Vigilance Is Required For Adequate Informed Consent

One of the main reasons for me writing this blog is to discuss medication safety and adverse effects. This is no small task since the orientation of most research and clinical work is making a diagnosis and where appropriate selecting the correct medication. A lot of work goes into those determinations but an equal amount of work needs to be directed toward managing common adverse effects and preventing serious adverse effects/events of the medication. In order to do that practitioners need to realize that they are treating a genetically diverse population. That means there will always be a subgroup of people who cannot tolerate medications. There will also be a subgroup of people who respond very well to medications and variations in between.

A good example is selective serotonin reuptake inhibitors (SSRIs). These medications are commonly first-line agents for depression and anxiety. About one person out of every seven will not be able to tolerate them. The same is true of every major class and psychiatric medications. That is a source of frustration for practitioners because it means that even if the correct diagnosis is made the optimal medication may not be available because the person cannot tolerate it. In the case of SSRIs, a person may not be able to tolerate any other medication in that class.

In addition to genetic heterogeneity affecting the pharmacokinetics and pharmacodynamics of drugs, patients are also taking other classes medications and have other medical morbidities that may contraindicate the use of certain psychotropic medications. In the case of bupropion, any history of eating disorder or current eating disorder, any seizure history, and any traumatic brain injury that may predispose to seizures are contraindications to using that medication. Appropriate medical care requires that practitioners are aware of all of the contraindications and precautions listed in FDA package inserts for medications.

What about the case of a healthy young person with no medical comorbidity who needs treatment for depression or anxiety. What is important for that person to know in order to safely take that medication? What should be explicitly discussed with them? What constitutes adequate informed consent? What can be done in the time a practitioner has to make the diagnosis and educate the patient? These are not trivial questions since most practices are scheduling patients every 15 minutes in some cases new patients are seen for 30 minutes. All that makes it seem like psychopharmacology is a very easy job but the information transfer during the sessions is critical and there is plenty of evidence that it is inadequate.

There is an excellent discussion of the problem by Rajnish Mago, MD in the references (2).  He considers a number of ways to assess and manage adverse effects including open-ended questions, checklists administered to the patient, structured interviews by clinicians, and spontaneous reports by patients. His review of this literature shows that the sensitivity and specificity of all of these methods are lacking and some of them take so much time they could not be applied clinically. He gave as an example of structured interviews administered by clinicians that take up to 60 minutes just to determine the adverse effects.  The other problem with determining the adverse effects is whether or not they can be attributed to the medication that has been prescribed. In clinical trials, researchers often estimate whether adverse effects/events are due to the medication or not. In practice that is a difficult determination due to both placebo and nocebo effects.

Vital signs and laboratory measures can also constitute adverse effect measurements. In psychiatry liver function tests, renal function including plasma creatinine and estimated GFR, CBC and ANC, TSH, T4, basic metabolic profile, electrocardiograms, and EEGs are all metrics that can be followed to determine medication effects. Vital signs should also be routinely done on anyone taking medications to check for effects on blood pressure, heart rate, and heart rhythm. Those measurements constitute more specific measures that could lead to clinical action.

There has been some emphasis on measurement-based practice that involves the extensive use of rating scales.  Many of the authors in this area seem to mistake rating scales as both objective and quantitative measures when they are neither.  I remain unconvinced that this is the best approach and think that it has resulted in the over medication of large numbers of people who have a certain rating scale score but no diagnosis.  There has been very little discussion of the analysis of longitudinal data and what these rating scale scores actually mean. The controversy in this area applies to both the diagnostic indices as well as the side effect indices. My approach in dealing with side effects is that they should be completely eliminated wherever possible and that irreversible adverse effects need to be avoided.

Dr. Mago’s paper reviews recommendations for improving adverse effect reporting and clinical trials and also his recommendations for clinical practice that basically come down to telling patients about all adverse effects that occur at a rate 5% greater than placebo and all potentially serious for life-threatening adverse effects even if they are rare. I am in complete agreement with those recommendations, and even have an approach that can work. It does require a degree of vigilance on the part of the clinician.

The attached table suggests why vigilance is required.  Psychiatrists need to be more vigilant than most physicians because no patient is expected to get complications or die as a direct result of our treatments. That historically has led the field to have a lower threshold for monitoring for potential side effects.  Given all of these constraints and the complexity of the situation is there a way to provide adequate informed consent about the medications that we prescribe?  I am talking about all physicians here and not just psychiatrists.  I think there is and I will walk through my process.

1.  I preface my remarks with my experience prescribing the medication: For example with common medications like naltrexone I will give an estimate of the percentage of people that tolerate the medication very well and the percentage that stop taking it and why. That sets an  expectation that a medication may or may not be well tolerated as a probability statement and that some people stop it because of adverse effects.

2.  I encourage people to do their own research. Anyone can pull up the FDA package insert on any medication these days by Googling: "[medication name] FDA package insert".  I tell them what to expect. I also tell them that I should be able to explain anything they find on the Internet about the medication if they have any questions or concerns. In the case of polypharmacy scenarios, I point out that the extremes of low doses and high doses of two agents and all of the combinations in between can be found this days with stated results ranging from very positive to very negative for the entire range of doses.  I also have the position that they can take as long as they want to do their own research and that in the meantime - no medication needs to be prescribed.

3.  I will discontinue the medication at any time and I am very explicit about that.  I do not expect anyone to "get used to" side effects because in my experience too many people get used to side effects and live with them on a long term basis.  I provide examples to illustrate the idea of living with side effects.

4.  I give them the MedlinePlus handout on the medication or show them how to get it.  The MedlinePlus handouts are really a product of American Society of Health-System Pharmacists (ASHP).  I have emails both into MedlinePlus and AHSP inquiring about the process they use to determine the bullet points for the listed precautions and tiers of side effects. At the time of this post I have not been contacted by either organization.

5.  I tell them the common side effects, contraindications to the medication, and precautions - specially if they are on a medication or have a medical condition that is flagged in the precaution section.

