As its legal landscape changes, the stigma of CBD use is as well, along with its popularity. Despite this rise to prominence, a few key questions remain; How can potential CDB treatments move forward while prioritizing patient safety? Additionally, how can those in the industry create a sustainable path for further research that includes both adequate funding and aids in the creation of guidelines for production and appropriate medical use?
What the Data says
There has been very little research on the potential long-term effects of CBD which makes it difficult to form well founded conclusions. Reported positive effects of the substance are mostly seen through anecdotal evidence and individual case studies. Other than its use in specific types of pediatric epilepsy, there is little documented evidence of its efficacy.
This potential area of research relates the combination of pediatric EEG’s and the use CBD. While the use of FDA approved anti-seizure medications is well documented, what happens when you utilize a CBD product in combination with a standard anti-seizure medication? The question becomes, which chemical is working, how, why and if the EEG does show improvement, is it the combination of drugs? Also, if CBD is working, what is the proper dosage, standard of care, short and/or long-term benefits and possible side effects?
One of the greatest challenges we have as an organization is the lack of published research data, credible resources and regulatory guidelines. Advocacy organizations have no baseline measures to go by. Currently, our hands are tied both in the advocacy world and in the research world. Resources gathering critical data are limited due to funding restrictions, paucity of research data and many unanswered, lingering questions about how the mechanisms in CBD chemicals and chemical combinations work. When a caregiver reaches out looking for answers to try and help their loved ones, we are unable to provide the information or assistance needed that will guide them to credible help. We are left with telling caregivers to follow your physician’s advice and hope for the best. Advocacy organizations, like Bridge the Gap – SYNGAP Education and Research Foundation, are safe havens for patients living with chronic and sometimes fatal diseases. We depend on guidance from both our scientific advisory board and government regulators in order to provide the best and most credible information to the patients and families we serve. It is our goal to provide compassionate guidance and current information about research, treatment and available services to help families and patients have an improved quality of life.
The scientific community, at this time, cannot give the definitive answers, so urgently needed by many, regarding the safety and efficacy of CBD derived marijuana use for medical purposes. Physicians and researchers are restricted from giving sound advice because of the lack of research and they do not want to be held liable for the consequences of recommending the use of an unregulated substance.
So Many Questions
The majority who use CBD products believe they are benefitting from its’ use and are not highly concerned about any long-term negative effects. While we as organization leaders hear reports from families about the beneficial use of CBD products and symptom relief, we recognize the paucity of scientific studies. Active users of CBD products always need to consider a possible “placebo” effect when taking a CBD product, CBD product quality, drug manufacturer, product safety, possible drug interactions, correct dosing and the risk involved when taking an unregulated product. This is all highly important when giving to a vulnerable patient population.
One of the greatest health risks are the unknown drug interactions, whether from long- or short-term usage. There are so many formulas of CBD, different ratios of THC and no regulatory guidelines to make sure there are quality controls and set standards. Many things need to be considered when manufacturing CBD products, such as growing the plant, hybrid crossing of plant species or the purifying process of the chemicals in the plant. There are not many studies done on drug interactions, and we fear that when combined with other FDA approved pharmaceuticals the long term and short-term side effects could be magnified. Education is a huge shortfall and understanding that there are many different chemicals in the marijuana plant. Many patients have no understanding about the different parts of the plant, or which chemicals may help alleviate specific symptoms.
What makes a patient population “vulnerable?”
Our population, SYNGAP1 patients, are especially vulnerable as many cannot verbalize/communicate what they are feeling and/or if they are in pain. They also may not have an ability to effectively communicate due to intellectual disability or their sensory processing issues. Our patient population tends to have an abnormally high pain threshold. These types of problems interfere with how they process the environment around them and even how they can express what they are feeling inside of their bodies. Thus, how any new treatment could affect them on a physical and emotional level, needs very careful consideration.
The Emotional and Mental Toll
We are not against the use of medicinal CBD products as long as they have been tested and been proven safe. We do encourage third-party lab testing to ensure the quality of CBD products, free from harmful chemicals and pesticides. The antidotal and case study reports of symptom improvements are enough to move forward with more research. However, without the science to back up the “why” and “how” it works, the “Wildwest of CBD” will continue to put desperate families at risk. Many families are looking for anything to help their loved one, while sometimes ignoring the possible long-term side effects of using CBD. Due to lack of research and product regulation, one doesn’t know when if the next purchase of a CBD product, that they have previously used without side effects, will be the one that could cause a medical problem or emergency. Parents of special needs children that have uncontrolled epilepsy are desperate to find anything to stop the uncontrolled seizures. 50% of the SYNAGP1 patient population have drug-resistant epilepsy. Many parents would do or give anything to help improve their child’s quality of life, even if it means “cooking” up concoctions in their own kitchen, traveling across stateliness at the risk of being thrown in jail in order to gain access to medications (legal or not). I have heard many stories within patient communities of families that were taken advantage of. Some families have purchased a “Generic” Brand of CBD, finding out later they were turning were basically sold “snake oil”. Unethical business operators sell “CBD” labeled products, (that may or may not contain CBD) with vast promises of a “cure” for a variety of ailments and symptoms. Families are desperate to help their children are being grossly taken advantage of by these unscrupulous business opportunists. We fear to ask how many have been harmed because a patient ingested a CBD product that was not labeled correctly, not formulated, sanitized or purified correctly, let alone dosing and fear of overdose to a “high” not necessarily meaning to.
Due to the growing prevalence of CBD usage in the United States and the differences in how states govern their own regulatory measures, now is the right time to consider de-scheduling CBD derived marijuana. This would allow funding, at a federal level, to be available for robust, scientific research studies. Studies are needed to ensure that we begin to have answers about the legitimate medical benefits of CBD. There are many patients that need viable treatments to improve medical conditions and their quality of life. These patients and their families deserve to understand the benefits and risks of all available treatments…including CBD. Unfortunately, many currently producing CBD are not in the game to make people healthy. The lure of money and the financial benefit is a strong motivator for some to get involved in the production of CBD products. While CBD products continue to be produced, without necessary safeguards in place, we continue putting our most vulnerable and loved population at risk, our children.