Psychedelics by decree

Psychedelics by decree: Trump speeds up FDA approval

Alle Artikel

ein pilz steht in einem office auf einem tisch, rechts ist die amerikanische flagge zu sehen

DESCRIPTION:

President Donald Trump signed an executive order accelerating FDA approval of psychedelics: ibogaine, psilocybin and MDMA for veterans with PTSD and mental health conditions. Joe Rogan, research into psychedelic drugs and the gap in scientific evidence.

Psychedelics by decree: Why Trump is fast-tracking FDA approval. The strange history of consciousness expansion

In 1970, Richard Nixon declared Timothy Leary “the most dangerous man in America”. Fifty-six years later, President Donald Trump signed an executive order in the Oval Office designed to fast-track the approval of psychedelic substances. The substance for which people were imprisoned for decades is now becoming a national reform project, a programme for veterans’ health, deregulation and industrial promotion all rolled into one. Anyone wishing to understand what is happening here should not look first to pharmacology, but to the narrative.

Trump’s executive order in the Oval Office: Joe Rogan, ibogaine and the FDA vouchers

The scene at the White House on 18 April 2026 was itself part of the message. When President Donald Trump signed the executive order to accelerate research into psychedelics, standing behind him were not scientists, but, among others, podcaster Joe Rogan, Congressman Morgan Luttrell, his brother Marcus Luttrell (a former Navy SEAL) and W. Bryan Hubbard, CEO of the lobby group Americans for Ibogaine. Rogan, who had previously discussed the substance with Health Secretary Robert F. Kennedy Jr., explained that a text message to the President had set the ball rolling. The executive order explicitly accelerates the approval of psychedelics with a view to treating veterans with post-traumatic stress disorder (PTSD), depression and suicidal tendencies.

Specifically, the White House directed the FDA to fast-track the approval of psychedelics. FDA chief Marty Makary announced National Priority Vouchers for three companies, designed to shorten the review period from several months to a few weeks: Compass Pathways (synthetic psilocybin, COMP360, for treatment-resistant depression), the Usona Institute and Transcend Therapeutics. Compass CEO Kabir Nath stated that they would be ready to go by the end of the year. Particular attention is being paid to ibogaine: Texas, with the involvement of former Governor Rick Perry, has allocated $50 million for research into this substance, which has promising therapeutic potential but carries significant cardiovascular risks and has been linked to documented fatalities. These substances are still classified as Schedule I: substances with no recognised medical benefit and a high potential for abuse, controlled by the Drug Enforcement Administration. It is precisely this status that Trump’s executive order aims to relax.

How reliable is the data? The substance: between efficacy and risk

First, the facts. COMP360, the synthetic psilocybin developed by Compass Pathways, met its primary endpoint in February 2026 in the second Phase 3 trial for treatment-resistant depression, following a previous trial at the end of 2025. Two fixed doses, three weeks apart; highly significant reduction in symptoms compared to the control dose; onset of effect from day 1; maintained for over six weeks; side effects predominantly mild. After decades of research hiatus due to prohibition, this is a solid result. FDA approval in 2026 or early 2027 is therefore realistic.

However, in 2024, the same FDA rejected MDMA therapy for PTSD due to methodological flaws, questionable blinding (anyone receiving a dose of ecstasy would notice) and reports of assaults during therapy sessions. What is remarkable about this is that it was, of all things, the modality with the best short-term evidence that failed to make the cut. Psychedelic research has a structural blinding problem that no sample size in the world can solve, and an expectation problem: hardly any other field of research is so steeped in hope of a cure. It is precisely into this unresolved situation that policymakers are now rushing headlong by decree. That is the first punchline.

Strong in the short term, weak in the long term, and that is precisely where the gap lies.

Anyone wishing to do justice to the state of the research must make a distinction that is regularly lost in the political debate: between short-term and long-term efficacy. In the short term, the evidence is surprisingly solid. In a Phase 3 study, MDMA therapy for PTSD reduced PTSD severity (measured using the CAPS-5 scale) significantly more than the identical placebo-controlled therapy, with an effect size of 0.7. In an earlier Phase 3 study, 67 per cent of participants no longer met the PTSD criteria after three sessions, and 88 per cent showed clinically significant improvement. For psilocybin in depression and cancer-related fear of death, randomised trials demonstrate rapid, substantial reductions in symptoms. These are remarkable figures for the acute phase, and they should not be reflexively downplayed.

