2019: A year of expansion in psychedelic research,industry,and deregulation

Abstract

Public and scientific interest into psychedelic drugs has grown steadily over much of the last two decades, before an exponential increase in recent years. We contend that 2019, in particular, involved myriad notable changes in the science, industry, and deregulation of psychedelic drugs. However, it is becoming increasingly difficult for professionals to keep up-to-date on these advancements given the rapid growth of the field. Further, broad contemporary synopses are critical in maintaining records in the history of science. To address these concerns, this article synthesizes the significant number of scientific, business, and regulatory changes related to psychedelic drugs which occurred in 2019. Establishment of psychedelic research centers, novel applications of the drugs, and international expansion of the field in 2019 seemed to solidify psychedelic research’s place in science. Additionally, many in the business and pharmaceutical industries stimulated considerable investment and innovation in psychedelics for the first time. In the US, successful decriminalization efforts and endorsements by eminent political figures, such as Alexandria Ocasio-Cortez, Andrew Yang, and the heads of the NIH and FDA, in 2019 were representative of unprecedented regulatory changes. Collectively, this article serves as a succinct summary of the changes psychedelic drugs made across various levels of society in 2019—by coalescing emerging research themes, industrial innovations, and attitude shifts.

Classic psychedelic drugs such as lysergic acid diethylamide (LSD), psilocybin, mescaline, and N,N-dimethyltryptamine (DMT) induce intense shifts in cognition, emotion, and consciousness through activation of serotonin 5-HT2A receptors (Vollenweider et al., 1998). These substances were the focus of tens of thousands of studies during the mid-20th century before political pressure and a tightening of pharmaceutical regulations curtailed research (Aday et al., 2019; Oram, 2016). In recent years, scientists have reopened investigations into these compounds, and the therapeutic findings reported to-date have led to considerable scientific and public interest. Advancements in the field were argued to culminate in 2018, because of changes in the scientific, public, and regulatory communities (Aday et al., 2019). Specifically, inclusion of psychedelic-related publications in high-impact journals, the success of Michael Pollan’s book How to Change Your Mind, and designation of psilocybin-assisted psychotherapy to “breakthrough therapy” status for treatment-resistant depression by the United States (US) Food and Drug Administration (FDA) were exemplars of these changes. Here, we posit that novel advancements in the research, business/industry, and deregulation of psychedelic drugs in 2019 were representative of another, perhaps even more, important year. This synthesis can serve as a succinct summary of recent developments in the field (i.e., not a comprehensive review) for those professionally involved in the discipline—pointing them towards emerging lines of research, budding industry figures, and an up-to-date overview of regulatory changes.

Research

Announcement of the Centre for Psychedelic Research at Imperial College London in April (O'Hare, 2019) and establishment of the Center for Psychedelic and Consciousness Research at Johns Hopkins University in September (Jones, 2019) were among the most newsworthy advancements in psychedelic science in 2019. While considerable funding and resources have been invested into psychedelic research over the last decade from private donors and foundations (as well as the federal government in some European countries), these are the first centers solely dedicated to the study of psychedelic drugs and lay groundwork for larger trials. It was further announced that the Johns Hopkins center would facilitate new directions of psychedelic research, including study of psilocybin’s use in treating Alzheimer’s disease, post-treatment Lyme disease syndrome, and anorexia nervosa. Although not generally considered a “classic” psychedelic, the first study examining 3,4-methyl​enedioxy​methamphetamine (MDMA)-assisted psychotherapy for alcohol use disorder was similarly illustrative of the novel applications of psychedelics in 2019 (Sessa et al., 2019). Additionally, there was a call to consider individual differences, such as age-related concerns in psychedelic treatment (Aday et al., 2020), and the first experiment to evaluate microdosing in a strictly older adult population was published online in late 2019 (Family et al., 2020). Finally, 2019 was an important year for psychedelic research because a number of impactful findings were published on the drugs’ effects on depression (Davis et al., 2019), substance misuse (Garcia-Romeu et al., 2019), mindfulness (Smigielski et al., 2019), life satisfaction (Uthaug et al., 2019), nature relatedness (Kettner et al., 2019), spiritual experiences (Griffiths et al., 2019), and neural processing (Pallavicini et al., 2019).

