On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, the first drug that contains a purified drug substance derived from cannabis.
This oral solution, produced by GW Research Ltd, has been clinically tested and FDA approved to treat seizures in individuals 2 years and older who have severe and rare forms of epilepsy.
According to the FDA: “Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.”
Artisan, regulated marijuana, however, hasn’t undergone extensive clinical trials to prove its claims. Instead, companies claim that it carries a host of benefits without having to prove those claims. What is proven, however, are the host of medical and public safety risks of marijuana—more impaired drivers on roads, spikes in children sent to hospitals for accidentally ingesting marijuana, and more frequent and more severe episodes of psychosis.
The differences are listed below:
• FDA approved
• Proven to be safe
• Proven to reduce seizures
• A purified extract of marijuana that is 99% CBD, less than 1% THC, marijuana’s psychoactive ingredient
• Controlled Clinical Trials
• Doctors prescribe.
• Standard doses, uniform strength
• Patients buy at pharmacies.
• Likely to be insured.
• Likely moved to a lower Schedule
• Dispensed with a patient Medication Guide listing uses and risks
Artisan Regulated Marijuana
• Not FDA approved
• Not proven to be safe
• Not proven to reduce seizures
• Unpurified extracts containing up to 20% CBD, THC, other components. Some are contaminated.
• No Clinical Trials
• Doctors recommend.
• Standard doses difficult to achieve
• Patients buy at dispensaries.
• Not insured.
• Likely to remain in Schedule 1
• No lists of studied risks provided