The FDA could give its blessings to the first cannabis-based drug as soon as June 27
It’s finally happening – after years of angling to take control of the CBD oil market, Big Pharma is about to pounce with its brand-new cannabis-based drug Epidiolex.
June 27 is the day that will live in infamy among the thousands of independent CBD retailers in the United States. That’s the expected date for the Federal Drug Administration (FDA) to officially approve the sale of Epidiolex, the first drug on the U.S. market derived from the cannabis plant. The beneficiary? Big Pharma, naturally.
The medication, which is manufactured by Britain’s mega-giant GW Pharmaceuticals, is used in the treatment of seizures associated with childhood epilepsy. According to the NY Times, Epidiolex is initially expected to cost U.S. patients between $2,500 to $5,000 a month. Initially.
The thing is, real CBD oil, as a dietary supplement, has been used successfully for the treatment of seizures associated with childhood epilepsy for many years – at a fraction of the projected Big Pharma price tag.
Pediatric physician Dr. David Sine 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 hemp was for making clothes.
“But I believe in evidence-based medicine,” Sine said. “And this works.”
This Is Why CBD Works
CBD (cannabidiol) is a plant compound found in hemp. Through various extraction methods (some more toxic than others), CBD is sourced to create an oil that offers tremendous health benefits. Once consumed, CBD acts on the body’s endocannabinoid system (ECS) to promote homeostasis and is a vital “cellular-signaling system” that is involved in modulating pain, appetite, mood, memory, and cellular life and death cycles. However, unlike the compound tetrahydrocannabinol (THC) found in marijuana, CBD has no psychoactive properties whatsoever.
Looking deeper, cannabinoid receptors, located throughout the body, are part of the ECS. There are currently two known subtypes of cannabinoid receptors, termed CB1 and CB2. The CB1 receptor is expressed mainly in the brain, but also in the lungs, liver, and kidneys. The CB2 receptor is expressed primarily in the immune system and in hematopoietic cells. Receptor pathways can eventually slow down or even stop altogether, therefore, compromising the holistic function of receptors in your own body. CBD can slowly help heal those receptors.
Epidiolex: The Smell Of Money
Like Sine, it would appear like Big Pharma has known for a long time that natural CBD works. Big Pharma also knows that CBD is a sure moneymaker in the evolving healthcare market that’s drifting away from conventional medicine in favor of holistic and functional approaches.
Put it all together and there’s plenty of motive for Big Pharma’s Machiavellian game plan to eliminate all competition in the CBD industry. As reported in Motherboard, the drug industry is pushing for legislation that would make CBD oil illegal by turning it into an FDA-approved drug.
Approval of Epidiolex certainly points in this direction as did the fight waged by GW Pharmaceutical’s armada of lobbyists last year against South Dakota Senate Bill SB 95. The bill was originally written to allow CBD products to be sold legally in South Dakota where medicinal marijuana is not allowed. However, the Big Pharma lobbyists fought aggressively for an amendment to the bill that would have limited the sale of CBD products in South Dakota to those only approved by the FDA – in other words, legal drugs like, ah, Epidiolex.
Had the amendment passed (it didn’t), it would have banned a myriad of CBD dietary supplement products that cost far less than Epidiolex and are potentially more effective for patients.
Melissa Mentele is the chairperson of New Approach South Dakota, a cannabis reform group. She was not pleased with GW Pharmaceuticals’ transparent efforts to lock down the CBD market in South Dakota.
“It was disgusting,” said Mentele, who herself found relief from chronic pain when she started taking CBD-rich cannabis oil. “Cannabis patients and caregivers fought for decades for the government to look at cannabis as a treatment option. So we as a community did the work for them and then Big Pharma swooped in and used an unfair monopoly and an inferior product to profit off the backs of catastrophically ill and dying people.”
More ominously, the Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical cannabis providers, according to natural health expert Dr. Joseph Mercola.
“GW Pharmaceuticals has reportedly contracted lobbyists in several different states to fight for its cause,” says Mercola. “Their combined efforts may well delay implementation of cannabis reform that could improve access to medicinal marijuana.”