And this is precisely the real reason why the political pace is so questionable. The government initiative, a permanent Texas programme, accelerated approval, and an entire care infrastructure are not justified by the acute effects, but by an unspoken long-term promise: treat once, cured for life; one to three sessions instead of daily medication. It is precisely this promise that is the methodologically weakest part of the entire data set. The long-term data comes almost exclusively from small samples, open-label follow-ups and crossover designs without a robust long-term control group. Whilst they do show that lasting improvements can occur, they do not show that the substance is responsible for them.

And the results themselves are inconsistent. In the case of cancer-related anxiety, improvements persisted in a follow-up study lasting an average of 4.5 years; 60 to 80 per cent continued to meet the response criteria; a remarkably sustained result, albeit in a tiny surviving subgroup of a crossover design.

In the case of treatment-resistant depression, however, a 12-month pilot study with US veterans showed the opposite: the effect waned after six months, and more markedly after nine; after twelve months, only 40 per cent remained in remission, 30 per cent in remission – out of ten (!) evaluated cases. In other words, for some, the effect lasts for years; for others, it fades within months; and no one can currently say with any certainty who belongs to which group.

Added to this is the blind spot of direct comparison. There is a near-total lack of long-term comparisons with established treatments, such as trauma therapy and antidepressants; commentaries in *The Lancet* (eClinicalMedicine) and the *BMJ* note that no robust evidence of superiority over existing methods has yet been established. The contrast with the ketamine derivative esketamine is instructive: there, relapse prevention is only effective with continued maintenance therapy – in other words, precisely the opposite of the ‘once-and-for-all’ logic with which the psychedelic wave is marketed. Whether psychedelics live up to this logic across all indications remains an open question for research. Yet policymakers treat it as settled.

How did the counterculture drug become a conservative project?

The cultural-historical twist is breathtaking when spelt out. Psychedelics were the sacrament of the counterculture: mind expansion as an escape from meritocracy, militarism and consumerism. Nixon’s War on Drugs was a war against this counterculture. In 2026, the same molecules are returning, but the labelling has been swapped. Now the talk is of veterans with PTSD, treatment-resistant depression, American leadership in innovation, and easing the burden of healthcare costs. The substance that was supposed to blow up the system has become one intended to repair it so its members can function again.

One can read this cynically. More interesting is the discourse-analytical interpretation: a substance has no political significance; it derives it from the society that speaks of it. The same chemical compound was released in 1968, the devil’s work in 1986, and is a national reform project in 2026. What has changed is not the molecule. It is society’s need. An exhausted, depressed, opioid-damaged nation does not need a mind-expanding experience, but rather healing. So the trip becomes treatment, ecstasy becomes the endpoint, and the set and setting become a standardisable protocol.

What is lost when the trip becomes treatment?

Psychedelic research itself has always emphasised that the substance is only one element of the equation. Set (the inner state) and setting (the context) account for the rest. It is precisely these two-thirds that are the hardest to scale. A psilocybin session following a study protocol requires two trained facilitators for six to eight hours, plus preparation and integration. The American healthcare system, which already produces months-long waiting times for regular psychotherapy, is now expected to roll out the most labour-intensive therapeutic format in history across the board, accelerated by a presidential voucher.

The foreseeable solution is the usual one: consolidation. Shorter support sessions, group settings, digital ‘integration’ via an app, and ultimately perhaps prescription with self-instruction. But this would eliminate precisely the factor that likely accounts for a significant part of the effect in the studies: intensive human support. It would be the bitter irony of this story if the clinical trials, with their elaborate settings, were to demonstrate an efficacy that the subsequent healthcare system systematically fails to match, and the failure were then blamed on the substance itself. We recognise this pattern from the history of antidepressants: first a miracle cure, then disappointment, then backlash. The hype is the precursor to disappointment.

Why does the psychedelic wave strike a religious chord?

It is worth taking the movement’s language seriously. The study reports speak of ego death, rebirth, unity and meaning. Michael Pollan titled his book, which ushered in the renaissance, “How to Change Your Mind”; the German edition bore the more telling title “Verändere dein Bewusstsein” (Change Your Consciousness). This is not pharmacological language. It is the vocabulary of revival. The psychedelic wave promises a secular society what it has lost with religion: transcendence by appointment, conversion under medical supervision, and the mystical experience as a reimbursable service.

The fact that the MAHA movement – Make America Healthy Again – of all things has adopted this narrative is only seemingly contradictory: it is itself a revivalist movement that frames health as a process of salvation. This brings us full circle to a recurring theme of this blog: From Joe Dispenza’s quantum healing to manifestation and the mindfulness industry – the market for secular salvation is growing wherever sources of meaning are dwindling, and exhaustion is mounting. Psychedelics are the most potent product on this shelf to date, with one crucial difference: they actually have a pharmacological effect. This does not make the distinction between treatment and promises of healing any easier; rather, it makes it more difficult.

