Volume 20, Issue 8, August 2020, Page 72-75.

The coronavirus disease-2019 (COVID-19) has caused shortages of life-sustaining medical resources, and future waves of the virus may cause further scarcity. The Yale New Haven Health System developed a triage protocol to allocate scarce medical resources during the COVID-19 pandemic, with the primary goal of saving the most lives possible, and a secondary goal of making triage assessments and decisions consistent, transparent, and fair. We outline the process of developing the protocol, summarize the protocol, and discuss the major ethical challenges (...) encountered, along with our answers to the challenges. These challenges include (1) the role of age and chronic comorbidities; (2) evaluating children and pregnant patients; (3) racial, ethnic, and socioeconomic disparities in health; (4) prioritization of healthcare workers; and (5) balancing clinical judgment versus protocolized assessments.We conclude with a review of the limitations of our protocol and the lessons learned. We hope that a robust public discussion of such protocols and the ethical challenges they raise will result in the fairest possible processes, less need for triage, and more lives saved during future waves of the pandemic and similar public health emergencies. (shrink)

We agree with Nielsen Busch and Mjaaland’s (2023) assessment that the Dead Donor Rule (DDR) should be viewed as an essential requirement of the organ donation process, and that the essence of the r...

This article offers some general criticisms of the idea that any political theory can legitimate public health interventions, and then some particular criticisms of Civic Republicanism as a political theory for public health. Civic Republicanism, I argue, legitimizes liberty-infringing public health interventions by demanding high levels of civic engagement in framing and reviewing them; to demand such engagement in pursuit of such a baseline value as health will leave insufficient civic energy for the pursuit of higher values.

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

We share Nair-Collins and Joffe's (2023) concern with the accuracy of the “whole brain-death” diagnosis, which fails to take into account current understandings of residual brain function (neurohor...

Volume 20, Issue 10, October 2020, Page 39-41.

Friesen et al. (2023) article explores tensions within institutional review boards (IRBs) when they aim both to protect participants from harm and to include under-represented populations in clinic...

We welcome and applaud Wilkinson’s impressive and subtle exploration of the possible considerations of frailty as a criterion for triage in times of pandemic-dr...

Every country's law permits medical experimentation on animals. While some countries protect particular kinds of animals from being subject to experimentation—notably great apes and endangered species—very few place concrete limitations on what researchers may cause animals to suffer, given sufficient scientific justification. What laws do, instead, is establish standards for the humane treatment and housing of animals in labs, and they encourage researchers to limit or seek alternatives to the use of animals, when doing that is consistent with the scientific (...) goals of their research.The system that has evolved in the United States combines elements of sometimes competing regulatory philosophies. The result is a complex, multilayered system that addresses the most important concerns, but, partly because of historical accident, also leaves some gaps. Even proponents of medical research on animals can see obvious ways in which the regulatory structure could be changed to benefit animals. Perhaps more important, though, is the fact that the existing regulatory structure, imperfect though it may be, is elastic enough to accommodate substantial changes that could reduce unnecessary animal suffering. (shrink)

The question of whether the normative testimony of ethics experts should be admissible under the rules of evidence has been the subject of much debate. Professor Imwinkelried's paper is an effort to get us, for a moment, to change that subject. He seeks to turn our attention, instead, to a means by which bioethics experts’ normative analyses might come before the court without regard to the rules of evidence - a means lying formally outside those rules’ jurisdiction. The court, he (...) argues, may freely consider evidence from expert bioethicists so long as it is performing a legislative rather than an adjudicative function. The rules of evidence apply to the court's efforts to find the facts of a particular case, Imwinkelried argues, but they do not constrain the court's investigations relative to its creative law-making efforts. (shrink)

The question of whether the normative testimony of ethics experts should be admissible under the rules of evidence has been the subject of much debate. Professor Imwinkelried's paper is an effort to get us, for a moment, to change that subject. He seeks to turn our attention, instead, to a means by which bioethics experts’ normative analyses might come before the court without regard to the rules of evidence - a means lying formally outside those rules’ jurisdiction. The court, he (...) argues, may freely consider evidence from expert bioethicists so long as it is performing a legislative rather than an adjudicative function. The rules of evidence apply to the court's efforts to find the facts of a particular case, Imwinkelried argues, but they do not constrain the court's investigations relative to its creative law-making efforts. (shrink)

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking (...) framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal. (shrink)

