A Dalgarno Research Report (DRR): An investigative analysis of political lobbying, anecdotal evidence, compromised research, and the lessons Australia failed to learn — and is now teaching the world

The Pattern Nobody Wants to Name

There is a template for how societies rush dangerous or under-evidenced drugs into mainstream medicine. It begins with a genuine, compelling human problem — suffering that existing treatments cannot adequately address. It continues with individual stories of miraculous recovery: a veteran who no longer wakes screaming, a cancer patient who made peace with death, a depressive who felt sunlight for the first time in years. These stories are real and they are moving – But however moving they are, they are not science.

From there, a well-funded advocacy movement forms, often backed by true believers and commercial interests simultaneously. Regulators face a flood of public submissions. Politicians sense an opportunity to be seen as compassionate and decisive. Expert committees issue cautions, but those cautions are overridden. The drug enters clinical practice before Phase III trials are complete, before long-term safety data exist, and before the health system has the infrastructure to administer it safely.

Harms accumulate quietly. The reckoning comes later — always later. This is not new, but it is readily forgotten.

Australia did this with medicinal cannabis and even to the surprise of the Psychedelic sector, with these substances as well. Now the world, with America leading the charge via executive order and Australia as a reluctant pioneer, is attempting to do it again with psychedelics.

The warning signs are not subtle – they are screaming.

Part I: The American Template — Anecdote by Presidential Decree

On April 18, 2026, President Donald Trump signed Executive Order 14401, titled Accelerating Medical Treatments for Serious Mental Illness, directing the FDA to fast-track psychedelic drugs including psilocybin, MDMA, and ibogaine as treatments for PTSD, major depression, and other conditions. The order committed $50 million in federal funding, directed the FDA and DEA to establish Right to Try pathways for patients to access psychedelic drugs still in clinical trials, and instructed the Attorney General to expedite rescheduling upon completion of Phase 3 trials.

The emotional architecture of the announcement was unmistakable. At the White House signing ceremony, veterans’ advocates, NFL-famous warriors, and Joe Rogan-adjacent commentators stood behind the president. The FDA commissioner issued priority review vouchers to three companies within days. The optics — and the politics — were impeccable.

But JAMA published a Viewpoint in July 2026 asking a harder question: is political urgency the same as clinical readiness? Harvard Law’s Petrie-Flom Center, in a detailed analysis by Professors I. Glenn Cohen and Mason Marks, identified multiple tensions within the order that enthusiasm had papered over. Cohen noted that while Priority Review Vouchers can compress the review timeline dramatically, there was reporting that the White House had itself removed Compass Pathways’ psilocybin product from the priority voucher list just weeks before the order was signed — and the order then re-included it, suggesting political winds rather than scientific evidence were driving the timetable.

Perhaps most alarmingly, the order specifically mentions ibogaine — a substance that, as Cohen noted, has arguably not met the basic safety requirements for Right to Try eligibility and about which Nora Volkow, the long-time director of the National Institute on Drug Abuse, has highlighted serious cardiac toxicity concerns. Ibogaine is documented to cause potentially fatal QT interval prolongation and ventricular arrhythmias, with peer-reviewed research published in 2026 confirming it induces clinically relevant QTc prolongation in 50% of subjects, with some cases lasting beyond 24 hours. It has been linked to cardiac arrest and deaths even at therapeutic doses and in individuals with no pre-existing heart conditions.

“My primary worry would be that FDA standards could be loosened for politically driven reasons,” said one researcher at Johns Hopkins. “While it’s unclear if this is the case, it’s evident that far more scientific research and an objective analysis of risks and benefits are essential.”*

Part II: The Science Is Not What the Headlines Say It Is

The excitement surrounding psychedelics as medicine is not entirely manufactured. Early trials have produced genuinely intriguing signals. But there is a chasm between “intriguing signals” and “safe, effective, prescribable medicine” — and the advocates, lobbyists, and politicians have been systematically leaping across that chasm while the scientists are still building the bridge.

The Conflict of Interest Problem

One psychedelic researcher, Manoj Doss, has noted that he knows “only one psychedelic researcher who’s never done psychedelics” — an acknowledged conflict of interest that pervades the entire field. This is not a trivial concern. When researchers have a pre-existing ideological or experiential commitment to a substance, the literature on “questionable research practices” and publication bias suggests that even unconscious biases can skew statistical results toward false positives. Psychedelic drug companies pay consultation fees to psychedelic researchers — fees disclosed in research papers but rarely foregrounded in media coverage.

