We'll See If MAPS Reaction to FDA Advisors Vote Against MDMA Therapy Is Right

Spoiler alert: The team at MAPS were disappointed to say the least. Find out how the MAPS founder reacted to the FDA advisory committee's recommendation to not approve MDMA therapy for PTSD, and if his prediction could be right in the coming weeks .

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Doblin is Upbeat Despite Vote Against MDMA Therapy

Hearing interviews with MAPS founder Rick Doblin in the weeks before the FDA advisory panel released their review of his stage 3 clinical trials on MDMA therapy for PTSD, it's clear he's pretty hopeful. So when the panel voted against the approval of MDMA therapy in June it was certain to have been a hard blow.

But Rick didn't let the advisory vote get him too down - he has access to psychedelic therapy that can help him cope with the loss. At least he was upbeat publicly.

Soon after the vote Doblin was on the record as saying there's a, "substantially more than a 50/50 chance the application will be approved in August".

Rick is meaning the actual FDA vote on MDMA therapy that's coming up. The one with FDA members that previously approved the trial methods that the advisory committee had issues with. Issues that were cited as a big part for why they recommended the FDA not approve MDMA therapy for PTSD treatment. It's a point along with several others that MAPS and Lykos are publicly calling into question or outright refuting.

In other words, holes are being blown in the advisory committee's recommendations well before the FDA takes its vote.

To be fair, no psychedelic medication has gotten the thumbs up yet. Also, some of the panel's points were either purely anecdotal or really a non-issue as per precedence already set by the FDA. So, there is reason to hope the FDA will go against the advisory panel's recommendation.

Possible Contributing Factors for the MDMA Therapy Down Vote

Everything was looking really positive and proponents were really expecting a win with the advisory panel vote. What happened?

Lykos Didn't Play Nice With ICER

Lykos Therapeutics (the biotech firm associated with MAPS) failed to work with Institute for Clinical and Economic Review, or ICER, to identify shortcomings in the research prior to submitting their application for FDA approval in February 2024. The following month ICER released a report about Lykos' research, which highlighted issues. It was a factor for the committee members that voted MDMA therapy down.

Chief among the concerns was bias on the part of the researchers and even some participants as well as the inability to do a true blind study. It's kind of obvious to many people if they got the placebo, especially if they've done the psychedelic before, which some of the Lykos study participants had.

But in actuality the last concern is a known issue for many medications, and it hasn't held up approval in the past.

Politics is Always a Part of Psychedelics

It's our personal belief that part of the recommendation against approval is partly due to it being an election year. This might have just been a way of feeling out what kind of backlash there could be if approval were denied.

Thorough analysis of the clinical trial methods and results need to happen to ensure efficacy, but the FDA advisory committee seemed to lean heavily on worst case scenario assumptions. Now it's up to the FDA to determine if MDMA therapy is effective enough to gain approval.

Find MDMA Therapists Near You

There are licensed therapists that are using psychedelics to help patients that can benefit from psychedelic-assisted therapy. Even if the therapist isn't able to prescribe MDMA, they can assist you with intention setting, reflection on the experience and integration. All of these things have been shown to improve the results of psychedelic therapies like MDMA therapy.

Get started by searching for psychedelic therapists based on location, profession and psychedelic therapies.