Person examining psilocybin mushrooms in lab.

Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation

By Tegan M. Carr

As a researcher studying the psychedelic experiences of people of color in hopes of driving equitable psychedelic health care, I’m concerned about the ways in which Black, Brown, and Indigenous contributions have been excluded in the development of the psychedelic field and investigation of novel psychedelic therapies. By excluding diverse contributions to the psychedelic field, we risk establishing psychedelic practices that exacerbate racial health inequities (disparities) in which people of color experience worse health outcomes as compared to whites on a population level. These patterns are already emerging in therapeutic psychedelic outcomes.

This piece identifies three interrelated topics that warrant scrutiny as drivers of psychedelic racial health inequities: the colonization of psychedelics, psychedelic commercialization & rent-seeking, and regulatory processes.

The Colonization of Psychedelics

The modern psychedelic field is the product of colonization. There is a common and problematic misconception that colonization was an isolated historical event and that the present is somehow divorced from its precedent. In reality, any process with origins in colonization is a colonizing process until it is deliberately decolonized and harm is repaired. To explore how colonization drives health inequities, we have to acknowledge the causal relationship between what is past and what is present and think critically about colonization. Let’s consider a foundational event in modern psychedelic history: the introduction of psilocybin mushrooms into Western society by Drs. Robert and Valentina Wasson, the researchers who infiltrated Mazatec ceremony under false pretenses and robbed Mazatec Healer María Sabina of medicinal psilocybin samples. Both Robert and Valentina Wasson published sensational magazine articles in Life! and This Week, respectively, along with subsequent texts that exposed María Sabina without consent, credit, or compensation. This work was a tremendous success for the Wassons and colleagues, but had a tragic impact on María Sabina and the greater Mazatec community.

The Wassons’ theft of culturally protected Indigenous technology was an egregious ethical violation, as is the West’s subsequent assimilation of the mushrooms. This is colonization by intentional manipulation, extraction, appropriation, and capitalization at the expense of Indigenous people and their knowledge systems.

Although the psychedelic field generally acknowledges the Wassons’ actions as unsavory, there’s a dissonance in the reluctance to also acknowledge the complicity of the scientific community in that present-day psilocybin therapy and research are the direct descendants of these events. There have yet to be reparative or repatriation efforts; thus, as the psilocybin industry evolves and multiplies, so does the harm. Acts of colonization such as these are justified through white supremacy, and this mindset has shaped the psychedelic landscape, including psychedelic research, therapy, commercialization, and pedagogy. To ensure the success of therapeutic psychedelics, we would do well to reflect on parallels in the colonization of other Indigenous medicines like tobacco and coca. Prior to Western extraction and commercialization, these plants were incorporated into systems for proper use. Through colonization, they became dangerous, habit-forming substances that have caused disproportionate harm to people of color.

Psychedelic Commercialization & Rent-Seeking

In recent years, psychedelic therapies have exploded into a multibillion-dollar commercial industry. With this, we’ve seen the emergence of a few dominant players engaged in what might be described as rent-seeking behavior, or seeking to monopolize aspects of the market for financial gain.

For decades, the U.S. federal government remained unresponsive to the wealth of evidence supporting the therapeutic use of psychedelics. As a result, psychedelic research has relied heavily on the private sector, creating a direct route to a dominant commercial psychedelic industry. A major facilitator of psychedelic industry growth is the Multidisciplinary Association for Psychedelic Studies (MAPS), the force and face of the “psychedelic renaissance.” MAPS has raised millions for psychedelic research while driving policy reform and popular interest around psychedelics. Another prominent entity, COMPASS Pathways, is spearheading clinical trials and generating powerful data contributions. While there are other dominant players in the field such as the Usona Institute, GH Research, and Mind Medicine, MAPS and COMPASS have been especially prominent in the public sphere; both organizations are credited with pioneering the psychedelic field. They have also been criticized for their outsized roles and using this centrality to shape the field with their own strengths and interests.

What this indicates is that for more than a century, in the development of psychedelic therapy protocols, the emergence of a psychedelic industry, formation and governance of leading psychedelic organizations, and the scientific and political appraisal of novel psychedelic therapies, Black, Brown, and Indigenous people, culture, and knowledge have been systematically marginalized and excluded.

