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posted by CoolHand on Tuesday June 26 2018, @03:34PM   Printer-friendly
from the green-america dept.

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.

Related: FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis
UC San Diego to Treat Autism Using Cannabidiol


Original Submission #1Original Submission #2

Related Stories

FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims 24 comments

The U.S. Food and Drug Administration is warning four companies that sell products containing cannabidiol (CBD) to stop making unsubstantiated health claims, such as "combats tumor and cancer cells":

The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases.

The companies in question are Greenroads Health, Natural Alchemist, That's Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC.

Also at Bloomberg, The Cannabist, The Hill, NBC, and Newsweek.

Related: U.S. Federal Cannabis Prohibition Remains Intact
"Hollyweed" and More Cannabis Stories
According to Gallup, American Support for Cannabis Legalization is at an All-Time High
Study Finds That More Frequent Use of Cannabis is Associated With Having More Sex


Original Submission

World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis 24 comments

The Schedule I status of cannabis and component compounds like cannabidiol (CBD) is being undermined yet again:

The US Drug Enforcement Administration has long held that the non-psychoactive component of marijuana, cannabidiol, is a schedule I drug. That is, a drug that has no accepted medical use and a high potential for abuse. But according to a preliminary report embraced by the World Health Organization this week, the DEA's long held stance is tripping.

In a preliminary report last month, the WHO's Expert Committee on Drug Dependence concluded—and WHO agreed—that clinical and pre-clinical studies of CBD show no evidence of a potential for users to abuse the drug or suffer any harms. Moreover, the experts found plenty of inklings that CBD has medical benefits, particularly for treating epilepsy. In its conclusion, the ECDD declared that the current data "does not justify scheduling of cannabidiol."

The ECDD's report is just a first glance, however. The committee, which is generally tasked with assessing which drugs should be internationally controlled (scheduled) and how, will take a more extensive look in May of 2018. Then, it will review cannabis overall, as well as other cannabis compounds.

CBD has shown promise in a trial as a treatment for psychosis:

An ingredient in cannabis called cannabidiol or CBD has shown promise in a clinical trial as a potential new treatment for psychosis, scientists said on Friday. Scientists conducted a small trial of people with psychosis and found patients treated with CBD had lower levels of psychotic symptoms than those who received a placebo. Psychosis is characterized by paranoia and hallucinations.

[...] In the trial, 88 patients with psychosis received either CBD or placebo for six weeks, alongside their existing antipsychotic medication. Beforehand and afterwards, the scientists assessed symptoms, functioning and cognitive performance, and the patients' psychiatrists rated their overall condition overall. "The study indicated that CBD may be effective in psychosis: patients treated with CBD showed a significant reduction in symptoms, and their treating psychiatrists rated them as having improved overall," said Philip McGuire, who co-led the trial.

Also at The Conversation.

Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial (DOI: 10.1176/appi.ajp.2017.17030325) (DX)


Original Submission

UC San Diego to Treat Autism Using Cannabidiol 6 comments

UC San Diego to use controversial marijuana compound to treat severe autism

UC San Diego will try to alleviate severe autism in children by giving them a non-psychoactive chemical found in marijuana, a project funded by the biggest private donation ever made in the U.S. for such research.

The $4.7 million study involves the controversial compound cannabidiol, or CBD, which is widely marketed nationwide as something of a miracle drug, capable of treating everything from cancer to post-traumatic stress disorder.

[...] UC San Diego dealt with the issue by asking the Ray and Tye Noorda Foundation of Lindon, Utah, for $4.7 million to study whether CBD can ease the most severe symptoms of autism, including seizures, self-injuring behavior, and crippling anxiety. The foundation agreed, and it is urging the federal government to remove marijuana from its list of Schedule 1 drugs so that cannabis can be widely studied.

Related: 4/20: The Mary Jane Majority
US experts back marijuana-based drug for childhood seizures


Original Submission

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  • (Score: 0, Funny) by Anonymous Coward on Tuesday June 26 2018, @03:42PM (3 children)

    by Anonymous Coward on Tuesday June 26 2018, @03:42PM (#698805)
    Ebony and Ivory live together in perfect harmony
    Side by side on my piano keyboard, oh Lord, why don't we?
    • (Score: -1, Offtopic) by Anonymous Coward on Tuesday June 26 2018, @04:12PM

      by Anonymous Coward on Tuesday June 26 2018, @04:12PM (#698822)

      Because Ebony bearing trees are threatened and Ivory bearing animals are endangered you insensitive clod! Every keyboard is another shoah!

