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Hypocritical Epidiolex Scheduling Spells Beginning of End of Cannabis Prohibition

Hypocritical Scheduling of First Ever Cannabis Derived Drug Foreshadows Legalization

 

Recently, the FDA approved the first ever “cannabis-derived” drug, Epidiolex, for use in patients with two rare forms of childhood epilepsy: Lennox-Gastaut Syndrome and Dravet’s Syndrome.1 However, in a move defying all rationale, the DEA decided that Cannabis Sativa should remain a Schedule I substance and federally illegal. How is that possible, you may ask? By the most unprecedented exercise of “cherry-picking” evidence, using junk science and (literally) taking things out of context that modern medicine has ever seen.

 

Cannabis Remains Schedule 1 (Like Heroin), But Epidiolex is Schedule 5

The cannabis plant remains a Schedule I drug, deemed to have no medical value and a high abuse potential (rubbing shoulders with other drugs in this category like heroin). Meanwhile a non-psychoactive component of that very same plant, Cannabidiol (CBD) is now isolated and sold as Epidiolex, a Schedule V prescription drug (the least restricted; proven medical value) used to treat two rare forms of childhood epilepsy.1

 

The Paradox to End Cannabis Prohibition: Toppling the House of Cards

Cannabis prohibition is and has always been a house of cards built upon a foundation of greed, manipulation, hidden agendas and flat-out lies. The approval and scheduling of the new drug, Epidiolex, has given this allegation more credence. While the author is painfully aware there are many interests that continue to have influence in the scheduling of cannabis, but from a purely medical and scientifically rational perspective, the hypocrisy is glaring.

However, as the saying goes, “you can’t have your cake and eat it too.” To state that a chemical of proven medicinal value and virtually no potential for abuse comes from a plant that has no medical value and a high potential for abuse is absurd. The good news is this circus and mockery of all things scientific and true can’t possibly go on for much longer. How was it possible to establish such a conclusion to begin with, though?

 

Semantics, Not Science: How a Schedule V Drug Comes from a Schedule I Plant

Cannabis Sativa is a medicinal plant of unique curiosity and unparalleled diversity; the sticky trichromes on every bud holds hundreds of active chemicals. Unlike the poppy plant, for instance, which provides only one active molecule known to be of value (opium; used to synthesize opioid drugs like morphine, heroin and fentanyl), cannabis contains over sixty known phytocannabinoids (e.g. THC, CBD, CBN, CBC, etc.) and several hundred cannabis-derived terpenoids (e.g. linalool, alpha-pinene, beta-myrcene, etc.).1 Various concentrations and permutations of these compounds interacting in harmony produce what is commonly known as the “entourage effect,” which is believed to underscore the clinical versatility and therapeutic efficacy of medical cannabis. 2,3,4

 

If Medicine Can Come From Cannabis, Why Isn’t Cannabis Medicine?

By understanding the diverse complexity of the cannabis plant, we can truly appreciate its therapeutic potential as a medicine. Ironically, because the cannabis plant has so many active chemical compounds, the “powers that be” justified isolating a non-psychoactive component of that plant (CBD) and leaving the rest, attributing medicinal value to the part but not the whole. If an approved drug can be isolated from cannabis (purely isolated—nothing synthetic about it), what is so bad about the plant? If you think it’s the THC, think again. It’s not quite so simple.

 

THC isn’t the Opposition’s “Target”

It can be argued that CBD is legal because it doesn’t “get you high” or have psychoactive properties. However, this implies that THC specifically (the primary psychoactive component responsible for the “high” in cannabis) is being demonized. However, an approved version of synthetic THC called “Marinol” already exists and is often used by cancer patients undergoing chemo (note that the synthetically produced THC in Marinol is not the same as organically derived CBD in Epidiolex). 5 Perhaps there’s some mortal danger in cannabis-derived THC that’s not present in Marinol? More likely, we just have finished prying our right of access from the cold, dying hands of past policies and precedents.

The Cannabis Plant is Not a Mere “Delivery System” for THC

Popularly known cannabis researcher and clinician, Dr. Ethan Russo, discusses how evidence has been pieced together to support the fact whole plant medicine is sometimes better than its naturally isolated products.3 While earlier work supported the idea that all the effects of cannabis were primarily due to THC, it is now accepted that the diversity of compounds in cannabis play a synergistic role with each other, as well as with the cannabis-like compounds produced by our own bodies.2

 

Cannabis Flower Bud

Single Molecule Medicine is Inferior to Whole Plant Medicine

Russo, in one of his recently published works, discusses studies that have shown cannabis extract to be two to four times more powerful than THC isolate alone.3,6 Clearly, there’s a lot more going on than can be attributed to just THC. The same could be said about the efficacy of whole plant, CBD-rich cannabis compared to Epidiolex, and this most certainly is a personal concern, and one I would think is shared by many others.

