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