The problem extends to financial conflicts. A wave of psychedelic drug companies have emerged, paying consultation fees to researchers, funding studies, and creating a commercialisation ecosystem that mirrors the worst excesses of the pharmaceutical industry — but with the added ideological layer of many researchers being true believers in the substances themselves.

The Blinding Problem

Any drug trial faces the challenge of blinding: keeping participants from knowing whether they received the active drug or placebo so their expectations don’t contaminate the results. For psychedelics, this challenge is essentially insurmountable. In a MindMed trial of LSD for anxiety, virtually all participants who received the active drug correctly guessed they had taken it. In a study of MDMA for alcohol use disorder, over 90% of both participants and therapists correctly identified the active allocation.

The FDA raised this as a primary concern in its review of MDMA-assisted therapy for PTSD, calling it “functional unblinding”. The problem generates not just participant expectancy bias but therapist expectancy bias — with therapists who believe in the treatment unconsciously (or consciously) influencing outcomes. FDA advisers noted that while large effect sizes can sometimes override bias concerns, the “hype” surrounding psychedelics made regulators appropriately more cautious: high expectations in a research field amplify, rather than dampen, expectancy effects.

The Small Samples, Specific Populations Problem

The trial evidence base is built on studies that are vanishingly small by the standards required for regulatory approval. The landmark 2021 NEJM trial comparing psilocybin to the antidepressant escitalopram — the first and, at the time of publication, only head-to-head comparison with an approved treatment — enrolled just 59 people. Prior studies ranged from 12 to 29 participants, some with no control group whatsoever.

Clinical trials in this space routinely exclude more than 90% of potential participants. Those excluded include people with recent suicide attempts, comorbid substance use disorders, a personal or family history of psychosis or mania, and those with aggression histories — precisely the populations who are most severely mentally ill and who would be most likely to seek these treatments if approved. What works in a carefully screened, supervised research population may perform very differently in real-world clinical settings.

Part III: The Harm That Was Hidden

If the evidence base is fragile, the documented harms are far more concrete — and they have been systematically minimised.

A Pattern of Abuse

The suggestibility induced by psychedelics is, paradoxically, central to both the proposed therapeutic mechanism and the gravest risk. Under MDMA or psilocybin, patients become emotionally open, vulnerable, and highly responsive to the guidance — or exploitation — of those around them. There is a documented history of sexual abuse within psychedelic therapy extending back decades.

The most extensively documented case involves Meaghan Buisson, a PTSD survivor who enrolled in a Phase II MAPS clinical trial in Canada. Video footage of her sessions, uncovered by New York Magazine‘s Cover Story: Power Trip podcast, showed her therapists — a married couple — stroking her, climbing into bed with her, asking her to spread her legs, and pinning her down while she screamed and fought against them. One therapist, Richard Yensen, later admitted to having sex with Buisson after the sessions while she was still enrolled in the trial. Three related papers were subsequently retracted by the journal Psychopharmacology in August 2024 due to “protocol violations amounting to unethical conduct”.

This was not an isolated incident. The FDA’s 2024 rejection of Lykos Therapeutics’ (formerly MAPS) application for MDMA-assisted therapy for PTSD cited not only questions about efficacy, but documented concerns about historic and contemporary sexual abuse of patients by therapists. Yet MAPS’ Executive Director Rick Doblin, when asked publicly about the risk of sexual abuse, responded with the extraordinary suggestion that the goal was to make healing “inside the patient” so they would be “stronger” against therapists who might pressure them into sexual relationships. The FDA, for its part, rejected the application in August 2024.

The Research Integrity Crisis

Beyond individual abuse cases, the entire MAPS MDMA research programme has faced serious questions of data integrity. The FDA rejection documented concerns about the design of late-stage studies and the necessity for additional data. Health Canada reviewed all MDMA clinical trials it had previously approved following complaints of investigator misconduct. A 2025 call for retraction of a Journal of Humanistic Psychology paper alleged that the 23 therapists interviewed had described practices that justify sexual assault “under the guise that these practices promote healing,” and that the lead author had concealed financial conflicts of interest and connections to practitioners facing abuse allegations.

The JAMA and broader medical literature has raised the prospect that “over-exuberant” scientific advocates are producing a literature that sounds far more certain and optimistic than the actual trial data warrants. The gap between the peer-reviewed results and the media coverage of those results has been persistent and significant.

Part IV: Australia’s Cannabis Cautionary Tale — The Lesson Not Learned

The irony of Australia’s position is that it contains within its own recent regulatory history an almost perfectly reproduced version of the mistake it is now making — and made first, for psychedelics — at a global level.

