FDA Approves First Drug Derived From Marijuana Plant (wsj.com)

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.

Comments

Reason #2 why Marijuana's not legal

[rsilvergun]

Reason #1 is our private prison industry, which wouldn't be profitable if the only people we locked up were actual violent criminals. Pot heads are great because they just quietly do their time.

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.

Re:Reason #2 why Marijuana's not legal

[alvinrod]

Focusing on the private prison industry (8% of total prisoners in the U.S.) is ignoring the bigger problem: prison guard unions support the same measures that increase prison population and they're much, much larger and politically more powerful. According to this article police and prison guard groups were responsible for about half of money raised to oppose legalizing recreational marijuana in California.

Re:Reason #2 why Marijuana's not legal

[rogoshen1]

Assigning a profit motive to incarceration is inherently *vile*.

Re:Reason #2 why Marijuana's not legal

[Darinbob]

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?

Schedule C

[PortHaven]

So then the Federal government should be forced to drop the Schedule C classification.

Re:Schedule C

[TheFakeTimCook]

So then the Federal government should be forced to drop the Schedule C classification.

Schedule 1; but yes.

Re:Schedule C

[Thelasko]

I believe you mean schedule 1.

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.

The current list just makes no sense.

Re:Schedule C

[sjames]

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.

Full stop

[TFlan91]

" 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

[HornWumpus]

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.

Re:Full stop

[HornWumpus]

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 you make a business of it, nobody cares.

For a proprietary strain, you don't know exactly what the parents are. You can guess, you can DNA test or you could just buy the non-proprietary cutting. The point is FDA legalities.

I have no experience growing high CBD strains.

Re:Full stop

[galabar]

It may not be patented, but rather, kept secret by the company.

Try some hemp underwear

[raymorris]

I always tell them to try some hemp underwear. So much better than cotton. If you're a masochist.

Minimal Euphoria

[lazlo]

"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.

Re:First drug other than Marinol?

[HornWumpus]

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.

Cue FDA vs. DEA pissing contest in 3, 2, 1...

[Ellis D. Tripp]

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...

[amicusNYCL]

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.

The DEA recently added "Cannnabis Extracts" to C1.

[Ellis D. Tripp]

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.

Re:Because:

[markdavis]

>"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:

[c6gunner]

That's great, but we can't all be liberal arts professors ...

Re: Because:

[markdavis]

>"That's great, but we can't all be liberal arts professors ..."

LOL! Nearly fell out of my chair reading that :)

Re:Because:

[kilfarsnar]

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.