The Czech Republic-based International Cannabis and Cannabinoids Institute is making an invaluable contribution to medical cannabis research worldwide, as Dr Ethan Russo tells Health Europa.
Medical cannabis has been legal since 2013 in the Czech Republic, which has attracted praise and criticism in equal measure for its liberal drug laws – a reputation which makes it ideally suited to hosting the world’s first centre of excellence in medical cannabis research: the International Cannabis and Cannabinoids Institute.
Here, Dr Ethan Russo, director of research and development at ICCI, discusses the current obstacles to cannabis treatments, the importance of multidisciplinary research, and the Czech Republic’s role at the forefront of this field.
How does traditional pharmaceutical development differ from cannabis studies?
Cannabis clinical studies may be performed in exactly the same manner as traditional pharmaceutical development via randomised controlled trials (RCTs). In the US, there is actually a blueprint for this process, the Botanical Drug Development Guidance for Industry.1
In each instance, to gain regulatory approval, a botanical agent must demonstrate safety, efficacy and consistency (chemistry, manufacture and control) through Phase I-III clinical trials along with toxicology and other basic science studies.
It is true to say that most studies of cannabis currently are differently structured as case reports, observational studies, or surveys. These do not carry the same weight as RCTs and have no effect at all in advancing the formal regulatory approval process.
What key obstacles are holding back clinical knowledge on the treatment effects of cannabis?
The first major obstacle is a near total lack of cannabis education in medical school and residency programmes. Unfortunately, and with no compelling reason, this problem extends to education on the endocannabinoid system, as well.
In many countries, particularly the USA, there are extremely daunting obstacles to performance of cannabis research studies, and restrictions on supply.
Between these factors and underlying prejudices against cannabis, it is very challenging to
What would you identify as the main research priorities for the advancement of cannabis and cannabinoid treatments, and how does the ICCI work to support these?
Because cannabis works through the endocannabinoid system, a major homeostatic regulator of physiological function, as a therapeutic agent it is of unparalleled versatility in treating many disorders heretofore recalcitrant to conventional medicines.
Probably the pre-eminent example is chronic pain, a major epidemiological challenge in our ageing societies. Cannabis-based medicines have a strong role here, particularly in their ability to reduce opioid usage and its attendant dangers of addiction and overdose mortality.
Beyond that, cannabis has a great deal to offer in many other areas that have yet to be fully realised, among them the treatment of:
- Diabetes and metabolic syndrome;
- PTSD and other psychiatric conditions;
- Alzheimer’s disease and other forms of dementia;
- Head injury and chronic traumatic encephalopathy; and
- Primary treatment of cancer.
ICCI is working with private companies and universities all over the world to investigate these areas and support their efforts.
How important is multidisciplinarity to the work of ICCI and the progress of medical cannabis research more widely?
Given the dwindling biomedical research support from most government agencies, particularly the previous world leader, the US National Institutes of Health, it falls to either private corporations or research consortiums such as ICCI to challenge the short-fall.
We believe that ICCI’s mission to support therapeutic cannabis research, and industrial and nutritional applications for cannabis hemp, fulfils a long-needed and crucial role in these efforts. We are attempting to provide expertise in all relevant areas to bring embryonic ideas to their full fruition for the greater benefit of society.
What lessons could other countries learn from the Czech Republic’s experience with legalising medical cannabis? How important has this been for advancing medical cannabis research in the country?
As I see it, ICCI has benefitted from a unique situation in the Czech Republic in that there is extremely good governmental and European Union support coupled with an extraordinarily talented and industrious cohort of physicians and scientists that can break through the current barriers to research to advance all the possibilities that cannabis brings to medicine and industry.
International Cannabis and Cannabinoids Institute
The International Cannabis and Cannabinoids Institute was announced in 2015 as a joint venture between stakeholders in the US and Czech Republic, among them the
member-based organisation Americans for Safe Access, Czech patient group KOPAC
and New York-based investment platform Dioscorides Global Holdings.
Today, the centre of excellence – the first of its kind – comprises a host of hi-tech companies, universities and associations, all working together with the key aim of identifying, co-ordinating and supporting global research priorities for the advancement of cannabis and cannabinoid treatments.
“The main work of the ICCI is to provide scientific instruments to public and private institutions all over the world,” explains ICCI CEO Pavel Kubu°.
“The purpose is to enable scientific examination of the relation between bioactive cannabis compounds and the effect on the human organism in the treatment of specific syndromes and, in the future, systemic
To this end, ICCI:
• Supports the design, management and data analysis of cannabis-related clinical trials;
• Provides big data, metabolomic and other services to support life, biomedical and social science, as well as policy investigations;
• Assists companies looking to navigate the complex journey from product development to market launch; and
• Facilitates product safety training and medical professional accredited education.
Through its multidisciplinary, evidence-based approach, ICCI is making an important contribution to dismantling the barriers to access for the millions of patients worldwide who could benefit from medical cannabis.
Dr Ethan Russo
Director of Research and Development
International Cannabis and Cannabinoids Institute
This article will appear in issue 5 of Health Europa Quarterly, which will be published in May.