it is 1989.  His speech at time is incoherent, but the staff observe him to be lucid at times.  Immediately prior to the incident, several staff report the patient coming out of his room into the hallway either nude or partially clothed.  He had to be redirected back into his room and asked to put a gown back on.  He was dancing and in some cases danced away from staff trying to help him into the gown.  With his history (and assuming that brain trauma has been ruled out) these can all be features of a severe psychosis.  His parents are concerned that they plan to discharge him without psychiatric consultation.  The hospital they are in does not have an acute inpatient psychiatric unit and he has not seen a psychiatric consultant.  They leave at some point to rent a car so that they can drive him to psychiatric facility if necessary.  While they are gone he becomes extremely agitated.  He is tasered several times and ultimately shot in the chest just 40 minutes later.

The New York Times article goes into detail about the issue of armed security in hospitals.  It reviews the number of people with mental illness who were shot or tasered and killed.  I have pointed out some of the problems with firearms in psychiatric hospitals in an article about visitors carrying firearms into Texas state psychiatric hospitals.  The same issues apply in this case.  Firearms are not a deterrent when confronting a person who is agitated and psychotic.  In this case the patient recalls that he was some kind of cyborg secret agent.  In that frame of mind he is likely to interpret any efforts to contain his agitation and aggression as potentially dangerous to him and it would provoke extreme behaviors to counter that aggression.  In every security setting where I have worked, security and law enforcement lock up their weapons and do not take them into patient care areas even if a patient is highly aggressive and out of control.  It takes well trained staff and security to be able to do this and recognize why this is the best approach.  It also involves a contingency plan to physically restrain the patient in a safe manner as quickly as possible if the patient does not respond to verbal deescalation.

The CMS document discloses several important pieces of information that are not in the media.  The first eye opener is that the hospital administration said the security officer was justified in shooting the patient because he had assaulted them.  That statement grates on any inpatient psychiatrist or nurse who recognizes that is not the appropriate frame of reference for this incident.  This is not a street fight.  This is a vulnerable patient in a hospital whose rights and standard of care needs to be recognized.  One of the implicit assumptions in most hospitals is that psychiatrists and psychiatric staff are supposed to view aggression as an occupational hazard.  A unidentified staff member speaks to that in the radio piece and is very explicit about the amount of aggressive behavior that he sees in the hospital and the fact that he gets hit.  That is not the case in other parts of the hospital where aggressive behavior is more frequently seen as criminal behavior.  Early statements from the hospital administration suggested that the law enforcement officers here were justified in shooting Alan Pean, but they were subsequently modifying their position.  He was also charged with 2 counts of aggravated assault on both of the law enforcement officers who entered his room.  Clearly this is a psychiatric problem and the patient needs  protection.  As I read through the 50 page document from CMS, the suggested solution varied from being vague to solutions that many hospitals already have such and an emergency response team for behavioral emergencies.  They suggest that armed law enforcement officers should be only in the ED, not be involved in the behavioral emergencies until all other resources have been exhausted and intervene only in the case of life-threatening or criminal activity.

One of the primary conclusions of the This American Life piece is that is could have been prevented if the patient had received a psychiatric evaluation.  A hospital staff person pointed out that this was standard procedure and also that any number of staff used to encountering aggressive patients could have contained the patient without firearms.  There is apparently an inpatient psychiatric unit at this medical center where he could have been transferred.  Alan Pean responds to Ira Glass's question about how it is that he went to the hospital with mania and psychosis and ended up getting shot in the hospital instead.  One of his conclusions is that he is a young black man and he does not think that it would happen if he was white.  He remains understandably traumatized by his near death experience.

The only logical conclusion here is one that I have already reached many times in many posts on this blog.  Violence and aggression are treatable problems when they are associated with psychiatric illnesses.  There needs to be psychiatric and psychiatric nursing expertise in major hospitals at several levels.  One of the unusual parts of this story was all of the information available suggesting that the patient in this case had a significant mental illness.  That was made even clearer when his physician father made the statement, requested the psychiatric evaluation, and was told that the patient was being discharged instead.  The CMS report does not address staffing levels in the hospital and whether there are adequate staff to address the problem.  In my experience, a nurse and another staff person going to address a situation where there is potential aggression by a young manic patient is not enough staff.  I have personally found myself in many situations when I walked in a room and there were four highly trained nursing assistants out in the hallway, ready to intervene if necessary.  In every case our goal was to protect the patient from injury.

