Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – October 5, 2020

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Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – October 5, 2020

Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – October 5, 2020

Supplies

  • This Health Affairs Blog by DeVore breaks down the supply chain flaws that have contributed to shortages of needed PPE and other medical supplies during the pandemic. The post identifies multiple waves of challenges that require response during the current pandemic and future emergencies. Specifically, the author identifies as critical:
    1. Overreliance on foreign sources for critical medical products, particularly PPE manufacturing, and the need to increase domestic investments and capacity
    2. Panic buying linked more closely to perceived than actual need
    3. Stockpile inadequacies, including in the Strategic National Stockpile (SNS), that were unable to meet the needs of a sustained response and lacked transparency
    4. Opaque supply chains for raw goods, particularly for active pharmaceutical ingredients (APIs)
    5. Ancillary supply issues, including lack of transparency and knowledge regarding the production of essential but often overlooked items such as vials, swabs, reagents, needles, and syringes.
  • This Scientific Reports article by Asadi et al. assesses the effectiveness of various mask types in reducing exhaled respiratory droplets. Study participants completed 4 activities (breathing, talking, coughing, and jaw movement simulating chewing) while wearing no mask and while wearing 6 types of mask (surgical, unvented KN95, homemade single-layer paper towel, homemade single-layer t-shirt, homemade double-layer t-shirt, vented N95). The study addresses only one aspect of mask effectiveness, and the authors note that shedding of fabric particles from homemade cotton masks may confound results. In this test, however, surgical masks and respirators, even without fit-testing, substantially reduced particle emission, while efficacy of cloth and paper masks was not as clear (even appearing to increase particle emissions). In general, the authors conclude that the results support the general effectiveness of mask-wearing for mitigation of respiratory disease spread but also highlight the importance of regular changing of disposable masks and washing of homemade masks.
  • Adding further challenge to PPE supply issues, this ECRI Report found that imported, non-NIOSH-certified KN95 respirators frequently lack the level of filtration performance they claim. KN95s have been used to supplement limited supply of N95s, which are NIOSH-certified, and KN95s should meet the same standard (95% filtration of airborne particles). However, ECRI’s analysis of 200 respirators across 15 different models found that 60-70% did not meet this standard. The report notes that many overseas KN95 manufacturers are either startups or repurposed manufacturing companies that may not meet the required standards. The report recommends independent testing to verify performance, investigation of company history, sample evaluation, and review of accredited laboratory test reports to assess conformity with safety standards. Additionally, the report suggests using non-NIOSH-approved respirators only for non-surgical procedures if possible, and using certified respirators for aerosol-generating procedures.

Allocation and Disparities

Two articles in JAMA Open Network add to the considerable body of evidence assessing racial disparities in the current pandemic, and an accompanying commentary adds crucial perspective.

  • This article by Muñoz-Price et al. reports a cross-sectional study of over 2500 patients in a large midwestern academic health system in Milwaukee, Wisconsin. The study found that positive COVID-19 tests were associated with Black race, male sex, and age over 60 years, that Black race and poverty were associated with hospitalization, and that poverty was associated with intensive care unit admission. Taken together, Black patients were more likely to test positive for the virus even when controlling for socioeconomic status, demographic and health characteristics, comorbidities, presenting symptoms, and zip-code clustering. The findings are consistent with other studies that indicate that the adverse outcomes and population mortality from the pandemic that disproportionately affect Black populations in the U.S. are primarily attributable to greater incidence in these communities stemming from systemic factors (e.g., housing disparities and representation among essential workers), rather than any biological differences in susceptibility.
  • Similarly, this article by Kabarriti et al. reports a cohort study of over 5900 patients with positive COVID-19 diagnosis treated a an academic medical center in New York. The study found that non-Hispanic Black and Hispanic patients were more likely to test positive for COVID-19 and more likely to have more than 2 comorbidities but had survival outcomes similar to non-Hispanic white patients when controlling for age, sex, and comorbidities.
  • An invited commentary by Khazanchi, Evans, and Marcelin that accompanies the articles makes explicit that the results of these studies, like others showing persistent racial and ethic inequities in COVID-19 morbidity, hospitalization, and mortality, reflect intergenerational, structural inequities (i.e., structural racism), rather than any biological differences – in other words, “racism, not race,” as the commentary’s title succinctly puts it. These findings can inform mitigation strategies and other interventions, but they also indicate that structural, system-level reforms will be more impactful in addressing the inequitable harms of the pandemic in marginalized communities.

Testing

  • FDA issued an emergency use authorization (EUA) for the first point-of-care serology test for COVID-19 antibodies. Approximately 50 different serology tests have received EUAs during the pandemic, but serology tests have previously required processing in a central lab, requiring time and resources. However, antibody tests detect immune system response, rather than the virus itself, and thus are not able to demonstrate active infection.
  • This AP news article reports that the federal government plans to distribute millions of rapid diagnostic tests to states to facilitate reopening of K-12 schools. The tests, produced by Abbott Laboratories, are able to deliver results in approximately 15 minutes and do not require specialty computer equipment for processing. They are, however, less accurate than some other forms of testing and may contribute to undercounting of positive results because they occur in diffuse locations outside the health care system.
|2020-10-05T08:34:30-04:00October 5th, 2020|COVID-19 Literature|0 Comments

About the Author: Daniel Orenstein

Daniel Orenstein
Daniel G. Orenstein, JD, MPH, is Visiting Assistant Professor of Law at the Indiana University Robert H. McKinney School of Law in Indianapolis. He teaches in the areas of administrative law, public health law, and health care law and policy. His research focuses on public health law, policy, and ethics, and he was previously Deputy Director of the Network for Public Health Law Western Region, where much of his work centered on emergency preparedness and response, including resource allocation and government authority during declared emergencies, as well as vaccination policy.

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