Medical Marijuana For Intractable Pain - The Minnesota Update

Minnesota made headlines at least within the state lately by qualifying intractable pain (typically known as chronic noncancer pain) as a condition for Minnesota's Medical Cannabis program.  I find it politically interesting that when you want to take over medical systems of care the strategy is to eliminate the word medical wherever that is possible.  But in this case when there is limited if any medical evidence for a treatment that carries significant risks and the initiative seems like part of a political movement toward the general legalization of marijuana that the word medical is added to seemingly legitimize the entire process.  I don't think that there is anything medical about marijuana or cannabis.  If you want it legalized, make that argument and don't pretend that a compound (or more appropriately compounds)  that has been around for 5,000 years has suddenly become a miracle drug.  

I previously posted about the original statute and will not repeat any of that in this post.  The full details of the intractable pain indication are listed on a separate DHS web site including the definition of intractable pain.  The statutory definition of intractable pain is quite complicated and seems to misunderstand the nature of chronic pain, ignore the addiction cofounder, and address the non-cannabis treatment of chronic pain with Schedule II to V drugs and issue that seems totally unrelated to cannabis use.  To cite a couple of examples:

"§ Subdivision 1.Definition. For purposes of this section, "intractable pain"means a pain state in which the cause of the pain cannot be removed or otherwise treated with the consent of the patient and in which, in the generally accepted course of medical practice, no relief or cure of the cause of the pain is possible, or none has been found after reasonable efforts. Reasonable efforts for relieving or curing the cause of the pain may be determined on the basis of, but are not limited to, the following:

(1) when treating a nonterminally ill patient for intractable pain, evaluation by the attending physician and one or more physicians specializing in pain medicine or the treatment of the area, system, or organ of the body perceived as the source of the pain; or...." 

With chronic noncancer pain is is generally accepted that there is no medical treatment that will eliminate the pain.  There is no medication that will totally alleviate the pain.  That includes high potency opiate medications.  Most of the literature suggests that whether high potency opiates, anticonvulsants, ar antidepressants are used the result is a moderate amount of pain relief at best and additional measures like physical therapy and psychotherapy are needed to produce optimal results.  There is really minimal to no evidence that the addition of cannabis to existing pain medications will add anything.  In this case, the statute also suggests that all of these pain patients will be referred to "one or more physicians specializing in pain medicine" or the part of the body that the pain is associated with.  This statute seems like it could easily set-up a physician or group of physicians who could add cannabis to the medications that they are already prescribing.  In other words the statute is providing a non-medical indication that can be used to alter medical practice on a large scale by the prescription of an addicting drug.  We have seen previous epidemics of use and overprescribing based on similar theories.

Subd 2. from the same statute gets in to existing medical practice for reasons that are not apparent to me.  It includes the following introductory paragraph and goes on to cite the non-applicability of the statute to the issue of treating substance use disorders, use for non-therapeutic purposes, providing a scheduled drug for the purpose of terminating life in a person with intractable pain, and using a non-approved drug.  Based on my experience Schedule II-V drugs are widely used for non-therapeutic purposes if use for any indication outside of analgesia is considered a non-therapeutic purpose.  A few examples include taking extra medication for insomnia, anxiety, depression as well as mixing the medication with alcohol for an added effect.  It seems more than a little naive to me to think that a controlled substance with broad effects on the conscious state that potentially reinforces its own use will be not be used for other purposes.  That includes the use of cannabis and marijuana.        

"§ Subd. 2.Prescription and administration of controlled substances for intractable pain. Notwithstanding any other provision of this chapter, a physician may prescribe or administer a controlled substance in Schedules II to V of section 152.02 to an individual in the course of the physician's treatment of the individual for a diagnosed condition causing intractable pain. No physician shall be subject to disciplinary action by the Board of Medical Practice for appropriately prescribing or administering a controlled substance in Schedules II to V of section 152.02 in the course of treatment of an individual for intractable pain, provided the physician keeps accurate records of the purpose, use, prescription, and disposal of controlled substances, writes accurate prescriptions, and prescribes medications in conformance with chapter 147."

There is some science added to the Intractable Pain page in the form of a review entitled: Medical Cannabis For Non-Cancer Pain-A Systematic Review.  It was prepared in the standard manner of most current literature reviews critiquing the quality of the studies and looking at what the evidence shows.  Most people who are uninterested in the details of these reviews could benefit from reading the executive summary.  Like most of these systematic reviews the authors conclude that the overall evidence is sketchy, that a few studies established a response better than placebo, that the clinical trials are of short duration and patient selection is not likely to reflect who might use the drug in Minnesota, and that most of the trials looked at adjunctive treatment of cannabis and limited forms rather than cannabis monotherapy.  They also conclude that cannabinoids were associated greater risk of any adverse events, serious adverse events, and events associated with withdrawal from the study than placebo.  The authors were aware of a recent review in JAMA provided an interesting analysis of that data in the context of their review on pages 22 and 23.  The authors point out that their review (unlike the JAMA review) did not use data from unpublished studies in the meta-analysis of treatment effects.  Their re-analysis of the JAMA review data generally shows either evidence that does not show superiority over placebo or in the case where it does - the evidence is of low or insufficient strength.