The lesson in this case is that if you go to a hospital with aggressive behavior due to a psychiatric disorder somebody on the receiving end needs to know what to do to keep you safe.  Only a fraction of American hospitals are set up to do this and provide the necessary psychiatric care to resolve the crisis.  Some hospitals will never be equipped to deal with this problem and the practical solution in most communities is to triage violent and aggressive people to more appropriate facilities.  Even though the New York Times article points out that there has been a 40% increase in hospital violence, many of the people with that problem never make it there.  There needs to be enough capacity to treat people so that people with violent and aggressive behavior from a psychiatric illness can go to a hospital knowing that their problem will be diagnosed and treated and that their safety will be assured.  
             
Nobody should ever have to experience what Alan Pean went through.



George Dawson, MD, DLFAPA




References:

1:  This American Life.  579: My Damn Mind.  February 12, 2016.

2:  Elisabeth Rosenthal.  When The Hospital Fired The bullet.  New York Times February 12, 2016.

3:  Department of Health and Human Services Centers for Medicare and Medicaid Services.  Statement of Deficiencies and Plan of Correction.  St. Joseph Medical Center; 1401 St. Joseph Parkway, Houston Texas 77002.


Supplementary 1:

In the report by This American Life, it was apparent that at least some authorities were looking for evidence that the patient had aggressive tendencies outside of the episodes of mania and psychosis.  They did this by asking his family if he had any criminal convictions.  In the original hospitalization he was also noted to have THC in his toxicology.  The fact that there were no other drugs present and that THC can persist a long time was emphasized in the This American Life piece.  In fact, THC is not a trivial compound in this case.  No conclusions can be made based on the existing data and the lack of direct assessment of this patient, but this compound should be avoided by anyone diagnosed with bipolar disorder, especially if there is any doubt about the diagnosis.


Twitter Graphic:

Anecdotes Are Not Evidence And Other "Evidence-Based" Fairy Tales

A lot depends on the kind of anecdote that you are talking about.  When we talk about anecdotes in medicine that generally means a case or a series of cases.  In the era of "evidence based medicine" this is considered to be weak or non-existent evidence.  Even 30 years ago when I was rounding with a group of medicine or surgery residents: "That's anecdotal..." became a popular part of roundsmanship as a way to put down someone basing their opinion on a case or series of cases.  At the time, series of cases were still acceptable for publications in many mainstream medical journals.  Since then there has been and inexorable march toward evidence-based medicine and that evidence is invariably clinical trials or meta-analyses of clinical trials.  In some cases the meta-analyses can be interpreted in a number of ways including interpretations that are opposed to the interpretation of the author.  It is easy to do if a biologically heterogeneous condition is being studied.

There has been some literature supporting the anecdotal but it is fairly thin.   Aronson and Hauben considered the issue of drug safety.  They made the point that isolated adverse drug reactions are rarely studied at a larger epidemiological level following the initial observation.  They argued that they could establish criteria for a definitive adverse event based on a single observation.  In the case of the adverse drug event they said the following criteria could be considered "definitive":  extracellular or intracellular deposition of the drug, a specific anatomic location or pattern of injury, physiological dysfunction or direct tissue damage, or infection as a result of an infective agent due to contamination (1).  They provide specific examples using drugs and conclude: "anecdotes can, under the right circumstances, be of high quality and can serve as powerful evidence.  In some cases other evidence may be more useful than a randomized clinical trial.  And combining randomized trials with observational studies, or with observational studies and case series, can sometimes yield information that is not in clinical trials alone."  This is essentially the basis for post marketing surveillance by the Food and Drug Administration (FDA).  In that case, monitoring adverse events on a population wide basis, increases the likelihood of finding rare but serious adverse events compared with the the original trial.

Enkin and Jadad had a paper that also considered anecdotal evidence as opposed to formal research (2).   They briefly review the value of informal observation and the associated heuristics, but also point out that these same observations and heuristics can lead some people to adhere to irrational beliefs.  The values of formal research is a check on this process when patterns emerge at a larger scale.  Several experts have applied Bayesian analysis to single case results, to illustrate how pre-existing data can be applied to single cases analyses with a high degree of success.  Pauker and Kopelman (3) looked at a case of hypertension and when to consider a search for secondary causes - in this case pheochromocytoma.  They made the interesting observation that:

"Because the probability of pheochromocytoma in a patient with poorly controlled hypertension who

does not have weight loss, paroxysms of sweating, or palpitations is not precisely known, the clinician often makes an intuitive estimate.  But the heuristics (rules of thumb) we use to judge the likelihood of diseases such as pheochromocytoma may well produce a substantial overestimate, because of the salient features of the tumor, its therapeutic importance, and the intellectual attraction of making the diagnosis."   

They take the reader through a complex presentation of hypertension and likelihood ratios used to analyze it and conclude:

"Hoofbeats usually signal the presence of horses, but the judicious application of Bayes' rule can help prevent clinicians from being trampled by a stampeding herd that occasionally includes a zebra."

