Rethinking #GOF #Experiments in the Context of the #COVID19 Pandemic (mBio, abstract)

[Source: mBio, full page: (LINK). Abstract, edited.]

Rethinking Gain-of-Function Experiments in the Context of the COVID-19 Pandemic

Michael J. Imperiale, Arturo Casadevall

DOI: 10.1128/mBio.01868-20

 

ABSTRACT

Proponents of the use of gain-of-function (GOF) experiments with pathogens with pandemic potential (PPP) have argued that such experiments are necessary because they reveal important facets of pathogenesis and can be performed safely. Opponents of GOF experiments with PPP have argued that the risks outweigh the knowledge gained. The COVID-19 pandemic demonstrates the vulnerability of human societies to a new PPP, while also validating some arguments of both camps, questioning others, and suggesting the need to rethink how we approach this class of experiments.

The views expressed in this article do not necessarily reflect the views of the journal or of ASM.

Keywords: SARS-CoV-2; COVID-19; Biological Hazards; Bioethics.

——

Provision of #ECPR during #COVID19: #evidence, #equity, and #ethical dilemmas (Crit Care, abstract)

[Source: Critical Care, full page: (LINK). Abstract, edited.]

Provision of ECPR during COVID-19: evidence, equity, and ethical dilemmas

Elliott Worku, Denzil Gill, Daniel Brodie, Roberto Lorusso, Alain Combes & Kiran Shekar

Critical Care volume 24, Article number: 462 (2020)

 

Abstract

The use of extracorporeal cardiopulmonary resuscitation (ECPR) to restore circulation during cardiac arrest is a time-critical, resource-intensive intervention of unproven efficacy. The current COVID-19 pandemic has brought additional complexity and significant barriers to the ongoing provision and implementation of ECPR services. The logistics of patient selection, expedient cannulation, healthcare worker safety, and post-resuscitation care must be weighed against the ethical considerations of providing an intervention of contentious benefit at a time when critical care resources are being overwhelmed by pandemic demand.

Keywords: SARS-CoV-2; COVID-19; Intensive Care; Bioethics.

—–

#Ethical implementation of ‘ #immunity #passports’ during the #COVID19 pandemic (J Infect Dis., abstract)

[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]

Ethical implementation of ‘immunity passports’ during the COVID-19 pandemic 

Teck Chuan Voo, Hannah Clapham, Clarence C Tam

The Journal of Infectious Diseases, jiaa352, https://doi.org/10.1093/infdis/jiaa352

Published: 25 June 2020

 

Abstract

A number of countries are planning the use of ‘immunity passports’ as a way to ease restrictive measures and allow infected and recovered people to return to work during the COVID-19 pandemic. This paper brings together key scientific uncertainties regarding the use of serological tests to assure immune status and a public health ethics perspective to inform key considerations in the ethical implementation of immunity passport policies. Ill-conceived policies have the potential to cause severe unintended harms that could result in greater inequity, the stigmatization of certain sectors of society, and heightened risks and unequal treatment of individuals due to erroneous test results. Immunity passports could however be used to achieve collective benefits and benefits for specific populations besides facilitating economic recovery. We conclude that sector-based policies that prioritize access to testing based on societal need are likely to be fairer and logistically more feasible, while minimizing stigma and reducing incentives for fraud. Clear guidelines need to be set out for which sectors of society should be prioritized for testing, and rigorous mechanisms should be in place to validate test results and identify cases of re-infection.

Issue Section: Brief Report

This content is only available as a PDF.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

——

#Variation in #Ventilator #Allocation #Guidelines by #US #State During the #Coronavirus Disease 2019 Pandemic – A Systematic Review (JAMA Netw Open, abstract)

[Source: JAMA Network Open, full page: (LINK). Abstract, edited.]

Variation in Ventilator Allocation Guidelines by US State During the Coronavirus Disease 2019 Pandemic – A Systematic Review

Gina M. Piscitello, MD1; Esha M. Kapania, MD1; William D. Miller, MD2; Juan C. Rojas, MD2; Mark Siegler, MD3,4; William F. Parker, MD2,4

Author Affiliations: 1 Department of Medicine, Rush University, Chicago, Illinois; 2 Department of Pulmonary and Critical Care, University of Chicago, Chicago, Illinois; 3 Department of Medicine, University of Chicago, Chicago, Illinois; 4 MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois

JAMA Netw Open. 2020;3(6):e2012606. doi:10.1001/jamanetworkopen.2020.12606

 

Key Points

  • Question  – How many US states have ventilator allocation guidelines and how do these guidelines compare with one another?
  • Findings  – In this systematic review of publicly available US state guidelines about ventilator allocation, only 26 states provided guidance on how this allocation should occur, and their guidelines varied significantly.
  • Meaning  – These findings suggest significant variation in US state ventilator guidelines, which could cause inequity in allocation of mechanical ventilatory support during a public health emergency, such as the coronavirus disease 2019 pandemic.

