FDA Approves First Drug Derived From Marijuana Plant (wsj.com) 116
The U.S. Food and Drug Administration on Monday approved the first prescription drug derived from the marijuana plant, as a treatment for rare forms of epilepsy that primarily afflict children. From a report: The FDA said Monday that it cleared GW Pharmaceuticals's Epidiolex, also known as cannabidiol, to reduce seizures associated with forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. Cannabidiol is derived from the cannabis plant, also known as marijuana. U.K.-based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis designed to maximize a therapeutic component while minimizing components that produce euphoria. GW Pharmaceuticals grows the plants in the U.K.
The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Further reading: StatNews, The Guardian, and FDA.
The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Further reading: StatNews, The Guardian, and FDA.
Because: (Score:2)
Euphoria is bad, MMkay?
Re: It's funny though... Trump got the druggie vot (Score:1)
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1) He won according to the rules all the candidates were bound by, and
2) When talking about individual counties, it is correct to say that he won some by a larger margin than others, regardless of the ultimate outcome.
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If you like euphoria, you're bad...so don't be bad.
Also, 90210 had an episode where Emily took Brandon to a rave where a guy sold "Euphoria" (a made up drug). Emily told Brandon that she knew he sold it because he had a football jersey with "U4" on it. Damn kids and their drugs
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Was that "Steve's rave?" Hey, you guys going to Steve's rave? Steve's hosting a rave! And it was just a normal house party.
Euphoria (U4EUh) not a made up drug... (Score:2)
https://en.wikipedia.org/wiki/... [wikipedia.org]
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Oh wow, all these years I thought it was one of those funny 90210 made up things. Point taken, thank you for clarifying =p
Re:Because: (Score:5, Insightful)
>"Euphoria is bad, MMkay?"
Yeah, being "high" can, indeed, be bad in any number of situations when you might need to take a medication... like driving, operating on someone, doing dangerous work, operating machinery, being paid to be productive, making important decisions of directing people, etc.
Being able to take medically-useful components out of marijuana, while suppressing the "high" is a great step forward that can benefit lots of people who otherwise would not be able to take it. It is unfortunate that the ridiculous listing of marijuana as "Schedule 1" makes it so difficult and dogmatic to do useful research and create useful products.
Re: Because: (Score:1)
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In a more polite way of putting it that may enlighten the GP, CBD dominant marijuana will not make you high (and can actually counteract the psychoactive component of THC that may be required for things like pain relief) but has been linked to numerous benefits including mood stabilization, anti-inflammation, allergy suppressant, and potentially cancer fighting.
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Sounds like we need research into CBD dominant marijuana then. It would be great if we had a time release pill with all those benefits rather than having to smoke it. And if we could isolate the chemicals involved and understand them, we might be able to create more drugs with those specific individual benefits.
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Sounds like we need research into CBD dominant marijuana then. It would be great if we had a time release pill with all those benefits rather than having to smoke it. And if we could isolate the chemicals involved and understand them, we might be able to create more drugs with those specific individual benefits.
Yes we do, only problem, as a few people mentioned already, Cannabis is classified as a schedule I drug under the DEA's narcotic classification list meaning it's right up there with other baddies like: LSD and Heroin. That's seriously limiting the ability for researchers to get their hands on it. Also what pisses me off is that the definition of a schedule 1 drug is: that they: "have high abuse potential, no medical use, and severe safety concerns" I don't know what the safety concerns of Cannabis would be
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I actually think that part of the effectiveness of some drugs, especially drugs aimed at pain, is enhanced by euphoria because it provides a mood elevation that counter-acts the mood depression of pain and the serious illness that often accompanies it.
I think that even if they create magic pills that block pain with zero euphoria they might find that in controlled testing the drugs are viewed as less effective because they don't treat the mood depression that accompanies pain-causing illness.
An interesting
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It is unfortunate that the ridiculous listing of marijuana as "Schedule 1" makes it so difficult and dogmatic to do useful research and create useful products.
I chuckled when I read the summary, because the US government is now officially contradicting itself. Schedule 1 drugs have a high potential for abuse and no knows medical use. Now we have the FDA approving a medical use. As a regular marijuana user, I appreciate the absurdity.
Re: Because: (Score:4, Funny)
That's great, but we can't all be liberal arts professors ...
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>"That's great, but we can't all be liberal arts professors ..."
LOL! Nearly fell out of my chair reading that :)
Reason #2 why Marijuana's not legal (Score:5, Insightful)
Bonus reason #3 is that our uneven law enforcement policy allows states to implement defacto segregation by harassing and locking up minorities that show up in the 'wrong' place. Bonus reason #4 is harassing people who get uppity about political issues like the hippy left.
