Is Psychedelic Therapy Ready for FDA Approval?
Robin Carhart-Harris, a consciousness and psychedelics researcher at UCSF, discusses the current state of psychedelic therapy research, including the FDA's denial of MDMA-assisted therapy approval, the critical importance of therapeutic context, and key risk factors and contraindications for psychedelic treatment.
Summary
Robin Carhart-Harris of UCSF discusses the state of psychedelic research in a wide-ranging interview. He describes the field as having passed through a hype cycle following Michael Pollan's 2018 book, with a subsequent market correction and the significant setback of the FDA denying Lykos/MAPS approval for MDMA-assisted therapy for PTSD. Despite this, he remains optimistic, noting that publication rates and trial quality are at all-time highs, and that Compass Pathways' psilocybin therapy for treatment-resistant depression is likely the closest to FDA approval.
Carhart-Harris argues that psychedelic therapy is fundamentally a combination treatment — the drug induces a neuroplastic state, and the therapeutic context ('set and setting') shapes what is done with that state. He is currently running controlled experiments manipulating context variables such as music, aesthetic environment, and quality of psychological support to empirically test this assumption. He describes the therapy model as largely non-directive during dosing sessions, with meaningful psychological support occurring in preparation and integration phases.
The interview addresses significant safety concerns, particularly around recovered memories. Carhart-Harris acknowledges that cases of alleged recovered memories have occurred at multiple major research sites, including his own. He warns that psychedelics could become 'hypnosis on steroids' if therapists impose their beliefs on vulnerable patients, and describes a specific case where a patient emerged with an uncertain recovered memory of attempted harm by a parent, leading to clinical worsening.
On contraindications, Carhart-Harris notes that clinical trials systematically screen out individuals with histories of psychotic illness or personality disorders. Data from real-world psychedelic use shows that people with personality disorder histories are four times more likely to experience worsening outcomes, while those with schizophrenia histories are twice as likely. He acknowledges this creates a 'cherry-picking' problem in clinical research. He also distinguishes MDMA from classic psychedelics like psilocybin and LSD, describing it as less unpredictable and more of a 'heart opener' than a 'head opener,' making it more compatible with conventional talk therapy formats.
Key Insights
- Carhart-Harris argues that the 'secret source' of psychedelic therapy is a combination of the drug inducing neural plasticity and the therapeutic context shaping that plastic state — he considers the two inseparable, and is currently running controlled experiments to empirically test how much context variables like music, aesthetics, and psychological support actually matter.
- Carhart-Harris explains that the FDA denied MDMA-assisted therapy approval partly because it was framed as a combination treatment ('MDMA-assisted therapy'), which the FDA said fell outside its remit as a drug-approval body — a framing problem he says Compass Pathways is deliberately avoiding with its psilocybin submission.
- Carhart-Harris warns that psychedelics could become 'hypnosis on steroids' when it comes to recovered memories, noting that cases of alleged recovered memories have occurred at his own trials and at Hopkins, and that therapists who impose their beliefs on vulnerable patients during sessions represent a serious and growing risk, including potential legal exploitation.
- Carhart-Harris reports that in real-world psychedelic use data, people with a history of personality disorder diagnosis were four times more likely to fall into the worst-outcome group, and that their decline was delayed — they showed slight short-term improvement before experiencing a clinically meaningful worsening further out — while those with schizophrenia history were twice as likely to have poor outcomes.
- Carhart-Harris acknowledges that clinical trials systematically screen out individuals with personality disorders and psychotic illness, and concedes this means the field has 'arguably and fairly cherrypicked' a more resilient population, making the published positive results less generalizable to the broader population that might seek psychedelic therapy.
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