I'm Back

With important drug policy developments abound over the past few months, I haven’t posted much. Perhaps you’ve noticed.

Don’t worry. I’m still here. I’ve just been in stealth mode, plotting and preparing a glorious return with serious and unserious projects alike, for example, pushing FOIA’s through DEA to uncover how many religious exemption application DEA has approved. (Answer: 0.)

Candidly, I needed some respite. Like many, I found the FDA’s thumbs-down decision on MDMA to be deflating, defeating, disappointing, disheartening, and many other words that begin with “d.” To be sure, I’ve been publicly critical of Lykos’s NDA submission—largely because I wanted it to get approved—particularly the inexplicable decision to orient the NDA around therapy as opposed to the drug.¹

But make no mistake: I favored approval. For now more than five-years, I’ve been fighting—pro bono—to liberalize research and therapeutic access to these promising substances, particularly in compromised patients. From my perch, the right call was approval with (1) a strong REMS to address the main issues with the therapy with post-marketing data to backfill whatever data had been deemed lacking (2) required modifications to recommended protocol to address any safety concerns and (3) phase 4 studies. No matter where you stand on the issue, even if all criticisms were valid—and I’m not saying that’s the case—there’s nothing to celebrate or bask in. At worst, a relatively safe drug that many people believe isn’t available, even under controlled circumstances.

It is now time to return. I’m reinvigorated and pounding this pavement again. That same surprising and energizing feeling of finding a half-eaten burrito in the fridge at 1 a.m. when you thought you had nothing left is coursing through my veins. Or, perhaps, the fluoride in the water is finally getting to my head.

Let me say this much. No matter how one feels about specific views on food/drug policies or health issues, so long as one sees the overall status quo as intolerable, there’s big opportunity here. Blame games aside, the real lesson from MDMA-thumbs-down-gate is that the system sucks. More than any actor or group, the system failed us. It continues to fail us. And the only way to shake it up is to introduce chaos agents. Only through chaos comes new order.

In that way, a new vanguard led by RFK Jr. could be very psychedelic—introspective, and threatening to the broken status quo. That every idea may not be right or even sane is unimportant. As I’ve written about in the past and will continue to write, this system is broken and in need of revolution. Revolutions do not begin or succeed with milquetoast ideas. They flourish with ideas that push boundaries and question fundamental assumptions. Inherently, some of those ideas may (even must) be off the mark.

So, as a very libertarian-minded drug policy warrior, I welcome regime change and new ideas with enthusiasm, even if some may ultimately miss the mark. As I recently discussed with Zach Haigney (cue cross-promotion), there’s a neuroplastic window approaching to make the kind of fundamental, meaningful structural changes to drug law that not only could liberate psychedelics and cannabis, but could reorient some antiquated aspects of drug law that withhold promising treatments from patients in need, even beyond psychedelics/cannabis.

Special Dispatch: Regulatory Plasticity with Matt Zorn

And on that note, today’s other drops on Emergency Use Authorization and Psychedelics coming to your inbox shortly.

1. I fully understand that therapy and integration are key aspects of psychedelic therapy that do the work, not the drug in isolation. It is no different than surgery, where an anesthetic isn’t doing the work, the surgeon and surgery do. Nonetheless, FDA approves anesthetics for use in surgery; it doesn’t approve anesthesia-assisted-surgery.