Dear Herb: Can you explain the difference between a 'proper' medical cannabis prescription product like Sativex and the products available under Canada's Access to Cannabis for Medical Purposes Regulations?
I know Sativex and Epidiolex are naturally-derived, so why are they treated so differently from processed cannabis products such as licensed producers' softgels? — Puzzled by Pharmaceuticals
Dear Puzzled: Excellent question.
There are a few reasons why those plant-derived formulas are approved by some government regulatory agencies as prescribable medications, while pharmaceutical-grade cannabis oil softgels produced by legal Canadian companies aren't.
First and foremost, Sativex and Epidiolex have both undergone large-scale, long-term, randomized, double-blind phased clinical trials in the same way as other modern pharmaceuticals, whereas cannabis — even in a processed, pill-like form — has not.
Those lengthy trials involve testing a new drug on increasing numbers of people — first on healthy volunteers to test safety, and then on larger groups of patients who don't know whether they're getting the real thing or a placebo.Advertisement
As you might imagine, clinical trials are hugely expensive. Usually the only people willing to foot the bill are pharmaceutical companies who know they can patent any resulting drug and recoup their investment.
Another reason is that both Sativex and Epidiolex were tested to treat very specific medical conditions: Sativex is meant to relieve neuropathic pain related to multiple sclerosis, and Epidiolex is meant for children who suffer from particular forms of epilepsy. Drugs like Sativex and Epidiolex are also tested in defined doses, with specific routes of administration.
Because dried cannabis and processed cannabis products like softgels have never undergone those phased clinical trials for specific indications, they have never been officially approved by Health Canada as therapeutic products. (That's not to say cannabis hasn't been studied from a medical perspective, but rather that the studies that have been done so far aren't sufficiently robust from the perspective of the medical powers that be.)
For that reason, even though Health Canada acknowledges "some potential therapeutic benefits" to cannabis, it warns that "the scientific evidence does not establish the safety and efficacy of cannabis, to the extent required by the Food and Drug Regulations for marketed drugs in Canada." (The Canadian federal government provides legal access to medical cannabis because courts ruled it had to, not because Health Canada looked at clinical trials and decided to approve it for Canadians.)
Since plant-form cannabis has never been approved by Health Canada, it doesn't have an official Drug Identification Number like Sativex. That means most health insurance plans won't cover it, although this is starting to change in certain employer-sponsored plans.
An increasing amount of high-quality research is being conducted on medical cannabis these days. I think it's likely that Health Canada will eventually classify dried cannabis and processed cannabis products as prescription drugs worthy of a DIN, and it will become an "official" prescription drug. That could usher in a whole new era for medical cannabis in Canada.
There are definitely some underlying social, political and economic reasons why dried cannabis isn't an official prescription while Sativex is, and why mainstream medical professionals might be skeptical of the therapeutic value of plant-form cannabis while accepting the potential of a cannabis-derived prescription drug.
If you're interested in learning more, take the time to read this Leaf News feature about why the medical establishment is still skeptical about cannabis at a time when more and more Canadians are using it as medicine.
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