I am not going to include an exhaustive review of the toxicity of cannabis or the developmental concerns of cannabis exposure in utero or in the developing adolescent brain.  I am considering a separate post on that topic.  For the purposes of an intractable pain post,  I will add a couple points about politics and regulation.  The first point is that chronic pain is a complex disorder.  It resembles what is commonly conceptualized as a psychiatric disorder much closer than what is considered a standard medical or surgical disorder.  Chronic pain is multidimensional and is frequently associated with depression, anxiety, and insomnia.  Pain ratings on any given day can reflect the state of those other conditions.  Cannabis can affect all of those other conditions in unpredictable ways.  The best example I can think of is the chronic marijuana smoker who starts in order to treat anxiety and stops years later because the anxiety is worse and he is now experiencing panic attacks or paranoia.  Anything that complicates the other dimensions of chronic pain will not be an acceptable overall treatment.  The second point is that some chronic pain patients end up taking a drug in an addictive manner independent of pain relief.  That is true for marijuana, opioids, and benzodiazepines.  Many patients will openly admit that they are using the drug because they like the effects, but it is not doing a thing for their pain.  The final point is that some people do not discriminate between numbness and analgesia.  The drug they take for pain has to induce a numb state - one where they generally have a difficult time functioning.  I include these points about chronic pain trials because these additional phenomena are usually not examined in the clinical trials.  The trial occurs as if every subject can rate their pain like they can take a blood pressure reading and that loses a lot of important information in the process.  The studies in the reviews listed here for cannabis in non-cancer pain can show weak positive effects and those kinds of studies will eventually be approved by the FDA as evidenced by some FDA actions where the regulatory considerations trump the scientific ones.  With marijuana being described as a fast growing $3 billion dollar a year business with a projected maximum market of $36.8 billion annually, you can bet there will be a large commercial lobby pushing for approval of whatever products they want to bring to market.  

I don't plan on getting too riled up about the Minnesota experiment and the political indications for "medical" marijuana.  It is clearly a response to the current cultural swing to view cannabis as a benign product and use the medical avenue to get total legalization.  When marijuana use gets as widespread as alcohol use, the population toxicity will be more evident.  In the meantime, I hope physicians don't get pulled into the politics - especially psychiatrists.

I don't plan on registering on the Medical Cannabis Registry and certifying patients for the political indications for its use.  I consider that to be a foolish endeavor.  It would be much easier to take physicians out of the loop instead of having them pretend to select patients for a drug with no medical indications.  If anything, the widespread use of marijuana or cannabis for whatever the reason will complicate psychiatric practice and increase the costs of treatment that is already rationed by healthcare businesses and the government.  


George Dawson, MD, DFAPA

Refs:

1:  Butler M, Krebs E, Sunderlin B, Kane RL.  Medical Cannabis for Non-Cancer Pain: A Systematic Review.  Prepared for: Office of Medical Cannabis Minnesota Department of Health, October 2015.

2:  Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA.2015;313(24):2456-2473. doi:10.1001/jama.2015.6358.


Attribution:

Jennifer Martin (Own work) [CC BY-SA 4.0 (http://creativecommons.org/licenses/by-sa/4.0)], via Wikimedia Commons at: https://commons.wikimedia.org/wiki/File%3AMarijuana_Plant_01.JPG

Does Identifying Bipolar I Disorder Come Down To 6 Proteins?

The Mayo Clinic puts on very good conferences in Psychiatry.  Two of the last three that I have attended had a strong biological and genetic emphasis.  I was interested when I saw a reference in my Facebook feed to a study of potential biological markers of Bipolar I Disorder.  It was even better that the article was published in the open access journal Translational Psychiatry.  In the current article the authors looks at the results from the analysis of serum protein levels in controls and adults seeking treatment for depression and bipolar disorder.  The sera of their subjects and controls was analyzed by Myriad RBM in a quantitative immunoassay designed to search for biomarkers through large numbers of proteins.  The actual product and the proteins analyzed are described on the company's web page.  All of the six proteins identified as possibly being discriminating as listed in the above graphic including growth differentiation factor 15 (GDF-15),  hemopexin (HPX), hepsin (HPN), matrix metalloproteinase-7 (MMP-7), retinol-binding protein 4 (RBP-4), and transthyretin (TTR) can be located on this page and additional information is provided about the specific proteins

The authors emphasize in several places that this is a pilot or exploratory study but also point out that sufficient power to detect odds ratios for pairwise comparisons between mood disorders versus controls, bipolar disorder versus controls, and bipolar I versus controls.  They looked at 272 proteins from 288 samples (141 controls, 52 Unipolar depression, 49 Bipolar II, and 46 Bipolar I).  It was a one time cross sectional sample and no longitudinal sampling was done.  Rigorous patient selection was used to reduce the risk of substance abuse disorders and inflammatory conditions. In a table describing patient characteristics, the cases had significantly greater BMI, greater lifetime illicit drug use,  greater BMI, greater percentage of smokers, and fewer years of education.  Existing symptoms were rated with the following scales IDS-C (depression), PHQ-9 (depression), GAD-7 (anxiety), YMRS (mania), and AUDIT (alcohol use).  The cases were also being actively treated with antipsychotics, AED mood stabilizers, lithium, antidepressants, sedative/hypnotics, and thyroxine supplement.