In other words, by using Bayes rule,  you won't subject patients with common conditions to excessive (and risky) testing in order to not miss an uncommon condition and you won't miss the uncommon condition.  Looking at the data that supports or refutes that condition will make it clear, if you have an idea about the larger probabilities.

How does all of this apply to psychiatry?  Consider a few vignettes:

Case 1:  A psychiatric consultant is asked to assess a patient by a medicine team.  The patient is a 42 year old man who just underwent cardiac angiography.  The angiogram was negative for coronary artery disease and no intervention was necessary.  Shortly afterwards the patient becomes acutely agitated and the intern notices that bipolar disorder is listed in the electronic health record.  He calls the consultant and suggests an urgent consult and possible transfer to psychiatry for treatment of an acute manic episode.  The consultant arrives to find a man sitting up in bed, appearing very angry and tearful and shaking his head from side to side.

Case 2:  A 62 year old woman is seen in an outpatient clinic for treatment resistant depression.  She has been depressed for 20 years and had had a significant number of medication changes before being referred to a psychiatric clinic.  All of the medications were prescribed by her primary care physician.  She gives the history that she gets an annual physical exam done each year and they have all been negative.  Except for fatigue and some lightheadedness, her review of systems is all negative.  She is taking lisinopril for hypertension, but has no history of cardiac disease.  She has had electrocardiograms (ECGs) in the past but no other cardiac testing.  The psychiatrist discusses the possibility of a tricyclic antidepressant.

Case 3:  An inpatient psychiatrist has just admitted a 46 year old woman who is concerned about the FBI.  She has been working and functioning at a high level until about a month ago when she started to notice red automobiles coming past her cul de sac at a regular frequency.  She remembered getting into an argument at work about American military interventions in the Middle East.  She made it very clear that she did not support this policy.  She started to make the connection between the red automobiles and the argument at work.  She concluded that an employee must have "turned her in" to the federal authorities.  These vehicles were probably the FBI or Homeland Security.  She noticed clicking noises on her iPhone and knew it had been cloned.  She stopped going into work and sat in the dark with the lights out.  She reasoned it would be easier to spot somebody breaking into her home by the trail of light they would leave.   There is absolutely no evidence of a mood disorder, substance use disorder, or family history of psychiatric problems.  She agrees to testing and all brain imaging and laboratory studies are normal.  She agrees to a trial of low dose antipsychotic medication, but does not tolerate 3 different medications at low doses.

These are just a very few examples of the types of clinical problems that psychiatrists encounter on a daily basis that require some level of analysis and intervention.  A psychiatrist over the course of a career is encountering 20 or 30 of these scenarios a day and ends up making tens of thousands of these decisions.  What is the "evidence basis" of these decisions?  There really is nothing beyond anecdotes with the availability of various strengths of confirmation.  What kinds of evidence would the evidence based crowd like to see?  In Case 1, a study that looked at behavioral disturbances after cardiac catheterization would be necessary, although Bayes would suggest the likelihood of that occurring would be very low.  In Case 2, a large trial of treatment approaches to 62 year old women with depression and fatigue would be useful.  I suppose another trial of what kinds of laboratory testing might be necessary although much of the literature suggests that fatigue is very nonspecific.  In most cases where patients are being seen in primary care - fatigue and depression are indistinguishable.  Extensive testing, even for newer inflammatory markers yields very little.  Further on the negative side,  evidence-based authorities suggest that a routine physical examination and screening tests really adds nothing to disease prevention or long term well being.  Case 3 is more interesting.  Here we have a case of paranoid psychosis that cannot be treated due to the patient experiencing intolerable side effects to the usual medication.  Every practicing psychiatrist knows that a significant number of people can't take entire classes of medications.  Here we clearly need a clinical trial of 40 year old women with paranoid psychoses who could not tolerate low dose antipsychotic medication.

By now my point should be obvious.  None of the suggested trials exist and they never will.  It is very difficult to match specific patients and their problems to clinical trials.  Some of the clinical occurrences are so rare (agitation after angiography for example) that it is very doubtful that enough subjects could be recruited and enrolled in a timely manner.  And there is the expense.  There are very few sources that would fund such a study and these days, very few practice environments or clinical researchers that would be interested in the work.  Practice environments these days are practically all managed care environments where physician employees spend much of their time administrative work, the company views clinical data as proprietary, and research is frequently focused on advertising and marketing rather than answering useful clinical questions.

