By Gregory L. Smith, MD, MPH
5 FDA-Approved Meds
I was recently asked to give a presentation on cannabinoid medications to 400 European physicians. I opened the talk by asking how many in the audience have received formal education on cannabis, cannabinoids, or the endocannabinoid system. Not one raised their hand. Ten years ago, I was confronted with the same result speaking to a room of U.S. physicians. Medical cannabis and CBD are still largely absent from the medical school curriculum. Fortunately, for stateside physicians, things are changing.
Since its discovery in the 1990s, the Endocannabinoid System (ECS) has been shown to interact with brain-related issues like pain perception, appetite, and sleep, as well as such bodily functions as pain perception, neurodegenerative diseases, inflammation, bowel motility, tumor suppression, and reproductive issues. These claims are backed up by over 25,000 basic science and clinical research studies on the ECS and the use of cannabinoid medications in PUBMED. There are now four FDA-approved drugs on the market that use synthetic THC or cannabis extracts, but education about this burgeoning new system in medical schools remains statistically low.
Currently, it takes twenty years after discovery for a didactic course on the new system to become entrenched in medical student education. However, this is not the case for medical education about the Endocannabinoid System and cannabis. A survey that I conducted of all the medical and osteopathic schools in the U.S. and Canada found that less than 25% of them currently offer a course on cannabinoid medications. Even fewer plan to offer a course within the next year. Those that will offer a course describe a short 2-to-4-hour lecture introduction.
The lack of course material on the ECS and cannabis is more complicated than anticipated. President Nixon’s “War on Drugs” in 1971 primarily focused on cannabis, which was strongly associated with the “anti-war movement” of the time. Cocaine and heroin were relegated to minor issues compared to the administration efforts to combat pot-smoking anti-war demonstrators. As part of the “War on Drugs” campaign, the Controlled Substances Act was introduced. As a direct result, cannabis was classified as Schedule I, which meant cannabis had no medicinal uses, was highly addictive, and carried minimum mandatory sentencing. Cannabis was added to a shortlist of substances that included the deadly drugs heroin and LSD. This was 20 years before the Endocannabinoid System was discovered.
As a result, all medical research on cannabis was brought to an abrupt halt. National Institutes of Health (NIH) grants and funding are vital for performing costly research. Once cannabis was classified as Schedule 1, the NIH pulled all funding on medical research on a plant with no medical use. However, the NIH did support the clinical research on the adverse and addictive effects of cannabis. This adversarial research supported the “Reefer Madness” myth perpetuated by the general public, the administration, and the medical community.
In the decades since the ECS was discovered, hundreds of non-clinical, basic science studies have been held using cell lines and animal models. These studies have made clear the intricate workings of the ECS. Once understood, the next step would be a round of research on drugs that can modulate the effects of the ECS that help with symptoms and conditions. In this case, those drugs would be cannabinoids like THC and CBD, both found in cannabis. However, since cannabis was believed to have no medical use, the 80’s pharmaceutical companies developed synthetic THC analogs. The two synthetic THC analogs are Marinol(r) and Cesamet(r). These analogs were extensively researched in humans and placed into Schedule II and Schedule III after FDA approval. These synthetic analogs were found to have significant side-effects that severely limited their utility. It was later discovered that THC needs to be balanced with CBD and other terpenes, naturally present in the plant, to reduce side-effects. The synthetic pharmaceuticals Marinol(r) and Cesamet(r) were pure THC. These two THC analogs are now considered historical medications. Superior medications are now available for the conditions that they were designed to treat in the 1980s. Another extract of cannabis, Sativex® has passed phase III trials and is currently awaiting FDA approval.
The federal government could no longer ignore the extensive research findings on the ECS and cannabinoids. In 1999, the U.S. Department of Health and Human Services (HHS) filed a patent on ‘Cannabinoids as Antioxidants and Neuroprotectants.’ The body of the patent read, “cannabinoids [are] useful in the treatment and prophylaxis of wide variety of associated oxidation diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, and HIV dementia.”
An increasing body of epidemiologic, basic science, and clinical research has shown that the use of cannabinoids may be a significant part of the solution to this crisis. Further emphasizing the need for medical and pharmaceutical student education on cannabis.
Still, medical cannabis and the ECS continue to be largely ignored by medical schools. After writing my book on medical cannabis (Medical Cannabis: Basic Science and Clinical Applications, Aylesbury Press 2016), I learned that several academic deans at U.S. medical schools stated that they were afraid of losing federal grant money if they offered classes or allowed clinical research on the ECS, medical cannabis, or cannabinoids.
Non-NIH supported clinical research is now being published in increasing volume. Countries such as Israel and Canada are becoming world leaders in cannabinoid therapeutics. Physicians are starting to take independent courses and participate in continued education classes on cannabis topics to make up for what current medical schools are lacking. Some states require a few hours of education on the ECS and cannabinoids prior to being allowed to certify patients for medicinal cannabis cards.
Hopefully, this rapidly emerging field of cannabinoid medicine will catch the attention of medical academia, and the federal government will remove cannabis from Schedule I classification. Only time will tell.