MAPS Bulletin Spring 2016 Vol. 26, No. 1

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Rick Doblin, Ph.D.

This special themed issue of the Multidisciplinary Association for Psychedelic Studies (MAPS) Bulletin, focused on "Psychedelics and the New Economy," is about integrating into business and philanthropic contexts the insights of psychedelic experiences and therapy. It is also about various approaches to creating legal commercial access to medicinal—and beyond medicinal— experiences with psychedelics and marijuana. This focus on business is about as mainstream of a topic as you can get in the United States.

The first special themed issue of the MAPS Bulletin on "Psychedelics and Creativity" was published in Autumn 2000. It has taken MAPS almost 16 years and 12 previous special themed issues to arrive at the theme of the new economy. We first needed to develop our psychedelic and marijuana research to the point where legal prescription access was a realistic possibility. We are now in the midst of preparing for our End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to plan the Phase 3 research needed to develop MDMA-assisted psychotherapy into a legal treatment for posttraumatic stress disorder (PTSD).

We have also begun thinking more proactively about post-FDA approval issues, as a result of the progress being made in in the U.S. and around the world towards critically reevaluating our failed approaches of mass incarceration and Prohibition. There are now widespread calls for a new approach anchored in public health rather than criminal justice. At the moment I write this, Natalie Ginsberg, MAPS Policy and Advocacy Manager, is in Vienna, Austria, at the United Nations General Assembly Special Session (UNGASS 2016) on the topic of international drug policy. MAPS is advocating for science over politics in psychedelic and marijuana research, and for psychedelic harm reduction.

Now the time feels ripe for our special issue theme to be about commerce. Completely independently, in May 2016, the annual two-day International Forum on Consciousness in Madison, Wisconsin, which for the last several years has focused in whole or in part on psychedelics, will be devoted to talks about “Awakened Consciousness and the Evolution of Business.” I’ve also spoken recently at Social Venture Network events, which pioneered these sorts of discussions.

I’m hoping readers of this special issue will seriously consider whether our culture can indeed integrate psychedelics and marijuana into the commercial fabric of our society. Legal access could be integrated with more effective and compassionate drug abuse treatment programs, and would result in fundamental benefits for public health, freedom of thought, freedom of religion, the expansion of human rights, and the pursuit of happiness.

In this issue, our discussion of the new economy includes a thoughtful evaluation of issues related to the ethical conduct of business, fair trade and labor practices, environmentally sustainable processes and sourcing of ingredients, and fair allocation of profits. Matt Neal’s article in this issue discusses the fundamental modification of for-profit corporations, which are legally required to maximize profits above anything else, with the alternative corporate structure of public benefit corporations such as the MAPS Public Benefit Corporation (MBPC), which has the legally protected goal of maximizing social benefits over profits.

MPBC—wholly owned and funded by the non-profit MAPS—was created by MAPS in 2014. It’s designed to be the vehicle for managing our clinical research, and soon the FDA-approved sale of MDMA by prescription, to pay taxes on income, and to use profits for mission-related purposes. We are currently in the midst of a process of consultation with ethicists at the University of Pennsylvania to specify exactly which social benefits we intend to produce through MPBC, and to develop a quantitative system for evaluating our progress towards realizing those benefits. (The Spring 2015 MAPS Bulletin has an article that discusses MPBC in more detail.)

While MAPS is primarily focusing on developing MDMA-assisted psychotherapy into an FDA-approved treatment for PTSD, we are also on the verge of starting a Phase 2 pilot study of marijuana for PTSD in 76 U.S. military veterans. This research is funded by a $2.15 million grant to MAPS from the State of Colorado Department of Public Health and Environment, and will be conducted with marijuana provided by the National Institute on Drug Abuse (NIDA).

My article in this special issue evaluates the possible economic implications of MAPS possibly one day obtaining FDA approval to market the marijuana plant in plant form, to be smoked or vaporized for the treatment of symptoms of PTSD. After such approval, there would be an initial three-year period of data exclusivity where MAPS might be the only source of FDA-regulated marijuana for PTSD. After that, marijuana would become a generic medicine. The eventual availability of generic, low-cost, high-quality, standardized strains of marijuana for a range of clinical conditions could serve the public interest as an additional treatment option beyond those offered by traditional for-profit pharmaceutical companies. These products would be marketed as patented drug delivery devices containing various combinations of cannabinoids and terpenes, at what would likely be much higher prices than similar combinations available in plant form. Sometimes the patented products would be physicians’ first choice for specific patients, and sometimes they would recommend the generic plant.

Unfortunately, the possibility of prescription marijuana in the U.S. is purely theoretical at this point due to the current Drug Enforcement Administration (DEA)-mandated NIDA monopoly on marijuana legal for federally regulated research. NIDA can provide marijuana for research, but not for legal prescription use. Until the NIDA monopoly ends, there is no alternative source of marijuana acceptable to the FDA that could be used in Phase 3 clinical trials or potentially sold by prescription. Fortunately, support for ending the NIDA monopoly is both building and bipartisan.

For a broader, more political view of the benefits of integrating psychedelics into our culture, you can watch the talk I gave recently at Google’s New York City offices: maps.org/googletalk.

As MAPS approaches our 30th anniversary, it is time to celebrate the remarkable collaborations we’ve built between MAPS donors, volunteers, staff, government regulators, and scientific researchers around the world. It has been a privilege to work together all these years. The shore is now visible on the horizon.

Rick Doblin, Ph.D.

MAPS Founder and Executive Director