MAPS Responds to FDA Advisors and Sets Future Goals
On July 16, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) responded to the FDA Advisory Committee (AdComm) recommendation against approving MDMA-assisted therapy for PTSD and articulated their forward-looking program goals in the webinar “MAPS, MDMA, and Beyond.”
MAPS leaders, including Executive Director Kris Lotlikar and directors overseeing communications and post-prohibition strategy, research, and policy articulated the non-profit organization’s diverse programs and emphasized its separation from Lykos Therapeutics, the pharmaceutical company overseeing the New Drug Application (NDA) for MDMA-AT. Lykos is the successor organization to the for-profit MAPS Public Benefit Corporation which initiated the research into MDMA-assisted therapy (MDMA-AT) for PTSD.
Gut Punch
Betty Aldworth, director of communications and post-prohibition strategy, acknowledged that MAPS took “quite some time” to provide a public statement about the Advisory Committee (AdComm) decision. “I know that’s been confusing, especially since you’ve counted on us for incredibly frequent updates for so many years now,” Aldworth said. “As difficult as it’s been to remain relatively quiet about the MDMA program and the FDA process, it’s also necessary.”
“The reality is our initial reaction to this internally was a gut punch,” Lotlikar said of the AdComm recommendations. “It was a major setback and disheartening. But MAPS has suffered setbacks before and remains committed to supporting this work.” Lotlikar acknowledged the long process during which the MAPS nonprofit “has been working to fully spin out Lykos Therapeutics, formerly MAPS Public Benefit Corporation, as a separate organization with its own board of directors and management team.” He noted “how difficult it’s been to navigate the last year where we have operated in parallel with Lykos, who [is] a highly regulated pharma company.”
On January 5, Lykos announced its change from a wholly-owned subsidiary of the nonprofit organization to an independent public benefit corporation. The MAPS nonprofit became the “largest single shareholder,” according to Amy Emerson, Lykos’s CEO. The shares held by the nonprofit entitled it to appoint six of the company’s nine-person board of directors, including Rick Doblin, MAPS Founder and President. Doblin’s absence from the webinar further illustrated the separation between the two entities.
“Lykos now fully owns the drug development and regulatory program,” Aldworth said. “The Lykos communications team is responsible for deciding what to announce and when. To reduce the confusion and to make sure that the right information is coming from the right people, we haven’t been communicating very much about Lykos, the FDA, or MDMA-assisted therapy for PTSD. I want to personally acknowledge that that’s probably been confusing and distressing to some of you, and I apologize for that,” she said. Aldworth added, “It’s hard for us in different ways to change some of those ways that we’re talking to you.”
For many years the MAPS nonprofit raised tax-exempt donations for research into MDMA-AT and other psychedelic therapies. When the for-profit MAPS PBC was created in 2014, it began raising capital from those who wanted to invest in these therapies. After Lykos succeeded the MAPS PBC, Doblin expressed regret that the nonprofit was not able to fund the MDMA-AT clinical trials with philanthropic donations alone. In January, Doblin told Lucid News that MAPS ultimately welcomed investors when the organization realized that failure to get FDA approval for MDMA-assisted therapy due to lack of resources would be the greatest loss of public benefit.
Lotlikar cheered Lykos for completing “two Phase 3 trials with substantial significance and clinically meaningful results,” and “the submission of the NDA for the first psychedelic-assisted therapy.” He emphasized that the AdComm recommendation and target August decision date are both “non-binding.” Lotlikar underscored MAPS’ respect for the ongoing regulatory process. He said, “Several of the novel elements merit careful consideration, patient safety needs to be prioritized, [and] critical feedback should be respected.”
“None of us at the nonprofit – not me, not Rick Doblin, not anyone – has a financial interest in Lykos,” said Lotlikar. “All of us at MAPS have done our best to keep our mission, and the individuals who will benefit from our work at the top of our minds and our decision-making,” Lotlikar said.
“We are engaging in new and groundbreaking work in psychedelics and mental health,” said Lotlikar. “Whatever the results in August, we at MAPS are committed to seeing this through.”
Beyond Medicalization
“The medicalization of psychedelics is an important piece of the puzzle,” said Allison Coker, director of research for MAPS. “However, medicalization is unlikely to answer all of the questions that we have about the best practices, access, and cultural adaptations for the use of these substances. As our collective knowledge expands, MAPS continues to serve as stewards of the psychedelic research landscape. We hope to initiate and support many projects that serve the community and contribute to our collective understanding of psychedelics,” Coker said.
Coker articulated the organization’s commitment to advancing the field through its research accelerator program, which prioritizes advancing research that “enables new investigative directions that serve the public interest; improves patient access and patient experience in the US and globally; and contributes to public knowledge and informs sensible drug policy and education.”
“MAPS has spent nearly four decades initiating first-in-class psychedelic clinical trials,” Coker said, “paving the way for the medicalization of psychedelic-assisted therapies.” She added, “Rigorous research on the risks and benefits of psychedelics in a medicalized context allows policies to be grounded in data and science rather than stigma, and they can help make psychedelics more accessible.”