6.  I discuss sexual side effects as a common side effects of medications.  About 20% of the people I see have this side effect from SSRI type antidepressants.  I review the possible effects on sexual function including decreased libido, impaired excitation phase (erections, lubrication), impaired orgasm, and altered ejaculation (delayed, retrograde).  This is a difficult issue for many people who have found an antidepressant that works but produces this side effect. The analysis of the problem is complicated by relationship problems and the initial effects of depression.  It is important to outline a strategy to address the problem even if the patient's preference is to delay any medication changes. 

A good example is the antidepressant duloxetine. The contraindications are straightforward - uncontrolled angle closure glaucoma and recent use of a monoamine oxidase inhibitor (MAOI). Beyond that clinical worsening and suicide risk, hepatotoxicity, orthostatic hypotension and syncope,  serotonin syndrome or neuroleptic malignant syndrome, abnormal bleeding, activation of mania/hypomania,  seizures, effect on blood pressure,  clinically important drug interactions, hyponatremia,  use in patients with concomitant illness, urinary hesitation and retention, and  laboratory test abnormalities are all listed as warnings and precautions.  The most important one that I typically discuss is liver function abnormalities due to alcohol use.  Although this is not a contraindication - the package insert basically says that a person with this problem should not take duloxetine. I have had people want to take the medication despite this warning and have had to discuss a monitoring plan with them as well as letting them know that my read of the package insert is that this plan carries with it more risk than one that adheres to the recommendations by the FDA.   The package insert also lists two different groups of Treatment Emergent Adverse Reactions in tables.  Both are more common than placebo and occur in 5% or 2% of patients in clinical trials.  There is a subsequent list of side effects defined with these frequencies:

"Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients." 

It takes a lot of practice to get the above informed consent discussions down to 10 minutes, especially when polypharmacy and other specific problems need to be addressed at the same time. Even then, it is important to present the information every time. Shortcuts can result in a patient experiencing an uncommon side effect and that leads to self doubt on the part of the physician of the form:

"If I had mentioned that problem like I usually do would it have led to a more timely intervention to reduce the adverse effect?"

That is a question that most physicians don't want to keep asking themselves and it is why my vigilance is high.

George Dawson, MD, DFAPA

References:

1: Bloom R, Amber KT. Identifying the incidence of rash, Stevens-Johnson syndrome and toxic epidermal necrolysis in patients taking lamotrigine: a systematic review of 122 randomized controlled trials. An Bras Dermatol. 2017 Jan-Feb;92(1):139-141. doi: 10.1590/abd1806-4841.20175070. PubMed PMID: 28225977; PubMed Central PMCID: PMC5312199.

2: Mago R. Adverse Effects of Psychotropic Medications: A Call to Action.Psychiatr Clin North Am. 2016 Sep;39(3):361-73. doi: 10.1016/j.psc.2016.04.005. Review. PubMed PMID: 27514294.

3: Tse L, Barr AM, Scarapicchia V, Vila-Rodriguez F. Neuroleptic Malignant Syndrome: A Review from a Clinically Oriented Perspective. Curr Neuropharmacol. 2015;13(3):395-406. Review. PubMed PMID: 26411967; PubMed Central PMCID: PMC4812801.

NEJM Case: Brain, Heart, and Parsimony

Cardiology factors prominently in psychiatry and psychiatric care. I have been fortunate on many occasions to work with psychiatrists who were also cardiologists and to have access to outstanding cardiologists as consultants. That gave me a great appreciation for what was possible in the detection treatment of cardiac problems. It also help me appreciate the importance of treating psychiatric disorders in patients with cardiac problems. The recognition that some medications can cause problems and the need for ECG screening was another change in psychiatric practice. Prior to that knowledge, there were some medications that delayed cardiac conduction to the point that they are no longer used.

One of the commonest scenarios I currently see is at the interface of anxiety and the effect it has on the heart. About 20 to 30% of the people I see have severe anxiety and panic attacks. About two thirds of them have made at least one trip to the emergency department because they thought they were experiencing a heart attack. They are generally young people with limited cardiac risk factors. When I asked them about the symptoms that led them to the ED, the most common answer is “my heart was pounding out of my chest and I thought I was having a heart attack”. Palpitations are another common symptom. They are harder to get at and people who have talked to cardiologists are better at describing them. I demonstrate by making an irregular thumping noise on my chest with my hand to indicate what it might feel like. The associated symptoms of panic attacks like swelling, lightheadedness, dizziness, chest tightness, shortness of breath, hyperventilation, and dizziness all reinforce the thought of a heart attack. Once the ED staff determine the patient is having a panic attack the way they are educated is critical in reducing ongoing symptoms. But that is another story.

An associated symptom in anxiety is what I like to call “cardiac awareness”. It happens in anxious people whether they have an anxiety disorder diagnosis or a stressor making them anxious. Laying in bed at night waiting to fall asleep many people can sense their heart beating without taking their pulse. They can sense other pulse points in the body and frequently they can sense large pulsations. This is a normal physiological process but anxiety can lead to a focus on it. I also lead to attaching other meetings to it such as the occasional palpitation is seen as evidence of heart disease leading to increased anxiety. In that situation it becomes very difficult to sleep leading to more anxiety and frequently - a faster heart rate the next day.

Cardiac pathology can compound the problem because there are various conditions like atrial fibrillation that can lead to people paying much more attention to their heart rate and rhythm. Atrial fibrillation is interesting in that regard because there are two management strategies. In a rate control strategy the person is given a medication to generally keep their heart rate less than 100 bpm but the rhythm could still be irregular and experienced as frequent palpitations. In a rhythm control strategy the person is either given a medication or treatment to maintain a regular sinus rhythm and palpitations would be much less frequent to nonexistent. Current thinking on treating atrial fibrillation is that the outcomes of both strategies are equivalent in terms of mortality but that patients with a rhythm control strategy rate themselves as having a higher quality of life.

