Israel Can be A Center of Excellence in Cannabis R&D
In the 1970s the legal drinking age in New Jersey was 18. Obtaining alcohol as an under age teen was a hassle but buying weed, despite its illegality, was a snap. A few bucks handed to another high schooler at the break bought a plastic baggy filled with coarsely ground dried plant parts. It was anyone’s guess what that dried matter contained.
Paraphernalia for marijuana consumption, such as pipes, bongs, rolling paper and glorified tweezers to hold the end of an almost finished joint, was readily available with no age restrictions. In the memories of my high school years, pretty much everyone smoked weed. While the local police did their best to enforce the law, there was woefully little deterrence for using marijuana.
Back in the 70s, the idea that marijuana would become legal anywhere in the US would have been considered a wild, unattainable dream. But now, forty years later and despite the federal status of the plant as an illegal narcotic, the medical use of marijuana is legal in NJ, as well as 28 other states. Throughout the US and other countries, therapeutic use of cannabis proliferates among patients supported by a growing consensus among medical professionals.
Cannabis contains several hundred active ingredients in the form of cannabinoids, terpenes, and flavonoids. A wide variety of cultivars, differing in their chemical components, have been developed around the world over the years. Assertions that the active ingredients in the cannabis plant have specific medicinal attributes stem from an extensive accumulation of knowledge, largely based on feedback by users and their caretakers backed by preclinical studies.
The lack of consistency, stability, and clinical veracity provided by an FDA (Food and Drug Administration) approved drug prevents cannabis from being considered a medicine by regulatory bodies. In fact, in the US it is illegal to attribute a medical benefit to the plant. Clinical research providing evidence based, scientifically verified and repeatable relationships between the plant’s active ingredients and medical efficacy is essential to obtaining regulatory and widespread medical acceptance. Traditional drug delivery systems, such as slow release gel caps, inhalers, and dermal patches, have to replace consumption by smoking, vaping, and edible oils.
A combination of factors is required to enable phytocannabinoid research on humans that can lead to the development of regulatory approved medicine by the FDA, EMA (European Medicines Agency), and other regulators. Access to medical institutions and investigators that can conduct clinical trials in compliance with strict protocols is essential. There has to be a supply of purified, active pharmaceutical ingredients (APIs) extracted from the plant and produced as consistent, stable formulations. The regulatory environment has to be accommodating to clinical research of cannabinoids on humans and there has to be a willing patient population.
Israel is currently the only place in the world where all the necessary factors merge to create the perfect ecosystem for conducting clinical research on phytocannabinoids including:
Mutual recognition by FDA and EMA so that clinical research conducted in Israel’s hospitals and medical centers can be submitted to those bodies as if the research had taken place in the U.S. or in Europe.
An extensive academic and scientific community that has been engaged in discovering and developing medicinal cannabinoids and their connection to the endocannabinoid system since Professor Raphael Mechoulam and his team identified and synthesized THC in 1964.
Government sanctioned use of cannabis for medicinal purposes for over 30 years enabling a patient and caretaker population, as well as a growing medical community, that has experienced and believes in cannabis as medicine.
Cultivation of high quality cannabis employing cutting-edge agricultural technologies as a source for drug formulations and clinical batches.
World leading scientists and institutions comprising the entire value chain from agricultural to medical research enabling the creation of solid intellectual property.
Advanced pharmaceutical manufacturing capabilities providing extraction of purified active ingredients, formulation services, production of clinical batches, and development of targeted drug delivery systems.
An internationally renowned drug development ecosystem offering all the services and resources needed to perform clinical trials from early stage lab testing to FDA approval as an investigative new drug (IND) and beyond.
A friendly regulatory environment that allows conducting cannabinoid research on humans.
A considerable cost advantage in conducting clinical trials as compared to the US or other western countries.
This unique conglomeration of factors gives Israel a window of opportunity to become a worldwide center of excellence. However, substantial research ecosystems are emerging in other countries, such as Canada and Australia. Now is the time for Israel to establish its leadership position. The various government and regulatory bodies would be wise to join forces to provide the support and resources needed for Israel to establish itself as the world leader in phytocannabinoid research.
Israel’s prime minister, instead of impeding legislation, should express support for Israeli leadership in the field. Academic, government, and regulatory bodies need to pool resources to create one platform for scientific study of cannabis on all levels, such as a nonpartisan government council engaging experts from academic, medical, and other disciplines. The country needs to reach out to researchers all over the world by promoting scientific conferences and events, enabling access to the wealth of accumulated knowledge through combined online databases, and establishing a single point of contact to communicate and disseminate information. Israel could even appoint a goodwill ambassador to work with other countries to coordinate policies and promote collaborations. By taking action now, Israel can solidify its position as the preeminent cannabis research center of excellence in phytocannabinoid medicine, bringing the virtues of this versatile plant to patients worldwide.