Psychedelic research also expanded to new regions of the world in 2019. A multicenter collaboration was initiated between Central Institute of Mental Health Mannheim, Charité Universitätsmedizin Berlin, and the MIND Foundation, which will be the first psychedelic trial for depression conducted in Germany since the 1970s (MIND European Foundation for Psychedelic Science, 2019). In Canada, it was announced in 2019 that the first psychedelic experiment conducted in the country in over four decades would be beginning in Vancouver (Banks, 2019). This study is a Phase III clinical trial evaluating MDMA’s efficacy in posttraumatic stress disorder (PTSD) treatment. Phase III is typically the last research phase before review for medical approval. Funding for the first psychedelic study in Australia was secured in early 2019 (Mannix and Booker, 2019). The trial, which began in April of 2019, is examining psilocybin’s use in treating depression and anxiety in terminally ill patients (PRISM, 2019). Lastly, Usona Institute, a nonprofit medical research organization (MRO), began a Phase II clinical trial investigating psilocybin-assisted psychotherapy for treatment-resistant depression across seven US research sites in 2019. These sites include Johns Hopkins University, New York University, University of California San Francisco, Yale University, University of Wisconsin-Madison, Great Lakes Clinical Trials in Chicago, and Segal Trials in Miami (NIH, 2019). In summary, the establishment of new research centers, novel applications of psychedelic drugs, and international expansion of psychedelic studies in 2019 helped make it a seminal year for psychedelic research.

Industry

The recent growth and legitimization of psychedelic research has led to increased interest and investment from some in the pharmaceutical industry. Most publicly, the US FDA approved Janssen Pharmaceuticals, Inc.’s nasal spray, Spravato (esketamine), for treatment-resistant depression in 2019 (FDA, 2019). Esketamine is a patented form of ketamine, a drug which has mood-altering and hallucinogenic properties (Singh et al., 2017), but is not generally considered a classic psychedelic because of its lack of 5-HT2A affinity as well as its unique dissociative and glutamatergic effects (Abdallah et al., 2018). Nonetheless, the endorsement stirred widespread news coverage and seems to be the psychedelic treatment that the American public has been most receptive to to-date. The fact that this treatment is new, or at least rebranded, as well as administered through a familiar route of medicinal administration, may be contributing to its acceptance. Another patentable psychedelic nasal spray was developed in 2019 in Jamaica by an Oregon company, Silo Wellness. The device administers “microdoses” of psilocybin, and this route of administration is claimed by the company to bypass the nausea sometimes associated with the drug and deliver more standardized dosages of psilocybin compared to oral ingestion of fungi material (Haridy, 2019). Also, in Jamaica, Field Trip Adventures Inc. opened a psilocybin research center in 2019, which will try to identify novel, patentable compounds in psilocybin mushrooms that contribute to their subjective effects (Goldhill, 2019). Further, Wuhan General Group China, Inc.’s plant medicine subsidiary, MJ MedTech, Inc., invested in a new division in 2019 which is committed to identifying innovative applications of psychedelic treatment (Nasdaq, 2019). A Canadian company, Mind Medicine, also formed in 2019 with the intention of testing novel applications of psychedelic treatment for disorders such as cluster headaches and attention-deficit/hyperactivity disorder (ADHD; MindMed, 2020). Finally, investigators from King’s College London in-conjunction with the company, Compass Pathways, shared research endorsing the safety of psilocybin therapy with a relatively large sample (N = 89; Rucker et al., 2019).

Attempting to get ahead of the curve, some entrepreneurs have begun public, but illicit, psilocybin businesses in areas where psilocybin is not yet legal but has become a low priority for law enforcement. We should note, however, that these businesses are distinct from the legal psychedelic industry which was previously described, and some tension exists between the camps. Sträva Craft Coffee, a Denver company, began developing coffee and tea infused with microdoses of psilocybin in 2019, and ultimately intends for the products to join their line of cannabidiol (CBD)-infused beverages (Norcia, 2019). Similarly, in Vancouver, an online shop called the Mushroom Dispensary began openly (and illegally) selling microdoses of psilocybin by mail order in 2019 (Browne, 2019). The company requires patients to provide proof of a medical diagnosis and residence in Canada. While the business is hoping these precautions will appease law enforcement, they claim to be prepared for legal litigation and argue that, similar to cannabis legalization, civil disobedience can ultimately facilitate a legal psilocybin market. While further discussion of the parallels between the cannabis and psychedelic industries is beyond the scope of this paper, we should note that there is likely much psychedelic entrepreneurs can learn from the trajectory and challenges accompanying the expansion of the cannabis industry (e.g., conflation of loosely regulated and highly regulated medical products, power of local initiatives, etc.). Nonetheless, it was evidently a year of growth in the industry of psychedelics, which was still very much in its infancy before 2019.