The graphic from the article labelled figure 2 above shows the differences in protein concentrations for the six proteins that were significantly different after Bonferroni correction by diagnosis.  As can be seen from the figure all six proteins were at the highest levels in Bipolar I disorder.  ROC curves and the ROC-AUC was used to determine which proteins were better predictors of Bipolar I Disorder.  The text contains theoretical and speculative discussions of these particular proteins, what they have been associated with so far, and what importance that has for the issue of why their concentrations may vary in bipolar disorder.

There are a number of relevant considerations when looking at this type of proteomic analysis.  The most obvious is the assumption that the underlying dynamics of the biological substrate can be measured in meaningful ways by knowing the protein signature of those systems.  Although most of us are used to looking at cartoon depictions of neuron and synapses but the reality is much more complex.  Recent work in Science shows that there are 62 proteins associated with synaptic bouton (2) and vesicle trafficking and that the copy number of these proteins varies greatly.  The authors of that paper speculate that the production and number of those proteins may vary because some physical locations within the neuron may allow for an enrichment effect.  One of the implicit assumptions in the Frye, et al paper is that psychiatric disorders may have a unique configuration in terms of synaptic architecture and that it will be reflected in the proteins responsible for that architecture.  A further assumption is these CNS protein changes are all going to be reflected in the periphery and detectable in blood samples.  

Although it is premature to draw many conclusions about the data in this study, the implications may be far reaching.  It will be an interesting day in psychiatry if and when proteins will be used as biomarkers.  It will be an interesting day even if variants can be found and reliably detected.  Until then students of neuroscience and psychiatry will be able to appreciate that information flow in these systems is significant and we are just on the cusp of being able to understand it.  We are just at the stage of moving from cartoon versions of neurons - to the real thing.


George Dawson, MD, DFAPA

References:

1: Frye MA, Nassan M, Jenkins GD, Kung S, Veldic M, Palmer BA, Feeder SE, Tye SJ, Choi DS, Biernacka JM. Feasibility of investigating differential proteomic expression in depression: implications for biomarker development in mood disorders. Transl Psychiatry. 2015 Dec 8;5:e689. doi: 10.1038/tp.2015.185. PubMed PMID: 26645624.

2: Wilhelm BG, Mandad S, Truckenbrodt S, Kröhnert K, Schäfer C, Rammner B, Koo SJ, Claßen GA, Krauss M, Haucke V, Urlaub H, Rizzoli SO. Composition of isolated synaptic boutons reveals the amounts of vesicle trafficking proteins. Science. 2014 May 30;344(6187):1023-8. doi: 10.1126/science.1252884. PubMed PMID: 24876496.

Attribution:

The figure at the top of this post is from the above reference 1 and is used per the conditions of a Creative Commons Attribution 4.0 International License.

Better Living Through Pharmacology

One of the great unspoken biases in psychopharmacology is the belief system about the medication.  What is the medication supposed to do after all?  Is it supposed to be life-changing in terms of positive improvements?  Is it supposed to eradicate all types of depression and anxiety?  Is it supposed to create the perfect cognitive and emotional state?  Is it supposed to turn an average student into an MIT professor?  Is it just supposed to treat a symptom and if so - how many symptoms?  Does it need to address some underlying physiological disturbance or can anyone take it and get the same benefits?  These are all unspoken biases about psychiatric medications that need to be explored with people who are taking the medications.  I don't think that a psychiatrist should even take for granted that a patient knows the difference between depression or anxiety or why thinking that Attention Deficit Hyperactivity Disorder (ADHD)  with essentially no impairment in professional, academic, or social life is not the same as having that diagnosis.

One of the best examples is the myth of the perfect mind.  If ADHD is finally diagnosed and treated, that means the person's mental functioning will either be normalized or be much better than it was in the past.  It should be possible to read entire book chapters and even books for the first time.  That is true isn't it?  It turns out that the effects of most medications for ADHD are modest and rarely life changing.  I have talked with many people who had clear diagnoses of ADHD as children who did not like the side effects of the medication and stopped taking it or even faked taking it in school.  They developed strategies for coping in the world and were able to achieve academic and vocational success.   Even some of the strongest proponents of medical treatment of ADHD will agree that proper care also involves lifestyle and management strategies and in some cases formal therapies in addition to medication.  That does not mean that some people will not do better with medications and worse with lifestyle modification, but it does mean that there is much more latitude in the treatment of this disorder than is commonly assumed.  It is fair to say that in many clinics these days, there are clinicians actively looking fro any treatable psychiatric disorder.  The theory seems to be: "If I treat the social anxiety disorder, bipolar disorder, ADHD, panic attacks, and insomnia this person will be a lot better off."  There is really no evidence that this is true or that there is even a good way to select what disorders should be treated first.

