Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to the best regulatory model for psychedelic drugs.

“I advocate strongly that [psychedelics] be allowed to be studied for medical research to see what their therapeutic indications are and how they can help us to understand the brain and the mind,” said Dr. Jeffrey Lieberman, the chair of Columbia University’s department, who argued against the motion.

Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), argued for a more permissive approach that would allow the use of psychedelics for those without a medical diagnosis. Doblin advocated for a licensed legalization model that would permit license holders to use psychedelics recreationally and as an adjunct to psychotherapy.

Incidentally, MAPS has organized Phase 3 trials to probe the potential of drugs like methylenedioxymethamphetamine (MDMA) to treat post-traumatic stress disorder.

In recent years, there has been a resurgence of interest in using psychedelics for therapeutic purposes. In 2019, FDA approved esketamine, the first psychedelic treatment for a psychiatric condition. Researchers are currently testing the potential of a range of other psychedelics — mainly to treat psychiatric disorders.

A small trial pitting psilocybin against Lexapro to treat depression was recently published in NEJM.

Lieberman, however, stressed the need to have guidelines in place to inform how psychedelics are used clinically before they are made more widely available. “There’s no established methodology which shows how they should be used, or what they should be used for, or what patient population for whom they would be indicated or contraindicated,” he said. “This is something that’s potentially feasible, but it doesn’t exist at this point.”

Lieberman also stated that the clinical trials investigating the use of psychedelics are not governed by a rigorous scientific evaluation of risks and benefits. Current clinical trials for the compounds are “not being done in a rigorous way,” Lieberman said. They don’t tend to have the same standards as studies for cardiovascular disease, infectious disease and brain disorders.

Doblin countered that his organization, MAPS, is researching psychedelics with “the highest standards of the FDA. We’ve had a successful Phase 3 study that’s about to be published in Nature Medicine. We are working at the same level that Big Pharma works, and [using] the same standards that FDA applies.”

Also arguing against the motion was Kevin Sabet, president and CEO of Smart Approaches to Marijuana. Sabet said he feared the prospect of corporations and investors taking over a psychedelics industry without sufficient understanding of the compounds they are selling.
“Let’s pursue the research,” he said. “Let’s be careful about that to make sure people aren’t hurt,” he said.

While Sabet and Lieberman briefly recommended decriminalization of psychedelics in the debate, Doblin warned against it. “I think one of the problems of decrim is that you still don’t have pure drugs, and we have a lot of problems with people getting adulterated drugs,” he said.

 

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Filed Under: Drug Discovery and Development
Tagged With: Big Pharma, FDA, Intelligence Squared, MAPS, psychedelics
 

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