million people affected worldwide
Psychedelic research currently is in Preclinical
- There are a number of issues surrounding equity and ethics in the field of psychedelics. From the clinical trial process to the awarding of patents, many issues need to be addressed as the field progresses.
- Indigenous groups who have stewarded psychedelic plant medicine for thousands of years are increasingly becoming alientated from their tradtiaitonal practices and cultural heritage. Some initiatives and companies in the space, such as Chacruna and Woven Scienece, are working with Indigenous groups to foster community reslience and preserve the knoweldge and practices are preserved.
- A collaborative effort from all in the field is needed to move past these issues and ensure psychdelic-assisted therapies are accessible and affordable to those most in need.
Psychedlics & 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 treat 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 of their own 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.
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 the mistakes of the past 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 at random from the eligible population, which is then split at random into a control group and an experimental group. Unfortunately, both the legal issues and potency of psychedelics are making it difficult to conduct these trials as normal.
Many of these trials involve small sample sizes which limit generality, all while larger-scale studies are conducted using surveys and are therefore limited due to the lack of experimental control . Furthermore, the potency of psychedelic drugs makes blinding and randomization difficult, although it has been possible when sample sizes are low .
In order 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 that there is 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 .
Timothy Michaels and colleagues found that out of 282 people partaking in clinical trials, 82.3 per cent of participants were non-Hispanic White . 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 the inclusion of 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 .
In order to achieve to establish fair standards of care, minimize outcome disparities between populations, and achieve and uphold social equity representative and diverse research participation is necessary, not only in psychedelic research but biomedicine as a whole .
A number of reasons have been put forward as to 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 of the trials investigating the potential of psychedelics are taking place, the War on Drugs has disproportionately affected people of African American ethnicity when compared to their white counterparts .
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 .
Furthermore, treatment models using psychedelics are now being adapted to fit western models of healthcare. In doing so, modern psychedelic research runs the risk of ostracizing the Indigenous communities from whom these practices originate.
Although the field of psychedelics is still in its relative infancy, the renaissance period has arguably come to an end. 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.
The rebirth of this field of research has been accompanied by an influx of actors into the field of psychedelics. Many of these actors bring with them vast amounts of capital and the hopes of making 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 psychedelic 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 is slowly helping to address the cultural baggage that has been attached to psychedelics since the 1960s with big-name investors and celebrities now endorsing these substances. However, a blessing for some 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 are continuing to contribute to the field. The use of psychedelics for their healing properties forms a major part of these groups’ cultural heritage, yet these groups are set to lose out as the rush to medicalize/westernize psychedelics is well 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 own cultural practices and consequently, the medical benefits of these practices . Furthermore, Indigenous groups are set to be deprived of any profits generated from their cultural heritage in the wake of medicalization/westernization.
If therapeutic models utilizing psychedelics are truly going to enter the mainstream and impact global mental health, it is important that controversies surrounding diversity and accessibility are 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 in detail. Central to their argument and this debate overall are the Indigenous groups who laid the foundations for modern psychedelic research and clinical practice.
Companies & Initiatives
In order 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 in a manner that is both equitable and ethical. 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 that is working toward ensuring access and benefit-sharing of psychedelic medicine to Indigenous groups. El Puente gives back through direct impact grants which are guided by a council of Indigenous leaders with veto powers. We recently caught up with Jesse Hudson who is 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 for 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. Some of these issues include pollution, deforestation, and a loss of biodiversity, amongst others. By promoting sustainable strategies, IRI is helping to pave the way toward a future where not only psychedelic medicine is preserved, but more importantly, the very 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 are focusing their efforts on what they call “keystone biocultures”: ayahuasca, bufo, iboga, peyote and psilocybe mushrooms.
The IMCF ensures conservation efforts are Indigenous-led and that any decisions are informed by ecological and community-based assessments. The fund is governed by both Indigenous and western experts who are experienced in both traditional knowledge and scientific methodology.
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 stems from the paperwork that accompanies working with controlled substances. Not only do the substances themselves have to meet high regulatory standards but so too does 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 therefore, keeps the prices high.
Thus, a change in drug policy is needed to ensure these substances are easier to manufacture and work with in order 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, by decreasing manufacturing costs the reduction in price 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 themselves, perhaps western medicine should 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 just help to advance this paradigm shift in mental health.
The awarding of patents on psychedelics remains contentious as some argue it can lead to gate-keeping activities and monopolies over certain psychedelic compounds. While patents have the ability to generate revenue to further advance research in the field, they also can keep costs of therapy 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 the manufacturing of psychedelics. The Open Science approach increases patients’ accessibility and the cost-effectiveness of the therapies they need, something which seems to be forgotten by many in an industry which seek to address the global mental health crisis.
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 about 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.
If psychedelics are truly going to address the global mental health crisis, as many investor decks would lead one to believe, we must ensure that ethical decision-making and equity for all are at the core of the movement. Even still, psychedelic-assisted therapies are likely to remain a privilege to those of us 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.
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
These are the institutes, from companies to universities, who are working on Equity and Ethics.
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 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 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.
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 is working with Mass General and their team at the Center for the Neuroscience of Psychedelics. Harvard Law School recently launched their POPLAR initiative.
These are some of the best-known people, from researchers to entrepreneurs, working on Equity and Ethics.
Bia Labate is the founder and executive director of Chacruna. She is a queer Brazilian anthropologist. The also works as adjunct faculty at CIIS, fulfils several roles at MAPS, and founded the Interdisciplinary Group for Psychoactive Studies (NEIP) in Brazil. She has worked on 21 books.
Linked Research Papers about Equity and Ethics