Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

By James Lytle

Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.

The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).

Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.

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New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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Lady Justice blindfolded with scales.

Health Justice Can’t Be Blind

By Daniel E. Dawes

“Justice is blind.” We have all heard this phrase before, and seen the iconic representation: the blindfolded Lady Justice.

That blindfold is supposed to symbolize impartiality. It represents our strict subscription to the notion that impartiality and objectivity are the principles upon which our system is built and by which it is protected. This notion that justice is blind is one rooted in equality.

But justice should not always be blind. Rather than prioritizing equal treatment, sometimes justice demands that we treat individuals differently to ensure equal outcomes. This notion of justice is rooted in the principle of equity.

Put simply, equity takes fairness as its aim. Where equality entails the equal (i.e., impartial) treatment of individuals, equity demands a nuanced approach to ensure equal outcomes.

To achieve justice in the realm of health, our focus must be on equity, and not on blind equality.

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Patient receives Covid-19 vaccine.

The Target of Health Justice

By Sridhar Venkatapuram 

As we amplify, further develop, and advise in the realizing of health justice, there would be much benefit in clarifying the basic units of moral concern.

This call for more specificity relates to both who is the primary unit of moral concern (individuals, communities, nation-states, etc.) as well as what it is that we care about in relation to them (i.e., liberties, resources including health care, basic needs, respect, opportunities, capabilities, relationships, etc.).

In the current context of the COVID-19 pandemic, where vaccines have become the preeminent goods of value worldwide, I focus my discussion here on how distributing vaccines equitably at the level of geographical units such as districts or nation-states may obfuscate or tolerate injustices, as well as provide suboptimal control of the pandemic.

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Bill of Health - A worker gives directions as motorists wait in lines to get the coronavirus (COVID-19) vaccine in a parking lot at Dodger Stadium, Friday, Jan. 15, 2021, in Los Angeles, covid vaccine distribution

Can Vaccine Allocation Plans Legally Respond to Racial Disparities?

By Govind Persad

Recently, Missouri expanded phase 2 vaccination eligibility with the goal of addressing disproportionate COVID-19 impacts.

Specifically, Missouri’s policy applies to “Disproportionately Affected Populations,” which is further defined as: “Populations at increased risk of acquiring or transmitting COVID-19, with emphasis on racial/ethnic minorities not otherwise included in 1B.”

This presents a much-debated and often misunderstood question I explore in a forthcoming University of Illinois Law Review article: can COVID-19 vaccine allocation legally recognize the outsized burden of cases and deaths that racial/ethnic minority communities have borne during the pandemic?

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an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

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empty hospital bed

COVID-19 Underscores Racial Disparity in Advance Directives

Cross-posted from The Hastings Center Bioethics Forum, where it originally appeared on May 26, 2020. 

By Stephen P. Wood

During a recent shift, I was the primary provider for a man in his 70s who was brought in by ambulance with respiratory failure. He had been sick for two days with a fever and a cough, weak and short of breath. The chest x-ray performed at his bedside revealed the diffuse, fluffy markings that are familiar signs of pneumonitis from COVID-19.

After giving him oxygen to improve his breathing, treating his fever, and running tests that are standard for COVID-19 patients, I clicked the admission button to cue him up for a bed. My patient and I then discussed goals of care and had a frank discussion about advance directives. He did not have an advance directive, but he knew he did not want to be resuscitated. He did not want to be put on a ventilator, go on dialysis, or receive artificial nutrition. He was quite clear and did not hesitate about these decisions. We signed the advance directive and filed it away in his chart.

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view of Chicago

What Two Neighborhoods in Chicago Show About Disparities During COVID-19

By Michael Atalla

Minorities, especially African-Americans in metropolitan areas, are being infected with and dying from COVID-19 at higher rates than their white counterparts.

This phenomenon is occurring in many large cities like New York, Detroit, and New Orleans. This piece focuses on Chicago — arguably the most segregated city in all of America. Comparing two zip codes within Chicago city limits with similar population sizes but divergent racial composition, the disparities are striking.

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