By Tom Shroder August 15, 2024 at 7:15 a.m. EDT Tom Shroder, a former Post editor, is the author of “Acid Test: LSD, Ecstasy, and the Power to Heal.”

This month, the Food and Drug Administration denied a new drug application by Lykos Therapeutics that would have allowed the first legal medical use of a psychedelic drug. The denial took some by surprise because 20 years of FDA-approved clinical trials had shown dramatic success in treating Post-traumatic stress disorder (PTSD) using a combination of talk therapy and MDMA — the rave drug known as ecstasy. PTSD, a devastating and difficult to treat condition, affects an estimated 13 million Americans and more than 350 million people worldwide.

In the final phase of the trials, encompassing almost 200 subjects with moderate to severe PTSD, just three sessions of MDMA plus therapy relieved symptoms of PTSD in two-thirds of the participants, so that they no longer met the diagnostic criteria for the condition. A six-month follow-up showed the benefits persisted.

The FDA’s denial followed a negative recommendation from an advisory committee. The panel of independent mental health and medical experts gave a handful of reasons for concluding that the seemingly strong results of the studies couldn’t be trusted. Most prominently, they pointed to the fact that the double-blind testing regime — intended to prevent both patient and therapist from knowing if the pill taken was the studied drug or a placebo — was compromised by the unique and well-known impact of psychedelic drugs on consciousness.

This is effectively saying the study was doomed from the start. Of course subjects would realize they got the real thing. Aldous Huxley described the effect of a psychedelic drug, mescaline, the first time he took it. Gazing at a vase of flowers, he saw “the miracle, moment by moment, of naked existence. What rose and iris and carnation so intensely signified was nothing more, and nothing less, than what they were — a transience that was yet eternal life, a perpetual perishing that was at the same time pure Being, a bundle of minute, unique particulars in which, by some unspeakable and yet self-evident paradox, was to be seen the divine source of all existence.”

That would be hard to miss.

A randomized double-blind study is the FDA’s “gold standard” of pharmacological research, but this one-size-fits-all approach privileges one narrow approach to medicine, the materialistic and mechanistic. MDMA is not intended to have a direct biochemical impact on disease. Instead, it rearranges the mind so that psychic blocks and harmful patterns of thought are transcended and therapy becomes more effective. For pharmaceutical researchers steeped in the mechanics of molecular biology, this can be hard to accept.

Widespread use of psychedelic therapy began more than half a century ago, before the drugs became a countercultural phenomenon and were demonized and prohibited. From the start, therapists remarked that those who had the most positive therapeutic outcomes were those who had the most transcendent experiences.

Transcendence is exactly what’s required to heal conditions such as PTSD, whose victims get locked into a subjective hell. At the same time, the hyper-defensiveness characteristic of PTSD makes them resistant to interventions. It’s like trying to treat a dog with a gaping flesh wound. The animal desperately needs your help, but as you approach, it snarls and snaps. Fear and pain make it incapable of receiving assistance.

MDMA, considered not only a psychedelic but an empathogen for its ability to generate intense feelings of trust and empathy, seems ideal in this situation.

There have been some suggestions that to get a true idea of MDMA’s effectiveness in treating PTSD, it would need to be administered alone, without accompanying talk therapy. But that is missing the point. The drug does not work directly on the disorder. Rather, it enables a positive therapeutic relationship while making psychic wounds less painful. This allows exploration of the disordering trauma without defensiveness or automatic recoil. The same drug-fueled sense of transcendence that makes the double-blind impossible is precisely what allows patients to escape toxic brain loops that have kept them trapped and hopeless. Subjects in the studies, encouraged to talk about the things that have tormented them relentlessly, commonly open up as they have never been able to, saying things like, “I feel protected.”

A typical case is that of the survivor of a sexual assault who reported that she felt like she’d been trapped on an active battlefield, paralyzed among the horror as bullets flew at her. But under the influence of MDMA, she said, “I knew I could walk through it, and I wasn’t afraid. The drug gave me the ability not to fear fear.”

That fearlessness, plus MDMA’s well-documented power to promote feelings of trust and closeness, are an ideal combination for effective therapy. But those same qualities increase the danger of therapeutic malpractice, which the panel also noted in light of an incident of inappropriate sexual contact between study therapists and a subject. This malpractice was reported to proper authorities as soon as it was discovered; the therapists were banned, and safeguards — clear ethical codes, training and monitoring — were reviewed and reinforced.

Yet the incident added to the lingering miasma of distrust of psychedelics and the double-bind of the double-blind. In the end, the panel advised the FDA to reject. The agency took the smaller step of calling for further study.

It’s not clear how this can happen. More study would require millions of dollars Lykos doesn’t have and possibly many years. And unless the medical community can open its own mind to more complex approaches to medicine, there is little point. We must not let narrow ideas of testing come before the needs of veterans, first responders and sexual assault survivors suffering from a cruel disorder.