A Sober Look at MDMA Therapy: What Happens Next?
As FDA deliberations loom, the promise and scrutiny of MDMA-assisted therapy for PTSD come to a head.
A landmark case for FDA approval of MDMA-assisted therapy (MDMA-AT) hangs in the balance. The precedence of the case is historic; it would be the first time a Schedule I (defined as having no medical use) substance would be rescheduled and the first time an FDA approval case was backed by donor support rather than pharmaceutical funding.
But on June 4th, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted against the approval of MDMA-AT, and their decision largely sets the tone for the final hearing, which happens mid-August.
Now, two essential questions need to be answered: What went wrong? And where do we go from here?
MDMA-assisted therapy (MDMA-AT) arose in a time of dire need for better solutions to post-traumatic stress disorder (PTSD). For decades, treatment options for PTSD have been stagnant, and none hold nearly as much promise as MDMA-AT.
While MDMA (AKA: ecstasy or Molly) is mostly known for being a recreational drug, it was, in actuality, being explored in psychotherapeutic research prior to entering the party scene. The psychoactive properties of MDMA were recognized by Alexander Shulgin in the 1970s, who introduced it to Leo Zeff, a psychotherapist who was impressed by the drug's ability to facilitate emotional openness, reduce fear, and enhance communication in therapeutic sessions.
MDMA became listed as a Schedule I substance in 1985, regardless of the opposition by researchers and clinicians at the time, who criticized the decision as a reaction to rising recreational use rather than on scientific evidence of harm.
The placement of MDMA in Schedule I effectively stifled scientific research on the drug for nearly a decade, and valuable time was lost that could have been used to explore its therapeutic potential and understand the risks and benefits.
This issue raises its head once again with MDMA-AT on the FDA chopping block in mid-August. Prior to the PDAC vote, there was a large overtone of optimism regarding MDMA-AT amongst leaders in the field. Now, in the aftermath, even the most optimistic hold the odds at 50/50.
However, it seems that most areas of contention regarding MDMA-AT are not regarding the treatment itself but rather the conduct of Lykos/MAPS, which is largely running the show of MDMA-AT.
MAPS, which has now rebranded to Lykos Therapeutics, has largely been credited with bringing psychedelic research to where it is today. After the illegalization of psychedelics, MAPS, along with its founder, Rick Doblin, pushed through the barriers imposed on research in order to prove that psychedelics indeed held therapeutic potential despite the pervasive war on drugs. However, issues began to arise in recent years, such as when researchers began to call out MAPS for misconduct and ethical concerns during their clinical trials.
The controversy surrounding MAPS/Lykos has become conflated with the question of whether or not MDMA-AT is a safe and effective means of treating PTSD. However, the hearing blurred the line between reviewing scientific research and public scrutiny of MAPS/Lykos.
MDMA-AT research already carries a greater burden of proof due to its Schedule I status, and there are concerns among researchers that the expectations of this will become all the more unreasonable if MDMA-AT is not approved in August.
For instance, a major point of contention is the functional blinding of participants during MDMA-AT clinical trials, which means that participants should not be able to tell what treatment they receive (MDMA vs. placebo). The problem is when working with psychoactive substances, it’s pretty easy to distinguish when you haven’t been given a drug.
A workaround to this issue is giving participants an active placebo, such as a low dose of MDMA or niacin, which causes face flushing and a feeling of warmth, so that the expectations of participants are less likely to affect the data.
But while there are still criticisms for the research design, there have been no offerings of better solutions, sending researchers on a Quixotic quest for answers.
In all of this, however, it seems most important to consider that, for some people, MDMA-AT does work. During the PDAC hearing, a phase III clinical trial participant, Cristina Pearse, related that “MDMA-assisted therapy saved my life.”
Pearse was sexually assaulted at the age of 5 and suffered from a severely adverse childhood. She grappled with PTSD, eventually being diagnosed at age 45, and did not find relief through conventional medications — one of which even made her feel energized to take her own life.
Pearse mentions:
"Within the first hour of the MDMA session, I felt an intense sense of repair — a spontaneous rewiring of my mind to body. The effects were immediate. The emotional flooding vanished. What used to feel like a tsunami of overwhelming panic was merely a puddle at my feet. A changed perspective is everything.”
Testimonies such as these highlight the necessity of developing the treatment model of MDMA-AT. Indeed, safety measures need to be put in place. Unscrupulous administration of MDMA-AT and improperly trained professionals would pose a risk of exacerbating PTSD symptoms. Developing a robust safety net for participants is an area of continual improvement that needs to be prioritized.
Ultimately, even if MDMA-AT is voted against during the final approval session in mid-August, this is not the end of the road. The research will carry on, as Dr. Rachel Yehuda, a leader in the field of PTSD and trauma research, aptly puts it,
“So now what? We keep going. Address the concerns methodically with more research. We’re not quitting but doubling down. A Gordon knot of issues were raised that must be untangled one by one. See that there is a need to educate and reassure even government advisory boards. We cannot deny trauma survivors, but we will have to up our game. Do better science. Prioritize safety over advocacy. Dim the hype. Hope the U.S. Department of Veterans Affairs will still help lead this charge. Our veterans with PTSD are counting on us. And not just veterans. It’s a setback and correction, not a game-over. We knew it wouldn’t be easy.”
Further Reading:
MAPS / Lykos: Who is to Blame and What Happens Next? (Ecstatic Integration)
A Psychedelic Train Wreck (The Journey)
MAPS is an MDMA Therapy Cult (Chemical Poetics)
Rolling Safe: Taking MDMA For the First Time (Tripsitter)
Alexander Shulgin's Greatest Psychedelic Hits (Tripsitter)
Designer Drug Exposé: Amphetamines & Other Stimulants (Tripsitter)
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