That brings me to the New England Journal of Medicine case listed in the references below.  This case continues a recent trend in incorporating more psychiatric expertise into these cases with psychiatrists as discussants. The patient was a 62-year-old man with depression and anxiety. The depression dated back 15 years with onset after he learned that his wife had cancer. His wife eventually died. Whichever psychiatrist are about seven years and eventually found that citalopram and clonazepam are effective. He continued with his primary care physician and eventually discontinued the citalopram. He was seen by one of the discussants due to recurrent anxiety depression and lethargy. Vital signs were noted to be abnormal with an irregular pulse of 130 bpm blood pressure 108/75. An ECG was done that showed new onset of atrial fibrillation. 

Echocardiography showed an enlarged left atrium and left ventricle, low normal LV ejection fraction, mild left ventricular hypertrophy, and no valvular disease. The subsequent ECG showed a prolonged QTc interval of 466 ms. At a subsequent visit he had an additional significant stressor also had started to binge drink. At that time he had weekly panic attacks that correlated with increased alcohol intake. When he was seen in the psychiatric clinic had weekly panic attacks that consisted of “racing heart, lightheadedness, restlessness, shaking, and generalized weakness and so the episodes lasted for several hours. A family history of depression and suicide was noted. He was noted to be drinking 4 to 6 standard drinks per week with occasional binges. Aripiprazole was added to the clonazepam and citalopram.

The patient subsequently had a near syncopal episode three weeks later I was noted to be hypertensive and tachycardic. The ECG showed atrial fibrillation and sinus pauses of six and seven seconds. A permanent pacemaker was placed in the metoprolol was discontinued.

He was noted to be improved on the psychiatric medication changes but the metoprolol is discontinued because of fatigue. Three weeks later he had increasing anxiety and the feeling that his heart was racing and “thumping” in his chest and that he was excessively worried. They aripiprazole was increased at that time.

Like most of these cases there is a differential diagnosis exercise included and the discussant in this case is a psychiatrist.  The exercise focuses on the fact that the central symptoms in this case-anxiety, palpitations, racing heart, restlessness, and fatigue are not specific for cardiac or psychiatric diagnosis. In fact all DSM diagnoses included criteria to rule out any medical causes of the syndrome. In this case all the usual suspects are discussed. From the medical side hyperthyroidism, return atrial fibrillation, dilated cardiomyopathy, Torsade de pointes, and rare medical causes are discussed. The duration of the patient’s symptoms rules out a lot of the acute causes. From psychiatric standpoint panic disorder, substance intoxication, and substance withdrawal were the primary considerations. The discussant Dr. Chen uses the term that we don’t hear enough of lately and that is parsimony specifically “The best diagnosis would parsimoniously explain the patient’s symptoms and the time course of his illness”. He concludes that there is a clear correlation with discontinuing metoprolol and experiencing recurrent atrial fibrillation.

From a cardiology standpoint the decision was made to improve rhythm control with sotalol and the rationale for choosing that agent was provided. He experienced a decrease number of episodes of atrial fibrillation that he was correlating with anxiety.

The discussion highlights the correlation of anxiety with atrial fibrillation. That anxiety is a product of experiencing the palpitations and also can be an etiological factor in the episodes of atrial fibrillation. Depression and anxiety also predict who experiences more severe symptoms of atrial fibrillation. Patient medications also discussed in terms of the prolonged QTc interval. The authors comment on the FDA warning about QTc prolongation with higher doses of citalopram. They point out that although citalopram prolongs QTc interval more than other antidepressants there is little evidence that it leads to torsade de pointes or sudden cardiac death. They also point out that the literature shows that when this warning led to decreasing the dose of citalopram the result was no worsening of cardiac outcomes but less than optimal psychiatric outcomes including more frequent hospitalizations and increased sedative hypnotic prescriptions.

Overall this was an excellent discussion of the cardiology-psychiatry interface. Psychiatrists are likely to see increasing numbers of patients with atrial fibrillation. I currently see number of patients who are taking multiple cardiac medications. Any patient with this degree of complexity it is important to discuss the possibilities in order to determine the likely sequence of events. In patients with cardiac risk factors who are hypertensive and appear to be describing panic attacks caution is necessary to make sure that there are no underlying cardiac conditions that need to be attended to. As illustrated in this case I have seen patients with severe panic attacks (but no atrial fibrillation) due to the abrupt discontinuations of metoprolol. In patients who have recently discontinued antihypertensive therapy and have panic attacks - clarifying whether there has been any exposure to beta blockers is important.  

Another relevant factor in this patient's demographic is that the sympathetic tone of the peripheral nervous system in humans seems to increase with age. That may predispose older populations to tachycardia, palpitations, hypertension, and anxiety either directly or indirectly by experiencing the cardiac symptoms.

Being able to make an assessment and determination of patient stability, whether or not they need urgent care, what further testing is needed, and what further referrals are necessary is a skill that every psychiatrist should have.

George Dawson, MD, DFAPA

Reference:

1: Chen JA, Ptaszek LM, Celano CM, Beach SR. Case 9-2019: A 62-Year-Old Man with Atrial Fibrillation, Depression, and Worsening Anxiety. N Engl J Med. 2019 Mar 21;380(12):1167-1174. doi: 10.1056/NEJMcpc1900140. PubMed PMID: 30893540. Full Text

See also for the critical references in this case.



Graphics Credit:

The human heart line drawing in the above graphic is from Shutterstock per their standard agreement.

Holding Tank Or Psychiatric Unit?

In the event that it is not obvious, the bulk of my career was spent as an acute care psychiatrist.  I staffed inpatient psychiatric units for about 22 years in one of the most acute care facilities in the largest Metro area in the state of Minnesota. That meant that most psychiatric emergencies, especially those involving aggressive behavior were generally brought to this facility and I was one of a handful of inpatient psychiatrists who would be seeing that person. In order to do that work even reasonably well there has to be a reasonable environment. I am an expert in that environment and this post is about how that environment deteriorated as a direct result of government and business intervention that was designed to turn healthcare over to the business community and out of the influence of physicians.

