Everything about the U.S. Food and Drug Administration’s (FDA) approval of GW Pharmaceuticals’ Epidiolex is just wrong.
Let’s be clear here: To the FDA, Big Pharma is like a favorite child, receiving preferential treatment even though the other children are smarter, kinder and have more character.
On June 25, the FDA gave GW Pharmaceuticals a thumbs-up, a pat on the back and a “make us proud” when it sanctioned Epidiolex, what the Big Pharma tabloids (press releases) call “the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD)” for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age or older.
In other words, Epidiolex is the first cannabis-based drug to be “officially” legalized in the United States by a government agency.
The problem is that GW Pharmaceuticals, which is partnered with Bayer/Monsanto, still can’t sell Epidiolex. The reason why says a lot about what’s going on. Just 19 months ago, the Drug Enforcement Administration (DEA) classified CBD (which, unlike marijuana has no psychoactive properties) as a Schedule 1 drug, right up there with heroin as a drug “with no medical use.”
This came as both a shock and outrage to the hundreds of companies that had been successfully selling the whole plant non-pharmaceutical version of hemp oil. This also came as a shock and outrage to the growing number of people who buy the whole plant non-pharmaceutical version of CBD for relief from a wide range of illnesses (backed by studies) including epilepsy, depression, anxiety, ALS, diabetes, Parkinson’s/MS, arthritis, heart disease and yes, even cancer.
And if that wasn’t enough, the whole plant non-pharmaceutical version of CBD has also helped people lose weight. The scientific journal Molecular and Cellular Biochemistry reported CBD oil can increase the number and activity of mitochondria, which increases the body’s ability to burn calories. CBD oil can also decrease the expression of proteins involved in lipogenesis (fat cell generation) as well as stimulate genes and proteins that enhance the breakdown and oxidation of fat.
“The concept of putting cannabidiol CBD as a schedule 1 drug, saying that it has no medical use and is highly dangerous, just flies in the face of fact and science and knowledge,” says Dr. Margaret Gedde, a Stanford-trained pathologist, and award-winning researcher.
But the DEA did not stop with the insane classification of CBD. It appears as though many sellers of CBD oil were targeted (including HoneyColony) following the DEA’s classification fiasco. The two favorite modes of attack: closing down merchant bank accounts and intimidating processors like PayPal to make CBD to customer transactions impossible.
Ah, Never Mind?
So what do you do if you’re a government agency that has just given one of the world’s largest drug companies the go ahead to sell a drug with a main ingredient that has recently been classified by another government agency as equivalent to heroin with “no medical use?”
You hatch a plan to resolve this gigantic snafu by simply reversing the original classification.
And that’s exactly what the DEA is expected to do so GW Pharmaceuticals can sell Epidiolex.
Even Wall Street investment publications like Seeking Alpha have documented the hypocrisy and sheer lunacy of the proposed CBD reclassification flip-flop.
“The approval of “Epidiolex” shows that the scheduling of (CBD) as having no medicinal benefit is inherently contradictory,” writes Seeking Alpha contributing writer Nick Cox. “This is further backed up by the millions of people who currently get medical benefits from cannabis oil and other derivatives.”
To accommodate the sale of Epidiolex, the DEA will most likely remove CBD from the heroin basket sometime before October.
Epidiolex And Bad Thoughts
Epidiolex lists an impressive array of side-effects including sleepiness, lethargy, decreased appetite, elevated liver enzymes, diarrhea, infections, and rashes.
“These side-effects create uncontrollable chronic illnesses within the body and mind, harming the gut-brain axis,” says certified integrative nutrition coach Connie Rogers. “The irony is that this seizure medication increases the risk for Alzheimer’s, depression, malnutrition, IBS, GERD, scleroderma, hepatitis C, kidney disease, colon cancer, and mitochondrial damage.”
Research, according to Rogers, shows that the signals triggered by whole plant CBD oil send instructions to our 10 systems helping them operate efficiently and bringing our body back into homeostasis.
“This is not the case when using Epidiolex,” says Rogers. “The efficacy of any pharmaceutical drug needs to outweigh any negative side-effects. One would have to be on numerous other pharmaceuticals to combat the side-effects of Epidiolex. What happened to first do no harm?”
According to the FDA’s own press release, the “most serious risks” are thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks.
And this is medicine for children?
Wasting Away Again In Epidiolexville
To read GW Pharmaceutical’s website, one might think GW Pharma invented CBD, or at the very least came up with the idea of using CBD to treat children with pernicious epilepsy. This from their About Us page:
GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
In reality, GW Pharmaceuticals has a “manufactured” grade CBD to offer, void of all the beneficial whole plant synergy found in non FDA approved CBD oil.
“Epidiolex is a CBD isolate,” says Elizabeth Moriarty, Clinical Herbalist and owner of Luminary Medicine Company. She is also the formulator behind two of our best-sellers Superior hemp oil and Curious lubricant.
Isolate as the name implies, isolates cannabidiol (CBD the cannabinoid). This is done through a refining process that strips out any additional cannabinoids, terpenes (unsaturated hydrocarbons that exist in the essential oils of plants), and plant components found in the hemp plant. The final product is a fine white powder that contains 99 percent cannabidiol. This is CBD in its purest form.
Whole plant hemp extract CBD, on the other hand, keeps the full properties of the hemp plant intact. In addition to CBD the cannabinoid, this extract includes terpenes, vitamins, minerals, fatty acids, phytonutrients and any other materials that are extracted from the hemp plant, including 99 other cannabinoids that provide their own unique benefits.
In whole plant (non-conventional) medicine, the entourage effect refers to hundreds of natural components within a plant interacting together and with the human body to produce a stronger impact than with any one of those components used alone.