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President Nixon, who lead the creation of current cannabis scheduling, was quoted as wanting cannabis to remain illegal (the SCOTUS had recently ruled that prior schemes to require tax stamps that were never sold were unconstitutional, rending it it legal) so that he could use it to prosecute his 'enemies' in the anti-war movement (white liberals, aka hippies) and and the civil rights movement (more hippies and blacks). [forbes.com]
So, aside from your childish denials, what can you bring to support your claims?
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"Why did we have to have a constitutional amendment to ban alcohol....and another one to legalize alcohol again, YET.....pot was outlawed with the stroke of a pen in congress?"
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Do YOU even know what you mean by that? Or is it just something you heard Alex Jones say and so you thought it must be true?
Here is a good example. This woman is so toxically vicious that Democrats are trying to stuff her back into her cage like a rabid pit bull:
https://www.realclearpolitics.... [realclearpolitics.com]
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Do YOU even know what you mean by that? Or is it just something you heard Alex Jones say and so you thought it must be true?
Here is a good example. This woman is so toxically vicious that Democrats are trying to stuff her back into her cage like a rabid pit bull: https://www.realclearpolitics.... [realclearpolitics.com]
Funny how Republicans never seem to do that. They put their toxically vicious people at the top of the ticket. Maxine Waters has said she advocates only peaceful protest. 404: Advocating violence not found. The Democrats are only trying to shut her up because they have no balls.
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Assigning a profit motive to incarceration is inherently *vile*.
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The problem isn't private prisons per se, but the government is basically washing their hands of the problem, 'outsourcing' the problem and failing to be accountable.
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Private prisons are not inherently bad but there can be problems like with any government operation that can use power of the state for corrupt purposes profiting specific people and companies.
Actually, they really are inherently bad. The companies are making money by locking people up, and therefore have a profit motive to maximize the number of people incarcerated, and for as long as possible. The incentive structure is just inherently fucked up. As you point out, it is also ripe for abuse and corruption. It's just bad all around.
Your bonus reason 3 is bogus and not substantiated by fact. Your bonus reason 4 is bogus and not substantiated by fact. Hippies also suck ass. The left is advocating violence and harassment. Maybe they need a time alone in a cage to think about their actions.
If you are interested, you should research the origins of the War on Drugs. It really is about racism and going after political enemies.
Re:Reason #2 why Marijuana's not legal (Score:4, Informative)
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It depends on the type of people being locked up. Minorities, hippies, street kids, runaways, well... if they get caught up in a drug abuse epidemic then lock up and forget about them seems to be society's response. But "normal" people caught up in the current opiate epidemic and now the problem needs to be solved with medical and social workers and not with prisons. A double standard?
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There's also the idea that some cops worry that small-time pot dealers (mostly blacks) will turn to other, potentially more dangerous, types of criminal behavior if pot is legalized and undermines their income.
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There was an op-ed in the local paper yesterday written by a former cop and police chief that said pretty much this.
It was in response to the city aborting a police sting operation that was busting small time pot dealers (some as low as 1-2 grams) selling on the street downtown.
It turned out that they only busted black people, but the apparent 100% racism isn't entirely clear since the chief *and* the downtown precinct commander are both black and at least one (if not both) of them would have approved of th
Schedule C (Score:3)
So then the Federal government should be forced to drop the Schedule C classification.
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So then the Federal government should be forced to drop the Schedule C classification.
Schedule 1; but yes.
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I don't understand how you can ban testing on a substance because it has no known medical use. If you can't test it, how will you ever know?
I could understand if the list of substances under schedule 1 was basically just potent poisons like arsenic, and cyanide. However, even those may have some therapeutic uses. [wikipedia.org]
The current list just makes no sense.
Re:Schedule C (Score:4, Informative)
You're confusing the categories. Sched 1 is SUPPOSED to be for drugs with high abuse potential, high addictive potential and NO recognized medical value.
Schedule 2 is for drugs with high abuse and addiction but with a recognized medical value.
Unfortunately, the scheduling is based on politics and the feels rather than an actual objective evaluation, even ignoring simple logic. Based on the simple logic that marijuana is actually prescribed by doctors in good standing wherever it is legal and that it is not considered addictive, it probably belongs in schedule 4 or 5 (since it does have potential for abuse). CBD oil shouldn't even be scheduled. At worst, it should be classified as a supplement.
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Actually, yes I can. If a DOCTOR in good professional standing prescribes the substance anywhere at all, it has a recognized medical value. Keeping it on schedule 1 after that is the DEA breaking the law.
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It's not prohibited where they prescribe it.