That brings us to the larger story of what the "evidence" is?  The anecdotes that everyone seems to complain about are really the foundation of clinical methods.  Training in medicine is required to experience these anecdotes as patterns to be recognized and classified for future work.  They are much more than defective heuristics.  How does that work?  Consider case #1.  The psychiatric consultant in this case sees an agitated and tearful man who appears to be in distress.  The medicine team sees a diagnosis of bipolar disorder and concludes the patient is having an acute episode of mood disturbance.  The consultant quickly determines the fact that the changes are acute and rejects the medical team's hypothesis that this is acute mania.  After about 5 questions he realizes that the patient is unable to answer, pulls a pen out of his pocket, and asks the patient to name of the pen.  When he is not able to do this, he performs a neurological exam and determines the patient has right arm weakness and hyperreflexia.  An MRI scan confirms the area of an embolic stroke and the patient is transferred to neurology rather than psychiatry.  The entire diagnostic process is based on the past anecdotal experience of diagnosing and treating neurological patients as a medical student, intern, and throughout his career.  Not to labor the point (too much) - it is not based on a clinical trial or a Cochrane review.                

The idea that the practice of medicine comes down to a collection of clinical trials that that are broken down according to a proprietary boilerplate and generally conclude that the quality of most studies is low and therefore there is not much to draw conclusions on is absurd.  Trusting meta-analyses for answers is equally problematic.  You might hope for some prior probability estimates for Bayesian analysis.  But you will find very little in the endless debate (4) about whether or not antidepressants work or they are dangerous.  You will find nothing when these studies are in the hands of journalists who are not schooled in how to practice medicine and know nothing about treating biologically heterogeneous populations and unique individuals.  No matter how many times the evidence based crowd tells you that you are treating the herd - a physician knows that if they treat the herd - it is one person at a time.  They also know that screening the herd can lead to more problems than solutions.

Treating the herd would not allow you to make a diagnosis of complete heart block and immediate referral to Cardiology for pacemaker placement (Case 2) or psychotherapy with no medications at all and eventual recovery (Case 3).  If you accept the results of many clinical trials or their interpretation by journalists - you might conclude that your chances of recovery from a complex disorder are not better than chance.  There is nothing further from the truth.

That is why most of us practice medicine.



George Dawson, MD, DLFAPA


References:

1:   Aronson JK, Hauben M. Anecdotes that provide definitive evidence. BMJ. 2006 Dec 16;333(7581):1267-9. Review. PubMed PMID: 17170419; PubMed Central PMCID: PMC1702478.

2:  Enkin MW, Jadad AR. Using anecdotal information in evidence-based health care:  heresy or necessity? Ann Oncol. 1998 Sep;9(9):963-6. Review. PubMed PMID: 9818068.

3:  Pauker SG, Kopelman RI. Interpreting hoofbeats: can Bayes help clear the haze? N Engl J Med. 1992 Oct 1;327(14):1009-13. PubMed PMID: 1298225.

4:  Scott Alexander.  SSRIS: MUCH MORE THAN YOU WANTED TO KNOW.  Slate Star Codex posted on July 7, 2014.

Attribution:

Photo at the top is Copyright Gudkov Andrey and downloaded from Shutterstock per their Standard License Agreement on 2/3/2016.

Data On Drug Price Comparisons - And The Myth Of Compromised Physicians

See Attributions For Reference

ND = no data

The response to my last post so far was as predicted by what I said in the post.  It is very difficult for people to get around the idea that they have heard for the past two decades - namely "Damn you Big Pharma!"  Over the past 20 years we have repeatedly heard all of the concerns about physicians essentially being bribed by Big Pharma in the form of speaker's fees, free lunch, various trinkets, ghost written research, and free vacations.  We have seen physicians criticized by a member of Congress for failing to disclose income from sources outside of their academic appointments.   We have seen psychiatrists selected out from other physicians with regard to Big Pharma financing despite the work of a well known non-partisan watchdog showing that they are nowhere near the top of the list in terms of total reimbursement or frequency.  Many people have made a career out of adding various conspiracy theories to the basic Big-Pharma<->physician conspiracy and how it has added unnecessary costs to the health care system, put patients at unnecessary risk,  and compromised professional ethics.   The only major change that I have detected is the elimination of the free lunch at Grand Rounds.  I do so appreciate that.  There was nothing that triggered my misophonia more than the sounds of mastication while I was trying to listen to the lecturer.  Now that all of those evil Big Pharma incentives have been eliminated and the risk of public shaming is in place through at least two databases, it would follow that Big Pharma should be hurting - right?  We should finally be getting reasonable priced pharmaceuticals - right?  Not if the following slide from the Kaiser Family Foundation is to be believed:

