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Health, Marijuana Prohibition, US

FDA Committee Recommends Approval of Pharmaceutical CBD

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Washington, D.C. — An advisory committee for the Food and Drug Administration (FDA) on Thursday recommended approval of the first pharmaceutical grade cannabidiol (CBD) medicine to treat severe epilepsy. In a unanimous decision, the committee voted to recommend GW Pharmaceuticals drug Epidiolex for approval.

Cannabidiol, commonly referred to as CBD, is a non-psychoactive cannabis derivative. The approval of Epidiolex would be limited to treating seizures in patients aged 2 and older caused by Lennox-Gastaut syndrome and Dravet syndrome.

“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.

[Related: In CBD-Legal Tennessee, Cops Raid Shops Selling Non-THC CBD Gummies]

Taking a natural product such as CBD oil and turning it into a FDA approved drug has the potential to limit the avenues that people have to access the natural product. Motherboard reported last year on the drug industry lobbying for legislation that would outlaw CBD oil by turning it into a drug. South Dakota Senate Bill 95 had sought to exempt CBD from the definition of cannabis, thus taking it off Schedule I controlled substance list and becoming a Schedule IV substance.

GW Pharmaceuticals and its U.S. subsidiary, Greenwich BioSciences, lobbied for an amendment to the legislation to limit CBD rescheduling to only FDA-approved products— in other words, they wanted only CBD drugs to be legally obtainable.

A 2017 report from Motherboard explained:

Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”

“Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …

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 …

[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those ‘full spectrum’ cannabis extracts also contain small amounts of THC and other medicinal components of the plant.

Motherboard also noted that “corporate lobbyists in more than 20 states are currently pushing to make sure the pharmaceutical industry has the only legal supply of CBD.” Thus, it appears the big pharma takeover of CBD is underway.

“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later,” said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, attempting to explain the importance of pharmaceutical intervention in the CBD market.

“It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity,” Devinsky told NBC News. “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”

NBC News reported that the FDA has indicated that it will likely approve Epidiolex. Although the recommended use for this particular product is very limited, doctors may prescribe it at their discretion.

“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA stated.

“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA said in briefing documents given to the advisory committee ahead of Thursday’s meeting.

“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”

Drug War, Featured, US

In CBD-Legal Tennessee, Cops Raid Shops Selling Non-THC CBD Gummies

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Police in Rutherford County, Tenn. padlocked 23 stores accused of selling non-THC cannabidiol (CBD) gummies in a county-wide raid called Operation: Candy Crush on Monday. The multi-agency raid included detectives from Rutherford County Sheriff’s Department, Murfreesboro Police, Smyrna Police, and the Tennessee Bureau of Investigation.

WREG-TV notes that 21 individuals have received indictments for selling the products.

However, given that the sale of hemp products and the possession of non-THC CBD products had been legalized in the state in recent years, questions have been raised as to the legality of the raid.

These CBD products do not contain significant quantities of THC, the active ingredient in marijuana that produces intoxication, and are mainly popular for medicinal uses, such as symptom management in seizure disorders.

A 2014 Tennessee law redefined hemp-derived products containing less than 0.3 percent THC as an industrial product rather than a controlled substance. A 2016 law created a pilot program for cultivating hemp and a licensing system for distributors.

“Any person who makes only retail sales of industrial hemp obtained from a licensed processor or distributor will not be required to obtain a license,” notes HB 2032.

[RELATED: Tennessee Governor Signs Cannabis Oil Legalization Bill into Law]

While those laws created a legal marketplace for hemp-derived CBD, another 2015 law, SB 0280, redefined the state definition of the controlled substance marijuana to exclude marijuana-derived CBD products with less than 0.9 percent THC, which stops short of creating a legal marketplace for those distinctly different but similar products, but prevents marijuana-derived possessors from being busted under pot laws.

While the TBI has not yet announced which products were seized in the raid and it is possible that some of the products seized were not made from hemp, the products depicted in a Rutherford County Sheriff’s Department Facebook post as examples of those items seized appear to be hemp-derived CBD gummies, which distributors claim are legal.

Tennessee Hemp Industries Association president Joe Kirkpatrick told The Tennessean, “Presently, under the new law, a person can possess an industrial hemp product. If in fact the products they’ve seized derived from industrial hemp, then the DA has broken federal law.” Federal law prohibits law enforcement agencies that receive federal funds from interfering in the cultivation and distribution of licensed industrial hemp.

Rutherford County Sheriff Mike Fitzhugh said, “We feel these stores are marketing these items toward minors. These items can commonly be confused by a child as candy and are illegal.” However, law enforcement officials acknowledge that the products cost between 7$ to $70, multiple times more expensive than traditional candy gummies.

District Attorney Jennings Jones claimed, “If you possess this without a prescription, you have broken the law. If you are selling this without a prescription or if you’re not a pharmacy selling it to someone with a prescription for it, you have broken the law.”

Truth in Media contacted several pharmacies in the state and none carry CBD products. A manager at a Nashville-based vape shop who did not want to be identified told Truth in Media that his store had previously carried hemp CBD gummies, but stopped prior to the raid out of confusion over different agencies’ interpretations of the legality of the products.

