What FDA’s Approval of Esketamine Signals for the Future of Psychedelic Medicine

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This month, the FDA approved the first new depression drug in decades. Now throw in the fact that the drug, esketamine, is a derivative of ketamine — a long-approved anesthetic and popular party drug with psychedelic effects — and you have some truly groundbreaking news.

Esketamine’s approval comes amidst a rapid proliferation of ‘ketamine clinics’ across the country, where patients can receive intravenous ketamine infusions for their depression. Unlike esketamine, however, the use of ketamine to treat depression has not been subject to FDA review and approval. Instead, because ketamine is approved for another indication (i.e., as an anesthetic), it can be prescribed by doctors to treat other conditions pursuant to the ‘Practice of Medicine Exception’. Under this exception, medical practitioners can use their expertise and discretion to prescribe approved drugs, such as ketamine, for non-approved uses without FDA oversight or approval . Consequently, ketamine clinics have gone largely unregulated and, as a result, have reportedly engaged in some predatory and unsafe practices.

For example, clinics have done little to ensure that patients don’t become addicted to or unsafely use ketamine — a known drug of abuse as well as an intense dissociative. In an attempt minimize similar harms associated with esketamine, FDA is requiring that esketamine be administered by a certified medical office where patients can be monitored for up to two hours after taking the drug — a unique requirement for a depression medication.

Esketamine is also notably the first approved depression medication that is not taken daily. Instead, it need only be administered a few times a week in order to take effect. In other words, unlike other depression drugs, esketamine does not need to be in the body in order to be effective. This fact signals a paradigm shift from the traditional psychiatric model, which posits that depression is the result of a chemical imbalance that must be addressed by pharmaceutical intervention. Pursuant to the theory, if there is no chemical in your body to directly mitigate the imbalance, your depression will return. Esketamine — as well as ketamine — however, seems to operate differently. Through its dissociative and psychedelic properties, esketamine appears to induce non-ordinary mental states, which cause a shift in perspective, which in turn precipitates lasting cognitive and behavioral changes. In other words, the anti-depressive effect of esketamine seemingly manifests, at least in part, on a psychological level (i.e., the stories we tell ourselves) rather than just a physiological, or chemical, level.

Conceptually, other psychedelics currently under investigation for the treatment of psychiatric indications — e.g., the use of psilocybin to treat depression/existential distress and MDMA to treat PTSD — operate similarly. These substances also need not be in the body to be effective and must only be taken once or a handful of times to abate the condition at issue. The protocols for the administration of these substances, however, are notably different from that of esketamine (and ketamine, although there is no official protocol) in several ways.

For example, the current protocols for MDMA and psilocybin treatments require that these substances be administered in conjunction with therapy. Specifically, patients must undergo several therapy sessions to prepare for their ‘trips’, which, per the protocols, take a notably psycho-spiritual approach. For instance, in these sessions, therapists discuss the ‘somatic manifestations of trauma’ and the innate ‘healing intelligence’ of the body. Patients are also instructed to surrender to whatever experiences arise on their trips — all notions drawn from eastern spirituality.

Furthermore, the MDMA and psilocybin protocols both require post-trip therapy sessions to help patients integrate the insights gained in their altered states into their daily lives. Among other things, these sessions entail focused body work and instruction on how to reinforce newfound perspectives through practices like meditation and yoga.

Esketamine (in addition to ketamine), on the other hand, while administered in a certified medical office, is not accompanied by therapy. As a result, patients are not primed for their mind-altering experiences. Similarly, patients are not given any guidance on how to integrate the insights gleaned from their experiences into their lives. Within the psychedelic community, however, integration is thought to be an essential part of the psychedelic experience. As the thinking goes, psychedelics merely provide a glimpse of a path that may ultimately lead to self-love and healing. While discovering that such a path exists can, in and of itself, be an extremely uplifting and therapeutic experience, it is incumbent upon individuals to actually walk that path through daily practices such as yoga and meditation. Only then will true, lasting healing take place. Consequently, without integration, it’s unclear that esketamine, and ketamine treatments more generally, will bring individuals the sustained relief from their depression that they seek.

Finally, the esketamine protocol is completely devoid of any psychospiritual notions. This fact is unsurprising given that esketamine and its protocols are the products of the pharmaceutical industry (namely, Janssen, the pharmaceutical arm of Johnson & Johnson). The MDMA and psilocybin protocols, on the other hand, were designed by the non-profit organization, the Multidisciplinary Association for Psychedelic Studies (MAPS). The approval of esketamine therefore arguably marks Big Pharma’s first encroachments into psychedelic medicine and provides a preview of the future of psychedelic medicine if pharmaceutical companies are to take the reins.

The resulting separation of psychedelic medicine from its psycho-spiritual underpinnings would be a great shame indeed given that MAPS’s attempts to incorporate psycho-spirituality into mainstream medicine is arguably as revolutionary as the psychedelic medicines themselves. For too long, mainstream medicine has addressed only the physiological causes of ill health. However, it’s now being discovered (or rather, rediscovered) that there is much more to health (e.g., unaddressed trauma, social isolation, beliefs). The MAPS’s protocols and their attempts to treat the whole person is therefore a promising first step toward integrating a broader conception of health into mainstream medicine.

Advocates of psychedelic medicine, and holistic health more generally, must therefore safeguard the MAPS model as pharmaceutical companies move into the space. Such efforts will not only help preserve the efficacy of psychedelic treatments but also to infuse mainstream medicine with a more enlightened and effective view of health.

Written by

Jennifer Mara Gumer is an attorney, professor of bioethics and certified yoga and meditation teacher.

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