Before I get into those details, let me describe my current perspective on inpatient psychiatric care from the vantage point of an outpatient psychiatrist.  In October of this year, I will have been working in an outpatient setting for a total of 10 years. I have seen hundreds of people who were detained or admitted to inpatient psychiatric units over that period of time. I always ask them what their care was like and the reviews are never positive.  The most common term that I hear as a description is that it was a "holding tank."  They describe incredible boredom, very brief contacts with staff, and the role of the psychiatrist as asking them if they were suicidal or not. Many of them knew they could adopt a game strategy: "I knew if I said I was not suicidal they would let me go and they did." They often tell me that arbitrary medication changes were made to medications they may have been taking for a number of years. Their psychiatrist or physician was rarely contacted. Follow up in these circumstances is not very good.  They discharge prescriptions were rarely filled and often they did not get an explanation for the medication changes.

My experience trying to get care for people who need inpatient care has been equally unsatisfactory.  I have been overruled by non-physicians working in emergency departments when I referred people in who needed acute care.  There is nobody in the world or the history of the world who knows more about who needs inpatient care than me. I have been unable to refer people for electroconvulsive therapy with severe depression and suicidal thoughts, even directly to the hospital where I used to work. I have been sent severely ill and unstable people to take care of in an outpatient setting - who should have been treated on an inpatient unit.  That level of care in unacceptable to me both as a professional who knows the field and as a family member who wants anyone with mental illness in my family to get the same care and resources as somebody who goes to the emergency department with chest pain.  They currently do not.

How did inpatient psychiatric care fall to such abysmal depths?  Basically by stealing the decision making ability from the physicians who were trained to make the decisions. The decisions I am talking about include treating the patient in a particular setting, the treatments and specific medications offered, and what their overall treatment trajectory would be. Beginning in the 1990s it was possible for an insurance company to deny treatment based on whatever basis they decided and sustain no liability for a wrong decision.  At that time a physician employee or contractor could just call the hospital, have a cursory discussion with the attending physician, and deny care. To illustrate how that works here is one of my typical conversations with one of these "utilization reviewers" from that time. The conversation refers to no specific case but represents an amalgam of these reviewer conversations:

Utilization Reviewer (UR):  "Hello I am Dr. X calling to review the care of Mr. Patient Y.  Why is he on your inpatient unit?"
Me: "He has longstanding depression and for the past two months has been drinking a fifth of vodka per day.  On the day he came in his wife found him sitting at their kitchen table with a loaded firearm saying he was going to kill himself.  He is currently being detoxified and treated for depression."
UR: "He needs to be sent to detox."
Me: "The county detox unit is a social detox with no medical coverage and they refuse to take anyone with suicidal ideation or behavior."
UR: "He needs to be sent to detox".
Me: "Did you just hear what I said?"
UR: "Is he suicidal RIGHT NOW?"
Me: "He has been under my care for less than 24 hours and at this time is at extremely high risk for immediate relapse and high risk for recurrent suicidal behavior. He needs stabilization."
UR: "But is he suicidal RIGHT NOW?"
Me:  "I don't understand what you mean. He has no access to a firearm right now. He is in a hospital."
UR: "Then we are done here. We are not going to cover the hospitalization."

Having many conversations like the one above over the years set the tone for the demise of inpatient care. At one point it was easier to recruit psychiatrists to be utilization reviewers because it was an easier job with no liability and predictable hours compared to psychiatrists trying to actually provide the care.  This process remains one of the greatest unspoken conspiracies in the history of American healthcare and it is the reason for the red transition arrow in the above graphic. It is also the reason why we began incarcerating people with severe mental illness rather than treating them.  It is how county jails are now opening jail facilities that they are calling mental health units. It "saves" any insurance company that adopts these polices a significant amount of money and puts all of the people who should be treated in a safe and supportive environment at risk for that profit to the company.

Holding tank is a term, that has come full circle.  We owe it all to the managed care  industry.


George Dawson, MD, DFAPA

The Most Important Fact About Suicidal Thinking

I am going to keep this post brief and to the point.  This is advice that I routinely discuss with people who tell me that they have suicidal thoughts.  In most cases they are surprised about what I tell them.  This is a beginning to help people conceptualize suicidal thoughts and frame them in a way that they know what they mean and are confident that they can do something about them. For clinicians, it is also an opportunity to expand the diagnostic interview into a therapeutic intervention.  In too many cases, the clinician asks a lengthy series of questions for the diagnostic interview and in some cases and additional set of questions for an assessment of suicide risk or aggression risk.  At the end of that process the patient being questioned may be more emotional or feeling drained by the process while they wait for a decision about hospitalization or other treatment recommendations.  I have found it is best to have a discussion about suicidal thoughts and attempts right at the time they are being discussed in the diagnostic process.  I discuss the following point.

Suicidal thoughts are irrational thoughts and it is a normal reaction to experience emotional distress when thinking about them.  The best way to think about them is to see them for what they are and that is either a symptom of depression or an irrational thought process.

When people get suicidal thoughts they often attach other meanings to them that increases their emotional reaction to them and keeps the thoughts going.  Over the years some of the meanings that I have encountered include:

"I am in a hopeless situation and I would be better off dead".

"I am worthless to my family and they would be better off without me".

"I am not living up to my potential and I have let people down and it would be easier if I was dead."

"If I wasn't such a chicken I would kill myself"

"My friend who killed himself had the right idea and I should follow in his footsteps."

The general pattern is that the thoughts can get more and more complicated but they always come to the same irrational conclusion.

In order to interrupt them - it is important to recognize that they have no particular meaning and that they must be recognized as an irrational thought or a symptom of depression.  They have no meaning past that.  In my experience most people have not thought of them that way and that is why the discussion is so important.  When people see the point of the discussion and recognize the importance of the discussion it is often very therapeutic for them.  They recognize for example that the thoughts are transient and that they do not really want to die.  They can say that 99.9% of the time they would never seriously contemplate suicide.  They realize that they have gone to bed at night with suicidal thoughts and awakened in the morning without them.  In many cases they go to work and while focused on their job never experience a suicidal thought.  This discussion is a jumping off point where the clinician can discuss a number of ways to intervene in this thought pattern and reduce the frequency and intensity of the suicidal thoughts to the point that they are likely to fade away.

The clinician seeing the patient can develop a treatment plan based on this important discussion.  That includes addressing any associated diagnosis.  But the focus on suicidal ideation and safety needs to continue until the thoughts are no longer a problem.  In the case where the discussion is not very productive and suicidal thinking is very prominent a more acute intervention may be required to assist the person experiencing these symptoms.

