Category: Govind Persad

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

How to Fairly Allocate Scarce COVID-19 Therapies

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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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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

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By Govind Persad, Patricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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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?

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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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Oxygen mask as part of artificial lungs ventilation machine in surgery room, closeup.

Arizona’s Crisis Standards of Care and Fair Allocation of Resources During COVID-19

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By Govind Persad

As COVID-19 cases spiked in Arizona, the state activated its crisis standards of care, which provide triage guidelines if absolute scarcity arises.

Arizona has done the right thing by adopting crisis standards of care instead of leaving these decisions about ventilators to be made ad hoc by medical staff, which presents the risk both of arbitrary and biased decisions and of greater distress for clinical staff who are forced to make decisions without a guidance framework.

Arizona’s activation of its crisis standards of care stands in contrast to most other states’ response to the pandemic, including New York, which ultimately did not activate its crisis standards of care. Even though Arizona and other states have not yet reached the stage of absolute scarcity where triage policies are invoked—and hopefully will take steps to avoid reaching it—the move has prompted discussions about fair triage policies and criticisms from some community organizations.

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LOMBARDIA, ITALY - FEBRUARY 26, 2020: Empty hospital field tent for the first AID, a mobile medical unit of red cross for patient with Corona Virus. Camp room for people infected with an epidemic.

Pandemic Guidelines, Not Changed Malpractice Rules, Are the Right Response to COVID-19

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By Valerie Gutmann Koch, Govind Persad, and Wendy Netter Epstein

On March 17, the Washington Post published an op-ed by Dr. Jeremy Faust, titled Make This Simple Change to Free Up Hospital Beds Now. In it, he argues that cities and states should “temporarily relax the legal standard of medical malpractice,” in order to encourage hospitals to admit, and physicians to treat, the patients who need help during the COVID-19 pandemic.

In a tweet promoting the piece, Dr. Faust expresses concern that in the absence of such a legal change, “docs will keep doing ‘usual’ low yield admissions.”

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Researcher works at a lab bench

Do Pharmaceutical Patents Generate Unique Global Health Duties?

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By Govind Persad

Imagine a Harvard MBA graduate trying to decide between jobs at Pfizer and at Snapchat. Both are immensely wealthy firms. Many of Pfizer’s products benefit global health. Snapchat’s are at best neutral and may even harm health. Yet many see Pfizer as distinctively culpable for global health deficits. These arguments often depend on the fact that Pfizer holds intellectual property (IP) in pharmaceuticals, whereas Snapchat holds cash and non-pharmaceutical IP.

In a recent paper in the Yale Journal of Health Policy, Law, and Ethics, Examining Pharmaceutical Exceptionalism: Intellectual Property, Practical Expediency, and Global Health, I argue for two conclusions:

  1.  Holders of pharmaceutical IP (like Pfizer) aren’t uniquely culpable for global health deficits. Other actors (like Snapchat) who fail to use available resources–including ordinary property and non-pharmaceutical IP–to address health deficits, or who affirmatively cause health deficits, also bear responsibility.
  2. But laws requiring pharmaceutical IP holders, but not others, to address global health deficits are nevertheless justifiable. Legal responsibility needn’t perfectly mirror moral responsibility.

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Two senior women jogging in a park

What Should We Ask About Age-Based Criteria in Healthcare?

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In the American health care system, age shapes patients’ options. Most people over age 65 are eligible for Medicare, which is inaccessible to almost everyone under 65.

But many providers limit older patients’ access to certain interventions—like in-vitro fertilization or organ transplants. Some clinical research studies also exclude older patients, while others stratify populations by age. And insurers in the Affordable Care Act’s individual marketplaces can legally charge older patients up to three times as much as younger patients, which has motivated calls to let people below 65 buy into the Medicare program (although these proposals use age 55 as an eligibility criterion). Many of these uses of age have generated debate in the past, and are likely to continue to generate debate in the future. Read More

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

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According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Read More