For the past three years, separate from my work as Enthereal’s Founder, I’ve been raising concerns about the potential pitfalls in the MAPS MDMA trials. With the FDA’s recent decision to deny approval for MDMA with “Assisted Therapy” (MDMA-AT) for PTSD treatment, those concerns have been tragically validated.
This denial isn’t merely a regulatory hurdle; it’s a significant moment of reckoning for MAPS, and Lykos PBC, and its leadership under Rick Doblin.
Participants in these trials, and those who might have followed, were led to believe that MDMA-AT was the “emerging gold standard” in PTSD treatment. However, as we delve deeper into the details, it becomes clear that the research conducted did not meet the rigorous standards necessary for a treatment of this importance.
Rick Doblin / Lykos / MAPS did their best, with clearly large resource pool, and they did not even do the correct studies. Nor did they do the incorrect studies ethically.
Now, the ethical and methodological cracks in MAPS’ approach have been exposed, culminating in not one but two (EDIT: THREE) retractions from Psychopharmacology, a journal under the same esteemed publishing umbrella as Nature.
These retractions are more than just a blemish on the record; they’re a testament to the significant ethical breaches that have occurred.
It’s important to clarify that this criticism isn’t about stifling innovation or preventing the development of therapies that could potentially change lives. I am deeply committed to advancing treatments for PTSD, a condition that I, and many others, have personally struggled with. However, the populations involved in these studies are incredibly vulnerable—I’ve seen this both as a patient and through my recent work in clinical practice.
The sensitivity and professionalism required in such work demand the highest levels of ethics and morality at every stage.
The recent revelations make it clear that these standards were not upheld. A significant article was retracted due to protocol violations amounting to unethical conduct. The authors, affiliated with MAPS, failed to disclose these violations or remove compromised data. Additionally, there were undisclosed conflicts of interest tied to MAPS, the very organization that funded and provided the MDMA for these trials.
Here’s an excerpt from the retraction notice from one – you can read it here:
“The Editors have retracted this article after they were informed of protocol violations amounting to unethical conduct at the MP4 study site by researchers associated with this project. The authors have subsequently confirmed that they were aware of these violations at the time of submission of this article but did not disclose this information to the journal or remove data generated by this site from their analysis. Additionally, the authors also did not fully declare a potential competing interest. Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS. As is stated in the Funding declaration, MAPS fully funded and provided the MDMA that was used in this trial, and MAPS PBC organized the trial.”
The FDA’s rejection, combined with these ethical breaches, should serve as a wake-up call. This isn’t just a minor setback; it’s a stark reminder that, no matter how promising a treatment might appear, the path to approval must be grounded in integrity, transparency, and an unwavering commitment to the well-being of participants.
This decision has far-reaching implications for the entire field of psychedelic research. It’s imperative that we learn from these mistakes and ensure that future studies are conducted with the highest ethical standards.
Sometimes, being correct is not what you want to be, and this is one of those times. I take no pleasure in being proven correct about my suspicions, mostly ignored, but the signs were there. Since before the summer of 2023, I’ve been warning about the potential challenges MAPS would face with their approach to MDMA clinical trials.
Rick Doblin’s focus on marketing and fundraising, rather than on maintaining rigorous scientific standards, has not helped. For those of us who met him in the 2000s and maybe were even caught up in the hype then, eventually the warning signs were there in 2021, 2022, and 2023, and we didn’t shrug them off.
We saw the signs, and sometimes, one does get to say, “We told you so.”
Kiya Kersh is Founder and CEO of Enthereal, cultivating a portfolio of value for access, sustainability, and resilience of essential medicines supply chains. Kiya also possesses lived experience of PTSD, and outlined world-first biosyntheses of sustainable Active Pharmaceutical Ingredients for essential medicines like ketamine and epinephrine. As well, Kiya worked at early biochemicals pioneer and Caltech / Frances Arnold spinout, Gevo, where she completed hands-on research work for the MSci, Chemistry degree, as well as holding a double-major MBA (Finance and Strategy) from Drucker School of Management, Claremont Graduate University. Kiya completed undergraduate studies at the home of QSAR (Quantitative Structure-Activity Relationships), Pomona College, also in Claremont, where she was introduced to MDMA, LSD, and other performance-enhancing approaches, such as flow psychology, in the late 1990s. She’s currently studying in an accelerated Emergency Medical Technician program through August 2024, in anticipation of more clinical work. Kiya loves sharing experiences with people in and around the mountains, oceans, and deserts of California.
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