Digital Commons Network^™

Antibacterial R & D At A Crossroads: We’Ve Pushed As Hard As We Can...Now We Need To Start Pulling!, John H. Rex, Kevin Outterson

Faculty Scholarship

In this issue of Clinical Infectious Diseases, Dheman et al [1] present an analysis by experts at the US Food and Drug Administration (FDA) of trends in antibacterial clinical development over the past 4 decades. By turns instructive and disturbing, this 40-year perspective provides insight into the impact of efforts to restore the antibacterial pipeline.

As a preview, the key messages from Dheman et al are all bad news for public health: (1) the number of new antibacterials in clinical development is (again) falling, (2) the risk of failure is rising, (3) the speed of clinical development …

Othering Across Borders, Steven Arrigg Koh

Faculty Scholarship

Our contemporary moment of reckoning presents an opportunity to evaluate racial subordination and structural inequality throughout our three-tiered domestic, transnational, and international criminal law system. In particular, this Essay exposes a pernicious racial dynamic in contemporary U.S. global criminal justice policy, which I call othering across borders. First, this othering may occur when race emboldens political and prosecutorial actors to prosecute foreign defendants. Second, racial animus may undermine U.S. engagement with international criminal legal institutions, specifically the International Criminal Court. This Essay concludes with measures to mitigate such othering.

Experimental? It Doesn't Mean What You Think It Means, Dorit Rubenstein Reiss, Arthur J. Caplan

Faculty Scholarship

No abstract provided.

Covid-19 And Regulating Vaccines, Dorit R. Reiss

Faculty Scholarship

No abstract provided.

Differential Etiology: Inferring Specific Causation In The Law From Group Data In Science, Joseph Sanders, David L. Faigman, Peter B. Imrey, Philip Dawid

Faculty Scholarship

In every toxic-tort case, the plaintiff must prove that the defendant exposed the plaintiff to something that caused an injury. The causal proof is in two parts: proof of general causation and proof of specific causation. General causation addresses the question of whether the exposure can cause injury in anyone. In the area of toxic torts, the evidence available to answer this question comes in the form of groupbasedstudies in the fields of toxicology, epidemiology, and genetics—studies that search for the effects of causes. Proof of general causation, however, is not enough. Because court cases focus on the individual, the …

More Than A Mask: Stay-At-Home Orders And Religious Freedom, Dorit Rubinstein Reiss, Madeline Thomas

Faculty Scholarship

No abstract provided.

School Police Reform: A Public Health Imperative, Thalia Gonzalez, Emma Kaeser

Faculty Scholarship

Out of the twin pandemics currently gripping the United States—deaths of unarmed Black victims at the hands of police and racialized health inequities resulting from COVID- 19—an antiracist health equity agenda has emerged that identifies racism as a public health crisis. Likewise, calls for reform of school policing by those advocating for civil rights, racial justice, and Black Lives Matter have simultaneously intensified. Yet each remains siloed, despite the natural connection and implicit overlap between these separate movements and debates. Indeed, there are documented negative health effects of school policing for Black, Indigenous, people of color (BIPOC) youth. But these …

Public Health Surveillance In The Context Of Covid-19, Jennifer D. Oliva

Faculty Scholarship

No abstract provided.

Safety, Crisis, And Criminal Law, Jenny E. Carroll

Faculty Scholarship

Concepts of safety and prevention of danger pervade the criminal law canon. Arizona is no exception. The state’s criminal systems pivot around central and entwined goals of protecting public safety and preventing danger. The state constitution permits pretrial detention both for the most serious offenses and when no other condition of release will adequately protect the community from the danger the accused’s freedom might pose. The rules of criminal procedure and the criminal code designate some offenses and actors “dangerous” and urge judges to weigh not only the accused’s risk of flight, but also his future dangerousness in making decisions …

Desirability Of Outcome Ranking For The Management Of Antimicrobial Therapy (Door Mat): A Framework For Assessing Antibiotic Selection Strategies In The Presence Of Drug Resistance, Brigid M. Wilson, Robin L.P. Jump, Federico Perez, Robert A. Bonomo

Faculty Scholarship

The complexities of antibiotic resistance mean that successful stewardship must consider both the effectiveness of a given antibiotic and the spectrum of that therapy to minimize imposing further selective pressure. To meet this challenge, we propose the Desirability of Outcome Ranking approach for the Management of Antimicrobial Therapy (DOOR MAT), a flexible quantitative framework that evaluates the desirability of antibiotic selection. Herein, we describe the steps required to implement DOOR MAT and present examples to illustrate how the desirability of treatment selection can be evaluated using resistance information. While treatments and the scoring of treatment selections must be adapted to …

A One Health Framework To Estimate The Cost Of Antimicrobial Resistance, Chantal Morel, Richard Alm, Christine Årdal, Alessandra Bandera, Giacomo Bruno, Elena Carrara, Giorgio Colombo, Marlieke De Kraker, Sabiha Essack, Isabel Frost, Bruno Gonzalez-Zorn, Herman Goossens, Luca Guardabassi, Stephan Harbarth, Peter Jørgensen, Souha Kanj, Tomislav Kostyanev, Ramanan Laxminarayan, Finola Leonard, Gabriel Levy Hara, Marc Mendelson, Malgorzata Mikulska, Nico Mutters, Kevin Outterson, Jesus Rodriguez Baňo, Evelina Tacconelli, Luigia Scudeller