Although the focus of this brief post has been on a typical clinical interaction I hope than anyone reading this post who is experiencing suicidal thoughts can use the advice or access help either through mental health crisis services or their health plan.  Remember the main message of this post: 

Suicidal thoughts are either a symptom of depression or the product of an irrational thought process.

And that means there is hope.  The best starting point is to talk with a clinician who has experience talking with people who have these thoughts and giving them advice on how to get rid of them.


George Dawson, MD, DFAPA

Will Physicians Be Superfluous In The Recreational Cannabis World?

When it comes to advising people to use cannabis for various problems I think the answer is yes.    Only a small fraction of people who can access recreational cannabis will be asking physicians for advice on using these products. There are a confluence of reasons but basically they involve cultural factors, political factors, the marketing of cannabis products, expense, and the inconvenience of seeing a doctor for advice and prescriptions when you can get advice from other people including dealers and producers.  I would go as far as saying that many of the advisors will be prominent media figures giving advice on the use of cannabis and expanding the marketplace.  It follows that the education of physicians should take these factors into account.

It is easy to get into disagreements on Twitter.  I think most physicians including myself are fairly easy to disagree with because we are not invested in “winning” an argument. As a psychiatrist I know that I certainly am not going to win against an ideologue or somebody was interested in calling me names. This week I got into a disagreement about the role of physicians in medical cannabis. The controversy was sparked by an article written by a medical student about why medical cannabis should be discussed in medical schools.  Any reader of this blog knows that my position has been that medical cannabis is basically a political lever to promote the widespread legalization of so-called recreational marijuana. I also believe that every state in the United States will eventually have recreational marijuana. I don't argue that point - I know it will happen.  At that point, we will have a better assessment of the risks involved with this policy and they will be significant.

The issue this week was a post suggesting that medical students and physicians should have more training in “medical cannabis”. My position was that if most states go the way that Colorado went physicians will be entirely superfluous in that process. It comes from my knowledge of interaction of American culture and the wide availability of recreational cannabis products in the state of Colorado. Medications especially those that are self-reinforcing or put more basically the ones that can get you high, attain mythical status in the American culture.  Practically everyone I know hoards opioids.  That supply of oxycodone or hydrocodone that is typically given for some type of injury used to be held onto for years. Neighbors would trade pills back and forth over the fence. Opioids no longer sit in a medicine cabinet for years as people actively seek out opioids to get high or sell.  Most Americans have a set idea of what opioids they would like for pain and that decision-making process is complex based on their experience and also what they’ve heard from other people.  The reality of that process is quite different.

In my opinion pain has been inadequately studied and continues to be inadequately studied. The concept of “self-medication” is at the top of that list. I usually hear about it in the form of this sentence:

“Look Doc, if you can’t get rid of this (anxiety, depression, insomnia, pain, fatigue, distractability) I know how to get rid of it for at least four hours.”

When I inquire about the method it invariably comes back to alcohol or some type of consciousness altering drug. I use the term consciousness altering because the drugs used are not necessarily addictive. A good example is a combination of antihistamines and muscle relaxants to cause a state of delirium and sedation. Alcohol is frequently used as a way to address chronic pain. The medical cannabis initiative basically started around the issue of chronic pain and terminal pain. From there it has expanded indications in those states that list their own like Colorado and Minnesota. A lot of people address the issue of chronic pain by altering their conscious state. I certainly have no problem with that in certain circumstances but it is a major unaddressed dimension in the treatment of chronic pain.

The American Society of Addiction Medicine (ASAM) has a lengthy position statement (1) on the physician’s role in medical cannabis. They review the need for scientific study and a regulatory process that will provide pure and consistent formulations from companies in a similar manner to the pharmaceutical industry. It is the only way to come up with standardized dosing for specific conditions.  The only problem I have with that statement is that it is fairly naive to think that people with a choice between purchasing high cost pharmaceutical grade medical cannabis and recreational cannabis that claims to have the same cannabinoid content will choose the former whether it is “prescribed” or not.

That leads me to what I see as the role for physicians in a society that has widespread availability of recreational cannabis. Colorado is a good case in point. Looking at what cannabinoid products are available in a Colorado gas station, it is hard to imagine that people will be consulting physicians for what products to use. I recently found a web site for Colorado gas station cannabis with a wide range of smokable and edible cannabis products.  The edible products contained up to 250 mg THC per bar.  Physicians currently have the role of certifying conditions for people who will get access to medical cannabis. In Minnesota advice about medical cannabis comes from the pharmacists dispensing it and not from physicians. There is widespread advice available on the Internet about how any interested user could start using cannabis.

All of these factors, lead me to conclude that there will be a very limited role for physicians in recommending cannabis or prescribing it. There have been limited medical studies of cannabis and limited indications. There are basically two FDA approved applications and even those medications will be obsolete when people have access to the recreational and less expensive forms. There is no logic at all to declaring a botanical product is on the one hand “medical” and on the other hand “recreational”.

A larger role for physicians will be in the treatment of the medical complications from cannabis and people who become addicted to it.  As millions and millions of people start using legal cannabis – the number of people addicted to it will also increase.

The best way to address cannabis in a medical school curriculum doesn’t require an extensive course in medical cannabis for an ever-increasing political list of indications.  It should not teach medical students that they are going to have a central role in the acquisition and prescription of cannabis.  It can be done in the following courses:

1.  Basic science: neuroanatomy and neurophysiology – the endocannabinoid system’s critical role in basic physiology and clinical correlations.

2.  Basic science: pharmacology – detailed pharmacology of cannabinoids.

3.  Addiction course- there needs to be a basic 2-week course added to the medical school curriculum on addiction and the prescription of drugs that reinforce their own use with necessary risk mitigation techniques.  Many medical schools have a 6-week course in psychiatry that is usually based on an inpatient unit.  I recommend adding two weeks to that with experience in an addiction clinic. I currently work in a program where we provide two week training programs to residents, medical students, and physicians for this purpose.

