I. Glenn Cohen, The Regulatory Review The convergence of current psychedelics regulatory pathways may bring benefits and new challenges….
Essentials of Informed Consent to Psychedelic Medicine
Mason Marks, Rebecca W. Brendel, Carmel Shachar, I. Glenn Cohen, JAMA Psychiatry Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks…
The Project on Psychedelics Law and Regulation (POPLAR)
Ongoing Petrie-Flom Center The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is engaged in a three-year initiative to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics. Launched in summer 2021 with a generous grant from the Saisei Foundation, the Project on Psychedelics Law and Regulation (POPLAR) at the…
State-Regulated Psychedelics on a Collision Course With FDA
Mason Marks, JAMA Interest in researching and commercializing psychedelic medicines is growing. Substances such as psilocybin and 3,4-methylenedioxymethamphetamine show potential for treating conditions including depression and posttraumatic stress disorder. The Food and Drug Administration (FDA) may soon approve psychedelics for these and other indications….
From Entheogens to Evangelicalism: Spiritual Practices Among Hispanic/Latin Americans
Fernando Espi Forcen, Psychiatric Annals Hispanic, Latinx people practice spirituality in a wide array of forms. Whereas Catholicism has been the dominant religion for centuries, a re-birth of Native American, African spirituality has taken place over the last few decades. In parallel, the influence of the United States in the Latin world is reflected in…
Psychometric brahman, psychedelic science: Walter Stace, transnational Vedanta, and the Mystical Experience Questionnaire
Jeffrey Breau and Paul Gillis-Smith, Interdisciplinary Science Reviews The longstanding juncture between science and religion in psychedelic research is mediated most notably by the Mystical Experience Questionnaire (MEQ). The MEQ is a psychometric survey for assessing mystical experiences, and it relies on the work of philosopher Walter Stace for its typology and philosophy of mysticism….
How Should the FDA Evaluate Psychedelic Medicine?
Mason Marks and I. Glenn Cohen, New England Journal of Medicine Mounting clinical evidence could lead to the approval of new psychedelic medicines. The FDA’s draft guidance on psychedelics research includes several recommendations that may be contentious….
Race, ethnicity moderate the associations between lifetime psilocybin use, crime arrests
Grant Jones, Maha Al-Suwaidi, Franchesca Castro-Ramirez, Taylor C. McGuire, Patrick Mair, Matthew K. Nock; Frontiers in Psychiatry This study investigates how race, ethnicity moderate the associations between lifetime psilocybin use, crime arrests. Using data from the National Survey on Drug Use, Health (2002–2020) with 734,061 adults, it finds that race, ethnicity significantly moderate the associations…
Psychedelics, Related Pharmacotherapies as Integrative Medicine for Older Adults in Palliative Care
Kabir Nigam, Kimberly A. Curseen, Yvan Beaussant, Clinics in Geriatric Medicine This review article discusses the potential of psychedelics, related pharmacotherapies as integrative medicine for older adults in palliative care. It explores the use of these substances in addressing existential distress, serious illness, end-of-life care, highlighting the need for further research, consideration of psychedelic-assisted therapy…
Pressing regulatory challenges for psychedelic medicine
Amy L. McGuire, Holly Fernandez Lynch, Lewis A. Grossman,, I. Glenn Cohen; Science This article discusses the regulatory challenges faced in the development of psychedelic medicine. It highlights the growing interest, investment in psychedelic drug development, the complexities of applying traditional clinical trial, premarket approval processes to these substances. The article emphasizes the need for…