A Wholly Public Benefit Model

MAPS Bulletin Autumn 2020: Vol. 30, No. 3
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“You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete.”
—Buckminster Fuller

Psychedelics Go Mainstream
Almost fifty years after the start of America’s War on Drugs, psychedelics have finally gone mainstream. On September 18, 2020, Compass Pathways pursued an initial public offering on the New York Stock Exchange, raising over $100 million and quickly achieving a market capitalization of over $1 billion (Statement, 2020). Less than two months later, voters in Oregon approved ballot measures to decriminalize drugs and permit the supervised use of psilocybin; voters in Washington D.C. joined those in other cities to decriminalize possession of psychedelic substances. These moments are milestones for the fields of psychedelic medicine, research, and policy. What was once seen as a fever dream of enthusiastic hippies has been decidedly embraced by the most buttoned-up financial institutions. This new era of billion-dollar psychedelic companies has us asking ourselves: where does MAPS fit, and how can we take advantage of this moment in history and the opportunity to create a better world?

Wholly Public Benefit Model
MAPS was established in 1986 as a 501(c)(3) non-profit research and educational organization to develop medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. In 2014, MAPS launched MAPS Public Benefit Corporation (MAPS PBC) as a subsidiary focused solely on completing the clinical research necessary to make MDMA an approved medicine by the U.S. Food and Drug Administration (FDA) and, eventually, to take this medicine to market. The non-profit organization wholly owns 100% of the public benefit corporation, so MAPS is the only shareholder and therefore, MAPS PBC’s only goal is to pursue MAPS’ mission while maximizing public benefit.


Over the last 34 years, MAPS’ wholly public benefit model has created tremendous public value and innovation. Without the constraint of focusing on profits for shareholders or just a few individuals, we can take intelligent risks, follow science, and focus on healing outcomes, while holding a meaningful seat at the table for questions of equity and access to be incorporated into our strategic planning. MAPS’ wholly public benefit model has allowed us to develop a thoughtful, a long-term strategy to bring MDMA-assisted psychotherapy to market, achieving breakthrough therapy designation with the FDA in the process, without sacrificing any primary endpoints (i.e., objectives) of its clinical studies for posttraumatic stress disorder (PTSD), an affliction that affects upwards of eight million Americans and 350 million people across the planet (Hoppen & Morina, 2019; Sareen, 2020).


Within our wholly public benefit model, MAPS evaluates the needs of all our stakeholders— patients, researchers, therapists, donors, staff, and policy makers— to create a platform for everyone to benefit, unlike companies prioritizing shareholders or the few who are putting up the capital. The wholly public benefit model aims to consider the collective over the individual, and honor the psychedelic traditions of generosity and transparency.

Turning Traditional Business Model on its Head
This fall, MAPS PBC launched the second Phase 3 trial of MDMA-assisted psychotherapy for PTSD in the U.S., Canada, and Israel, and opened enrollment for Phase 2 trials in multiple European countries. In addition to the clinical trials, we have been given breakthrough designation by the FDA, allowing for an expanded access/compassionate use program to provide the treatment to some patients prior to approval and in turn allowing more locations to start the MAPS PBC protocol early. As we review results from the first Phase 3 study, we are embarking on a number of pathways to innovate patient access and go-to-market strategies with a clear-eyed focus on public benefit. Similar to how MAPS has defined public education around the healing properties of psychedelics over the last 34 years, MAPS PBC is defining the road ahead for psychedelic research and patient access. The mainstreaming of psychedelics didn’t happen overnight and it didn’t happen by accident; MAPS, along with other leaders in the field, has been methodically and persistently building the case for this moment over the last three decades, and will continue to transparently share all of our materials in a bid for trust and building a new paradigm in psychedelic clinical research.


