Last week saw yet another acknowledgment of the seizure reducing capacity of CBD in childhood epilepsy when results of a Stage 3 clinical trial testing GW Pharmaceutical’s CBD based drug Epidiolex were announced.
The study saw an average reduction in seizures of 40%, which could be enough for the cannabis based drug to be approved. Welcome news for parents of children with epilepsy. But why has it taken so long to confirm what scientists have known for the last 30 years?
Pioneer trial on CBD and epilepsy by Professor Mechoulam in 1980
That’s a question Professor Raphael Mechoulam had been asking himself for a while now. Back in 1980 he was the lead researcher on small double blind trial examining the effectiveness of CBD on patients with epilepsy, with half of the volunteers remaining seizure free for the duration of the study. The report concluded that more research on a greater number of patients was needed, and yet, until GW Pharmaceuticals came into the arena, no further clinical trials had taken place.
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First study into cannabinoids and epilepsy buried?
But if you think Mechoulam’s study was the first time cannabinoids had been tested on humans, you’d be wrong.
It’s well documented that cannabis has been used since the 11th century to quell seizures, although it wasn’t until the 19th Century that its use was recorded in the West through the work of William Brooke O’Shaughnessy.
But fast forward half a century to when cannabis was the target of a slur campaign by Federal Bureau of Narcotics chief Harry Anslinger, one human trial did in fact take place. Carried out in 1947 by JEAN P. DAVIS, M.D., and H.H. RAMSEY, M.D, the study entitled ‘Anti-Epileptic Action Of Marijuana-Active Substances’ sought to prove the anticonvulsant effects of a synthetic version of the cannabinoid, cannabinol (CBN).
The study, conducted on five children, was covered at the time by Salt Lake City Telegram. It reported, “the drugs have been found effective about 50% of the time. Future for epileptics appears “very bright,” she said, “because of not only one new drug, but a whole field of new compounds to combat epileptic seizures.”
However, the research team’s excitement was short lived, as they found themselves the unwanted focus of the Federal Bureau of Narcotics’ attention. Needless to say, until Mechoulam’s CBD trial in 1980, no follow up study took place, and the trial itself was effectively buried.
So what took so long?
Anslinger’s vendetta against the cannabis plant cannot be underestimated. According to the book ‘Reefer madness: the history of marijuana in America’ by Larry Sloman, Anslinger had his own method for making sure medical cannabis trials got no where. A retired field agents revealed, “Harry, had a special desk with a well-respected chemist to take care of such requests. Anyway, that chemist knew what Anslinger wanted and always found some scientific reason to deny incoming Federal permit requests for medical research — if it had anything to do with Cannabis.”
Not long after came the United Nations Single Convention on Narcotic Drugs in 1961 in which cannabis was classified as a schedule 1 substance ‘with no accepted medical use and a high potential for abuse.’
According to Greg Gerdeman, Assistant Professor of Biology specialising in the endocannabinoid system at Eckerd College in Florida, this schedule 1 status had massive implications on medical cannabis research:
“Let’s face it, as a public policy agenda, the demonization of cannabis was wildly successful. These notions were bolstered for decades by the NIH (National Institute of Health) funding structure which even today accepts the completely inappropriate categorization of cannabis and all its constituents as a Schedule I substance.
“So throughout the 80’s and 90’s, the only funding to study cannabis or cannabinoids was under the auspices of NIDA (National Institute on Drug Abuse). Research hypotheses therefore had to study the paradigms of drug abuse and addiction.”
Another factor explaining the lack of progress regarding in CBD clinical research was the cannabinoid’s perceived benign nature compared to its psychoactive cousin, THC.
Gerdeman: “Cannabidiol simply didn’t fit in with the NIDA funding priority, its value was contrary to (prejudiced) expectations; and the scientific literature on CBD was so small; I think the early studies grabbed very little attention.”
And so, CBD’s anti-seizure potential remained largely unexplored in a clinical setting until GW Pharmaceuticals came onto the scene.
GW Pharmaceuticals – the first ever medical cannabis pharmaceutical company
GW Pharma is a British pharmaceutical company specialised in the “development of plant-derived cannabinoid therapeutics.” Founded in 1998, it already has one cannabis based medicine, Sativex, on the market in many countries worldwide (but not the United States).
Epidiolex, an oral solution of pure, plant derived CBD (98%) has been developed to treat rare forms of childhood epilepsy such as Dravet Syndrome and Lennox-Gastaut Syndrome. It has been deemed successful in the randomized, double-blind, placebo-controlled human trial – considered the gold standard for any medicine.
What would Epidiolex FDA approval mean for the existing CBD oil market?
Based on these relatively positive findings, it seems FDA (Food and Drugs Administration) approval for Epidiolex in the United States is just around the corner, particularly when you consider the CBD based drug was fast tracked by the agency in 2014. And what happens in the United States quickly echoes around the world.
Surely this must mean CBD is getting the official recognition it deserves, which is a good thing right?
Well, that depends on which side of the fence you are on. GW Pharma has spent millions on developing Epidiolex, which if passed will be the first ever approved, pharmaceutical standardised CBD medication. And many suspect that in return for all this time and investment, the company will insist that the FDA starts cracking down on the hundreds of CBD companies selling their products as nutritional supplements.
And yet, some of these CBD oil products are the very ones that have caught the public imagination by dramatically reducing the seizures of children such as Charlotte Figi, Katelyn Lambert and Ava Twomey.
They all took products that were extracted from the whole plant, meaning that they contained mostly CBD, but also other minor cannabinoids and terpenes. Studies suggest that whole plant cannabis medicine is more effective than single cannabinoids, but because of their complexity are next to impossible to patent or turn into FDA approved standardised medicine.
Mother of Dravet syndrome child defends right to choose whole plant CBD
Vera Twomey, mother of Dravet sufferer Ava Barry, has no doubts that whole plant CBD oil is best for her daughter. Ava’s seizures have reduced by 90% since taking CBD oil.
In an interview with Endoca she says, “I can say that from personal experience, the findings of the Epidiolex are nowhere near as significant as the results of CBD oils have provided for patients.”
Concerned that whole plant CBD oils may no longer be available she states:
“A life without Ava’s whole plant CBD oil is a terrifying reality. The people who have children whose lives have been completely altered for the better – they will have to stand up and say ‘no’. Because if it’s allowed to happen, it will mean the devastation of the precious progress that families like ours have made with our children and family members.”
What do you think about the future of CBD? Would you be happy for it to be in the hands of the pharmaceutical companies? Please leave your thoughts in the comment section below.