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Bioethics, Psychedelic Therapy Abuse, and the Risk of Ethics Washing

March 1, 2024February 27, 2024 The Petrie-Flom Center Staff Leave a comment

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?

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Food is Medicine Approaches to Address Diet-Related Health Conditions

February 28, 2024February 23, 2024 Hannah Rahim Leave a comment

By Hannah Rahim

Food is Medicine interventions aim to prevent and treat diet-related chronic health conditions and reduce food insecurity by providing food to individuals and communities, in connection with the health care system. While Food is Medicine has been gaining prominence in recent years, it has also received some criticism. This article will explore the development of Food is Medicine and its limitations, and briefly offer recommendations for successful Food is Medicine initiatives.

Are Embryos Children? The Alabama Supreme Court Says Yes

February 22, 2024February 22, 2024 Joelle Boxer Leave a comment

By Joelle Boxer

This month, the Alabama Supreme Court held that the term “children” in a state statute includes embryos, or “extrauterine children.”

As fertility treatments like in vitro fertilization (IVF) involve the creation of multiple embryos, not all of which are implanted, the implications of this ruling could be far-reaching. Four million births each year in the U.S. are via IVF, an important pathway to parenthood for couples with infertility, LGBTQ couples, and single parents.

This article will examine the Alabama Supreme Court’s decision in LePage v. Mobile Infirmary Clinic and its consequences for Americans building their families through fertility services.

The Beginning of a Bad TRIP – Alabama’s Embryonic Personhood Decision and Targeted Restrictions on IVF Provision

February 21, 2024February 22, 2024 kkraschel Leave a comment

By Katherine L. Kraschel

Last week, the Alabama Supreme Court called frozen embryos created via in vitro fertilization (IVF) “extrauterine children” and referred to the cryotanks where they are stored as “cryogenic nurser(ies).” The Court sided with couples who claim the accidental destruction of frozen embryos created through IVF and cryopreserved ought to be treated equally to the death of a child.

The case, LePage v. Center for Reproductive Medicine, involves plaintiffs seeking punitive damages from an Alabama fertility clinic for the “wrongful death” of their embryos that were destroyed when a patient in the hospital where they were stored removed them from the cryotank. While the lower Alabama Courts concluded that the cryopreserved embryos were not a person or child under the state’s law, the Alabama Supreme Court disagreed and held that the state’s Wrongful Death of a Minor Act “applies to all unborn children, regardless of their location,” and that the plaintiff’s wrongful death claims could proceed.

Thoughtful scholars have argued that existing state laws do not sufficiently redress mistakes and accidents that occur in the process of fertility care, pregnancy, and birth. However, the ends do not justify the means in this case; likening frozen embryos to children is not a legally sound mechanism to hold fertility clinics accountable for negligently storing embryos. It illustrates how sympathetic stories can be used to further the agendas of those who seek to equate embryos and fetuses to “people” under the law and undercut the critical role modern fertility care plays in (re)defining the bonds that create families, and particularly, many LGBTQ+ and single parent families.

Specifically, lawmaking in fertility care stands to fuel the movement to create fetal personhood rights and a federal abortion ban. It may also signify an inflection point in regulating assisted reproduction reminiscent of pre-Dobbs targeted restrictions on abortion provider (TRAP) laws that sought to limit abortion provision by imposing restrictions. TRAP laws’ new sibling – targeted restrictions on IVF Provision – or TRIP laws, as I call them, stand to rob patients of their ability to build their families by compelling physicians to provide less effective, more expensive care. TRIP laws will erect barriers and exacerbate long standing racial disparities in accessing fertility care, and they will disproportionately impact members of the LGBTQ+ community who wish to build families through fertility treatments. The Alabama decision is severe, but it should serve as a warning to state legislators with a new responsibility to safeguard reproductive health care without the floor of Roe’s protections – proceed with extreme care and regard for “unintended” consequences of regulating fertility care. Read More

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History Rhymes with the Psychedelic Boom

February 1, 2024January 29, 2024 The Petrie-Flom Center Staff Leave a comment

By David Herzberg

As a historian of psychoactive pharmaceuticals in the 20^th century U.S., I see history rhyming in potentially dangerous ways in the current psychedelic boom. After decades of being associated with insanity, violence, and social disorder, psychedelics are now being embraced as potential wonder drugs. What appears to be a radical, 180-degree shift in reputation, however, masks an underlying similarity: both of these mirror-image stories belong to the mythologies of the consumer culture, which attribute broad transformational power to individual acts of consumption. Seeing drugs through this mythological lens prevents us from accessing their potential benefits, while exposing us to the real possibility that they could make things worse.

Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype

January 29, 2024January 29, 2024 The Petrie-Flom Center Staff Leave a comment

By Neşe Devenot

Since the 2022 publication of “Preparing for the Bursting of the Psychedelic Hype Bubble,” a JAMA Psychiatry Viewpoint by David Yaden and colleagues, a wave of scholarship and commentaries has emphasized the ethical importance of nuanced science communication about the still-nascent field of psychedelic medicine.

