figurine with a void shape of a child and family of parents with a child. Surrogacy concept.

Regulating International Commercial Surrogacy

By Hannah Rahim

In January 2024, Pope Francis called for a universal ban on surrogacy as a threat to global peace and human dignity, claiming that the practice is a “grave violation” of the mother and child’s dignity and based on the “exploitation of situations of the mother’s material needs.” Surrogacy raises complex ethical and legal issues, particularly in cases of international surrogacy, where people seek surrogacy services from another country. There is currently no regulation of international surrogacy. Creating such regulation is important to allow appropriate access to surrogacy services while mitigating its harmful consequences.

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rendering of luminous DNA with gene being removed with forceps.

Designer Babies? The Ethical and Regulatory Implications of Polygenic Embryo Screening

By Hannah Rahim

New technologies are increasing the accessibility of polygenic embryo screening, which can assess the likelihood of an embryo developing polygenic diseases (e.g., diabetes, schizophrenia) or provide insight into certain polygenic traits (e.g., height, intelligence). This procedure has many complex clinical, social, and ethical implications, but is currently unregulated in the U.S.

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Doctor working with modern computer interface.

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.

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Yellow folder file with magnifying glass.

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?

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Culturing cells in tissue culture plates.

R&D Mini-Me? New Legal Questions for Organoids

By Adithi Iyer

I have written previously about the not-so-distant possibility and promise of regenerative medicine, an area concerned with therapies that encourage the body to repair or heal itself. Cell-mediated and tissue-based technologies hold promise in inducing self-repair from within the body, and they’re making their way to market in traditional medicine. Much has been made of recently discussed CAR-T cell therapies for cancer, which have been around since 2017, and in-human sickle cell treatment Casgevy. Such applications of regenerative medicine and tissue engineering are wide-spanning and range across the bench-to-bedside pathway.

One application of regenerative medicine gaining some ground in the R&D space is the organoid. Organoids are lab-grown masses of cells and tissue that assemble to form miniature organs or organ systems in vitro. They come, too, in different forms and types, and while some organoid applications are heavily modified for specific functions, many are meant to recreate and model the naturally occurring organ systems we would find in our own bodies.

Organoids may sound especially futuristic, but are currently used regularly in labs for different research and therapeutic applications. A functional “organ” model not attached to a human body could offer the opportunity to model diseases and test treatments in real time without the need for an animal model (like the mice used today), especially in preclinical and early clinical trials for new drugs. Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. The production of these models occurs in-lab, often involving stem cells that can divide and organize into tissues and organs on their own.

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Colorful lottery balls in a rotating bingo machine.

Applying Luck Egalitarianism to Health Resource Allocation

By Hannah Rahim

Luck egalitarianism is a theory of political philosophy that provides that inequalities resulting from an individual’s informed choices are just and need not be reduced, whereas inequalities resulting from circumstances over which an individual has no control are unjust and should be reduced. The application of luck egalitarianism to health inequalities has some value when allocating health care resources, but it often conceptualizes health too narrowly and risks exacerbating existing unjust disparities. If luck egalitarianism is to be applied in developing health care policy, it must only be used in clearly defined circumstances and with a holistic approach.

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Judicial Court Files And Judge Gavel.

When the Law of Scientific Evidence Collides with Medical Practice

By Barbara Pfeffer Billauer

Approaches to resolving scientific evidentiary issues continue to diverge throughout the country.[1] A prominent recent example includes the rejection of the medical diagnosis of Shaken Baby Syndrome (SBS) to reflect disparate views in the scientific, medical, and legal communities.

Under guise of making a scientific evidentiary ruling, a New Jersey court has just dismembered the medical diagnosis of SBS, with the judge disavowing the condition’s validity. The decision concerned two babies, both under one year old, who suffered devastating neurological injuries while under the care of their fathers.

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Doctor asking patient to fill out survey before medical treatment.

Key Considerations for Patient-Reported Outcome Measures

By Sharona Hoffman

Patient-reported outcome measures (PROMs) are questionnaires that patients fill out on tablets or other computers or devices. They ask patients to check boxes in answer to questions about their symptoms, treatment effects, and ability to function physically, emotionally, and socially. They thus may solicit very sensitive information about matters such as anxiety, depression, and sexual satisfaction. To illustrate, a query might be “in the past month, how often did you have a lot of trouble falling asleep,” and the patient is asked to check “never,” “rarely,” “sometimes,” “often,” or “always.”

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. For example, insurers hypothetically could decide to decline coverage of particular treatments based on PROM responses indicating that many patients find them to be unhelpful.

I first became interested in patient-reported outcome measures because of an experience my husband had. Andy has Parkinson’s disease, and one of the neurologists he saw asked him to fill out a long questionnaire on a tablet computer before each appointment. This task was difficult for Andy because he had a hand tremor, and it was stressful because Andy worried that he would not have time to complete the survey before his appointment began. Moreover, Andy’s physician never referred to his responses and appeared never to look at them. Upon investigation, I found little to no analysis of PROMs in the legal literature, so Andy and I recently published a law review article about them.

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