The Cannabis Template

Australia legalised medicinal cannabis in 2016 under significant public, media, and state government pressure, in the midst of powerful emotive campaigns featuring sick children and suffering patients. The federal government effectively determined that Australians could legally access cannabis for medicinal purposes before the regulatory framework was fully equipped to manage it. Prescriptions exploded: from 231 in 2017 to more than one million by early 2024, generating an estimated market value of AUD $445.6 million — a figure that in itself signals the power of commercial forces in driving access over evidence.

The consequences have been serious and underreported. Between July 2022 and June 2025, the TGA received 615 adverse event reports related to unapproved medicinal cannabis products. These included more than 50 reports of psychosis, 14 instances of suicidal ideation or behaviour, three reports related to schizophrenia, two of homicidal ideation, and one of a delusion of parasitosis. Despite receiving these reports, the TGA acknowledged it had not investigated the safety of most medicinal cannabis products, stating it had identified no “safety signals” — a claim the ABC exposed as inconsistent with the existing evidence.

By October 2025, the Australian Medical Association and the Pharmacy Guild had written jointly to the Health Minister warning of “excessive and poorly regulated prescribing practices,” “coercive practices by cannabis companies,” and adverse health outcomes among vulnerable populations. They described prescriptions being issued without proper clinical oversight, patients bypassing GPs, and a system “being exploited”. What began as a humanitarian special access pathway had, without adequate regulatory infrastructure, become a largely unregulated commercial free-for-all.

The Psychedelic Déjà Vu

The TGA’s February 2023 decision to approve psilocybin and MDMA for clinical use — making Australia the first country in the world to do so — followed the same script almost scene for scene. The driving force was Mind Medicine Australia (MMA), a charity and lobby group that mounted an aggressive multi-year campaign. The TGA head, Professor John Skerritt, acknowledged he had to counsel staff on multiple occasions about MMA’s aggressive lobbying, telling ABC that MMA was “perhaps working against their own case by frankly, being so aggressive”.

The sequence was remarkable. The TGA’s own expert committee, the Advisory Committee on Medicines Scheduling (ACMS), had advised against scheduling, citing:

• The lack of Phase III trials
• The broadness of the proposed indications
• The problems of translating clinical trial settings to clinical practice
• The risk of diversion at points in the supply chain
• The fact that no approved therapeutic product containing psilocybin existed anywhere in the world at the time

The Royal Australian and New Zealand College of Psychiatrists and the Australian Psychological Society both supported the interim decision not to down-schedule. Professor Patrick McGorry, one of Australia’s most prominent psychiatrists, publicly asked: “Can we be reassured that approval is not due to intense private lobbying/special pleading by a zealous private group?”

And yet the TGA reversed course — in a “delegate-only” decision made without reference to the ACMS — after MMA mobilised over 3,000 public submissions opposing the interim decision. The TGA delegate noted that most submissions came from the general public, were brief, and failed to address any of the reservations expressed in the interim decision. Professor Nigel Strauss, a psychiatrist who supports psychedelic research, put it simply: “I’m not really aware of what drove the TGA to make this change decision. All I can say is that it’s definitely not research because there hasn’t been any great change.”

An independent report commissioned by the TGA — the very report that was supposed to inform the decision — concluded that while MDMA and psilocybin showed promise in highly selected populations in closely supervised settings, the certainty of evidence was rated as “low or very low” using the Cochrane Collaboration’s GRADE framework. That report was effectively set aside.

Part V: The Present and Future Dangers

The convergence of political pressure, commercial interest, weak evidence, and documented harm creates a set of real and compounding dangers — not theoretical ones.

The Clinical Readiness Gap

Australia currently has very few psychiatrists trained to administer psychedelic-assisted therapy as intended by the research protocols. The intensity of the therapy means it is prohibitively expensive for most patients. The gap between the controlled, closely monitored clinical trial environment and an authorised prescriber operating without the rigorous oversight of a registered trial creates precisely the conditions in which the documented abuses can recur and multiply — and without the paper trail of a formal trial, they are far less likely to be discovered.

The Vulnerable Patient Problem

The patients most likely to seek these treatments are those who have already exhausted conventional options: the severely, chronically mentally ill; trauma survivors; those with treatment-resistant depression. These are also the patients most vulnerable to exploitation, most likely to have the comorbidities that were exclusion criteria in research trials, and most likely to suffer serious adverse events outside of the highly controlled trial environment. The move from clinical trial to clinical practice is not a minor administrative transition — it is a seismic change in the risk environment.

