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247The importance of getting the ethics right in a pandemic treatyThe Lancet Infectious Diseases. forthcoming.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…Read more
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138A Multicenter Weighted Lottery to Equitably Allocate Scarce COVID-19 TherapeuticsAmerican Journal of Respiratory and Critical Care Medicine 206 (4). 2022.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…Read more
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Allocating Medicine Fairly in an Unfair PandemicUniversity of Illinois Law Review 2021 (3): 1085-1134. 2021.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…Read more
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122Fair domestic allocation of monkeypox virus countermeasuresLancet Public Health 8 (5). 2023.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 all…Read more
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165The shared ethical framework to allocate scarce medical resources: a lesson from COVID-19The Lancet 401 (10391). 2023.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 substantiv…Read more
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11Considering Vaccination StatusHastings Law Journal 74 399. 2022.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 va…Read more
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150Dose optimisation and scarce resource allocation: two sides of the same coinBMJ Open 12 (10). 2022.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 …Read more
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119A comprehensive Covid-19 response—the need for economic evaluationNew England Journal of Medicine 386 (26). 2022.
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157Reserve system design for allocation of scarce medical resources in a pandemic: some perspectives from the fieldOxford Review of Economic Policy 38 (4). 2022.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 de…Read more
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14Equal Protection and Scarce Therapies: The Role of Race, Sex, and Other Protected ClassificationsSmu Law Review Forum 75 226. 2022.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…Read more
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26Differential payment to research participants in the same study: an ethical analysisJournal of Medical Ethics 45 (5): 318-322. 2019.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 …Read more
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15Errors in Converting Principles to Protocols: Where the Bioethics of U.S. Covid‐19 Vaccine Allocation Went WrongHastings Center Report 52 (5): 8-14. 2022.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 reco…Read more
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183COVID-19 Vaccine Refusal and Fair Allocation of Scarce Medical ResourcesJAMA Health Forum 3 (4). 2022.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 sca…Read more
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401Coronavirus 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 pati…Read more
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16Fair allocation at COVID-19 mass vaccination sitesJAMA Health Forum 2 (4). 2021.We propose 4 equity-advancing operational improvements to eligibility and sign-up processes at mass vaccination sites: (1) preregistration using existing information, (2) eligibility rules that recognize the greater burden of COVID-19 in underserved neighborhoods, (3) appointment assignment that prioritizes those with disadvantage, and (4) socioculturally informed outreach to lottery selectees.
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160The 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 …Read more
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311Determining the Number of Refugees to Be Resettled in the United States: An Ethical and Policy Analysis of Policy-Level Stakeholder ViewsJournal of Immigrant and Refugee Studies 19 (2): 142-156. 2021.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…Read more
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216Ethical considerations of offering benefits to COVID-19 vaccine recipientsJAMA 326 (3): 221-222. 2021.We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines s…Read more
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41As hospitals in the US and elsewhere fill again with patients with covid-19, discussions about how to fairly allocate scarce medical resources have come to the fore once again. One frequently voiced concern is that non-covid-19 patients with urgent health needs are facing indefinitely postponed surgeries, long-distance hospital transfers, or even are unable to access medical treatment. In our view, a reserve or categorised priority system could help. It could be used to fairly distribute scarce …Read more
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552What are the obligations of pharmaceutical companies in a global health emergency?Lancet 398 (10304): 1015. 2021.All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including…Read more
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387COVID-19 vaccine boosters for all adults: An optimal U.s. approach?Annals of Internal Medicine 175 (2): 280-282. 2022.By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the si…Read more
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26Tailoring public health policiesAmerican Journal of Law and Medicine 47 (2-3). 2021.In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies. In Part II, I identify two types o…Read more
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181Obligations in a global health emergency - Authors’ replyLancet 398 (10316): 2072. 2021.In response to commentators, we argue that whether waiving patent rights will meaningfully improve access to COVID-19 vaccines for low income and middle-income countries (LMICs), particularly in the short term, is an empirical matter. We also reject preferentially allocating vaccines to countries that hosted trials because doing so unethically favours those with research infrastructure, rather than those facing the worst burdens from COVID-19.
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188Fair 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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221Off-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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341Against 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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Expensive 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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22Incorporating 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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273Improving 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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28Prioritizing 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
Denver, Colorado, United States of America
Areas of Specialization
Medicine and Law |
Biomedical Ethics |
Applied Ethics |
Social and Political Philosophy |