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

The U.S. Supreme Court has likely already decided how much, if any, of President Obama's signature Affordable Care Act it is going to strike down as unconstitutional; its holding will be published this summer. No matter what the Court decides, though, it will send state and federal legislators scrambling—either to implement the law or to deal with the consequences of its alteration. There are various decisions the Court might make, but it is still most apt either to leave the ACA (...) standing, or to selectively invalidate some of its mandate‐related provisions. In either case, there will be exchanges to design and manage, subsidies to allocate, transparency standards to design and enforce. The Court's decision will thus mark the beginning, not the end, of health reform. (shrink)

Three states—Oregon, Washington, and Vermont—have used straightforwardly democratic means to legalize the practice formerly known as “physician‐assisted suicide” but now termed “aid‐in‐dying.” In two states—Montana and New Mexico—aid‐in‐dying has been declared legal neither by directly democratic action by citizens nor by representatively democratic action by the legislature but by court rulings in cases brought by aid‐in‐dying activists. The court case in New Mexico (Morris v. New Mexico, 2014) is undoubtedly of greater significance to the rest of the states. The Morris (...) opinion is as interesting for what it declined to hold as for what it held. (shrink)

Ethicists and physicians all over the world have been working on triage protocols to plan for the possibility that the Covid‐19 pandemic will result in shortages of intensive care unit beds, ventilators, blood products, or medications. In reflecting on those protocols, many health care workers have noticed that, outside the pandemic shortage situation, we routinely supply patients in the ICU with invasive and painful care that will not help the patients survive even their hospitalization. This is the kind of pointless (...) care that even the most basic protocol would triage against. Perhaps this widespread reflection on triage standards will draw our attention to our ongoing custom of supplying burdensome and inefficacious care to those near the end of life—care that most health care providers would not want for themselves. This essay argues that reflecting on triage could help us improve end‐of‐life care. (shrink)

For the past few years I've had the distinct privilege to edit the Hastings Center Report's Policy & Politics column. The column—as indicated by a little block of text at its end—was originally conceived as, and remains, a joint production of HCR and the American Society for Bioethics and Humanities. For me, as column editor, this means that I can accept contributions only from ASBH members. Luckily this presents me with an extremely large pool of talent from which to draw! (...) I am very proud of the fact that a large majority of contributors to the column in the last several years had never written in HCR before I invited them to contribute. But naturally, I don't know everyone, and I can't keep track of everything. I'd love to get even more unsolicited offers of P&P contributions than I already enjoy. (shrink)

In bioethics as in other areas of health policy, historical institutional factors can shape policy independently of interests or public opinion. This article finds policy divergence among countries with similar national moral views of stem cell research, and explains that divergence as the product of path-dependency.

My aim in this paper is simply to show that, in bioethics no less than in other areas of health care, policy in democracies is shaped not only by principles and values, but also — and to some extent independently — by the shape and history of particular political institutions and past policies. “Path dependency,” or what one scholar has called the “accidental logics” of already-existing institutions, condition and guide national policy choices. These institutional and historical pressures can even create (...) substantial policy divergences between quite likeminded nations. I shall illustrate the point using some comparative data about national policies regarding research on human embryonic stem cells. The fact that gaps can develop between values and policies is readily visible to anyone who compares national stemcell research policies to the expressed attitudes of the citizens of various democratic countries regarding human embryonic stem-cell research. The role of path dependency and the accidental logics of institutional structure in creating those gaps can be illustrated by tracking down the details of the development of human embryonic stem cell policies in a few different countries. (shrink)

The prelims comprise: Introduction: The Moral Arbitrariness of Health Status Justice as a Social Virtue Libertarian and Conservative Arguments Utilitarian Approaches to Justice in Health Care Finance Rawls' s Theory of Justice Justice and the Social Determinants of Health The Capabilities Approach International Justice and Health Conclusion References.

These are hard days for globalism. A major candidate for the United States presidency ran on an anti-immigration, anti-free-trade platform and denounced such venerable international institutions as the North Atlantic Treaty Organization and the United Nations. The European Union is under threat after the vote for Brexit; the Euro is under strain. China is denouncing and ignoring the result of an international arbitration over its claims to the South China Sea. Nationalist, xenophobic political parties are in the ascendency around the (...) world, buoyed by the fears and pains of populations for whom global trade has been no boon and to whom waves of new immigrants seem threatening both economically and socially. So it is both strange and uplifting, in this atmosphere, to encounter the ambitious and enthusiastic globalism of Lawrence Gostin's important, field-founding work, Global Health Law. Equal parts encyclopedia and manifesto, the book seeks both to provide exhaustive and up-to-date descriptions of the already-substantial body of international health law and of its implementing institutions and to chart Gostin's vision for their vigorous expansion. And that vision is nothing if not expansive. (shrink)

Volume 20, Issue 8, August 2020, Page 23-25.

