Commentary on “Medical” Cannabis in AAAP newsletter-Spring 2020
J. Kimber Rotchford, M.D., M.P.H.
Diversity is predictable within human nature and life in general. There are conservatives and there are liberals. There are those who resist change, and those stimulated by change. There are those who readily follow established sources of authority, and those who seem to follow another “drummer”. Such diversities are age old. Similar contrasts are pertinent to the discussion on “medical” cannabis. One such conflict is reflected in the one between the Pharisees and Jesus. There are those who follow laws and tradition regardless of their consequences, and others acknowledge the inherent imperfections of “law” and it is only a means to an end. Laws can challenge the virtue of justice, the sense of right and wrong, and the imposition of laws can induce righteous indignation as well as the feelings of fairness and security. Wise judges and other safeguards related to “due process” can put laws in context and better assure fairness. The “Black Lives Matter” movement highlights that there are commonly subconscious, yet lethal patterns promoted by social and longstanding legal practices. It is acknowledged and apparent that black lives and others of color have disproportionately suffered because of draconian enforcement associated with the “War on Drugs”.
Another pervasive human attribute is an attachment to power, influence, and prestige. These attachments result in money, property, stature, and wealth being overvalued and induce violence and wars. People commonly become attached to surrogate markers of progress rather than the actual desired outcomes. For instance, money and wealth become equated to safety and security. When evaluating progress in substance use disorders one measures abstinence and adherence to therapeutic plans. As helpful as these and other surrogate markers may be, they do not always correlate with the best of health. Abstinence is life threatening for those with significant opioid use disorders and, depending on the context, abstinence from alcohol for someone with a serious alcohol use disorder could be fatal. We choose surrogate markers in medicine for they are readily measured and studied. As a result, physicians can become unwittingly attached to the surrogate markers
Because of the attachment to the objective and measurable variables, our evidence-based approaches and findings become confused or even synonymous with meaningful and direct measures of health. FDA approved pharmaceuticals become synonymous with safe and effective medicines. By extension, non-FDA approved substances or procedures are not considered safe or even medicines. These sort of perversions of the intended role for evidence-based approaches must not, however, lead us to disdain or eliminate surrogate markers and other evidence-based approaches. Tools in the proper context are of course valuable. We must avoid though making everything a nail because all we have is a hammer. Our surrogate markers are but tools to promote the best outcomes. As with laws, evidence-based principles are to be only a means to the desired outcome. Physicians are professionally obliged to be attached to improving morbidity and mortality. Understandably, physicians can become distracted from their job to improve morbidity and mortality, particularly when following processes and rules are so highly rewarded. Physicians risk to be considered like Pharisees, the so-called vipers who squeeze out life. This contrasts with Mose’s fiery (spirit) serpent, which was made and set upon a rod under God’s direction. The rod and fiery serpent were intended to protect people from the dangerous serpents (matters of the world and flesh?). This story of Moses and the wise and healing serpent appears to have predated Greek mythologies and symbols concerning physicians and healing. It arguably represents the origin of the caduceus.
In our work to limit morbidity and mortality physicians have a valuable and honored role. It pains me to see some within the profession act like Pharisees, who demand that rules and traditions are followed, even though it likely means the detriment to patients and communities. This tendency is now commonly seen where physicians have refused to prescribe opioids in cases where the patient has apparent indications, commonly a serious opioid use disorder, and so life-threatening consequences are predictable. An attachment to established approaches and traditions seems often to be associated with self-righteousness and even arrogance, as in the case of the Pharisees. This association might be the basis for the self-righteousness and arrogance which has been labeled “American Exceptionalism”. While perhaps understandable, it is grievous to see the myth of “American Exceptionalism” so prevalent among physicians. The practice of medicine warrants humility. Americans lag much of the world in terms of morbidity and mortality. Those who clamor for the primacy American medicine and who are attached to evidence might be humbled by this evidence. Our health outcomes represent a clear slap to the face of “American Exceptionalism”.
