million people affected worldwide

Current Treatments

Psychedelic research currently is in Preclinical

Key Insights

  • There are several issues surrounding equity and ethics in the field of psychedelics. From the clinical trial process to the awarding of patents, many issues must be addressed as the field progresses.
  • Indigenous groups who have stewarded psychedelic plant medicine for thousands of years are increasingly alienated from their traditional practices and cultural heritage. Some initiatives and companies in the space, such as Chacruna and Woven Science, are working with Indigenous groups to foster community resilience and preserve the knowledge and practices.
  • A collaborative effort from all in the field is needed to move past these issues and ensure psychedelic-assisted therapies are accessible and affordable to those most in need.

Psychedelics & Equity and Ethics

Psychedelic-assisted therapies are poised to be the next big thing in mental health care. However, whether or not everyone living with a mental disorder will reap the benefits of psychedelic treatment models remains to be seen.

Issues surrounding accessibility and affordability are to the fore for those of us in the western world. On the other hand, the Indigenous communities who have stewarded psychedelic plant medicine for thousands of years face issues as actors in the space are set to profit from their cultural heritage.

In this article, we explore some of the ethical issues inherent to psychedelic medicine, how people in people in the field are working toward preserving traditional knowledge, ensuring the equitable governance of these substances and more.

Psychedelic Research

The first wave of psychedelic research in the 1950s and 1960s was marred with methodological flaws and unethical practices by today’s standards. During this era, researchers were perhaps overenthusiastic about the potential of psychedelics, which contributed to the downfall of psychedelic research.

Moreover, the escape of psychedelics from the laboratory and traditional spaces and into the US counterculture movement in the 1960s also severely hampered the chances of psychedelics becoming legitimate medicines.

Modern-day researchers are now tasked with overcoming past mistakes and complying with the highest regulatory and ethical standards.

To do so, researchers trying to prove the safety and efficacy of psychedelic treatment models today are working with the gold standards of biomedicine: randomized-controlled trials (RCTs).

In an RCT, a population is chosen randomly from the eligible population and then split into a control group and an experimental group. Unfortunately, the legal issues and potency of psychedelics make it difficult to conduct these trials as normal.

Many of these trials involve small sample sizes, which limit generality. At the same time, larger-scale studies are conducted using surveys and are therefore limited due to the lack of experimental control [1]. Furthermore, the potency of psychedelic drugs makes blinding and randomization difficult, although it has been possible when sample sizes are low [2].

For novel drugs to gain approval from regulatory agencies like the FDA, sample sizes must be large enough to enhance statistical significance and generalizability. Additionally, results must be unbiased and achieved through randomization. Although some progress has been made, the generalizability of results from clinical trials with psychedelics remains an issue faced by psychedelics.

One does not have to look far to see an overall lack of diversity in psychedelic science. This is reflected in the demographics of those participating in clinical trials exploring the potential of psychedelics. Clinical trials suffer from WEIRD bias, which refers to the majority of trial participants coming from western, educated, industrialized, rich and democratic (WEIRD) societies [3].

Timothy Michaels and colleagues found that out of 282 people partaking in clinical trials, 82.3 per cent of participants were non-Hispanic White [4]. Such findings have implications when considering the generalizability of psychedelic-assisted therapies, as findings from such trials may not extend to people of different ethnic and cultural backgrounds.

In 1993, the National Institute of Health in the US introduced the Revitalization Act to establish guidelines for including women and minorities in clinical research. Unfortunately, issues surrounding diversity in clinical trials are not unique to the field of psychedelics and remain a more widespread issue in biomedical research [5].

Establishing fair standards of care, minimising outcome disparities between populations, and achieving and upholding social equity representative and diverse research participation is necessary, not only in psychedelic research but biomedicine as a whole [6].

Several reasons have been put forward why minority populations may not feel as comfortable participating in clinical trials. One theory stems from the so-called War on Drugs.

In the US, where many trials investigating the potential of psychedelics are taking place, the War on Drugs has disproportionately affected people of African American ethnicity compared to their white counterparts [7].

Monnica Williams and Beatriz Labate have argued that the impact of policies relating to the War on Drugs has psychologically impacted this group, so much so that the resulting race-based trauma has made therapy using illegal drugs like psychedelics somewhat of an unfathomable concept for African Americans and people of colour in general [8].

