Govind Persad

This article evaluates seven strategies for managing the high costs of GLP-1 receptor agonists (GLP-1RAs) like semaglutide and tirzepatide for weight management: complete exclusion of coverage, annual cost increase caps, lifetime cost caps, tiered access, formulary reevaluation, subscription payment models, and patent reform. The authors assess each strategy against three ethical objectives: benefiting people and preventing harm, showing equal moral concern, and mitigating disadvantage. Complete coverage exclusions, arbitrary reimbursement caps, and lifetime limits are deemed unethical as they fail to meet these objectives. Tiering access based on relative benefit is considered justifiable, though current implementation often unfairly favors diabetes over obesity treatment. The authors recommend formulary reevaluation as the most ethical approach for smaller health plans, allowing them to prioritize more cost-effective treatments. For larger payers with market power and for governments, subscription payment models and patent reforms are potentially ethical solutions if implemented sustainably. The authors conclude that health plans should avoid ad hoc restrictions on GLP-1RAs in favor of comprehensive policy reforms that ensure sustainable access to these and future breakthrough treatments.

This correspondence piece responds to commentaries on the authors' survey of U.S. bioethicists. The authors address two key questions: the definition of a bioethicist and how bioethics should evolve. They identify four distinct roles bioethicists occupy: researchers, pedagogues, consultants, and advocates/activists. The article examines various aspects of inclusiveness in bioethics - demographic, viewpoint, methodological, and topical - while acknowledging inherent tensions and trade-offs between them. For example, including religiously or geographically diverse voices may conflict with other inclusivity goals. The authors argue that while demographic inclusiveness is crucial, other forms of inclusiveness require careful consideration of trade-offs and empirical research to assess their impacts. They emphasize the need for systematic research on bioethicists' beliefs and reasoning, particularly regarding complex issues like disability and racial health disparities. The piece concludes by calling for continued dialogue and better funding for empirical research on ethical perspectives across different groups.

This commentary examines the role of sustainability in the latest draft of the WHO pandemic accord, highlighting its notable absence from the official list of guiding principles despite being mentioned frequently throughout the text. It argues that sustainability should be explicitly acknowledged as a core principle and given a clear definition tailored to pandemic preparedness, and proposes defining sustainability as ensuring that immediate emergency responses don't compromise future pandemic preparedness and response capabilities. Including sustainability as a guiding principle would serve two key purposes: validating the relevance of ethical principles in the accord's provisions and emphasizing the importance of long-term planning in pandemic preparedness. The commentary notes that while humans naturally discount future consequences, sustainable pandemic planning requires considering impacts beyond the next pandemic. It recommends coupling any reforms, such as intellectual property changes, with alternative innovation incentives to maintain a balanced approach to pandemic preparedness and response.

In our reply to critiques of our GLP-1 receptor agonist allocation framework, we explain that using potential years of life lost (PYLL) as a metric addresses racial health disparities without explicitly allocating resources based on race. This approach is "racism-conscious" and has legal and ethical challenges over race-based approaches. Meanwhile, though acknowledging the importance of cardiovascular risk assessment, we maintain in response to other interlocutors that focusing solely on immediate risk would ignore the broader goal of mitigating disadvantage. We emphasize that our framework balances multiple ethical objectives beyond just maximizing medical benefits.

This Viewpoint analyzes policies for covering GLP-1 receptor agonist drugs for obesity treatment across 13 high-income countries. It identifies four key lessons for developing coverage policies: 1) using up-to-date cost-effectiveness analyses that incorporate new evidence of benefits, 2) negotiating lower prices while preserving innovation incentives, 3) prioritizing coverage for specific populations rather than issuing blanket denials, and 4) treating obesity medications similarly to high-cost drugs for other conditions. It argues that blanket coverage denials are unethical and that countries should implement targeted coverage policies that maximize benefits while managing costs.

In response to a crisis, policymakers face the decision of whether to enumerate specific actions the public must do or, instead, to aim at an overall outcome while leaving room open for choice. This essay evaluates the merits and demerits of crisis response that leaves room open for choice, with a particular focus on pandemic response. I evaluate two approaches: trades and offsets. Trades allow individuals or groups to exchange protection against harm or entitlement to engage in risky activity. Offsets allow the same actors to pay to mitigate the effects of decisions that increase risk for others. Choice-friendly approaches can free people to better align their actions with their values, harness local knowledge for better social outcomes, and act as natural experiments. However, they also are subject to objections, including negative externalities, agency problems, exploitation, and exacerbating inequality.

Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists’ views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists’ normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists’ views do not align with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population—less diverse even than other academic disciplines—suggesting far more work needs to be done to build an inclusive field.

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, such as tirzepatide, have been found to be effective for treating obesity and diabetes, significantly reducing weight and the risk or predicted risk of adverse cardiovascular events. There is a global shortage of these medications that could last several years and raises questions about how limited supplies should be allocated. We propose a fair-allocation framework that enables evaluation of the ethics of current practices and could guide governments, professional societies, and physicians in allocation decisions.