The patient side of this problem seems to be the myth of the perfect mind extended to many conditions.  It is evident in a number of ways.  Some people present with some very basic knowledge of psychopharmacology.  They may suggest that their "serotonin" or "dopamine" is out of whack and that they heard that there are specific medications to correct that.  In some cases they will suggest a medication.  In other cases, a person will not be very stress tolerant and suggest that they need something that will either reduce day to day stress or significant stress from predictable major life stressors like the disruption of a job or relationship.  They seem to think that there is a medication that will both reduce the emotional reaction to this pain but also remove the cognitive elements from their mental life.  Depending on the person's baseline cognitive state, they can become quite demanding if they think that they are not getting adequate relief or it is not happening fast enough.  The risk in these situations is starting to take a number of medications with substantial side effects that frequently precludes them getting back to their baseline conscious state.  There is often a focus on a person's baseline in psychiatry or medicine, but that baseline is almost never adequately characterized.  That is true in the case of blood pressure but more true in the case of mental illnesses.  In the case of severe mental illnesses like bipolar disorder baseline is almost always defined in terms of the presence or absence of a few symptoms.  Wide areas of a person's life like their baseline intellectual functioning, social behavior, and typical stream of consciousness are rarely considered - even in research studies.

Addiction makes everything worse and therefore it also provides the best illustration.  The graphs at the top of the page show two drug response curves with the blue lines showing a good response.  A person who is using an addictive drug and the high risk response to that drug is conditioned to expect the drug response curve on the right - a continued therapeutic response for increasing doses of the medication.  In that case there is no element of safety or toxicity.  True drug responses are represented by the curve on the left - an interval of response followed by toxicity and limited response at the higher levels.  Addictions have a second effect by creating a bias that mental states can be fine tuned within the space of hours by drugs.  Any feeling state can be immediately modified by the addition of benzodiazepines, stimulants, opioids or alcohol.  This is often erroneously referred to as "self-medication" and it is a strong conditioned response that generalizes to the treatment of disorders with non-addicting drugs.

The psychological effects of these patterns are significant.  They can lead to continued addiction and disrupted care.  A person may have the belief: "If this doctor can't give me something that will get rid of the negative way I feel right now - I will take something to get rid of it."  It may lead to disruption of the therapeutic alliance, through anger and open criticism about the lack of immediate effects or minimization of physician concern about side effects and a general lack of concern about toxicity on the part of the patient.  There is often an associated belief: "I have a very high tolerance for drugs and you can give me higher starting doses and higher maintenance doses of drugs than you give most people."  Many people in this situation experience very high levels of anxiety if they are not getting high doses or the physician does not seem to be increasing the medication fast enough.

The thoughts and feelings about medications is one of the most difficult areas in psychiatry.  Contrary to what is written by critics - nobody is complaining about being overmedicated.  Most of the complaints I hear about are about not getting enough medication and not getting to those high doses fast enough.  The solution is rarely to provide the medication and amount requested.  The solution is to spend enough time talking with the patient about these issues.  I generally start with the limitations of the defined treatment and a medication strategy that is risk avoidant.  In that initial conversation I usually tell the person whether or not they have a diagnosis or if I agree with a pre-existing diagnosis.  If I detect signs that unrealistic expectations about the medication are present I move into that area, point out that the medication will not lead to a perfect mind, and what they have to do in addition to taking medication.  If I find that they are really focused on medication issues to the point that they are experiencing anxiety from it - I usually encourage them to think about something else and provide some examples of what else can be done.

There is some literature on psychodynamic issues and medication in the transference that I have not found very useful. I suppose you could say that from what I have written the medication has meaning far beyond its pharmacology.  There is an interpersonal and intrapsychic context.  I think it is addressable in what is usually considered straightforward supportive psychotherapy, but it definitely needs to be addressed.  It is a frequent cause of medication or treatment "failures".


