Cannabis oil can only be sold legally in Britain if it contains less than 0.05% THC. But the nation’s medicines regulator, the MHRA, announced recently that even pure CBD could not be sold as a medicine without first going through the usual clinical testing and safety checks required for all new medicines. This month, the US Food and Drug Administration will consider the approval of Epidiolex, a CBD-based medicine from GW Pharmaceuticals, which has completed such clinical trials. The European Medicines Agency (EMA) will rule on the drug early next year. If the EMA approves Epidiolex, it could be available to prescribe to named patients in Britain next year, Brexit notwithstanding.
Four drugs based on cannabis compounds are already on the market in Europe. Among them are Nabilone, a synthetic compound that mimics THC, is prescribed for nausea and vomiting caused by chemotherapy, and Sativex, an oil that contains equal parts THC and CBD, is used to treat muscle spasms in multiple sclerosis. Both contain too much THC to administer to children. “The only medicines that are approved in the UK would get children stoned,” said David Nutt, professor of neuropsychopharmacology at Imperial College, London.
CBD is an anticonvulsant, and some other compounds in the plant, including THC and cannabidivarin, may be too. There is good evidence from clinical trials in the US and Europe that pharmaceutical preparations of CBD can treat two severe forms of childhood epilepsy known as Dravet syndrome and Lennox-Gastaut syndrome. Both forms of epilepsy often fail to improve with existing epilepsy drugs. CBD is generally considered safe, but some trials have reported side effects including dry mouth, lightheadedness and altered liver enzyme activity.
Is cannabis oil illegal?
Cannabis oils are extracts from cannabis plants. Unprocessed, they contain the same 100 or so active ingredients as the plants, but the balance of compounds depends on the specific plants the oil comes from. The two main active substances in cannabis plants are cannabidiol, or CBD, and delta-9 tetrahydrocannabinol, or THC. Oil extracted from hemp plants can contain a lot of CBD, while oil from skunk plants will contain far more THC. THC produces the high that recreational cannabis users seek, while oils for medical use contain mostly CBD.
Other forms of cannabis are solid and are usually sold either as resin or dried plant material. In commercially-produced medical cannabis oils, the concentrations of CBD and THC tend to be well-controlled, which makes it easy to calculate doses.
Europe is a patchwork of cannabis legislation. In the Netherlands, doctors can prescribe cannabis and cannabis preparations for symptoms caused by multiple sclerosis, HIV/AIDS, cancer, long-term pain and the tics associated with Tourette’s syndrome. Other European nations are following suit. In the US, at least 29 states allow medical uses of cannabis, and earlier this year, California became the eighth state to permit recreational use of the drug, too.
Generally, the more THC the product contains, the greater these risks are.
Epidyolex can be prescribed for patients with Lennox-Gastaut syndrome and Dravet syndrome (both rare forms of epilepsy).
Cannabis bought illegally off the street, where the quality, ingredients and strength are not known, is the most dangerous form to use.
Is medical cannabis safe?
After taking medical cannabis, it’s possible to develop any of the following side effects:
A prescription for medical cannabis would only be given when it was believed to be in your best interests, and when other treatments had not worked or were not suitable.
And some cannabis-based products are available on prescription as medicinal cannabis. These are only likely to benefit a very small number of patients.
The risks of using cannabis products containing THC (the chemical that gets you high) are not currently clear. That’s why clinical trials are needed before they can be used.
To get medical marijuana, you need a written recommendation from a licensed doctor in states where that is legal. (Not every doctor is willing to recommend medical marijuana for their patients.) You must have a condition that qualifies for medical marijuana use. Each state has its own list of qualifying conditions. Your state may also require you to get a medical marijuana ID card. Once you have that card, you can buy medical marijuana at a store called a dispensary.
National Conference of State Legislatures: “State Medical Marijuana Laws.”
He shared some background on medical marijuana’s uses and potential side effects.
Which states allow medical marijuana?
The cannabidiol Epidiolex was approved in 2018 for treating seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. In addition, the FDA has approved two man-made cannabinoid medicines — dronabinol (Marinol, Syndros) and nabilone (Cesamet) — to treat nausea and vomiting from chemotherapy. The cannabidiol Epidiolex was approved in 2018 for treating seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
The agency did, however, agree to support additional research on marijuana and make the process easier for researchers. “Research is critically needed, because we have to be able to advise patients and doctors on the safe and effective use of cannabis,” Bonn-Miller says.
Department of Health and Human Services.
Marcel Bonn-Miller, PhD, adjunct assistant professor, University of Pennsylvania Perelman School of Medicine.