Arizona: Beautiful State, Ugly Politics
Take Arizona, for example. As reported in Wikileaf, INSYS Therapeutics, a specialty pharmaceutical company, donated roughly $500,000 to help defeat the legalization of marijuana in Arizona. Why? Because natural cannabis is viewed by INSYS as a serious competitor to its FDA-approved drugs called Marinol and Syndros.
Marijuana contains THC, a chemical found in the cannabis plant that studies prove helps with chemotherapy-induced nausea and vomiting. INSYS claims their products, which contain fake (synthetic) THC (Dronabinol) also help chemo patients with their side effects. Only problem is that the Big Pharma drug is more expensive (up to $800 per prescription) and far less effective than natural cannabis because it lacks the other beneficial, natural chemical compounds present in the whole cannabis plant, compounds that work together in a synergistic phenomenon known as the entourage effect.
The Cannabist recently interviewed GW Pharmaceuticals CEO Justin Gover about his perspective on the potential of Epidiolex and his views on the future for cannabinoid pharmaceuticals.
“We consider ourselves to be world leaders,” says Gover. “Our job is to stay in that position as long as we can.”
World leaders or world dominators?
In addition to Epidiolex, GW Pharma, with the help of the U.S. Patent and Trademark Office, owns eight patents with another 22 pending for the treatment of conditions including epilepsy, cancer, constipation, general pain, and nausea as well as for the methods of extraction, propriety uses, and hybrid strains of cannabis.
One of the big ones is patent No. 8,790,719, which makes an intellectual property claim for the use of plant-derived cannabinoids in the treatment of prostate cancer, breast cancer, and colon cancer.
Another salient patent is No. 9,205,063, clearly, a play to claim ownership of cannabis as a drug in the prevention and treatment of Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis.
Getting Cozy: GW, Bayer, And Monsanto
GW Pharma even has licensing agreements with German-owned pharmaceutical giant Bayer. Operating under the flagship corporation IG Farben, Bayer was so instrumental in the Nazi war effort that the 1946 Nuremberg War Crimes Tribunal concluded the Second World War would simply have not been possible without them.
As of May 29, this connection also now extends to Monsanto following Federal antitrust regulators granting the merger of Monsanto and Bayer after the two companies agreed to spin off $9 billion worth of assets, the largest such sale of corporate assets ever required by the Department of Justice.
Some view this merger as the perfect match made in hell. Monsanto’s most notable contributions to society are agent orange, DDT, PCB, dioxin-based pesticides, aspartame, rBGH (genetically engineered bovine growth hormone), Roundup (glyphosate) herbicides, which damage beneficial gut bacteria, and Roundup Ready crops (seeds genetically engineered to withstand glyphosate).
In just one of their many crimes against humanity, Monsanto was fined $700 million for intentionally polluting an economically deprived Alabama town with deadly PCBs, which earned them this glowing review by the courts: “So outrageous in character and extreme in degree as to go beyond all possible bounds of decency so as to be regarded as atrocious and utterly intolerable in a civilized society.”
How Is This Different From Organized Crime?
The Daily Beast calls Big Pharma “America’s New Mafia.”
And, just like America’s old Mafia or even successful drug cartels, Big Pharma has friends in high places who clear paths.
How else does one explain the federal government criminalizing the natural plant but legalizing and distributing the fake, more dangerous version of it in Dronabinol?
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.
Then there’s the now infamous Drug Enforcement Administration (DEA) reclassification of CBD in January 2017. Perhaps no other single turn of events did more to bring attention to Big Pharma’s shameless profit motives aided by “the law.” This is when the DEA inexplicably decided to classify CBD from marijuana extract (as opposed to industrial hemp) as a Schedule 1 substance – in the same category as heroin and LSD. This despite that 14 years earlier, the government patented cannabinoids as antioxidants and neuroprotectants.
“Not only is CBD non-psychoactive (like LSD), it is remarkably non-toxic, much less toxic than even over the counter medications that are commonly used,” says Dr. Margaret Gedde, a Stanford-trained pathologist, and award-winning researcher.
“The concept of putting cannabidiol CBD on schedule 1 of the drug schedule, saying that it has no medical use, and it’s highly dangerous, just flies in the face of fact and science and knowledge,” says Gedde.
The Hemp Industries Association, Centuria Natural Foods, and other hemp businesses (collectively, “HIA”), thought so, too, and filed a petition against the DEA seeking a Court order either striking down the ruling or clarifying it.