George Dawson, MD, DFAPA        

Never Miss An Opportunity To Harass A Physician

Despite some PR releases to the contrary, pharmacy benefit managers (PBM) continue to harass physicians and waste their time.  My latest inane conversation occurred after a pharmacy left their usual message about prior authorization and an 800 number about a prescription that I had written.  Unless I call the PBM and jump through all of the necessary hoops they will not cover my patient's prescription and it will likely go unfilled.  It was a newer medication and more importantly one that I had not started in the first place.  In other words, the patient had been maintained on this medication before seeing me.  That means the specific prescription had been approved from another physician a few months earlier.  I was writing this prescription because the patient did not have access to the previous pharmacy and I was the physician of record in another treatment facility.  The conversation with the PBM went like this:

PBM:  "Is this a doctor's office or a pharmacy?"
Me:  "Doctor".
PBM:  "Who is the doctor?"
Me:  "George Dawson"
PBM:  "Who are you?"
Me:  "George Dawson"
PBM: "OK - I was just checking.  What is your fax number?  I can fax you the form in 20 minutes"
Me: (fax number given)
PBM: "OK - you will need to complete the form and then fax it back to us and we will have 15 days to make a determination?"
Me:  "Do you understand that the patient needed this medication two days ago and I just got a notification about this today?"
PBM:  "That is the patient's policy.  We can do an expedited review and give you a determination in 3 days if you like?  But that is in the patient's policy.  We have either 15 days or 3 days to make a determination.  Do you have any questions about that?"
Me:  "Well no I do not.  I am only concerned about appropriate medical care and this delay is not appropriate medical care.  I don't care about your policies.  Your policies have nothing to do with appropriate medical care."
PBM:  "Is there anything else that I can do for you today?"
Me:  "No there is not."

I expected to receive the fax in 20 minutes but did not get it until the next day.  The form is designed to waste additional physician time.  It could have been pre-populated with all of my information and the patients information - but it was not and I had to complete the form by hand.  There were two sections on the form that had to do with failed medication trials.  One wanted specific dates.  Since I am a consultant I do not have specific dates and my experience with most patients is that they have a difficult enough time with the names of medications.  I do know that the patient had tried 8 different medications from the same class and stopped them due to lack of efficacy or intolerable side effects.  I added them to the section and wrote "refer to the previous section" on the redundant form.  Total time to complete the form and try to figure out what they wanted was 20 minutes.   I was seeing other patients it took me an additional 2 1/2 hours to complete the form and fax it.  The 72 hour clock started at that point but there was no place on the form to request an "expedited review".  

I have several posts about PBMs on this blog.  They all have the same modus operandi.  PBMs are at the very minimum a significant delaying action.  They are hoping that the physician, the patient, or both just give up and either withdraw the prescription or opt for a much cheaper generic prescription.  There are a couple of significant problems with that theory.  The first is that all generics in the same so-called drug class are not equivalent.  Any physician with a modicum of experience knows that individual patients have highly individualized responses to medications that are broadly similar and that there are generally sound pharmacological reasons for those responses.  Secondly, physicians have been prescribing less expensive generics medications for decades now and if a new unique medication is being prescribed the odds are very high that the person has not responded to that medication.  In the example given here,  I had a list of 8 medications in my record that failed due to intolerable side effects or a lack of efficacy.  They were all inexpensive generics.  I listed them on the form and faxed it back to them.

This behavior does highlight an important difference in ethics between physicians and medical businesses.  In every case where I prescribe a medication for a patient, the medication is carefully selected and monitored for how well it is tolerated and the effectiveness.  The ethical concept here for physicians is to provide continuity of care for the patient.  That is the reason that I am obligated to provide follow up prescriptions to patients who leave one care setting and go to another.  The PBM obviously has no similar constraint.  I would argue that their 15 or even 3 day policy ignores the fact that the patient needs the medication right now.  The telephone conversation makes it explicit - the company cares more about the policy than the patient who needs the medication.

The political process in all of this is frequently ignored.  How is it possible for a private company to waste so much physician time and interfere with patient care?  A long time ago the healthcare industry and its friends in government sold the American public on the idea that businesses should ration health care.  They sold that idea with rhetoric about how physicians were greedy and tended to squander health care dollars on unnecessary tests, surgical procedures and medicines.  They sold that idea in spite of the fact that the largest independent review organization of physicians documented a trivial amount of excessive resource use.  Businesses are now firmly entrenched as middle men whose only job is to ration health care and that includes prescription medications.  They do that in part by having physicians make tens of thousands of calls like the one outlined here every day and essentially leaving that physician and their patient in the lurch.

Health care businesses currently have the best of all possible worlds.  They are funded by mandatory health care insurance that is essentially the second largest tax on all Americans.  The annual health care premiums easily exceed property taxes, state income taxes, and state sales taxes for almost all Americans.  The does not include the amount of physician and patient time that is wasted by these rationing tactics.  In return Americans get a system of corporate management that consistently places the interests of the corporation and corporate profits ahead of them.  They talk like they are competitive businesses - but they are in fact some of the most heavily subsidized businesses in the US and nobody seems to make the connection between the most expensive health care system in the world and this corporate welfare.

It is well past the time for change and the first step should be to return medical decision making to physicians and stop pretending that a for-profit company cares more about patients than the monied interests of the corporation.