4.  Elective course - experience in specialty programs where there may be more cannabinoid use (pain clinics, palliative care, toxicology) that can be tailored to a student’s interest.

5.  Clear identification of resources for further study - during lectures I always mention the major addiction texts and their organization. Additional state-of-the art references could be posted in a self study syllabus - primarily because a clinical focus would not allow enough time to cover the necessary basic science.

6.  Advice on the regulatory burden - in the foreseeable future that means familiarity with the statutes and regulations in each state.  Medical schools generally do not teach these practical aspects of medical care.  States recognize that physicians can't prescribe a CSA Schedule 1 drug, and limit the physicians role to certifying the conditions that qualify the patient for medical cannabis. Some states require physicians to get approval for that role.  That seems like overkill to me. Any medical record with the qualifying condition listed should lead to certification and would probably be more objective. 

Any effort beyond what I have listed above is probably unrealistic based on the fact that this is (along with supervised practice) is the basic approach to any medication that physicians prescribe.  I am not aware of any medical school initiatives to intensify the training for opioids, benzodiazepines, or stimulants but would appreciate hearing about any of those courses. In the course where I teach, we see medical students, residents, and physicians from all over the US and Canada.

In closing are there possibly ways where physicians will end up in a more central role? Only if the FDA and other regulatory bodies put them there.  For example, in my post on Epidiolex I asked about the patentability of CBD products, specifically this one that was an extraction product of cannabis.  Physicians prescribing these FDA products need to learn to prescribe them like any new product, but is there a chance that FDA approved and patented cannabis products are a threat to the products available for recreational and medical use from dispensaries?  There is currently a story circulating saying that the FDA is going to ban all CBD oil use except for Epidiolex and it will cost all users $32, 500 a year. That would favor the pharmaceutical industry but I don't think that will happen. It is more likely that other products designed to affect the endocannabinoid system will be developed like standard pharmaceuticals and that will lead to physician prescribing - if there is anyone left at that point who is not using recreational cannabis.

George Dawson, MD, DFAPA




Supplementary Information:

I recently encountered an interesting twist by a cannabis advocate in a state where recreational cannabis is not yet legal and medical cannabis is strictly controlled as non-smokable products.  He argued that the terms recreational cannabis and medical cannabis should be changed to cannabis for non-prescription and prescription use.  He argued that this would normalize the political process since nobody designates alcohol as recreational or medical. The obvious reason is that alcohol has extremely limited roles as a medication.  The term medical cannabis may have lost some of its luster as a politically correct approach.    




References:

1:  The Role of the Physician in “Medical” Marijuana. ASAM Public Policy Statement (2010) Link


Graphic:

Downloaded from Shutterstock per their standard licensing agreement.

An Effort To Distance Critical Psychiatry From Antipsychiatry

I read the paper “Critical psychiatry: a brief overview” by Middleton and Moncrieff. This paper was the basis for the commentary by Peter Tyrer in the previous post on this blog. The authors try to make an argument to differentiate critical psychiatry from antipsychiatry. They claim that critical psychiatry offers constructive criticism of the field whereas antipsychiatry seeks to abolish the field. Constructive criticism needs to be valid criticism I hope to point out why critical psychiatry does not meet that threshold.

One of the interests for me in reading this paper was to see if critical psychiatry in fact could be distinguished from typical antipsychiatry rhetoric. That might be the easiest way to illustrate a significant difference. An associated strategy might be to show that critical psychiatry had origins that were clearly independent of antipsychiatry.   The authors suggest multiple common origins.  They both have the same heroes - Szasz and Foucault. They both draw heavily on the defective ideas of Szasz and Foucault. These ideas have no scientific basis and are not logically derived.

Social control is one concept that ties in what the authors claim is “controversy” about the institution of 19^th century psychiatry and the ideas of Szasz and Foucault. By the authors own definition Szasz trivializes serious mental illness as a social disorder and socially deviant behavior rather than a potentially lethal illness. In order to consider a mental illness to be a true disease, Szasz believed it would have to be a “neurological” illness.  That does not recognize that a significant number of these disorders have no known pathophysiological mechanism.  Szasz and the authors paint themselves into a corner with this construct given the clear medical, neurological, and substance induced disorders listed in any diagnostic manual for psychiatry. They also seem to not realize that these distinctions are all arbitrary definitions by Szasz. Most medical professionals and lay people do not believe that a specific pathophysiological mechanism is the basis for disease, illness, or treatment in most cases. For the antipsychiatry and critical psychiatry adherents of Szasz this is one of their most predictable arguments.

On the issue of social control, the antipsychiatry arguments are as weak. The authors explain Foucault’s position as:

“Thus, the birthplace of institutional psychiatry can be considered arrangements for managing unproductive behaviour in a system of wage labour and industrial production. The growth of psychiatry in the 19th century legitimated this system by presenting it as a medical and therapeutic endeavor.”

I really doubt that Foucault was accurate in his historical observations.  German psychiatry at the time was clearly focused on persons with significant psychopathology and who could eventually be discharged as well as the biological basis of psychopathology. Have psychiatrists ever had the influence to run governments and dictate government policy? What ever spin Foucault could put on old history we all know what is happening now. Psychiatry is nearly completely marginalized.  Despite the antipsychiatry movement there is widespread agreement that there are too few psychiatrists and that people do not have enough time with them.  That process also highlights the true agents of social control.  Federal and state governments have supervised rationing bed resources to the point where they are extremely low.  At the same time there has been a huge increase in the mentally ill who are incarcerated, making county jails the largest psychiatric institutions in the country. Los Angeles County jail is building a new facility that is designed to hold a population with mental illness. They are calling it the Mental Health Treatment Center.  Foucault's speculation has not stood the test of time. There should be no doubt that the true agents of social control are federal and state governments, law enforcement, and businesses that profit from their relationships with government officials and not a marginalized medical specialty.  