See Attribution Section Below For The Full Credit For This Graphic

It seems that the public shaming of physicians and eliminating the various forms of the Big Pharma free lunch have not led to the Utopian state of better pharmaceutical pricing.  The really telling information is in the tables at the top.  This data is widely quoted in a number of sources, but is also readily available from the original source.  The US has the market cornered when it comes to the absolute maximum drug prices.  In some cases other countries are only paying about a quarter as much.  My table also removed the maximum prices in the US that are in some cases much higher than is quoted in this table.   This data illustrates why taking physicians out of the equation has has done nothing.  Of course it will be interesting to look at the data over  time databases and make sure that there is the expected lack of correlation.  This data as well as the data on prescription pricing explodes the myth that physician collusion with Big Pharma had anything to do with pharmaceutical company profits.  For years we have had to tolerate vague rhetoric from Pharmascolds like: "If they (Big Pharma) didn't get a return (on their various trinkets, meals, other incentives) - they wouldn't do it."  There was the associated argument that getting free pens would make you start prescribing the advertised drug like you were a Big Pharma Manchurian candidate.  Neither of those arguments had any traction with me, but then again I had not talked with a pharmaceutical rep in over 20 years.  Compare these arguments with the clinical reality that physicians face every day and that is being harassed by managed care companies if they do not prescribe the least expensive drugs.  Any physician prescribing only the latest antidepressant would spend most of their time on the phone with pharmaceutical benefit managers.  They would not be able to practice.

The third argument was the moral one.  That it was somehow unethical to work for a pharmaceutical company or accept anything from them because it represented a conflict of interest.  Notice I did not use the term appearance of conflict of interest.  That is because the Institute of Medicine has decided for all of us that it is so hard to determine a real conflict of interest from the appearance of conflict of interest - why bother?  Consider it all to be conflict of interest.  To me that always seemed like a variation of the automaton argument - I have accepted pizza or a pen and now I can no longer think for myself - I will just automatically prescribe the suggested drug.  Nobody ever examined the strong reinforcement associated with the idea that:  "I don't eat the free lunch and therefore I am morally superior to you."  That unexamined thought seemed palpable on many blogs and websites where daily outrage about these practices was common.

The fallout from this lack of examination has been significant:

1.  Fewer physicians wanting to work with the industry - medicine is probably the only technical profession that makes this suggestion.  In many professions standards are set by active collaboration with industries.  I don't know how a pharmaceutical company can look for new molecular entities without an eye to problems that clinicians encounter and a solid knowledge of the shortcomings of current therapies.  You can't find that in a lab.

2.  Overgeneralizations about psychiatry based on the predictably negative press - psychiatry takes more of a negative hit on just about anything than the rest of medicine.  The Myth of Compromised Physicians has allowed an absurd level of criticism to be leveled at the field and ignore even basic realities that psychiatry specialty organizations and psychiatrists are hardly the most involved specialists with Big Pharma.  You would not get that impression by reading the popular press or the various antipsychiatry sites in the Internet.

3.  An absurd emphasis on evidence based medicine - as though that could somehow save us from the evils of Big Pharma or ourselves.  There have been endless politically biased analyses to prove that psychiatric treatments do or do not work.  In many cases, the result of the study can be predicted by the author's bias.  In many cases the author's bias is evident even without financial conflict of interest disclosures, all that you have to do is read their previous writing.  Many of these papers are foregone conclusions.  They naturally add nothing to the field because they either lack scholarship or that was not their intent in the first place.  They miss on three standards.  The first involves the intent of regulation of drugs in the United States and the science of pharmaceutical research.  There are no perfect drug trials and the results don't have to be perfect to get approval.  In some cases the results are far from perfect and the drug is approved, even against the vote of the involved scientific committee.  Safety considerations are often clarified in post marketing surveillance.   The second involves the positive experience of clinicians using the drug.  Drugs are often prescribed off label with great success and experienced clinicians have often treated many more patients by themselves than were in the original trial.  They may have better results in the trial largely by their experience using the drug and more comprehensive treatment than is available in drug trials.  There are many reasons why the experience of clinicians using the drug would be expected to be better than the trial, but the trial is considered the gold standard of whether or not a drug "works."  The third involves the safety considerations of the physicians using the drug.  There have been some studies that go back and look at all of the side effects of the drug in clinical trials and try to recalculate risks or side effects and adverse outcomes or to prove the pharmaceutical company or researchers were covering something up - they weren't transparent.  Any clinician who studies the FDA approved package insert for the drug and pays close attention to what their patients tell them, will know much more about the dangers of the drug and its side effects, how to detect and treat them better than any group of people reading research reports.  To think otherwise is folly.  