Faculty Scholarship

Objectives/purpose

The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ON€) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized …

Setting The Standard: Multidisciplinary Hallmarks For Structural, Equitable And Tracked Antibiotic Policy, Claas Kirchhelle, Paul Atkinson, Alex Broom, Komatra Chuengsatiansup, Jorge Pinto Ferreira, Nicolas Fortané, Isabel Frost, Christoph Gradmann, Stephen Hinchliffe, Steven J. Hoffman, Javier Lezaun, Susan Nayiga, Scott H. Podolsky, Kevin Outterson, Stephanie Raymond, Adam P. Roberts, Andrew C. Singer, Anthony D. So, Luechai Sringernyuang, Elizabeth Tayler, Susan Rogers Van Katwyk, Clare I. R. Chandler

Faculty Scholarship

There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an ‘implementation gap’. At a policy level, the design of internationally salient solutions that are able to address AMR’s interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by …

Integrated Approaches To Reveal Mechanisms By Which Rna Viruses Reprogram The Cellular Environment, Christina Haddad, Jesse Davila-Calderon, Blanton S. Tolbert

Faculty Scholarship

RNA viruses are major threats to global society and mass outbreaks can cause long-lasting damage to international economies. RNA and related retro viruses represent a large and diverse family that contribute to the onset of human diseases such as AIDS; certain cancers like T cell lymphoma; severe acute respiratory illnesses as seen with COVID-19; and others. The hallmark of this viral family is the storage of genetic material in the form of RNA, and upon infecting host cells, their RNA genomes reprogram the cellular environment to favor productive viral replication. RNA is a multifunctional biomolecule that not only stores and …

Pretrial Detention In The Time Of Covid-19, Jenny E. Carroll

Faculty Scholarship

It is hard to overstate the impact of COVID-19. When it comes to the criminal justice system, the current COVID-19 crisis has shone a light on pre-existing flaws. Long before the first confirmed case in Seattle or elsewhere, America’s jails and prisons were particularly susceptible to contagions, exacerbated by problems from overcrowding to over policing to lack of reentry programs. This Essay focuses on one aspect of the challenges the criminal justice system faces in light of COVID-19 and beyond—that of a pretrial detention system that falls more harshly on poor and minority defendants, has swollen local jail populations, and …

China's Innovative Turn And The Changing Pharmaceutical Landscape, Peter K. Yu

Faculty Scholarship

For more than a decade, China has been the world's leading supplier of active pharmaceutical ingredients. Today, it is not only the world's second largest pharmaceutical market, behind only the United States, but it also produces about four percent of the world's new pharmaceutical products. Despite these impressive accomplishments, China does not have internationally recognized pharmaceutical brands that are comparable to those found in Europe or the United States, such as Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Sanofi. Nor does China rival India in its status as the "pharmacy of the world," providing generic drugs to needy countries …

How Big Data And Artificial Intelligence Can Help Better Manage The Covid-19 Pandemic, Giovanni Damiani

Faculty Scholarship

SARS-CoV2 is a novel coronavirus, responsible for the COVID-19 pandemic declared by the World Health Organization. Thanks to the latest advancements in the field of molecular and computational techniques and information and communication technologies (ICTs), artificial intelligence (AI) and Big Data can help in handling the huge, unprecedented amount of data derived from public health surveillance, real-time epidemic outbreaks monitoring, trend now-casting/forecasting, regular situation briefing and updating from governmental institutions and organisms, and health facility utilization information. The present review is aimed at overviewing the potential applications of AI and Big Data in the global effort to manage the pandemic. …

Why We (Probably) Must Deliberately Infect, Adam J. Kolber

Faculty Scholarship

No abstract provided.

Indemnifying Precaution: Economic Insights For Regulation Of A Highly Infectious Disease, Christopher Robertson, K Aleks Schaefer, Daniel Scheitrum, Sergio Puig, Keith Joiner

Faculty Scholarship

Economic insights are powerful for understanding the challenge of managing a highly infectious disease, such as COVID-19, through behavioral precautions including social distancing. One problem is a form of moral hazard, which arises when some individuals face less personal risk of harm or bear greater personal costs of taking precautions. Without legal intervention, some individuals will see socially risky behaviors as personally less costly than socially beneficial behaviors, a balance that makes those beneficial behaviors unsustainable. For insights, we review health insurance moral hazard, agricultural infectious disease policy, and deterrence theory, but find that classic enforcement strategies of punishing noncompliant …

Sars-Cov-2 Infection In A Patient On Chronic Hydroxychloroquine Therapy: Implications For Prophylaxis, Khalid M. Dousa, Sharad S. Malavade, Jennifer Furin, Barbara Gripshover, Marjorie Hatszegi, Leila Hojat, Elie Saade, Robert A. Salata

Faculty Scholarship

People exposed to COVID-19 have a risk of developing disease, and health care workers are at risk at a time when they are badly needed during a health care crisis. Hydroxychloroquine and chloroquine have been used as treatment and are being considered as prophylaxis. Our patient developed COVID-19 while on hydroxychloroquine and although more work is needed, this calls into question the role of these medications as preventive therapy.