Furthermore, treatment models using psychedelics are now being adapted to fit western healthcare models. In doing so, modern psychedelic research risks ostracizing the Indigenous communities from which these practices originate.

Indigenous Reciprocity

Although the field of psychedelics is still in its relative infancy, the renaissance period has arguably ended. We are now well aware of the therapeutic potential that psychedelics possess, thanks to evidence-based research and the dissemination of positive research findings in the age of mass media.

An influx of actors has accompanied the rebirth of this field of research into the field of psychedelics. Many of these actors bring vast amounts of capital and hope to make their “proprietary formulation” of a given psychedelic both accessible and profitable. Much like the industrial revolution that came not long after the classic renaissance, the industrialization of psychedelics has begun.

The influx of actors and capital is undoubtedly helping researchers to unearth more about the mysteries of psychedelics and advance this new paradigm in mental health care. Additionally, it has been slowly helping to address the cultural baggage attached to psychedelics since the 1960s, with big-name investors and celebrities now endorsing these substances. However, a blessing can be seen as a curse for others.

For thousands of years, psychedelic plant medicines have been used by various cultures across the globe for their perceived therapeutic potential. These Indigenous groups laid the foundations for modern-day psychedelic medicine and continue contributing to the field. The use of psychedelics for their healing properties forms a significant part of these groups’ cultural heritage. Yet, these groups are set to lose out as the rush to medicalise/westernise psychedelics is underway.

The work of the Indigenous people, racial minorities, women, and other marginalized groups is often not supported or highlighted in the discourse of psychedelic medicine. Indigenous groups have thus become alienated from their cultural practices and, consequently, the medical benefits of these practices [7]. Furthermore, Indigenous groups are set to be deprived of any profits from their cultural heritage in the wake of medicalisation/westernisation.

Suppose therapeutic models utilizing psychedelics will truly enter the mainstream and impact global mental health. In that case, controversies surrounding diversity and accessibility must be addressed as western medicine appropriates the cultural practices of Indigenous groups.

Given that the race to grab intellectual property in the field has already begun, the opportunity to acknowledge the contributions of Indigenous medicine to this paradigm should be seized, especially in light of the predicted profits.

Debates surrounding patents and the possibility of creating an ethical psychedelic company are now dominating the discourse surrounding psychedelics as the prospect of medicalizing these substances is slowly becoming a reality. A recent scientific article from the POPLAR Initiative at Harvard Law School explores the implications of patenting psychedelics. The Indigenous groups who laid the foundations for modern psychedelic research and clinical practice are central to their argument and this debate.

Companies & Initiatives

To ensure the contributions of Indigenous groups are not forgotten, a select few companies and initiatives are working with these groups.

One such company is the San Francisco-based Journey Colab. On top of exploring the potential of mescaline to treat alcohol use disorder, Journey Collab has created the Journey Reciprocity Trust. The trust has been designed to “share the value generated by the company’s success with Indigenous communities that have traditionally used psychedelics and other community stakeholders, including those working to ensure equitable access to mental health treatment and those working on the conservation of naturally occurring psychedelics.”

North Star is also working toward making psychedelics accessible, equitably and ethically. The non-profit organization developed the North Start Ethics Pledge to create a set of shared values in the field of psychedelics.

Woven Science has set up El Puente, a non-profit working toward ensuring access and benefit-sharing of psychedelic medicine to Indigenous groups. El Puente gives back through direct impact grants guided by a council of Indigenous leaders with veto powers. We recently caught up with Jesse Hudson, spearheading the El Puente initiative at Woven. For details on the work he and the team at Woven are doing, check out the full interview here.

The Chacruna Institute for Institute for Psychedelic Plant Medicine is a non-profit dedicated to providing “public education and cultural understanding about psychedelic plant medicines and promote a bridge between the ceremonial use of sacred plants and psychedelic science.”

The work of Chacruna has helped to raise awareness surrounding the issues of diversity in the field of psychedelics and the equitable governance and accessibility of these substances. Moreover, Chacruna is helping to give back to the Indigenous groups from whence these practices came through their Indigenous Reciprocity Initiative (IRI).

The IRI works directly with Indigenous groups by supporting them at the grassroots level. Through donations, the IRI is helping to foster resilience within Indigenous communities by helping them to combat the many issues driven by globalization processes. These issues include pollution, deforestation, and biodiversity loss, amongst others. By promoting sustainable strategies, IRI is helping to pave the way toward a future where not only is psychedelic medicine preserved, but more importantly, the communities from where this knowledge came have promising futures.

