In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.
Category: Pharmaceuticals
Insurance Coverage for Psychedelic Therapy
By Vincent Joralemon
As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient.
These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedelic therapies, can help to inform coverage policies moving forward.
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.
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.
Thank Ketamine for the Telehealth Extension
By Vincent Joralemon
In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.
One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.
Psychedelic Lobbying and Regulatory Capture
By Vincent Joralemon
Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.
Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”
Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.
Bioethics, Psychedelic Therapy Abuse, and the Risk of Ethics Washing
By Tehseen Noorani and Neşe Devenot
Introduction
The academic discipline of bioethics is becoming a prominent arena for the discussion of ethics abuses in psychedelic therapy. With this being a relatively new topic of research for bioethics, it may be opportune to consider blind spots in the discipline’s own gaze and operations, which can otherwise hinder effective engagement with the issues at hand. We write in the wake of an extensive search by Gather Well Psychedelics, a psychedelic therapy training organization, to contract professional bioethicists to conduct an ethics audit of their organization. We ask, what challenges arise for bioethicists offering professional services when taking on commissions to work for organizations such as Gather Well that are emerging out of the psychedelic underground?
Psychedelic Inequities and Unexplored Risk: Colonization, Commercialization, and Regulation
By Tegan M. Carr
As a researcher studying the psychedelic experiences of people of color in hopes of driving equitable psychedelic health care, I’m concerned about the ways in which Black, Brown, and Indigenous contributions have been excluded in the development of the psychedelic field and investigation of novel psychedelic therapies. By excluding diverse contributions to the psychedelic field, we risk establishing psychedelic practices that exacerbate racial health inequities (disparities) in which people of color experience worse health outcomes as compared to whites on a population level. These patterns are already emerging in therapeutic psychedelic outcomes.
This piece identifies three interrelated topics that warrant scrutiny as drivers of psychedelic racial health inequities: the colonization of psychedelics, psychedelic commercialization & rent-seeking, and regulatory processes.
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.
Should a Psychedelic Therapist Be Able to Continue Therapy for Their Patients Beyond Formal Integration Sessions?
By Samuel Hatfield
Psilocybin and MDMA were recently rescheduled in Australia for clinical use, leading many mental health professionals to question how psychedelic therapy will work in practice. As part of a research team at the University of Sydney, I recently interviewed as number of experts in the field, with the aim of developing a comprehensive taxonomy of matters relating to psychedelic therapy that are or could be regulated. We also sought to identify where there was uncertainty or disagreement about the implementation of these matters. One point of contention was the provision of ongoing psychotherapy by the psychedelic therapist beyond the formal integration phase — which, given the vulnerability and suggestibility of patients undergoing psychedelic therapy, may give rise to important ethical considerations. With practitioners from a range of professions likely to act in the role of psychedelic therapist, this is an issue with cross-disciplinary relevance.