Infectious Diseases Society Of America Guidelines On The Treatment And Management Of Patients With Covid-19, Amy Hirsch, Yngve Falck-Ytter

Faculty Scholarship

Background: There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. Objective: Develop evidence-based rapid guidelines intended to support patients, clinicians and other health-care professionals in their decisions about treatment and management of patients with COVID-19. Methods: IDSA formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise. Process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and …

Social Work, Ethics And Vulnerable Groups In The Time Of Coronavirus And Covid-19, Kathleen J. Farkas, Jaroslaw Richard Romaniuk

Faculty Scholarship

The profession of social work is dedicated to the betterment of society and to the protection of marginalized and vulnerable groups. The profession’s mission is detailed in the set of seven core values: service; social justice; dignity and work of the person; importance of human relationships; integrity; and competence. Relationships between people and among groups are the primary tools of social work assessment, intervention and evaluation. In the time of coronavirus and COVID-19, there are many challenges for professional practitioners to adhere to social work’s core values as well as to maintain their own health and welfare in a time …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

Unprecedented Solutions For Extraordinary Times: Helping Long-Term Care Settings Deal With The Covid-19 Pandemic, Robin L.P. Jump

Faculty Scholarship

No abstract provided.

Network-Based Drug Repurposing For Novel Coronavirus 2019-Ncov/Sars-Cov-2, Yuan Hou, Feixiong Cheng

Faculty Scholarship

Human coronaviruses (HCoVs), including severe acute respiratory syndrome coronavirus (SARS-CoV) and 2019 novel coronavirus (2019-nCoV, also known as SARS-CoV-2), lead global epidemics with high morbidity and mortality. However, there are currently no effective drugs targeting 2019-nCoV/SARS-CoV-2. Drug repurposing, representing as an effective drug discovery strategy from existing drugs, could shorten the time and reduce the cost compared to de novo drug discovery. In this study, we present an integrative, antiviral drug repurposing methodology implementing a systems pharmacology-based network medicine platform, quantifying the interplay between the HCoV-host interactome and drug targets in the human protein-protein interaction network. Phylogenetic analyses of 15 …

Yearning To Breathe Free: Migration Related Confinement In America, Danielle C. Jefferis

Faculty Scholarship

No abstract provided.

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Covid-19 And Prisoners’ Rights, Gregory Bernstein, Stephanie Guzman, Maggie Hadley, Rosalyn M. Huff, Alison Hung, Anita N.H. Yandle, Alexis Hoag, Bernard E. Harcourt

Faculty Scholarship

As COVID-19 continues to spread rapidly across the country, the crowded and unsanitary conditions in prisons, jails, juvenile detention, and immigration detention centers leave incarcerated individuals especially vulnerable. This chapter will discuss potential avenues for detained persons and their lawyers seeking to use the legal system to obtain relief, including potential release, during this extraordinary, unprecedented crisis.

Privacy And Pandemics, Clarisa Long

Faculty Scholarship

The beginning of 2020 marked an unexpected turn for the world, the global pandemic of COVID-19 has affected every aspect of life. It has also created an unprecedented opportunity for governments to justify the expansion of their surveillance and collection of data. The foregoing essay, which was first published in Faculty Publications at Scholarship Archive of the Columbia Law School focuses on two types of data collection – governmental mass collection of nonanonymized location data and state-collected nonanonymized data on people's health and immunity status. Several countries have applied one or both practices and it is relevant to look into …

Executive Overreach And Underreach In The Pandemic, Kim Lane Scheppele, David E. Pozen

Faculty Scholarship

The pandemic that convulsed the globe in 2020 was long foretold but still surprising to many. Within a few months of its appearance, COVID-19 became one of the leading causes of death worldwide. Governments struggled at first to comprehend what was happening – and then reacted in very different ways. Most political leaders followed the advice of epidemiologists. Many declared states of emergency. A few pursued autocratic agendas. And some did almost nothing.

During emergencies, constitutional scholars normally worry about executive aggrandizement at the expense of human rights and democratic values. Emergencies often require national executives to act quickly and …

Executive Underreach, In Pandemics And Otherwise, David E. Pozen, Kim Lane Scheppele

Faculty Scholarship

Legal scholars are familiar with the problem of executive overreach, especially in emergencies. But sometimes, instead of being too audacious or extreme, a national executive's attempts to address a true threat prove far too limited and insubstantial. In this Essay, we seek to define and clarify the phenomenon of executive underreach, with special reference to the COVID-19 crisis; to outline ways in which such underreach may compromise constitutional governance and the international legal order; and to suggest a partial remedy.