In the United States, while it is legal for physicians to prescribe drugs for “off-label” indications (uses for which the drugs do not have Food and Drug Administration approval), it is largely—though not entirely—illegal for drug manufacturers to promote off-label uses of their drugs to physicians. In recent months, the rules against off-label marketing have been rigorously enforced: in October, Allergan reached a $375 million settlement over off-label promotion of Botox; in September, Novartis settled an off-label marketing dispute for $422.5 (...) million, and Forest Laboratories settled one for $313 million. These were only the latest in a series of criminal and civil settlements on off-label promotion, the most .. (shrink)

On the fourth day of his presidency, Donald Trump reinstated and greatly expanded the “Mexico City policy,” which imposes antiabortion restrictions on U.S. foreign health aid. In general, the policy has prohibited U.S. funding of any family-planning groups that use even non-U.S. funds to perform abortions; prohibited aid recipients from lobbying for liberalization of abortion laws; prohibited nongovernment organizations from creating educational materials on abortion as a family-planning method; and prohibited health workers from referring patients for legal abortions in any (...) cases other than rape, incest, or to save the life of the mother. The policy's prohibition on giving aid to any organization that performs abortions is aimed at limiting alleged indirect funding of abortions. The argument is that if U.S. money is used to fund nonabortion programs of an abortion-providing NGO, then the NGO can simply shift the money thus saved into its abortion budget. Outside the context of abortion, we do not reason this way. And the policy's remaining three prohibitions are deeply troubling. (shrink)

A response to “Normalizing Aid-in-Dying within the Practice of Medicine,” by Kathryn L. Tucker.

Reply to a commentary by Timothy F. Murphy.

The United Kingdom's coalition government has just begun the most sweeping overhaul of the National Health Service since its inception.1 Under the reforms, 80 percent of the NHS budget will be handed over to about five hundred local consortia of primary care physicians, who will be empowered to make medical spending and allocation decisions for their patients. The 152 existing Primary Care Trusts (PCTs), which purchase hospital and community care for patients and oversee primary care physicians in their regions, will (...) close their doors, leaving local doctors with the power to decide which interventions are appropriate, and which too expensive.2 Hospitals and community service providers will have greater freedom .. (shrink)

We punish people who recklessly or deliberately expose others to HIV? Why not try to force HIV-positive individuals to disclose their.

The United Kingdom is partway through a multiyear process of revising its law on surrogacy, both traditional and gestational. In October of 2019, the Law Commission of England and Wales and the Scottish Law Commission—statutorily created independent bodies charged with keeping the law under review and recommending reforms whenever necessary—completed a public consultation on surrogacy. In June, the commissions published an extensive consultation paper laying out the case for surrogacy reform and making tentative recommendations about how revision should proceed. The (...) commissions are now digesting the public's responses, and they aim to have a final report on their proposed revisions of the law and a draft bill for consideration by Parliament in 2021. The foundation of current U.K. surrogacy law was laid in the Surrogacy Arrangements Act of 1985. There are numerous problems with the existing regime. (shrink)

Hastings Center Report, Volume 52, Issue 5, Page 4-5, September–October 2022.

Early in 2018, the Trump administration's Centers for Medicare and Medicaid Services issued a guidance letter outlining a new and controversial kind of Medicaid waiver proposal. The administration invited states to propose waivers that would impose work (or other “community engagement”) requirements as a condition of eligibility for Medicaid. The Trump administration and state proponents of work requirements want to force able‐bodied Medicaid beneficiaries into the workplace. Critics allege that this is because they mistakenly believe that low‐income individuals are not (...) working because they're lazy or because aid programs provide them with a disincentive to work. Proponents respond that the requirements can lower the public programs' costs while helping its recipients. Medicaid data seems to show that the work‐requirement proposals are a solution in search of a real‐life problem. (shrink)

Fox’s update of her pivotal 2007 study on ethics consultations in U.S. hospitals found that the gap in ethics consultations is widening between large teaching hospitals and small community hospital...

The American Journal of Bioethics, Volume 11, Issue 10, Page 36-37, October 2011.