Digital Commons Network^™

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

Evaluation Of Periodontal Status And Cytokine Levels In Saliva And Gingival Crevicular Fluid Of Patients With Inflammatory Bowel Diseases, Andre Paes Batista Da Silva

Faculty Scholarship

Background: Periodontal diseases and inflammatory bowel diseases (IBD, ulcerative colitis [UC] and Crohn disease [CD]) have been reported to present with increased salivary and gingival crevicular fluid (GCF) concentrations of cytokines. The aim of this study was to evaluate the salivary and GCF levels of TNF-α, IL-1β, IL-10, and IL-17A and their associations with the periodontal statuses of UC, CD, and non-IBD patients, and to analyze the interrelationships among these cytokines, IBD conditions, and periodontal diseases. Methods: This cross-sectional study was performed with a total of 131 patients (62 women and 69 men, mean age 42.96±13.02 years). Patients were divided …

Omicron Infection Milder In Nursing Home Residents, Robin L.P. Jump

Faculty Scholarship

No abstract provided.

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S. F. Orubu, John Rex, Christine Årdal, Muhammad H. Zaman

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to patient access to effective antibacterial therapy.

Seroprevalence Of Severe Acute Respiratory Syndrome Coronavirus-2 (Sars-Cov-2) Among Healthcare Providers Prior To The Vaccine Era In An Integrated Midwestern Healthcare System, Elie A. Saade, Xiaochun Zhang, Jaime H. Noguez, Lisa M. Stempak, Daniel Tisch, Christine Schmotzer, Robert A. Salata

Faculty Scholarship

We performed severe acute respiratory coronavirus virus 2 (SARS-CoV-2) antinucleocapsid IgG testing on 5,557 healthcare providers and found a seroprevalence of 3.9%. African Americans were more likely to test positive than Whites, and HCWs with household exposure and those working on COVID-19 cohorting units were more likely to test positive than their peers.

A Theory Of City Biogeography And The Origin Of Urban Species, Ryan A. Martin

Faculty Scholarship

Many of the choices humans make with regard to infrastructure, urban planning and other phenomena have impacts that will last thousands of years. This can readily be seen in modern cities in which contemporary streets run along street grids that were laid out thousands of years prior or even in which ancient viaducts still play a role. However, rarely do evolutionary biologists explicitly consider the future of life likely to be associated with the decisions we are making today. Here, we consider the evolutionary future of species in cities with a focus on the origin of lineages and species. We …

Expanding The Definition Beyond Surveillance Criteria Reveals A Large Burden Of Osteomyelitis Caused By Group B Streptococcus In The United States Veterans Health Administration, Taissa A. Bej, Brigid Wilson, Sunah Song, Robin L.P. Jump, Federico Perez

Faculty Scholarship

Background: Population-based surveillance studies may underestimate osteomyelitis caused by Group B Streptococcus (GBS). We analyzed cases of GBS osteomyelitis, including patients diagnosed using an expanded case definition that incorporates cultures from non-sterile sites, as well as cultures from normally sterile sites. Methods: We retrospectively examined a cohort of veterans with the diagnosis of osteomyelitis between 2008 and 2017. Cases of definite GBS osteomyelitis required GBS isolation from normally sterile sites, (e.g., blood or bone). Cases of probable GBS osteomyelitis permitted GBS isolation from non-sterile sites (e.g., surgical sites, wounds). We compared comorbid conditions, lower extremity amputation and mortality rates in …

The Epistemology Of Second Best, Gary S. Lawson

Faculty Scholarship

Second best theory “holds that where it is not possible to satisfy all the conditions necessary for a[] . . . system to reach an overall optimum, it is not generally desirable to satisfy as many of those conditions as possible.” Adrian Vermeule, Foreword: System Effects and the Constitution, 123 HARV. L. REV. 4, 17 (2009). In other words, if you are not moving all the way to the ideal state of affairs, it is unclear whether partial moves that seem to go in the direction of the ideal make the world “better” or “worse” – with “better” or “worse” …