Coker detailed some of the other programs that MAPS is supporting to diversify its research focus. Building on its longstanding clinical trial efforts, Coker explained MAPS seeks ongoing collaborations with subject matter experts “to develop unique projects that may not occur as part of a normal drug development pathway.” She cited developing partnerships to produce qualitative research to evaluate “the best practices for psychedelic-assisted therapies in new populations.”
The organization financially supports mission-aligned research through its grantmaking and fiscal sponsorship programs. “We want to fund researchers worldwide to advance our collective understanding of the potential applications and risks associated with psychedelics, and to enable new clinical applications of well-studied treatments,” Coker said. Current grantees are developing projects evaluating psychedelic-assisted mass prolonged exposure therapy and assessing the feasibility of psychedelic-assisted therapy in refugee populations. “We hope to increase our funding capacity in the coming year to continue to support more mission-aligned research,” said Coker.
Additionally, MAPS hosts international therapist education programs “to equip therapy providers with foundational knowledge and practical therapeutic skills in psychedelic-assisted therapies,” Coker said. These programs aim to “increase awareness and activate potential research initiatives across the globe,” said Coker.
“We work with local advocates to create dual learning opportunities and wisdom sharing between diverse therapists and MAPS,” Coker explained. This approach helps develop understanding of “the historical context and cultural adaptability of psychedelic-assisted therapy around the world,” Coker said. It also helps establish “a community of global therapists who can support each other” and provide “culturally informed care in their regions.”
Consciousness, Not Criminalization
“MAPS envisions a post-prohibition future based on consciousness, not criminalization,” said Ismail Ali, director of policy and advocacy for MAPS. “We should be conscious—aware and responsible for—the impacts of drug policy approaches that we propose.”
Ali outlined the organization’s goal of designing a harmonious drug policy ecosystem that balances public health, individual liberty, choice, and equitable access through a variety of regulatory approaches. “This means embracing a multiple model ecosystem, which includes medicalization, decriminalization, and various forms of regulated access, along with state-administered mechanisms to fund projects and gather more information, such as research grants and task forces,” Ali explained. “We need them all. We need to work to increase coherence between these mechanisms to increase points of access and implement appropriate oversight and accountability.”
Ali firmly rejected the criminalization of individuals who grow, make, distribute, or use drugs. “Criminalization increases the risk of drug use and dangers of the drugs themselves [and] the drug economies. It doesn’t actually keep people who use drugs, or our families and communities, any safer, even if we thought that mistakenly 50 years ago, 40 years ago, even 30 years ago,” he said.
Since its policy department was founded in 2015, MAPS says it has provided advisory input, technical advising, public comments and testimony for bills, committees, proposals, and task forces in Washington D.C., across the U.S., and globally at the United Nations and in countries around the world. “Our efforts have advanced successful reforms and first-of-their-kind proposals,” Ali said, ”and we’re grateful to be part of an increasing chorus of voices advancing policy change.”
Real World Impacts
During the webinar, Aldworth spotlighted the organization’s First Responder Training, a partnership with the City and County of Denver to provide comprehensive training on psychedelic crisis assessment and intervention. The training program “aims to enhance the knowledge, skills and attitudes of first responders to quickly recognize and effectively respond to emotional and behavioral crisis incidents involving psilocybin and other psychedelics,” according to a statement issued by MAPS in March.
Aldworth emphasized the positive impact of this training. “The experience of interacting with law enforcement or EMTs during such events can be very damaging or jarring,” Aldworth said. However, with more information and training, responders can quickly move individuals out of crisis states, resulting in better outcomes for both the person experiencing the crisis and the responders. “The dangers are reduced across the board,” Aldworth said.
Coker announced that MAPS is challenging an FDA decision that prevents real-world research on smoked and vaporized cannabis. Ali noted that MAPS is working in coalitions to reform drug sentencing guidelines. Current activity includes a “multi-organizational campaign to influence the U.S. Sentencing Commission to review the drug conversion tables,” Ali said. He also cited a MAPS-initiated project producing “a literature review and other resources to explore the legal, ethical, and practical considerations related to offering psychedelic-assisted care to people impacted by the criminal legal system.”
Changing Public Opinion About Psychedelics
“We’re still fighting a lot of deeply rooted stigmas about psychedelics and the people who use them for medical, spiritual wellness, or celebratory purposes,” Aldworth said. “We also hear the misinformation and we see how easily false or inflated narratives have taken over the public conversation. Evidence-based psychedelic education, research, and policy reform are as critically needed today as they always have been,” she added.
“A truth about doing world-changing work is that it’s always perceived as either inevitable or impossible, and neither is ever true,” Aldworth said. “We were founded almost 40 years ago because stigma interfered with science at the time.” Since then, Aldworth noted, MAPS has developed “tremendous experience and demonstrated success” in combating that stigma through its programs. “Moving forward,” Aldworth said, the focus areas of MAPS programs will be “advancing research, changing policy, and shaping culture.”