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233Fair allocation of scarce therapies for COVID-19Clinical Infectious Diseases 18. 2021.The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and…Read more
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266Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal IssuesPediatrics 2021. 2021.We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.
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373Against Exclusive Survivalism: Preventing Lost Life and Protecting the Disadvantaged in Resource AllocationHastings Center Report 51 (5): 47-51. 2021.When life-saving medical resources are scarce and not everyone can be saved, is the only relevant goal saving the most lives? Or can other factors be considered, at least as tiebreakers, such as how early in life the people we don't save will die or how much future life they are likely to lose? This commentary defends a multiprinciple allocation approach that considers objectives in addition to saving more lives, including preventing early death and preventing harm in the form of lost future lif…Read more
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4Expensive Patients, Reinsurance, and the Future of Health Care ReformEmory Law Journal 69. 2019.In 2017, Americans spent over $3.4 trillion-nearly 18% of gross domestic poduct-on health care. This spending is unevenly distributed: Almost a quarter is spent on the costliest 1% of patients, and almost half on the costliest 5%. Most of these patients soon return to a lower percentile, but many continue to incur health care costs in the top percentiles year after year. This Article focuses on the challenges that persistently expensive patients present for health law and policy, and how fairly …Read more
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28Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in CaliforniaAmerican Journal of Public Health 1 (1). 2021.California has focused on health equity in the state’s COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California’s 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier’s test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 …Read more
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319Improving the Ethical Review of Health Policy and Systems Research: Some SuggestionsJournal of Law, Medicine and Ethics 49 (1): 123-125. 2021.Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area
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38Prioritizing the Prevention of Early Deaths during Covid‐19Hastings Center Report 51 (2): 42-43. 2021.In this Correspondence, I argue that given that scarcity has existed both for critical care resources and for vaccines, allocating critical care resources to prioritize the prevention of early COVID-19 deaths (i.e. COVID-19 deaths among younger patients) could valuably counterbalance the disproportionate exclusion of minority patients and those with life shortening disabilities that age-based vaccine allocation produces. Covid-19 deaths early in life have overwhelmingly befallen minorities and p…Read more
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33Public Perspectives on COVID-19 Vaccine PrioritizationJAMA Network Open 4 (4). 2021.In this survey study of 4735 US adults, respondents of all demographic and political affiliations agreed with prioritizing COVID-19 vaccine access for health care workers, adults of any age with serious comorbid conditions, frontline workers (eg, teachers and grocery workers), and Black, Hispanic, Native American, and other communities that have been disproportionately affected by COVID-19. Older adult respondents were less likely than younger respondents to list healthy people older than 65 yea…Read more
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47Allocating scarce life-saving resources: the proper role of ageJournal of Medical Ethics 47 (12): 836-838. 2021.The COVID-19 pandemic has forced clinicians, policy-makers and the public to wrestle with stark choices about who should receive potentially life-saving interventions such as ventilators, ICU beds and dialysis machines if demand overwhelms capacity. Many allocation schemes face the question of whether to consider age. We offer two underdiscussed arguments for prioritising younger patients in allocation policies, which are grounded in prudence and fairness rather than purely in maximising benefit…Read more
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38Sustainability, equal treatment, and temporal neutralityJournal of Medical Ethics 47 (2): 106-107. 2021.Addressing distributive justice issues in health policy—ranging from the allocation of health system funding to the allocation of scarce COVID-19 interventions like intensive care unit beds and vaccines—involves the application of ethical principles. Should a principle of sustainability be among them? I suggest that while the value of temporal neutrality underlying such a principle is compelling, it is already implicit in the more basic principle of equal treatment. Munthe et al imagine sustaina…Read more
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85Fairly Prioritizing Groups for Access to COVID-19 VaccinesJAMA 1 (16). 2020.Initial vaccine allocations for the coronavirus disease 2019 (COVID-19) will be limited. It is crucial to assess the ethical values associated with different methods of allocation, as well as important scientific and practical questions. This Viewpoint identifies three ethical values, benefiting people and limiting harm; prioritizing disadvantaged populations; and equal concern for all. It then explains why these values support prioritizing three groups: health care workers; other essential work…Read more
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1834An ethical framework for global vaccine allocationScience 1. 2020.In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, s…Read more
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360Setting priorities fairly in response to Covid-19: identifying overlapping consensus and reasonable disagreementJournal of Law and the Biosciences 1 (1). 2020.Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of fir…Read more
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45Disability Law and the Case for Evidence-Based Triage in a PandemicYale Law Journal Forum 130 26-50. 2020.This Essay explains why model policies proposed or adopted in response to the COVID-19 pandemic that allocate scarce medical resources by using medical evidence to pursue two core goals—saving more lives and saving more years of life—are compatible and consonant with disability law. Disability law, properly understood, permits considering medical evidence about patients’ probability of surviving treatment and the quantity of scarce treatments they will likely use. It also permits prioritizing he…Read more
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576Advance Directives and Transformative Experience: Resilience in the Face of ChangeAmerican Journal of Bioethics 20 (8): 69-71. 2020.In this commentary, I critique three aspects of Emily Walsh's proposal to reduce the moral and legal weight of advance directives: (1) the ambiguity of its initial thesis, (2) its views about the ethics and legality of clinical practice, and (3) its interpretation and application of Ronald Dworkin’s account of advance directives and L.A. Paul's view on transformative experience. I also consider what Walsh’s proposal would mean for people facing the prospect of dementia. I conclude that our reaso…Read more
