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These have been very challenging times at MAPS, at Lykos, in the entire psychedelic ecosystem, and in the world at large. Personally, I’ve been working at MAPS for more than 38 years towards FDA approval of MDMA-assisted therapy, including focusing on this topic in my 2001 Ph.D. dissertation. Lykos, MAPS, and the entire movement have just experienced a massive setback with FDA’s rejection of Lykos’ New Drug Application (NDA) for MDMA-assisted therapy for PTSD, and the unrelated retraction of three scientific papers. This week has culminated in the last day of work at MAPS for several friends and colleagues whose talent and dedication have been a gift to MAPS over the years. We will miss them greatly.
Appeals, though the outcomes are uncertain, are in process for the FDA’s rejection and the retraction of the papers. FDA has called for a third Phase 3 study, and if Lykos is unsuccessful in its appeal, potential FDA approval is now at least two years away, possibly more. I believe Lykos will eventually succeed in obtaining FDA approval. We must sustain resilience and passionate persistence in the face of adversity. Tragically, people suffering from PTSD do not have the luxury of time. I am most devastated for those who could benefit from these treatments and deserve access to effective healing. I pledge to continue to fight for them. This moment is sobering, yet it anchors me and MAPS more strongly than ever in our commitment to creating safe and legal access to psychedelics for beneficial use: healing, creativity, spirituality, celebration, connection, couples therapy, and beyond. |
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I’ve encountered many difficult moments in this four-decade-long journey. As we say in the Zendo principles, “difficult is not the same as bad.” Difficult experiences, with acceptance rather than resistance, can lead to growth, creativity, new directions, community, and unexpected allies. We acknowledge how hard these outcomes are for so many people who have been relying on our success, and we share this disappointment with each of you. Now is a time for a clear-headed analysis of where we fell short and how we can do better moving forward. It is a time for us to recalibrate our strategy, rebuild trust with our stakeholders, and draw strength from our spiritual audacity to continue to build the future we know is possible. For several years, I have been heavily constrained in my ability to speak freely. The Lykos and MAPS Boards feared that, as a member of the Lykos Board, my activist voice could be interpreted to violate my fiduciary responsibilities or result in compliance issues within the heavily regulated pharmaceutical industry. As FDA’s rejection makes MAPS’ work all the more urgent, I’ve resigned from the Board of Lykos. Now I can advocate and speak freely as I refocus on public education, policy reform, and global research into MDMA-assisted therapy for PTSD in places with high burdens of trauma and inadequate access to resources, couples therapy research, and more. I can now also work on developing public benefit metrics to hold psychedelic companies like Lykos accountable for their public benefit mission. My activist voice and vision are needed now more than ever at MAPS and in our broader community. I am proud to be called an activist — someone willing to take action to try to improve the world. In 1984, I left the first nonprofit I co-founded to try to protect the legal therapeutic use of MDMA because it became too difficult for me to keep our community aligned together as I spoke out both on protecting the therapeutic use of MDMA and on opposing drug prohibition. I founded MAPS in 1986, in the wake of the 1985 criminalization of MDMA, in order to conduct rigorous research to show MDMA’s therapeutic potential through the FDA drug development process and with the explicitly comprehensive mission of advocating for drug policy reform. I am now leaving the Lykos Board for similar reasons, to be free to advocate for a complex agenda. MAPS’ four decades of work — pioneering research, bold policy reform, and evidence-based public education — has paved the way for the emerging field of legal psychedelic medicine. Now, hundreds of for-profit psychedelic companies, a handful of public benefit for-profit companies, dozens of nonprofits, and countless community circles form a broad and diverse community. To our supporters, researchers, participants, and the entire MAPS family: thank you for your dedication. Together, we’ve helped shift culture and created an entire field around psychedelics. MAPS’ psychedelic work continues, and I am more committed than ever to seeing our vision through. If you are struggling to find hope right now, I encourage you to find community with your local psychedelic society or reach out to the Fireside Project, a free psychedelic support line. I look forward to being in community with you all at Psychedelic Science 2025 in Denver, if not sooner. As we move forward, let’s keep our eyes on the horizon — a world where psychedelics are safely accessible to all who need them, where stigma is replaced by understanding, and where we continue to make strides toward mass mental health and a world without drug prohibition. To Healing for All and Seeing Past the Paradox, Rick Doblin, Ph.D. |