    • (Score: 0) by Anonymous Coward on Tuesday June 26 2018, @04:44PM

      by Anonymous Coward on Tuesday June 26 2018, @04:44PM (#698841)

      We probably could, if you weren't just butt ugly.

    • (Score: 2) by takyon on Tuesday June 26 2018, @11:02PM

      by takyon (881) <takyonNO@SPAMsoylentnews.org> on Tuesday June 26 2018, @11:02PM (#699010) Journal
      --
      [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
  • (Score: 1) by khallow on Tuesday June 26 2018, @04:09PM (8 children)

    by khallow (3766) Subscriber Badge on Tuesday June 26 2018, @04:09PM (#698820) Journal
    One wonders how soon something like Epidiolex would have come out, if marijuana had been legal all along. Looks like 80-90 years of cessation into such work because of the prohibition games of the time.
    • (Score: 4, Insightful) by frojack on Tuesday June 26 2018, @04:24PM (3 children)

      by frojack (1554) on Tuesday June 26 2018, @04:24PM (#698833) Journal

      With the number of states legalizing Marijuana (recreational or medical) approaching a majority, soon a simple up or down vote is probably all that is needed to remove it entirely from DEA's mandate. None of the horror stories have come true. Even in the road crashes cases where marijuana was claimed a large percentage of had other alcohol involved.

      Canada is lighting up this month.

      Junk science takes way too long to be exposed.

      --
      No, you are mistaken. I've always had this sig.
      • (Score: 5, Insightful) by Thexalon on Tuesday June 26 2018, @04:54PM

        by Thexalon (636) on Tuesday June 26 2018, @04:54PM (#698845)

        Junk science takes way too long to be exposed.

        Especially when there's so much money to be made from it not being exposed.

        --
        The only thing that stops a bad guy with a compiler is a good guy with a compiler.
      • (Score: 2, Funny) by realDonaldTrump on Tuesday June 26 2018, @06:33PM (1 child)

        by realDonaldTrump (6614) on Tuesday June 26 2018, @06:33PM (#698892) Homepage Journal

        Let me tell you, there's no vote. There's a guy that decides. I pick that guy -- could be a lady -- and the Senate gives an OK. Or maybe the Senate is very foolish and they tell me, pick another guy. I haven't picked my permanent permanent guy for DEA. But I have Robert W. Patterson as the acting guy.

        • (Score: 1) by realDonaldTrump on Tuesday June 26 2018, @07:17PM

          by realDonaldTrump (6614) on Tuesday June 26 2018, @07:17PM (#698923) Homepage Journal

          Looks like someone thinks just about every recent tweet I have made is a troll.

          I think that someone lost very badly when we did have a vote -- when our great Electoral College voted in 2016 -- and now she hates our Country. She hates our terrific government. She lost to me. But she would have lost to Lyin' Ted. To Kasich. To Carson. And possibly even to Low Energy Jeb!

    • (Score: 2) by Runaway1956 on Tuesday June 26 2018, @04:37PM

      by Runaway1956 (2926) Subscriber Badge on Tuesday June 26 2018, @04:37PM (#698838) Journal

      Came to say very much the same. This would be awesome, if it were 1918. Now, in 2018, it's more like, "About frigging time!"

    • (Score: 3, Informative) by ilPapa on Tuesday June 26 2018, @06:52PM

      by ilPapa (2366) on Tuesday June 26 2018, @06:52PM (#698912) Journal

      One wonders how soon something like Epidiolex would have come out, if marijuana had been legal all along.

      Yeah, just legalize it. I live in a state where it's legal to grow, sell, possess and smoke pot, and you don't have to go through the dramatics of getting a doctor's note. Hell, in my town, you can have it delivered. And guess what? the world did not end. There are not crazed dope fiends running wild through the streets and children aren't being exposed to weed any more than they were previously.

      I'm not a smoker, but it's pretty ridiculous that there are states that haven't done this yet. Legal weed is creating jobs, businesses, tax revenue, and people who aren't quite so stressed. I'm all for it.

      --
      You are still welcome on my lawn.
    • (Score: 2) by krishnoid on Wednesday June 27 2018, @07:37AM (1 child)

      by krishnoid (1156) on Wednesday June 27 2018, @07:37AM (#699185)

      So there's no similar pharmaceutical from other countries with saner drug (and socialized medicine) policies? Maybe the epileptic conditions it treats are too rare to be interesting research targets? This sounds kind of suspicious.