Full stop (Score:5, Insightful)
" is made from a proprietary strain of cannabis"
Full fuckin stop right there.
How is DNA proprietary? If I have two plants at home and they spawn a seed with similar genetics, am I going to get sued for some patent violation?
Re:Full stop (Score:4, Informative)
You breed two strains. You have a F1 hybrid with unique properties, it will not breed true and nobody except you knows exactly which strains you crossed.
As a practical matter, you own it.
They can square the plant (manipulate the genetics of a cutting to make it produce male parts) than cross it to itself. But that produces an inbred version, which won't be as good as the original (see modern 'Trainwreck'). As noted above, a regular self cross (breeding two instances in the regular way) won't produce more of the same, rather a 3rd generation with each individual having randomized properties, some being 100% like original parent 1, some 100% like parent 2, each trait being mixed individually).
Seed companies have 'owned' strains of hybridized plants since _long_ before genetic engineering. There are patented rose strains, taking cuttings is criminal.
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So you're saying that my "experimentation" of cross-breeding plants and getting lucky with a seed strain similar to the one in FTFA would not violate any patents?
Let's say I had two of these seeds. I planted the first, found out what it could do, then planted the second and turned it into a mother plant from which I take a lot of clones.
Or what if I continue to cross-breed the original two strains?
Honestly curious, you're first answer has me even more curious.
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A similar strain violates nothing, high CBD, low THC strains are readily available. Theirs is nothing 'special', just FDA reviewed, which will have been an expensive process. By putting a particular strain's output to FDA review, they can own the FDA CBD market, for a while. But now that this drug has passed review, chemically similar drugs from non-proprietary strains will have really good odds at the FDA, but who will fund the studies?
It is already 'illegal' to take cuttings from some roses, but unless
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Legality 'ship has sailed' in the USA.
This does setup a DEA vs FDA pissing contest. All pot is still illegal per the DEA, but they can't find juries to convict and the last people that care are on the verge of death from old age.
To say nothing of the old folks that now use legal pot for their aches and pains, many of them are realizing they were lied to.
There are many high CBD low THC strains that aren't 'owned'. There is one that has passed FDA review. They all remain theoretically illegal, but are
Re:Full stop (Score:4, Insightful)
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Patenting plants is not new. Most of the vegetables you eat are probably from a patented strain developed and mass produced for sale to farmers. Bananas without seeds, corn that grows with less water while producing more fruit, soybeans that resists insects, crops that will only grow from the bought seed and all of the resulting seeds are sterile, etc. It guarantees a farmer can sell their yields for authorized purposes (food for cattle and humans for example) but prevents them from selling the seeds to
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If I have two plants at home and they spawn a seed with similar genetics, am I going to get sued for some patent violation?
Monsanto has been trying educate bees on copyright law for several years -- they've been spreading the round-up ready gene all over the place.
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How is DNA proprietary?
Because Fuck You, that's why. [nih.gov]
Although at least they invalidated patents on genes found in nature.
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Proprietary can mean secret - they have developed a cultivar that they aren't making available to anyone else.
Proprietary could also mean that yes, they do have a "patent" on the cultivar via something known as "Plant Breeder's Rights". That's something that's been around for a long time because developing new cultivars of plants is something that takes years of trial and error and much expense.
I come from a family that's been in horticulture for a few generations and my grandfather obtained PBR on a type o
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" is made from a proprietary strain of cannabis"
Full fuckin stop right there.
How is DNA proprietary? If I have two plants at home and they spawn a seed with similar genetics, am I going to get sued for some patent violation?
Yes, if Monsanto(Bayer) owns the DNA.
Try some hemp underwear (Score:3, Funny)
I always tell them to try some hemp underwear. So much better than cotton. If you're a masochist.
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Did you know the reason marijuana is illegal is because of the cotton industry didn't want the hemp industry to happen? Some guy told me that at a concert once. Blew my mind. Hemp is much superior to cotton. That is why people who smoke pot love hemp. They are intensely interested in material science.
DuPont and Nylon; but yes.
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Right. Nylon. Potheads are really interested in Nylon. And DuPont.
No, you vegetable.
DuPont had just invented Nylon. Nylon was used to make rope, like for Navy ships.
Hemp was the traditional fiber for Ropemaking.
DuPont worked behind the scenes to get Pot (and thus also Hemp) "demonized", and eventually made illegal.
1. No more Hemp for rope. No more competition for Nylon.
2. ???
3. DuPont Profits!
Don't believe me: Here's the first reference I could find to this almost forgotten bit of history:
http://www.ozarkia.net/bill/po... [ozarkia.net]
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There is truth to that, but it was bolstered by racism and xenophobia. Marijuana was a drug thought to be smoked by Latin Americans coming North to take our jobs. It was also popular in Jazz circles, music mostly created by African Americans. White America couldn't stand the thought of their sons and daughters smoking pot and associating with blacks and hispanics.