The authors also march out the old Foucault quote “psychiatry is a moral practice, overlaid by the myths of positivism”.  Philosophers have the annoying practice of coming to a conclusion that is not backed up by any data or proof. That may be why Foucault also has to discredit positivism. He is basically in his own little parallel universe.  Let’s forget about the fact that no psychiatrist I have ever met was trained to exert social control and manage “unproductive behavior” by putting the poor and disabled into almshouses. Present day psychiatrists in the US are most commonly battling with insurance companies to get minimally adequate care for their patients.  That insurance company rationing has also resulted in the bed crunch that leads to incarceration, chronicity, and associated medical problems. Foucault’s proclamations about psychiatry have not withstood the test of time and in the modern world are wrong. 

  

An offshoot of the social control speculation is the authors comments about the sick role:

“Psychiatry’s institutional functions are legitimated by the designation of its clients or patients as ill or ‘sick’.”

They speculate that when the designation occurs the person is relieved from their social responsibilities as long as they play ball and remain in a passive sick role following the advice of their psychiatrist. Unfortunately for the authors they seem to have no real-world experience in what happens to people with psychiatric disabilities. They live in poverty. In the US, they may have to spend a much larger portion of their income on medical expenses. They have significant medical morbidity and have less access to care.  Substandard living conditions exposes them to more violent crime than the average person. They are at higher risk for incarceration. If they receive assistance from the state or federal government, these stipends can be reduced or stopped at any point resulting in homelessness – another significant risk in this population.  All of these factors combine to illustrate that there is no contract with society.  American society has shown time and time again – persons with mental illness are the first people thrown under the bus. So much for another critical psychiatry theory.

The final section is a recap about social control and they have an interesting paragraph where they blame psychiatry for both homosexuality as an illness and drapetomania as an illness.  No mention of the fact that Spitzer changed that designation about homosexuality in 1973, decades before the rest of the world caught on (some still have not).  Blaming psychiatry for drapetomania is standard antipsychiatry rhetoric. Anyone reading that word should realize this. It was a term coined in 1851 by Samuel Cartwright, an American physician to suggest that when slaves ran away it was a sign of mental illness. Antipsychiatrists have locked onto to this term since Whitaker put it in his provocative book Mad In America (p 171) as something else to blame psychiatrists for. The only problem is that Cartwright was not a psychiatrist and his off the wall theories were widely discredited at the time. The term has nothing to do with psychiatry or any psychiatric diagnostic system. Anyone using either homosexuality or drapetomania as examples of a powerful group (implicitly psychiatry) defining socially repudiated behavior as a mental illness to eradicate or control it (the authors words) – is by definition an antipsychiatrist.

The authors proceed to discuss treatment and how it differs if provided by critical psychiatrists.  This discussion contains very little that is remarkable.  They suggest that psychotherapeutic outcomes are broadly similar and discuss very broad definitions of psychotherapy. Anyone familiar with psychotherapy would not agree with these broad generalizations. They provide no real evidence for their conclusion that there are obstacles in place that discourage the relationship dimensions of therapists and encourage “paternalizing and instrumental approaches”.  It sounds to me like they are not approving of research based psychotherapies.   

On the medical side of things, I have serious questions about whether they do anything at all that is medical.  They suggest that psychiatry needs to be affiliated with medicine in order to get professional legitimacy. They have apparently never picked up a copy of Lishman’s Organic Psychiatry, Lipowski’s Delirium: Acute Confusional States, or Principles and Practice of Sleep Medicine by Kryger, Roth, and Dement.  Professional legitimacy is a two way street and psychiatry gives as much as it gets.  They can also find those biomarkers they are looking for in any sleep medicine text.

The section on “drug treatment” explains the critical psychiatry theory of a “drug centered” model.  In this model, there are no specific mechanisms of action – only alterations in normal mental processes, emotion, and behavior.  They include a table showing that the effects of most modern psychiatric medications depend on producing sedation, cognitive impairment, dysphoria, and loss of libido.  When I read this section I had three thoughts.  The first is that this table contains list of side effects.  I had to look again to confirm that the authors are calling them psychoactive effects.  The second is that none of the critical psychiatrists treats anyone with severe psychiatric disorders or monitors side effects very well.  The most striking feature of treating people with severe illnesses is when their acute symptoms of hallucinations, delusions, mania, or severe depression go away. The associated goal is when their side effects are managed so that they have none.  Not noticing either of these effects may be because you are just not treating very ill people. My third thought was that the authors just don’t know very much about pharmacology.  We are currently talking about decades of study of some of these systems where the behavioral pharmacology and imaging studies have been done. If you don’t know that stimulants can cause hallucinations and delusions, that non stimulant dopamine receptor agonists can do the same thing and that dopamine receptor antagonists can reverse these effects – you have just not been paying very much attention. This is basic pharmacology that every psychiatric resident should know.

The authors conclude that “critical psychiatry is not antipsychiatry” but the problem is they have not offered any compelling arguments to back that statement. If anything, the bulk of their discussion illustrates that their philosophical origins and rhetoric against clinical aspects of modern psychiatry is right out of the antipsychiatry playbook.  They claim to be not be anti-science and have clearly rejected modern pharmacology and brain science in favor of a meaningless theory of drug effects.  The closing paragraphs on the existence of social problems and the importance of the therapeutic relationship is nothing new to the practice of psychiatry - everybody does it.

The only logical conclusion is that critical psychiatry is antipsychiatry.  Just like Szasz and Laing they eschew the term, but there is just no getting around it.  I want to end with a quick note about the practical implications of critical psychiatry coming out into the light. The first is that clinicians doing the work every day should not be surprised to see this rhetoric surface time and time again. There is nothing innovative about critical psychiatry - how could there be? Nothing will deter them from making these arguments in the foreseeable future.  My concern is the potential impact on patients. I have certainly seen patients affected by antipsychiatry cults. I have concerns about the effects in large health care organizations. Is it just money that caused psychiatric resources to be cut to the bone and our patients incarcerated or is there somebody making these decisions who embraces critical psychiatry or antipsychiatry?

At the academic level, the best way to deal with these biases against psychiatry is to leave the people perpetuating these biases back in the mid-19th and 20th centuries. Psychiatry has given many of these authors plenty of space in journals and debates.  They thrive on freedom of speech and expression. I think there is a problem with academic or clinical departments allowing the expression of information that in many cases reflects poor scholarship, is largely rhetorical, and in some cases is patently false. No other medical departments do this. 