Implementation Of An Antibiotic Stewardship Program In Long-Term Care Facilities Across The Us, Robin L.P. Jump

Faculty Scholarship

Importance: Antibiotic overuse in long-term care (LTC) is common, prompting calls for antibiotic stewardship programs (ASPs) designed for specific use in these settings. The optimal approach to establish robust, sustainable ASPs in LTC facilities is unknown. Objectives: To determine if the Agency for Healthcare Research and Quality (AHRQ) Safety Program for Improving Antibiotic Use, an educational initiative to establish ASPs focusing on patient safety, is associated with reductions in antibiotic use in LTC settings. Design, Setting, and Participants: This quality improvement study including 439 LTC facilities in the US assessed antibiotic therapy data following a pragmatic quality-improvement program, which was …

Similar Mortality Among United States Veterans With Invasive And Noninvasive Pneumonia Due To Group B Streptococcus, Brigid M. Wilson, Sunah Song, Robin L.P. Jump, Federico Perez

Faculty Scholarship

Background: The nosology of noninvasive pneumonia due to group B Streptococcus (GBS) is not well defined. This study compared clinical characteristics and outcomes of patients with invasive pneumonia and noninvasive pneumonia caused by GBS. Methods: We conducted a retrospective cohort study among Veterans Affairs (VA) healthcare users between 2008 and 2017. Using data from electronic health records, we identified patients who had blood or respiratory cultures that grew GBS and had invasive pneumonia or noninvasive pneumonia. We analyzed patient and infection characteristics associated with all-cause mortality, including among the subset of patients with cultures that were monomicrobial for GBS. Results: …

Statues Of Fraud : Confederate Monuments As Public Nuisances, Emily T. Behzadi

Faculty Scholarship

The deaths of George Floyd, Breonna Taylor, and countless other African Americans have capitulated a new wave of social activism throughout the United States. Notwithstanding the existence of one of the most infectious diseases of the 21st century, racist and unrestrained police violence continues to plague American society. The unprecedented national uprisings resulting from the brutal killings of African Americans have positioned the U.S. on the precipice of immense social and political change. This transitory period is marked by an amalgamation of social, political, and cultural influences. However, the continued exhibition of Confederate monuments inexorably stymies the ability to remedy …

Antibiotic Exposure And Acquisition Of Antibiotic-Resistant Gram-Negative Bacteria Among Outpatients At A Us Veterans Affairs Medical Center, Brigid M. Wilson, Sunah Song, Federico Perez, Robin L.P. Jump

Faculty Scholarship

Objectives: To assess the prevalence of antibiotic-resistant gram-negative bacteria (R-GNB) among patients without recent hospitalization and to examine the influence of outpatient antibiotic exposure on the risk of acquiring R-GNB in this population. Design: 2-year retrospective cohort study. Setting: Regional Veterans Affairs healthcare system. Patients: Outpatients at 13 community-based clinics. Methods: We examined the rate of acquisition of R-GNB within 90 days following an outpatient visit from 2018 to 2019. We used clinical and administrative databases to determine and summarize prescriptions for systemic antibiotics, associated infectious diagnoses, and subsequent R-GNB acquisition among patients without recent hospitalizations. We also calculated the …

Emotional Distress Recovery For Mishandling Of Human Remains: A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Faculty Scholarship

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Public Nuisance As Risk Regulation, Thomas W. Merrill

Faculty Scholarship

Public nuisance has always been defined in terms of the object of protection – the community, the public, or perhaps even the state as a whole. Public nuisance in this regard has been juxtaposed to private nuisance, which protects individual persons and their use and enjoyment of land. Commentary on public nuisance has thus long been concerned with defining (without notable success) what it means to advance a public as opposed to a private right.

