Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

In this week's episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine. In April, FDA issued National Priority Vouchers to three companies conducting clinical trials of psilocybin for treatment-resistant depression and major depressive disorder, and methylone for PTSD, as well as an IND to study ibogaine for treatment of alcohol use disorder. This came after the president issued an executive order vowing to accelerate drug approvals of psychedelic drugs. “One thing that they seem to want to do is reverse Nixon's War on Drugs, which stopped all of the psychedelic drugs research in its tracks in the '70s,” Paul said. Some oncologists are not opposed to this reversal, particularly as clinical trials evaluating psilocybin as a treatment for cancer-related anxiety, depression, demoralization, fear of recurrence, and other psychological conditions have been ongoing since 2008. But the story behind the policy change is cause for concern. At a press conference in the Oval Office, President Donald Trump sat next to Joe Rogan, comedian and host of “The Joe Rogan Experience" podcast. Just two and half weeks before, Rogan published a two-hour long interview on ibogaine. Rogan texted Trump about the psychadelic’s promise as a treatment for drug addiction, brain trauma, and cognitive decline. “The text message came back: ‘Sounds great, do you want FDA approval?’ It was literally that quick,” Rogan said at a subsequent press conference with Trump in the Oval Office. “This is a very unscientific way to roll back the scientific kibosh,” Paul said. The policy change didn’t appear to come from scientific consensus by an expert panel brought together by FDA or NIH. “When the President of the United States can text you saying, ‘Would you like an FDA approval?’ I worry about prescribing, but especially off label,” said Paul, editor and publisher of The Cancer Letter. “This thing is not approved, by the way, to give credit to FDA right now.”Stories mentioned in this podcast include:Is psilocybin heading to a cancer clinic near you?What NHS-Galleri taught us—and what it didn’tThe NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studiesFDA clears a way for dramatic reduction in animal toxicology studies in cancerProposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back