Contributor: Dona Kim Murphey, MD PhD CHW
To learn more about Dona, click here.
July is National Minority Mental Health Awareness Month. The mental health ecosystem comprises education and awareness initiatives, primary care screening, therapeutic (including holistic and complementary) products and services, treatment facilities, insurance, support groups, employee assistance programs (EAP), drug development, and government policies which give shape to everything else.
In 2020, around $280 billion was spent on therapeutic services in mental health alone, a quarter of which went disproportionately to Medicaid. With an overrepresentation of Black (20%) and Latino (30%) patients, there is a racialization of poverty as there is for many other social determinants of mental health. There appears to be no disproportionate incidence of mental health disorders for minoritized populations, but health disparities manifest in various ways for these groups, including lower rates of diagnosis and treatment, greater severity and longer duration of illness, and decreased access to culturally competent counsel and care. What remains poorly exposed in this ecosystem are the myriad ways in which drug development efforts, haunted by a history of racialized exploitation, continue to reproduce health disparities. Examining, for instance, the explosive interest in psychedelics, reveals the contemporary challenges that remain willfully ignored.
There are currently over 200 clinical trials of psychedelics for various mental health conditions registered as looking for subjects or active with clinicaltrials.gov. From 2010-2015, a single trial was initiated. From 2015-2020, there were 19. And from 2020-2025, 199. Patenting and drug development efforts of psychedelics have tried to exploit long-held Indigenous knowledge about the therapeutic and transformative properties of these substances. This has not happened without organized resistance. But most Western researchers and companies have nonetheless moved forward without adequately recognizing or compensating these communities. They engage in a form of “biopiracy,” which monetizes a communal asset and renders it difficult for the very people whose wisdom has been exploited to access the products they have helped to create.
Beyond the grotesque injustice to Indigenous communities that have stewarded this knowledge for generations, current clinical research about the potential therapeutic effects of psychedelics is undermined by historical atrocities such as the Tuskegee Syphilis Study and the unauthorized use of DNA samples from the Havasupai Tribe, which has understandably fueled mistrust in clinical research and medical institutions. While guidelines advanced in the Belmont Report in 1976, today upheld through Institutional Review Boards (IRBs), endeavor to assure research participants of some ethical standards, there is the additional contemporary challenge of cultivating trust with communities that were historically exploited and of being more deliberate about how they are included in clinical trials.
The NIH Revitalization Act of 1993 mandated guidelines for the inclusion of women and individuals from racial and ethnic minority groups in clinical research, aiming to ensure study participants represent real-world diversity for generalizability of research findings across populations. NIH continued to prioritize inclusion efforts through initiatives such as the NIH Research, Conditions and Disease Categorization Inclusion Statistics Report, which provides data on participant demographics, but it was not until 2017, that they mandated valid analyses by sex/gender, race, and ethnicity in applicable Phase III clinical trials submitted to Clinicaltrials.gov.
Still, the inclusion of minoritized groups in psychedelic medicine studies in treating a wide range of mental health disorders, including depression, post-traumatic stress disorder (PTSD), anxiety disorders, addiction, obsessive-compulsive disorder (OCD), eating disorders, chronic pain, and even end-of-life anxiety, remains very poor.
On December 29, 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), intended to promote diversity in late-stage clinical trial enrollment. Yes, representation in Phase III clinical trials is crucial for evaluating safety and efficacy of a compound, especially for those disproportionately impacted by a disease. By this stage, volunteers might benefit medically, and it is not by accident that minorities are underrepresented. From that perspective, FDORA offers an important intervention (however incremental) in promoting health equity. But the failure to examine the entire process of drug development, including a closer look at Phase 1 trials will perpetuate racialized health disparities.
The earliest stage of clinical trials, Phase I, involves testing new drugs for the first time in human subjects, usually healthy volunteers, to evaluate safety. These trials are undertaken to characterize the risk of injury at various doses of a compound and can be hazardous to the health of those enrolled. While participants typically don't expect health benefits at this stage, they are compensated, attracting those who are low-income, often Black or Hispanic (again due to the racialization of poverty), due to financial incentives. Historically, minorities have been overrepresented in Phase I trials, raising ethical concerns about exploitation and the need for protective policies. Vulnerable groups, including individuals who are unhoused or struggling with mental illness have also been targeted for early-stage drug development in the past.
Specifically in Phase 1 trials for psychedelics (for which there is a general risk of seizures that corresponds to the incidence of epilepsy in the population at large), there is likely increased risk for subjects whose demographics we know to be overrepresented in early-stage clinical research and are at disproportionate risk for epilepsy but who also tend to be grossly underdiagnosed. Screening by history in this population, which is often by self-report, is inadequate.
But now, say that screening, whether by clinical history or by electroencephalogram (EEG), one of the main diagnostic tests for seizures, is used to exclude epilepsy patients from clinical research on psychedelics. This is also distinctly discriminatory, as for these patients, who often have highly co-morbid mood and anxiety disorders, safety data for psychedelics will be entirely lacking. The acute solution here, beyond what can be done in terms of addressing social determinants of mental health that generate these disparities, is greater vigilance around screening and monitoring. Equitably safeguarding participant health will also require transparency and accountability.
The market for psychedelics is expected to reach $6.8 billion by 2027. With biopharma investing abundantly in this growth area, let’s hope decision makers commit not only to reducing suffering in mental health disorders but to protecting those at greatest risk of harm both during drug development and disproportionately without access to safe and effective treatment.
Contact Dona via her LinkedIn page.