Predictably, the court did neither in rendering its decision May 1 – less than two weeks after FDA advisors voted to recommend approval for GW Pharma’s expensive Epidiolex. (FDA approval removes the Schedule 1 classification).
And keep in mind that we do not know exactly what is in Epidiolex. It is processed and adulterated by removing some of the THC. In addition, other similar THC pharmaceutical brands use toxic ethanol and/or propylene glycol, which are toxic. HoneyColony was unable to find a formal list of the active ingredients in this drug, but suffice it to say, Epidiolex is not organic as in the non-FDA approved CBD oil. Purified is not the same as pure.
The Hits Keep On Coming
And, just like in the Mexican novellas, it appears as though many non Big Pharma sellers of CBD have been targeted (including Target) since the DEA’s reclassification. The two favorite modes of attack: closing down merchant bank accounts and intimidating processors like PayPal to make CBD to customer transactions impossible.
Luisa Benton (who prefers not to use her real name for fear of retribution) works for a company that makes perfectly legal hemp-derived CBD products, which had been marketed using a well-established YouTube channel. All that changed one day when YouTube unceremoniously terminated their channel without notification or chance to fix it to adhere to any guidelines.
“Basically our CEO went to pitch our brand to a potential investor and all of our videos on our website were missing,” says Benton. “That was our first indication YouTube had a problem with us.”
The Year Of Whack-A-Mole
Last year was a particularly arduous one for HoneyColony. Given the string of events, HoneyColony co-founder Maryam Henein now wonders whether her magazine and marketplace were targeted possibly due to investigative pieces into Big Pharma or because of HoneyColony’s reputation for selling an extremely popular, superior brand of CBD.
“I refer to 2017 as the Year Of Playing Whack-A-Mole,” says Henein, who has been studying the food supply and food politics for a decade and is also the director of the award-winning documentary Vanishing of the Bees narrated by actress Ellen Page. “After four years of hard work building this company from scratch, we were starting to see the fruits of our efforts. But instead of doubling our business, we experienced more than $200k of losses indirectly because of the politics of CBD .”
During the year of Whack-A-Mole, the company was shut down by many of the mainstream processors such as Square, Stripe, and Paypal. Every time HoneyColony was shut down, the company lost the ability to make transactions.
Consequently, HoneyColony was forced to create an entirely new website to carry their CBD oil, and when they finally found a high-risk merchant processor, they were defrauded $20k.
By this time so much capital was lost that HoneyColony was forced to take out high interest “cash payouts.” Eventually, the second “high risk” processor also shut HoneyColony down, possibly because Henein questioned their compliance requests that included scrubbing words like cancer from testimonials, and unlinking to any research that the FDA may deem bias.
Today HoneyColony has solved their issues but it’s come at a cost. Henein has been personally sued, been banned by Go Fund Me, Paypal, and given interviews that have been removed from social media.
And, like Benton, Henein had a two-year-old YouTube video removed without any forewarning. The YouTube video was about the struggle to get CBD to those who need it.
Attorney Rod Kight, who represents legal cannabis businesses, says he has no idea why Henein’s video, which he calls “a good” video, was removed.
“My opinion is that YouTube misunderstands the law and believes that CBD is an unlawful substance,” says Kight.
Henein says she knows of at least a handful other sellers of legal CBD oil who have had experiences similar to hers but none as dramatic.
It’s not just individual retailers feeling the wrath of DEA’s capricious CBD classification. In September 2017, Target sold CBD for about two weeks then suddenly pulled the product line. Why? No one knows. Target executives and their CBD supplier refused to address the media.
Kight says he is “no friend of GW Pharma” and “fully recognizes the threat that it and other large pharmaceutical companies pose to the hemp extract/CBD industry.” But he’s also not a believer in the Big Pharma conspiracy theory.
“GW Pharmaceuticals wants to carve out a significant niche in the CBD industry,” says Kight. “The issue is really the extent to which it corners the market and the methods it uses to do so.”
The problem is that “niche” could very well become all-encompassing. In the Cannabist interview, CEO Gover made it quite clear:
If Epidiolex is approved, GW will continue full steam ahead on moving through its pipeline of cannabinoid therapies in addition to evaluating Epidiolex for other conditions.
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