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92A Conceptual Framework for Clearer Ethical Discussions About COVID-19 ResponseAmerican Journal of Bioethics 20 (7): 98-101. 2020.In this Commentary, I propose an ethical framework for ethical discussions around the allocation of scarce resources in COVID-19 response. The framework incorporates four principles: beneficence (benefiting people by saving lives or years of life), equality, remedying disadvantage, and recognizing past conduct. I then discuss how the framework interacts with ethical constraints against using people as a mere means and against causing death. The commentary closes by criticizing the equation of de…Read more
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51Respecting Disability Rights — Toward Improved Crisis Standards of CareNew England Journal of Medicine (5). 2020.We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expecta…Read more
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33Eliminating Categorical Exclusion Criteria in Crisis Standards of Care FrameworksAmerican Journal of Bioethics 20 (7): 28-36. 2020.During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by “crisis standards of care,” but they have key differences. We critically appraise one of the most fundamental differences among policies, …Read more
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72The Ethics of COVID-19 Immunity-Based Licenses (“Immunity Passports”)Journal of the American Medical Association. 2020.Certifications of immunity are sometimes called “immunity passports” but are better conceptualized as immunity-based licenses. Such policies raise important questions about fairness, stigma, and counterproductive incentives but could also further individual freedom and improve public health. Immunity licenses should not be evaluated against a baseline of normalcy, ie, uninfected free movement. Rather, they should be compared to the alternatives of enforcing strict public health restrictions for…Read more
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224Fair Allocation of Scarce Medical Resources in the Time of Covid-19New England Journal of Medicine 45. 2020.Four ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all Covid-19 and non–Covid-19 patients.
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549Cost-Effectiveness in Animal Health: An Ethical AnalysisIn Bob Fischer (ed.), Routledge Handbook of Animal Ethics, Routledge. 2019.This chapter evaluates the ethical issues that using cost-effectiveness considerations to set animal health priorities might present, and its conclusions are cautiously optimistic. While using cost-effectiveness calculations in animal health is not without ethical pitfalls, these calculations offer a pathway toward more rigorous priority-setting efforts that allow money spent on animal well-being to do more good. Although assessing quality of life for animals may be more challenging than in huma…Read more
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513The Case for Valuing Non-Health and Indirect BenefitsIn Ole F. Norheim, Ezekiel J. Emanuel & Joseph Millum (eds.), Global Health Priority-Setting: Beyond Cost-Effectiveness, Oxford University Press. pp. 207-222. 2019.Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health …Read more
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38Are Medicaid Closed Formularies Unethical? Social Values and Limit-SettingAMA Journal of Ethics 21 (8). 2019.State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor pa…Read more
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47Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global HealthYale Journal of Health Policy, Law, and Ethics 18 157-90. 2019.Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, th…Read more
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1023Considering Quality of Life while Repudiating Disability Injustice: A Pathways Approach to Setting PrioritiesJournal of Law, Medicine and Ethics 47 (2): 294-303. 2019.This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cas…Read more
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331Sufficiency, Comprehensiveness of Health Care Coverage, and Cost-Sharing Arrangements in the Realpolitik of Health PolicyIn Carina Fourie & Annette Rid (eds.), What is Enough?: Sufficiency, Justice, and Health, Oxford University Press. pp. 267-280. 2017.This chapter explores two questions in detail: How should we determine the threshold for costs that individuals are asked to bear through insurance premiums or care-related out-of-pocket costs, including user fees and copayments? and What is an adequate relationship between costs and benefits? This chapter argues that preventing impoverishment is a morally more urgent priority than protecting households against income fluctuations, and that many health insurance plans may not adequately protect …Read more
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1103Will more organs save more lives? Cost‐effectiveness and the ethics of expanding organ procurementBioethics 33 (6): 684-690. 2019.The assumption that procuring more organs will save more lives has inspired increasingly forceful calls to increase organ procurement. This project, in contrast, directly questions the premise that more organ transplantation means more lives saved. Its argument begins with the fact that resources are limited and medical procedures have opportunity costs. Because many other lifesaving interventions are more cost‐effective than transplantation and compete with transplantation for a limited budget,…Read more
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56Evaluating the Legality of Age-Based Criteria in Health Care: From Nondiscrimination and Discretion to Distributive JusticeBoston College Law Review 60 (3): 889-949. 2019.Recent disputes over whether older people should pay more for health insurance, or receive lower priority for transplantable organs, highlight broader disagreements regarding the legality of using age-based criteria in health care. These debates will likely intensify given the changing age structure of the American population and the turmoil surrounding the financing of American health care. This Article provides a comprehensive examination of the legality and normative desirability of age-based…Read more
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432Transparency Trade-Offs: Priority Setting, Scarcity, and Health FairnessIn I. Glenn Cohen, Barbara Evans, Holly Lynch & Carmel Shachar (eds.), Transparency in Health and Health Care, Cambridge Up. 2019.This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.
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32Differential Payments to Research Participants in the Same Study: An Ethical AnalysisJournal of Medical Ethics 1. 2019.Recognizing that offers of payment to research participants can serve various purposes—reimbursement, compensation, and incentive—helps uncover differences between participants that 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 pre-participation financial baseline. Differential compensation can be acceptable when some research participants commit mor…Read more
Denver, Colorado, United States of America
Areas of Specialization
Medicine and Law |
Biomedical Ethics |
Applied Ethics |
Social and Political Philosophy |