4.  A serious lack of appreciation of what the real problems are in clinical trials and that is biological heterogeneity.  Any number of polygene determined illnesses will understandably not yield positive and uniform results with great effect sizes in response to a treatment.  I don't care if the illness being studied is depression or asthma or diabetes mellitus.  Why is that shocking or surprising?  Why would it be surprising that some researchers want to break these large heterogeneous groups into small subgroups and see if the treatment response can’t be refined?

5.  A stunning lack of examination of the real problem.  That real problem is quite simply special access to all levels of government on the legislative and regulatory side by industry lobbyists.  Industry in this case includes insurance and managed care companies, and pharmaceutical companies.  Physician professional organizations have no similar access.  Nothing guarantees profits more than lobbyists sitting in a smoke-filled room and writing legislation that regulates your industry.

Take physicians out of the loop and what do you have?

The most expensive prescription drugs (by far) in the world.



George Dawson, MD, DFAPA




Supplementary:

Doctor databases: These databases are there to list payments to physicians from pharmaceutical or medical device manufacturers.  I refer to them as public shaming databases because that is  what they are used for in the press and blogosphere.  There are also obvious comparisons for similar databases that exist for Congress and the obvious fact that transparency doesn't work.  Feel free to look for my name, but I can tell you in advance that you won't find it:

Open Payments - The Official US Government Web site - https://openpaymentsdata.cms.gov/

ProPublica - Dollars For Docs



Attributions:

1:  The Table "2013 Drug Prices In Various Countries" is from a report by the International Federation of Health Plans.  The report is titled: "2013 Comparative Price Report Variation in Medical and Hospital Prices by Country."  It is quoted in many places including the reference below and the report is freely available as a PDF document.  It was accessed on 1/30/2016.

2:  The graphic of "Growth In Prescription Drug Spending......" was downloaded as a Power Point Presentation entitled Attachment-Rx-Spending-and-Use-UPDATED 12.31.2015.  Author is The Henry J. Kaiser Family Foundation. It was accessed on 1/30/2016 and is used by a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License

Asthmatics Held Hostage

I never thought in my wildest dreams that I would end up paying $275 for 0.3 mg of epinephrine.  My allergist told me that the range of the patients he sees is about $150-200.  My allergic friends tell me that in some cases they are paying as low as $80 depending on insurance coverage.  Most Americans are on high-deductible insurance plans like I am.  That means that for the first half of the year or longer - expect to pay the full retail price for medications.  Despite the fact that the price of the autoinjectors has skyrocketed in the past few years, they still contain just a few dollars worth of drug in a fancy injector.  Most people who have anaphylaxis experience occasional reactions when exposed to a certain allergen and do not need to use the pens on a routine basis.  They are warned that the pens expire at a certain date and need to be replaced.  A 2014 paper (1) that looked at an emergency department intervention for anaphylaxis commented on the costs of the auto-injector weighed against both inadequate treatment of anaphylaxis and the potential adverse consequences of administering the wrong dose.  They looked at Average Wholesale Price (AWP) of the autoinjector containing 0.3 mg and 0.15 mg doses of epinephrine ($75.00) and a 1 mg vial of 1:1000 epinephrine ($3.00).  Obviously if you are having an anaphylactic reaction it is useful to have a viable and easily usable form handy to address the problem.  On the other hand what is it about packaging that results higher costs?  Until recently there has been no competition for epinephrine auto-injectors.

The other factor driving the cost is that manufacturers and insurance companies know that patients who need this device are over a barrel.  They need the medication and will pay for it.  If a steep copay or paying retail price due to a deductible is required - many will pay that price rather than risk death.  I said many because the high price of the auto-injector is preventing some patients from refilling their prescriptions.  A letter (2) found that only 40% of adults and teens and 60% of children refilled the auto-injectors at the appropriate time and suggested that cost may have been a factor.  In many ways this could be viewed as an unintended consequence of high deductible insurance and contrary to the pop economic theory that consumers will be more price sensitive when they are spending their own money.  That can only happen when there are price competitive products.

For that reason I have included the Advair Diskus Inhaler.  I have suggested in previous posts that asthma and most severe mental illnesses have a lot in common because of complicated genetics, diverse mechanisms, phenotypic heterogeneity, poor treatment response and chronicity.  Contrary to what most of us were taught in medical school most asthmatics are symptomatic.  Although many of the precipitants of worsening asthma control are known - there seems to be very little interest in doing much about it.  From a marketing standpoint that creates a lot of demand for products to address those issues.  Although there is no clear evidence that one product is superior to others,  Advair Diskus Inhalers have demanded a large market share.  During some recent years they have sold over $13 billion of product in a market where one billion in sales is considered a blockbuster drug.  In 2013, it was the third highest in pharmaceutical sales.  The inhaler pictured at the top of this post cost me $345.  The critical deductible period of my health insurance plan is the reason why I am paying that much cash to take a medication that I take all year long.  Once again it is all in the packaging.  The patent on the fluticasone/salmeterol drug combination ran out in 2010.  The unique disk delivery system remains on patent until mid-2016.  There is still debate about what will constitute a generic substitute.

