A Bitter Pill to Swallow

Why did an independent panel convened by the FDA reject MAPS' efforts to legalize MDMA-assisted psychotherapy?

“Fascists on an LSD trip,” 2024

Last Tuesday, an independent advisory panel convened by the Food and Drug Administration (FDA) held a nine-hour hearing to consider the approval of MDMA (Ecstasy) as a treatment for Post-Traumatic Stress Disorder (PTSD). In the end, the panel, comprising psychiatrists and other experts, resoundingly rejected MDMA-assisted psychotherapy as a treatment for PTSD.

The effort to gain approval for MDMA, also known as Ecstasy, was spearheaded by Lykos Therapeutics, a for-profit pharmaceutical company created by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) specifically for this purpose. Lykos raised $100 million in a Series A round earlier this year. On Instagram, a MAPS coordinator admitted, “This is a deeply humbling moment for Lykos, MAPS, and our entire field.” Psychedelic therapist and writer Jules Evans wrote on X: “It could mark something of an ebb in the general public and media interest in psychedelics and their return somewhat to margins of alternative health / spirituality. Possible — I’m not sure.”

The final decision is expected in August. The FDA retains the authority to approve MDMA-assisted therapy for PTSD (MDMA-AT) despite the panel's recommendation. However, given that the panel voted 9-2 against approval, it is a major challenge for MDMA-assisted therapy to overcome the regulatory hurdles at this time. This would be a blow for the psychedelic movement, with many repercussions. Ultimately, it may mean that corporations with deeper pockets but far less ethical concerns will succeed where Lykos/MAPS have failed. One of these companies is Compass Pathways, with a $568 million valuation, funded by Peter Thiel and other Right Wing billionaires, receiving $263 million so far. Compass is seeking approval for their patent-protected Psilocybin therapy.

Libertarian billionaire Christian Angermayer, founder of Atai Life Sciences and the major investor in Compass Pathways, sees the failure of Lykos as an opportunity. He was rejected by MAPS from participating in the initial Lykos offering. He wrote (incredibly poorly) on X:

Yesterday’s disaster is also a critical tale of capitalists who might be (secretly) ashamed of their financial success and hence anchored on one topic – MDMA and psychedelics – and denounced capitalism in relation to those substances. Drunk on virtue signaling, those MAPS supporters have done a huge disservice to the MDMA and psychedelic renaissance.

Even if the original / racemic MDMA does not recover from this setback, atai has a new, potentially better and patent-protected version of MDMA in its pipeline, which in early trials has demonstrated a much better initial safety profile.

For decades, MAPS has directed a tremendous amount of the psychedelic movement’s energy and resources toward the goal of legalizing MDMA therapy. MDMA-AT shows extraordinary efficacy for curing treatment-averse forms of PTSD, including with veterans from the Iraq and Afghanistan Wars, who have a high suicide rate. Gaining approval of MDMA-AT has been promoted as the first step in removing the legal stigma from psychedelics as a whole. For MAPS / Lykos to go back to the drawing board and try again could require raising significant additional investment with a long time delay. Conceivably, it might never happen.

Since the mid-1980s, MAPS, under the direction of the indefatigable Rick Doblin, has led the way in taking psychedelics from the cultural margins to the mainstream. As most readers know, I played a small role in this movement. My 2002 book on psychedelic shamanism, Breaking Open the Head was one of the first to receive mainstream media approval after the demonization of psychedelics in the 1970s. It helped inspire a new generation of psychonauts. I started Reality Sandwich, a popular web magazine on psychedelic culture in 2006 with the recently deceased Ken Jordan. We published hundreds of writers offering a vast range of perspectives on altered states, psychoactive compounds, and indigenous rituals, along with many anthologies. (The magazine was later taken over by Delic, a company in the psychedelic space, which has ruined it).

I am not a scientist or even a science journalist and I haven’t been following the recent snowballing of the psychedelic field too closely. There are many aspects of the entrepreneurial and corporate “gold rush” over psychedelics I find depressing. I have thoughts about what has happened in this case, which I will explore in what follows.

A number of issues were raised by the hearings. These included the difficulty of conducting “double blind” research with MDMA, as patients quickly know whether they have received a placebo or not (this is called “functional unblinding”). Another issue is that the FDA doesn’t have a mechanism for dealing with psychotherapy-assisted treatments. They approved Ketamine as a treatment because it doesn’t require a therapist on hand, as the MAPS / Lykos’ protocol requires. This is new territory for them, and it may be a “bridge too far,” at this point.

These were among the main reasons the independent panel voted against Lykos. Another problem is a group of dedicated — one might say fanatic — “apostates” within the so-called “psychedelic community” (a hard-to-define term) who have dedicated themselves to derailing MAPS and attacking others in the psychedelic world. These mean-spirited ideological purists use a veneer of moral righteousness as cover for a bizarre yet familiar form of power-tripping and clout-chasing. Instead of building anything of value themselves, they waste their intellect and their lives by attacking and seeking to harm the work of others.

This self-cannibalizing is something common to “progressive” or radical movements oriented toward healing, environmental and social justice: A few individuals, hyped up on anger and moral fervor, are able to commandeer the media, potentially ruining what others have spent many years working to build. As insiders, the apostates do this by applying laser-focus to anything they can criticize, blowing up any mistakes made by the organization or its founders, any contradictions, hypocritical acts or comments. In this way, they serve the bitter agenda of “the Cancel God”:

I don’t know if there is any way to “inoculate” delicate progressive movements from the kind of borderline personalities who find pleasure in seeking to crush what other people give their lives to build. The first step, at least, is to recognize what the problem is and how the dynamic works. Nassim Taleb’s “The Most Intolerant Wins: The Dictatorship of the Small Minority”, a useful read on this topic, helps explain the success of such cliques. The problem, generally, is that it is much, much harder to build something — particularly something new — than to wreck it.

That being said, of course, there are many reasons one can criticize Doblin and MAPS / Lykos. Doblin started MAPS on the counterculture / hippie-ish margins. The organization has repackaged itself over time as the psychedelic field has become more professionalized and as funding has flowed into it. But inevitably, it still retains vestiges of a more idealistic, transformational ethos. It isn’t a purely streamlined, profit-seeking enterprise — but that is part of what makes it good! There is sincere idealism at its core.