Big Pharma-Produced Cannabis Is Likely Coming to the U.S.

Alice O'Leary Randall Become a fan Medical Cannabis Pioneer


Big Pharma-Produced Cannabis Is Likely Coming to the U.S.

Posted: <time datetime="2015-08-03T18:18:57-04:00"> 08/03/2015 6:18 pm EDT </time> Updated: <time datetime="2015-08-03T18:59:01-04:00"> 08/03/2015 6:59 pm EDT </time>

<header>
</header>
For those hoping that Big Pharma could still be blocked from the medical cannabis scene there is bad news: the deal is done. Look for the first naturally-derived, Big Pharma-produced cannabis product to be on the market by the first half of 2016, perhaps even sooner.
Epidiolex is a liquid formulation of pure, plant-derived cannabidiol (CBD) manufactured by the British company, G.W. Pharmaceuticals. It is currently on the FDA Fast Track and has entered its final Phase 3 study for pediatric epilepsy disorders such as Dravet's and Lennox-Gastaut's syndromes with results scheduled for the first quarter of 2016.
Barring an unlikely catastrophic finding, there are plenty of signs that Epidiolex will breeze through this final stage and will thus have cleared the FDA's testing requirements. For any other drug the remaining details would be purely administrative but Epidiolex is derived from cannabis and that puts a few more hurdles in the way before marketing can begin. There are, however, plenty of signs that government officials are literally paving the way for this new player.
Among the most significant occurred on June 24, 2015. Before a packed hearing room, the U.S. Senate Caucus on International Narcotics Control, established in 1985 to "expand international cooperation against drug abuse and narcotics trafficking" took on the decidedly domestic issue of what to do about medical cannabis. The meeting was chaired by two unlikely medical cannabis proponents, Senators Charles Grassley (R-Iowa) and Dianne Feinstein (D-CA).
For long-time medical cannabis activists it was a surreal moment to watch these two veteran senators (with a cumulative total of 57 years in the Senate) bob-and-weave their way through unfamiliar territory. Normally these drug warriors would be proposing tougher penalties and increased enforcement. But on June 24th, and in a subsequent editorial in Time Magazine, Grassley and Feinstein supported "expanding compassionate access programs where possible, to benefit as many children as possible.
The hearings were eerily familiar for this medical cannabis pioneer. They immediately hearkened memories of another time when pressure on federal officials forced a "readjustment" of policy. It was 1980 and public interest in medical cannabis was being fueled by heart-wrenching stories from cancer patients undergoing chemotherapy. Their compelling stories of marijuana's effectiveness in reducing or eliminating chemo-induced nausea and vomiting had led to the passage of state laws that recognized marijuana's medical value and sought to establish state-wide programs of research using federal supplies of marijuana. There was a big problem, however. The federal government, which regularly grew a research supply of marijuana on a small plot at the University of Mississippi, didn't have enough marijuana to supply the demand from these states.
In desperation federal officials turned to the synthetic version of the psychoactive ingredient in cannabis, delta-9 tetrahydrocannabinol (THC). The drug was developed in the late 1960s to facilitate animal research. It was not originally intended for human use although researchers did begin using it in humans in the 1970s and in 1980 it was all the government had to stem the demand for medical access to cannabis.
In May 1980, Rep. Stephen L. Neal (D-NC), a member of the Select Committee on Narcotics Abuse and Control, convened a Task Force on Therapeutic Uses of Marihuana and Schedule I Drugs.
The Task Force hearings lasted all day but it was the afternoon session that would bring the bombshell when representatives from the National Cancer Institute (NCI) announced that delta-9 THC would be released through the NCI's Group C Treatment Program.It was an unparalleled moment. The federal government was agreeing to produce and distribute, via the NCI, the most psychoactive compound in cannabis. With the tacit blessing of the Congressional Task Force on Therapeutic Uses of Marihuana and Schedule I Drugs, delta-9 THC would be released to hundreds of NCI pharmacies throughout the country. Oncologists would be notified, patients would have access, and the public pressure to "do something" about medical marijuana would be assuaged.
The government would herald this action as the release of "the pot pill" and the American public, not yet sophisticated with respect to cannabinoid knowledge, would breathe a sigh of relief that relatives would no longer be forced to the black market for their chemotherapy anti-nausea drug.
The Neal hearings paved the way for Marinol and, similarly, the Grassley/Feinstein hearings will pave the way for Epidiolex. The scenarios are slightly different, of course. The involvement of GW Pharmaceuticals from the very beginning has been far more pleasing to the FDA and other federal agencies. There is no "Group C" for pediatric epilepsy patients but it is reported that more than 400 patients are already receiving the drug via expanded access INDs.
The question that haunts this senior observer of the medical cannabis movement is: what will the federal government do once Epidiolex is on the market? Will there be a "crackdown" on the growing and enthusiastic CBD market that is flourishing online? ("Legal" CBD is produced from hemp and contains less the 0.03% delta-9 THC.) As Epidiolex is scheduled in the Controlled Substances Act will authorities tighten the control of natural CBD? Consider that Marinol, a synthetic version of the most psychoactive ingredient in cannabis, is Schedule III while the plant itself is Schedule I. Such inconsistency has, of course, been codified and is rather benignly referred to as "differential" scheduling. But, like so many things in the nation's drug policy, it strikes many as a little crazy. The craziness of the federal policy with respect to marijuana should not be underestimated, nor should it be assumed that the growing tide of legal cannabis states will automatically signal a reform in federal law.

Follow Alice O'Leary Randall on Twitter: www.twitter.com/alicesrq
More:

Medical Marijuana Marijuana Epidiolex GW Pharmaceuticals
This Blogger's Books and Other Items from...