George Dawson, MD, DFAPA

Minnesota Psychiatrist Workforce Shortage

It should be well known by now that Minnesota has a shortage of psychiatrists.  Government officials and administrators everywhere think that the solutions are simple - hire more psychiatrists or (even better from the administrators perspective) - hire more non-physicians to prescribe increasing amounts of medications for psychiatric disorders.  Various posts on this blog elaborate what the real problems are and why it is not a straightforward hiring problem.  There are various markers that point to the real problem as rationing and business approaches to psychiatric care.  At the latest Minnesota Psychiatric Society meeting, there was an invitation to participate in an interview project that is being conducted by the Minnesota Department of Health.  I am posting the following description of that project here as a public service announcement.  I think it offers a rare opportunity to provide direct information on the practice environment to government officials.  Please contact Ms. Morgenstern for the interview if you are interested.  She will provide you with a document of the standard interview questions.  I encourage everyone to be very frank about the practice environment here in Minnesota and what is wrong with it.

The Minnesota Department of Health Office of Rural and Primary Care is doing an interview project on the psychiatric workforce shortage. We wish to conduct ethnographic-style interviews of 30 minutes to a half hour in length with practicing and retired psychiatrists to get their perspectives on job satisfaction, location desirability, and difficulties in entering the workforce. This information will be used in conjunction with other workforce data in a report to the Mental Health Workforce Commission, which is charged with making recommendations to the legislature. If you would like to be a part of this project, please email Gabrielle.Morgenstern@state.mn.us



George Dawson, MD, DFAPA




Attribution:

By Alexrk2 (Own work) [GFDL (http://www.gnu.org/copyleft/fdl.html) or CC BY 3.0 (http://creativecommons.org/licenses/by/3.0)], via Wikimedia Commons

Dreaming of the EHR

The Dream:

I am at the APA convention.

It is in a crummy hotel attached to a mall. I am going down to the street level in an elevator and it stops at a level where there is a big cinema complex. An 8 year old boy runs excitedly into the elevator and jams in to my left. The elevator is crowded. He looks at my name badge and says: "What would George Dawson say if the Watson computer said he wasn't doing a good job?"

I glance down at him and say: "George Dawson would not care."

The kid says: "That's not good" and laughs intensely.......


It is all a dream. I had that dream early Saturday morning. It doesn't require detailed analysis. That last thing I did on Friday was try to review a 22-page paper record that was generated by a modern electronic health record (EHR) system. With the exception of a few paragraphs it was largely unintelligible. It contained bits and pieces of information. I was looking for imaging (CT, MRI, ultrasound reports) and ECG data, but instead could find only a few lines that summarized fewer results. There were no dates - no hospital admission or discharge date.  Although the hospitalization was longer than a week - there was no medication administration record or MAR - showing the specific dates when medications were changed.  There were no comprehensive reports that I am used to seeing for the past 30 years from Radiologists. There was no discharge summary. The documentation was basically unacceptable as a source of clinical information and yet it was created by a very high end, enterprise wide EHR system. It brought back a memory of a mandatory meeting I had with a "coding specialist" about 10 years ago. That person let me know that I had "passed" the documentation review in that I had ticked off the necessary "bullet points" so that documentation specialists would approve my EHR note for the day and the associated billing document that had to be submitted with each note.  She showed me how I could do things faster by ticking off a series of check boxes and electronically signing the note.  She was shocked when I told her that I really could not sign my name to that document because there was no sign that an intelligent human being had seen the patient.  For all of these reasons, very poor documentation in the EHR is always on my mind.

My attempt to read the last report may have been enough of a reason for the dream, but I also spent time on Thursday with a colleague who really dislikes the EHR for additional reasons. We regaled our spouses with tales of incomprehensible reports.  In addition, his reports require a synthesis of many imaging, lab, and clinical reports.  He previously used a system where all of the reports showed up in a queue and he could go down that list in chronological order to dictate the report.  In the new system, he has to go to tabs to find all of the reports he is looking for.  Some of these tabs are hyperlinked and the reports don't load very well.  In the end, he and his colleagues end up printing out all of the reports on paper so they can dictate then more efficiently without having to search for what they need in real time in the EHR.  That reminded me of an experiment I did about 8 years ago with the same EHR.  I went in and read all of the clinical notes looking for chronic diagnoses that were not addressed.  I came up with an additional 8 diagnoses from 340 clinical notes buried in the EHR. There is generally no good way for physicians to mine data on their own patients to make sure that they have done the most thorough assessment of their problems.  On the other hand administrators can get detailed numbers of mouse clicks by nurses in primary care clinics and rate their productivity in terms of mouse clicks, screen views, or tasks completed.  My colleague's theory was that the current EHR is selected for the administrative capabilities like monitoring doctors or nurses rather than any inherent advantage for medical staff.  The major evidence for that is that many EHR vendors have permanent staff in the hospital and they are making constant modifications to the EHR.  In many cases there are meetings of all the physicians in a particular department about these modifications.  The hospitals and clinics purchasing these systems are purchasing incomplete products that require what seems like constant revisions.

