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Failure with MDMA in 2024 does not imply acceptance of pharmacological reductionism
The best representation of the state of mind at the Psychedelic Science 2025 conference, which began on Wednesday, June 18th, came from Rick Doblin himself, who founded the Multidisciplinary Association for Psychedelic Studies (MAPS) in 1986.]
Two years ago, in the same city, Denver, he entered the plenary stage dressed all in white, but this time only his jacket and sneakers were that color. “I added a little black and blue,” he joked.
He was referring to the setback suffered by the field when the FDA rejected the application for MDMA-supported psychotherapy (ecstasy) for post-traumatic stress disorder last Auguust. The bureaucrats’ decision was itself traumatic, and Doblin said he was personally crushed.
MAPS had already capitulated to the market, ceding its clinical research arm to private investors who converted it into the Lykos company, only to see the firm fail in its clash with the FDA. More than three decades raising millions of dollars in philanthropic funds to pay for the rejected clinical trials went wasted.
MAPS, created with the mission of rehabilitating MDMA as a medicine, found itself deprived of its raison d’être. It also saw its cash flow dwindle, as investors now had the option of betting on the psychedelic cause with the prospect of profit, with the proliferation of startups.
MAPS, created with the mission of rehabilitating MDMA as a medicine, found itself deprived of its raison d’être. It also saw its cash flow dwindle, as investors now had the option of betting on the psychedelic cause with the prospect of profit, with the proliferation of startups.
It was in this climate that Doblin, nevertheless, maintained his motivational speech in Denver and said that “the psychedelic renaissance is alive and well.” He used the image of a phoenix rising from the ashes and listed a series of recent advances and investments by MAPS, but nothing that compares to the feat of conducting two phase III clinical trials without official research funding, only with donor resources.
Yes, in Oregon, psilocybin services have already served “magic” mushrooms to 10,000 clients since 2023, when state legislation adopted by referendum in 2020 went into effect. But the MAPS’ leader did not mention the downside of this initiative, the cost. This prohibitive cost of $1,500 and up restricts access and reduces the number of beneficiaries, which is tiny compared to the three million Americans who suffer from depression that is resistant to available treatments.
Yes, Colorado and New Mexico have also adopted state laws facilitating access to psychedelics, as has the Czech Republic. Texas and the Department of Defense have allocated millions to studies on MDMA and ibogaine. In Australia, Canada, and Switzerland, there is compassionate legal access to MDMA and psilocybin.
However, nothing compares to the avalanche of flexibility expected in 2023 after the coming of FDA approval, which was taken for granted. It did not come, and the plan backfired: companies investing in clinical trials of psychedelics began to minimize the psychotherapeutic component or eliminate it altogether, in the hope of appeasing the FDA, an easy – and wrong, as Doblin lamented – solution to the difficulty.
The most emphatic defense of psychotherapy came from Rachel Yehuda, of the Mount Sinai School of Medicine, who expressed that there is an imperative to maintain the therapy, which is known to benefit patients, and not to withdraw it just to satisfy the agency. “I don’t think the FDA has to regulate therapy; they need to understand the process,” she said.
Yehuda and others at the conference believe that the flexibility of thought obtained by way of psychedelics will only be sustained if accompanied by the therapeutic process needed to incorporate changes into daily life in order to lift entrenched barriers of suffering.
“We have an ethical obligation to explain the elements that we think should be present.” In her opinion, giving up psychotherapy in clinical trials with these innovative treatments would be equivalent to testing a new surgical technique without applying anesthesia; that is, leaving the patient on her or his own when dealing with the profusion of emotions, insights, and images mediated by the drug.
She and others at the conference believe that the flexibility of thought obtained by way of psychedelics will only be sustained if accompanied by the therapeutic process needed to incorporate changes into daily life in order to lift entrenched barriers of suffering. Yehuda doesn’t think these transformations are sustained by the acute neurological effect of substances—that’s where current psychiatry has gone astray.
Art by Karina Alvarez.
Note: A version of this story appeared originally in Portuguese in the blog Virada Psicodélica published by the Brazilian daily newspaper Folha de S.Paulo and can be found here.
DISCLAIMER: The views expressed here are by Leite, and not Chacruna. Leite sits on the advisory board of Chacruna.
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