FDA LEGALIZES CBD OIL FROM MARIJUANA
FDA KEEPS CANNABIS ENEMIES CLOSE
"Today, the FDA approved CBD oil as a pharmaceutical drug. It's a fine day, for CBD will soon be available across the country in the pharmacy. But make no mistake, the FDA decision is really part of a strategy to create a format for the big pharmaceutical industry to take over cannabis based medicine. The FDA has set the table to ruthless eradicate the founders and independent status quo players in the cannabis industry today." - Johnny Rod
In a historic decision, the FDA legalized a cannabis formulation made from a proprietary strain of cannabis, effectively reversing nearly a century of persecution and diatribe against marijuana.
The formulation called Epidiolex,is based on a high-CBD, low THC hybrid by British company GW Pharmaceuticals. Under the Federal pharmaceutical system, Epidiolex may be prescribed for two conditions, Dravet or Lennox-Gastaut syndromes.
"The Feds had lost nearly all credibility by persecuting and raiding CBD producers in marijuana legal states. We're talking about arresting at gunpoint professional outfits, staffed with professionals adhering to the pharmaceutical industries code of standards. By legalizing the CBD "drug", or more accurately, a concentrated herbal tincture, the Feds have taken a step back from the brink to regain some form of legitimacy." - Johnny Rod
INDEPENDENT OPERATORS BROUGHT YOU THE GOODS - NOT BIG PHARMA
Big pharma was part of a consortium that made cannabis illegal in the first place, after two hundred years of medical use in America no less. Then they were able to erase it from the medical books so thoroughly that by the 1960's, not even the hippies knew it was prescribed out of pharmacies by regular doctors early in the last century. Cannabis extracts were listed in US Pharmacopeia and it's prescription was recommended in medical schools circa 1920's
The general public needs to know that private innovators and researchers made all the discoveries and strains. The pharmaceutical companies offer only one thing, standardized downgraded formulations that don't work as good as a mom and pop made with love tincture from fresh organic weed. No doubt, they're going to fast food it, and put it in a nice package, and charge you through the nose.
The Food and Drug Administration - June 2018 - approved America's first drug made from cannabis, for the treatment of two serious forms of epilepsy.
"Trust the pharmaceutical industry to name a herbal remedy something like Epidiolex-whatthefuck. Trust them to claim proprietary rights to a high-CBD strain. What they're doing is what the whole industry has been doing for the past forty years, and that is selectively breed new strains."- Johnny Rod
GW Pharmaceuticals’ cannabis drug Epidiolex, is made of cannabidiol, or CBD, a non-psychoactive component of cannabis that does get users a high. Copying the organically formed cannabis industry it is an oil formulation. In clinical trials, the formulation was found to reduce the number of seizures by about 40 percent in Dravet or Lennox-Gastaut syndrome patients. In other forms of Epilepsy and certain patient types, there is significant evidence that seizure prevention is significantly higher.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”
The FDA’s decision was rumored for a while, but it's still a little shocking to see that the advisory panel unanimously recommended approval of the pharmaceutical industry's first organic cannabis drug. This sets the precedent for the approval of many other formulations.
You can thank Trump for this one. His 3 D chess move sets up Fed legalization of marijuana. Here's why. Before GW markets Epidiolex the Drug Enforcement Administration will have to reclassify CBD. Before under Reefer Madness policy, the safe and medicinal BCD was classified as a the most dangerous of drugs up there with heroin and crack. Since everyone knows that CBD has never been a street drug, is safe, and is only used medically especially for children. the Fed had gone too far, to the point that the FDA lost ALL credibility.
So, on the tail of the FDA approval for CBD drugs (more or less) they have to, and will reclassify CBD as a medically useful drug, whereby the pharmaceutical industry can sink its hooks in and take over the business of CBD. Nonetheless, the people will be able to get CBD to treat their kids seizures and other conditions.
"This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine, these patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care."
The price list has yet to be set.
Lennox-Gastaut and Dravet syndrome typically emerge in the first few years of life, and results in debilitating and recurrent seizures,often dozens a day. One in five patients dies before they reach 20 years old. CBD offers safe treatment over other prescribed pharmaceuticals, there are six other drugs approved for seizures of Lennox-Gastaut, and none approved for Dravet.
Although Epidiolex was approved for just two specific conditions, analysts expect doctors to prescribe it off label in many of epileptic diseases. The GW drug comes from a proprietary strain of cannabis grown hat has been specially bred for high levels of CBD and low levels of psychoactive THC..
"GW Pharmaceutical did not discover high CBD strains, they did not discover that it worked for Epileptics. That was done by off the grid scientists, doctors and a handful of real researchers. GW Pharmaceuticals is riding on the tail, and profiting on the work of others. The pioneers took a lot of crap to see this day, a day where the big bad pharmaceutical companies take the glory. Nonetheless, it's still a great day. Everyone knows who the real heros are."
While the FDA has previously approved synthetic medications that resemble or are identical to natural THC, these synthetics are classified as Schedule II and Schedule III, and have medicinal value with the potential for abuse. It will be interesting to see if CBD based formulations from natural sources will be reclassified as medical with potential for abuse. Since it is well know that CBD is not an addictive substance and has no street value recreationally, in the act of reclassification, we'll know if the FDA is starting to come clean or not.