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need (1). Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oral antiviral Paxlovid (2) Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend to disadvantage individuals with barriers in access to care (3). There is mounting evidence of racial, ethnic, and socioeconomic disparities in access to medications for COVID-19 (4, 5). One potential method to promote equitable allocation is to use a weighted lottery, which is an allocation strategy that gives all eligible patients a chance to receive the scarce treatment while also allowing the assignment of higher or lower chances according to other ethical considerations (6). We sought to assess the feasibility of implementing a weighted lottery to allocate scarce COVID-19 medications in a large U.S. health system and to determine whether the weighted lottery promotes equitable allocation

America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue that, to pass muster under current law, policymaking in this area must recognize a crucial distinction: prioritizing minority communities, such as hard-hit neighborhoods, without regard to individual race is typically legal, but prioritizing individuals on the basis of their racial identity faces is likely not. I also explain how prioritization on the basis of Native American status is allowable and legally distinct from prioritization on the basis of individual race. In Part II, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part III, I argue that randomly allocating scarce medical interventions, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part IV, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require focusing on factors other than race, or potentially considering race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part V, I examine two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in hard-hit occupations, potentially alongside race-sensitive aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in education, would narrow disparities without classifying individuals by race. The other strategy would address the starkly disparate racial impact of deaths early in life by limiting the use of age-based exclusions from vaccine or treatment access that explicitly deprioritize the prevention of early deaths and so disparately exclude minorities, and by considering policies that prioritize the prevention of early deaths.

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; and treating similar individuals similarly. Ethically and equitably marshalling available countermeasures requires articulating these fundamental objectives, identifying priority tiers, and recognising trade-offs between prioritising the people at the highest risk of infection and the people at the highest risk of harm if infected. These five values can provide guidance on preferable priority categories for a more ethically sound response and suggest methods for optimising allocation of countermeasures for mpox and other diseases for which countermeasures are in short supply. Properly marshalling available countermeasures will be crucial for future effective and equitable national responses to outbreaks.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

Objective: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. Summary of key data: The vast majority of drug development and repurposing during the COVID-19 pandemic – an event that has made clear the ever-present scarcity in healthcare systems –has been ignorant of scarcity and dose optimisation's ability to help address it. Conclusions: Future pandemic clinical trials systems should obtain dose optimisation data, as these appear necessary to enable appropriate scarce resource allocation according to societal values.

This Article examines whether policies—sometimes termed “vaccine mandates” or “vaccine requirements”— that consider vaccination status as a condition of employment, receipt of goods and services, or educational or other activity for participation are legally permitted, and whether such policies may even sometimes be legally required. It does so with particular reference to COVID-19 vaccines. Part I explains the legality of private actors, such as employers or private universities, considering vaccination status, and concludes that such consideration is almost always legally permissible unless foreclosed by specific state legislation. Part II examines the consideration of vaccination status by state or federal policy. It concludes that such consideration is similarly allowed at the state level unless expressly foreclosed, and is allowed at the federal level if appropriately supported by federal regulatory authority. Part III examines what may be a future front in these debates: whether policies considering vaccination status may be required rather than merely permitted, just as some courts have found that mask requirements may be federally required in certain circumstances.

Although policymakers and investigators still struggle to quantify and compare the effects of various Covid-related interventions, we are steadily amassing data that could help inform choices. The pandemic’s medical, social, and economic harms have been immense, and they warrant a continuous policy response. All decision makers use some type of mental model to weigh the pros and cons of various policy options. Rigorous economic evaluation formalizes this process. Value judgments will still be required, but economic evaluation can make the decision-making process more systematic, comprehensive, and transparent.

Reserve systems are a tool to allocate scarce resources when stakeholders do not have a single objective. This paper introduces some basic concepts about reserve systems for pandemic medical resource allocation. At the onset of the Covid-19 pandemic, we proposed that reserve systems can help practitioners arrive at compromises between competing stakeholders. More than a dozen states and local jurisdictions adopted reserve systems in initial phases of vaccine distribution. We highlight several design issues arising in some of these implementations. We also offer suggestions about ways practitioners can take advantage of the flexibility offered by reserve systems.

The allocation of scarce medical treatments, such as antivirals and antibody therapies for COVID-19 patients, has important legal dimensions. This Essay examines a currently debated issue: how will courts view the consideration of characteristics shielded by equal protection law, such as race, sex, age, health, and even vaccination status, in allocation? Part II explains the application of strict scrutiny to allocation criteria that consider individual race, which have been recently debated, and concludes that such criteria are unlikely to succeed under present Supreme Court precedent. Part III analyzes the use of sex-based therapy allocation criteria, which are also in current use, and argues that they also face substantial legal obstacles, despite only being subject to intermediate scrutiny. Parts IV and V examine the use of age and health status in allocation. Part VI discusses how the nascent law on “vaccination status” discrimination might apply to therapy allocation.

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research.

For much of 2021, allocating the scarce supply of Covid‐19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy‐five years of age as the only criterion to identify individuals at high risk of death from Covid‐19 during phase 1b, failing to recommend place‐based vaccine distribution, and implicitly endorsing first‐come, first‐served allocation. More rigorous empirical work and the development of a complete ethical framework that recognizes trade‐offs between principles may have prevented these mistakes and saved lives.

When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should, while others disagree. We offer a framework for evaluating when it is ethical and briefly discuss its legality in American law.

Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, and health policy discuss if age should guide rationing decisions.

The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), and equal access may compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods.

Through engagement with key informants and review of ethical theories applicable to refugee policy, this paper examines the ethical and policy considerations that policy-level stakeholders believe should factor into setting the refugee resettlement ceiling. We find that the ceiling traditionally has been influenced by policy goals, underlying values, and practical considerations. These factors map onto several ethical approaches to resettlement. There is significant alignment between U.S. policy interests and ethical obligations toward refugees. We argue that the refugee ceiling should be restored to historical norms, and that there exists a corresponding obligation to counter negative public perceptions about refugees and the costs of resettlement.