Another initiative working toward preserving this cultural knowledge is the Indigenous Medicine Conservation Fund (IMCF). The IMCF was established “for the sovereign protection of the plants, ecologies & traditional healing wisdom which Indigenous communities have relied on for thousands of years.” They focus their efforts on “keystone biocultures”: ayahuasca, bufo, iboga, peyote and psilocybe mushrooms.

The IMCF ensures conservation efforts are Indigenous-led and that ecological and community-based assessments inform any decisions. The fund is governed by Indigenous and western experts who are experienced in traditional knowledge and scientific methodology.

Final Thoughts

The issues surrounding equity and ethics in psychedelic medicine can be addressed, with some initiatives already underway. However, more can be done to ensure that psychedelic medicine is accessible and affordable to those who need it.

One of the most pertinent issues that need to be addressed relates to the psychedelic’s current classification as Schedule I substances. This current classification makes it both difficult and expensive to work with psychedelics.

Much of the high costs associated with clinical research and Schedule I substances stem from the paperwork that accompanies working with controlled substances. Not only do the substances themselves have to meet high regulatory standards but so too do the equipment and even the people working with these substances. The rules and regulations surrounding controlled substances leave little commercial incentive for companies to manufacture them and keeps prices high.

Thus, a change in drug policy is needed to ensure these substances are easier to manufacture and work with to generate the evidence required to transform these substances into viable therapy options. Furthermore, rescheduling is of benefit to those seeking treatment. Not only does rescheduling increase accessibility, but by decreasing manufacturing costs, the price reduction can trickle down through the research process and also be felt by the people in need of these therapies.

In terms of issues within clinical trials, western medicine may look beyond the randomized-controlled trial and instead embrace the idea of medical pluralism. At the core of psychedelic medicine lies ideals which epistemically diverge from that of biomedicine. Embracing these different ways of knowing might help advance this paradigm shift in mental health.

Awarding patents on psychedelics remains contentious as some argue it can lead to gate-keeping activities and monopolies over certain psychedelic compounds. While patents can generate revenue to further advance research in the field, they also can keep therapy costs high. As detailed in the recent article from the POPLAR initiative, there are some ways to ensure the governance of these substances is equitable.

The ideology of Open Science is not new in the world of psychedelics, with many in the field already embracing it. A prime example is a recent publication from researchers at MAPS which details the synthesis of pharmaceutical-grade MDMA.

The publication of this process in an open-access format emphasizes the value of taking an Open Science approach to manufacturing psychedelics. The Open Science approach increases patients’ accessibility and the cost-effectiveness of the therapies they need, which seems to be forgotten by many in an industry that seeks to address the global mental health crisis.

Researchers at the Usona Institute have also embraced the idea of Open Science. The researchers have published the process for synthesising psilocybin a year previous.

Finally, Indigenous reciprocity should be embraced by all actors in the field. The very foundations of the field of psychedelic medicine were laid by the traditional knowledge and practices of Indigenous groups. Now, these groups are being forgotten as the rush to bring these therapies to market is taking precedence by many in the field. Companies should work with initiatives like the IRI and El Puente instead of promising restitution further down the line.

Suppose psychedelics are genuinely going to address the global mental health crisis. In that case, as many investor decks would lead one to believe, we must ensure that ethical decision-making and equity for all are at the movement’s core. Even still, psychedelic-assisted therapies are likely to remain a privilege to those in the Global North. If we want to address the mental health crisis on a global scale, we need systemic change, but that’s an issue for another day.

References

1. Petranker, R., Anderson, T., & Farb, N. (2020). Psychedelic Research and the Need for Transparency: Polishing Alice’s Looking Glass. Frontiers in Psychology, 11, 1681. https://doi.org/10.3389/fpsyg.2020.01681

2. Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., Finan, P. H., & Griffiths, R. R. (2020). Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.