I think that there are valuable lessons in the marketing and sales of both Advair Diskus and EpiPen that are relevant now that pharmaceutical sales are spiking again.  There is also a valuable lesson about the "market forces" argument for high-deductible insurance.  Packaging alone in these two cases is enough to capture all of that $3000-6000 deductible from anyone who wants to keep taking a prescribed medication.  It also illustrates that rather than being an intermediary for cost effectiveness, insurance companies are much more likely to step aside, and let their customers absorb the  full retail cost of a medication rather than negotiating better prices with manufacturers.  It may take a while for an American public that has been accustomed to Big Pharma and physician conspiracy theories to realize what is really going on.

There is also an associated lack of data on exactly how much people are paying.  I have been describing health care costs as a hidden tax (even before the Obamacare penalty) because it easily exceeds property taxes for most people and is their second highest expenditure after income taxes.  A recent paper by the Urban Institute backs that opinion up with data.  The authors looked at health care costs based on income as a percentage of the Federal Poverty Level (single person = $11,770, 2 person family = $15,930).   The authors looked at a simulation of various income brackets for people enrolled in Affordable Care Act (ACA) compliant non-group plans.  They found that people in both the median and 90th percentile in each bracket pay substantial amounts for premiums and out-of-pocket expenses as a percentage of their income.  As an example, a couple earning 300-400% of the FPL earns about $48,000-$64,000 per year.  At the median income they would pay 14.5% of their income for health care premiums and out-of-pocket expenses.  At the 90th percentile, they would pay 22.2% of their income.   According to this simulation, only those at < 200% of the FPL or > 500% of the FPL would pay less than 10% of their income toward health care expenses.  The range for all two person families was 10.8-13.4% for incomes of $32,000 to $80,000 per year.   That number easily exceeds the average nation wide property tax figure of $2,800 per year.

The title of this post was intentionally dramatic.  I hoped to illustrate just how incredibly expensive health care costs are here in the United States.  I encourage rethinking some of the issues related to this cost.  In this post, it is apparent that business leverage still carries the day.  The pharmaceutical and insurance/managed care businesses can still make as much money as they want to.  It is possible by the pharmaceutical funding and insurance rules that exist out there and of course they are all approved or written by business friendly politicians.  The second shocking fact are the estimates of health care cost for middle income Americans as 10.8-13.4% of their income.  That easily exceeds property tax costs and for most Americans it also exceeds their state income tax bill.

That leads me to conclude that health care costs are really the second largest tax on all Americans, exceeded only by federal taxes.  That fact should stop anyone in their tracks and lead them to think about all of the free market rhetoric and the relationship between this industry and Congress.  It should be clear that there really is no market competition or savings as a result of the current managed care system.  The only management that is being done is managing to put a significant portion of your personal finances in the control of the healthcare industry.  The best solution is to get rid of this system rather than continue to tax Americans to subsidize companies whose products have value only in an artificially inflated marketplace - inflated by this health care tax.       


George Dawson, MD, DFAPA

References:

1: Manivannan, Veena et al. “A Multifaceted Intervention Increases Epinephrine Use in Adult Emergency Department Anaphylaxis Patients.” The Journal of Allergy and Clinical Immunology. In practice 2.3 (2014): 294–299.e1. PMC. Web. 30 Jan. 2016.

2: Westermann-Clark E, Fitzhugh DJ, Lockey RF.  Increasing cost of epinephrine autoinjectors. J Allergy Clin Immunol. 2012 Sep;130(3):822-3. doi: 10.1016/j.jaci.2012.06.018. Epub 2012 Jul 22. PubMed PMID: 22828415.

3:  Linda J. Blumberg, John Holahan, and Matthew Buettgens.  How Much Do Marketplace and Other Nongroup Enrollees Spend on Health Care Relative to Their Incomes?  Robert Wood Johnson Foundation; Urban Institute.  December 2015.  Accessed on January 29, 2016.

The Real Solution To Burnout

One of my favorite things these days is the concept (or is it diagnosis?) of burnout.  It seems to be a popular topic in medical and psychiatric news these days.  In the Psychiatric Times January 2016 edition, Editor in Chief Allan Tasman, MD published a column on burnout entitled My New Years Prescription for You.  He goes on to detail the syndrome and what can be done about it.  He points out the high prevalence of burnout in physicians including house staff, physicians in general and psychiatrists.  These studies generally depend on checklist surveys of symptoms suggestive of "burnout."  Dr. Tasman points out that they are relatively nonspecific and people may not see psychiatrists about burnout until there are more recognizable syndromes of anxiety or depression.

