Psychedelic Therapy Scrutinized by FDA Advisory Committee?

Marks, Mason

doi:10.1001/jama.2024.13370

JAMA

2024

DOI: 10.1001/jama.2024.13370

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Psychedelic Therapy Scrutinized by FDA Advisory Committee?

Mason Marks

Abstract: This Viewpoint analyzes the Psychopharmacologic Drugs Advisory Committee’s decisions regarding 3,4-methylenedioxymethamphetamine–assisted therapy and what they mean for psychedelic research.

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2024

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The Birth of the Psychedelic Industry: Capitalising on the Psychedelic Renaissance

Yoo,

Sakopoulos

2024

Future Humanities

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The resurgence of psychedelic medicine, often termed ‘the psychedelic renaissance,’ marks a profound shift from decades of repressed research to a burgeoning field characterised by significant scientific, regulatory, and economic transformations. Once marginalised, psychedelics are now experiencing widespread interest and investment, spurred by changes in legal frameworks, public attitudes, and an influx of venture capital (VC). This article explores the interplay between scientific innovation and capital investment within the psychedelic sector, highlighting how private funding shapes the form of research and its financialization. The study investigates the roles of VC and private interests in driving the psychedelic renaissance, examining how these financial forces influence ethical considerations and broader socio‐political implications. Through in‐depth interviews with key stakeholders in the industry, including in‐house scientists and investors, the research uncovers how market‐driven imperatives and financial conflicts of interest shape both scientific practices and public perceptions of psychedelic medicine—and how these perceptions, in turn, influence the industry. The analysis underscores the tension between the idealistic and capitalist narratives surrounding psychedelic medicine, suggesting that the psychedelic industry reflects broader trends in biotech and pharmaceutical industries, where innovation is closely tied to financial investment and market dynamics. At the same time, it highlights the paradox of psychedelic mysticism, which remains elusive to the rigid criteria of evidence‐based medicine, thereby challenging the prevailing paradigm of psychopharmacological research. The findings call for a critical examination, through continuous public engagement, of the ethical dimensions of integrating psychedelics into mainstream medicine, highlighting the need to focus on the emergence of grey areas within capital networks where cultural and political values are constantly rearranged and restructured.

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The Birth of the Psychedelic Industry: Capitalising on the Psychedelic Renaissance

Yoo,

Sakopoulos

2024

Future Humanities

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A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Roseman

2024

J Psychopharmacol

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The recent rejection of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy by the U.S. Food and Drug Administration (FDA) is a dramatic moment in the re-emergence of psychedelic research. In this perspective, I argue that it represents a case study for paradigmatic tensions within psychopharmacology. The regulatory system is still influenced by a paradigm that sees the therapeutic effects of drugs as primarily biological, and context is noise to control for. An emergent paradigm considers the therapeutic effects of drugs as interactive with context. Psychedelics are the anomaly that questions the dominant paradigm, mainly due to the determination of psychedelic researchers that the medicines are drugs with psychotherapy. While some of the critique offered by the FDA towards MAPS/Lykos’s studies is crucial, much of it is related to the experiential and psychotherapeutic elements – which the FDA claims not to regulate. This leads to some paradoxes within the regulatory procedure, which hint at a need for a shift in how psychedelic-assisted therapy is regulated and researched. Both regulators and researchers will need to find ways to accommodate each other in service of a successful integration of a new paradigm in which drugs and psychotherapy interact.

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Expert recommendations for Germany’s integration of psychedelic-assisted therapy

Perez Rosal,

La Torre,

Birnkammer

et al. 2024

BMC Med Educ

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As clinical trials for psychedelics move into phase III in the USA, Europe must address its lag in integrating professional education around psychedelic-assisted therapy (PAT) and supporting psychedelic drug research. This paper evaluates the necessary frameworks for implementing PAT in Germany, emphasizing the nation’s potential leadership role within the European Union. With Australia having already approved MDMA and psilocybin for mental health indications, the Ukrainian government exploring MDMA treatment for war-related PTSD, and initial clinical trials involving MDMA and LSD with patients in Switzerland which restarted the restricted medical use of these substances around 2014, the medical authorization of psychedelics in these countries establishes precedent showcasing both the promise and challenges of researching and implementing PAT in nations where the substances were formally scheduled as illicit substances. Key challenges include establishing rigorous standards for practitioner training, accessibility, and defining regulatory oversight. This paper focuses on the development of robust infrastructure in Germany, which will support the roll out of PAT, and details ethical considerations, training protocols, and governmental roles in the formulation of treatment frameworks. This approach aims not only to guide Germany in adopting PAT but also to influence broader European policy, ensuring that patients receive ethically sound and proficient care. The findings suggest pathways for Europe to reclaim its historical lead in psychiatric and therapeutic innovation. Supplementary Information The online version contains supplementary material available at 10.1186/s12909-024-06141-3.

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Psychedelic Therapy Scrutinized by FDA Advisory Committee?

Abstract: This Viewpoint analyzes the Psychopharmacologic Drugs Advisory Committee’s decisions regarding 3,4-methylenedioxymethamphetamine–assisted therapy and what they mean for psychedelic research.

Cited by 3 publications

References 7 publications

The Birth of the Psychedelic Industry: Capitalising on the Psychedelic Renaissance

The Birth of the Psychedelic Industry: Capitalising on the Psychedelic Renaissance

A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Expert recommendations for Germany’s integration of psychedelic-assisted therapy

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