Funding, High-Quality Science, are Essential to the Future of Psychedelic Therapies

Mental health is a pressing and persistent national issue. Across the United States, roughly seven percent of Americans will experience post traumatic stress disorder (PTSD) at some point in their life. In 2020, the Center for Disease Control found that slightly more than 18 percent of U.S. adults had reported a diagnosis of depression at some point in their life.

Mental health disorders account for a significant cause of global disease burden, and while further study is necessary, it’s clear that there are limitations to the existing treatments for PTSD and depression. For some, their illness doesn’t respond to the treatment while others have intolerable side-effects. For these individuals who have treatment-resistant illness, they have few options but to endure the pain.

Over the past two decades, researchers and clinicians have become interested in the potential of a class of drugs referred to as serotonergic psychedelics; this class of drugs include psilocybin, lysergic acid diethylamide (LSD) and dimethyltryptamine (DMT). Early research suggests that, unlike most existing treatments for mental health disorders, psychedelics may produce rapid and long-lasting reductions in depression and PTSD after just one or two doses. 

The promise of psychedelics is great, but there is an urgent need for rigorous research to translate the therapeutic potential of these compounds into reality. However, research on psychedelics faces a stifling regulatory environment, limited funding and methodological challenges.

Psychedelics are designated Schedule I status by the Drug Enforcement Agency (DEA). Drugs under this status are defined as having no therapeutic value, high abuse liability, and have the highest level of regulatory scrutiny and requirements. Beyond the DEA, investigators have to obtain approval from the Food and Drug Administration in order to conduct clinical trials with any investigational drug and study protocols have to be approved by the research site’s Institutional Review Board (IRB). These regulatory processes take a significant amount of time and effort. Even at an institution like Yale, which has a long history of studying psychedelic drugs, it has taken more than two years for some psychedelic protocols to receive approval.

Many investigators and institutions are shy to accept the risk of working with Schedule I drugs, and the result is a self-fulfilling negative feedback loop. In academia, it’s essential to generate and publish research, especially in the early stages of one’s career. Spending two years to gain regulatory approval is simply not feasible for many and animates the saying “publish or perish.” This, in effect, throttles the breadth and depth of available research, which then limits the availability of funding. In the life of a junior investigator eager to work in the area, waiting for two years could be a death knell to their budding research career. 

Amplifying the constellation of regulatory requirements and timelines, the gold standard for evaluating the efficacy and safety of new drug treatments is the randomized, double-blind, placebo-controlled study. Given that psychedelic compounds produce unmistakable acute psychedelic effects, blinding is very challenging. Most patients who take part in studies, and the staff evaluating them, are able to figure out treatment assignments, which make it difficult to interpret the results of the study.  

In addition to regulatory and evaluation challenges, the historical stigma associated with psychedelics and their Schedule I status creates an environment where research funding is limited. Without adequate funding and infrastructure, this line of research is almost impossible to initiate, especially for junior investigators, who often bring bright new ideas to the field. 

While many of these policies are necessary to ensure ethical administration and shepherd good and safe science, there is a need for foundations and other entities to accelerate high-quality science and advocate for policy evolution in order to advance our understanding of psychedelic substances and the potential for scalable therapeutics for these pernicious ailments. At the federal level, yes, more funding would be a gamechanger, but reducing the regulatory barrier to research would be a catalyst of seismic proportions. 

America’s research universities are one of the engines that will drive progress. The Sodhi Foundation recently gave $3 million to Yale University to establish the university’s first ever endowed professorship to promote psychedelic research. These continued and recurring funding sources are essential – they provide the necessary backing to manage the long timelines of this work, and pave the way for long-term support from organizations that have traditionally demurred. There are green shoots in this field, and as with all budding opportunities, they require attention and resources if they are to keep growing. We can’t let archaic policy and regulatory hurdles force science to turn its back on these potentially transformative substances and treatments.