Ecstasy's path to approval for PTSD treatment faces doubts from FDA staff | Hacker News Reader

Ecstasy's path to approval for PTSD treatment faces doubts from FDA staff

washingtonpost.com

26 pointsbookofjoe18 comments

>The FDA noted that it asked the company to collect reports associated with abuse, but researchers failed to capture effects such as “euphoria” or “elated mood,” information that could gauge the risk of abuse.

God-forbid someone simultaneously experience joy from a substance that is shown to be clinically beneficial. This is not oxycontin, for heaven's sake. This is an occasionally-to-be-used, in-clinic, last-stop medicine with well-documented clinical benefit.

An odd kind of "approval", isn't it, when it's of the form:

"I'm going to take this substance because I've researched it may fix my crippling illness and the risk reward is comfortable to me - but I hear you bunch throw people into cages if you see them do things like that, so can I get your promise you won't throw me into a cage if I try to cure myself in this specific way?".

Classic "are we the baddies?" scenario.

How long did it take to reschedule marijuana again?

I’m not a pot head, but the hypocrisy was hard to miss.

Marijuana remains Schedule I in the US:

> 7360 Marijuana, including cannabis resin > 7350 Marijuana extracts; cannabinoids

The alleged rescheduling to Schedule III has yet to pass muster with the White House Office of Management and Budget, so it remains vaporware until then and the scheduling will likely not be changed for months after that.

https://en.wikipedia.org/wiki/List_of_Schedule_I_drugs_(US)

Ho, isn’t that the icing on the cake.

Double blind when you have mind altering substances is hard.

Maybe they need a confounding effect from something else?

But if in the end, the combination of MDMA and therapy works, the fact that double blind couldn't prove it may matter less, if some other acceptable basis of measurement can be drawn up.

Maybe double blind in assessment of pre- and post- treatment mental states by independent health professionals on test scores, satisfaction surveys, or whatever?

What if the psychoactive effects are the beneficial part of MDMA?

Right, exactly. They very well could be.

I personally think that the psychoactive effects are symptoms, not causes of the brain plasticity which permits therapy to make lasting changes in ideation.

ie, it's not the mood, or the visuals: its the underlying changes in brain connectivity and how they persist.

Not all drugs are the same. MDMA was used in couples therapy in the 1970 not because of its lasting brain changes, but because when you're being flooded by egregious amounts of serotonin and oxytocin it's easier to be more open, loving and understanding toward your loved ones. In social settings, it's hard not to fall in love with any random stranger. In therapy, you might fall in love with your partner once again, if just for a few hours.

Everyone that has taken MDMA once could attest to that.

The long term effects of methylenedioxymethamphetamine are, like its composition suggests, mostly bad unless used with moderation ("no more than once a season", suggested Ann Shulgin)

MDMA is very different from ketamine or psilocybin that have lasting mood lifting effects. Low-grade, short-term depression is usually the result of a good MDMA session if not properly managed.

One could endeavor to design a blinded study by putting patients under general anesthesia.

Double-blind studies are not always possible (anesthetics are a perfect example) and the clinical evidence for the benefits of MDMA are formidable.

I have never attended a protest in my life, but will be on the first flight out to Maryland if the FDA rejects this drug.

You'll be happy to know that it has been tried with ketamine: https://www.nature.com/articles/s44220-023-00140-x

https://archive.ph/EE4Hm

MDMA (what's ecstasy?) could get approval but it could also result in people getting addicted to it. Doesn't take a lot of searching to find stories of people who damage their brains after prolonged usage. I'm sure MDMA has its benefits, but there's probably other risks involved in prescribing it in a healthcare setting. Benzodiazepines were routinely given out by doctors, but probably worsened overall anxiety in a lot of patients. Now they are rarely prescribed.

The protocol submitted for FDA approval is for just three doses, once per month, in a supervised setting. And that’s it. This isn’t a situation where people will be picking up a 90-pill, 3 month supply from their pharmacy for daily at home use.

This will not significantly contribute MDMA supply to the black market, and is unlikely to create “dependence” in the way that indefinite daily opiate or benzo prescriptions do.

I'm really sceptical about the idea of treating people with mental heal issues with MDMA, as the "comedown" from it can be horrendous and causes a period low mood, depression, fatigue, anxiety, etc. Not the kind of thing you want people with PTSD experiencing! Those side effects are of course dose dependant. There is no mention of what is considered a dose, but it no uncommon for people to take a gram or more recreationally over the course of an evening.

A gram will keep you up for three days. That seems excessive to me.

For a small therapeutic dose of 150mg (1.5-2mg/kg) the come-down is minimal and presents more as "fragile" and not "depressed". That beautiful sunset really hits you to the core. Wow, there's a lot of negative energy in this airport.

I'm glad it's proposed as a therapy aid. Both during and after a journey having a scribe and guide seem like it would lead to many breakthroughs.

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