Medical Marijuana in America: Memoir of a Pioneer
by Alice O'Leary-Randall

Marijuana Rx: The Patients' Fight for Medicinal Pot
by Robert C. Randall, Alice M. O'Leary


http://www.huffingtonpost.com/alice-oleary-randall/medical-cannabis-issue-th_b_7925956.html

Jeebus, that is some bad news. Pretty soon they'll be suing, putting smaller growers out of business backed by Monsanto et al. Then, before you know it, Bayer Cannaspirin. F them !

World War 3 for cannabis geez

big secret:

you actually get a lot higher whne you're stoned and fucking assholes in the head than if you're just hanging out.

try it! next time you get high (eg. already) instead of chilling, go fuck with some piece of shit and sort them the fuck out.

tell me if you don't feel a whole lot higher than if you'd been reclining.

...... I prefeer to kayak when stoned rather than chill.....^^^^^^^cbd then on to thc is my guess...yeehaw... I will always grow my own so I don't really care...I don't care what the law says..its a plant, I aint afraid ,and I can grow it anywhere...I grew in a fridge,under bed,in attic,in basement. outside,,ect... I have no doubt between corporations and government/state its gonna get ugly for growers....I aint worried one bit..nothing much will change for me

Wonder what the cost will be ?

if they make it too expensive the black market will actually grow for cbd products as its becomes more accepted..imho....yeehaw

stoned-trout said:

if they make it too expensive the black market will actually grow for cbd products as its becomes more accepted..imho....yeehaw

Click to expand...

that's the only way we will survive, Pharma and big Tabaco are poised and waiting, what pisses me off is we cant even trade mark anything cannabis related until its off the sch 1 drug list but Pharma can.

That whole CBD thing has always thrown me for a loop. Because, as far as I know, it never was illegal. Anyone could order CBD on the internet, legally, such as: www.cbdstore.co and that place was just the first one that showed up when I Googled it.

Then the FL legislature made all this silly noise about approving it. But it was always just the THC was illegal, not CBD. Or am I missing something?

Now that big British drug company GW is gonna field some new shit. But so what? All I see is a bunch of money grubbing dorks trying to elbow their way into something that has actually been around for thousands of years already.

I'm with trout about the "so what" attitude. I can, and will continue to, grow my own anyway, no matter what anyone says or does. So will thousands, maybe millions at some point, of other people.

I would like a trustworthy caregiver that I could buy quality organic from at a reasonable price, cause my back is really fucked-up and just bending over and picking up a pot is getting really tough. But I don't see that legal caregiver thing happening anytime soon here, so I'll just grow my own whether these idiots say it's illegal or not. Or if some freaking weirdos have synthesized a new compound they think they can cash-in on.

This is not at all unforeseen or any big surprise, just maybe not preferred. But kinda inevitable, and is actually kinda comical to watch in one way of looking at it.

<cite><cite class="_Rm">


</cite></cite><cite class="_Rm"></cite>

You cannot totally isolate CBD...there are other components of cannabis. High CBD plants just means a higher ratio in conjunction w/ THC (lower), CBN and numerous other properties cannabis has as a living plant.

The push has been mostly for medical instead of total deregulation, so what did you all expect - the sacred ganj but not legal drug dealers being part of the controlled substance dispensing system? I'm not seeing the federal government having a west coast or Europe aura around it any time soon. You should be expecting only expensive FDA-approved dosages of pure cannabinoids, if you get anything.

All extracts of cannabis including Epidiolex and even the essential oil are unambiguously schedule 1 under federal law, when enforced. Marinol is synthetic. Many of the recent state laws regarding CBD do not alter the state law that's almost always the same as the federal definition of marijuana. The only way the following paragraph changes is by an act of Congress.

The term marihuana means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

G.O. Joe said:

The push has been mostly for medical instead of total deregulation, so what did you all expect - the sacred ganj but not legal drug dealers being part of the controlled substance dispensing system? I'm not seeing the federal government having a west coast or Europe aura around it any time soon. You should be expecting only expensive FDA-approved dosages of pure cannabinoids, if you get anything.

All extracts of cannabis including Epidiolex and even the essential oil are unambiguously schedule 1 under federal law, when enforced. Marinol is synthetic. Many of the recent state laws regarding CBD do not alter the state law that's almost always the same as the federal definition of marijuana. The only way the following paragraph changes is by an act of Congress.

The term marihuana means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Click to expand...

Could you please cite where that italicized quote was taken from?

It’s listed under “Definitions” in the Controlled Substances Act. See item #16 in the attached link.

http://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm

1) GW is not "big pharma." They are small pharma and, to my knowlege, only produce Cannabis drugs. I expect before too long they will be a take-over target for one of the real big pharma companies.

2) GW has done and is doing some of the very best medical Cannabis research in the world. I've learned a lot from their publications and, of course, most of what they know is kept proprietary. The only other place where they are doing good research combined with clinical trials is Israel. This research is critical in coming to understand the plant and what she can do.

3) Will GW make money off it? I hope so. They deserve it.

4) The seeds you own and the plants you grow are yours. Nobody can patent or get exclusive rights to the Cannabis species. At the worst, in some future time when Cannabis takes its place alongside all other agricultural products people may breed legally acceptable cultivars which can be protected. That is not the case now except with registered European hemp varieties.

What I took from the article was that she never said GW was big pharma but used them as an example and then also went on to describe hearings, etc., and ended with the piece with speculative questions. Maybe the headline is a bit misleading but I got that she wasn't calling GW big pharma, but using their new drug as an example of things to come.