In this paper, I offer a different take on the function of public nuisance. The common law is designed to provide redress for actual harm, …

Approvals And Timing Of New Formulations Of Novel Drugs Approved By The Us Food And Drug Administration Between 1995 And 2010 And Followed Through 2021, Ravi Gupta, Christopher J. Morten, Angela J. Zhu, Reshma Ramachandran, Nilay D. Shah, Joseph S. Ross

Faculty Scholarship

New formulations of prescription drugs can improve convenience and tolerability for patients, but they also constitute manufacturer strategies to extend brand-name drug market exclusivity periods. We examined whether new formulations of brand-name novel drugs were associated with novel drugs’ sales and/or therapeutic value, as well as characterized first new formulations’ approval timing relative to the novel drug’s generic approval. We found that manufacturers are several times more likely to secure Food and Drug Administration approval for a new formulation for existing drugs that have reached blockbuster status. (Blockbuster drugs are the most profitable drugs with more than $1 billion in …

The Need For Social Support From Law Schools During The Era Of Social Distancing, Michele Okoh, Inès Ndonko Nnoko

Faculty Scholarship

Law students have been faced with unparalleled stress during the syndemic. They must cope with being students during the COVID-19 pandemic but also must deal with stress related to social and political unrest. This essay recommends that law schools apply social support theory in developing interventions to effectively address the needs of law students now and in the future.

Social support theory focuses on the value and benefits one receives from positive interpersonal relationships. These positive relationships impact both mental and physical health and promote beneficial short and long-term overall health. However, not all supports are the same, and social …

The Law, Economics, And Governance Of Generation Covid-19 Long-Haul, Julia Puaschunder, Martin Gelter

Faculty Scholarship

The SARS-CoV-2 novel coronavirus is an external shock to all societies with lasting impacts that have changed individual, political, and corporate decisions profoundly. Increasing evidence reveals that an estimated 10-50% of those previously infected with COVID-19 face a longer-term or long-term health impact and/or chronic debilitation that in many cases comes and goes in waves. This phenomenon has already been referred to as a pandemic within the pandemic. The broad-based and long-term impact of COVID Long Haulers have also holds the potential to change our world and modern society, lasting through the following three outlined speculative trends: (1) The coronavirus …

Jail Health And Early Release Practices, Brandon L. Garrett, Deniz Ariturk, Jessica Carda-Auten, David L. Rosen

Faculty Scholarship

Local jails in the United States incarcerate millions of people each year. The COVID-19 pandemic made jail health a pressing public health concern nationally, where releasing individuals from jails occurred across the country in order to prevent pandemic spread. But releases also faced substantial resistance and exposed long-standing challenges in delivering adequate healthcare in jail settings. People in jail have substantially higher levels of medical need than individuals in the general population, with large numbers having serious mental illnesses and substance use disorders. Further, overcrowded conditions and poor healthcare standards and delivery make jails harmful to those already-vulnerable people. What …

Viral Injustice, Brandon L. Garrett, Lee Kovarsky

Faculty Scholarship

The COVID-19 pandemic blighted all aspects of American life, but people in jails, prisons, and other detention sites experienced singular harm and neglect. Housing vulnerable detainee populations with elevated medical needs, these facilities were ticking time bombs. They were overcrowded, underfunded, unsanitary, insufficiently ventilated, and failed to meet even minimum health-and-safety standards. Every unit of national and sub-national government failed to prevent detainee communities from becoming pandemic epicenters, and judges were no exception.

This Article takes a comprehensive look at the decisional law growing out of COVID-19 detainee litigation and situates the judicial response as part of a comprehensive institutional …

Market Myopia's Climate Bubble, Madison Condon

Faculty Scholarship

A growing number of financial institutions, ranging from BlackRock to the Bank of England, have warned that markets may not be accurately incorporating climate change-related risks into asset prices. This Article seeks to explain how this mispricing can exist at the level of individual assets drawing from scholarship on corporate governance and the mechanisms of market (in)efficiency. Market actors: 1. Lack the fine-grained asset-level data they need in order to assess risk exposure; 2. Continue to rely on outdated means of assessing risk; 3. Have misaligned incentives resulting in climate-specific agency costs; 4. Have myopic biases exacerbated by climate change …

Introduction: Amr Belongs In The Pandemic Instrument, Susan Rogers Van Katwyk, Kevin Outterson

