Digital Commons Network^™

A Retrospective Case Study Of Successful Translational Research: Gazelle Hb Variant Point-Of-Care Diagnostic Device For Sickle Cell Disease, Kelli Qua, Shannon M. Swiatkowski, Umut A. Gurkan, Clara M. Pelfrey

Faculty Scholarship

Evaluation researchers at Clinical and Translational Science Award (CTSA) hubs are conducting retrospective case studies to evaluate the translational research process. The objective of this study was to deepen knowledge of the translational process and identify contributors to successful translation. We investigated the successful translation of the HemeChip, a low-cost point-of-care diagnostic device for sickle cell disease, using a protocol for retrospective translational science case studies of health interventions developed by evaluators at the National Health Institutes (NIH) and CTSA hubs. Development of the HemeChip began in 2013 and evidence of device use and impact on public health is growing. …

Covid-19 Relief And The Ordinary Inmate, Jenny E. Carroll

Faculty Scholarship

As scholars and advocates have lamented the deficiencies of remedies pre- and post-conviction for the extraordinary, the “ordinary” are not saddled with slow and deficient remedies -- they have none. This Essay explores this absence of such relief for those unable to make an extraordinary claim during the COVID-19 public health crisis of 2020. For the ordinary men, women, and children held in custody in 2020 and beyond, pretrial detention and sentencing laws make no exception in the face of a potentially fatal contagion or the public health crisis it creates. Yet, the pandemic highlights the reality that systematic flaws …

Desirability Of Outcome Ranking For The Management Of Antimicrobial Therapy (Door Mat) Reveals Improvements In The Treatment Of Bloodstream Infections Caused By Escherichia Coli And Klebsiella Pneumoniae In Patients From The Veterans Health Administration, Federico Perez, Brigid M. Wilson, Elie Saade, Robin L.P. Jump, Robert A. Bonomo

Faculty Scholarship

Background: Reductions in the use of broad-spectrum antibiotics is a cornerstone of antimicrobial stewardship. We aim to demonstrate use of the Desirability of Outcome Ranking Approach for the Management of Antimicrobial Therapy (DOOR MAT) to evaluate the treatment of Escherichia coli and Klebsiella pneumoniae bloodstream infections in patients from the Veterans Health Administration (VHA) across a decade. Methods: Using electronic records, we determined empiric and definitive antibiotic treatments, clinical characteristics, and 30-day mortality of patients with monomicrobial E. coli and K. pneumoniae bloodstream infections hospitalized in VHA medical centers from 2009 to 2018. Focusing on patients treated with parenteral β-lactams …

Mandating Covid-19 Vaccine For Nursing Home Staff: An Ethical Obligation, Robin L.P. Jump

Faculty Scholarship

No abstract provided.

The Jury Trial Reinvented, Christopher Robertson, Michael Shammas

Faculty Scholarship

The Framers of the Sixth and Seventh Amendments to the United States Constitution recognized that jury trials were essential for maintaining democratic legitimacy and avoiding epistemic crises. As an institution, the jury trial is purpose-built to engage citizens in the process of deliberative, participatory democracy with ground rules. The jury trial provides a carefully constructed setting aimed at sorting truth from falsehood.
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/="/">Despite its value, the jury trial has been under assault for decades. Concededly, jury trials can sometimes be inefficient, unreliable, unpredictable, and impractical. The COVID–19 pandemic rendered most physical jury trials unworkable but spurred some courts …

Antibiotic Resistance In The Patient With Cancer: Escalating Challenges And Paths Forward, Amila K. Nanayakkara, Helen W. Boucher, Vance G. Fowler Jr., Amanda Jezek, Kevin Outterson, David E. Greenberg

Faculty Scholarship

Infection is the second leading cause of death in patients with cancer. Loss of efficacy in antibiotics due to antibiotic resistance in bacteria is an urgent threat against the continuing success of cancer therapy. In this review, the authors focus on recent updates on the impact of antibiotic resistance in the cancer setting, particularly on the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.). This review highlights the health and financial impact of antibiotic resistance in patients with cancer. Furthermore, the authors recommend measures to control …