The question is where and when that line should be drawn and as readers may have guessed - my threshold is lower than most.      

George Dawson, MD, DFAPA



Supplemental:

In their Szaszian efforts to act like psychiatric disorders are not illnesses, diseases, or diagnoses, antipsychiatrists typically refer to them using the pejorative term "labels".  The following philosophical cartoon illustrates why a psychiatric diagnosis is no more a label than a hot dog is a sandwich.  Cartoon here. 

Ref:

Middleton H, Moncrieff J.  Critical psychiatry: a brief overview. BJPsych Advances (2019), vol 25, 45-54.    

Critical Psychiatry or Antipsychiatry?

Peter Tyrer wrote a commentary on Critical Psychiatry in a recent edition of British Journal of Psychiatry Advances.  It was in response to a paper by Middleton and Moncrieff that focuses primarily on distancing critical psychiatry from antipsychiatry. Dr. Tyrer is very clear about the fatal flaws of critical psychiatry. He takes on Middleton and Moncrieff’s false dichotomy between medicine psychiatry and characterizes it as "arrant nonsense". He cites a few of the many lines of evidence that psychiatry developed as a medical discipline and that great majority of us are still on that pathway.

He also takes on the pseudoscience and philosophical aspects of critical psychiatry most notably the lack of positivism. His definition positivism is “a philosophy that argues that understanding can only be achieved by logic and scientific verification and that other philosophical systems are therefore of no value”. That makes psychiatrists in the training program of psychiatrists positivist in nature. This is a significant difference since much of critical psychiatry does not depend on logic or science.   That is an unappreciated difference for many people who use philosophy to criticize psychiatry. I have an excellent example on this blog of a philosopher who decided that the DSM-5 was really a recommended blueprint for living by psychiatrists. It was clear from his position that he had no knowledge of the DSM-5, had not discussed it with a psychiatrist, and did not know how it was applied. Even those limitations did not prevent him from giving a philosophical opinion on what was wrong with the DSM-5. That is a clear example of criticism that has no value.

Dr. Tyrer’s second major point has to do with the critical psychiatrists criticism of the diagnostic process. He had co-authored a book on personality disorders for the general public and apparently got a “storm of protest and hostile reviews from service users”. The critical psychiatrist writing the review suggests that this was due to the standard medical sequence of diagnosis and then treatment. Apparently the critical psychiatry thinking is that people can be “treated” or not without making a diagnosis. One of the distinguishing characteristics of critical psychiatry is vagueness. In reading the writings of critical psychiatrists how they actually practice psychiatry is unclear. Why people see critical psychiatrists is really not clear. The outcomes of critical psychiatry practice is even less clear. The associated issue illustrated here is that critical psychiatry is a social media magnet for people who are self proclaimed experts who find it easy to embrace rhetoric rather than study science.

Dr. Tyrer’s commentary starts out in a charitable way where he suggests that critical psychiatry may have a useful role in pointing out there is frequently exuberance about a particular new therapy that never pans out. In my experience, noncritical psychiatrists and average clinical psychiatrists provide the best criticism and feedback in that area. He incorrectly cites “chemical imbalance” theories as legitimate criticism by critical psychiatrists. In my library I have 40 years of psychopharmacology texts and not a single one of them refers to “chemical imbalance”. To me chemical imbalance is a red herring marker of both anti-psychiatrists and critical psychiatrists. He points out the importance of culture and suggest that this is another area where critical psychiatrists may have a role. The role of culture has been discussed in the DSM, many departments of psychiatry have cross-cultural departments with interpreters, and in the past 20 years I’ve attended numerous conferences where cross-cultural psychiatry was either the main component or one of the significant lectures. I doubt that critical psychiatry as had anywhere near the impact of regular psychiatrists who go to work every day and practice cross-cultural psychiatry. He cites “coercion” in psychiatry is another area where critical psychiatry may have some legitimacy. In fact, every state in the United States as safeguards written into their statutes that describe the circumstances where involuntary treatment may be ordered by a court. Critical psychiatry and anti-psychiatry continue to confuse the legal system, psychiatry, and involuntary treatment of mental illness whenever it is convenient.

Dr. Tyrer also suggests that critical psychiatry has a role in “correcting the growing belief that mental illnesses are just diseases of the brain and can soon be transferred to neurology”. It is no longer the early 20^th century. The neuroscientific study of the brain and mind is growing exponentially. As we appreciate that complexity it should be apparent to everyone in the field that no single practitioner or scientist will be able to master all of that information. Psychiatrists are not neurologists even though many of us share the same personality characteristics. Psychiatrists are still trained in the importance of the interpersonal relationship and its meaning whether or not the underlying biology of the process is completely known or not. This is an ongoing scientific endeavor also occurs at the clinical level and I think it is unlikely that the hundreds of newly identified clinical entities will ultimately be classified as neurological conditions.

I agree completely with Dr. Tyrer’s main points but as noted above don’t think he went far enough.  Critical psychiatry really is not an exercise in scientific criticism - it is an exercise in rhetoric. Speaking to his metaphor critical psychiatry is not "becoming Luddite" - it has always been.  He does not give the field of psychiatry enough credit in the area criticizing itself. He also gives critical psychiatry too much credit for constructive criticism while pointing out that they have created “increasingly destructive commentaries”.  He points out that critical psychiatry is adding little knowledge to the field and serving a brake on progress but does not comment on significant conflict of interest that exists with much of this criticism.

There is also a question of how much harm is caused by these destructive commentaries and anti-psychiatry websites and anonymous posters suggesting to readers that the treatments working for them are toxic and that psychiatrists are inherently bad people. As physicians we need to be very explicit about that problem.

I plan to read the Middleton and Moncrieff paper and post a critique here the end of the weekend.  I have already done much of that work on this blog. It will hopefully be useful to see what their positions really are.

George Dawson, MD, DFAPA

Reference:

1.  Tyrer P.  Critical psychiatry is becoming Luddite. BrJPsych Advances 2019, vol 25: 55-58.