🫠 This Week in Psychedelics

[5-min read] FDA advisory committee weighs in on MDMA.

Welcome to Tricycle Day. We’re the psychedelics newsletter that knows you have a brave heart. They may take our medicine, but they’ll never take our freedom! ⚔️

Here’s what we got this week.

  • FDA AdComm reviews MDMA 💊

  • Arizona is funding whole-mushroom research 🍄

  • A psychedelic health club from the Whole Foods founder 🛒

  • Masterclass: establish a sacred medicine church 💒

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MICRODOSES
🔬 Research

Picture this: Imperial College London and Beckley Psytech are partnering on the first 5-MeO-DMT brain imaging study.
Breaking bad: Filament Health will move forward with a Phase 2 trial of its botanical psilocybin drug for meth addiction.
Show me the data: What does the research actually say about microdosing?
When things fall apart: Psychedelic users share their most effective coping strategies for post-trip challenges.
Here’s your chance: Johns Hopkins is looking for volunteers with PTSD to participate in a psilocybin clinical trial.

🏛️ Policy

Work it: The governor of Vermont signed a bill into law to create a psychedelic therapy working group.
Must be a New England thing: The Massachusetts House also approved a veteran-focused bill that would create a psychedelics working group.
Pick up the pace: A federal watchdog is calling on the DEA to clarify its religious exemption process for psychedelics.

📈 Business

Export quality: Health Canada has licensed Optimi Health to send MDMA and psilocybin to Australia.
Bridging the gap: Filament Health completed a $1m round of bridge financing.
Mycelial network outage: Employees of Paul Stamets’ mushroom company are trying to unionize but facing resistance.
Master of ceremonies: The University of Ottawa just launched the world’s first master’s program in psychedelics and consciousness studies.
Founder story: Ashley Walsh is shifting psilocybin research toward women’s health.

🫠 Just for fun

Total 180: After demonizing drugs for decades, Americans are now doing them every day.
Mushrooms can save the world: This underwater fungus breaks down ocean plastic.
The Road to Eleusis: Did psychedelics give rise to early Christianity?
Meme of the week: When you take the psychedelics but skip the integration

THE PEAK EXPERIENCE
FDA advisors given the chance to be on the right side of history

MDMA couldn’t open their hearts

Take a seat, Cyclists. We won’t sugarcoat this one.

Yesterday, the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) held a public meeting to discuss Lykos Therapeutics’ new drug application for MDMA-assisted therapy in PTSD.

And they gave it a big, fat thumbs down. 👎

After a marathon of a meeting (catch the replay if you happen to have 9 hours to spare), the committee voted 9-2 that the available data do not show the treatment is effective and 10-1 that its benefits do not outweigh its risks. Big ooof energy.

Their skepticism really came down to these main issues.

  • 🙈 Unblinding bias. The committee felt that the intense acute effects of MDMA made it impossible to truly blind the studies, which could have skewed the results in favor of the treatment.

  • 🤷‍♀️ Unclear role of psychotherapy. MDMA wasn't studied on its own, but in combination with psychotherapy. The committee couldn't tease apart how much each component contributed to the overall effect.

  • 🚨 Safety questions. From cardiovascular risks to abuse potential, the committee had concerns about MDMA's safety profile that weren't adequately addressed by the data.

  • 🗣️ Troubling public testimony. Several speakers raised serious allegations of misconduct and boundary violations in the clinical trials, which may have given the committee pause.

Now, it's important to note that the AdComm's votes are non-binding. And to be fair, the FDA has gone against these recommendations before. But let's be real. Things aren’t looking great for MDMA's chances of approval.

The FDA is expected to make its final decision by August 11.

In the meantime, we’ll be doing everything we can to keep our hearts and minds open… And yes, that includes taking a break from full-day government livestreams. 🫠

AFTERGLOW
Refilling your prescription in 2030

Full-spectrum healing

Nowadays, people toss around the words “psilocybin” and “mushrooms” interchangeably. But the truth is, they’re two different things. Despite psilocybin’s rise to “it molecule status, real ones know there’s a lot more magic in mushrooms to unpack. Enter the Scottsdale Research Institute (SRI). With $2.75 million in Arizona state funding, they’re kicking off the first ever DEA-approved clinical study using natural, self-grown, whole psilocybin mushrooms.

There’s a reason most of the research to date has used synthetic or extracted psilocybin: that’s what regulators know and expect. Putting an entire plant (or fungus, as the case may be) through the FDA review process? That’s playing the game on hard mode. Yet, it’s exactly what SRI plans to do. Because they have a hunch that whole mushrooms—with all their molecules working together in perfect balance—might be more effective than psilocybin alone.

SRI’s current plan is to recruit 24 participants for their study, with conditions ranging from chronic pain and long Covid to OCD and depression. If all goes well, maybe we’ll live to see pharmacists dispensing Jedi Mind F*ck by bottle.

Whole Soul Foods Market

John Mackey may have stepped down as Whole Foods CEO, but he's still out here disrupting. His latest brainchild is Love.Life, a chain of wellness clubs he hopes will do to doctors’ offices what Whole Foods did to grocery stores. Think: a one-stop shop for all your holistic health needs, from functional medicine and bodywork to meditation and pickleball. Oh, and psychedelic therapy, too—once it's legal.

Mind you, Mackey's no stranger to the medicine. In his new memoir, he credits psychedelics and breathwork for some of his biggest epiphanies—like awakening to a deeper spiritual reality (thanks, LSD) and realizing that love is the most important thing in life (s/o to MDMA). Now, he wants to bring those revelations to the masses through Love.Life's plant-forward restaurants, personalized health plans, and psychedelic sessions.

The first Love.Life location opens in California this July, but Mackey's got his heart set on expansion. His vision? To make people wonder how the current healthcare system ever operated the way it did. Oh, don’t worry, John. We’re all already baffled.

CYCLISTS’ PICKS
UNTIL NEXT TIME

That’s all for today, Cyclists! Whenever you’re ready, here’s how we can help.

ONE CYCLIST’S REVIEW
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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.

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