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- Symposium in Brazil Debates Psychedelics at a Political Crossroads - December 13, 2024
- Conference in Rio Defends Psychedelics in Public Health - December 11, 2024
Fiasco at the FDA may be offset by advances in Europe and, who would have thought, with Trump
The annus horribilis of 2024 has come to an end. The hottest year following the 2023 record, the first with global temperatures above 1.5 Celsius red line, climbing carbon emissions, Trump elected again, Putin and Bolsonaro at large, genocide in Gaza with a hundred hostages still cowardly held…
To top it all off, in the psychedelic world there were fiascos that threw a bucket of ice water on the hopes of millions with mental disorders such as depression, post-traumatic stress disorder (PTSD) and substance abuse. Still, here is the good news for 2025: it got so bad in 2024 that, from now on, it is likelier to get better.
Still, here is the good news for 2025: it got so bad in 2024 that, from now on, it is likelier to get better.
So, tread carefully with your optimism. Last year brought a stream of bad news, the first coming in March with the unfavorable assessment of MDMA-assisted psychotherapy published by the Institute for Clinical and Economic Review (ICER), an independent body that analyzes the costs and benefits of new therapies. In June, an advisory committee of the FDA went down the same path against Lykos Therapeutics’ protocol to treat PTSD with MDMA.
It was less of a surprise, then, when the FDA itself dashed expectations for the approval of the psychedelic treatment, in August. Then in the elections of November, a referendum aimed at decriminalizing psychedelics in Massachusetts was defeated.
Shortly before the turn of the year, it came to light that a similar congressional initiative in New Jersey would be put on hold. The anti-prohibitionist avalanche expected after the precedents in Oregon and Colorado is not yet under way.
Some see such failures as a necessary brake to curb the hype, but it looks more like a rollback. Even though they survived, companies that invested in the therapeutic innovation had to amputate parts of their structures and readjust plans for a protracted convalescence, such as announced by Lykos and Compass Pathways.
It was perhaps to be expected, but few had predicted it, that the crux—or scapegoat—of the biomedical setback would happen to be the psychotherapeutic component of psychedelic therapy. Unable to wrap their heads around it, luminaries of evidence-based medicine threw the baby (objective data on efficacy) out with the bathwater (non-standardized methods of psychological care).
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Two diversionary strategies to bypass that regulatory obstacle could make some headway in 2025. One of them would be to abandon psychotherapy altogether and go ahead with clinical trials measuring only the efficacy of the drug on its own, without psychological integration sessions (interpretation, etc.) that until now were almost omnipresent in psychedelic research protocols – companies like Compass are already moving in this direction.
Another maneuver that some researchers are betting on is to design molecules inspired by substances similar to psilocybin or ibogaine but deprived of psychedelic effects. I have already advocated for designating them as parapsychedelics, but to my chagrin it didn’t stick.
The best-known expert pursuing that strategy is David Olson at the University of California, Davis, a proponent of so-called psychoplastogens, drugs that would work like current antidepressants, pills to be taken regularly and independently of psychotherapy (remembering that, in addition to side effects, they don’t work for at least a third of patients). In 2023, 12 phase I to phase III studies with psychoplastogens were started.
Others understand that there is no way to take shortcuts to get around the meandering psyche. If there was indeed any lack of rigor in the application of therapeutic methods, as a recent systematic review in the journal Lancet seems to indicate, the right thing to do would be to improve them, not give them up. In any case, leaders in the field such as Rick Doblin and Michael Mithoefer disagree that there was any laxity in the phase III trials conducted by MAPS/Lykos.
The year that just started opens a wide avenue to learn from the failure at the FDA. Companies such as Cybin are already improving their protocols based on the lessons learned, and the company is preparing to seek approval for a modified form of psilocybin (CYB003) in 2027.
There are other indications that 2025 could be the comeback year for psychedelics, starting in Europe. An example of the therapeutic potential envisaged is the decision of the European Association for Palliative Care (EAPC) to allocate €6.5 million ($6.7 million) to the PsyPal clinical trial.
The proposal is to investigate the use of psilocybin to alleviate suffering in four progressive diseases: chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and atypical parkinsonism. Launched in 2024, the study plans to recruit more than 100 patients.
In the Netherlands, a commission of experts recommended that the government invest in studies with psychedelics. Not only clinical trials, but also research into the growing adult use of substances such as psilocybin and mushrooms, away from clinical settings.
Another good omen comes from the receptive attitude towards psychedelics on the part of health professionals in the US. A Brain Futures survey of academic leaders in the areas of counseling, social work, nursing and psychology showed that 79% of them consider psychedelic treatments to be promising for psychiatric disorders.
Another good omen comes from the receptive attitude towards psychedelics on the part of health professionals in the US. A Brain Futures survey of academic leaders in the areas of counseling, social work, nursing and psychology showed that 79% of them consider psychedelic treatments to be promising for psychiatric disorders.
Paradoxically enough, the greatest excitement about the prospects for psychedelic psychotherapies in 2025 comes from Trump’s return to the US Presidency. He has appointed Robert Kennedy Jr., a controversial vaccine opponent who, however, defends psychedelics, to head the Department of Health and Human Services.
If Trump, seconded by rocket man Elon Musk (another right-wing supporter of psychedelics), manages to implement all the deregulatory, protectionist and xenophobic measures he promised, not only Americans, but all Earth dwellers, will need a lot of drugs to overcome the adverse effects of his policies.
The worst will not come in 2025, but in the following years. As the saying goes, the consequences always come later.
Art by Mulinga.
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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