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The Future of Medical Cannabis Includes Pharma

By: Jacquie Cohen Roth

The future of medical cannabis is promising, yet it requires the leveraging of best practices and knowledge assets of the following industries: cannabis, technology, traditional Western medicine and pharmaceutical.

Last year, my company, CannabizMD, hosted a panel discussion entitled “Cannabis + Innovation”. The discussion with cannabis industry leaders focused on the need for ongoing application of cutting-edge technology with high-level science, data capture and meta-analysis. One year later, and one more year in the cannabis industry, including graduate studies in the science of medical cannabis, I recognize that the pharmaceutical industry’s best practices and knowledge assets are necessary to drive substantive growth and success for the medical cannabis industry.

Many believe the federal prohibition of cannabis in the US will end in the next few years, but exactly when is dependent upon US politics. Cannabis (marijuana) has been in therapeutic use for thousands of years. Cannabis was used in relatively “modern medicine”, by physicians for therapeutic patient treatment from the mid-19th century in Europe and made its way to the US Pharmacopeia in 1851. It became illegal in the US in 1937 when President Franklin D. Roosevelt signed the Marihuana Tax Act of 1937 (the spelling of the time was racially biased against minorities). This law effectively banned the possession of cannabis and required a stamp for purchase. Requiring purchasers to obtain a tax stamp meant buyers had to provide details about the amount and location of their purchase, therefore incriminating themselves in an illicit activity.

The future of medical cannabis is a hot debate topic among industry professionals, current hypotheses include:

  1. The medical cannabis industry will disaggregate and evolve.
  2. Medical cannabis will remain but gain advantages over adult-use cannabis.
  3. Medical cannabis will disappear with the introduction of adult use (recreational).

My hypothesis is a fourth, and a combination of hypothesis 1 and 2.

First, as a whole the cannabis industry will evolve into three lanes: wellness; adult use and medical cannabis. Second, medical cannabis will thrive and revenues will exceed those of the other two lanes, but not without the inclusion of pharma. Leveraging the best practices and knowledge assets of the existing cannabis industry with those of the pharmaceutical industry, in the development and application of phytocannabinoids, there will be new effective plant-based drug formulations and new drug delivery systems.

The pharmaceutical industry will be a big player in the global end of federal prohibition. There is tremendous economic opportunity which will incentivize it to be impactful in the end of prohibition. In the US medical cannabis annual sales are projected to grow to an estimated $13.1 billion by 2025 - and that’s without pharma involved! A number of pharmaceutical companies already have new cannabinoid drug formulations in different stages of development. Three synthetic cannabinoid drugs have been on the market for several years, Marinol and Cesamet - both are used to treat severe nausea and vomiting due to chemotherapy - and Sativex, used to treat MS-related symptoms. It is projected there will be quite a bit of merger and acquisition activity over the next couple of years as the cannabis industry recovers from the financial impact of COVID 19 and restructures. There’s an opportunity for smart money to begin to create strategic partnerships and consolidations between the cannabis and pharmaceutical industries. Clearly, pharma has available funds.

Epidiolex, manufactured by UK-based GW Pharmaceuticals, is the first plant-based cannabinoid medication, formulated to treat the severe seizure disorders. Of note, Epidiolex does not contain THC which does have psychotropic effects, it is a CBD oral solution. Recently, Epidiolex was declassified by the DEA and removed from their list of controlled substances. Despite this and the legalization of medical cannabis in 33 states, in addition to Washington DC, and Puerto Rico, cannabis remains a Schedule 1 drug, offering no accepted medical use and high potential for drug abuse, and is still federally illegal. Most countries apply similar standards to cannabis, but the DEA’s declassification of Epidiolex marks a positive sign for cannabis and pharma, and the growing acceptance of plant-based cannabinoid formulation for therapeutic treatment. The cannabis industry is actually three industries in one and each is referred to as a vertical: agricultural/cultivation; manufacturing/processing and retail/dispensaries. Each vertical has its own set of complex rules and regulations. There’s tremendous value in knowing how to successfully navigate through them. The knowledge assets of the traditional cannabis industry are necessary, delivering time and cost savings to move into the future. Of course, these regulations will change when pharma becomes more involved but the experience is adaptable and valuable.

The medical cannabis industry needs the pharmaceutical industry’s knowledge assets and best practices of standardized Good Manufacturing Practices (GMP – no standardized GMP exist in the cannabis industry). In the US, because medical cannabis is illegal at the federal level, the industry is regulated on a state-by-state basis rather than the Food and Drug Administration (FDA) which regulates the US food and drug industries. Additionally, the cannabis industry is missing standardized research, randomized controlled trials and meta-analysis of the pharma industry. Pharmaceutical regulation varies by country, but critical for success is an easing of restrictions across the globe to enable clinical trials with cannabis, for a far better understanding of the properties and vast potential of plant-based cannabinoids.

Many pharmaceutical drug formulators have already transitioned to the cannabis industry, bringing with them innovation that will transition clinical application away from combustion-based consumption, e.g. smoking and vaping, to more innovative formulations and delivery methods. Formulations of this kind will allow for a prescribed time of onset, duration of action, bio-availability, and dose consistency which all synthetic drugs have.

The traditional cannabis industry is founded upon decades of experience of best growing techniques and strain development including the benefits of incorporating terpenes (plant-based essential oils which have medicinal value). These strains have demonstrated success in treating a multitude of disease and disorder symptoms. Several medical cannabis companies across the globe have launched their own studies focused on patient experience and efficacy, delivering valuable insight and data for a faster track towards new formulations. Studies reflect, cannabinoid treatment with full-spectrum plant-based terpene and cannabinoid combinations are more effective than singular synthetic cannabinoid treatment with, for example, Marinol (synthetic THC only).

Perhaps the most famous cannabis strain is Charlotte’s Web which was developed by seven brothers in 2012 in Colorado and was originally known as Hippies Disappointment for its lack of psychotropic effects - a high CBD strain that doesn’t get the user “high”. The strain was renamed Charlotte’s Web for Charlotte Figgi who died in April 2020 at age 14, possibly due to complications of COVID 19. Charlotte’s parents successfully treated her severe form of a seizure disorder from a toddler with Charlotte’s Web. An entire new industry was built upon the success of Charlotte’s treatment.

Technological innovation improving the ability to accurately dose medical cannabis, is enabling newer delivery methods to optimize the balance between therapeutic effects and psychoactive events. Yet these methods are not currently in use, and lack the acceptance of conservative, traditional healthcare providers. This is due to cannabis’ Schedule 1 classification preventing access to gold standard FDA clinical trials. Application from the pharmaceutical industry’s drug delivery methods and innovation will benefit the optimization and patient safety.

Universal application of blockchain technology in the cannabis industry does not yet exist. Blockchain delivers the ability to maintain strain purity with accurate analysis of data on strains and product formulations most effective for specific disease and disorder symptoms as well as the capture of dosage data and determining product origins.

Lastly, an important quality of the cannabis industry is an almost universal passion for safe and effective therapies, which do not deliver the unpleasant side effects common to most pharmaceutical products. The future is bright and exciting for medical cannabis, and it gets there even faster with the mindful integration of respective industry knowledge assets and passion.

Jacquie Cohen Roth is Founder/CEO of CannabizMD, a platform focused on cannabis industry and healthcare provider education. She’s in the 2021 cohort of MS in Medical Cannabis Science and Therapeutics at the University of Maryland, Baltimore School of Pharmacy.