An eerie bit of news has graced today’s 4/20 celebrations across America. (“Four twenty” is code for smoking marijuana, making the day 4/20 special in cannabis culture.)
On Thursday, the FDA, notorious for approving fatal opioids and other drugs – and attacking plants and homeopathics – bestowed its blessing on a new epilepsy drug that contains actual plant-based cannabidiol (CBD). That is to say an FDA advisory committee made the recommendation for approval of Epidiolex – the first marijuana-derived drug to get such a green light.
Epidiolex is “a breakthrough in the field of epilepsy,” said Justin Gover, CEO of GW Pharmaceuticals PLC, the UK-based biopharmaceutical company that made the drug. “It’s the first cannabis-based pharmaceutical to be approved by the FDA. It’s the first in a new class of treatments with a new mechanism of action against epilepsy.”
The [FDA] committee’s recommendation was delivered after reviewing data from the drug’s maker, GW Pharmaceuticals PLC, a UK-based biopharmaceutical company.
“We’re obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex,” GW CEO Justin Gover said. “It’s a very important milestone in the approval process.”
Epidiolex, GW’s lead cannabinoid product candidate, was developed for severe, early-onset epilepsy syndromes, including Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life; Lennox-Gastaut syndrome, a type of epilepsy with multiple types of seizures; and tuberous sclerosis complex and infantile spasms, both of which begin in infancy and cause a sudden stiffening of the body, arms and legs with the head bent forward.
One-third of Americans who have epilepsy have found no therapies that will control their seizures, according to the Epilepsy Foundation. This represents about 1 million families.
Though FDA approval would limit use of the drug to epilepsy patients, doctors would have the option to prescribe it “off-label” for other uses.
The FDA is expected to vote on approval of the drug by June. The anticipated commercial availability of this drug has cheers from epilepsy sufferers, some of whom have had their seizures stopped by the drug.
Although Epidiolex has nothing but glowing reports on its efficacy, there is the side effect of possible liver damage. More specifically, an “unknown [form] of chronic liver injury” or “smoldering inflammatory response” that could potentially cause issues for someone down the line. (This writer has not heard of any liver side effects from pure CBD extracts, such as those derived from hemp.)
Aside from side effects related to the drug, the question now becomes: How can the government reconcile its longstanding, negative position toward marijuana now that it has supported the benefits of it for use in a drug that’s anticipated to receive official FDA approval? Why is a substance only valid from a lab instead of a field?
How can the government continue to attack plants and block consumer access, but allow mass corporations to profit from them at the same time? Government agencies still cling to the claim that marijuana is dangerous and of no medicinal value, thus it remains highly illegal – yet here we are reporting the government’s blessing of the same exact substance but only when it is wrapped in the white sheath of a pharma drug…
Nowhere is this hypocrisy seen more than in the DEA’s sneaky move to reclassify CBD (hemp) as an illegal substance and approve of synthetic THC made by a pharma opioid maker!
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