The “Right to Try” Precedent

The American executive order’s invocation of the Right to Try Act for ibogaine — a substance that has caused cardiac deaths, that has not completed Phase I clinical trials in the US, and that the FDA has previously resisted researching due to heart-related risks — represents a particularly dangerous precedent. Right to Try was designed for terminally ill patients seeking access to experimental treatments when no alternatives exist. Using it as a backdoor for psychedelic access, particularly for ibogaine, before safety data are established, sets a precedent for regulatory bypass that could outlast any particular executive order.

The Commercial Capture Risk

The wave of psychedelic pharmaceutical companies that have formed — Compass Pathways, Lykos (formerly MAPS), Usona Institute, Transcend Therapeutics — have significant financial stakes in rapid approval. Following the Trump executive order, shares in psychedelic drug developers surged as Wall Street analysts suggested the order could “lend legitimacy to an industry historically viewed as marginal”. The conflation of scientific progress with investor returns is one of the most reliable predictors of regulatory capture. Researchers on company payrolls, a commercialised media landscape hungry for breakthrough narratives, and a political class eager for visible wins against the mental health crisis create a feedback loop that is very difficult to interrupt.

The Australia Effect

Because Australia moved first — and because the rest of the world is watching — Australia’s regulatory framework effectively serves as a global template. If the Australian experiment produces documented harms, those harms will both vindicate the critics and, more importantly, harm real patients who deserve better than to be casualties of a poorly executed clinical experiment. If those harms are minimised or not investigated — as occurred with medicinal cannabis adverse events — the template will be exported before the problems are visible.

Part VI: What Good Practice Actually Requires

The question is not whether psychedelics may have genuine therapeutic potential. The question is whether the current political and commercial moment is allowing the evidence to catch up with the enthusiasm.

Good pharmaceutical practice demands:

• Completed Phase III randomised controlled trials with adequate blinding methodologies and active comparators — not just placebo — before prescribing approval
• Independent expert committee review, not delegate-only decisions influenced by public lobbying campaigns
• Mandatory long-term follow-up data given the unknown duration of effects and the documented suicidal ideation signals at higher psilocybin doses
• Rigorous safeguards against therapist abuse, including mandatory two-person therapy teams, video recording, and independent oversight — none of which are currently consistently required
• A regulatory pathway that does not confuse public enthusiasm (13,000 submissions, mostly from the general public) with clinical evidence
• Clear separation between commercial and research interests

The JAMA consensus statement on ethics and policy for psychedelic clinical care identified precisely these issues: the need for informed consent processes that account for the drug’s effects on suggestibility; the critical importance of professional boundary enforcement; and the serious concern that the field is moving toward clinical integration before the ethical infrastructure is in place.

Conclusion: The Anecdote Is Not the Data

Meaghan Buisson’s story is real. So are the stories of veterans who describe profound relief from PTSD through psychedelic-assisted therapy. So, too, are the stories of children whose seizures were reduced by medicinal cannabis. Individual human suffering and individual recovery are both genuine and genuinely irrelevant as clinical evidence. They tell us a treatment might work. They tell us nothing about whether it works consistently, safely, for whom, at what dose, in what context, and with what long-term consequences.

What regulators are for — what the entire apparatus of clinical trials, expert committees, evidence grading, and pharmaceutical good practice exists to determine — is the population-level question. It is an inherently statistical, impersonal, and unglamorous exercise. It is also the only thing standing between a compelling anecdote and a clinical catastrophe.

Australia learned this lesson expensively with cannabis. More than 600 adverse event reports, including psychosis and suicidal ideation, accumulated before the TGA was pressed to even begin a review. The AMA and Pharmacy Guild are still trying to claw back the governance that was surrendered in 2016 to lobbying and emotion.

The world is now learning it again, faster and at greater scale, with psychedelics. An American president has signed an executive order. An Australian regulator made a world-first decision against its own expert committee’s advice. Papers have been retracted. Patients have been abused. The evidence is still, stubbornly, not where the enthusiasm has already arrived.

The tragedy of the present moment is not that psychedelic research is happening. It is that the mechanism by which it is being converted into medicine — politics, anecdote, lobbying, and regulatory shortcuts — is the one mechanism that is most reliably associated, across the history of pharmacology, with harm.

Written and Compiled by D.A.R.Think Tank, Dalgarno Institute

Sources drawn from: JAMA Viewpoint on the Psychedelic Therapies Executive Order (July 2026); NoBrainer Australia analysis of psychedelic research evidence and TGA lobbying; peer-reviewed literature in ANZJP, JAMA Network Open, Science, STAT News, and Addiction; ABC investigative reporting on TGA medicinal cannabis oversight failures; Harvard Law Petrie-Flom Center analysis of Executive Order 14401; and documented MAPS/Lykos clinical trial misconduct records.