State Rep. Jeremy Faison (R-District 11) said in a Facebook post on the incident, “There is a whole lot more to this story than what is being reported. I spoke with the TBI tonight. Several of these stores were selling products from China and other countries. After the TBI took products to their lab, they found that multiple compounds of substances were found in packaged material and they weren’t even labeled to have the compounds found. Melatonin, sugar, ibuprofen, Benadryl, and other things like that were found. From what I have been told nothing was necessarily dangerous or found to be an intoxicant.”

“This is one of the very main reasons we should pass the Medical Cannabis Only bill. We can have a regulated, predictable, safe, and lab tested product. Tennesseans should never be left to purchase something that is derived from the cannabis plant without knowing exactly what they are getting,” Faison added. “I imagine that the majority of the charges will not turn into convictions. One day in the very near future, Tennessee will realize 3 things: cannabis is not the problem, cannabis is far safer than many FDA approved pills, and cannabis actually does work for some very sick Tennesseans.”

According to the Times Free Press, Rep. Faison and Sen. Steve Dickerson(R-Nashville) introduced the Medical Cannabis Only bill on January 18, which would expand medical marijuana access to individuals with qualified serious medical conditions.

The 21 individuals indicted in this case are due in court on February 16.

Health, US

Epileptic child has been seizure free thanks to cannabis oil

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A child in Oregon who has suffered from seizures brought on by epilepsy has been seizure free for close to nine-weeks now thanks to cannabis oil.

A week after Forrest Smelser turned eight, he was diagnosed with epilepsy, which would cause him to go into seizures, sometimes lasting upwards of 15 minutes.  According to the Epilepsy Foundation, any seizure lasting longer then five minutes requires immediate medical attention and may result in permanent brain damage.

His mother Tanesha took Forrest to the emergency room many times until finally the doctors prescribed Forrest with an anti-seizure drug called Trileptal.  However, the medication only seemed to make things worse for Forrest.  “He would scream, he would fight, he would punch himself,” said Tanesha according to KATU.  

The FDA  has said these side effects are not common, but they do occur in about one in every 500 people.  

At this point, Tanesha said Forrest became suicidal, which she and her family blame on the medications.  Then, Tanesha and her family began to look into other medical options for Forrest.

Forrest’s family began to read into the uses of medical marijuana and its benefits, and made the conscious choice to begin Forrest on a medical marijuana treatment.

After nine weeks of giving Forrest cannabidiol (CBD), the second most active component of medical marijuana, the family reports Forrest has been seizure free.

The strain of medical marijuana Forrest is taking contains mostly CBDs, according to Medical Daily.  Normally, THC, the component which provides the high behind smoking marijuana, is the main component in medical marijuana, but because this strain is mostly CBD, there is virtually no high.  Instead, the CBDs provide anti-seizure, anti-inflammatory, and analgesic effects on the patient.

This link provides further studies by Project CBD on the effects of CBD in a medical setting.

However, Forrest is not smoking the medical marijuana, rather he is taking it through pill form like any other medication.

“Now that I’m on this medication, I feel like a normal boy,” Forrest said.

“I feel like it’s saved his life,” said Tanesha.  “I know it sounds scary, and I know it sounds unconventional, but it’s working. It’s working!”

Drug War, Featured, Marijuana Prohibition, Swann TV, Truth In Media Episodes, US, Videos

Truth in Media: Feds Say Cannabis Is Not Medicine While Holding The Patent on Cannabis as Medicine

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Activate: Click here for 10 Steps You Can Take To Change and Confront the Culture on This Issue

For those who believe in marijuana and cannabis freedom, the future has never been brighter. Right now there is an awakening to the benefits of cannabis for medicinal purposes, specifically something called CBD oil. But is the new CBD craze being manipulated by media and politicians? If it weren’t we wouldn’t need to do a show about it.

The first step toward truth is to be informed.

CBD Oil… you’ve probably heard of it by now. Thanks to CNN’s Dr. Sanjay Gupta, and his special report “Weed” millions are now aware of the cannabinoid rich oil being used to help children in colorado with epilepsy. Especially this one little girl Charlotte Figi after whom the Charlotte’s Web strain of cannabis has been named.

I wanted to learn what CBD oil and the push behind it is all about so I traveled to Denver, Colorado. Home to legalized marijuana and the Stanley brothers, the family behind the charlottes web strain of cannabis oil.

The Stanley’s were the ones to prove in Charlotte Figi’s case that CBD rich cannabis oil can prevent seizures in children.

“We have this strain that we were going to use for cancer patients because studies have shown that CBD helps stop the metastasizing of cancer. We went ahead and tried it and after she (Charlotte Figi) had it a week she went a week seizure free” says Jesse Stanley.

Charlotte Figi’s life was transformed by CBD oil. Now to understand what is unique about CBD oil, you have to understand what a cannabinoid is.

In marijuana there are multiple cannabinoids including THC, CBD, CBN, CBA, THCA, THCB and over 160 other compounds in the plant including terpenes from the plant that create the most effective medicine.

