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.
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?
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.
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.
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
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
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?
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.
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.
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
