Examing the Safety and Efficacy of CBD
Feb/March 2020 CBD Health & Wellness
At CBD Expo East, industry experts gathered to discuss many topics, from the latest and greatest innovations in packaging and product design to novel cultivation and extraction techniques and technologies. However, between these conversations about the future of the industry, a regular point of contention would rear its head–namely how, despite such marvelous advancements in such a short period, there remains a tremendous amount of public stigma and misinformation on even the most basic cannabidiol (CBD)-related issues. Fortunately, early on during the event, a number of physicians, researchers, and advocates sat down to navigate some basic questions and update the conference audience on what we know about the safety, efficacy, and pharmacology of phytocannabinoids and endocannabinoid therapy. Present on the panel were: Loren DeVito, PhD, Editor-in-Chief of CBD Health & Wellness Magazine; Adam Abodeely, MD, MBA, FACS, FASCRS, founder of ReserveMD; Edward Martino, PhD, cannabis advocate and researcher; and Craig Sicinski, BPharm, community pharmacist and board member of Biohealth Technology.
The most fundamental question of the conference, and unfortunately to regulators it appears, seems to be the question of whether or not CBD is safe. Dr. DeVito was quick and clear in her initial response to this issue, stating that CBD is safe and tolerable at certain dosage ranges, as per the US Food and Drug Administration (FDA), given the approval of the medication Epidiolex®. Indeed, the FDA released dosage and prescribing guidelines for Epidiolex, as they do with all new drugs, that outlines a 1500 mg dosage ceiling. This is important to consider, continued Dr. Abodeely, as studies that have shown serious side effects of CBD are predicated on dosages much higher than this with delivery systems that are fundamentally different (intravenous vs. oral). In the context of a consumer market where some individuals take less than 10 mg of CBD per day and others limit use to products like topicals, Dr. Abodeely was confident in describing these levels as safe.
“The dose makes the poison,” Dr. Martino continued. He discussed the personal nature of cannabinoid medicine and the role of the endocannabinoid system and how it is modulated. Understanding dosage is important because there are various strategies to using CBD and phytocannabinoid therapies but some exhibit different levels of efficacy and potential for negative side effects. Craig took the opportunity to distinguish between isolate-based products like Epidiolex and full-spectrum products and how, from a pharmaceutical perspective, we are still far from understanding a universal paradigm of dosage for phytocannabinoids. Indeed, with the proliferation of consumer products and medications including cannabinoids, it becomes more difficult to discuss questions on the safety or efficacy of CBD without greater context.
There are, of course, the potential for side effects with CBD as with any treatment, Dr. DeVito pointed out. However, we need to better understand the true risk and magnitude of these harms to gauge whether phytocannabinoid therapies would be beneficial for certain patients. Craig noted, “It is a very promising sign that we don’t see more cases of drug interactions and higher reported negative side effects.” No drug will work for everyone, which is why there are so many different types of blood thinners, he further remarked, and why ultimately it is important to work with a physician to craft the best cannabis treatment that is right for you. A sentiment with which the panel agreed wholeheartedly.
The diversity and lack of reliability across product types, as well as access to these products, was a critical consideration for many of the panelists when the conversation shifted to discussing what makes an informed consumer and the diversity of ways CBD may or may not fit into the lives of various people. Craig pointed out how important it is to meet patients and people where they currently are. Whether it is cost, personal preference, or a potential negative experience, not everyone is going to switch over entirely to CBD or phytocannabinoid therapies. We have to accept the benefits and limitations of where the market and regulations are and try and find a way to guide people into cannabinoid treatments with the lowest risk.
When the panel was asked further about these risks and how consumers may navigate them, Dr. Abodeely was quick to return to some of the initial points that were brought up when discussing the safety and efficacy of CBD. He broke these issues into two groups–reasons not to use cannabinoid therapies and reasons to continue looking for the right cannabinoid therapy. In the first camp, as a physician, he further explained, it was his role to help patients navigate side effects like nausea and fatigue. By asking if individuals were dieting and exercising and modulating dosage or delivery form, he continued, there is a tremendous potential to curb these effects early. Side effects like cannabinoid hyperemesis or depression–particularly in the case of people with mood disorders–might be indicators to him that phytocannabinoid therapies aren’t the best fit.
Despite agreement that physicians can help patients navigate the path to successful phytocannabinoid treatment outcomes, Dr. DeVito pointed out the wealth of education that has become readily accessible to patients and how to critically evaluate this information by checking the validity of sources used to support claims about CBD. Additionally, she remarked, there are a number of ways to consume CBD to fit different patient preferences and needs. Because of the increasing availability of products, the time has never been better to evaluate the potential use of CBD and cannabinoid products to assess what level of fit they may make for any particular consumer. Personalized medicine, Dr. DeVito concluded, should be the goal of our development and the orientation of cannabis physicians.
As the industry does head in that direction though, Dr. Martino was eager to steer the conversation toward the role of different delivery systems. Topicals are a reliable and accessible delivery system that might benefit certain patients and sublingual products are also proving to be a good method, while there are additional innovations to come such as inhalers and other delivery systems providing higher bioavailability and improved onset time. Understanding that cannabinoids can deliver different benefits at the acute and chronic level also helps inform a more personalized medicine. While moving advice away from the helpful but basic “start low and go slow” rule of thumb, product-based recommendations are also an important step in the same direction.
When talking about the benefits and strategies of phytocannabinoid therapies, it is impossible to ignore the role of regulations, or lack thereof, in ensuring patient and consumer safety. There can be little transparency from regulatory agencies, remarked Dr. Abodeely, and so it’s important to look for companies that take the extra step to provide information before it’s asked or needed. For instance, he continued, look for third-party testing, reliable labels, and packaging, as well as supply chain integrity and reliable certificates of analysis. There is definitely room for concern when thinking about plant-derived concentrates, including the risk of residual solvents and pesticides, along with inconsistent plant cannabinoid ratios, chimed in Dr. Martino.
Some of these questions though also boil down to preference and timing. We are still seeing new products being developed, and it is already a hard start diving into the world of CBD for the first time, said Dr. DeVito. Therefore, it is important to be proactive as a consumer, patient, or manufacturer in understanding what is legal and what the latest and best methods of analysis and testing are. Being a smart consumer can seem daunting at first but education from CBD Health & Wellness Magazine and the CBD Expo Tour, among others, are great resources for everyone.
Staying informed about current regulatory trends is going to be important, concluded Craig. As control over the industry shifts from the Drug Enforcement Administration to the FDA, there will be issues with standardization and accessibility in the over-the-counter market still to come. Luckily, the inherent potential of these products makes them a bright light. The panelists and audience seemed optimistic as the conversation concluded. All in attendance seemed in agreement that CBD is safe and that the potential of phytocannabinoids is far greater than associated harms. This is an important conclusion, as the progress of cannabis is from one of compassionate medicine, relegated to only the most extreme of cases, to an integral component of a wide array of treatment modalities. As regulatory gears continue to churn and the market continues to grow, it is important to look toward the future. Questions of drug interactions, negative side effects, and treatment complications are important but the reality is that we are far past a paradigm of cannabis that embraces the plant as anything but a worthwhile medicine.