Deregulation

Regulatory bodies began loosening restrictions around personal possession of psychedelic plants and fungi in a number of places in 2019, particularly in the US. Denver, Colorado passed a decriminalization initiative in 2019 declaring that psilocybin should be the lowest priority for law enforcement officials (Angell, 2019a). The city subsequently pioneered a “Psilocybin Mushroom Policy Review Panel,” which will monitor the effects of the policy (AP News, 2019). Oakland, California followed suit by decriminalizing several entheogenic plants and fungi (e.g., psilocybin, ayahuasca/DMT, peyote, ibogaine; Angell, 2019b), and a proposal was submitted in 2019 to the Secretary of State’s office to decriminalize psilocybin across the entire state of California (Metz, 2020). In October of 2019, the city counsel of Chicago, Illinois passed a decriminalization resolution that was similar in scope to Oakland’s, but further levels of bureaucratic approval are necessary for it to take effect (McGhee, 2019). A petition to get psilocybin decriminalization on the 2020 election ballot was filed in Oregon in July of 2019 (Eckert and Eckert, 2019 and it passed in November of 2020). This effort seems to be the most ambitious to-date, as it will extend beyond decriminalizing psilocybin fungi by requiring the Oregon Health Authority to develop a division to regulate the production, distribution, and possession of psilocybin as well as administration of “psilocybin services.” Another decriminalization bill for entheogenic plants and fungi moved along to a citizen commission in Berkeley, California (Britschgi, 2019), and a mostly symbolic psilocybin decriminalization effort failed in the Iowa house in 2019 (Voytko, 2019). Deregulation has been met with some resistance though as several Native American leaders have voiced concerns over gentrification of their sacred medicine and preserving natural resources of hallucinogenic plants (Sahagun, 2020). Others in the psychedelic community have noted that medicalization and/or deregulation of psychedelics may lead to profit-driven philosophical divides for the field, and that therapeutic efficacy could be compromised as psychedelic treatment is scaled up (Noorani, 2019).

In-line with the encouraging research findings and successful community-driven decriminalization initiatives, several mainstream political and regulatory figures endorsed research into psychedelics’ medicinal applications and/or decriminalization for the first time in 2019. Alexandria Ocasio-Cortez, a prominent congressional representative in New York, filed legislation in June of 2019 that would ease regulatory restrictions surrounding research into psychedelic compounds and openly called for more studies (Keshavan, 2019). While running for the Democratic nomination for president in the US, Andrew Yang claimed to be “very open” to psychedelic legalization in 2019 and endorsed further investigations (MacDonald, 2019). Importantly, the heads of the US FDA and National Institute of Health (NIH) penned a coauthored letter in 2019 acknowledging the value that psychedelic treatment has provided to patients to-date, and similarly called for increased expansion of psychedelic research (Sharpless and Collins, 2019). To this end, psilocybin-assisted psychotherapy was deemed to be a “breakthrough therapy” for Major Depressive Disorder by the US FDA in 2019 (Rahhal, 2019), approximately a year after receiving the same designation for treatment-resistant depression. Collectively, successful psychedelic decriminalization efforts as well as endorsements by eminent political figures in 2019 were indicative of movement towards loosening regulations around the drugs.

Conclusion

Across scientific, business, and regulatory communities, interest into psychedelic drugs led to a number of novel advancements in 2019. The establishment of psychedelic research centers, new applications of the drugs, and international expansion of the field in 2019 solidified psychedelic research’s place in science. For the first time, many in the business and pharmaceutical industries stimulated investment and innovation in psychedelics, suggesting that some industry leaders foresee continued growth in the field. Successful decriminalization efforts and mainstream political endorsements in the US in 2019 were representative of regulatory changes. Altogether, this article serves as a summary of the changes psychedelic drugs made across various levels of society in 2019—by coalescing emerging research themes, innovations, and attitude shifts. Entering the new decade, this synthesis suggests that psychedelic science is a revived paradigm in therapy and consciousness research, which has broad business and regulatory implications.