My problem with the concept of burnout is that it doesn't accurately describe the problem.  As I think back on some of my most engaging clinical rotations in training - the teams frequently worked to the point of exhaustion.  The attending came in the next day.  There was an air of collegiality and a lot of learning occurred.  There was a lot of dark humor on the part of house staff.  There was an understanding that all of this exhausting work would end some day when you made the transition to a staff or attending physicians and could work more normal hours.  That was the late 1980s and early 1990s.  As politicians and business people wrested control away from physicians, suddenly most physicians continue to work like they are house staff.  Senior physicians in their 60s are suddenly taking all night call and working 60-70 hours per week.  Hospitalist services were invented requiring physicians to work 7 days on and 7 days off - another exhausting schedule.  I have observed to many of these physicians that they are working like they did when they were house staff - interns and residents.  They numbly shake their heads in the affirmative when I ask them that question.  They also acknowledge the fact that by day 6, their cognitive capacity is markedly diminished.  Suddenly it takes them twice as long to do tasks especially all of the documentation.

The reference to Studer in the Tasman article is interesting.  I don't know if any other physicians have had to suffer through a business consultant-based inservice on how to improve "customer satisfaction scores".  There are discussions on how to introduce yourself to the "customer".  There are the usual business based mnemonics.  Physicians may actually have to demonstrate that they know how to introduce themselves to "customers"!  Think about that for a second, especially if you are a psychiatrist who was trained for years in how to interact with patients rather than customers.  If you are a psychiatrist who passed the oral boards,  you know that failing to make the appropriate introduction led to an immediate failure on that exam.  Now flash forward to the bizarre world where patients are "customers" and now there is a formula designed by business people who know relatively nothing about interacting with patients in a therapeutic manner.   You are expected to demonstrate competency in this shallow business paradigm that is setup to optimize results on customer satisfaction surveys.  This is a great example of how physicians are stressed on a regular basis in health care organizations and their time is wasted.  It is also a great example of how public relations, rather than the latest medical knowledge is the dominant performance metric for healthcare organizations.  If there is a recipe for burnout - this is it.

The dynamics of burnout are the dynamics of many clinical situations that psychiatrists try to address.  The referrals are people with chronic depression or depression that seems to have occurred as a result of a sudden change in their life circumstances.  A common scenario is an unreasonable employer or work supervisor.  I will understand it if the employers jump in here and say that they are entitled to tell people how they want them to work for their salary or that their employees are free to find another job.  Those are political arguments that I don't really care about.  Those arguments are also improbable ways of addressing burnout.

When I am faced with person who is chronically anxious and depressed, chronically sleep deprived due to forced swing shifts or double shifts, is dealing with an obnoxious demanding boss, and is not able to change jobs for economic or insurance reasons - I know the patient and I are up against a wall.  I speculate that there are millions of people in this situation who are diagnosed with one anxiety or depressive disorder or another or chronic insomnia and who are trying to get some kind of treatment to alleviate this stress.  There is no evidence that I am aware of that treatment that targets what is basically a chronic stress response is effective.  There may be some small incremental changes if people feel supported and are getting active feedback in therapy about how to deal with the stress in realistic ways, how the dynamics may have personal meaning, and how to reframe the stressful relationships but many people are likely to stay in treatment for the diagnosis for months or years and have little to show for it.  Many people have the expectation that there is a medication that will restore their ability to function in this situation and not require any significant changes on their part.  That is completely false.

That brings me to the issue of physician burnout.  Burnout is more than the clinical diagnoses that are used to describe people who are experiencing chronic workplace stress.  The current work environment for physicians is designed to produce burnout, anxiety, depression, and all of the associated comorbidity.  One of the central dynamics is administrators with no medical knowledge creating an environment that moves physicians away from patients and creates an onerous clerical and administrative burden.  The large increase in managers has created an environment that is both hostile and full of busy work.  The idea that this is something that can be overcome with medications, meditation, exercise, lifestyle management or psychotherapy leaves a lot to be desired.  It is time that psychiatrists focus on an optimized environment for mental and physical well being rather than than trying to treat the fallout from some of those horrific scenarios.

Addressing burnout in physicians is more than a health and wellness consult.  It is more than a weekend retreat to a local resort.  It is more than "lifestyle changes" when you don't have enough time to have a life.  It is a lot more than going on vacation and realizing that on the day you come back - it is like you never left.  Optimizing the work environment for physicians rather than treating burnout is a good place to start.  Recognizing this when it happens in our patients is also more useful than treating it like depression.



George Dawson, MD, DFAPA