Cannabidiol (CBD) is derived from hemp and has a vast range of health properties including anti-inflammatory, antianxiety, and antipsychotic (Russo, 2017). It is closely related to tetrahydrocannabinol (THC), both having the same chemical formula but different arrangement of atoms. However, CBD and THC react with different receptors in the brain causing different benefits and reactions. CBD has been used to treat a vast variety of diseases including multiple sclerosis, epilepsy, Huntington’s disease, depression, and cancer (Kogan & Mechoulam, 2007). CBD has been prescribed by physicians and can be purchased online, at dispensaries and at grocery stores including Sprouts.
Charlotte’s Web, one of the first strains of CBD available commercially, was developed in 2011 by the Stanley brothers of Colorado by crossbreeding marijuana with industrial hemp. It was created to have a 30:1 ratio of CBD to THC and had all the medicinal properties without the psychoactive effects (Boshoff, 2017). Soon after its creation, Charlotte’s web was used to treat children with seizure disorders, including Charlotte Figi who suffered from a rare form of epilepsy called Dravet’s syndrome. Other strains of CBD with similar ratios to Charlotte's Web are currently being used as a treatment for multiple forms of epilepsy.
During the next eight years, many studies would be completed testing the efficacy of CBD on treating epilepsy disorders. A randomized controlled trial completed in 2016 tested the efficacy and safety of CBD in patients with Lennox-Gastaut syndrome. This syndrome is often resistant to treatments and current treatments involving antiepileptic drugs (AED) (Halford et al, 2018). Data from this trial showed that the mean monthly drop seizures decreased by 48-70% with overall amount of seizures decreasing by 48%-62% (Halford et al, 2018). However, adverse events occurred in a majority of the patients in this study including vomiting, diarrhea and decreased appetite with 83% of the symptoms reported to be mild or moderate severity (Hartford et al, 2018). Another study published in 2016 utilized CBD to treat drug resistant epilepsy in tuberous sclerosis complex (Hess,2016). Data from this study shows a decrease in the total weekly seizure frequency in four different seizure types (Hess, 2016). With the decrease in number of seizures also came adverse side effects including drowsiness, ataxia, diarrhea and agitation (Hess, 2016).
Given the information on the benefits and negative side effects associated with using CBD to treat epilepsy, do you think it is ethical to use CBD to treat children with epilepsy? What ethical principles are you using in your decision?
References:
Boshoff, L. (2017, Sept 20). The Story of Charlotte's Web CBD Oil - Can It Work for Your Child Too? Retrieved from https://medium.com/@liezeboshoff/the-story-of-charlottes-web-can-it-work-for-your-child-too-ecc4382e40b7.
Halford, J., Marsh, E., Mazurkiewicz-Beldzinska, M., Gunning, B., Checketts, D., Roberts, C., & Thiele, E. (2018). Long-term Safety and Efficacy of Cannabidiol (CBD) in Patients with Lennox-Gastaut Syndrome (LGS): results from open-label extension trial (GWPCARE5)(P1. 264).
Hess, E. J., Moody, K. A., Geffrey, A. L., Pollack, S. F., Skirvin, L. A., Bruno, P. L., ... & Thiele, E. A. (2016). Cannabidiol as a new treatment for drug‐resistant epilepsy in tuberous sclerosis complex. Epilepsia, 57(10), 1617-1624.
Kogan, N. M., & Mechoulam, R. (2007). Cannabinoids in health and disease. Dialogues in clinical neuroscience, 9(4), 413–430.
Russo, E. B. (2017). Cannabidiol claims and misconceptions. Trends in pharmacological sciences, 38(3), 198-201.
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ReplyDeleteKierian, what an interesting topic! Of the four biomedical ethical principles, I think the most applicable is beneficence. This is the idea of promoting the welfare of or removal of harm from others (in this case children with epilepsy). I think the imminent harm of epilepsy is the neurological damage caused by seizures and the lower quality of life. If CBD can lessen these burdens and promotes a child's wellbeing, then I believe it is worthy of exploration as a treatment option, even if side effects occur. Many drugs have undesirable/unpleasant side effects, which is unfortunate, but if the overall effect is positive then we typically consider it successful.