Towards Access For All: 1st Working Group Report For The Global Gene Therapy Initiative (Ggti), Mohamed Draz, Umut Gurkan, Olabimpe Olayiwola

Faculty Scholarship

The gene and cell therapy field saw its first approved treatments in Europe in 2012 and the United States in 2017 and is projected to be at least a $10B USD industry by 2025. Despite this success, a massive gap exists between the companies, clinics, and researchers developing these therapeutic approaches, and their availability to the patients who need them. The unacceptable reality is a geographic exclusion of low-and middle-income countries (LMIC) in gene therapy development and ultimately the provision of gene therapies to patients in LMIC. This is particularly relevant for gene therapies to treat human immunodeficiency virus infection …

Antimicrobial Resistance: Is Health Technology Assessment Part Of The Solution Or Part Of The Problem?, Abigail Colson, Alec Morton, Christine Årdal, Kalipso Chalkidou, Sally Davies, Louis Garrison, Mark Jit, Ramanan Laxminarayan, Itamar Megiddo, Chantal Morel, Justice Nonvignon, Kevin Outterson, John Rex, Abdur Razzaque Sarker, Mark Sculpher, Beth Woods, Yue Xiao

Faculty Scholarship

Antimicrobial resistance is a serious challenge to the success and sustainability of our healthcare systems. There has been increasing policy attention given to antimicrobial resistance in the last few years, and increased amounts of funding have been channeled into funding for research and development of antimicrobial agents. Nevertheless, manufacturers doubt whether there will be a market for new antimicrobial technologies sufficient to enable them to recoup their investment. Health technology assessment (HTA) has a critical role in creating confidence that if valuable technologies can be developed they will be reimbursed at a level that captures their true value. We identify …

Shifting Standards Of Judicial Review During The Coronavirus Pandemic In The United States, Wendy K. Mariner

Faculty Scholarship

Emergencies are exceptions to the rule. Laws that respond to emergencies can create exceptions to rules that protect human rights. In long lasting emergencies, these exceptions can become the rule, diluting human rights and eroding the rule of law. In the United States, the COVID-19 pandemic prompted states to change rules governing commercial and personal activities to prevent the spread of the coronavirus. Many governors’ executive orders were challenged as violations of the constitutionally protected rights of those affected. Judges are deciding whether emergencies can justify more restrictions than would be permitted in normal circumstances and whether some rights deserve …

Molecular Diagnosis Of Sars-Cov-2: Assessing And Interpreting Nucleic Acid And Antigen Tests, Peter A. Zimmerman, Christopher L. King, Mahmoud Ghannoum, Robert A. Bonomo, Gary W. Procop

Faculty Scholarship

In this review, we summarize the current status of nucleic acid and antigen testing required for diagnosing SARS-CoV-2 infection and COVID-19 disease. Nucleic acid amplification (NAAT) and antigen-detection (Ag) tests occupy a critically important frontline of defense against SARS-CoV-2 in clinical and public health settings. In early stages of this outbreak, we observed that identifying the causative agent of a new illness of unknown origin was greatly accelerated by characterizing the nucleic acid signature of the novel coronavirus. Results from nucleic acid sequencing led to the development of highly sensitive RT-PCR testing for use in clinical settings and to informing …

Sweet Are The Uses Of Adversity, Nicholas Allard

Faculty Scholarship

No abstract provided.

American Punishment And Pandemic, Danielle C. Jefferis

Faculty Scholarship

Many of the sites of the worst outbreaks of the disease caused by the novel coronavirus (COVID-19) are America’s prisons and jails. As of March 2021, the virus has infected hundreds of thousands of incarcerated people and well over two thousand have died as a result contracting the disease caused by the virus. Prisons and jails have been on perpetual lockdowns since the onset of the pandemic, with family visits suspended and some facilities resorting to solitary confinement to mitigate the virus’s spread, thereby exacerbating the punitiveness and harmfulness of incarceration. With the majority of the 2.3 million people incarcerated …

Trade Marking ‘Covid’ And ‘Coronavirus’ In The Usa: An Empirical Review, Irene Calboli

Faculty Scholarship

Famous and sensational events often lead to several entities filing trade mark applications that include terms related to these events. The most recent example of this phenomenon is the COVID-19 pandemic, which has led to large numbers of (largely controversial) filings worldwide.

