Here, Robin Emerson, Head of CSR at Brains Bioceutical charts the priorities for cannabis research
Cannabis policy is shifting around the world and moving from a prohibitionist model to controlled access for medical cannabis and open CBD markets. Within this unique landscape, there is a general need for higher quality, more nuanced studies across methodologies and applications of cannabis.
The events of 2020 have also sparked research into its effectiveness for reducing symptoms of COVID-19 and how it can help the recovery process. While still in early stages, there have been positive results recorded so far, particularly in U.S. and Israeli academic studies.
However, challenges remain. Patient access to medical cannabis remains roadblocked despite the change in legislation in November 2018 and there are continuous calls for evidence including randomised controlled trials by regulatory bodies before cannabis can be accepted, formalised and integrated into the health ecosystem as a medicine. Some experts like David Nutt, DM, of Imperial College London, and colleagues criticised British physicians for using the lack of RCTs as an excuse for not prescribing medical cannabis, saying “it is utterly deceitful for people who need it not to be offered medical cannabis.” He said that clinicians should evaluate other published evidence, including observational studies and patient-focused trials (BMJ Open, 21 Sept 2020). It is clear that more work has to be done to prove the efficacy of cannabis.
To address research gaps, improve quality and overcome barriers, we need to prioritise the following:
Create a research agenda
Currently, the global research framework is insufficient and disjointed.
With countries across Europe taking a different approach to legislation and differing rules such as the maximum allowed levels of THC and CBD concentrations, we need a unified research framework to inform medical cannabis policy and set acceptable standards of its production. Across Europe, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is interested in extending evidence-informed policies for medical cannabis use but their criteria set different baselines from the UK’s National Institute for Health and Care Excellence (NICE). This leaves countries operating, testing, researching and formulating government policy in their own independent and inefficient vacuums.
No research can be done without considering funding. However, this is complex across the UK and beyond. Drug, device, and product development is typically under the remit of the pharmaceutical and commercial industries, but there are barriers in relation to intellectual property and health claims which has led to investment limits in drug development pathways and bringing them to market. Research on new cannabinoid drugs, devices, and technologies (e.g. DNA sequencing, extraction, isolation) and data capture (e.g. registries, ‘big data’) need to be supported along with investments in laboratory testing methods, standards, and capacity.
So far, research on medical cannabis has received no direct support under the current research programme in the EU and there has been little coordination regarding research projects on medical cannabis in the Member States. Even Canada, which is seen to be the leader of progressive cannabis policies and access, has only secured two government-funded clinical research studies within the first 14 years of their first patient access programme. To effectively guide health care decisions and inform public policy, cannabis research needs funding to produce conclusive, actionable evidence.
Focus on areas which could bring the greatest added value to patients
The list of conditions which cannabis can alleviate symptoms for include Multiple Sclerosis, epilepsy, and chronic pain. This list could grow if further research to develop a wider range of products for other treatments is allowed. Getting a conclusive database on the health effects of cannabis is also dependent on having a comprehensive data set. Examining the effects of cannabis use across conditions, but also in at-risk or under-researched populations, such as children-youths and older populations, pregnant and breastfeeding women will address gaps and provide clinicians with guidance based on sufficient evidence at scale.
Standardise and open research access to various cannabis strains
An objective and evidence-based analysis of cannabis is necessary. Research needs to be standardised, consistent and accurate so that once proven, patients with the same condition can receive treatment,
Cannabis is a plant that has a complex pharmacology and has varying levels of its core properties (including cannabinoids, terpenes, and flavonoids) across different strains. Generalising one strain against another may adversely impact data sets, so research needs to be done across strains and analysed to inform consumers and policy-makers alike.
High standards are important to the cannabis industry to ensure patients receive safe, consistent, pharmaceutical-grade cannabis. This applies to CBD as well. There are over 900 CBD companies in the EU, but only three hold licences to manufacture from a natural source. It is important that we raise the bar on the products being developed through research and ensure that products on the shelves are safe for consumer consumption. More quality and refined cannabis products entering the market will prove that the benefits of legal cannabis improve patient experiences and access.
Research equals increased knowledge and understanding
There is a great deal that producers, policy advisors, pharmaceutical companies, doctors, and researchers could learn from collated experiences. If we coordinate and collaborate on data, unifying priorities for cannabis research, we will be able to help inform health care practices, priorities, safety standards, national policy and ultimately open patient access.
Pushing scientific and clinical research on cannabis and its compounds, growing sources of research-grade cannabis, and driving the development of approved medications derived from cannabis such as CBD or other cannabis compounds will help clinicians and policy-makers understand cannabis and cannabis-based medicinal products (CBMPs) to support prescriptions and funding decisions.
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