CBD Medicine Taken Off Schedule I!! But Only For Big Pharma
Can you imagine a world where real medicine is outlawed except when it’s packaged and sold as an extract from Big Pharma? The DEA and FDA certainly can.
It’s been about three months since the anti-seizure, cannabis-derived pharma product, Epidiolex, was approved for market. And today the DEA, with the approval of the FDA, has declared that pharma CBD is OFF Schedule I. The DEA document states that “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% THC in Schedule V.
We speculated about this back in July when the FDA approved the release of Epiodiolex. Because, surely, no sane government (oxymoron alert) agency could allow the approval of cannabis-derived medicine but disallow cannabis itself. Certainly the DEA must be frantically preparing a total reversal on its May, 2018 CBD scheduling fubar. Surely.
No, actually. The DEA appears to have actually paved the way for Big Pharma by placing CBD on the Schedule I list in the first place, right prior to the FDA approving the pharma CBD product 3 months later. Have you thrown your computer out the window yet?
So, guess how many cannabis medicines this new de-scheduling bonanza covers? One. Just Epidiolex. And I must add a caveat on the use of the word “medicine” as there are so many dangerous side effects coupled with questionable efficacy, that it may not earn that qualification.
Epiodiolex is GW Pharmaceutical’s attempt at an anti-seizure medication that matches the efficacy of full-spectrum cannabis, such as Charlotte’s Web. It doesn’t, as we covered: here. It has been actually shown, in some patients, to increase seizure frequency and status epilepticus. What? Will the real cannabis please stand up because we know ain’t nobody got time for that.
Take a read for yourself:
WARNINGS AND PRECAUTIONS
- Hepatocellular Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations
- Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. (5.2)
- Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. (5.3)
- Hypersenstivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. (5.4)
- Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. (5.5)
The opening to get CBD medicine approved is now so narrow, few will be able to fund the marathon to FDA approval. And THIS may actually cause burden to patients by reducing competition in the market and allowing gut-gouging prices to be the norm. It is estimated that Epidiolex will cost the average patient $32,500 USD per year to stay ‘maybe seizure-free, probably not, but watch out for that pesky suicidal ideation thang’.
Incidentally, the cost is TENS OF THOUSANDS above even the tippy top shelf high-CBD medicine. Think about that.
Epidiolex is expected to hit market in about 6 weeks.