“Big Pharma does not understand botanical medicine,” said Ethan Russo in a recent Undark article. Russo is a neurologist and former medical adviser at GW Pharmaceuticals who now serves as director of research and development at the International Cannabis and Cannabinoids Institute. Undark focuses on the intersection of science and society. “I can tell you having worked with GW, they were sure aware of (the entourage effect).”
But apparently they chose to ignore it.
The entourage effect is the reason whole plant CBD medicine has been so effective at helping children with epilepsy – long before GW Pharmaceuticals staked its claims.
Take pediatric physician Dr. David Sine who practices in Central California. For the past 22 years, he has treated children with special needs fragile health care, as well as hospice patients. Six and a half years ago, he began using different CBD blends. More than 100 children later, he has yet to have a patient who did not benefit from CBD oil.
For Sine it began with a toddler who had severe infantile seizures — sometimes dozens per day. After conventional pharmaceuticals failed to help, the parents of the child turned to CBD, unbeknown to Sine.
“The next time I saw them, the toddler was doing significantly better,” Sine said. “The seizures had stopped and the brain was reconnecting. All this after only six weeks of the CBD.”
Sine said the parents compared the remarkable turnaround to early model televisions that used rabbit ear antennas to receive signals. By moving the antenna around, the picture got better.
“The toddler had a clear picture again,” Sine said. “He was talking and walking without assistance and eventually became normal.”
Sine said in medical school all he learned about marijuana is that it was bad and that hemp was for making clothes.
“But I believe in evidence-based medicine,” Sine said. “And this works.”
Epidiolex may be considered a CBD isolate but it has the consistency of a strawberry-flavored cough syrup due to inactive ingredients added to Epidiolex that GW Pharma has kept secret. However, if you read the FDA cheat sheet, the total formula is revealed: CBD plus dehydrated alcohol, sesame oil, strawberry flavor, and sucrose.
“These are just inactives used for creating a palatable delivery, common in supplement and Pharma,” says Moriarty. “It’s very similar to what you will find in any cheap isolated CBD product.”
Money For Nothin’And Side-Effects For Free
Big Pharma is the beneficiary of a system that turns a blind eye to excessive profit-making at the expense of society. The examples are many:
- Remember Martin Shkreli? He’s the American businessman and former hedge fund manager who obtained the manufacturing license for the AIDS drug Daraprim and raised its price by a factor of 56, from $13.50 to $750 a pill.
- When Rodelis Therapeutics purchased the rights to the tuberculosis drug cycloserine, it promptly bumped its price up from $500 to $10,800 for 30 capsules.
Ingredients aside, GW Pharmaceuticals has been even less forthcoming in discussing its pricing of Epidiolex. However, according to the NY Times, Epidiolex could initially cost U.S. patients up to $60,000 a year. Initially.
The typical family using whole plant non-FDA approved CBD to treat childhood epilepsy spends about $1,800 per year on the substance.
So why would anyone buy a less effective CBD product and pay three times more?
“I think this is the big question,” says Dr. Jordan Tishler, a Harvard-trained holistic care expert and president of inhaleMD. “I don’t see people buying Epidiolex over illegal CBD products.”
“Unfortunately, people can be duped into believing in pharmaceuticals. Billions are spent on advertising and deaths are ignored. Designer drugs are never designed to reduce inflammation, they’re designed for the bottom line, to create sales. Big Pharma’s method of operation is to synthesize, patent, and control.”
It’s generally believed that medical insurance will pay for Epidiolex, adding to the long list of overpriced pharmaceuticals, costs that are inevitably passed onto consumers in the form of higher copays and premiums.
The New Drug Cartel?
Perhaps the most disturbing aspect of the politics of CBD is the ongoing cozy relationship between Big Pharma and government agencies.
The Daily Beast refers to Big Pharma as “America’s New Mafia.”
And, just like America’s old Mafia or even successful drug cartels, Big Pharma has friends in high places who make things happen.
As reported in Wikileaf, small cannabis businesses operate in constant fear of being shut down by the feds while Big Pharma innovates fake weed that is potentially killing people. Add that to the fact that Big Pharma — through its lobbyists and campaign donations — basically funds congress and the FDA.
In a press release, the FDA said that even after the DEA flip-flops on its CBD classification, it will continue to “take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”
In the FDA’s world, only products that have received formal FDA approval can make such claims, typically requiring clinical trials, costing millions that only mega pharmaceuticals like GW Pharma can afford.
At the end of the day, the FDA and DEA have brought on much of the antipathy toward them through their ignorance of the CBD industry.
Attorney Rod Kight, who represents legal cannabis businesses, points to the FDA press release of June 25 announcing the approval of Epidiolex. The FDA said:
Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant.
“This is, of course, totally wrong,” says Kight, “and flies in the face of several DEA press releases and the recent ruling in the Ninth Circuit Court of Appeals that the CSA does not regulate industrial hemp.
“CBD derived from industrial hemp is not a controlled substance. It is lawful. CBD itself is not a scheduled compound. The FDA statement recognizes that CBD can only be considered scheduled if it is derived from an illegal plant.”
The problem here, says Kight, is that the FDA press release named the wrong plant.
“The term it used, cannabis, is a botanical term with no legal meaning. What the FDA clearly meant was marijuana.”
Well, yes, but is anyone really surprised?
Thomas Ropp Longtime journalist Thomas Ropp is an environmental advocate and proponent of living healthier. After spending most of his life in Arizona, he relocated to a Costa Rican rainforest ten years ago and helped with reforestation projects to expand the habitat of the endangered mono titi monkey. He has dual residency in the United States and Costa Rica.
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