ReplyDeleteI found a few studies that looked at cannabinoids as treatments, and many concluded that more study was needed to determine long term effects. One study I found particularly interesting was a pediatric epilepsy clinical trial that examined the combination of CBD with clobazam. A majority of the subjects experienced a >50% reduction in seizures. Did you find any other studies that looked at CBD as part of a larger treatment plan that included other drugs? If a combination was found that reduced seizures and had lesser side effects than the ones mentioned in your post, what would your stance be?
Geffrey, A. L., Pollack, S. F., Bruno, P. L., & Thiele, E. A. (2015). Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy. Epilepsia, 56(8), 1246–1251. https://doi.org/10.1111/epi.13060
Kierian:
ReplyDeleteAs Alyssa has previously elaborated, while most every available drug marketed in the United States has potential adverse reactions and/or negative interactions with other medications, it is important to consider whether these potential risks outweigh the benefits of using the medication.
Recently as of June 2018, oral cannabidiol (CBD) has been approved by the U.S. Food and Drug Administration under the name Epidiolex for use in treatment of seizures resulting from Lennox-Gastaut syndrome or Dravet Syndrome (in patients above the age of 2). Interestingly, while there is mention of risk for somnolence and sedation or suicidal behavior and ideation, which Epidiolex shares with second-line and third-line medications such as Topamax and Klonopin respectively, the FDA also outlines potential risks of cannabidiol hypersensitivity (emesis, diarrhea, decreased appetite) and hepatocellular injury, with 13% of patients having elevated transaminase, requiring that patients undergo periodic serum transaminase and total bilirubin chemistry studies while using the medication for monitoring purposes.
Evidently, these guidelines established by the FDA provide a clear method of prescribing cannabidiol in management of Lennox-Gastaut or Dravet Syndrome related seizures (beneficence), requiring stringent and regular testing to prevent harm to the patient (non-malfeasance). With careful monitoring and continuity of care with a primary care physician, I anticipate that the use of Epidiolex would be unlikely to result in significant harm to the patient. Thus, in congruence with the idea of evidence-based medical practice, I support the use of Epidiolex as a potential first-line option for treatment of seizures in children suffering from Lennox-Gastaut syndrome or Dravet Syndrome.
Additionally, given the information above, because cannabidiol does not produce the same psychoactive effects as tetrahydrocannabinol, it brings into question whether there is any concern for addiction or recreational use for Epidiolex that exists with more aggressive third-line treatments such as Klonopin (a benzodiazepine) or potentially with third-party cannabis strains that still contain THC. Per the FDC guidelines, Epidiolex did not promote animal self-administration during clinical trials, suggesting that it does not produce any rewarding effects involved in addiction. In line with non-malfeasance, the prescription of Epidiolex could potentially reduce the number of patients (or well-meaning guardians) who are self-medicated using third-party cannabis-related medications, which have both not undergone clinical trials and do not involve formal monitoring by a trained healthcare provider.
References
U.S. Food and Drug Administration. (2018). EPIDIOLEX (cannabidiol) oral solution.
U.S. Food and Drug Administration. (2013). Klonopin Tablets (clonazepam).
U.S. Food and Drug Administration. (2012). Topamax (topiramate) oral tablets.
What is Dravet Syndrome? (2019, July 16). Retrieved October 13, 2019, from https://www.dravetfoundation.org/what-is-dravet-syndrome/.
I think this is a very interesting topic. I don't think something can ever be 100% ethical because there are a lot of things to take into consideration and we have to look at whether the ethical aspects of things outweigh the non ethical aspects of things. Not only has CBD been shown to be beneficial for epilepsy but also other diseases such as cardiovascular disease, autoimmune, neurodegenerative and kidney diseases. So I think yes it is beneficial in the aspect of treating and reducing pain for people. Especially if no other form of treatment is working for them. But then also theres also other things to think about like the idea of whether or not pure, 100% CBD is being used since it's so hard to isolate.
ReplyDeletePacher, P., Kogan, N. M., & Mechoulam, R. (2019, October 3). Beyond THC and Endocannabinoids. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/31580774.