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FDA rejects ecstasy as a therapy: what’s next for psychedelics? (www.nature.com)

submitted 2 months ago by ArcticDagger@feddit.dk to c/science@lemmy.world

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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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[–] ArcticDagger@feddit.dk 3 points 2 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 2 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 2 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 2 months ago* (last edited 2 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.