AI, Copyright, and Open Science: Health Implications of the New York Times/OpenAI Lawsuit

January 24, 2024January 22, 2024 Adithi Iyer Leave a comment

By Adithi Iyer

The legal world is atwitter with the developing artificial intelligence (“AI”) copyright cage match between The New York Times and OpenAI. The Times filed its complaint in Manhattan Federal District Court on December 27 accusing OpenAI of unlawfully using its (copyrighted and paywalled) articles to train ChatGPT. OpenAI, in turn, published a sharply-worded response on January 8, claiming that its incorporation of the material for training purposes squarely constitutes fair use. This follows ongoing suits by authors against OpenAI on similar grounds, but the titanic scale of the Times-OpenAI dispute and its application of these issues to media in federal litigation makes it one to watch. While much of the buzz around the case has centered on its intellectual property and First Amendment implications, there may be implications for the health and biotech industries. Here’s a rundown of the major legal questions at play and the health-related stakes for a future decision.

Conclusion to the Symposium: From Principles to Practice: Human Rights and Public Health Emergencies

January 18, 2024January 18, 2024 The Petrie-Flom Center Staff Leave a comment

By Timothy Fish Hodgson, Roojin Habibi, and Alicia Ely Yamin

In developing the digital symposium, From Principles to Practice: Human Rights and Public Health Emergencies (which ran from October – December 2023), as editors we endeavored to get scholars, human rights advocates, judges, and policy makers to engage critically with the expert Principles and Guidelines on Human Rights and Public Health Emergencies (the PHE Principles), published by the International Commission of Jurists and the Global Health Law Consortium in May 2023. In doing so, we encouraged contributors to comment on the Principles’ potential usefulness as guidance in addressing real emergency situations, as well as any possible gaps and weaknesses.

While summarizing the entire content of the 13 blogs comprising this symposium in any depth is not possible here, this concluding post will attempt to synthesize some of the major inputs from the contributions. We also provide some of our own observations, as participants in the drafting of the Principles, with the aim of pushing the discussion prompted by the posts forward.

The NCAA May Pay a Healthy Sum to Student Athletes

January 8, 2024January 5, 2024 Bobby Stroup Leave a comment

By Bobby Stroup

Right now in a Los Angeles courtroom, the fate of the NCAA hangs in the balance. Perhaps as a way to preempt the outcome, on December 6, NCAA President Charlie Baker sent a letter proposing some schools should be allowed to compensate student athletes for using their name, image and likeness (NIL). President Baker is right to try and get ahead of the student-athlete compensation issue, but NIL payments are not the only issue at play. Health care will also be a critical part of future student-athlete compensation conversations.

The NCAA describes the compensation lawsuits as beginning in 2009, yet exploring this topic reveals the debate is not so novel. The NIL terminology is newer, but limiting this to an NIL problem is overly narrow. The challenge of student-athlete compensation is a broader issue that started at the founding of the organization. This issue is rooted in more than a century of health policy, and understanding that history is essential to understanding future NCAA negotiations.

Don’t Be Too Alarmed by the New SCOTUS Antibody Ruling

December 8, 2023December 8, 2023 Timothy Bonis Leave a comment

Amgen v. Sanofi is an important case, but it won’t transform patent law on its own.

By Timothy Bonis

Last April, the Supreme Court ruled in Amgen v. Sanofi, a closely watched patent case where the justices upheld the invalidation of two monoclonal antibody patents for lack of enablement. The ruling has attracted significant interest for two reasons.

First, Amgen involved genus claims in biological and chemical fields, which some experts believe the Federal Circuit has made unduly hard to obtain. This viewpoint, most prominently expressed by Mark Lemley, Sean Seymore, and Dmitry Karshtedt in The Death of The Genus Claim (2021), informed much of the debate about Amgen, although it has been challenged by scholars like Christopher Holman.

Second, Amgen dealt with monoclonal antibody patents, which now represent some of the most valuable intellectual property. (The global market for monoclonals in 2022 was $210B.) Moreover, the scope of antibody patent claims has been narrowed markedly by heightened standards for enablement and written description introduced over the past two decades; antibody inventors once received broad protection through functional claims, but the Patent and Trademark Office (PTO) has raised its requirements, partially in response to repeated invalidations of antibody genus claims at the Federal Circuit (see Chiron v. Genentech, 2004, Centocor v. Abbott, 2011, and AbbVie v. Janssen, 2014).

The decision in Amgen continues the trend of narrowing antibody patents and the perceived trend of limiting genus claims. Thus, how impactful Amgen will be on its own remains uncertain. Does it add new constraints to the patentability of antibodies, small molecules, and chemicals, or does it merely recapitulate the Federal Circuit’s previous rulings? This post reviews that debate. Part I examines how scholars and attorneys have reacted to Amgen, focusing on whether they think the case will have a legal and practical impact. Part II synthesizes these perspectives, arguing that Amgen’s direct impact will be limited. A companion piece summarizing the ruling’s significance for the industry and innovation will follow.

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