The Cannabis Clinic for R&D
A new policy for medicinal cannabis
Review of the role of the Office for Medical Cannabis
In 2021, approximately 20 years since the establishment of the Office for Medical Cannabis, the Dutch medicinal cannabis program is due for reform.
According to the experts of the Medical Cannabis Society, the Cannabis Clinic for R&D, where patients undergo medicinal cannabis treatment, feeding medical scientific research and clinical studies at the same time, offers an optimal policy solution, allowing both for collecting evidence of efficacy and for developing cannabinoids-based drugs. To support this policy change, the Medical Cannabis Society has set up a scientific research plan that is currently being discussed with several parties (scientists, policymakers and industry).
In order to realize the project of a cannabis clinic for R&D, we first need to review the role of the Office for Medical Cannabis, redifine it in the light of a dynamic international context, and if necessary even dismantle it. The Dutch state monopoly, drastically limiting the number of producers and consquently the product choice for prescribing physicians and patients, definetely stands in the way of the purpose for which the governemental agency was originally set up, namely: to promote medical scientific research on cannabis and cannabis based preparations or derived substances, and for the production of medicines.
According to the Dutch Society of General Practitioners (NHG Standpunt Cannabis, 2018), cannabis varieties and cannabis preparations currently produced in the Netherlands do not provide enough scientific evidence of efficacy and they accordingly advise fellow physicians against prescribing medicinal cannabis.
Based on this recommendation alone and if it is true that this (the scientific evidence) should be the criterion to assess the policy results of 20 years of Office of Medical Cannabis, the new Minister of Public Health has a simple conclusion to draw. This conclusion: the dismantlement of the Office of Medical Cannabis was, by the way, already taken into account in the Explanatory Memorandum (amendment of the Opium Act, 2001, Parliamentary Document 27874, no. 3): “However, if research leads to the conclusion that these substances do not have the properties that make them suitable for use as medicines, the national agency will be abolished. “
Compared to what is happening in other even European countries (where no national cannabis agency has been set up), clinical research on medicinal cannabis is still difficult to get off the ground in the Netherlands and no cannabis drug has been marketed in 20 years, whereas the phenomenon of illegal production of cannabis oil is still increasing in proportion.
Medicinal cannabis still needs to be regulatated as a medicine
It is well known that many coffeeshop visitors (50% of them, according a the survey conducted by coffeeshops unions a few years ago) use recreational cannabis (also) for medicinal purposes, i.e., for self-medication.
If the current medical cannabis policy is not accordingly reformed, the Dutch Legal Cannabis Experiment (and later the Closed Coffee Shop Chain Act, if passed by the Senate) will likely see an increase in the number of medicinal cannabis users visiting the coffeeshops.
This (potential) increase is undesirable because: a) recreational cannabis cannot meet the high-quality standards required for medicinal cannabis; b) that would definetely blurr the line between medicinal and recreational use resulting in the ultimate policy failure of integrating medicinal cannabis into the regular healthcare system.
In an ideal world, medicinal cannabis, cannabis preparations and cannabinoids’ medicines would be available on prescription through physicians, who have received the necessary training on the functioning of the endocannabinoid system and are willing to resort to medicinal cannabis as a viable treatment. To achieve this goals still requires more scientific research and education.
But what kind of (medical) scientific research?
International reviews (such as, NASEM, 2017) establish efficacy for a number of indications (such as chronic pain, side effects of chemotherapy treatments, and spasticity in multiple sclerosis) with sufficient certainty (conclusive / substantial evidence), but most studies often point to the limitations of the research design, namely: a) the lack of observations (follow-ups) over longer periods, b) the limited number of participants, c) the lack of relevant control groups, c) the lack of research into the different cannabis varieties.
We cannot deny that in recent years, the motions of D66 Member of Parliament Vera Bergkamp have had a positive effect and compelled the government to initiate more scientific research.
In 2020, a subsidy of 1.9 ml euros was provided by ZonMw for fundamental research into chronic pain, and a new subsidy round is expected in 2021.
However, the question is whether the traditional route (fundamental research and clinical studies) is only the right route to arrive at the necessary evidence.
Two examples from abroad may help to answer this question. Prof. David Nutt, neuropsycho-pharmacologist (Imperial College London) believes that medical cannabis should be embraced by doctors just like penicillin was about 70 years ago:
“About 70 years ago another natural medicine came into the medical arena, this was welcomed enthusiastically by UK doctors even though there had been no placebo-controlled trials of its efficacy because it was seen to fulfill a major clinical need. That drug was penicillin. If today’s medical profession could embrace cannabis in the same way as it did penicillin, then the true value of this plant medicine should rapidly be realized.”
By abandoning clinical trials for the time being, Drug Science, the organization of Prof. David Nutt, has set up Project Twentyone, the UK’s first national patient registry for medical cannabis.
Thanks to Project Twenty21, eligible patients can access affordable medical cannabis treatment. The project aims to create the largest data collection (registry) in the UK for the effectiveness and safety of medical cannabis. Once it can be proven that the benefits of treatment with medicinal cannabis outweigh the potential risks, reimbursement by the NHS (UK Healthcare Authority) will expectedly ensue.
Within Project Twentyone, medicinal cannabis is provided to patients who are being treated for 7 different conditions (from anxiety disorders to adult epilepsy) through a network of private cannabis clinics.
In Israel Prof. David Meiri, founder of the Technion’s Laboratory of Cancer Biology and Cannabinoid Research, has demonstrated that a database where cannabis varieties are matched with patients’ follow-ups can help to select the most appropriate varieties (chemotypes) to devlop studies on the “entourage effect”. Once the clinical has ascertained that a specific chemovar works well for example for cancer patients, it is much easier to identify the active substances that are responsible for the therapeutic effect. This lab analysis and the cell-biology often show that a fraction of three cannabinoids produces the same effect as the extract from the whole plant. If you can work with three cannabinoids instead of the approximately 600 different substances, contained in the cannabis plant it becomes also possible to develop effective cannabis drugs that can eventually meet international registration criteria. Based on the results from fundamental research originating from patients’ feedback, several clinical studies on different combinations of cannabinoids are currently being conducted at the Technion.
The Medical Cannabis Society’s research proposal:
The end goal of our research proposal is to develop personalized cannabis medicines: the right cannabis variety or preparation, the right dosage for the right patient.
We can describe this research as follows: medical scientific research into the effectiveness of cannabis and cannabis preparations for the treatment of a range of physical and/or psychological disorders conducted on a statistically relevant group of medicinal users and aimed at setting up a database where follow-ups with patients and their genetic profiles are matched: a) with data on the composition of the administered cannabis varieties or preparations; (b) with results from in vitro or in vivo studies and later; c) with the results from clinical studies.
Based on the data analysis and the development of statistical models, it will be possible to determine whether a personalized cannabis drug can be developed for each group of patients.
The Research Framework
Conducting medical research into the effectiveness of cannabis requires a multidisciplinary approach in which chemical analysis, cell biology, qualitative research into patient experiences form the building blocks of an integrated system thanks to which valid conclusions can be reached.
Ideally, this research takes place in the cannabis clinic where all research units (or as many research units as possible) are brought together under one roof. This structure consists of:
- a front-end where patients receive periodic consultations and follow-ups and where they can collect their cannabis prescription.
- a back-end consisting of a (bio) chemical laboratory, an extraction facility and a secure storage of all cannabis products. At least a physician, a pharmacist and a biochemist must be present at this location as part of the staff.
All scientific data collected in the research clinic is ultimately transferred to a bioinformatics research unit that develops the static models.