The FDA said there wasn't enough data showing the drugs helped patients and asked for another clinical trial.

The US has denied a bid to allow MDMA, commonly known as ecstasy or molly, to be used in the treatment for post-traumatic stress disorder (PTSD).

The US Food and Drug Administration (FDA) was examining the psychedelic drug made by Lykos Therapeutics to treat the mental health disorder in combination with talk therapy.

  • Yer Ma@lemm.ee
    532·
    5 months ago

    Okay I’ll just go back to killing myself with alcohol so I can sleep

  • FrenziedFelidFanatic@yiffit.net
    281·
    5 months ago

    Personally, I want FDA approval to mean it is as provably safe and effective as possible. They said they wanted more evidence before approval, and I think that’s okay. Good, even.

    The way the US treats recreational drug use and self-medication is horrific, but it’s not really the domain of the FDA.

    I would rather have not-yet-FDA-approved legal-for-personal-use mdma than what we have now or an unproven drug approved by the FDA.

    • frezik@midwest.social
      1·
      5 months ago

      IIRC, advocates in this space were expecting this outcome. The research around MDMA-based treatment is promising but not quite there yet.

      Psilocybin-based treatment, on the other hand, is looking more solid.

    • Cethin@lemmy.zipEnglish
      47·
      5 months ago

      Shouldn’t it need to be shown to be unsafe to remove people’s choice to use it though? Proving it safe would be great, but the claim to prevent usage should be that it’s harmful. It’s removing a choice. We shouldn’t have to prove everything is safe to be allowed to do it. We do plenty of things that are unsafe, but these drugs aren’t allowed for no good reason.

      • Blueberrydreamer@lemmynsfw.com
        10·
        5 months ago

        Allowing anyone to just sell whatever chemical they come up with without first showing that it’s safe would be insanely irresponsible.

      • Firoaren
        31·
        5 months ago

        ???

        K, well, you also have the choice to eat literally any mushroom you find growing in the ground, doesn’t mean it’d be legal to sell them as shishkabs on the street. Wtf are you on about mate

        • Cethin@lemmy.zipEnglish
          54·
          5 months ago

          It’s illegal to use these drugs, no matter how you get them. Should that be the case just because some old people don’t like people using them, not because they’re particularly harmful? Alcohol causes a ton of harm, but it’s legal to use. Why is it different?

          • lath@lemmy.world
            25·
            5 months ago

            Prohibition. Moonshine. Anyone can make alcohol at home out of fruit.

            Can you make ecstasy at home out of fruit?

            • Cethin@lemmy.zipEnglish
              43·
              5 months ago

              Strawman. You aren’t legally allowed to make ecstacy at home even if you are capable, nor are you allowed to consume it if you have it. Also, ecstacy wasn’t illegal during the prohibition. That’s all irrelevant.

              People should be allowed to do what they want as long as it doesn’t pose a serious risk to others. Racism is most of what caused the war on drugs, and it’s mostly futile, and often actively harmful. It prevents people from accessing things that may help them (or they may just enjoy), and creating black markets where none need exist. It also creates situations where people may buy stuff and it not be pure, which could be controlled for if legal.

              • lath@lemmy.world
                14·
                5 months ago

                Yes, you are a straw man. Alcohol worked because it’s different from ecstasy. Everyone could and did make it at home out of food. Can you make ecstasy at home out of regular food or does everyone do it regardless of law? No. The two are too different in circumstances and so can’t be placed in the same category.

                Black markets exist because they’re profitable. The war on drugs was for money, racism was just the hook to get the investors on board.

                Also, legality is dependent on the legalizers. Where corruption is rife and consequences nil, legality is worthless when it comes to quality control.

                • Cethin@lemmy.zipEnglish
                  12·
                  5 months ago

                  Yes, you are a straw man.

                  Lol. What does that mean? Your argument was a strawman argument. You constructed something new to argue against instead of my original argument.

                  Everyone could and did make it at home out of food. Can you make ecstasy at home out of regular food or does everyone do it regardless of law? No. The two are too different in circumstances and so can’t be placed in the same category.

                  I can grow my own mushrooms with psilocybin. It’s under the same controls as ecstacy. Do you stand by your logic and agree it should be legal to grow and consume? That isn’t the logic used to make it illegal though, which is what matters.

                  Black markets exist because they’re profitable.

                  Yes, and it’s profitable because there’s no legal alternative. There are very few black markets for alcohol, for example, because it’s not necessary and not profitable when a legal option is easily available with checks to ensure it’s safe and actually what it says it is. Legalize drugs and we can make them safer to use and mostly eliminate black markets, which create a lot of danger and criminal activity.

                  The war on drugs was for money, racism was just the hook to get the investors on board.

                  No, it was mostly for politics, and winning them through racism. It’s fairly well documented.

                  Also, legality is dependent on the legalizers. Where corruption is rife and consequences nil, legality is worthless when it comes to quality control.

                  If there is proof of quality, even without consequences from the government (which should probably also be in place), consumers wouldn’t purchase from places selling a bad product unless it’s significantly cheaper. The consequence would be fewer buyers and having to have lower prices. Legality also allows people to seek treatment without fear of being held accountable for using an illegal product. It let’s people openly discuss options and issues. It also creates an environment for legal competition, not just turf wars. Legalizing drugs has a huge number of benefits without going into things like the harm caused by policing.

    • bobs_monkey@lemm.ee
      2·
      5 months ago

      Exactly. Why have a cheap, one off drug when you can make billions with something expensive that’ll be needed for the duration of your life, and might possibly give you side effects that’ll require additional drugs that they also happen to sell? To not do so would be socialism!

  • NotMyOldRedditName@lemmy.world
    171·
    5 months ago

    When they deny something like this because of claimed flaws in study, do they give detailed descriptions of the flaws and help (maybe for a fee) the petitioner make a new study?

    Or do they leave it vague enough so they can just perpetually say it’s flawed?