What does approval mean for Germany?

The German-speaking discourse lags months or even years behind developments on the US market, and for once this presents an opportunity: we can learn from the American experiment before repeating it. Psilocybin is not authorised for sale in Germany; EMA approval would follow an FDA decision, not pre-empt it, and the EMA has recently (see Lecanemab) demonstrated that it does not automatically follow the American fast-track approach. A realistic timeframe is several years, during which one thing in particular will grow here: the grey market. Retreats in the Netherlands, truffle ceremonies, self-appointed guides without training – the demand generated by the American narrative will seek out its own supply.

For patients with severe depression, two things are therefore important. Firstly, psilocybin is a candidate to be taken seriously, not a miracle cure. The research concerns narrowly defined groups under intensive professional supervision, not self-treatment. Secondly, anyone experimenting on their own initiative now is not replicating the study, but is foregoing its most effective component: the framework. A psychedelic experience without preparation, supervision and post-event integration would be a high-risk procedure with an uncertain outcome, particularly for those with a vulnerable psyche.

What would be a responsible stance between hype and knee-jerk scepticism?

The comfortable positions are already taken: the enthusiasts have their narrative of salvation, the sceptics their reflexive opposition. The uncomfortable middle ground is this: the first substantially new treatment for depression in decades may well be emerging here, and at the same time, it is being swept up by a political-economic acceleration machine that has little to do with evidence. Both are true. Seriousness means taking the data seriously. The FDA’s decision on COMP360 will not be the end of this story, but rather its true beginning, for that is when the real-world test begins. Whether a healthcare system optimised for efficiency can support a therapeutic format whose active ingredient is also the care itself.

Summary: Psychedelics, politics and the promise of healing

· On 18 April 2026, President Donald Trump signed an executive order to accelerate the research and approval of psychedelics; among those present at the signing in the Oval Office were podcaster Joe Rogan and Bryan Hubbard (Americans for Ibogaine).

· FDA chief Marty Makary announced National Priority Vouchers for three companies (Compass Pathways, Usona Institute, Transcend Therapeutics), which will reduce the review time from months to weeks. Texas is providing $50 million for research into ibogaine, a substance with potential but significant cardiac risk.

· Compass Pathways’ COMP360 (synthetic psilocybin, treatment-resistant depression) has met both Phase 3 endpoints; FDA approval in 2026/27 is a realistic prospect.

· The warning remains: in 2024, MDMA therapy failed due to blinding and methodological issues, despite being the modality with the strongest short-term evidence. The acceleration follows the narrative, not the evidence.

· Key distinction: Short-term efficacy is robust (MDMA for PTSD, effect size 0.7; after three sessions, 67% no longer met the criteria for PTSD; psilocybin with rapid, substantial effects for depression and fear of dying from cancer). Weaknesses include poor long-term durability, small sample sizes, open-label follow-ups, and crossover designs without long-term control.

· The long-term findings are inconsistent: for cancer-related distress, a 60–80% response rate after 4.5 years (tiny subgroup); for treatment-resistant depression, however, a waning effect from month 9 onwards, with only a 40% response rate and 30% remission after 12 months. No one can predict who will benefit in the long term.

· The crux of the discrepancy: the government initiative (the ongoing Texas programme, Fast-Track) justifies itself with a long-term promise of a cure – treat once, cured for life – which, ironically, is the weakest part of the evidence methodologically. A direct long-term comparison with established treatments is lacking (Lancet, BMJ); the esketamine comparison shows that relapse prevention often only holds with maintenance therapy.

· A cultural-historical twist: the same substance was a rebellion in 1968, the devil’s work in 1986, and a national reform project in 2026 (veterans’ health, deregulation, industrial promotion). It is not the molecule that has changed, but the needs of the society that narrates it.

· Scaling problem: Set and setting, the labour-intensive factors influencing efficacy, are the hardest to scale up; the foreseeable consolidation threatens to rationalise away precisely the proportion of efficacy that underpins the study results.

· The psychedelic wave caters to a secular longing for salvation (death of the ego, rebirth, meaning), linking in with Dispenza, manifestation, the mindfulness industry, but with genuinely effective pharmacology, which makes the distinction harder to draw.

· For Germany: a multi-year window without approval, a growing grey market (retreats, ceremonies); self-experiments do not replicate the study, but remove its most effective component: the professional framework.

· A responsible approach: take the data seriously, dissect the narrative; the real test begins after approval, in everyday clinical practice.