
FDA approves first marijuana-derived drug and it may spark DEA rescheduling - mikece
https://arstechnica.com/science/2018/06/fda-approves-first-marijuana-derived-drug-and-it-may-spark-dea-rescheduling/
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spruciefic399
The current drug regulation regime strikes me as backwards--it seems that the
more appropriate assumption should be to not regulate a substance, until it
can be shown to be harmful (I'm not talking about label accuracy; I see that
as more of a truth-in-labeling issue).

To me, cannabis illustrates how absurd the current drug regulation paradigm
is. The idea that it would be classified as a Schedule I substance is
ridiculous. But to get the FDA to change anything, you have to have people
engaging in illegal behavior, to create a demand for specific legislative
action about a specific substance, to drive a market for a derivative
chemical, to petition to the FDA, to begrudgingly change the scheduling.

I've come to the conclusion that drug scheduling and the war on drugs is an
economic failure, leads to police abuse and socioeconomic injustices, and acts
to reinforce monopolies in the health care market, by ceding power over access
to specific providers.

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saagarjha
> it seems that the more appropriate assumption should be to not regulate a
> substance, until it can be shown to be harmful

How are you going to stop people from dying when I sell arsenic as a baldness
cure?

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AstralStorm
It is not just about harm. FDA rules on medical products also in fitness of
purpose. If you can show that your arsenic preparation is effective and safe,
it will be allowed on the market. Likewise MDMA preparations and cannabis
preparations for specific purposes. (They cannot because it is schedule I. )

DEA governs the drug schedule, not FDA. That should be don from almost
strictly criminal point of view, with major politicization.

~~~
gumby
> It is not just about harm. FDA rules on medical products also in fitness of
> purpose.

This is because most drugs aren't really that good for you, however in the
context of some illness, the disease may be worse than the unwanted effects of
the drug.

A good example is methotrexate (MTX): wow, it really clears up its patients'
arthritis, but it's so toxic that it's only administered to patients who are
more at risk of dying of cancer than of the MTX.

I've appeared before the FDA (in pursuit of drug approval) and in my
experience they're actually more than fair. The biggest problem is the
assholes who try to game the system, which just gums up the works for
everyone.

edit: I'm no longer in that biz so have nothing to gain by praising or
condemning the FDA. The approval process is far from perfect but I honestly
think it's pretty good overall.

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freeone3000
Researchers having trouble due to Schedule 1 status in the states seems weird,
when Canada just legalized recreational use. What has this war on drugs given
America?

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TrashQuestion
The honest answer is that it gives conservatives the ability to be racist and
imprison minorities for minor offenses.

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dang
Taking HN threads into flamewar is not allowed here. We ban accounts that do
this, so please don't. The effects on the community are destructive and
basically always the same.

[https://news.ycombinator.com/newsguidelines.html](https://news.ycombinator.com/newsguidelines.html)

~~~
King-Aaron
It should be noted that the above comment is likely far less trying to incite
a flame war, and more likely referencing the alleged reasoning for the 'war on
drugs' was to directly marginalise African Americans and 'hippies'.

"The Nixon campaign in 1968, and the Nixon White House after that, had two
enemies: the antiwar left and black people. You understand what I'm saying? We
knew we couldn't make it illegal to be either against the war or black, but by
getting the public to associate the hippies with marijuana and blacks with
heroin, and then criminalizing both heavily, we could disrupt those
communities. We could arrest their leaders, raid their homes, break up their
meetings, and vilify them night after night on the evening news. Did we know
we were lying about the drugs? Of course we did."

— John D. Ehrlichman, former Nixon aide, interview with Dan Baum

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TrashQuestion
This is what i was going for, i should have cited my source

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refurb
THC is already an approved drug in the US under the name nabilone. It’s
schedule 2.

This newly approved drug is CBD. There is no need for the DEA to reschedule
marijuana. They’ve already been ok with this contradictory scheduling for over
a decade.

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24gttghh
>THC is already an approved drug in the US under the name nabilone. It’s
schedule 2.

Nabilone is a THC _analog_ , with a slightly different molecular makeup than
THC extracted from Cannabis. So no, THC is not schedule 2 under US law, as it
is explicitly listed schedule I under the Controlled Substances Act.

Granted, the WHO recommends it be listed schedule III or IV, which I agree
with...

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refurb
Good point on nabilone being an analogue, not THC itself.

I guess my point is that the DEA doesn’t require it’s scheduling to be logical
at all.

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joveian
There is also GHB/sodium oxybate. It would be nice if this approval caused a
major shift, but I tend to doubt it.

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gwbas1c
Most important quote:

> We’ll continue to support rigorous scientific research on the potential
> medical uses of marijuana-derived products and work with product developers
> who are interested in bringing patients safe and effective, high-quality
> products. But, at the same time, we are prepared to take action when we see
> the illegal marketing of CBD-containing products with serious, unproven
> medical claims. Marketing unapproved products, with uncertain dosages and
> formulations, can keep patients from accessing appropriate, recognized
> therapies to treat serious and even fatal diseases.

I can't believe the number of ridiculous statements I've seen and heard about
medical marijuana. It's our modern-day equivalent of the witch doctor.

Looks like the FDA is finally going to allow legitimate research and medicine.
[Edit] This will reign in all the unproven claims that marijuana is
essentially a cure-all.

[Edit] I support complete legalization of marijuana for recreational use.

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GordonS
Perhaps someone from the US could help me understand the federal vs state
legality of cannabis in the USA?

Can a state override _any_ federal law?

Could federal-level law enforcement theoretically charge someone in a
cannabis-legal state for drug offenses?

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taejo
> Can a state override any federal law?

No, by the "Supremacy clause" of the Constitution.

> Could federal-level law enforcement theoretically charge someone in a
> cannabis-legal state for drug offenses?

Yes. Because people interact much more with local police than federal police,
it makes a big difference whether or not the local police enforce these laws.
The Obama administration also chose not to enforce federal marijuana laws in
states with less restrictive state laws. But both of these relate to
enforcement rather than legality.

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gremlinsinc
Actually, IIRC/IANAL, SINCE recreational use is legal in D.C., federally the
government's hands are tied, because I believe what is legal in D.C. is legal
in all federal jurisdictions (except where state laws says otherwise), so
Federally, I believe Marijuana is no longer prosecutable per se, I could be
wrong -- but states that still ban it can prosecute since it's their state
law.

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taejo
Sounds like a legal urban legend.

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gremlinsinc
Maybe, I heard it on here, and they probably were 'IANAL' too.

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king_nothing
Marijuana is only schedule 1 because of Nixon attacks against his “enemies,”
hippies and blacks, as cooberated by Ehrlichman. And as the 1920’s and
Portugal prove, Prohibition always backfires and helps criminals.

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trisimix
Wait sched 1? I can buy it at the vape shop nextdoor in detroit.

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freehunter
It's legal/decriminalized in some states/cities but that is in spite of
federal law, not because of it. It's still illegal at the federal level.

