For many thousands of patients around the world, cannabis offers potential relief for a wide range of medical symptoms, both chronic and acute. If you have used a medical cannabis treatment, and had some success as a result, then naturally you will be its greatest advocate, encourage its use and become frustrated that it does not have more support amongst the medical community.
There are plenty of stories out there about the therapeutic properties of medical cannabis from seemingly credible sources. Nevertheless, governments and medical authorities have been slow to embrace the potential of medical cannabis, and this leads to frustration amongst those who benefit (or who may benefit) from medical cannabis treatment. The medical authorities are perceived as dragging their feet over its efficacy, or even accused of blocking it from happening.
While it is true that there is a lot of caution surrounding medical cannabis treatment, particularly as marijuana is so loaded with a political dynamic, what many people don’t fully grasp is the amount of time it takes to establish any new medical treatment, cannabis or not. While the roll out of the covid vaccine is a high profile exception to the rule, normally all new medical treatments need to go through a lengthy procedure of clinical trials and testing before they are accepted as beneficial and safe for patients and safe to use for medical practice.
Paradise Seeds has been involved with the Medical Cannabis Bike Tour since 2013. What began as a simple quest to fund the research of Spanish scientists into the use of medical cannabis to treat glioblastoma patients quickly became a lesson in the reality of the complexities of setting up a clinical trial which only now – seven years later – is ‘just around the corner’.
What Happens in a Medical Cannabis Clinical Trial?
A recent research article in the open access journal, Frontiers, is a good illustration of the lengthy and detailed process behind establishing ‘safe’ medical practice and procedure on which scientific evidence relies. A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas reports on the research conducted in a private hospital in New South Wales, Australia.
The aim of this medical cannabis clinical trial, involving 88 participants (diagnosed with a recurrent or inoperable high-grade glioma ie brain tumor), was to assess the impact of administering a single nightly dose of THC on patient wellbeing and safety. The study was carried out over a 12 week period. The dose started at 0.25mL of THC and was increased to 0.3mL – or decreased to 0.2mL the next night – based on patient functionality after receiving the dose.
Each night, the dose was increased or decreased by 0.05mL depending on how the participant felt. The trial was ‘blinded’, meaning patients were unaware of which one of the two ‘standardized’ oil-based organic whole plant extracts they were receiving – a 1:1 or a 4:1 ratio of THC : CBD (1:1 THC 4.6mg/ml:CBD 4.8mg/ml and 4:1 THC 15mg/ml:CBD 3.8mg/ml).
The result of the trial was that, of the 88 patients in the trial, 11% of 61 participants had a reduction in disease, 34% were stable, 16% had slight enhancement, and 10% had progressive disease. The conclusion was, “This study demonstrated that a single nightly dose of THC-containing medicinal cannabis was safe, had no serious adverse effects and was well tolerated in patients. Medicinal cannabis significantly improved sleep, functional wellbeing, and quality of life.”
Involving a hospital, numerous health and care professionals, research doctors and the supply of the ‘standardized’ doses of cannabinoids (which will themselves have been rigorously tested before being granted approval from medical authorities for use) the cost of this trial is likely to have run into several hundred thousand dollars.
Why are Medical Cannabis Clinical Trials Necessary?
For those medical users (outside the trial) with experience of homemade medical cannabis treatments – like many of those enrolled with the Paradise Seeds Medical Cannabis Program – this scientific conclusion is hardly big news. Many will say, “it just proves what we’ve been telling you all this time”. And yes, scientists will tell you, that is the point! This is an example of a clinical trial which has produced another essential foundation block on which medical cannabis therapies can be built for use by general patient groups. It won’t happen overnight, but this is the speed that is normal for the trialing and testing of new medical treatments.
Unfortunately, those who will benefit will be future generations of sufferers and for this reason the medical trial process can seem quite cold and uncaring, especially for medical patients seeking treatment now. Impatience therefore is natural, however the development of new therapies is always guided by results and it’s only with these that medical professionals have the confidence to back any anecdotal claims.