The U.S. Food and Drug Administration this week approved GW Pharma’s Epidiolex to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, a marijuana-derived therapy.
The approval is significant because it is the first prescription pharmaceutical formulation of plant-derived cannabidiol and the first in a new category of anti-epileptic drugs.
But what is also significant is that patients will need to wait before the drug is available because before patients can buy Epidolex, the U.S. Drug Enforcement Agency will need to change its status from a Schedule I substance, even though formulated to prevent a patient from experience the high associated with marijuana.
In other words, I can visit my local dispensary, which like a wine shop features a range of varietals with full descriptions of the profile of each, or buy edibles ranging from gummy bear-like treats to chocolate bars and cookies ideal for a picnic with The Grateful Dead. Kids with uncontrolled seizures, however, must wait for the drug to be rescheduled by the DEA. Marijuana is considered a Schedule 1 drug like heroin and LSD because it is considered to have no medical use and high potential for abuse. The DEA is expected to act within 90 days.
This also points to a bigger problem with the medicinal application of marijuana. Proponents make a wide range of claims for the beneficial use of marijuana, but we’re without the gold standard of placebo-controlled clinical trials to substantiate such claims, as well as determining appropriate dosing and safety. All Bud, an online site focused on the world of cannabis, compiled a list of health claims for the wonder weed. It noted that some states that have passed medical marijuana laws list as many as 40 conditions that can be treated with the substance.
Among the ailments proponents claim include pain, insomnia, appetite stimulation, nightmares, Parkinson’s-related spasms and tremors, auto-immune conditions, bowel disease, traumatic brain injury, glaucoma, side effects from cancer therapies (nausea, sleep disorders, loss of appetite, pain), depression, multiple sclerosis-related spasms, Alzheimer’s (THC is said to slow development of amyloid plaque).
Many rare disease patients, without available therapies for their conditions, have sought to see if marijuana can relieve some of their symptoms. Others too have sought relief when conventional drugs have don’t do the job or present other concerns.
A relative of mine suffers from severe osteoarthritis. Her doctor prescribed opiates for her pain. She minimizes her use and tries to avoid the opiates from fear of developing an addiction and doesn’t like its side effects. As a result, she often lives with pain instead of getting the relief she seeks. I have suggested she try marijuana to see if it would provide her relief, but she can’t bring herself to using it because of long-standing beliefs about who uses it and what it does to them, recalling of her days working in the Catskill mountains in the 1950s and memories of musicians there who indulged (think Refer Madness).
I did convince her to try CBD oil, an extract that does not provide the high of marijuana, but there was little guidance on appropriate therapeutic dosing. After two days without benefit, she gave up on the idea.
Unfortunately, our federal policy towards marijuana has stymied research into its risks and benefits and the possible therapeutic uses.
A 2017 report from the National Academy of Sciences looked at the current state of evidence and recommendations for research into cannabis and cannabinoids. It laid out recommendations to address research gaps, improve the quality of research, improve surveillance, and address research barriers, including the constrained access to research grade marijuana. There is much work to be done.
The Epidiolex approval is encouraging because it does provide patients with a much-needed therapy that has been subjected to the type of rigorous review drugs should go through to demonstrate both safety and efficacy. Hopefully this will help clear the way to a more sober appraisal of the benefits, risks, and uses of marijuana and products derived from it free of the hysteria and hype that has characterized much of its history to date.