Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

The FDA Backdoor to MDMA Rescheduling

By Vincent Joralemon

MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.

A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.

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Businessman's hands typing on laptop keyboard in morning light

Sorry, You Probably Cannot Get MDMA Through Telehealth

By Vincent Joralemon

The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.” 

Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.

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Two hands exchanging a pill.

Let Go and Surrender: Considerations on MDMA Couples Therapy and Coercive Control

Note from Susannah Baruch, Petrie-Flom Center: Following this recent post in the Critical Psychedelic Studies symposium on the Bill of Health blog, two sets of researchers whose studies were described in the post expressed concerns that the post contained inaccuracies. As the Executive Director of the Petrie-Flom Center, which publishes Bill of Health, I made the decision to temporarily remove the original post to look at the issues carefully and to give the author and researchers more time and space for discussion. The original post is now back up [below] with an addendum from the author. My thanks to everyone involved for being helpful and patient while we gathered more information.

By Kayla Greenstien

From 2016 – 2022, I worked in client-facing community support work, focusing on domestic abuse and sexual assault. Throughout this time, I regularly witnessed how the mental health system struggled to respond to non-physical violence in the form of coercive control — an insidious form of abuse that involves intimidation, threats, and manipulation to restrict the autonomy of another person. On countless occasions, I saw coercive and controlling behavior entirely attributed to mental illness, resulting in missed opportunities and devastating injustices. Outside of work, I also started to notice how little of the content in my psychology coursework discussed domestic abuse. Little (if any) content focused on the psychology of people who engage in abuse and coercive control. Despite more open discourse on domestic abuse, it seemed like the mental health system was still deeply reticent to talk about power and control.  

At the same time, a new wave of research on psychedelic and MDMA therapy was underway. In 2021, I signed up for a psychedelic therapist training program, and the next year I started a PhD in Australia, studying the theoretical underpinnings of psychedelic therapies. I saw psychedelic therapy as a “paradigm shift” in mental health care. I wanted to believe psychedelics could get rid of the patriarchy, just like Ben Sessa said it did at raves in the 1980s. (Sessa is now facing medical practitioners’ tribunal in the U.K. for an alleged relationship with a patient.) But as I learned more about the theories and practices accompanying clinical trials of psychedelics and MDMA, I found misogyny, queerphobia, and alt-right New Age spirituality woven throughout. When multiple reports of sexual abuse emerged from underground, ceremonial, and clinical trial settings, I heard the same tropes that are used to discredit women in court: “It was a consensual relationship…She has BPD and manipulated him…This is all about a scorned woman seeking and revenge…”. Slowly, I started to see how historic and contemporary discussions on psychedelic and MDMA research largely ignored theories on power, control, and abusive interpersonal relationships, particularly in couples therapy.   

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Mushrooms, capsules, and dropper bottle.

Psychedelics Are Cheap. Psychedelic Treatment Is Not.

By Vincent Joralemon

Psychedelics hold immense potential to address an array of conditions that are otherwise challenging to treat, but accessing these therapies can be costly, which means that potential benefits will be stratified along the lines of socioeconomic status.

This is an acute concern, because many with conditions that psychedelics may help to treat — such as post-traumatic stress disorder, postpartum depression, treatment-resistant depression, and alcohol use disorder — lack the resources to pay for effective health treatments.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

What Macrodosing Can Learn from Microdosing

By Dustin Marlan

Following a recent wave of unbridled positivity culminating in a “shroom boom,” the psychedelic renaissance now finds itself under fire amidst concerns of predatory capitalism, cultural appropriation, adverse psychological effects, and sexual abuse and boundary issues by guides and therapists.

Nonetheless, the psychedelics industry is moving ahead at full speed. Oregon will begin accepting applications from businesses to run psilocybin service centers in January 2023. MDMA clinical trials are nearing completion and expected to result in FDA approval. And corporations are readying psychedelic compounds — natural and synthetic — to produce and deliver to the masses.

All of this begs the question of how psychedelics dosage should be regulated, particularly where, as journalist Shayla Love points out, “there’s reason to worry that there hasn’t been enough preparation for negative outcomes amidst the hype.”

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LSD Microdosing. Small or micro doses of LSD drug cut from a tab, presented on a finger.

A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

By Sarah Hashkes

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. This article will look at three main questions and ambiguities regarding the term “microdosing psychedelics” and suggest a definition that would help promote coherence in the field.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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