The Second Wave: Why History Is Repeating and How It Might Not

“The people building the current psychedelic renaissance have read Storming Heaven. They are explicitly trying not to repeat 1968. Whether they will succeed is the open question.”

Jay Stevens ended Storming Heaven in 1968. Fifty-five years later, the research program he mourned has resumed. The question Storming Heaven's history now poses is not historical but prospective: will the current psychedelic renaissance avoid the collapse that ended the first one?

The people building the current renaissance have read Stevens's book, or something equivalent. The explicit institutional memory of what went wrong in the 1960s is present in every major clinical psychedelic research organization. Matthew Johnson's 2008 safety guidelines for human psychedelic research, which have become the baseline protocol for clinical trials, were written with the specific goal of preventing the kind of adverse events and public credibility damage that enabled the 1968 prohibition. The guidelines specify: screening for contraindicated conditions, therapeutic alliance established before dosing, trained monitors present during sessions, post-session integration, careful management of public communication.

This is the clinical tradition Osmond and Huxley built, formalized into something that can survive its most charismatic exponents. The problem in the 1960s was that the clinical tradition depended on individual practitioners, Osmond, Hoffer, Grof, Pahnke, and the moment it was disrupted by public controversy, the institutional infrastructure that might have sustained it did not exist. The current infrastructure, the Society for Psychedelic Outreach, Reform and Education, the Multidisciplinary Association for Psychedelic Studies, the academic centers at Hopkins, NYU, Imperial, and elsewhere, is designed to be more durable.

The specific risks that Stevens documented are also more visible now. The Leary risk, mass public advocacy that overtaxes the regulatory goodwill needed for clinical approval, has materialized in the ayahuasca retreat industry, in the ketamine wellness clinic proliferation, and in the general 'psychedelic renaissance' media coverage that sometimes outruns the evidence. The FDA's August 2024 rejection of the MDMA-assisted therapy application for PTSD was partly a response to this problem: not a rejection of the underlying science, but a finding that the trial design had insufficient safeguards against expectation effects and therapeutic boundary violations. The FDA's concern was not that MDMA doesn't work, it was that the trial design couldn't prove it works in a way that would survive commercialization at scale.

This is the 1968 problem in new form: the substance is promising, the evidence is promising, and the enthusiasm of advocates is threatening to outrun the methodological rigor needed to make the evidence stick.

The industry Phase 3 trials for psilocybin in treatment-resistant depression, reporting in June 2025 and February 2026, represent the methodologically rigorous approach: double-blind design, active placebo comparison, pre-registered primary endpoints, independent data monitoring, and a trial population (treatment-resistant patients) where the effect size is most meaningful. The results met primary endpoints with high statistical significance. The NDA submission is targeted for Q4 2026.

If approved, and the current trajectory suggests approval in late 2026 or early 2027, synthetic psilocybin will be the first psychedelic-assisted therapy with full FDA approval. This is not what the 1960s research was close to producing; the 1960s research would have taken another decade of refinement to reach this point. The fifty-five-year interruption is ending, and it is ending with better methodology than what was interrupted.

But Stevens's other warning, about the co-optation of the clinical tradition by commercial and cultural forces that transform it into something it wasn't designed to be, is still live. The economic incentives in the legal psychedelic market are substantial. The distance between a rigorous clinical protocol and a commercial psychedelic retreat is the distance between Osmond's Weyburn and Kesey's Trips Festival. That distance exists regardless of whether synthetic psilocybin gets approved.

What Storming Heaven shows, and what the current renaissance has to reckon with, is that the clinical and the cultural cannot be cleanly separated. They were not separable in the 1960s, and they are not separable now. The question is not whether to manage the relationship but how.

Sources

• Stevens, Storming Heaven (1987)
• Johnson et al., Human hallucinogen research guidelines for safety, J Psychopharmacol (2008)
• FDA decision on MDMA-assisted therapy for PTSD (August 2024)
• Industry Phase 3 psilocybin trial results (2025-2026)
• Davis et al., Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder, JAMA Psychiatry (2021)