Abstract
Psilocybin has a long history of non-medical use and some seem to infer from this that it has therapeutic utility. Early phase clinical trials with psilocybin are encouraging, but suggest only that larger, multicentre trials are required. These are ongoing but will take many years to complete. Meanwhile, retreat centers offering paid experiences with psilocybin truffles have opened in some countries, often using early phase clinical trial data as a basis for bold, public facing claims. This seems unwise. Early phase trials are not designed for their results to be generalized outside the setting they were undertaken in. To do so risks being misleading. Providing what may be seen as an unregulated drug intervention as a paid service is difficult to reconcile with long-held ethical principles underpinning human research and treatment development that were laid down by the 1947 Nuremberg Code and the 1962 Kefauver Harris Amendments. By using psilocybin before it has been properly tested, retreat centers may be undermining their own credibility and the credibility of the wider field.
Highlights
Retreat centers offering paid experiences with psilocybin truffles have opened in some countries, often using early phase clinical trial data as a basis for bold, public facing claims
Since psilocybin is a drug, this burden of proof is a set of gold standard clinical trials
Websites of retreat centers promote narratives of personal growth, emotional breakthroughs and spiritual development. They use the results of early phase clinical trials with psilocybin to bolster claims to potential customers, despite the fact that those trials were never designed for that purpose and should not be extrapolated in this way
Summary
Retreat centers offering paid experiences with psilocybin truffles have opened in some countries, often using early phase clinical trial data as a basis for bold, public facing claims. The Kefauver Harris Amendments introduced a legal requirement for manufacturers of drugs for human use to provide proof of effectiveness and safety prior to marketing.
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