First drug other than Marinol? (Score:1)
And by first drug, they mean the first one since Marinol, the Schedule III medical grade THC right?
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Marinol is pure _synthetic_ THC. It was never a pot plant.
Marinol is the way to go if you've got a fed related job that includes 'pissing on command' in the job description. The script, not the pills, they can't tell.
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And by first drug, they mean the first one since Marinol, the Schedule III medical grade THC right?
Marinol was completely symthetic; but yes.
The DEA recently added "Cannnabis Extracts" to C1. (Score:3)
Marinol is "dronabinol", a name apparently invented for synthetic THC, which as you noted, is Schedule III, simply because it came from a lab, not a plant.
THC (or any other compound) extracted from an actual cannabis plant is a naughty Schedule I drug.
Minimal Euphoria (Score:4)
"citing minimal reports of euphoria in patients who took the drug in clinical studies."
This is, of course, after controlling for the natural euphoria that comes from not having seizures.
That'd be like (Score:2)
Trojan creating a line of condoms that, "Stops pregnancy and the spread of STDs, all without the pesky euphoria that comes from sexual intercourse!"
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Yes.
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From a chemical that comes from a plant that does not have any addictive qualities and a person can quit cold turkey if they want to? WOW!
Exactly.
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>"From a chemical that comes from a plant that does not have any addictive qualities and a person can quit cold turkey if they want to?"
Quite a few people would argue with that statement. Just because something isn't physically addictive doesn't mean it can't create a physiological dependency (an older term for addiction). Semantics aside, it absolutely is an intoxicant and it is quite evident that some people will go to great lengths to get stoned over and over again on pot, even if it costs them thei
Cue FDA vs. DEA pissing contest in 3, 2, 1... (Score:5, Interesting)
The active ingredient in this drug (cannabidiol, CBD) is still listed as a Schedule 1 controlled substance (Cannabis Extracts), and rescheduling it would be a public admission that the plant it is derived from also has medical applications, and itself would then be disqualified for Schedule 1 status.
Will be really interesting how the inter-agency pissing contest over this plays out, now that Big Pharma has some skin in the game...
Re:Cue FDA vs. DEA pissing contest in 3, 2, 1... (Score:4, Interesting)
My money is on no laws changing and the government continuing to act like there is no accepted medical use. It will probably take a court case to force them to change, especially with Sessions being there.
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Until they approve only the patented strains "invented" by big pharma, and put the screws to everyone else.
Must have that $100,000 testing and approval done before it can be sold as medical. Everyone else is still breaking the law as desired.
Why not both? (Score:2)
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Does the DEA still even care about marijuana?
While I'm sure individuals in the DEA are still subscribed to a marijuana-driven moral panic and opposed to anything other than jailing marijuana users and dealers, the broader culture has moved so far towards legalization and acceptance its hard to see how the DEA isn't affected by this, too.
Maybe they hold out some kind of hope that the next state to legalize marijuana has all kinds of provable problems related to it or the public loses interest, it seems like
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There is more medical support behind Marijuana than just epilepsy. It is also useful for treating nausea for cancer patients and chronic pain. But I agree that part of the problem with medical marijuana is that some of the strongest proponents are just potheads latching onto the medical angle. I've had people downplay the need for medical research into Marijuana under the argument that people can just smoke it.
Don't try peddling this devil oil to me! (Score:2)
Epilepsy in post-children? (Score:2)
"... as a treatment for rare forms of epilepsy that primarily afflict children."
So what happens with time?
1 They grow out of the epilepsy
2 It change to a different form in adults
3 It kill most sufferers before adulthood
4 The statement is wrong, it should say onset is in children
Lennox-Gastaut syndrome [wikipedia.org]
No support for 1 or 2, refutes 3 (mortality rate on order of 5% over 10 years).
Dravet syndrome [wikipedia.org]
Refutes 1 and 2.
Doesn't cause a high (Score:1)
Thank goodness (Score:2)
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We finally found a "medical" reason to grow the stuff! said stoners everywhere.
We only needed a medical reason because, "I like it, and it's relatively harmless" wasn't good enough for some people.
Epidiolex, also known as cannabidiol... (Score:1)
Where were all the headlines when companies were selling CBD derived from hemp? Same compound, different source. It doesn't matter what strain it came from, it's
Ronald Reagan says: (Score:2)
... taken by mouth ... (Score:2)
That will be ideal as a treatment for vomiting.