Certainly,we all heard about 2 months ago the validation of the US Food and Drug Administration (FDA) regarding the marketing of the drug Epidiolex, offering Cannabidiol (CBD). The community is happy about the situation, but the reality is much darker for all cannabinoid activists. The FDA approves Epidiolex: CBD companies are dismissed by Big Pharma
what exactly is Epidiolex?
The FDA approved Epidiolex first cannabidiol (commonly known as CBD) drug for the pharmaceutical market, spelling bad news for CBD users and CBD companies. While some advocates celebrate the government’s “change of heart”, the underlying effects of this approval will shake the industry and decimate the CBD market and all CBD companies on their way.
Actually,GW Pharmaceuticals has been studying and testing CBD for epilepsy since 2007. Finally,after years of internal testing, they formulated a CBD product to be submitted to the FDA for clinical trials in 2013. This product, known as Epidiolex, has now been approved by the FDA to become the first Cannabidiol drug approved by the FDA.
In fact,to see the FDA, the organization that oversees and controls drug programming, ‘approving a CBD product is a huge leap forward in their eyes. While, republicans like Chuck Schumer defending the hemp bill in agriculture, the Senate is calling for disapproval of the Cannabis Nationwide, and now the FDA is coming on board; the government sees cannabis for what it is and changes air!
Well … it’s only part of the story.
“The truth and implications surrounding this historic event are much deeper and darker than it seems …”
Epidiolex: the drug itself
Although the paths are very different, almost every study, interview, testimonial and even the occasional e-mail I read, all in their core, have the same message. The only way that CBD has been significantly effective in the treatment of epilepsy has been the FULL SPECTRUM CBD. So,this means that GW has (or should have) studied with cannabis-derived CBD that has
traces of other cannabinoids such as THC, CBD, and CBN.
GW Pharmaceuticals and the FDA claim that the CBD they used in the formulation of the drug was “purified”, but does not explain how much capacity or shared lab results. From labeling information, inactive ingredients include:
Dehydrated alcohol (most likely ethanol from extraction), Sesame seed oil (probably as a cutting agent), Strawberry flavor and Sucralose
Since ethanol is one of the few nonvolatile extraction methods that keep the cannabinoid structures intact, this suggests that there is a chance that they intentionally use the rest of the cannabinoids in their product. So,The possibility of unknowingly including them, these extra cannabinoids to create the ever-popular “entourage” effect is less likely. Stripped, they are essentially a highly regulated chemical production company with rigorous testing methods by third parties. But when it comes to Big Pharma, nothing surprises me anymore. I would be interested in sending one of these pills to the lab to see what’s inside.
That’s if I can afford it …
The cost of Epidiolex
Basically,all drugs on the market must go through FDA clinical trials to be licensed in the pharmaceutical market. These studies are not cheap. On average, the cost of a new drug to research, formulate, study and approve for marketing is about $ 1 billion. Knowing the hurdles that GW had to overcome to make this process with Cannabis, it was probably a lot more.
Although GW has not officially declared what the prices will be, our sources tell us that the cost could be around $ 45,000 a year, and insurance will not cover it.
Here are some thoughts from our sources:
“Insurance companies will want five years or more of empirical data about the results. It will now be necessary for further research to be submitted before being approved for the coverage of their forms. That’s the answer I got from Kaiser’s representative with whom I had lunch. Each carrier will have its protocol and criteria, there may be ways to request access before that, but it will be one-by-one and not a large-scale coverage for an additional period. »- Dede Kennedy-Simington, Benassist Health Insurance
FDA stops CBD companies “not approved”
In the statement of FDA Commissioner Scott Gottlieb, he explains that CBD, derived from cannabis, provides new treatments to patients. It also notes that they do not endorse any product or aspect of cannabis other than THIS PRODUCT or “any other product that is undergoing FDA clinical trials” and have “taken recent action against companies distributing unapproved CBD products”.
But, what does that mean?
Why create CBD cannabis now? If the CBD has not hurt anyone, it works and is sold almost everywhere in the country … why stop it and make it an FDA approved the drug?
Will they go after hemp CBD, Cannabis CBD, or maybe both? Is it a game to control the market?
These are all questions that will eventually be resolved. But,for now, this seems to be the first step, publicly, of Big Pharma and Feds to “clean” the CBD market and consolidate it for medical uses only in a pharmacy.
In short, the government sees the considerable benefits it can draw from the “legalization” of the CBD in a way that they can only benefit from. Unfortunately, the effects of this move will cause serious damage to our community.
To have another point of view, Evan DeMarco, Marketing Manager at Omax Health said :
“Now that Epidiolex, an epilepsy drug containing CBD from the Sativa cannabis plant, has been approved by the FDA, I think it will jeopardize the nutraceutical industry and the pharmaceutical industry.
Nutraceutical companies must educate the public about what the CBD is, not for the public to be able to decide on their own if the CBD suits them. It is even more important for nutraceutical companies to bring science-based products backed by clinical trials, such as Omax Health Stress Remedy with CBD. The natural product space must hold itself accountable for providing only the best and most effective supplements to create an anchor in the CBD space that Big Pharma is unable to destroy.
On the one hand, we are pushing for progressive legalization of plants and products that we know and love. On the other hand, this process could eliminate many of the businesses into which we shed our blood, sweat, and tears; just give it to Big Pharma. So,Epidiolex is only the first of many to come out. GW already has a product called Sativex, which contains THC and CBD, which is in phase 3 clinical trials with the FDA, due out in late 2019. For what will happen, only time will tell. But as Stephanie Bozzuto says with Cannabis Connect Insurance:
“I think it’s a positive change that has been adopted, but it’s going to change the market. This could help more people who want to use cannabis and try it for their health conditions that could boost incomes in the economy. But do not forget, in the end, that the government holds patents for the use of cannabis. It’s crazy … they’ve criminalized it, but they have it … “
With the approval of Epidiolex, this is changing the face of the industry. New ground has been dug in a world where cannabis and CBD will not only be accepted but will also take up space on pharmacy shelves. Finally,legalization is imminent, which will be a great victory for our community. But, soon enough,we’ll see what we’re going to lose to get it.