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FDA approves country's first medicine made from marijuana
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. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
"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 expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.
Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.
Cannabidiol (CBD).
Also at TechCrunch.
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World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis
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(Score: 3, Informative) by stormwyrm on Wednesday June 27 2018, @12:01AM (1 child)
There are good reasons to prefer purified active ingredients, and none of them have anything to do with patents. My favourite example is a drug known as digoxin, which is used to treat cardiac arrhythmias. It can be obtained from the foxglove plant (genus Digitalis) and had been used for treating such heart ailments since at least the 18th century. The only problem is that digoxin has a rather narrow therapeutic index so if you were to make a concoction out of some foxglove plant which for whatever reason just happens to have a higher than normal amount of digoxin, you could kill the person you administered it to. Frankly, I'd rather have purified active ingredients in an expensive patented pill rather than playing what amounts to Russian roulette with dirt-cheap plants that may have too much or not enough of the active ingredient in them thank you very much. The scientists, pharmacologists, and physicians who did all the hard work of figuring out what in a plant does medically useful things and how much of it to properly administer have earned their keep I think. However, selling the same active ingredient in the form of a plant whose purity you cannot really assess and whose medical quality you cannot measure doesn't make you a horrible monster, but at most a fool who may injure oneself or others. As far as I can tell the FDA isn't going after naturopaths who administer foxglove tea, though they probably should.
This is a totally separate issue from marijuana prohibition though. The fact that it's been illegal for so long means that the kind of research needed to even figure out what sorts of active ingredients it has that are medically useful has been stunted. They made marijuana illegal for political reasons unrelated to its medical usefulness or lack thereof. The history of its prohibition is heavily tainted by racism [businessinsider.com]. No, Big Pharma, for all its faults and sins, is not to blame for this.
Numquam ponenda est pluralitas sine necessitate.
(Score: 2) by takyon on Wednesday June 27 2018, @01:54AM
Schedule I status is based on the DEA's own arbitrary
standardsfeelings. You can find plenty of research that identifies medical uses for cannabis, LSD, etc., but they are still on Schedule I. It's all bullshit, even before you take into account stuff like [vice.com] this [vice.com].[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]