5 Psychedelic Stories You Should Know This Week
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This week: The FDA sketches a faster path, LSD clears another major trial, Psilocybin shows promise beyond mental health & researchers ask how you give someone a believable fake trip. Plus, the darker side of the “God Molecule.”
Story #1: FDA Officials Outline a Faster Path to Psychedelic Therapies
Synopsis: FDA officials have outlined a framework to bring Psychedelic therapies to patients more quickly. Writing in the New England Journal of Medicine, four agency staffers described combining expedited reviews with potential initial approvals based on benefits demonstrated over a clinically meaningful period, such as 12 weeks, alongside longer safety follow-up. Some questions about repeat dosing & continued efficacy could be addressed after approval. They also acknowledged a persistent challenge in Psychedelic research: participants can usually tell whether they received the drug or a placebo. The agency is open to alternative comparators & innovative trial designs. This is a proposed path to faster approval, with safety requirements still attached.
My Take: This is a big story. Politicians saying they support Psychedelics is one thing…FDA officials explaining how they could get these treatments through the approval process faster is considerably more useful.
I’m particularly glad they’re acknowledging the placebo problem. If you take a substantial dose of Psilocybin, you probably know you didn’t get the sugar pill. That complicates research, but demanding that Psychedelics fit perfectly into a model built for drugs with far less obvious effects would be a great way to keep patients waiting forever.
For people who have exhausted conventional treatments, a faster path matters. Years spent depressed, traumatized, or struggling with addiction aren’t some abstract regulatory consideration. They’re years of someone’s life.
But I’ll keep making the distinction: medical approval is progress. It is also a narrow slice of the larger question of whether adults should be allowed to alter their own consciousness. You shouldn’t have to prove you’re broken before you’re allowed to explore your mind.
Story #2: Could Psilocybin Protect Patients From Chemotherapy’s Nerve Damage?
Synopsis: In a study published in Science, MD Anderson researchers gave Psilocybin before chemotherapy & found that it prevented nerve damage, numbness & sensitivity in preclinical models, including after repeated treatment cycles. The researchers say the effect appears to involve protecting the nerves’ energy supply. A clinical trial will test whether the benefit carries over to cancer patients.
My Take: Most conversations about Psilocybin & cancer focus on helping patients cope with fear of death or depression. This asks a different question: could the drug protect their bodies from the treatment itself? The results are still preclinical, but preventing nerve damage that can last long after chemotherapy would be a substantial benefit.
Psilocybin acts on the body, too…it’s more than a mental health tool or a drug that makes you hallucinate.
Story #3: LSD Eases Anxiety in a Second Late-Stage Trial
Synopsis: Definium Therapeutics reports that a single 100-microgram dose of its LSD formulation reduced symptoms of generalized anxiety disorder in a second Phase 3 trial. After 12 weeks, anxiety scores had fallen 9.8 points in the LSD group, compared with 4.7 points in the placebo group. The company plans to file for FDA approval in 2027. These are topline results released by Definium; the full study has not yet been published.
My Take: LSD has spent decades as shorthand for everything supposedly reckless about the 1960s. Now it has 2 positive late-stage trials for anxiety, and a company preparing to ask the FDA for approval.
That’s quite a career change.
The result deserves attention, especially because the improvement followed a single dose. But the full data still matter, as does the question running through this entire field: how well can you disguise LSD from someone who just took LSD? Which brings us to the next story.
Story #4: How Do You Give a Psychedelic a Convincing Placebo?
Synopsis: In a JAMA Psychiatry viewpoint, researchers argue that Psychedelic trials need better ways to keep participants from knowing whether they received the active drug. They propose testing combinations of other drugs that might produce an unfamiliar altered state, making the comparison more convincing than a standard placebo. The approach raises safety & consent questions of its own. It is a proposal, not a tested solution.
My Take: Give one person Psilocybin & another a sugar pill, then ask them to guess who got which. We can stop pretending this is a difficult quiz.
I agree the problem matters. If people know they received the drug, their expectations can influence the result. But giving the comparison group a cocktail of other drugs introduces a fresh set of questions. How safe is it? What exactly are we comparing? And how much can you withhold from participants while still calling their consent informed?
The answer isn’t to wave away the placebo problem because Psychedelics are special. It’s to test better methods without treating a convincing imitation trip as a scientific victory in itself.
Story #5: The Dark Side of the ‘God Molecule’
Synopsis: In a new Nautilus interview, journalist Kimon de Greef discusses The Ego Trip, his book about the rise of toad-derived 5-MeO-DMT. He traces how a charismatic facilitator known as “El Doctor Sapo” helped turn the substance into a spiritual phenomenon while allegedly neglecting basic safeguards, with several deaths occurring on his watch. The book also examines the disputed story of an ancient Indigenous ritual & the growing pressure that harvesting toad secretion puts on collectors & the toads themselves.
My Take: I’ve worked with the God Molecule several times. It is the single most powerful Psychedelic experience a human can have. My journeys with the toad changed the trajectory of my life. That doesn’t mean we should grant the person who administers it spiritual authority…a profound experience doesn’t excuse reckless practices.
And the molecule can be synthesized without the toad. We should be able to take the experience seriously without buying the mythology or the guru.
This week’s Sunday Insider: I went to Sayulita to explore its Psychedelic culture & found a beach town full of beautiful people living on borrowed time.
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