Medicine and Health Sciences Commons^™

Physician Assisted Dying: A Turning Point?, Lawrence O. Gostin, Anna E. Roberts

Georgetown Law Faculty Publications and Other Works

Physician Assisted Dying (PAD) has been lawful in some countries since the 1940s and in the United States since 1997. There is a body of social and scientific research that has focused on whether the practice has been misused and whether gaps exist in legislative safeguards. There are multiple concerns with physicians assisting patients to die: incompatibility with the physician’s role as a healer, devaluation of human life, coercion of vulnerable individuals (e.g., the poor and disabled), and the risk that PAD will be used beyond a narrow group of terminally ill individuals. Statutes in the United States have been …

Law, Ethics, And Public Health In The Vaccination Debates: Politics Of The Measles Outbreak, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The measles outbreak of early 2015 is symptomatic of a larger societal problem–the growing number of parents who decide against vaccinating their children. This failure is causing the resurgence of childhood diseases once eliminated from the United States.

This article explores the legal and ethical landscape of vaccine exemptions. While all states require childhood vaccinations, they differ significantly in the types of religious and/or philosophical exemptions permitted, the rigor of the application process, and available review mechanisms. States with relaxed exemption policies disproportionately experience more outbreaks of vaccine-preventable disease.

Vaccine exemptions are an illustration of the “tragedy of the commons,” …

Legal And Ethical Responsibilities Following Brain Death: The Mcmath And Muñoz Cases, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

What are the legal and ethical implications of continuing to treat a brain dead patient? And may a hospital refuse to provide such treatment? These ethical and legal problems are raised in two recent cases. In the first Marlise Muñoz, a pregnant woman declared brain dead, was kept on life support against her family’s wishes due to the treating hospital’s interpretation of a Texas fetal protection law. In the other a hospital refused to treat Jahi McMath, a brain dead girl, despite her family's entreaties. The cases, at first, appear similar because in each case the hospital was refusing to …

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …

Public Health Emergencies: What Counts?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccines and drugs to prevent and treat Ebola Virus Disease that have never been tested in humans, and in scarce supply raise profound ethical challenges. What if good evidence emerged demonstrating safety and efficacy of drugs? What would be an ethical method of allocating scarce beneficial resources? The apparent preference given to foreign aid workers over West Africans provoked a firestorm. In addition to discussing the ethical allocation of scarce drugs, this article also asks a more fundamental question: Why did it take nearly 40 years after the first Ebola outbreak in 1976 to launch clinical trials?

Tobacco Endgame Strategies: Challenges In Ethics And Law, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

There are complex legal and ethical tradeoffs involved in using intensified regulation to bring smoking prevalence to near-zero levels. The authors explore these tradeoffs through a lens of health justice, paying particular attention to the potential impact on vulnerable populations. The ethical tradeoffs explored include the charge that heavy regulation is paternalistic; the potentially regressive impact of heavily taxing a product consumed disproportionately by the poor; the simple loss of enjoyment to heavily addicted smokers; the health risks posed by, for example, regulating nicotine content in cigarettes—where doing so leads to increased consumption. Turning to legalistic concerns, the authors explore …

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

Ethical Challenges Of Preexposure Prophylaxis For Hiv, Jonathan S. Jay, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution …

Book Review: Social Justice: The Moral Foundations Of Public Health And Health Policy, Robin West

Georgetown Law Faculty Publications and Other Works

This essay is a review of Social Justice: The Moral Foundations of Public Health and Health Policy by Madison Powers & Ruth Faden (2006).

In this pathbreaking book, senior bioethicists Powers and Faden confront foundational issues about health and justice. How much inequality in health can a just society tolerate? In a world filled with inequalities in health and well-being, which inequalities matter most and are the most morally urgent to address? In order to answer these questions, Powers and Faden develop a unique theory of social justice that, while developed for the specific contexts of public health and health …

The Market For Medical Ethics, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

At the core of Kenneth Arrow’s classic 1963 essay on medical uncertainty is a claim that has failed to carry the day among economists. This claim—that physician adherence to an anti-competitive ethic of fidelity to patients and suppression of pecuniary influences on clinical judgment pushes medical markets toward social optimality—has won Arrow near-iconic status among medical ethicists (and many physicians). Yet conventional wisdom among health economists, including several participants in this symposium, holds that this claim is either naïve or outdated. Health economists admire Arrow’s article for its path-breaking analysis of market failures resulting from information asymmetry, uncertainty, and moral …

Dedicatory Essay: Honoring Ian Mccoll Kennedy, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Ian Kennedy is perhaps the best known and most important figure in health law and ethics in the United Kingdom, and probably one of the most significant in Europe and North America. How did his life and career evolve to the point where he would wield such influence? This essay examines the leadership, erudition, and passion Ian Kennedy has brought to the field of health law and ethics. It is perhaps not an overstatement to suggest that Professor Kennedy virtually invented the field in the United Kingdom. He did so through his scholarship, public advocacy, and influence in shaping institutions, …

Genetic Discrimination: The Use Of Genetically Based Diagnostic And Prognostic Tests By Employers And Insurers, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This paper analyzes the law, ethics and public policy concerning "genetic discrimination," defined as the denial of rights, privileges or opportunities on the basis of information obtained from genetically based diagnostic and prognostic tests. The Human Genome Initiative will enhance the ability to gather and organize information that may predict a person's future potential and disabilities. Enormous human benefits may ensue from understanding the etiology and pathophysiology of genetic disorders, including disease prevention through genetic counseling, and treatment of the disorders through genetic manipulation. This information will help clinicians understand and eventually treat many of the more than 4,000 diseases …

Ethical Principles For The Conduct Of Human Subject Research: Population-Based Research And Ethics, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This paper provides a halting first step in organizing a set of ethical guidelines for the conduct of population-based research, surveillance and practice. These principles are not distinct from, but an expansion of, traditional ethics. Research ethics, which matured significantly from the Nuremberg Code through to the Helsinki IV and the Council for International Organizations of Medical Sciences (CIOMS) guidelines, nourished the individual human spirit. Ethical principles should have a similarly profound impact in the development of science and the protection of human populations in the 1990s and beyond.

A Moment In Human Development: Legal Protection, Ethical Standards And Social Policy On The Selective Non-Treatment Of Handicapped Neonates, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Selective non-treatment decisions involving severely handicapped neonates have recently come under renewed judicial and legislative scrutiny. In this article, the author examines the legal, ethical and social considerations attendant to the non-treatment decision. In Part II he discusses the predominant ethical viewpoints relating to this issue and proposes a new moral standard based on personal interests. Part III presents a survey of the jurisprudence relating to selective non-treatment decisions. Parts IV and V of this article provide a critical examination of the recently enacted Child Abuse Amendments of 1984, a federal legislative initiative designed to regulate treatment decisions relating to …