this post was submitted on 14 Aug 2024
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But Marks points out that the FDA typically follows the advice of its independent advisory committees — and the one that evaluated MDMA in June overwhelmingly voted against approving the drug, citing problems with clinical trial design that the advisers felt made it difficult to determine the drug’s safety and efficacy. One concern was about the difficulty of conducting a true placebo-controlled study with a hallucinogen: around 90% of the participants in Lykos’s trials guessed correctly whether they had received the drug or a placebo, and the expectation that MDMA should have an effect might have coloured their perception of whether it treated their symptoms.

Another concern was about Lykos’s strategy of administering the drug alongside psychotherapy. Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), the non-profit organization that created Lykos, has said that he thinks the drug’s effects are inseparable from guided therapy. MDMA is thought to help people with PTSD be more receptive and open to revisiting traumatic events with a therapist. But because the FDA doesn’t regulate psychotherapy, the agency and advisory panel struggled to evaluate this claim. “It was an attempt to fit a square peg into a round hole,” Marks says.

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[–] some_guy@lemmy.sdf.org 17 points 3 months ago

I was on MDMA when I had an aha moment that allowed me to set down my mother's bigotry and stop being homophobic. Smoking cigarettes outside in light rain at a rave, this flamboyantly gay guy was cracking jokes and was really funny. I had the thought, "He just wants to take drugs and have a good time on a Saturday night, he's just like me." Instant loss of homophobia forever.

I advocate MDMA use in therapy. I'm convinced it can be useful.

[–] homesweethomeMrL@lemmy.world 12 points 3 months ago

So (to point #1) we can’t approve a psychedelic for medicinal use because we can’t fool people into thinking they took this psychedelic. Despite the evidence it’s helpful as a medicine.

Somehow that’s reminiscent of Nixon making pot a schedule I drug - highly dangerous - to prevent Democratic votes.

[–] BackOnMyBS@lemmy.autism.place 12 points 3 months ago (2 children)

around 90% of the participants in Lykos’s trials guessed correctly whether they had received the drug or a placebo

I understand the logic with using a placebo comparison, but who cares if people got better solely because they know they took ecstasy?

[–] SynonymousStoat@lemmy.world 21 points 3 months ago (2 children)

I'm no scientist, but I don't really know how you can have a study of a psychoactive drug and the participants not be able to guess if they had the drug or the placebo.

[–] Nighed@sffa.community 9 points 3 months ago

Give them a different psychoactive drug I guess... Not really a true placebo though.

[–] WhatAmLemmy@lemmy.world 4 points 3 months ago* (last edited 3 months ago) (1 children)

These people are scientific bureaucrats who just go "computer says no". This is clearly a case where "the gold standard" fails and another approach is necessary. That's if they're not on the payroll of big pharma to hamstring adoption of alternatives they can't patent.

[–] ArcticDagger@feddit.dk 3 points 3 months ago (1 children)

I agree that it's a shame that it's so difficult to eliminate the placebo effect from psychoactive drugs. There's probably alternative ways of teasing out the effect, if any, from MDMA therapy, but human studies take a long time and, consequently, costs a lot of money. I'd imagine the researchers would love to do the studies, but doesn't have the resources for it

I think the critique about conflicts of interest seems a bit misguided. It's not the scientists who doesn't want to move further with this. It's the FDA

[–] lolcatnip@reddthat.com 3 points 3 months ago (1 children)

I didn't think the idea of a placebo effect is even valid for a treatment for which no placebo exists. At best, it's a thought experiment, but IMHO it's more of a distinction without a difference.