In this article, I review the applications including the terms ‘COVID’ and ‘Coronavirus’ filed with the United States Patent and Trademark Office (USPTO) in 2020 based on the data available and recorded by the end of January 2021. These data offer significant information related to the type of products for which the applications were filed, the type of …

The Effect Of Generic Market Entry On Antibiotic Prescriptions In The United States, Cecilia Kållberg, Jemma Hudson, Hege Salvesen Blix, Christine Årdal, Eili Klein, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 …

Use Of Electronic Pharmacy Transaction Data And Website Development To Assess Antibiotic Use In Nursing Homes, Sunah Song, Brigid M. Wilson, Robin L.P. Jump

Faculty Scholarship

Background: In 2017, the Centers for Medicare and Medicaid Services required all long-term care facilities, including nursing homes, to have an antibiotic stewardship program. Many nursing homes lack the resources, expertise, or infrastructure to track and analyze antibiotic use measures. Here, we demonstrate that pharmacy invoices are a viable source of data to track and report antibiotic use in nursing homes. Methods: The dispensing pharmacy working with several nursing homes in the same healthcare corporation provided pharmacy invoices from 2014 to 2016 as files formatted as comma separated values. We aggregated these files by aligning elements into a consistent set …

Transmission Of Severe Acute Respiratory Syndrome Coronavirus 2 (Sars-Cov-2) In A Patient Transport Van, Lucas D. Jones, Ernest R. Chan, Sarah N. Redmond, Jeffrey D. Kovach, Marlin Linger, Peter A. Zimmerman, Curtis J. Donskey

Faculty Scholarship

We report 2 episodes of potential SARS-CoV-2 transmission from infected van drivers to passengers despite masking and physical distancing. Whole-genome sequencing confirmed relatedness of driver and passenger SARS-CoV-2. With the heater operating, fluorescent microspheres were transported by airflow >3 meters from the front to the back of the van.

Disposable Lives: Covid-19, Vaccines, And The Uprising, Matiangai Sirleaf

Faculty Scholarship

Two French doctors appeared on television and publicly discussed potentially utilizing African subjects in experimental trials for a tuberculosis vaccine as an antidote to the novel coronavirus (COVID-19). Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO), denounced these kinds of racist remarks as a “hangover from ‘colonial mentality’” and maintained that “Africa can’t and won’t be a testing ground for any vaccine.” The fallout on social media was similarly swift, with Samuel Eto’o, a Cameroonian football legend, referring to the doctors as “[d]es assasins” and several others questioning the motives behind testing a vaccine on the African …

Are You There, Law? It's Me, Semen, Anita Bernstein

Faculty Scholarship

No abstract provided.

Crisis And Cultural Evolution: Steering The Next Normal From Self-Interest To Concern And Fairness, Robert A. Bohrer

Faculty Scholarship

This essay examines the current time of crisis and offers a vision of the way in which our society and our law can evolve in response. Crises of this scale are evolution-forcing events and I argue that the current moment can move us towards a fundamentally different vision of law and justice. It is the first essay or article to show that the autonomous pursuit of self-interest was a common assumption or value in the major intellectual forces of the twentieth century: classical free market economics, behavioral economics, and sociobiology, as well as in the competing visions of a just …

The Healthcare System And Pandemics: Where Is The Market Failure?, Sophia S. Helland, Edward R. Morrison

Faculty Scholarship

Barak D. Richman and Steven L. Schwarcz argue that healthcare providers played a central – and failing – role in stemming the fallout from the COVID-19 pandemic. Analogizing to the financial crisis of 2008, they view our healthcare system as a collection of providers, each maximizing returns to its own stakeholders in a laissez-faire regulatory environment that ignored the essential interconnectedness of providers. Because neither hospitals nor regulators were attuned to this interconnectedness, our healthcare system was unprepared for the pandemic, resulting in a reduced standard of care. Just as Dodd-Frank and related legislation view financial institutions as part of …

Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …

Covid-19 And Comparative Corporate Governance, Martin Gelter, Julia M. Puaschunder

Faculty Scholarship

With the pandemic caused by the novel coronavirus SARS-CoV-2 raging around the world, many countries’ economies are at a crucial juncture. The COVID-19 external shock to the economy has the potential to affect corporate governance profoundly. This Article explores its possible impact on comparative corporate governance. For an economy to operate successfully, a society must first find a politically sustainable social equilibrium. In many countries, historical crises—such as the Great Depression and World War II—have resulted in a reconfiguration of corporate governance institutions that set the course for generations. While it is not yet clear whether COVID-19 will have a …

The Clean Air Act Of 1963: Postwar Environmental Politics And The Debate Over Federal Power, Adam D. Orford

Faculty Scholarship

This Article explores the development of the Clean Air Act of 1963, the first law to allow the federal government to fight air pollution rather than study it. The Article focuses on the postwar years (1945-1963) and explores the rise of public health medical research, cooperative federalism, and the desire to harness the powers of the federal government for domestic social improvement, as key precursors to environmental law. It examines the origins of the idea that the federal government should “do something” about air pollution, and how that idea was translated, through drafting, lobbying, politicking, hearings, debate, influence, and votes, …

Macromedical Regulation, Barak D. Richman, Steven L. Schwarcz

Faculty Scholarship

The COVID-19 pandemic has dramatically shown that a localized disease can be transmitted to the broader population, nationally and worldwide. This Article analyzes how to design regulation to help control that transmission. To that end, we first observe that existing healthcare regulation focuses almost exclusively on regulating individual components of the medical and healthcare industry, while lacking a capacity to address how those components work together as a system -a system that pandemics can destabilize. Indeed, one factor that contributed to COVID-19's spread was the inability of U.S. healthcare regulation to operate on a societal level, to protect certain components …

The Right To Mental Health In Yemen, Waleed Alhariri, Amanda Mcnally, Sarah Knuckey

Faculty Scholarship

Mental health issues are all too common consequences of conflict and atrocity crimes, often causing upwards of one-quarter of the post-conflict, post-atrocity population to suffer from physical and mental sequelae that linger long after weapons have been silenced. After more than six years of ongoing conflict, Yemen’s already weak health care system is on the brink of collapse, and population resilience has been severely stressed by indiscriminate attacks, airstrikes, torture, food insecurity, unemployment, cholera, and now the COVID-19 pandemic. This paper examines Yemen’s responsibilities regarding the right to mental health and details the few actions the government has taken to …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Paying Americans To Take The Vaccine - Would It Help Or Backfire?, Christopher Robertson, Daniel Scheitrum, K. Aleks Schaefer, Trey Malone, Brandon R. Mcfadden, Kent D. Messer, Paul J. Ferraro

Faculty Scholarship

This research investigates the extent to which financial incentives (conditional cash transfers) would induce Americans to opt for vaccination against COVID-19. We performed a randomized survey experiment with a representative sample of 1,000 American adults in December 2020. Respondents were asked whether they would opt for vaccination under one of three incentive conditions ($1,000, $1,500, or $2,000 financial incentive) or a no-incentive condition. We find that—without coupled financial incentives—only 58% of survey respondents would elect for vaccination. A coupled financial incentive yields an 8-percentage-point increase in vaccine uptake relative to this baseline. The size of the cash transfer does not …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Faculty Scholarship

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Antibiotic Development Incentives That Reflect Societal Value Of Antibiotics, Helen Boucher, Thomas M. File, Vance Fowler, Amanda Jezek, John Rex, Kevin Outterson

Faculty Scholarship

TO THE EDITOR—Rome and Kesselheim [1] claimed that rewarding developers of novel antibiotics with transferable exclusivity vouchers is an expensive approach to promoting antibiotic development. This analysis is incomplete as it focuses only on the cost of bringing new antibiotics to market without acknowledging their societal value. The authors also did not suggest an alternative approach. With patients running out of treatment options for resistant infections, failing to strengthen the antibiotic pipeline is not a reasonable option.