Speed over science?

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MYRNA BROWN, HOST: It’s Thursday the 23rd of April. Glad to have you along for today’s edition of The World and Everything in It. 

Good morning, I’m Myrna Brown.

MARY REICHARD, HOST: And I’m Mary Reichard.

First up: will psychedelics cure what ails ya?

Researchers will be taking a closer look at hallucinogenic drugs following an executive order signed by President Trump on Saturday.

TRUMP: In many cases, these experimental treatments have shown life changing potential for those suffering from severe mental illness and depression, including our cherished veterans...

BROWN: Advocates—including military veterans and influential podcaster Joe Rogan—welcome the potential for new treatment options for conditions conventional medicine fails to cure.

But critics worry it sends the wrong message and could poison the drug approval process.

WORLD’s Harrison Watters has the story.

HARRISON WATTERS: Jon Kostas had tried just about everything to end his alcohol addiction at age 25.

KOSTAS: It was either this or I knew I was going to die from my drinking…that's how desperate I was.

In 2015, he learned about a clinical trial for psilocybin, a compound derived from hallucinogenic mushrooms. Kostas had lots of questions.

KOSTAS: You know, can I get stuck in a trip?...Is this going to change my personality? Is this going to, you know, I didn't know if this was something similar to lobotomy.

Psychedelics like psilocybin are regulated as Schedule 1 controlled substances, with high potential for abuse and no legitimate medical purpose. They also distort the user's perception of reality for hours or days at a time. But in recent years, researchers have begun studying how psychedelics affect addiction cravings. 

Kostas took part in a randomized controlled trial under constant medical supervision in a hospital.

KOSTAS: This worked like an antibiotic almost, for me, where I was sick with the disease, I went in, I got treated, and I was fine. I didn't need to treat my disease anymore.

Today, Kostas is Executive Director for the Association for Prescription Psychedelics, advocating for reviewing and legalizing psychedelics for wider use.

President Trump’s executive order puts that goal within reach. 

It directs the Food and Drug Administration to prioritize reviewing psychedelic compounds that are in the clinical trial pipeline, including psilocybin. The order relies on a program that gives FDA Commissioner Marty Makary the authority to accelerate review and approval.

MAKARY: Under this new program in this administration, drugs can get approved in weeks, not a year or a year plus, but in weeks, if they are in line with our national priorities.

The order also authorizes human trials to research a more obscure drug called ibogaine. It’s made from the bark of a West African shrub, and anecdotal evidence suggests it can provide long-term relief from opioid addiction. 

After learning about ibogaine’s potential in a recent interview, Joe Rogan says he texted President Trump about it.

ROGAN: The text message came back, “Sounds great. Do you want FDA approval? Let's do it.” [laughter] Literally that quick.

In a phone call yesterday, Commissioner Makary told WORLD there’s good precedent for getting drugs reviewed and approved quickly.

MAKARY: The fastest FDA approved drug in U.S. history was during the HIV epidemic. Well, we need the same sense of urgency that we had with HIV to address mental illness, PTSD, addiction, and other intractable and debilitating mental illnesses.

Not only was the executive order quick, it’s light on details that some say need to be addressed.

Paul Larkin was a Department of Justice attorney and is now a Senior Legal Fellow at the think tank Advancing American Freedom. He’s concerned the order is focused more on satisfying demand than ensuring public health.

LARKIN: All it referred to was getting it through the federal government regulatory approval process as quickly as possible. It didn't mention any of the downsides. And there are some.

In addition to hallucination, research has found that ibogaine specifically can cause cardiac arrest. And in 2024, the FDA found a different psychedelic-assisted treatment for post traumatic stress disorder wasn’t safe and effective.

On Saturday, NIH Director Jay Bhattacharya said scientists cannot take safe psychedelics for granted. That caught President Trump’s attention.

BHATTACHARYA: We still got to figure out sometimes how it works, or why it works, that we gotta keep doing even as we move forward fast so—

TRUMP: But it does work?

BHATTACHARYA: Some, some of those, I mean, absolutely, some of those treatments absolutely works

VETERAN: Yes, it works.

TRUMP: I’m trying to get an answer because it either works or it doesn't. I would think that there's been a lot of research already, indirect research, maybe the ultimate research, people that have taken it…

Larkin and others are concerned that political pressure from the White House is rushing scientific research of drugs that are not yet well understood. But Dr. Makary told WORLD the drug developers still need to demonstrate in multiple rounds of testing that they are safe and effective. 

Even with approval, he says psychedelics will require careful prescription.

MAKARY: So we want to ensure that these are not medications that can simply be picked up at a pharmacy counter or mailed to your home after a tele-health visit. That will not be happening with psychedelics on our watch. We have set clear conditions by which these drugs would be administered in a medical setting and administered safely.

It’s now up to FDA researchers to discern if psychedelic treatments are truly good medicine and not just good politics.

Reporting for WORLD, I’m Harrison Watters.

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