"These GW type of formulations and library of synthetics were made back in the 1960's forward by Dr. Mechoulam of Israel, though his work did not center so much on CBD. Mechoulam also synthesized many analogs. Essentially all GW has to do is sift through Mechoulam, etal's notes and PubMed publications and start pumping out the goods." - Johnny Rod
The pressure on the Fed to legalize natural cannabis, and CBD herbal concentrates in particular came from the many families moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD. " Experts" call for regulated medication with standard dosing and supply is crucial for patient safety, a sentiment echoed by the FDA Gottlieb in his statement Monday. This is the strategy, sets the stage for the pharmaceutical industry's takeover of cannabis based medicine.
"The FDA did the 180, they're saying that only their regulations will make your marijuana safe. We'll see that only the best sprays and chemicals are used, and we'll X-Ray it so no bacteria or mold will get into your system, etc. etc. " - Johnny Rod
FDA Gottlieb vouched for the years-long clinical development of Epidiolex as a model for bringing products made from marijuana to the market. What really happened is that the non-establishment nailed down which strains worked, how much, and for what kinds of conditions. The guys at GW just copied, basically stole every idea from the people, who had to work outside mainstream of the medical system, due to, well the FDA.
The FDA said they are now willing to help companies that want to pursue similar cannabis medical research programs which prove the purity, safety and efficacy of their products in clinical trials. What this really means is that small companies cannot afford to bring cannabis based medicines to market and must partner with big-pharma. Still the small guys can make a dime under this model, albeit, like the Beatles and every other act, they have to SELL OUT.
“This is an important medical advance, it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.” - Gottlieb
The above statement is more of a face saving political diatribe thing to say. It's CBD from weed in oil. The approved synthetic THC is made to be chemically identical to the natural. What the FDA is really saying is that we are only going to approve a cannabis based medicine that can be patented in some way. This is the way they keep all non-patentable organic medicines out of the pharmacy, or at least out of consideration of your doctor for prescription, by the way.
"GW Pharmaceuticals among a couple of other startups are hand picked by the consortium of big corporations to commercialize cannabis based medicines, under the same old pharma discovery drug model. The table is set, the fundamental research now done, the synthetic molecules created. All GW et.al. has to do is buy, copy or emulate formulations and patents and bang out "novel" cannabis drugs, bang, bang, bang." - Johnny Rod
In a movie to kill the competition for the pharmaceutical industry, Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren’t backed up by evidence. The FDA has sent warning letters to companies that claimed that their products helped in cancer or Alzheimer’s
“Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.” = FDA Gottlieb
At the end of the day, we're a step closer to full on legalization, albeit controlled. The next step in the battle, is to get the the innovators and founders of the medical cannabis revolution out of the cross hairs of big pharma and their FDA henchmen. That means getting the Fed out of the States marijuana affairs, and to let free market service the wants and needs of the peoples.
"In the pharmaceutical business, it's not like the mafia, it is the mafia. if you're in the club, you're golden, if you're not, your days are numbered and poverty awaits."
420EVALUATIONSONLINE - We provide new and old patients with 100% online cannabis recommendations and Cannabis ID cards in the State of California. Medical patients save 20,30,40$ per ounce on their dispensary purchases, can buy, possess and grow double (or more for certain conditions). This means if you see a sale of say, $140 an ounce on blue dream, you can buy two ounces in one shot, while a rec user may be limited to an ounce or less.
"Under Prop 215, medical patients and caregivers will still be entitled to grow however much is required for their personal medical needs under state law; however the courts have ruled that local ordinances can override state law. Non-medical growers are limited to six plants per residence by AUMA and locals cannot ban 6-plant gardens; however they can "reasonably regulate" them, including driving them indoors." - Cali NORML
This means medical patients in practice can grow at least 12 plants, and if you have a chronic condition, like pain, AIDS, Cancer, the number can be increased so that you can grow 10 or even 30 grams worth of bud per day, which can be two dozen or more plants.
Without a medical card, recreational users can be busted for anything more than six plants.
The Food and Drug Administration on Monday approved the country’s first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy. The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. FDA approves country's first medicine made from marijuana ...
U.S. health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.
The Food and Drug Administration approved the medication from GW Pharmaceuticals on Monday to treat two rare forms of childhood epilepsy. The strawberry-flavored syrup is a purified form of a chemical in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, known as CBD, reduces seizures in some people. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis. FDA officials said the drug reduced seizures when combined with older epilepsy drugs.
GW has been researching cannabinoids since 1998 and has established a world leading position in the development of plant-derived cannabinoid therapeutics through our proven drug discovery and development processes, our intellectual property portfolio and our regulatory and manufacturing expertise. GW’s research explores the potential therapeutic application of cannabinoids and we have evaluated the pharmacology of a number of cannabinoids across a wide range of disease areas.
Our primary focus is on disorders of the central nervous system (CNS) including epilepsy. Our lead cannabinoid product candidate is Epidiolex®, a liquid formulation of pure plant-derived cannabidiol, or CBD, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders.
We commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States.
We have a deep pipeline of additional cannabinoid product candidates which include compounds in development for epilepsy, glioma and schizophrenia.
GW is in a unique position to develop and manufacture plant-derived cannabinoid formulations worldwide at sufficient quality, uniformity and scale for the purposes of pharmaceutical development and to meet international regulatory requirements.
- Approval for seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe childhood-onset epilepsies -
London, UK, Carlsbad, CA, 6 June, 2018: GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that GW management will present at the Goldman Sachs 39th Annual Global Healthcare Conference on Wednesday,
GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences Announce Publication in The New England Journal of Medicine of a Phase 3 Study of Epidiolex® (cannabidiol oral solution) in Lennox-Gastaut Syndrome
– First dose-ranging study comparing pharmaceutical formulation of cannabidiol to placebo as add-on therapy in Lennox-Gastaut syndrome, a rare, severe and difficult to treat form of childhood-onset epilepsy –