Faculty Scholarship

In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance …

A Pandemic Instrument Can Start Turning Collective Problems Into Collective Solutions By Governing The Common-Pool Resource Of Antimicrobial Effectiveness, Isaac Weldon, Kathy Liddell, Susan Rogers Van Katwyk, Steven J. Hoffman, Timo Minssen, Kevin Outterson, Stephanie Palmer, A. M. Viens, Jorge Viñuales

Faculty Scholarship

To address the complex challenge of global antimicrobial resistance (AMR), a pandemic treaty should include mechanisms that 1) equitably address the access gap for antimicrobials, diagnostic technologies, and alternative therapies; 2) equitably conserve antimicrobials to sustain effectiveness and access across time and space; 3) equitably finance the investment, discovery, development, and distribution of new technologies; and 4) equitably finance and establish greater upstream and midstream infection prevention measures globally. Biodiversity, climate, and nuclear governance offer lessons for addressing these challenges.

Race, Public Health, And The Epidemic Of Incarceration, Thalia Gonzalez, Emma Kaeser

Faculty Scholarship

No abstract provided.

Strengthening Systems Of Care For People With Or At Risk For Hiv, Hcv And Opioid Use Disorder: A Call For Enhanced Data Collection, Jennifer D. Oliva, Anthony J. Eller

Faculty Scholarship

Background: The syndemic between opioid use disorder (OUD), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) results in excessive burdens on the healthcare system. Integrating these siloed systems of care is critical to address all three conditions adequately. In this implementation project, we assessed the data capacity of the health system to measure a cascade of care (COC) across HIV, HCV and OUD services in five states to help guide public health planning. Materials and methods: Data for this study were gathered from publicly available datasets and reports from government (SAMSHA, CMS, HRSA and CDC) sites. We created, where …

Law In The Service Of Misinformation: How Anti-Vaccine Groups Use The Law To Help Spin A False Narrative, Dorit R. Reiss, Viridiana Ordonez

Faculty Scholarship

Social movements use legal tools to create narratives. Those narratives support social agendas which certain movements leverage to mislead their followers and potential followers. In this Article, we examine one influential anti-vaccine organization, the Informed Consent Action Network (ICAN), that uses its far-reaching platform to create false narratives around legal action. Again and again, this anti-vaccine group misrepresented both the legal and the factual meanings of court decisions, settlements, and other legal actions to create a narrative to galvanize its followers and influence newcomers. ICAN filed lawsuits that make anti-vaccine arguments—even when the legal framework did not fit doing so—and …

Colorblind Nationalism And The Limits Of Liberalism, Ming Hsu Chen

Faculty Scholarship

Policymakers and lawyers posit formal citizenship as the key to inclusion. Rather than presume that formal citizenship will necessarily promote equality, this Article examines the relationship between citizenship, racial equality, and nationalism. It asks: What role does formal citizenship play in excluding noncitizens and Asian, Latinx, and Muslim citizens racialized as foreigners? What effects does it have on the meaning of being American as a non-White citizen? The Article argues that commitments to colorblind equality and democratic self-governance of the nation stand in contradiction to aspirations to protect all persons within the nation. Consequently, individual rights designed to remedy racial …

What The Pandemic Taught Us: The Health Care System We Have Is Not The System We Hoped We Had, William M. Sage

Faculty Scholarship

The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community.

Why this happened is clearly important. But that it happened is …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …

Are Vaccine Lotteries Worth The Money?, Christopher Robertson, K. Aleks Schaefer, Daniel Scheitrum

Faculty Scholarship

This research evaluates the effects of the twelve statewide vaccine lottery schemes that were announced as of June 7, 2021 on state vaccination rates. We construct a dataset that matches information on the timing and location of these lotteries with daily, county-level data from the U.S. Centers for Disease Control (CDC) on the cumulative number of people who have received at least one dose of an emergency-authorized Covid-19 vaccine. We find that 10 of the 12 statewide lotteries studied (i.e., all but Arkansas and California) generated a positive, statistically significant, and economically meaningful impact on vaccine uptake after thirty days. …