Last week the second annual Cann10 Conference was held in Tel Aviv, Israel. It brought together many experts in the medical cannabis field both internationally and locally. It was a forum in which scientists, medical practitioners, entrepreneurs and investors could get together and share their ideas and findings in a formal setting. One of the primary issues to emerge from this forum is the vexing question of how to medically validate and standardize treatments with medical cannabis.

 

In the field of clinical medicine, the way a treatment is validated and approved for use is always via double blind, randomized clinical trials. These trials are considered the gold standard of medical and pharmacological research. While there have been many documented http://www.health.state.mn.us/topics/cannabis/practitioners/dosage.pdf  http://norml.org/library/recent-research-on-medical-marijuana clinical trials with medical cannabis they do not come close to the enormous amount of anecdotal evidence that doctors and dispensaries have gathered over many years of clinical practice. Is clinical practice so much less valuable than controlled, clinical trials in assessing the efficacy of a cannabis treatment? The answer to that perhaps lies in the purpose of the treatment. Drug treatments are given to patients for two reasons. Either to help them cope better with the illness or to actually modify the disease. If someone has a bacterial infection in the throat, for example, they would be prescribed antibiotic treatment to destroy the disease causing bacteria. In this case the drug treatment aims to actually modify the disease. The patient will also most probably be offered fever reducing, pain medicine such as ibuprofen or paracetamol to bring down the fever and reduce the subjective experience of pain. This doesn’t modify the disease, but is no less valuable to the patient who feels awful.

 

Medical cannabis has been repeatedly proved effective both in clinical trials and anecdotally for chronic pain – particularly neuropathic pain which is notoriously difficult to treat – sleep disorders, epilepsy and spasticity – a major symptom of multiple sclerosis. It’s efficacy as a disease modifier has been studied less to date, and the evidence so far is less conclusive. Dr. Jonathan Grunfeld a neuro-oncologist charged with the palliative care in a 900 bed hospital in Israel, outlined the difficulty with relying only on clinical trials to validate the use of medical cannabis, particularly with regard to palliative care. For Grunfeld, there is a demonstrable clash between the relentless drive for reproducible, tightly controlled clinical trials, and the clinical practice that he has been engaged in over many years involving thousands of patients. He describes trials that have been stopped for lack of efficacy in which the therapeutic dosage is set at a strict 2.5 mg. He argues that this simply is not how cannabis treatment works in a real world setting. There are patients that note remarkable relief of pain at 2.5 mg and those that may need up to 10 mg in order to feel any relief. Does this then mean that cannabis is not an effective treatment for pain? Of course not. Yet clinical trials may repeatedly come to this conclusion given their methodology.

 

Grunfeld characterizes the discrepancy between what he calls “institutional medicine” and anecdotal observations as the clash between relying on single molecule pharmacological intervention aimed at a single primary outcome, and the success of cannabis treatments being attributable to multiple molecule intervention attaining multiple clinical objectives. This multiplicity, which may be at the base of clinical success with cannabis, is the very thing that renders controlled clinical trials with this complex compound so difficult. Perhaps those of us on a quest to find the most effective treatments for medical cannabis patients must strive to find the balance between these seemingly incompatible worlds?

 

Grunfeld advocates for what he calls a narrative approach to treatment. This involves being attentive to the specific needs of the individual patient, and providing them with a broad range of cannabis species in various modes of use. He places great emphasis with this approach on adherence to treatment protocols, close follow up and the accessibility of medical professionals to the patient. Grunfeld proposes this three stage process as the best way to bring efficacy and reliability closer to each other: Study success, import into reproducible patterns of practice and re-evaluate regularly. In order for this to be achieved the strict protocols of controlled clinical trials involving fixed dosages and few specified preparations, must give way to a more flexible regimen involving more loosely defined dosages and a broader range of preparations. One of Grunfeld’s patients, previously in immense pain from a liver tumor, characterizes his feeling as follows “The way I see it the difference between the feelings with cannabis and without it, is the difference between heaven and earth.” While this individual patient’s description of his feelings may not hold much evidentiary scientific weight, it is surely the way that every medical practitioner would want  their patients to feel about any chosen course of treatment.

Avihu Tamir – CEO