Therapeutic Advances in Psychopharmacology
January 1, 2023
Michiel van Elk, Eiko I. Fried
126 citations
Despite a decade of optimism about psychedelics for treating mental disorders, psychedelic science faces serious challenges that threaten the validity of core findings. The paper identifies 10 pressing problems grouped into easy, moderate, and hard categories, showing how they undermine internal validity (treatment effects due to unrelated factors), external validity (lack of generalizability), construct validity (unclear working mechanisms), and statistical conclusion validity (conclusions not supported by data). These problems often co-occur, limiting conclusions about safety and efficacy. The authors provide a roadmap and checklist for stakeholders to assess study quality, emphasizing that addressing these issues is necessary to determine whether therapeutic optimism is warranted and to avoid repeating past mistakes.
March 10, 2023
Michiel van Elk, Eiko I. Fried
30 citations
preprint
Despite a decade of optimism about psychedelics for treating mental disorders, the field faces ten pressing challenges that threaten the validity of core findings. These problems undermine internal validity (treatment effects from non-treatment factors), external validity (poor generalizability), construct validity (unclear mechanisms), and statistical conclusion validity (conclusions unsupported by data and methods). The challenges co-occur, strongly limiting conclusions about safety and efficacy. A roadmap and checklist are provided for researchers, journalists, funders, and policymakers to assess study quality. Addressing these issues is necessary to determine whether the optimism is warranted and to avoid repeating past mistakes.
BMJ
November 19, 2024
Cédric Lemarchand, Raphaël Chopin, M Paul et al.
9 citations
The authors identify weaknesses in the evidence regarding the efficacy and safety of hallucinogens and raise concerns about the use of expedited regulatory pathways for these substances.
JAMA Psychiatry
April 10, 2024
Eiko I. Fried, Ioana A. Cristea, Florian Naudet
2 citations
A letter to the editor raises three concerns about a published study that tested 25 mg of psilocybin in 15 patients with treatment-resistant type 2 bipolar depression. The authors of the letter identify specific methodological issues with the study protocol but do not present new data or findings.