3. American Psychological Association. (2010). Are your findings ‘WEIRD’? American Psychological Association. https://www.apa.org/monitor/2010/05/weird

4. Michaels, T., Purdon, J., Collins, A., & Williams, M. (2018). Inclusion of people of colour in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. https://doi.org/10.1186/s12888-018-1824-6

5. Redwood, S., & Gill, P. (2013). Under-representation of minority ethnic groups in research — call for action. British Journal of General Practice, 342-343. https://doi.org/10.3399/bjgp13X668456

6. Sharma, A., & Palaniappan, L. (2021). Improving diversity in medical research. Nature Reviews Disease Primers. https://doi.org/10.1038/s41572-021-00316-8

7. George, J., Michaels, T., Sevelius, J., & Williams, M. (2020). The psychedelic renaissance and the limitations of a White-dominant medical. Journal of Psychedelic Studies, 4-15. https://doi.org/10.1556/2054.2019.015

8. Williams, M., & Labate, B. (2020). Diversity, equity, and access in psychedelic medicine. Journal of Psychedelic Studies, 1-2. https://psycnet.apa.org/doi/10.1556/2054.2019.032

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Highlighted Institutes

These are the institutes, from companies to universities, who are working on Equity and Ethics.

University of Ottawa

The University of Ottawa launched  The Psychedelics & Spirituality Studies Initiative (PSSI) in 2021. PSSI is an interdisciplinary group of faculty and graduate students who share a common interest in the study of psychedelics, spirituality and integrative healing.

Chacruna

The Chacruna Institute for Psychedelic Plant Medicine is a non-profit that organizes many different (legal) councils with a relationship to ayahuasca, peyote, and psychedelic drugs in general.

Woven Science

Woven Science is a company that aims to build several arms related to the treatment of mental health disorders with psychedelics. They do this with taking indigenous rights into account and through a holistic lens.

Journey Colab

Journey Colab aims to develop a portfolio of psychedelic compounds for use in therapy, the first of which is (synthetic) mescaline. The company puts a strong focus on collaborating with non-profits, Indigenous groups, and clinicians.

Indigenous Medicine Conservation Fund

The Indigenous Medicine Conservation Fund (IMCF) was established “for the sovereign protection of the plants, ecologies & traditional healing wisdom which Indigenous communities have relied on for thousands of years.”

Harvard University

Harvard is working with Mass General and their team at the Center for the Neuroscience of Psychedelics. Harvard Law School recently launched their POPLAR initiative.

Highlighted People

These are some of the best-known people, from researchers to entrepreneurs, working on Equity and Ethics.

Bia Labate

Beatriz 'Bia' Caiuby Labate is the founder and executive director of Chacruna. She is a queer Brazilian anthropologist. She fulfils several roles at MAPS and founded the Interdisciplinary Group for Psychoactive Studies (NEIP) in Brazil. She has worked on 25 books.

Linked Research Papers about Equity and Ethics

Research abuses against people of colour and other vulnerable groups in early psychedelic research

Culture and psychedelic psychotherapy: Ethnic and racial themes from three Black women therapists

Acute and enduring effects of naturalistic psychedelic use among Indigenous peoples in Canada and the United States

MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial

Developing a new national MDMA policy: Results of a multi-decision multi-criterion decision analysis (MD-MCDA)

Special considerations for evaluating psilocybin-facilitated psychotherapy in vulnerable populations

Lay Perceptions of Treating Mental Illness with Psychedelic Assisted Therapy

Socio-psychedelic imaginaries: envisioning and building legal psychedelic worlds in the United States

Integration in Psychedelic-Assisted Treatments: Recurring Themes in Current Providers’ Definitions, Challenges, and Concerns

Constructing drug effects: a history of set and setting

How psychedelic researchers’ self-admitted substance use and their association with psychedelic culture affect people’s perceptions of their scientific integrity and the quality of their research

Interest in receiving psychedelic-assisted therapy among marginalized women: Implications and findings from a community-based study in Canada

Asymmetry in Psychoactive Research: A Bibliometric Study on 15 Psychoactive Drugs

Towards psychedelic apprenticeship: Developing a gentle touch for the mediation and validation of psychedelic-induced insights and revelations

A Prehistoric Mural in Spain Depicting Neurotropic Psilocybe Mushrooms?