It has been about 15 years since the blight of the EHR hit physicians.  It was originally called the electronic medical record (EMR) but I suppose some business type decided that they could really solidify the corporate stranglehold on medicine by eliminating the word "medical" from another phrase.  Corporate psychology also dictates that they give the impression that they are maintaining health rather than treating medical problems.  That is another good reason for eliminating the word medical from the corporate lexicon.

The marketing of the EHR has been masterful.  The political hype promised untold savings.  National candidates seemed to suggest that we could actually "save" enough with the EHR that it would cover a substantial part of American health care inflation.  Any physician involved in the implementation phase of enterprise EHRs knew that was a bold faced lie.  There is no way that annual multimillion dollar a year licensing fees as far as the eye can see are going to save anybody any money.  In fact, I am certain that many clinics and hospitals have had to cut staff and services just to bankroll the EHR. Nobody has ever followed the money on the EHR debacle as far as I know.  Congress is well known to invent businesses and turn people into billionaires overnight.  All it takes is a few Congressional mandates about the need to use an EHR and electronic prescribing.  There is no mandate to keep things cost effective of make sure that independent practitioners can afford it.  There are mandates to implement EHRs and electronic prescribing and the White House brags about it.  The following graphic and text are from a White House document on the EHR entitled: More than Half of Doctors Now Use Electronic Health Records Thanks to Administration Policies.

The problem with the White House statement is that despite spending about $3 billion dollars a year and in some cases $44,000 per physician,  the value of the EHR for the reasons already stated remains in question.  It is very handy to be able to pull up lab results and x-rays on a computer screen.  It is also very handy to be able to send electronic prescriptions to any pharmacy in the country.  On the other hand, it is reasonable to expect that a multimillion dollar piece of software will write a report that any hundred dollar database software from the 1990s could write.  That same software should be capable of allowing physicians to search their own patient results for quality and report writing purposes.  In the end we are left with very expensive, high maintenance systems, and massive amounts of information that is either buried in storage because it is not easily accessible or because it is worthless and generated primarily for justifying a billing document.

That is one of the many real costs of having a health care system run by bureaucrats and politicians.  


George Dawson, MD, DFAPA


Attribution:

Photo at the top of this blog is by Paco Burrola on Flickr and is used courtesy of this Creative Commons license.

NEJM Review of Generalized Anxiety Disorder

There was a review of Generalized Anxiety Disorder (GAD) in this week's New England Journal of Medicine by Stein and Sareen (1).  I just did a bit of a critical review of the concept here and thought I would look at what these authors had to say.  

They start the review with a clinical vignette of a 46 year old married woman with insomnia, headaches, back pain, and excessive worry about a number of daily stressors.  She is also drinking alcohol on a daily basis to "self-medicate".  She is described as a person who comes in frequently for appointments.  After reviewing the phenomenology,  comorbidity, and differential diagnosis - the authors come back to this case and apply what is in the review.

Their review of the diagnosis does highlight a few things that are problematic about the diagnosis.  The key diagnostic feature is chronic excessive worry.  The worry has to be there for at least 6 months.  In their review of other psychiatric causes of anxiety they omit diagnoses that can cause short term worry or anxiety - the adjustment disorders.  They point out that GAD is more common in primary care clinics where it usually presents with a chief compliant of somatic problems rather than excessive worry.  They discuss major depression as a common co-occuring condition and suggest that anhedonia may be a distinguishing symptom for depression.  They also describe anxious depression as episodic depression superimposed on chronic anxiety.  There is no mention of the low diagnostic reliability of the disorder and why that might occur.  I think that any psychiatrist who sees GAD over time experiences the same problem that occurred in the DSM-5 field trials, the diagnosis can seem to change between visits from GAD to major depression, even in the absence of any new stressful life events.  Critics of psychiatry frequently cite this as a problem with DSM-5.  I think that DSM-5 does a good job with the symptom descriptors, but we don't know why this change occurs and I have not heard anyone talk about it like it is a real phenomenon.

Alcohol use is described as a common co-morbidity with 35% of people with GAD "self-medicating."  I put that term in quotes because it suggests that alcohol can actually be used for the purpose of medication.  What really occurs is that over time the person becomes more anxious and sleep deprived because of the negative effects of alcohol on sleep, baseline anxiety, and baseline mood.  Practically everyone I talk with who has an alcohol use disorder can recognize this pattern and modify any remarks about self-medication to "feel better for a few hours" or "knock myself out and forget about my problems".  There is also the issue of alcohol use being the cause of an anxiety disorder rather than temporary relief.  While I am on the topic of substance use and GAD, at one point the authors make the statement: "Data are also lacking on the use, usefulness, and safety of medicinal marijuana for generalized anxiety disorder" (p. 2066).  Many if not most anxious people are averse to the use of marijuana for anxiety.  Initial use of marijuana typically causes a drop in blood pressure with a compensatory tachycardia.  Tachycardia especially if there is a noticeable accentuation of heart beats is not tolerated well by patients with anxiety.  Many have had panic attacks.  Others have cardiac awareness and are sensitive to any changes in heart rate or intensity.  Many people tell me they thought that marijuana was effective for anxiety, but over time it seemed to make them more and more anxious, they developed panic attacks, and they had to stop using it.  These features combined with a tendency of patients to stop talking to their primary care physicians about substance use are good reasons to heavily educate them about these problems at the earliest possible time.

