U.S. Government Funds First Therapeutic Psilocybin Research in 50 Years

U.S. Government Funds First Therapeutic Psilocybin Research in 50 Years

11/11/2021

This fall, the federal government granted researchers funding to study the therapeutic potential of a classic psychedelic for the first time in 50 years. The National Institutes of Health granted Johns Hopkins Medicine, in collaboration with University of Alabama at Birmingham and New York University, $4 million to investigate if psilocybin — one of the primary psychoactive ingredients in psychedelic mushrooms — can help people quit smoking.

“This is a huge step for really solidifying the science [behind psychedelic research],” says principal investigator Matthew Johnson, Ph.D., professor of psychiatry and behavioral sciences at Johns Hopkins University. “NIH is the largest funder of biomedical research not just in the United States, but in the world and, in fact, the majority of the research upon which any pharmaceutical company is operating has been funded largely through NIH.”

We’re now amidst what many are referring to as the “Psychedelic Renaissance.” Around the time President Richard Nixon signed the Controlled Substances Act into law in 1970, the flourishing research into psychedelics as therapeutic tools almost entirely stopped. Then, beginning in the 1990s with a study looking at DMT, and picking up in the 2000s with research at Johns Hopkins University looking at psilocybin for depression and anxiety in terminally ill patients, an abundance of psychedelic research began again — but it’s been funded privately, through philanthropy and investments.

Clinical trials are expensive. The median cost for developing a new drug in the U.S. is $985 million, according to a study published in the medical journal JAMA. NIH was a major funder of the early research that showed the promise of psychedelics for mental health decades ago — they once funded more than 130 studies just looking at LSD. But amid the political and media frenzy surrounding psychedelics, which ultimately led to the signing of the Controlled Substances Act, NIH, in large part, stopped funding psychedelic research, too. The psychedelic renaissance is now several decades old — and growing exponentially, with a wave of for-profit psychedelic drug development companies now raising millions of dollars to take various psychedelic compounds through the FDA approval process and get them to market.

“A lot of folks say, ‘How do you get past DEA [the Drug Enforcement Administration] and FDA? They’ve been onboard for decades now. If you have your protocols right, the t’s crossed and i’s dotted, they’re going to approve your protocol,” says Johnson. “The public still hasn’t gotten that in terms of the government, the funding side of the government has been last to the party.”

Luckily for researchers like Johnson, that seems to finally be changing. The grant that he and his fellow researchers received came specifically from a pool of money allocated by NIDA — the National Institute on Drug Abuse, which exists under the National Institutes of Health — for novel treatments for substance use. Since his study could identify a treatment to help people quit smoking, he was eligible; researchers wanting to study psilocybin for depression, PTSD, or any other indication for which psilocybin has also shown promise would not have been.

In a Senate budget hearing in May, former NIH director Dr. Francis Collins said NIH and the agencies that fall under it will “want to have a hard look” at the promise of psychedelic compounds for mental health. “I think as we’ve learned more about how the brain works, we began to realize that these are potential tools for research purposes and might be clinically beneficial,” Collins said, acknowledging that for a long time psychedelics weren’t considered a legitimate research subject. NIDA told Johnson, too, when he was applying for the grant that they are open to funding studies on psychedelics.

“I told them ‘If I’m wasting my time and you just don’t think it’s feasible to conduct a study looking at the therapeutic potential of a psychedelic, I’d appreciate it a lot if you’d let me know,” says Johnson. “I was told that it wasn’t going to be rejected just on principle for involving a psychedelic. That it wasn’t going to be a simplistic political reaction like that.”

There’s been some movement in Congress, too. Melissa Lavasani, Founder and Executive Director of Plant Medicine Coalition, a women-led, non-profit advocacy organization working on psychedelic reform at the federal level, made it one of her primary goals this year to get $100 million approved in federal funding specifically for studying psychedelics. Federal funding, she believes, is underrated as one of the most important components to furthering the psychedelic movement. She and her team at the Plant Medicine Coalition didn’t succeed in getting the funding this year — they were competing with too many other big items in Congress, she says, such as President Joseph Biden’s $550 billion infrastructure bill. But they made significant headway: They met with more than 100 Congressional officers and laid the groundwork for the first-ever psychedelic caucus, which would reside in the House and help get the funding approved in the future.

The funding, says Lavasani, is about so much more than simply securing resources to look at psychedelics for mental health. Yes, federally-funded research could help drug development companies get these treatments, in conjunction with therapy, to market. Johnson actually has already aligned with a drug development company, Mydecine, which is interested in using his federally-funded research to support their efforts in getting psilocybin on the market for tobacco addiction. But, says Lavasani, relying on drug development companies to do research can also be “really limiting” as they’re focused on studying particular compounds for particular indications (such as psilocybin for depression), and, if they’re funded by investors, must typically also take the potential for profit into account. Anecdotally, and in small studies, however, psychedelics have shown promise for physical conditions, from neurodegeneration to inflammation, which are also worth researching.

“If we want to see psychedelics as a part of our healthcare system, we need to have much broader research and we need to do it in the pursuit of a good and positive societal impact,” says Lavasani, who also headed the initiative which successfully decriminalized natural psychedelics in Washington, D.C. last November. “When policymakers are looking at research, they want to look at federally-funded research.”

One challenge, however, is that actually getting a grant from the federal government can be incredibly difficult, even when the funding is there. The grants themselves are often hundreds of pages long. “You have to be very competent, very intelligent, you have to have a track record in research,” says Jeffrey Becker, Co-Founder of Bexson Biomedical, a company developing a unique formulation of ketamine for chronic and acute pain disorders. “Even if a grant fund is perfect, you might not get funded for six months and then the money might not even reach your department for two months.”

It took Johns Hopkins Medicine roughly two years to get their grant approved: first, NIH wanted them to make changes and resubmit it; then, it took about half a year for NIH to review it again; then, NIH said it looked good but had run out of funding for the time being. This is all to say that it’s not as though the federal coffers have been opened for psychedelics per se. But in addition to the importance of the funds for furthering research, they’re symbolically important, too.

Federally-funded research is not only important for politicians to perceive psychedelics as legitimate, they’re also hugely important to garner the support of researchers and academic institutions. “A lot of researchers left psychedelics willingly cause they were seen as potential career suicide,” says Becker.

This was something Johnson experienced. As a young researcher, when he told colleagues he was interested in investigating psychedelics, he was sarcastically told “good luck” and that, in order to have a chance at becoming a full professor at a university and working at a research institute, he’d need to get NIH funding, which didn’t seem possible at the time. “That was the thing that really killed the work,” he says of the slowing of psychedelic research decades ago. “The idea that it was a career killer.”

All these years later, he’s hopeful about what this grant signifies, not only for the psychedelic movement, but also for aspiring researchers, who are where he once was. “It means a lot to academics,” he says. “Just to have the potential of NIH funding there tells young researchers that they can have a career in this.”

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