Regulatory Process

Ideally, a novel therapy will undergo a translational process through which efficacy is determined and the therapy is adapted for delivery in diverse health care settings. It should be shaped by rigorous testing, refinement, and case study as it is gradually adopted in real-world health care settings, providing naturalistic data on implementation, feasibility, and patient-centered outcomes across diverse settings. However, the explosive emergence and expansion of the psychedelic field is rapidly moving psychedelic-assisted therapy (PAT) from experimental therapy status to accessible health care modality without a translational stage. Existing data demonstrate that PAT has the potential to be powerfully efficacious, but provides little indication of how it plays out in the real world. Are the outcomes consistent across settings and populations? What modality of psychotherapy is best suited for each psychedelic? Will health care settings have the resources and capacity to implement equitable preparatory and follow-up measures?

In theory, the scientific field should provide an open market to confirm, challenge, or refine any existing finding. However, in the case of psychedelics, the state of regulatory affairs has suppressed diverse contributions. The process to obtain the necessary requirements to carry out psychedelic research is incredibly restrictive; in some regions, it is still impossible to do this work and the existing barriers that marginalize researchers of color and diverse contributions are amplified by the rent-seeking activity described in the above section.

Federal research funding is skewed towards institutions with the most existing funding, public prestige, and access to resources; and Black and Brown researchers are less likely to receive federal funds than white researchers regardless of their institution or resources. When funding is allocated for research, there are few, if any, standards in place to ensure research is proactively addressing health inequities. The NIH mandates that funded research must include people of color in the participant sample, but this presents a severely limited approach to addressing racial inequities.

More meaningful diversity and equity considerations remain absent from the regulatory process; for example, in June 2023, the HHS, FDA, and CDER released a draft guidance document for the clinical investigation of psychedelic drugs. The document considers pharmacology, manufacturing and controls, abuse potential, and clinical and nonclinical considerations, but makes no mention of diverse representation, equitable measures, or consultation of preceding knowledge or research outside of the western biomedical field, such as that of Indigenous peoples. Cross-referencing and integrating these existing bodies of knowledge should be a matter of diligence for any scientific study of psychedelics, Western or otherwise. Diverse representation on the investigative team should be a matter of academic integrity, and diversity in the participant sample should be a matter of sample quality. What is unstated but inferred in the above-mentioned guidance document, as well as in the Western body of evidence for psychedelic medicine, is that Western science and knowledge is objectively superior to Indigenous science and knowledge, which entails the white supremacist assertions that diverse perspectives are irrelevant to scientific advancement, and that people of color have nothing to offer that “great white minds” can’t produce for themselves. The result, as we are already seeing, is data and subsequent therapies with disparate outcomes and inadequate generalizability across the population.

The regulatory processes at both the institutional and federal levels need to establish standards that address systemic inequities upstream of the data to build equity into research before it is conducted. They might begin to do this by ensuring that 1) population demographics are proportionately represented in the participant sample, as well as on the investigator team and data monitoring boards; 2) investigators consult diverse data and knowledge systems, including those not traditionally recognized by Western medicine, such as the oral records and living practices around Indigenous psychedelic medicine; and 3) investigators assess equitable outcomes within a trial by demonstrating that safety and efficacy are maintained when analyzed by race and ethnicity.

Conclusions

The scientific community needs to actively drive critical discourse and encourage the psychedelic field to make space for implementation science, public health considerations, balanced perspectives, and data diversity. Further, for psychedelic therapies to reach their full potential, we are in need of a culture shift towards challenging colonization and reconsidering the inherent value of extracolonial scientific inquiry and bodies of knowledge that are entirely legitimate, substantially larger, and often better established. It’s time for the psychedelic field and greater Western biomedical community to acknowledge that the superiority complex of Western knowledge systems, scientific process, epistemologies, and ontologies are merely the academic variety of white supremacy, and that we can, and should, do better.

Tegan M. Carr is a Consultant, Researcher, Artist-Activist, Community Healer, and the Founder and CEO of The Medicine Objective Inc.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.