The authors take a risk factor analysis approach to looking at historical features that can also be associated with the diagnosis.  They point out that they are nonspecific and amy be associated with other psychiatric diagnoses.  I would encourage a more developmental approach, looking back at the first recollection of anxiety - usually at some point in childhood and how that developed in the childhood environment.  It is fairly common for the patient to describe one or both parents being anxious and how that was transmitted to them  eg. ) "I started to worry about the same things my  mother worried about" or "I started to worry about my mother because she was worried all of the time - I worried that something was going to happen to her."  Those learning patterns associated with adult anxiety are fairly common and may explain the low heritability (15-20%) of the disorder.  The authors do discuss one feature that is important in this context and that is intolerance of uncertainty.  Clinically that translates to excessive and at times catastrophic worry about uncertain situations.  They are unsure about the biological or experiential origins of the symptom.  I think the important part is that with a careful enough history and sometimes collateral information the learning aspects of this bias can be examined and it can be unlearned in therapy.

The authors advocate for a stepped approach to treatment and I certainly agree.  This approach would include an initial medical assessment to look for common medical conditions that can cause anxiety followed by education about anxiety and lifestyle changes to address sleep, exercise, caffeine intake and alcohol use with monitoring response to those interventions.  Those first two phases could be accomplished at the initial visit.  If those initial interventions don't help moving on to "low intensity psychological interventions" like self-help books, computer-assisted psychotherapy, and support groups.  The next step up is more intensive psychological interventions like individualized cognitive behavioral therapy (CBT) or pharmacological management based on the patient's preference.  The highest level of care would include pharmacotherapy and more intensive CBT alone or in combination with other therapies (psychodynamic or acceptance and commitment therapy (ACT)).  The practical issue with this 4 step algorithmic approach to care is that it is generally not available in primary care settings.  In many of those settings, the patient is screened with the Generalized Anxiety Disorder 7-item questionnaire (GAD-7) and the patient is treated with a medication.  This is viewed as "cost-effective" care by managed care systems because an inexpensive prescription and a 20 minute appointment with a physician is apparently much more "cost effective" to the organization than maintaining computerized psychotherapy or educational and monitoring systems.  There is also the largely undetermined effect of the patient taking a completely passive role in their care.  There is a significant difference between a patient who is actively engaged in lifestyle changes and self education and one who expects a complete cure from a pill.  The actively participating patient has better outcomes.   

The authors include a table of 16 medications used to treat GAD.  They point out that the effects of medication are modest at best and no single medication has better efficacy.  They discuss vilazodone as a promising medication in clinical trials and do not include it in the list.  My current prescribing information says that it is FDA approved only for major depression, but only 4 of the 16 drugs on the list are approved for GAD: paroxetine, venlafaxine XR, duloxetine, and buspirone.   The authors comment on the practice of using hydroxyzine for GAD and suggest not to use it.  I am in complete agreement with that recommendation and think that any anti-anxiety effect comes from the non-specific sedating effect of antihistamines.  The side effect profile is also not very favorable.  They point out the benzodiazepine paradox with GAD - they are recommended for short term (3-6 month) use but the condition is chronic.  There is even more subtlety there.  Some early studies of GAD treated with antidepressants suggests that patients needed to take the medication only 30% of the time over ten years of treatment.  I don't think you will see a similar study with benzodiazepines and I think it has to do with the behavioral pharmacology of the drug.  The single-most important issue when it comes to benzodiazepines is the informed consent and letting the patient know that they are taking a potentially addictive drug.  

The  authors are silent about the fact that GAD may be the most heterogenous of all of the DSM-5 categories.  In October and November of this year, I went to three excellent conferences.  One of the central themes was phenotypic diversity in DSM-5 categories and what it implies for biology and genetics.  GAD seems to offer some of the best clinical features for distinguishing intermediate phenotypes and I outline a few in my previous post.  There are problems with a diagnostic category that says "excessive worry" is a discriminating feature and ignores real physiological markers like persistent tachycardia, hypertension, body mass index, and hyperarousal at the time of sleep.   This also points out how basic science can drive clinical diagnoses in psychiatry and hopefully at some point in the near future we will see this kind of research.

    

I think that we have gotten as much as we can out of the GAD diagnosis at this point and it is time to break it down into what can be more reliably observed. 

George Dawson, MD, DFAPA

References:

1: Stein MB, Sareen J. Generalized Anxiety Disorder. N Engl J Med. 2015 Nov 19;373(21):2059-68. doi: 10.1056/NEJMcp1502514. PubMed PMID: 26580998.