Specific Response to President's Comments
The implications regarding responsible care of our patients and our communities attest to the need for dramatic changes in our approaches to substance misuse. In the President’s column, “Medical” Cannabis, the president states: “As physicians, we are guardians of an approach to treating patients based on evidence of efficacy, safety, and responsibility to society.” I disagree. Physicians are to be guardians of the health of their patients and all within their communities, not the “approaches” used. We need to focus on limiting morbidity and mortality for all and not unduly attached to laws and traditions as were the Pharisees. Physicians also need to be cautious about feeling responsible to society, for while we are licensed by governments, we must fight against societal injustices and societal norms that do not protect the value of all human life. The revised Hippocratic oath as well as the original oath calls us to focus on the well-being of patients, respect for life, and to oppose societal norms that interfere with the same.
I also disagree with the president’s emphasis on efficacy. Much of professional medical care will never be proven based on ideal and controlled circumstances that are associated with efficacy. Efficacy is toward the pinnacle of evidence-based findings for it often reflects findings from properly randomized and controlled clinical trials. Evidence of efficacy is valuable, but it is not the only credible form of evidence or should it be. Modern medicine is not based on ideal or controlled studies. Professional medical care reflects what a reasonable and prudent physician would likely do. Aptitude, education, training, and experience in clinical work as well as demonstrated understandings in traditional areas of medical study such as anatomy, physiology, pathophysiology, biochemistry, pharmacology, embryology, surgery, pharmacodynamics and kinetics, scientific methodology, etc. as well as newer understandings and findings related to psychological, social/cultural, environmental, and even financial factors that influence morbidity and mortality are extremely important in the care physicians provide and provide the basis for the care we provide. Evidence encompasses all these understandings and recognizes the wide diversity in human behavior, and responses not only among humans, but across species. Evidence acknowledges the value of clinical experience and expertise and a value to the formal case report, both for research and clinical practice. For several good reasons, establishing efficacy is feasible and most relevant to pharmaceuticals. The immense financial conflicts of interest associated with pharmaceuticals also demand extra attention. Most surgical procedures have also not been established as efficacious. In brief, efficacy is not a prerequisite for evidence nor should it be. Cost-effective outcomes, that is performance under real world conditions, are what we seek for patients and their communities. Given current morbidity and mortality rates, and the amount of money Americans spend on health care, our approaches must be held suspect. I suggest that blaming or even shaming politicians and others will not help, particularly in the long run. As with racism, we are dealing with longstanding system dysfunction in addition to human foibles.
The president’s emphasis on safety may also be misleading. As physicians we are to weigh the benefits and the risks of any intervention. Ideally, we are also prepared to compare accessible alternatives. While “primum non nocere” is an old and valued slogan in medicine, it remains virtually impossible to do no harm. Simply driving to see a physician has inherent risks of harm.
I have been authorizing medical cannabis for about 20 years and my experience is that a subgroup of patients do benefit. In contrast to current research paradigms, my experience supports that it is not their diagnoses that defines the subgroup, rather it is their history for having experienced significant trauma or traumas. This clinical finding correlates with where cannabinoid receptors are concentrated in the brain. I expect there are also genetic variants in cannabinoid receptors and this as with other substances impacts clinical responses. As with any substance used for medicinal purposes, dosing, route of administration, stability of blood levels, other substances used, patient’s health status, age, etc determine safety and effectiveness. Current research regarding medical cannabis fails to establish these prerequisites when judging the benefits and risks of medical cannabis. Let us remember that the lack of evidence is not synonymous with evidence against the therapeutic value for an intervention, particularly when considering subgroups of patients.
I attended Berkeley starting in the late sixties when cannabis use was common and relatively socially acceptable. I have published a small book, Medical Cannabis - Initial Medical Consultation . I have, like anyone my biases and one could argue these include financial interests. I also have relative extensive clinical experience in authorizing medical cannabis. Besides being F.A.S.A.M. I am also a Fellow of the American College of Preventive Medicine. Perhaps better than most these areas of medical expertise, these allow me to better appreciate the strengths and weaknesses of evidence?
Despite my acknowledged “biases” toward the benefits of medical cannabis, I am it seems more conservative than many colleagues in terms of the risks of cannabis use, and the importance of professional oversight. It makes no sense that cannabis should be less regulated than blood pressure medications, antibiotics, and other prescribed substances. There are benefits and there are significant risks associated with cannabis use. The benefits and risks associated with cannabis seem comparable to most pharmaceuticals and medical interventions. Whether for recreational or medical use, I consider the regular use of cannabis warrants a physician’s care and attention. And why are we not talking about tobacco products and why isn’t tobacco a Schedule 1 substance?
