FDA rejects ecstasy as a therapy: what’s next for psychedelics?
FDA rejects ecstasy as a therapy: what’s next for psychedelics?
Following the US drug agency’s decision, Nature examines the outlook for other hallucinogens that are in clinical trials as psychiatric treatments.
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.
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.
17around 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?
12I'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.
21Give them a different psychoactive drug I guess... Not really a true placebo though.
9
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
12Yeah, 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?
9Yeah, 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.
3
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.
12It'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
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