Just a few years ago, investments in medicinal psychedelic research were rare in even the riskiest of financial portfolios. But with entrepreneurs and financiers now pouring money into developing psychedelic treatments for mental and behavioral health issues, it’s clear that investors, like many scientists, envision a psychedelic path for psychiatry. There’s a notable holdout though: the National Institutes of Health, the world’s largest public funder of medical research.
The NIH’s absence from investment in psychedelic medicine is unfortunate, since it is preventing talented researchers from entering the field and possibly slowing the development of urgently needed innovative treatments.
While humanity shares an ancient and admittedly complicated relationship with psychedelics — ayahuasca, dimethyltryptamine, ibogaine, LSD, MDMA (better known as ecstasy), mescaline, psilocybin, and others — they didn’t reach Western medicine until the 1950s and 1960s, when LSD and psilocybin were used to enhance psychotherapy. Unfortunately, after being embraced by 1960s counterculture, psychedelics became politicized and were declared in the 1970s to be Schedule I drugs — substances with high abuse potential and no accepted medical use. Promising investigations into their clinical applications subsequently stalled.
Scientists and philanthropic organizations are reviving medicinal psychedelic research, and this work is once again bearing fruit. For example, results published in May of the first Phase 3 trial of using MDMA to treat post-traumatic stress disorder showed that more than twice as many participants receiving MDMA-assisted psychotherapy no longer met diagnostic criteria for PTSD compared to those receiving therapy and placebo medication. With one more successful Phase 3 trial, the U.S. Food and Drug Administration could approve prescription use of MDMA-assisted psychotherapy as early as 2023.
And with other psychedelics demonstrating possible treatment efficacy for alcohol addiction, bereavement, depression, end-of-life distress, nicotine addiction, and opioid addiction, MDMA might not be the only one rejoining psychiatry’s armamentarium in coming years.
Propelled by these findings and the prospects of lucrative initial public offerings, venture capital firms have gone from investing $1 million in psychedelic biotech startups in 2017 to $329 million during the first four months of 2021 alone.
Though this investment could accelerate medicinal psychedelic development, it’s also generating concerns. While academic investigators have adhered to safety guidelines in psychedelic clinical trials, some observers worry that venture-capital-backed psychedelic biotechs could sacrifice caution amid a rush for profits, harming participants. And with these companies now attempting to patent almost anything related to psychedelics, many in psychedelic medicine are wondering if the field’s communal ethos is at risk.
Given the overwhelming support for medicinal psychedelic research within psychiatry, the reluctance of the NIH — and particularly the National Institutes of Mental Health (NIMH), one of its 27 institutes and centers — to fund such work is surprising. The NIMH’s focus on targeted drug development in recent years likely explains much of this perplexing hesitancy, since the organization is increasingly funding basic neuroscience aimed at uncovering therapeutic targets rather than clinical trials.
The NIH’s persistent support for studies conceptualizing psychedelics primarily as drugs of abuse — though their addictive potential pales in comparison to that of countless FDA-approved medications — is also probably to blame.
Even with robust private funding materializing, lack of NIH support will continue to impede psychedelic medicine’s progress for several reasons.
Chief among these is that more than 300,000 investigators, mostly based in universities, rely primarily — often exclusively — on the NIH for research funding. Their involvement in medicinal psychedelic research is crucial since industry, with an eye toward developing near-term marketable products, has little incentive to plumb psychedelics for illuminating the brain’s inner workings.
Such research, which has dramatically enriched our understanding of brain network connectivity, the default mode network, and personality change, is powerfully appealing to academic investigators. Yet without NIH or highly sought-after philanthropic support, they have limited options for pursuing any medicinal psychedelic research. While they can advise psychedelic biotechs or direct clinical trials for them, many academics prefer to conduct their own studies and avoid industry collaboration because of conflict of interest concerns.
Efforts to improve diversity and representation within psychedelic medicine could also face greater challenges without NIH support. Currently, psychedelic clinical trials are concentrated in a few well-resourced medical centers, and limited diversity among their faculties may contribute to underrepresentation of people of color in studies. By extending psychedelic research to other institutions, the NIH could help increase trial participant diversity and improve generalizability of findings.
The NIH’s lack of involvement is also constraining biopharma companies, which rely on the NIH to fund financially high-risk foundational studies so they can focus on later-stage drug development. If the NIH did this with psychedelics, it could enable industry to develop psychedelic medicines for conditions for which they have potential but pilot data are lacking, such as functional neurological disorder, persistent vegetative states, and personality disorder. Gaining access to the NIH’s numerous public-private research partnerships could also significantly benefit psychedelic biotechs.
Thankfully, the NIH may be changing course. In December 2019, Roland Griffiths, professor of psychiatry and neuroscience at Johns Hopkins University School of Medicine and founding director of Hopkins’ Center for Psychedelic and Consciousness Research, who is behind some of psychedelic medicine’s most seminal studies, was invited by the NIMH to discuss his work. Such an invitation even a year or two earlier would have been beyond belief.
And in April 2021, the NIH awarded what appears to be its first grant dedicated to medicinal psychedelic research: a $190,000 career development award to physician Benjamin Kelmendi who plans to use neuroimaging to search for neuronal correlates of clinical change in patients with obsessive-compulsive disorder treated with psilocybin. While the actual clinical trial of psilocybin for obsessive-compulsive disorder that Kelmendi will draw his neuroimaging data from is privately funded, the NIH’s decision to support his work is a watershed moment.
If this exciting development represents the NIH’s first step towards making its mark on the psychedelic renaissance, the scientific community’s efforts to harness psychedelics for deciphering and mending the mind may be on the brink of a giant leap forward.
Brian Barnett is a psychiatrist in Cleveland, Ohio. Rick Doblin is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies. Julie Holland is a psychiatrist and author whose latest book is “Good Chemistry: The Science of Connection, from Soul to Psychedelics” (Harper Wave, 2020).
The NIH again is the elephant in the room, or should we say mammoth? For exactly the same “reasons” there has been shamefully little research on cannabinoids, and once the stigma on that disappears a Pandora Box opens for millions who suffer from pain, gastro-intestinal diseases, muscular diseases, neurological diseases. Likewise, psychedelics are natural compounds that with smart tried-and-tested management will do miracles for millions with emotional / mental / neurological afflictions. The NIH simply has to get over the ancient stigmas, and finally roll into modern times, where many developed nations already are – for years.
Do you know of a state where they are legal
I just can’t find any with my friends..
My doctor can’t prescribe them because the FDA hasn’t approved them.
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