this post was submitted on 14 Aug 2024
3 points (100.0% liked)

science

14546 readers
176 users here now

just science related topics. please contribute

note: clickbait sources/headlines aren't liked generally. I've posted crap sources and later deleted or edit to improve after complaints. whoops, sry

Rule 1) Be kind.

lemmy.world rules: https://mastodon.world/about

I don't screen everything, lrn2scroll

founded 1 year ago
MODERATORS
 

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.

top 14 comments
sorted by: hot top controversial new old
[–] some_guy@lemmy.sdf.org 1 points 2 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.

[–] BackOnMyBS@lemmy.autism.place 0 points 2 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 1 points 2 months ago (1 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.

[–] WhatAmLemmy@lemmy.world 1 points 2 months ago* (last edited 2 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 0 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 0 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 1 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.

[–] ArcticDagger@feddit.dk 0 points 2 months ago (1 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 1 points 2 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?

[–] rand_alpha19@moist.catsweat.com 0 points 2 months ago (1 children)

So, let's just use an example of a pill that treats headaches so I can understand, because I'm kinda stupid.

It works super well, and most patients taking it in double blind trials find it relieves headache pain considerably. Why is it a bad thing, to the point of rejecting it as a treatment, that the patient feels that the pill is working very well and has concluded on their own that this is probably not a placebo?

I can understand a patient being misled by coincidence, but surely a measurable, verifiable, and repeatable benefit to the patient compared to pills without medicinal ingredients would warrant a different conclusion, wouldn't it?

In your coma scenario, I'm sure there is a statistical analysis that can be performed to show with a degree of certainty that a specific medication has a higher likelihood of being effective than a placebo in a controlled experiment.

I commented on this same story a while ago when it first broke that it was likely to be rejected and I don't think anyone explained it in the thread.

[–] qaz@lemmy.world 0 points 2 months ago* (last edited 2 months ago) (1 children)

It works super well, and most patients taking it in double blind trials find it relieves headache pain considerably. Why is it a bad thing, to the point of rejecting it as a treatment, that the patient feels that the pill is working very well and has concluded on their own that this is probably not a placebo?

The problem is that it's not a double blind trial because the participants can tell whether they are on it. The placebo effect is also a problem because there is no real control group.

[–] rand_alpha19@moist.catsweat.com 0 points 2 months ago (1 children)

But why is that such a problem that it's worth rejecting what is otherwise widely considered an effective treatment?

I am fundamentally not understanding the inherent risk to patients resulting from the structure of the study that is apparently so harmful that it must not continue.

Why is being able to tell that your medication is working a negative thing in a study? And such a negative thing that it apparently negates all other positive aspects of the medication.

[–] qaz@lemmy.world 1 points 2 months ago

The problem is that you can't tell if it's truly working due to the placebo effect.