      • (Score: 1) by khallow on Wednesday June 27 2018, @11:17AM

        by khallow (3766) Subscriber Badge on Wednesday June 27 2018, @11:17AM (#699230) Journal

        So there's no similar pharmaceutical from other countries with saner drug (and socialized medicine) policies?

        Why develop a drug that you know from the start is going to be excluded from the most profitable market in the world?

  • (Score: 5, Insightful) by Thexalon on Tuesday June 26 2018, @04:52PM (4 children)

    by Thexalon (636) on Tuesday June 26 2018, @04:52PM (#698843)

    If you sell an active ingredient as an expensive patented pill, that's just good business and an advance in medicine. If you sell the same active ingredient in the form of a (as far as anyone can tell basically harmless) dirt-cheap plant, then you're a horrible monster who deserves to rot in jail forever.

    That's official US government policy. It makes about as much sense as Chewbacca living on Endor.

    --
    The only thing that stops a bad guy with a compiler is a good guy with a compiler.
    • (Score: 1, Troll) by realDonaldTrump on Tuesday June 26 2018, @06:42PM

      by realDonaldTrump (6614) on Tuesday June 26 2018, @06:42PM (#698907) Homepage Journal

      The only way to solve the drug problem is through toughness. When you catch a drug dealer you got to put him away for a long time.

      When I was in China and other places, by the way, I said, "Mr. President, do you have a drug problem?" "No, no, no, we do not." I said, "huh." Big country, 1.4 billion people, right? Not much of a drug problem. I said "what do you attribute that to?" "Well, the death penalty."

      Singapore, I said, "Mr. President, what happens with your drugs?" "No. We don't have a problem, President." I said, "really, why?" "We have a zero tolerance." And he is not playing games. "So what do you mean no problem?" "We have a zero tolerance policy." "What does that mean?" "That means if we catch a drug dealer, death penalty."

    • (Score: 2, Funny) by Anonymous Coward on Tuesday June 26 2018, @11:29PM

      by Anonymous Coward on Tuesday June 26 2018, @11:29PM (#699021)

      It can be an implanted pump.

      It can be a rectal suppository.

      It can be a spinal catheter.

      It can be injections into the eyeball.

      It can be a spray that goes up your nose.

      BTW, all of these are real.

    • (Score: 3, Informative) by stormwyrm on Wednesday June 27 2018, @12:01AM (1 child)

      by stormwyrm (717) on Wednesday June 27 2018, @12:01AM (#699036) Journal

      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

        by takyon (881) <takyonNO@SPAMsoylentnews.org> on Wednesday June 27 2018, @01:54AM (#699071) Journal

        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.

        Schedule I status is based on the DEA's own arbitrary standards feelings. 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]
  • (Score: 2) by DannyB on Tuesday June 26 2018, @05:41PM (3 children)

    by DannyB (5839) Subscriber Badge on Tuesday June 26 2018, @05:41PM (#698866) Journal

    It's about high time.

    --
    The people who rely on government handouts and refuse to work should be kicked out of congress.
    • (Score: 2) by NewNic on Tuesday June 26 2018, @05:49PM (2 children)

      by NewNic (6420) on Tuesday June 26 2018, @05:49PM (#698872) Journal

      It's about high time.

      Not really, they only approved the use of CBD and not THC (THC is what gets you high).

      --
      lib·er·tar·i·an·ism ˌlibərˈterēənizəm/ noun: Magical thinking that useful idiots mistake for serious political theory
      • (Score: 2) by realDonaldTrump on Tuesday June 26 2018, @06:48PM

        by realDonaldTrump (6614) on Tuesday June 26 2018, @06:48PM (#698910) Homepage Journal

        The THC was already approved. But only the artificial, they call it Marinol. And only for cancer & AIDS. Not for getting high!!!!

      • (Score: 2) by DannyB on Tuesday June 26 2018, @07:22PM

        by DannyB (5839) Subscriber Badge on Tuesday June 26 2018, @07:22PM (#698926) Journal

        It's about high time, since, I think about the 1930's.

        --
        The people who rely on government handouts and refuse to work should be kicked out of congress.
  • (Score: 0) by Anonymous Coward on Wednesday June 27 2018, @03:18AM (1 child)

    by Anonymous Coward on Wednesday June 27 2018, @03:18AM (#699104)

    Will they overturn those civil forfeiture cases against cash held by people possessing MJ?

    Land of the free, my balls!
                                                ^
    Why punctuation is important, friends.

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