Consumption of Ayahuasca by Children and Pregnant Women: Medical Controversies and Religious Perspectives

Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges

Effects of Schedule I drug laws on neuroscience research and treatment innovation

User perceptions of the benefits and harms of hallucinogenic drug use: A web-based questionnaire study

Self-Experiments with Psychoactive Substances: A Historical Perspective

Cancer Healthcare Workers' Perceptions toward Psychedelic-Assisted Therapy: A Preliminary Investigation

Two Models of Legalization of Psychedelic Substances: Reasons for Concern

Moral Psychopharmacology Needs Moral Inquiry: The Case of Psychedelics

A Nationwide Study Comparing Mental Health Professionals' Willingness to Try Hallucinogenic Drugs in Basic Research or Clinical Practice

How Religion, Race, and the Weedy Agency of Plants Shape Amazonian Home Gardens

A Survey of American Psychiatrists’ Attitudes Toward Classic Hallucinogens

Psychedelic perceptions: mental health service user attitudes to psilocybin therapy

Psychedelic medicalization, public discourse, and the morality of ego dissolution

Reconciling Mystical Experiences with Naturalistic Psychedelic Science: Reply to Sanders and Zijlmans

The socialization of hallucinations. Cultural priors, social interactions and contextual factors in the use of psychedelics

Practices in search of legitimacy. The contemporary use of ayahuasca, between religious and therapeutic vindications

Integrating Psychedelic Medicines and Psychiatry: Theory and Methods of a Model Clinic

Psychedelic Knowledge and Opinions in Psychiatrists at Two Professional Conferences: An Exploratory Survey

LSD treatment in Scandinavia: emphasizing indications and short-term treatment outcomes of 151 patients in Denmark

The Use of Salvia divinorum from a Mazatec Perspective

The need for publicly funded research on therapeutic use of psychedelic drugs

MDA, MDMA and other mescaline-like substances in the US military’s search for a truth drug (1940s to 1960s)

Relational Processes in Ayahuasca Groups of Palestinians and Israelis

Psychedelic drug use in healthy individuals: A review of benefits, costs, and implications for drug policy

Pahnke’s ‘Good Friday Experiment’: a long-term follow-up and methodological critique

LSD experiments by the United States Army

Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial

The challenges ahead for psychedelic ‘medicine’

Presence, Trust, and Empathy: Preferred Characteristics of Psychedelic Carers

Translating Psychedelic Therapies From Clinical Trials to Community Clinics: Building Bridges and Addressing Potential Challenges Ahead

The Psychedelic Renaissance in Clinical Research: A Bibliometric Analysis of Three Decades of Human Studies with Classical Psychedelics

The Need for Psychedelic-Assisted Therapy in the Black Community and the Burdens of its Provision

Overcoming epistemic injustices in the biomedical study of ayahuasca: Towards ethical and sustainable regulation

Psilocybin: crystal structure solutions enable phase analysis of prior art and recently patented examples

Palliative care provider attitudes toward existential distress and treatment with psychedelic-assisted therapies

Fully Validated, Multi-Kilogram cGMP Synthesis of MDMA

Toward a positive psychology of psychoactive drug use

Right-Wing Psychedelia: Case Studies in Cultural Plasticity and Political Pluripotency

A Spectrum of Selves Reinforced in Multilevel Coherence: A Contextual Behavioural Response to the Challenges of Psychedelic-Assisted Therapy Development

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

The readiness of psychiatrists to implement psychedelic-assisted psychotherapy

Psychedelics as Tools for Belief Transmission. Set, Setting, Suggestibility, and Persuasion in the Ritual Use of Hallucinogens

Psychedelic injustice: should bioethics tune in to the voices of psychedelic-using communities?

The Power of Social Attribution: Perspectives on the Healing Efficacy of Ayahuasca

Patents on Psychedelics: The Next Legal Battlefront of Drug Development

Why was early therapeutic research on psychedelic drugs abandoned?

Parental Attitudes Toward Use of Ketamine in Adolescent Mood Disorders and Suicidality

Communalistic use of psychoactive plants as a bridge between traditional healing practices and Western medicine: A new path for the Global Mental Health movement

The frontiers of new psychedelic therapies: A survey of sociological themes and issues

A Qualitative Exploration of Relational Ethical Challenges and Practices in Psychedelic Healing

“Meeting the Medicine Halfway”: Ayahuasca Ceremony Leaders’ Perspectives on Preparation and Integration Practices for Participants

Attitudes and Beliefs about the Therapeutic Use of Psychedelic Drugs among Psychologists in the United States

MDMA-Assisted Therapy for Posttraumatic Stress Disorder: A Mixed-Methods Case Study of a Participant of Color From an Open-Label Trial

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