Dear fellow physisicans and prospective WeCann students,
After eight years of longing, the recent revision of Resolution No. 2113/2014 of the Federal Council of Medicine regarding the prescription of Cannabis-based medicines has caused us a real surprise. It simply ignored several scientific and regulatory advances that have occurred in recent years in Brazil and in dozens of other countries around the world.
The bibliographic references used for the publication of the Resolution date back to 2014. In other words, there was no literature review, no scientific update. There was an infamous copy of 2014 Resolution.
Taking into consideration the criteria of Evidence-Based Medicine, we can state that today, there is a conclusive and substantial level of scientific evidence, that is, there are studies of qualified methodology to indicate medical Cannabis in at least three more clinical scenarios:
● Chronic pain, especially neuropathic pain in adults;
● Muscle spasticity in multiple sclerosis;
● Nausea and vomiting induced by chemotherapy.
The restriction of Resolution regarding the prescription of other chemical elements of Cannabis, besides cannabidiol, also does not find grounds. Mevatyl®️, a Cannabis-based medicine, is registered by Anvisa in Brazil since 2017, which contains equal proportions of Tetrahydrocannabinol and Cannabidiol. This medicine, also registered with over 40 other regulatory authorities around the world under the name Sativex®️, has clinical studies attesting to its safety and efficacy for the treatment of pain associated with multiple sclerosis spasticity.
Several methodologically qualified studies that culminated in the registration of the formulation of Mevatyl®️ as a medicine in the country, are available to prove the safety and efficacy of the therapeutic potential of the phytocannabinoid Tetrahydrocannabinol.
This molecule, by the way, was “misspelled” in the Resolution itself. The spelling of “Tetrahydrocannabidiol” was used to refer to THC. A term often used by lay people, who mistake it for the terminology of another important phytocannabinoid, the Cannabidiol. This again leads to the lack of technical knowledge and/or carelessness of the rapporteurs on the subject.
The Resolution’s rapporteurs technical ignorance on the subject is such that they didn’t even notice that, according to the Resolution, physicians would be prohibited from prescribing a medicine duly registered with ANVISA.
From a medical ethics point of view, the Resolution represents much more than a step backwards: it represents a violation of legal and constitutional rights.
The Resolution directly harms the medical autonomy in the way of treating and judging the most convenient for the patient, as well as, the patient’s autonomy of desiring or not to be treated by the way proposed by the assistant doctor, which are constitutional guarantees, inviolable, that cannot be disrespected especially in the case of refractory disease to conventional treatment, having support in the Universal Declaration of Human Rights, as well as, the recognition of the Federal Medicine Council’s own legal competences.
Interestingly, the same CFM recently came out to advocate medical autonomy in prescribing chloroquine and hydroxychloroquine for patients with COVID-19. According to the current president of the CFM, José Hiran da Silva Gallo:
“The physician shall decide whether or not to indicate the treatment he or she deems appropriate, in agreement with the patient, having the principle of beneficence to the patient.” “People, institutions or organizations that act differently, trying to limit the right of physisicans and patients - in one way or another, is an act that disrespects those who are in the front line and to all who seek in them guidance to treat their illnesses.”
Furthermore, the restriction of cannabidiol treatment to epilepsies of children and adolescents with Dravet Syndrome and Lennox-Gastaut or Tuberous Sclerosis Complex is either Machiavellian or simply stupid. Will this same child, this same adolescent, who has achieved satisfactory results with the use of cannabidiol for his or her disease and reaches the age of 18, have to stop treatment? Will a patient diagnosed with Dravet Syndrome, Lennox-Gastaut and Tuberous Sclerosis Complex over the age of 18, not be able to be treated with cannabidiol?
Furthermore, what to do with the thousands of patients with other types of epilepsies, patients with other neurodegenerative diseases such as Alzheimer’s dementia, Parkinson’s disease, multiple sclerosis, autistic spectrum disorder, patients with several chronic pain conditions, patients with disabling symptoms associated with cancer who are already using medical Cannabis with satisfactory results and good control of their clinical condition?
While dozens of countries in the world, especially the main references in health systems, promote regulatory advances and the incorporation of this tool safely in medical practice and witnessing increasingly promising results with their patients, we see our primary authorities missing the opportunity to foster the subject with responsibility, impartiality and science.
WeCann Academy is considering legal-administrative ways to guarantee and promote the absolute respect for medical autonomy in the prescription of proven safe and potentially effective therapies in the management of patients with severe, incapacitating and refractory diseases.
We are moving forward, continuously enhancing our knowledge to use the best of scientific progress for the benefit of our patients. WeCann community continues to exercise its leading role in guiding the therapeutic approach to Cannabis in a highly qualified way to thousands of physicians in Brazil and around the world with great responsibility, always valuing the technical excellence and the ethical exercise of the profession.
During the course, WeCann students have access to all the scientific background necessary for the prescription of cannabinoid derivatives safely and effectively, as well as the support of colleagues who have been prescribing these drugs for 10-20 years (long before the CFM resolutions on the subject) for thousands of patients, and access to all the prescriptive guidelines and best practices for you, fellow physician, to apply this knowledge in your medical practice with excellence and safety.
The team of experts at WeCann Academy and I are available to cooperate with the Federal Council of Medicine, as well as with all regional medical councils and the main centers of medical continuing education in the Country, to assure and promote the technical and impartial level of this discussion.
Patrícia Montagner, M.D.
CRM 14782 / RQE 12500