To be clear, in order to get a high from cannabis you need a high level of one cannabinoid, THC. Again, just one particular cannabinoid. In the Stanley’s case they began growing cannabis with lower THC and higher CBD.

“CBD is known to be a neuro-protectant, it is also one of the few things that causes neuro-genesis. So its not just seizures that this helps in epileptics, it is auto-immune disorders whether that’s cancer, crohn’s, lupus, there are so many different types of things” says Stanley.

Today, in the stunningly short time since Charlotte Figi’s story became famous, the Stanley’s have thousands of patients on a waiting list for their CBD oil. In fact there are thousands of families who have already traveled to Colorado for this CBD oil and thousands more on the way. They are called cannabis refugees.

All of that has led to other states wanting to legalize CBD oil. The governor of Utah signed a CBD bill into law legalizing possession of the oil. A bill in Alabama has passed the legislature and is awaiting the governors signature. Lawmakers in Kentucky, Florida, South Carolina, Wisconsin and other states have or will consider CBD bills this year.

“We’re at 20 states right now, so you already have twenty laws on the books that the people wanted or the people’s representatives wanted” says Mark Slaugh of iComply, a Denver based company which is fighting to keep small growers compliant with state regulation on marijuana. There are eight strict guidelines that must be followed. Mark says states are jumping on board with CBD but not with marijuana.

“I think what most politicians don’t realize when they start trying to play where the puck was and not where the puck is going to be is that regulating just one compound greatly underserves most of the patients who really need this medicine. So along the lines of medical efficacy it isn’t reasonable” says Slaugh.

The reality that Mark addresses is how media and politicians are jumping on the CBD train because it doesn’t get you high, but they are ignoring some very important medical facts about cannabinoids.

I talked with Shona Bonda about this very issue.

“I was diagnosed with crohn’s disease. In my first year I had my first bowl resection and i went downhill after that. My immune system recognized that there was something wrong and it essentially attacked itself.” “You’re in pain constantly and you can’t think straight. It’s hard to go through your day to day life when all you can do is think about pain. It is a terrible disease” says Bonda.

Shona’s condition was so bad that her teeth literally became soft and the roof of her mouth had turned black. She couldn’t stand and says she parented her children from the couch. Described a like having a stomach flu every day for years, despite all the medications and doctors, Shona was rotting from the inside out.

Her break came when she saw the YouTube documentary “Run From The Cure” by Rick Simpson which explained how to extract CBD and THC oil from marijuana. Shona had started smoking marijuana just to be able to function but she wasn’t getting better. Shona’s husband at the time wanted to get her a vaporizer… but that vaporizer became the road to so much more.

“He went and got me a very old fashioned vaporizer from the 1970’s. I was reading a book and I pinched off the tube for way too long and oil started forming on the dome. So he went and got a rubber spatula and I started scraping off the oil three times a day and I started putting whatever I could get into a gel cap. Within three days I didn’t need my cane anymore to walk and I started healing quite rapidly. So rapidly that I started to write in a journal” says Bonda.

That journal would become the book, “Live Free or Die”, Shona’s mantra for her own life and the lives of the people she continues to educate across the country on the benefits of cannabis oil.

But politicians and media are making CBD oil into the good kind of cannabis while arguing that THC is the bad kind of cannabis. While that is not how any of this works, that is the case that is subtly being made.

As that happens, two forces will likely come into play. One, in order to push the market away from small sellers and harvesters of CBD oil, states and the feds will likely create a regulatory climate that is so difficult to manage, they will, through cronyism force CBD oil into the hands of a few, which in turn limits supply and forces the price to rise considerably.

Two, big pharmaceutical companies will being putting out a “safe”, “legitimate” form of CBD oil. That is already starting to happen.

“GWB pharmaceuticals out of Great Britain has been producing Evaz which is a 50/50 blend of CBD and THC. They have no real research behind whether or not 50/50 is even the right ratio and they certainly don’t include the other terpenes and other chemical compounds from the cannabis plant. So we could see the bone tossed to the pharmaceutical dog, its certainly a possibility but i think that if more people would take a stand for de-scheduling marijuana, regulating it in a manner similar to alcohol is really the best model to move forward with” says Mark Slaugh.

What you need to know, is where the U.S. government actually stands on this issue. Cannabis, marijuana, is today still a Schedule 1 Drug. That means, according to our government it has no medicinal use and has a high potential for abuse. Does our government really believe that? No. In 1999, the U.S. Department of Health and Human Services filed for a patent for the use of cannabinoids for medicinal purposes.

Also in 1999, HHS filed for a second patent, specifically for cannabis oil for the treatment of disease. That’s right, our government through the taxpayer funded Department of Health and Human Services holds two patents on cannabinoids and cannabis oil to treat certain diseases like alzheimer’s and auto-immune diseases like crohn’s.

Meanwhile, our government through taxpayer funded agencies like the Department of Justice pursue, arrest and in prison Americans who would attempt to access or use cannabis oil to heal their own bodies. Because in public they claim cannabis oil is not medicine and in private they seek to own the rights to that medicine.

Truth means that Humanity is Greater than Politics.