Monday, July 10, 2023

In Philly and nationwide, interest is rising in psychedelics to treat depression. The FDA released new research guidelines.

2023/07/10
Jason Wallach, assistant professor of pharmaceutical sciences at Saint Joseph’ s University, left, and Garrett Walker, pharmacology and toxicology major, right, examine slides in the lab. 
- Melissa Kelly/Saint Joseph’s University/TNS/TNS

When Jason Wallach started researching psychedelic compounds just over a decade ago, he expected he would spend his career laboring in obscurity.

Now the Food and Drug Administration is taking new steps to advise scientists studying these drugs, a sign that the federal government, and society at large, are paying closer attention to his rapidly-growing field of research. Wallach, a professor at Philadelphia's St. Joseph's University, develops psychedelic drugs to treat depression and other mental illnesses.

In June, for the first time, the FDA released a draft list of guidelines for conducting clinical research studies with those drugs.

The FDA has been approving studies for these drugs for some time, Wallach said, but the release of guidelines shows that interest in psychedelic compounds is higher than ever.

"They realize there's a lot of studies going on actively and likely to be a lot more," he said.

Wallach recalls how not long ago most researchers dismissed the possible therapeutic uses of hallucinogenic drugs like LCD and psilocybin, and more experienced colleagues told him to get out of the field entirely.

"A faculty member told me there was no funding, that people just don't understand the potential, and that prohibition and the drug war has done so much damage that it's just a bad career move. I didn't take that advice," he said, laughing.

Rising interest in Philadelphia

In Philadelphia, there's rising interest in the field of psychedelics, a class of hallucinogenic drugs that can alter people's senses and perceptions. Last November, hundreds of advocates and therapists met at a conference at the Independence Visitor Center aimed at helping attendees navigate the fast-growing industry.

Pennsylvania has not legalized many psychedelic drugs for therapeutic use, as Oregon and Colorado have. But there is a small but growing industry of clinicians in Philadelphia who incorporate psychedelic therapy into their work.

Some prescribe patients the hallucinogenic drug ketamine — which is legal in the state — to use under observation and in combination with therapy sessions. (The new FDA guidelines do not include studies researching ketamine.)

There's also an underground network of "trip sitters" who guide people through experiences with psychedelics that haven't been legalized here.

Wallach isn't involved in clinical studies, but for the last two years has partnered with Compass Pathways, a British biotech company, to develop psychedelic compounds to treat depression and other mental health issues. He partners with Compass researchers currently running trials, and the new guidelines won't change their existing work.

Stephen Levine, Compass's senior vice president for patient access and medical affairs, said the company is pleased to see the FDA recommend "rigorous" standards for psychedelic studies, just as they would any other drug. Currently, the company is running large-scale human trials on a psilocybin compound aimed at alleviating treatment-resistant depression.

"There are huge unmet needs out there — millions of people suffering," Levine said. "But we still do have a lot of unanswered questions. We have to make sure these things actually help people, and make sure that a safe framework is set up."

Unique research challenges

The new FDA guidelines — for which the agency is accepting public comment through Aug. 25 — apply to "classic psychedelics," a class of drugs that includes LSD, MDMA, and psilocybin, the active ingredient in psychedelic mushrooms.

They include recommendations on how to safely monitor study participants while they take the drugs, and note concerns around the potential for abuse of psychedelics.

The Drug Enforcement Administration classifies psychedelics as Schedule I drugs, those with "no currently accepted medical use and a high potential for abuse." Researchers have to comply with additional DEA regulations to study Schedule I substances.

The FDA also highlighted the unique challenges of designing effective studies with psychedelic drugs. For example, psychedelic drugs can cause people to experience hallucinations or alter their senses. So blind studies, in which one group of participants receives a drug and the other receives a placebo an effort to generate unbiased results, are more difficult to conduct.

"If you give one group psychedelics and one group a placebo, you're going to know which is which and they're going to know which is which," said Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania.

The FDA is holding psychedelic drugs to the same regulatory standards as any other new medication, she said: "Researchers are going to have to demonstrate in some meaningful way that [the drugs] have their intended affect."

© The Philadelphia Inquirer

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