As David Hodes first noted in The Green Market Report, the U.S. National Institutes of Health (NIH)’s growing interest in psychedelic studies is remarkable.
The agency annually invests about $41.7 billion in medical research as a whole, while more than 80 percent of the funding is awarded for extramural research through 50,000 competitive grants to researchers at universities, medical schools and other research institutions.
In a recent reply letter to Sen. Brian Schatz, the NIH stated that it is currently funding 57 psychedelics projects for a total $34.4 million, including 36 applied studies for the National Institute of Mental Health (NIMH). The agency has also been working with the FDA, the DEA, and the White House Office of National Drug Control Policy to facilitate the task of obtaining a registration to conduct research with controlled substances like psychedelics.
Yet despite fund-granting, the NIH believes that issues in psychedelics research still exist in what NIH directives have called a “knowledge gap,” partly due to insufficient diversity amongst participants of trials.
They were referring to racial and ethnical diversity and to participants with diverse medical histories, too. The fact is that most psychedelics trials exclude people with a family or personal history of psychosis or suicidal thoughts or behaviors.
Regarding support besides funding, the NIMH organized a NIH workshop on Psychedelics as Therapeutics in January 2022, and most notably collaborated on the study providing the first FDA-approval to any psychedelic-derived substance, a version of ketamine with brand name Spravato.
NIMH director Dr. Joshua Gordon stated in the January workshop: “We’ve been supporting research on ketamine, both at the NIMH in the full research program and on other sites for a couple of decades. And in fact, it does seem like ketamine can mean effective therapy, rapidly acting therapy for treatment-resistant depression. And it’s not only ketamine, but of course, esketamine, which was developed by a drug company, tested and shown to be effective in treatment-resistant depression through a randomized clinical trial. It is now FDA approved.”
Gordon further said that understanding the neurobiological effects of psychedelic medicines is key to obtaining funding: “So we can think of NIMH’s interests in studying psychedelics, both in terms of proving that they work and also in terms of demonstrating the mechanisms by which they work. And in fact, the mechanism focus is really part and parcel of the drug development priorities throughout NIMH, when we think of how we want to try to study novel therapies.”
On her behalf, the director of the National Institute on Drug Abuse (NIDA) Dr. Nora Volkow expressed that there are still several questions for which there are no answers. “But at the same time, I see this as an incredible opportunity to modify the way that we are doing things.”
Volkow too asks about the possible actions the NIH can take to help accelerate research “so that we can truly understand what are the potentials and, ultimately, the application of interventions that are based on psychedelic drugs.”
From that perspective, Volkow said that it is fundamentally a simple choice: “We need to have a greater in-depth understanding of the characteristics of the drugs that we call psychedelics. I do recognize the concern that we just don’t limit the description of these psychedelic drugs to their pharmacological target. We need to go beyond that and understand the downstream effects, the functional consequences,” she said.
Volkow finalized her exposition with the message that it is equally important “to bring the patients into the discussions,” so that their priorities and concerns are actually incorporated to the agency’s research plans. “I think we need to basically very clearly understand where we are in history, and what we’ve learned from the past, so that we do not commit the same mistakes and errors.”
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