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.
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.
The problem is that you can’t tell if it’s truly working due to the placebo effect.
Yeah, I understand that. But if there’s a measurable difference between the efficacy of the 2 pills that even the patient is obviously aware of, why does that warrant extreme caution versus another pill that doesn’t have this effect?
Like why is it better to have a study in which the patient literally can’t tell the difference between treatments? Why is it not detrimental for a federal agency to unilaterally dismiss this?
I understand that people online aren’t obligated to engage with me thoughtfully, but I was hoping for an actual explanation that is longer than 50 words from someone who is more knowledgeable than me regarding the validity of scientific experiments as they relate to pharmaceuticals.
The idea of modern medicine is to sell chemical compounds that actually have an effect. It’s a philosophical and ethical thing. All products have a unique psychological effect that gets intertwined with their biochemical effect. If you can’t study them individually, it’s impossible to tell if the biochemical effect even exists at all. If your medicine relies heavily, or even entirely, on the psychological side, it’s no different than homeopathy. The idea of modern medicine is to be better than the old stuff that preceded it.
I prefer to think of this as an equation like this: Pm+Bm=Pp+Bp
Pm=psychological effect, medicine
Bm=biochemical effect, medicine
Pp=psychological effect, placebo = surprisingly big
Bp=biochemical effect, placebo = 0
If these sides are equivalent, the medicine is just as effective as placebo. If the medicine side is bigger, you’ll want to know how much of it comes from the P and B terms. In order to figure that out, you would need to know some values. Normally, you can just assume that Pm=Pp, but if you can’t assume that, it you’re left with two unknowns in that equation. In this case, you really can’t assume them to be equal, which means that your data won’t allow you to figure out how much of the total effect comes from psychological and biochemical effects. It could be 50/50, 10/90, who knows. That sort of uncertainty is a serious problem, because of the philosophical and ethical side of developing medicine.
I’m not sure if the biochemical effects of a placebo are 0.
Shamelessly stolen from Wikipedia because I couldn’t find the original source