Traditional pharmaceutical companies invest billions of dollars in research and marketing for new medications, often ignoring off-patent medicines like MDMA in favor of drugs that they can invent and make millions of dollars from. Their ability to engage in cutting-edge research for select patient populations is further impacted by their duty to maximize profits for shareholders. This has not served them well in building trust with the public. MAPS has solved the problem of prioritizing financial returns over human returns by turning the traditional business model for drug development on its head and creating a wholly public benefit model.

Business as Unusual
As with any strategy, there are trade-offs. MAPS is funded entirely by donations, solely on the merits of our work and its potential to create a public benefit. MAPS and MAPS PBC’s work have world-changing potential, but bringing it to the whole world comes with a high price tag. Since MAPS’ founding, Rick Doblin, Ph.D., has continually inspired donors to support the next project, then demonstrate progress and success, and then raise funds for the next phase of work. The challenge has always been to share the vision of healing over profits, but it has kept MAPS and MAPS PBC dynamic, focused, and accountable. MAPS PBC’s next phase is to develop thoughtful go-to-market strategies that prioritize patient safety and equitable access rather than the highest profit possible, and any sales revenue will go towards further research, supporting public education, harm reduction, and drug policy reform, rather than providing returns to shareholders.


MAPS and MAPS PBC continue to attract and keep talent without offering millions in stock options. The reality is that there are an increasing number of people for whom meaningful work and the potential to leave a legacy is at a premium. Many members of the MAPS and MAPS PBC staff are leaders in their fields, have come out of retirement, or left behind highly paid consultant positions to join us because they believe the eventual impact on the mental healthcare system will be historic. They innovate alongside the cadre of pro bono advisors who work for free for MAPS and MAPS PBC because they also believe public benefit is more important than personal wealth. These growing and evolving teams get to work with amazing teammates, and also have the opportunity to leave a meaningful legacy for humanity.


MAPS PBC is years ahead of any other effort within the field of psychedelic science, with our first successful Phase 3 clinical trial now behind us and commercialization rapidly approaching. We know that faster and bigger aren’t always better, and having a thoughtful strategy going to market is key to our long term strategy; we balance this intentionality with the reality that millions of PTSD patients are waiting.

Historical Legacy of Psychedelic Medicine
Our wholly public benefit model aligns with the historical legacy our work is built upon as MAPS’ success derives from the hard work and ideas of many others. This model is consistent with the history of psychedelic healing, which is steeped in and informed by Indigenous practices, traditional healers, early psychedelic researchers, breath-workers, somatic healers, and many others who have led the way. MAPS did not invent psychedelics. MAPS did not invent psychedelic therapy. MAPS did not even invent MDMA. It is important not to repeat the mistakes of the past by appropriating knowledge and know-how of others for individual gain. The “rediscovery” of psychedelics by Western culture has inspired a new wave of researchers, writers, botanists, and artists who became interested in psychedelics for their wide array of uses: psychiatric healing, artistic inspiration, and even spiritual growth and enhancement.


We all hold a piece of the puzzle, and our hope is that we can work together as partners, instead of competitors, in building out the ecosystem. With our multidisciplinary approach and wholly public benefit model, we endeavour to collaboratively focus on the root causes of the challenges we face together. Thanks to the generosity of each of our donors, we have been able to focus solely on a public benefit buildout of a fledgling but resilient psychedelic-assisted therapy ecosystem: a mycelial network of psychedelic therapy clinics across the United States, and now in Canada, Israel, and Europe. We believe that by working together— as did our predecessors in these psychedelic endeavors— we can achieve better results for humanity. MAPS’ support of other organizations, through fiscal sponsorship and grants, has ensured that we are not the only organization engaging in research because our hope is that together, we can shift the way mental health services are brought to communities. Our dedication to open science and to creating, establishing, and researching best practices for psychedelic-assisted therapy and therapist training will ensure that future generations of researchers— including the new generation of for-profit companies— will have access to and benefit from our training materials, drug compound chemistry, research protocols, and any other materials we develop (Cooperation over Competition, 2018). In a sense, we have already “gone public” through our commitment to creating a new model for the delivery of mental health services to all people who may benefit.