 

Abstract

Importance  

During the coronavirus disease 2019 pandemic, there may be too few ventilators to meet medical demands. It is unknown how many US states have ventilator allocation guidelines and how these state guidelines compare with one another.

Objective  

To evaluate the number of publicly available US state guidelines for ventilator allocation and the variation in state recommendations for how ventilator allocation decisions should occur and to assess whether unique criteria exist for pediatric patients.

Evidence Review  

This systematic review evaluated publicly available guidelines about ventilator allocation for all states in the US and in the District of Columbia using department of health websites for each state and internet searches. Documents with any discussion of a process to triage mechanical ventilatory support during a public health emergency were screened for inclusion. Articles were excluded if they did not include specific ventilator allocation recommendations, were in draft status, did not include their state department of health, or were not the most up-to-date guideline. All documents were individually assessed and reassessed by 2 independent reviewers from March 30 to April 2 and May 8 to 10, 2020.

Findings  

As of May 10, 2020, 26 states had publicly available ventilator guidelines, and 14 states had pediatric guidelines. Use of the Sequential Organ Failure Assessment score in the initial rank of adult patients was recommended in 15 state guidelines (58%), and assessment of limited life expectancy from underlying conditions or comorbidities was included in 6 state guidelines (23%). Priority was recommended for specific groups in the initial evaluation of patients in 6 states (23%) (ie, Illinois, Maryland, Massachusetts, Michigan, Pennsylvania, and Utah). Many states recommended exclusion criteria in adult (11 of 26 states [42%]) and pediatric (10 of 14 states [71%]) ventilator allocation. Withdrawal of mechanical ventilation from a patient to give to another if a shortage occurs was discussed in 22 of 26 adult guidelines (85%) and 9 of 14 pediatric guidelines (64%).

Conclusions and Relevance  

These findings suggest that although allocation guidelines for mechanical ventilatory support are essential in a public health emergency, only 26 US states provided public guidance on how this allocation should occur. Guidelines among states, including adjacent states, varied significantly and could cause inequity in the allocation of mechanical ventilatory support during a public health emergency, such as the coronavirus disease 2019 pandemic.

Keywords: SARS-CoV-2; COVID-19; Intensive Care; USA; Bioethics.

——

#Digital #Smartphone #Tracking for #COVID19 – #PublicHealth and Civil #Liberties in Tension (JAMA, summary)

[Source: JAMA, full page: (LINK). Summary, edited.]

Digital Smartphone Tracking for COVID-19Public Health and Civil Liberties in Tension

I. Glenn Cohen, JD1; Lawrence O. Gostin, JD2; Daniel J. Weitzner, JD3

Author Affiliations: 1 Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, Massachusetts; 2 O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC; 3 MIT Computer Science and Artificial Intelligence Lab, Cambridge, Massachusetts

JAMA. Published online May 27, 2020. doi:10.1001/jama.2020.8570

___

Contact investigations have been a vital public health strategy, most recently in controlling tuberculosis and sexually transmitted infections including HIV. Yet, the sheer scale of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections poses major challenges to contact investigations. Strategies in China, Singapore, South Korea, and Taiwan have supplemented traditional manual approaches with digital surveillance through smartphone applications.

The US has not used digital surveillance as a tool, but Google, Apple, the Massachusetts Institute of Technology (MIT), as well as 2 pan-European consortia and a variety of independent efforts are developing Bluetooth smartphone technology to enable rapid notification of users that they have had a close exposure to individuals diagnosed with medically verified coronavirus disease 2019 (COVID-19). How does digital tracking differ from manual tracing? Although digital surveillance has the distinct advantages of scale and speed, does it confer sufficient public health benefit to justify adoption given privacy concerns? How do the design choices of digital contact tracing systems affect public health and privacy?

(…)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

——

Need for #Transparency and Reliable #Evidence in Emergency Use #Authorizations for #Coronavirus Disease 2019 (#COVID19) #Therapies (JAMA Intern Med., summary)

[Source: JAMA Internal Medicine, full page: (LINK). Summary, edited.]

Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

Mike Z. Zhai, BA1; Carolyn T. Lye, BA2,3; Aaron S. Kesselheim, MD, JD, MPH1

Author Affiliations: 1 Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine,  Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts; 2 Yale School of Medicine, New Haven, Connecticut; 3 Yale Law School, New Haven, Connecticut

JAMA Intern Med. Published online May 19, 2020. doi:10.1001/jamainternmed.2020.2402

___

On March 28, 2020, the US Food and Drug Administration (FDA) issued an emergency use  authorization (EUA) for the use of hydroxychloroquine and chloroquine for certain  hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19).1  Hydroxychloroquine and chloroquine have long been approved for the prophylaxis and  treatment of malaria, with the former also used in the treatment of systemic lupus  erythematosus and rheumatoid arthritis. Although these drugs appear to inhibit  coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical  evidence to support the use of these drugs to treat COVID-19 in patients.