[–] ArcticDagger@feddit.dk 0 points 3 months ago (1 children)

That's an interesting point. But maybe there are some compounds that can induce a state that fools people who've never tried psychoactive compounds? I've heard of studies using dehydrated water as a placebo for alcohol as it induces some of the same effects:

Like ethanol, heavy water temporarily changes the relative density of cupula relative to the endolymph in the vestibular organ, causing positional nystagmus, illusions of bodily rotations, dizziness, and nausea. However, the direction of nystagmus is in the opposite direction of ethanol, since it is denser than water, not lighter.

https://en.m.wikipedia.org/wiki/Heavy_water

[–] WhatAmLemmy@lemmy.world 2 points 3 months ago* (last edited 3 months ago)

That example is not a placebo. It's the opposite of a placebo. A placebo is supposed to be the control. The baseline "truth" in a hypothesis. The entire idea of the placebo effect is that the individual's own psychology — their expectation of an effect — induces a physiological response, which pollutes the baseline hypothesis and all test data. Thus, the entire purpose of a double blind is to negate that bias from impacting the researcher, or the rat being studied.

That is fucking stupid when studying pretty much any drug people bother to take recreationally. They take them recreationally because they have an acutely noticeable effect. Unless you're a virgin amish person or child, you're gonna know when you're drunk or high; MDMA, LSD, or Psilocybin are on a whole other level, especially at the doses taken for psychiatric treatment. A placebo would only make sense if you were testing micro-doses that are so low they're widely considered to be imperceptible.

So no. The "gold standard" is wholly insufficient to adequately study drugs that induce a significant psychological response. These drugs need to be analyzed by people who hold a greater understanding of their effects, and our perception of reality, than bureaucrats who have zero experience with what they're studying. The only thing worse than a pseudo double blind would be rejecting significant drugs because they don't fit into our existing ape-like understanding of reality (or capitalism), resigning to "computer says no", and preventing millions of people from receiving an improvement in their quality of life; ignorance, stupidity, and maliciousness can cause the same level of damage.

[–] ArcticDagger@feddit.dk 12 points 3 months ago (2 children)

But if they know they're getting ecstasy, the improvement might originate from placebo which means that they're not actually getting better from ecstasy. They're just getting better because they think they should be getting better

[–] Hamartiogonic@sopuli.xyz 9 points 3 months ago (1 children)

Yeah, that’s the thing with placebo. It’s surprisingly effective, and separating the psychological effect from actual chemistry can be very tricky. If most participants can correctly identify if they’re bing fed the real drug or a placebo, it makes it impossible to figure out how much each effect contributes to the end result. Ideally, you would only use effective medicine that does not need the placebo effect to actually work.

Imagine, if all medicine had lots of placebo effect in them. How would you treat patients who are in a coma or otherwise unconscious?

[–] BackOnMyBS@lemmy.autism.place 3 points 3 months ago (1 children)

Yeah, that's my point. What does it matter that they got better because they think they should get better? To me, what matters is that they got better, regardless of the reason. Bonus: they got high on ecstasy while under medical supervision.

Option A: Take a pill that doesn't feel like ecstasy and no one gets better.

Option B: Don't tell patients that ecstasy makes them feel better. Give them ecstacy. 20% of patients get better.

Option C: Tell patients that ecstasy can make them feel better. Give them ecstacy. 40% of patients get better.

Personally, option C seems like the most effective and thus preferred option. I don't see any downside whatsoever.

[–] ArcticDagger@feddit.dk 2 points 3 months ago

To a certain extent I agree, but I also think it's a tricky topic that deals a fair bit with the ethics of medicine. The Atlantic has a pretty good article with arguments for and against: https://web.archive.org/web/20230201192052/https://www.theatlantic.com/health/archive/2011/12/the-placebo-debate-is-it-unethical-to-prescribe-them-to-patients/250161/

Yes, in your three situations, I'd agree that option C is the best one. But you're disregarding a major component of any drug: side effects. Presumably ecstasy has some nonnegligible side effects so just looking at the improvement on the treated disease might now show the full picture

[–] VubDapple@lemmy.world 2 points 3 months ago

It's viewed as a drug of abuse and not as a legitimate drug so the people with a hard-on for being anti-drug care