Growing awareness among the medical community of the virtues of medical cannabis and the potential size of this nascent market is steadily attracting new players. At the same time, less than 1% of the US population uses cannabis for medical purposes on a regular basis.
A key obstacle to mainstream acceptance of cannabis as medical treatment is the lack of clinical trials that prove safety, efficacy, and consistency of treatment outcomes. The FDA will not allow medical or health claims on cannabis products that have not been proven in clinical trials, which currently cannot be conducted on cannabis as it is considered a dangerous Schedule 1 substance.
The current environment is fragmented, consisting of small-scale enterprises that compete against each other with little significant differentiation. As is typical in emerging industries, the cannabis industry is driven by a lack of coherent business models, unrealistic dreams, and inflated evaluation. Despite the enthusiasm of early adopters, a majority of these companies will fail before they can cross the chasm to the next stage of industry maturity.
Despite the progressive affirmation by America’s most respected medical organization, a regulatory web woven by federal oversight bodies restricts clinical research to an almost invisible trickle, making the development of cannabinoid-based drugs in the US virtually impossible. Until now only one institution, the University of Mississippi, has been granted a license to grow marijuana for medical research by the US Drug Enforcement Agency.
In August 2016, the DEA denied a petition to redesignate marijuana, but ended the university’s monopoly by allowing other entities to apply to grow marijuana for research.
Marijuana provided for research is supplied as cigarettes or bulk material (only bulk going forward) composed of plant matter from various strains of marijuana.
Several categories of bulk marijuana are available in predetermined ratios of THC and CBD. None of the other cannabinoids – and there are at least 113 exhibiting varied effects – are available for research purposes.
The DEA determines yearly production quotas in collaboration with the National Institute on Drug Abuse (NIDA), which is charged with approving applications for research on medical marijuana. Researchers conducting federally approved studies complain of excessively long waiting periods, up to two years in some cases, to receive their supply. In many cases the product received is of poor quality and unusable.
The Food and Drug Administration is responsible for approving new drugs.
However, to date the FDA has not approved any drug product containing marijuana. In a review of 566 abstracts of scientific articles published and available in the public domain before February 2013, the FDA did not find a single study that met their criteria of an adequate and well-controlled study to determine the safety and efficacy of a human drug. In short, the DEA and NIDA provide medical marijuana for research that fails to meet the requirements used by the FDA to determine the acceptable use of a drug, thereby obstructing the progress of cannabis based drug development.
Another issue impacting this nascent industry is the lack of effective drug delivery platforms. The pharmacokinetics and bioavailability of a substance in the human body very much depends on the method of administration. Current methods used in marijuana drug research in the US, whether inhaled as smoke or vapor or taken orally in food or as whole plant extracts, do not allow for the efficient uptake of active ingredients in the body. The total lack of a controlled-delivery platform that ensures that precise, repeatable doses of specific pharmacological ingredients are administered is a significant impediment to establishing a cannabinoid-based drug industry.
Israel boasts by far the most progressive regulatory environment for medical cannabis use worldwide. Most recently Israel’s Health Ministry decided to allow distribution through pharmacies, driving the alignment of medical marijuana with other prescription drugs. Research on medical marijuana is being conducted from pre-clinical through all phases of clinical trials at leading FDA-approved hospitals.
Until now the vast majority of drug research and treatment is done using whole plant organic material or whole plant extracts. However, the establishment of a cannabis-based pharmacology requires a leap into the pharma world of precise, consistent formulations and advanced drug delivery systems. This can only be achieved through deriving the active ingredients from the plant and then re-combining them in a controlled platform.
In other words, the individual compounds within the plant have to be extracted at 99% purity in order to be formulated into a drug that can be delivered as a tablet, gel cap, dermal application, or some other FDA-accepted drug delivery system.
The fragmented nature of the medical cannabis industry in the US blocks the creation of the economies of scale and the investment required to build pharmaceutical- grade production capacity. Whole plant extracts are categorized as food supplements – which are nice to have but are limited in their efficacy and use.
So many factors influence the active ingredients in a botanical that it’s impossible to ensure that every dose is exactly the same as the one before it and the one after. Consistency in the production of the active ingredient is imperative for it to be considered a pharmaceutical drug.
Israeli companies are pioneering advanced cannabinoid drug-delivery platforms. Combining these delivery systems with unique formulations creates treatments for a wide range of medical conditions. BOI Pharma, for instance, currently supplies cannabinoid-active pharmaceutical ingredients (APIs) and formulations to drug developers that are conducting clinical trials on indications such as intestinal, neurological, and brain diseases as well as several skin conditions.
The company invites biotech and pharma researchers from around the world to come to Israel and use the company’s APIs and formulation capabilities to conduct clinical trials at Israel’s highly advanced medical institutions.
Israel is already established as a worldwide hub of cannabis-based medical research. Israeli researchers at the country’s top hospitals and medical schools conduct this research. With its conducive regulatory environment, access to some of the top scientific minds, and advanced medical infrastructure, Israel provides a unique ecosystem for conducting medical cannabis research. Given the availability of research grade APIs, formulation and production capabilities, and access to an extensive expert network that companies can provide, Israel can serve US researchers as the bridge between proof of concept and an FDA-approved marketable drug.
The writer is the CEO of BOL Pharma, which supplies cannabinoid APIs and finished products to the pharma and biotech industry.
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