Private Sector: Innovation in the United States and around the Globe

I have discussed several private sector institutions regarding this topic in previous posts and in the health policy brief. But for review, the major private innovators in the United States (US) regarding the use of psychedelics are the Multidisciplinary Association for Psychedelic Studies (MAPS) and John Hopkins Center for Psychedelic Consciousness and Research (CPCR). Because of the regulations and taboo nature of psychedelics, their use in the treatment of mental health disorders is inherently innovative. However, since they have been used by spiritual traditions as a method of healing for hundreds of years, and one might also argue that they are not innovative at all. Yet innovation in this context could be defined as the use of an idea/treatment that was previously believed to hold no value or merit and now demonstrates promise within modern medicine.

In January of 2020, the Federal Drug Administration (FDA) agreed to an expanded access program for patients diagnosed with PTSD (MAPS, 2020). The program allows MAPS to enroll 50 patients at ten sites within the US for treatment with MDMA-assisted psychotherapy. The expanded access protocol is still required to be approved by the DEA and the IRB, but MAPS does not anticipate any concerns about gaining these approvals. MAPS currently has Phase 3 clinical trials for MDMA-assisted psychotherapy and is expected to be completed in 2021. MDMA-assisted psychotherapy has a breakthrough therapy designation by the FDA. John Hopkins CPCR has multiple ongoing studies with psilocybin. Their studies, along with others, continue to demonstrate psilocybins efficacy in the treatment of depression, addiction, and other mental health disorders. They believe that if psilocybin is approved as a medication that it would be appropriate to place it into the Schedule IV category (John Hopkins, n.d.).

Around the world, hallucinogen laws and research vary. China has some of the strictest drug laws, and drug addiction treatment is controlled by law enforcement (Meng & Burris, 2013). Drug-users are required to be registered with the police, and individuals undergoing methadone treatment are required to be approved by the police before the start of treatment. No active research on hallucinogens in China could be found. Brazil, Jamaica, and the Netherlands have some of the most relaxed laws for hallucinogens. The University of the West Indies in Jamaica received funding from a Canadian company in 2019 to develop a research and cultivation facility for psilocybin mushrooms (Field Trip Ventures, 2019). The barriers for research in Jamaica are far less than for other countries because of the legal status of psilocybin. Although the UK and much of Europe model the US in terms of restrictions on hallucinogens, research is being done. The Beckley Foundation in the UK and the University of Zurich in Switzerland have several current and past studies with hallucinogens that show promise.

Although the primary focus of the blog is policy within the United States, I believed it was appropriate to include a perspective on laws and research advancements from around the world. By doing so, we see that others are also interested and have found merit in this research. We can learn and develop new policies and perspectives within the US by learning from those who have different policies than our own.

Field Trip Ventures. (2019, September 19). Field Trip Ventures Inc. partners with the University of the West Indies to create the world’s first legal Research and cultivation facility for psilocybin. Retrieved from https://www.prnewswire.com/news-releases/field-trip-ventures-inc-partners-with-the-university-of-the-west-indies-to-create-the-worlds-first-legal-research-and-cultivation-facility-for-psilocybin-300921399.html

John Hopkins. (n.d.). Center for Psychedelic & Consciousness Research. Retrieved from https://hopkinspsychedelic.org/index/#research

Multidisciplinary Association for Psychedelic Studies. (2020, January 17). Press release: FDA agrees to expanded access program for MDMA-assisted psychotherapy for PTSD. Retrieved from https://maps.org/news/media/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd

Meng, J. & Burris, S. (2013). Chinese drug laws: Police-controlled approach to drug abuse. National Institute on Drug Abuse. Beasley School of Law, Temple University, United States.