(…)

Keywords: SARS-CoV-2; COVID-19; Antivirals; Chloroquine; USA; Bioethics.

——

#Health #inequity during the #COVID19 pandemic: a cry for #ethical global #leadership (Lancet, summary)

[Source: Lancet, full page: (LINK). Summary, edited.]

Health inequity during the COVID-19 pandemic: a cry for ethical global leadership

David Chiriboga, Juan Garay, Paulo Buss, Rocío Sáenz Madrigal, Laetitia Charmaine Rispel

Published: May 15, 2020 | DOI: https://doi.org/10.1016/S0140-6736(20)31145-4

___

Widespread reports of disproportionate impact of the COVID-19 pandemic among  already vulnerable communities worldwide, from New York City to New Orleans and  Chicago, to the shocking pictures of bodies lying in the streets in Ecuador, represent a  prelude of the impact in low-income and middle-income countries, home to more than  80% of the world’s population. Disadvantaged people are at higher risk of infection and  death from COVID-19, and they have less access to care due to systems that treat health  as a commodity and not a human right. Furthermore, most health-care systems are not  prepared to handle a pandemic of this magnitude. Overwhelmed European and US  systems are ominous reminders of the challenges faced in poor countries. Despite widespread acts of solidarity, we are witnessing unconscionable stockpiling by wealthy countries and attempts by many to extract profits from the crisis. Hoarding and speculation should be condemned in the strongest terms and measures taken globally to ensure equitable access for countries with fewer resources.

(…)

Keywords: SARS-CoV-2; COVID-19; Society; Poverty.

——

#Inequity in #Crisis #Standards of #Care (N Engl J Med., summary)

[Source: The New England Journal of Medicine, full page: (LINK). Summary, edited.]

Inequity in Crisis Standards of Care

Emily Cleveland Manchanda, M.D., M.P.H.,  Cheri Couillard, M.A.,  and Karthik Sivashanker, M.D., M.P.H.

___

In Racism without Racists, Eduardo Bonilla-Silva articulates why “color blindness,” an  ethos based on the belief that race is no longer relevant, is contradictory and harmful.  Color-blind policies, such as race-neutral mortgage practices and Medicare and Medicaid  rules, have resulted in discrimination against black people and greater burdens on  communities of color. To insist on color blindness is to deny the experience of people of  color in a highly racialized society and to absolve oneself of any role in the process. Many  clinicians and policymakers are therefore alarmed by recent state-based crisis  standards of care (CSCs) that provide a color-blind process for determining whether a  patient with Covid-19 respiratory failure lives or dies.

(…)

Keywords: SARS-CoV-2; COVID-19; Society; Racism; USA; Bioethics.

——

#CPR in the #Covid19 Era — An #Ethical #Framework (N Engl J Med., summary)

[Source: The New England Journal of Medicine, full page: (LINK). Summary, edited.]

CPR in the Covid-19 Era — An Ethical Framework

Daniel B. Kramer, M.D., M.P.H., Bernard Lo, M.D., and Neal W. Dickert, M.D., Ph.D.

___

The coronavirus pandemic is forcing clinicians, health care institutions, and public officials to develop crisis standards of care that differ radically from ordinary care for services such as diagnostic testing and mechanical ventilation. Under normal conditions, cardiopulmonary resuscitation (CPR) is provided unless a patient has a do-not-resuscitate (DNR) order that is based on the wishes of the patient or a surrogate. Health care workers are trained to start resuscitation immediately and not wait for more experienced personnel to arrive. It is assumed that intensive care will be available subsequently and that resuscitation attempts pose no substantial risks to clinicians or other patients. Crisis standards during a major surge in Covid-19 patients challenge typical assumptions regarding resuscitation and default provision of CPR.

(…)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

—–

The #Ethics of #COVID19 #Immunity-Based #Licenses (“Immunity #Passports”) (JAMA, summary)

[Source: JAMA, full page: (LINK). Summary, edited.]

The Ethics of COVID-19 Immunity-Based Licenses (“Immunity Passports”)

Govind Persad, JD, PhD1; Ezekiel J. Emanuel, MD, PhD2

Author Affiliations: 1 Sturm College of Law, University of Denver, Denver, Colorado; 2 Department of Medical Ethics and Health Policy, Perelman School of Medicine,  Department of Healthcare Management, The Wharton School, University of  Pennsylvania, Philadelphia

JAMA. Published online May 6, 2020. doi:10.1001/jama.2020.8102

___

Chile, Germany, and the UK, among others, have indicated they will implement certifications that a person has contracted and recovered from coronavirus disease 2019 (COVID-19) or, in the future, has received a COVID-19 vaccine. Such policies have been discussed, but not implemented, in the US. However, if other countries require these certifications for entrance, the US may adopt them to enable travel, generating calls to use them more broadly. 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.

(…)

Keywords: SARS-CoV-2; COVID-19; Bioethics.

——