So what do we know about cannabis oil and its effects on epilepsy seizures?
Epilepsy drugs don’t work well, or at all, for about one-third of people with the condition. Unfortunately, these hard-to-treat epilepsies are associated with an increased risk of premature death.
In a similar case, six-year-old Alfie Dingle, who suffers from severe epilepsy, had been successful treated with cannabis oil in the Netherlands. Alfie’s mother, Hannah Deacon, has been campaigning to allow her son to be provided with cannabis oil in the UK.
The reason that Billy’s cannabis oil was seized at Heathrow airport was that it didn’t just contain CBD, it also contained THC at higher levels than legally permitted.
The two main constituents of cannabis oil are THC (tetrahydrocannabinol) and CBD (cannabidiol). Oil containing CBD alone (CBD oil) can be legally bought in the UK without a prescription because it contains only very low quantities of THC. But cannabis oil that contains THC at higher levels (more than 0.3%) is illegal. THC is a schedule 1 drug, that is to say, it is deemed to have no medicinal value.
The government has now also relented in Alfie’s case following the concerns raised around the confiscation and return of Billy Caldwell’s medicine.
Home secretary, Sajid Javid, intervened in Billy Caldwell case and returned a bottle of cannabis oil. EPA/Andy Rain
In May 2019, the Transportation Security Administration (TSA) updated its guidelines on traveling with CBD products. When you fly, you can now carry on or pack in checked baggage products/medications that contain hemp-derived CBD (with less than 0.3% THC) or are approved by the FDA, such as Epidiolex.
The 2018 Farm Bill, signed into law by President Trump in December 2018, exempts hemp and hemp-derived products, including CBD, from the Controlled Substances Act. Previously, hemp-derivatives were classified as Schedule I cannabis products, meaning they had no acceptable medical use and had a high potential for abuse. The Farm Bill lifts federal restrictions surrounding CBD and legalizes the cultivation, manufacturing, and sale of these products across the United States. However, this does not mean that all hemp-derived products, including CBD, are medically appropriate.
Traveling with CBD Products
The use of cannabis to treat epilepsy and other neurological conditions has been studied for a number of years. It has been hotly debated too.
Over half of U.S. states have laws allowing cannabis to be recommended and dispensed to people for medical reasons. The 2018 Farm Bill does not change existing laws surrounding state medical cannabis programs. Individuals who purchase treatments through a medical dispensary and via a recommendation from their physician are still required to follow the regulations set forth including registration, renewal of medical cards, and other requirements decided by each state.
Cannabis is known by many names – the most common is marijuana. Cannabis is the Latin name used most often by botanists and pharmaceutical companies. The word marijuana usually refers to the leaves and female flowers of the cannabis plant. Medical cannabis is whole plant marijuana or chemicals in the plant used for medical purposes.
It is interesting to note that the artisanal cannabis reports and the short- and long-term Epidiolex studies reported other positive side effects not directly related to seizure control. The beneficial effects of CBD-enriched cannabis, other than reduced seizures, were reported in all studies related to artisanal cannabis use and included: increased alertness (>50%); improved sleep (25%–68%), behavior (33%), language (10%), and motor skills (10%–20%); and decreased self-stimulation (32%).34,35,37–39 Although there is no specific reference to these effects in the Epidiolex studies, a recent report on quality of life (QoL) in pediatric patients enrolled in a CBD (via Epidiolex) study has shown significant improvement in caregiver-reported QoL in multiple domains, as well as in general. This may be related to both better seizure control as well as additional positive changes noted in the patients’ conditions.51
Abnormal elevation in liver enzymes (transaminases) can occur with concomitant use of valproate and CBD without significant changes in the valproate levels, suggesting a pharmacodynamic rather than a pharmacokinetic interaction.32
Various ancient cultures have mentioned cannabis as a useful tool to treat epileptic convulsions. There are historical records from ancient China dating back to 2700 BC1 and tablets written by the Sumerian and Akkadian peoples in 1800 BC,2 as well as other ancient historical records. In the nineteenth century several leading physicians published papers on its use as an anticonvulsant, presenting both case reports3 and their general impression on its effectiveness when added to bromides.4
CANNABIDIOL AND CANNABIDIOL-ENRICHED CANNABIS ADVERSE EVENTS AND POSITIVE NON-EPILEPSY-RELATED EFFECTS
The adverse events reported in the well-controlled trials of both artisanal cannabis use and Epidiolex were qualitatively similar and included fatigue, decreased appetite, somnolence, vomiting, diarrhea, and seizures. Somnolence was more frequently reported in patients treated with Epidiolex in addition to clobazam.47,48 In the extensive chart review by Sulak et al., related to artisanal cannabis use, the main side effects were somnolence and fatigue in up to 20% of patients.39 The same side effects with similar or slightly higher rates were reported in the other artisanal cannabis studies,34,38 while various Epidiolex studies showed a significantly higher side effects rate. In the open-label study by Devinski et al.,40 a 79% adverse event rate was reported, with 25% somnolence, 19% decreased appetite, 19% diarrhea, 13% fatigue, and 11% convulsions; 3% of patients discontinued treatment because of an adverse event. Serious adverse events as defined by the research protocol were reported in 30% patients; in 12% these effects were possibly related to cannabidiol use, the most common of which was status epilepticus (6%). For LGS treatment, a comparison study of two CBD dosage groups, 10 mg and 20 mg, reported adverse events in 84% and 94%, respectively, but a significant adverse event rate of 72% was also reported in the placebo arm. The investigators judged 89% of the events to be of mild or moderate severity. The most common adverse events were, again, somnolence, decreased appetite, diarrhea, upper respiratory tract infection, pyrexia, and vomiting.43
The marijuana plant, Cannabis sativa, and Cannabis indica contain up to 500 chemical species, with more than 100 different phytocannabinoid compounds.12 The two main components of cannabis—Δ-9-tetrahydrocannabiniol (THC) and CBD—have generated the most interest in terms of their putative effectiveness as anti-seizure agents: THC is a psychoactive agent, with equivocal value for seizure control and a potential to trigger seizure activity; CBD is a non-psychoactive agent with both anecdotal and scientific evidence suggesting its usefulness as an antiepileptic medication.13,14
While the use of artisanal cannabis preparations can be criticized as being inaccurate and not as precise as expected for other drug treatments in the medical community, a more well-controlled process leading to FDA and European Medicines Agency (EMA) approval was performed for a pure CBD extract produced by GW Pharma called “Epidiolex.”
Cannabidiol has been tested in several animal epileptic models, including maximal electroshock, pentylenetetrazol, pilocarpine, penicillin, audiogenic seizures, 6-Hz, subcutaneous metrazol threshold test, and cobalt implantation,22–26 and was found to have an anticonvulsant effect in all models. Its anticonvulsant profile was re-evaluated using the focused screening protocol developed by the National Institute of Neurological Disorders and Stroke (NINDS)-funded Epilepsy Therapy Screening Program. Intraperitoneal introduction of CBD produced a dose-dependent protection against maximal electroshock-induced seizures in mice and rats and was found to be effective in the 6 Hz, 44 mA seizure model and the corneal kindling model in mice.27