Professional oversight only makes sense particularly when the use of the substance can impair insight and judgment. One man’s food has always been another’s poison. Health care is best individualized with attention to patient selection and comorbid conditions. When using a substance, the dose, route of administration, blood levels, and appreciation of basic principles of pharmacodynamics and kinetics always apply. Clinical trials and their finding are to be only part of a wise and expert professional consultation. The therapeutic relationship with patients is also most important. This is particularly the case when addressing complex chronic conditions such as SUDs. Unfortunately, the therapeutic relationship receives limited attention. How we finance medical care and the emphasis put on regulatory and legal concerns contribute to the therapeutic relationship being compromised. Patients can readily recognize when clinicians are more preoccupied with their own well-being.
I encourage accountability but suggest less rules and regulations. I suggest immediate steps to mitigate the punitive approach to substance misuse. The casting of stones and all punitive approaches are to be replaced by robust and comprehensive rehabilitation of individuals and their communities. The “War on Drugs” remains a failure. The evidence is incontrovertible. In my book, Opidemic-A Public Health Epidemic, I elaborate more on the paradox of attempts to “control” substance misuse resulting in less control, as well as a myriad of untoward consequences. I urge for more robust Public Health interventions. Indeed, Public Health interventions are supported by overwhelming evidence for cost-effectiveness. Grievously we seem married to clinical, regulatory, and too often shaming and punitive interventions.
The paradox regarding issues around control is inherent in the first step of AA. “We came to accept our powerlessness over...” All of us would benefit from a greater appreciation of this paradox in all our affairs. The acceptance of powerlessness can be most empowering.
Professional interventions whether they be behavioral, natural, pharmaceutical, spiritual, psychological, social, etc., are to be evaluated based on their potential benefits and risks. The clinical practice of medicine is not one of certainties. We are dealing with the complexities of human behavior as well as basic physiology, etc.
As physicians we need to acknowledge and accept that our interpretations regarding evidence are influenced by subconscious processes stemming from both individual and cultural conditioning. Failure to properly evaluate evidence can also be a matter of ignorance and lack of training. Even in prestigious journals one encounters opinions that a lack of evidence for an intervention means that an intervention is without merit, or conversely conclusions about efficacy are made and not necessarily supported by the clinical design and findings.
The tendency to not respect established historical and international understandings and practices is also problematic. Medicines and medical care reflect much more than current “American” approaches. For those physicians who limit medicines or prescriptions to FDA approved medications they are to be reminded that even the FDA concedes that their findings are only guidelines, and can only be such, based on the tenets of scientific methodology. Context will always matter in clinical and real-world care. Even within the strict confines of a well planned and executed clinical trial, one generally can only conclude that either there is, or is not adequate evidence (based on accepted levels of uncertainty) that allows one to reject the null hypothesis.
There are immense financial pressures and incentives that drive the behavior and practices of the FDA, the larger regulatory system, the medical profession, and of course the pharmaceutical industry. Even what is studied, is commonly driven by financial incentives or disincentives, let alone regulatory concerns. It is not only those who are in favor of medical cannabis who suffer from conflicts of interest based on money, not to mention power, and prestige.
For the sake of professional integrity, I encourage the AAAP newsletter to publish a comprehensive rebuttal of the perspectives expressed by AAAP’s president. I recuse myself based on acknowledged conflicts of interest and limited resources. I practice outside of an institutional setting. Nonetheless, I hope that this limited discussion about human nature, medical cannabis, and the nature of evidence and its place in medical care motivates a comprehensive review of additional perspectives regarding medical cannabis.
While perhaps beyond the scope of the newsletter, I suggest that further discussion of the role and nature of evidence in medical and psychiatric care would be useful. I find that psychiatric research remains especially problematic because the diseases treated are most often consensus-based labels and criteria absent of clinically relevant measurable pathology. Substance use disorders are a case in point. Perhaps primary outcomes related to overall well-being and health as reflected in the WHO-5 screening test, as well as direct measures of morbidity and mortality would be preferable? That is a whole other discussion.
Link to Original Article from AAAP’s President