Multidisciplinary Roots
The “M” in MAPS stands for multidisciplinary because MAPS combines scientific research and drug development with education and advocacy. We recognize that public health and criminal legal reform are inextricably linked, and we will not forget how we got here: the racist War on Drugs that repressed scientific advancement, destroyed countless lives, and ultimately held back psychedelic medicine breakthroughs for decades. We are proud that MAPS PBC just completed the first half of a successful Phase 3 trial for MDMA, a Schedule I controlled substance that was declared to have no medical value in 1985. We are not going to be able to address the health disparities plaguing mental health if we don’t change the drug laws, too, so we are determined to change laws and treat patients in equal measure. Perhaps the most important aspect of our wholly public benefit model is MAPS’ ability and willingness to take risky political positions and stand by what we believe is right for the public benefit. In part because of MAPS’ freedom from investors, who sometimes discourage controversial stances to avoid turning off their potential customers, many of MAPS’ early “controversial” positions have slowly become mainstream.

*MAPS Public Benefit Corporation is owned by one shareholder.
MAPS Public Benefit Corporation (MAPS PBC), is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS funds MAPS PBC to cover the costs of research, clinical trials, programs, and operations. MAPS PBC’s proceeds further MAPS’ mission.


Defining Public Benefit
When your goal is radical change, there are bound to be obstacles. Operating within a wholly public benefit model in the pharmaceutical space raises questions and increases complexity. How do we define and track our success in achieving public benefits and outcomes? How do we meet our financial needs while listening to all stakeholders? How do we maintain our values and principles while working inside economic systems that are built around profit and extraction? Over the next year, MAPS intends to define in specific terms how we will measure and report our public benefit. This will allow our community to better engage with the work we do and hold us accountable.
Psychedelics are undoubtedly stepping out of the shadows. But that does not mean that MAPS and MAPS PBC are abandoning unique approaches to problem solving. We dream of a future where pharmaceutical companies begin asking themselves whether a model focused on healing and public benefit has the potential to outperform the old paradigm, not only for specific shareholders but for the public at large. MAPS’ 34-year track record of collaboratively creating a new ecosystem has been accomplished with the faith and trust of our supporters, staff, and volunteers. Thanks to them— and each of you— we will continue to develop and implement the wholly public benefit model, and co-create a future that challenges all of our beliefs about what is possible.

ana

Ana LaDou serves as the Chief Operating Officer (COO) for MAPS Public Benefit Corporation (MAPS PBC) where she oversees IT, People Operations and Culture, Facilities, Corporate Communications, Governance, and GxP QA and Compliance. Prior to joining the MAPS team, she led organizations with local, national, and international reach where her strengths in relationship building, collaborative leadership, and process development ensured efficiency and innovation. Ana graduated from Columbia University in New York and launched her career in marketing at Miramax Films. She went on to hold leadership roles at a number of technology firms and nonprofits where she became known for her ability to work across an organization to deliver credible and visionary strategies. She is committed to her Vipassana mindfulness and Nonviolent Communication (NVC) practices, and making our world a more compassionate and equitable home for all living beings.

kris

Kris Lotlikar serves as the Deputy Director for MAPS. Kris is an experienced entrepreneur and futurist. Kris founded Renewable Choice and served as President for fifteen years. Renewable Choice was a leading supplier of renewable energy to global corporations and clients included over 150 companies from the Fortune 500. It was awarded Green Power Supplier of the Year four times between 2011 and 2016 by the EPA. Renewable Choice was acquired by Schneider Electric in 2017. Kris has maintained a life-long commitment to drug policy reform since founding Students for Sensible Drug Policy (SSDP) twenty-two years ago. SSDP has grown to a UN-recognized NGO with a presence on 300 campuses in 32 countries. Kris has served on the Board of Directors for SSDP, the League of Young Votes, the Flex Your Rights Foundation, and the Arcview Group.