FDA Rejects MDMA for PTSD: Archaic Gatekeeping
A Setback For The Entire Psychedelic Ecosystem
Today, the FDA rejected Lykos Therapeutics' (formerly MAPS PBC) application for MDMA-assisted therapy in treating PTSD.
A deeply saddening and frustrating outcome… but are we entirely surprised?
The advisory committee meeting held in June brought to light several concerns about the trials themselves including the study’s lack of control over participants’ expectations, inadequate measures to track addiction potential, lack of double blinding and reports of alleged misconduct during the trials.
While some of these concerns are valid ones, the FDA (Fear-Driven Authority) committee members appeared to be blinded by their own narrow-minded lens.
These flaws were characterized as mountains.
The language used was fixed.
The evidence cited was poor and in some cases non-existent.
This is more than just a bureaucratic setback; it reveals significant flaws in our regulatory system. Despite decades of research and advocacy, along with years of hand-holding between MAPS and the FDA to reach a collective agreement, today’s decision underscores a critical issue: the FDA’s rigid adherence to outdated standards that stifle innovation.
A Sad Day For Advocates
For the vast majority of psychedelic advocates, this rejection lands like a gut punch.
Not just because it feels like 40 years of advocacy, philanthropy and hard work has been halted, but because our hearts and souls are driving this movement.
Among the different concerns raised during the June hearing, one that stood out to me the most was the concern that the nature of this movement might conflate the findings of the studies and compromise their scientific integrity.
What a load of garbage.
The world is in dire need of a movement for mental wellness.
Current solutions for mental health are awful. Pharmaceutical companies are literally profiting off of the sick… a global tragedy that has been clearly documented now for years — in fact there is an entire Netflix special detailing one corner of it.
The concern that we should be careful not to get too distracted by the “hype” of this movement is baffling when you look at what we’re up against.
Psychedelic evangelism is one thing but a psychedelic movement grounded in peer-reviewed science, decades of underground research and millions of personal experiences is another.
I am so grateful to be part of this movement.
It is one of the most heart-driven and soul lead that I have ever come across and it is this movement which is going to ensure psychedelics become accessible.
Archaic Gatekeeping
The FDA feels like an archaic gatekeeper, blocking innovative treatments based on narrow, one-sided ways of knowing.
The agency’s decision to demand further trials, which could take years, shows a fixation on control rather than progress.
This approach not only delays the availability of potentially life-saving therapies but also hinders the exploration of new, holistic approaches to mental health care.
Our regulatory system should be evolving to meet the needs of modern medicine, yet it remains stuck in outdated frameworks that prioritize bureaucratic procedure over patient outcomes and results. This decision by the FDA is a disservice to those who are desperately seeking effective treatments and to the scientific community that has worked tirelessly to bring these therapies to the forefront.
Looking Forward
The FDA’s rejection of MDMA-assisted therapy for PTSD serves as a wake-up call.
An entire industry has been built around the expectation of this high and mighty “YES”.
Corporations both public and private have anchored themselves to this decision with their mission and visions hanging on one simple word.
What path lies ahead now following this significant setback?
On the one hand, we can take this moment as an opportunity to critically and carefully examine the potential drawbacks of the clinical trials that MAPS & Lykos have pioneered. As a community, we can retreat and pivot, redirecting our energy and trying again to appease the FDA with the changes they are requesting.
On the other hand, we can challenge the rigidity of our regulatory system and advocate for a more inclusive, forward-thinking approach to evaluating new treatments. We can take this moment as an opportunity to seriously consider entirely different methods of access that focus on bottom-up, community lead systems. To shift our focus away from medicalization and towards a process that actually extends from the psychedelic experience itself.
Taking inspiration from mycelium and from nature.
Taking inspiration from the myriad of connected experiences many of us have shared and forge a new path forward.
The potential of psychedelic therapies should not be stifled by archaic gatekeeping and we should not have to appease an agency and a system that put us in our peril in the first place.
Instead, we need a system that embraces innovation, recognizes the value of holistic healing, and prioritizes the well-being of those suffering from mental health conditions.
I think there is merit in both of these pathways and I am confident both will gain traction simultaneously. We need both. But we need to stop overemphasizing one over the other.
As Lykos Therapeutics navigates the challenges ahead, it’s crucial for the psychedelic community to continue advocating for change. The fight for safe, effective, and equitable access to transformative therapies is far from over.
By shining a light on the flaws in our regulatory system, and by bringing our authentic stories and experiences forward, we can push for the necessary reforms to ensure that groundbreaking treatments like MDMA-assisted therapy are given the fair evaluation they deserve.
We’ve fought for this long.
We’ll keep going.
Farewell Until Next Time 👋
If you have any feedback or thoughts around this article, feel free to leave a comment below. I hope to follow this one up in the near future with a more concise and thorough analysis but for now, my emotional reaction will have to do.
I hope you keep your eyes on the path forward and don’t let this discourage you from doing the important work that you are doing. As for me, I am off next weekend to host another MDMA Retreat.
If you enjoyed the article, please forward it to a friend.
With psychedelic love and gratitude,
- Michael & The Flying Sage Team 🤍
Thank you for sharing your passionate words on this poignant topic ❤️🙏🏻
This is bang on. 🙌🏻