Article written by Stephanie Illich Stroll exclusively for Boston Biotech Advisors.
Medical cannabis presents both opportunities and challenges, particularly regarding the FDA's oversight. While the FDA has approved specific cannabinoid-based medications like Epidiolex for the treatment of epilepsy, the regulatory body has not established a comprehensive framework for the multitude of cannabis products available on the market. This lack of oversight raises concerns about product quality, dosage accuracy, and therapeutic efficacy, especially for patients with hard-to-treat diseases such as cancer, multiple sclerosis, and Crohn’s disease.
Regulatory Complexity of Natural Cannabis Products
The FDA lacks direct oversight of natural medical cannabis products due to its classification as a Schedule I substance under the Controlled Substances Act, which designates it as having no accepted medical use and a high potential for abuse. While the FDA can regulate products containing cannabis-derived compounds marketed for medical purposes—such as Epidiolex (CBD) and synthetic THC products like Marinol—it faces limitations in enforcing uniform standards for natural cannabis. This fragmented regulatory landscape, shaped by varying state laws, results in inconsistent oversight, quality control, and labeling practices across the industry. Consequently, patients encounter challenges in accessing reliable therapeutic options, and research into the efficacy and safety of natural cannabis is hindered.
Diseases Treated with Medical Cannabis
Medical cannabis has shown promise in managing a variety of challenging conditions. Patients suffering from chronic pain, nausea associated with chemotherapy, muscle spasms from multiple sclerosis and Parkinson's disease. Research suggests medicinal cannabis can treat appetite loss due to cancer treatments. Research also indicates that medical cannabis may help alleviate symptoms of PTSD and anxiety disorders, making it a versatile option for patients in need of alternative therapies.
The Science Behind Cannabis and Its Effects
At the heart of medical cannabis are cannabinoids, the active compounds that interact with the body's endocannabinoid system (ECS). The ECS plays a crucial role in regulating various physiological processes, including pain, mood, appetite, and inflammation. The primary cannabinoids, THC (tetrahydrocannabinol) and CBD (cannabidiol), bind to cannabinoid receptors in the brain and body, producing therapeutic effects. While THC is well-known for its psychoactive properties, CBD is celebrated for its non-intoxicating effects, making it an attractive option for patients seeking relief without the high.
Non-Psychoactive Compounds with Medicinal Benefits
It's essential to note that not all cannabis compounds induce a high. Cannabinoids like CBD and CBG (cannabigerol) possess significant medicinal properties without the intoxicating effects of THC. For instance, CBD has been shown to reduce anxiety and inflammation, while CBG may help with neuroprotection and antibacterial effects. These non-psychoactive compounds provide patients with a range of therapeutic options to manage their conditions effectively.
FDA-Approved Synthetic Cannabis Products for Disease
The FDA has approved several synthetic cannabis medications that offer therapeutic benefits, including Marinol, Syndros, and Cesamet. Marinol and Syndros contain dronabinol, which is a synthetic form of THC (tetrahydrocannabinol), the primary psychoactive compound found in cannabis. These medications are primarily prescribed to manage nausea and vomiting associated with chemotherapy, as well as to stimulate appetite in patients with AIDS. Cesamet, on the other hand, contains nabilone, a synthetic cannabinoid that closely resembles THC in its chemical structure and effects. Both nabilone and dronabinol provide patients with a consistent and regulated dosage, making them viable options for those who may benefit from cannabis-derived therapies without the variability associated with natural cannabis products.
Shortcomings of FDA-Approved Synthetic Cannabis
While FDA-approved synthetic drugs like Marinol, Syndros, and Cesamet offer regulated dosing and consistency, they often fall short compared to natural cannabis for medicinal use. One of the primary limitations is that synthetic cannabinoids contain only isolated compounds, such as dronabinol or nabilone, which means they lack the full spectrum of phytochemicals found in the cannabis plant. Natural cannabis encompasses a wide array of cannabinoids, terpenes, and flavonoids that work synergistically—a phenomenon known as the "entourage effect." This synergy can enhance therapeutic benefits and create a more balanced patient experience, as these compounds can modulate the effects of each other, potentially reducing side effects and improving efficacy. Consequently, many patients report a more holistic and satisfying therapeutic effect from natural cannabis, as opposed to the narrower effects of synthetic alternatives.
Conclusion
The intersection of FDA oversight and medical cannabis presents a complex scenario for patients seeking effective treatments for hard-to-treat diseases. As research progresses and regulations evolve, synthetic and natural medical cannabis products holds the potential to alleviate or even cure patient suffering from various conditions. For further information on medical cannabis business or regulatory strategy, visit our website or contact Boston Biotech Advisors by email at info@bostonbiotechadvisors.com.
Stephanie Illich Stroll - Professional Biography
Stephanie Illich Stroll is a distinguished expert in the field of cannabis and regulatory compliance, holding an impressive array of 10 certifications from the Cannabis Training University. Her credentials encompass Medical Cannabis, cannabis laws and regulations across all 50 U.S. states, Canada, and Europe, as well as cannabis business, indoor and outdoor cultivation, extraction, and cannabis-infused culinary arts.
In addition to her extensive training in cannabis, Stephanie is a recognized authority in FDA and EMA regulatory affairs. She specializes in helping companies achieve authorization and compliance for pharmaceutical, biotechnology, regenerative medicine and medical device products within both the U.S. and European markets. Her expertise not only ensures adherence to regulatory requirements but also fosters innovation in the rapidly evolving landscape of cannabis and medical products. Through her commitment to excellence and comprehensive understanding of the industry, Stephanie is dedicated to advancing the responsible use of cannabis for hard-to-treat diseases.