 

The Single-Molecule Nature of Epidiolex May Be its Undoing

The inferiority of single molecule, isolated cannabinoids to their whole-plant counterparts is concerning due to Epidiolex being only isolated CBD. While the first post-marketing clinical trial reports aren’t due until April of 2020 (4/2020; coincidence?), it is definitely possible that Epidiolex will not be as successful as it could have been as a full-spectrum extract. What happens then?

 

When Both Sides Say, “I Told You So”, No One Listens

The fear is both sides will say, “I told you so,” without listening to the other. The pro-cannabis team will obviously state that by stripping the plant of everything and taking one molecule out of context, you are denying the patient the full impact of cannabis’s healing potential. Meanwhile, the opposition (now desperately grabbing at imaginary straws) will indignantly state that this is proof the therapeutic efficacy of cannabis was just a “hype” that never lived up to its potential. Only time will tell how this may play out in the future.

 

More Than Likely the Target is Whole Plant Medicine

Something the author would like to note is the relatively well-established understanding in the cannabis community and many scientific circles that whole plant medicine is better than single molecule extractions.7 A large, randomized, double blind, placebo controlled trial testing synthetically produced and isolated THC (sold as Marinol) to Sativex (a 1:1 whole-plant cannabis formulation by GW Pharma available only in the UK) would help further elucidate this mystery. Nonetheless, though it has been reported that Sativex is the better drug, Americans continue to be denied access to Sativex, while both synthetic THC and pure, naturally derived CBD are available as prescription drugs in the United States.

 

Scheduling System for Controlled Substances Should Be Based in Science

The scheduling system for controlled substances is far from rational or effective. In the midst of the opioid crisis, more and more are finding that medical cannabis is their only way out.8 While the poppy plant is illegal due to it containing opium, the illegal nature of cannabis has never been more in question than it is now.

Dismantling Cannabinoids from the Cannabis Plant

Dismantling and pigeon-holing the extracted and isolated constituents of Cannabis Sativa does indeed seem to detract from the full therapeutic efficacy offered by cannabis for a host of conditions. Nonetheless, in doing exactly that with the production and approval of Epidiolex, the federal government has set in motion a chain of events that most certainly spells out the end of cannabis prohibition as we know it today. As the smoke clears and the truth unravels, one thing is certain: the level of hypocrisy that is cannabis regulation in the US has reached levels that are no longer sustainable. The time for change was yesterday, but the time for action is now.

by Gaurav Dubey (M.S. Biotechnology),
Clinical Researcher Pediatric Cardiothoracic Surgery, Rush Medical Center,
Active Cannabis Blogger (The Medical Cannabis CommunityGreen Flower MediaBloomMCC)
Co-Founder & President Karmik, LLC

 

 

WORKS CITED

  1. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 tr… – PubMed – NCBI. Available at: https://www.ncbi.nlm.nih.gov/pubmed/29395273. (Accessed: 4th January 2019)
  2. Russo, E. B. & Marcu, J. Cannabis Pharmacology: The Usual Suspects and a Few Promising Leads. Adv. Pharmacol. San Diego Calif 80, 67–134 (2017).
  3. Russo, E. B. Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. Br. J. Pharmacol. 163, 1344–1364 (2011).
  4. Atakan, Z. Cannabis, a complex plant: different compounds and different effects on individuals. Ther. Adv. Psychopharmacol. 2, 241–254 (2012).
  5. MARIJUANA AND CANCER – Marijuana as Medicine? – NCBI Bookshelf. Available at: https://www.ncbi.nlm.nih.gov/books/NBK224387/. (Accessed: 5th January 2019)
  6. Carlini, E. A., Karniol, I. G., Renault, P. F. & Schuster, C. R. Effects of marihuana in laboratory animals and in man. Br. J. Pharmacol. 50, 299–309 (1974).
  7. Russo, E. B. Cannabinoids in the management of difficult to treat pain. Ther. Clin. Risk Manag. 4, 245–259 (2008).
  8. Bradford, A. C., Bradford, W. D., Abraham, A. & Bagwell Adams, G. Association Between US State Medical Cannabis Laws and Opioid Prescribing in the Medicare Part D Population. JAMA Intern. Med. (2018). doi:10.1001/jamainternmed.2018.0266