Health Law and Policy Commons^™

Ethical Challenges In The Middle Tier Of Covid-19 Vaccine Allocation: Guidance For Organizational Decision-Making, Nancy Berlinger, Matthew Wynia, Tia Powell, Aimee Milliken, Parinda Khatri, Fatma Marouf, Keisha Ray, Johanna Crane

Faculty Scholarship

This supplement to The Hastings Center’s “Ethical Framework” aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health …

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.

The Future Of Facts: The Politics Of Public Health And Medicine In Abortion Law, Aziza Ahmed

Faculty Scholarship

While a great deal of public scrutiny has focused on how information circulates through online outlets including Twitter and Facebook, less attention has been devoted to how more traditional institutions traffic in factual assertions for the sake of setting a particular distributional agenda into motion.[1] Of these more traditional institutions, courts play a central role in legitimating legal and factual claims in the process of applying and clarifying legal rules. In public health-related adjudication, courts play at least two important roles: first, judges and juries make decisions between competing sets of public health and medical claims and second, courts …

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

The Covid-19 Pandemic And The Technology Trust Gap, Johanna Gunawan, David Choffnes, Woodrow Hartzog, Christo Wilson

Faculty Scholarship

Industry and government tried to use information technologies to respond to the COVID-19 pandemic, but using the internet as a tool for disease surveillance, public health messaging, and testing logistics turned out to be a disappointment. Why weren’t these efforts more effective? This Essay argues that industry and government efforts to leverage technology were doomed to fail because tech platforms have failed over the past few decades to make their tools trustworthy, and lawmakers have done little to hold these companies accountable. People cannot trust the interfaces they interact with, the devices they use, and the systems that power tech …

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 …

Litigation As Education: The Role Of Public Health To Prevent Weaponizing Second Amendment Rights, Michael Ulrich

Faculty Scholarship

Tobacco litigation was unquestionably successful, but it is dangerous to expect that it can be easily duplicated. An unrealistic reliance on litigation as a regulatory measure can blind public health advocates to other mechanisms of change. And that includes litigation as a means of enabling actual regulation. Firearms and the gun violence epidemic provides a useful case study. The Protection of Lawful Commerce in Arms Act (PLCAA) essentially bars litigation as a regulatory tool for firearms. This legislation means every time someone pulls the trigger, they become the party to blame. Soto v. Bushmaster Firearms presents a rare exception based …

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 …

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 …

On Skepticism, Modesty, And Embracing Those With Whom We Disagree: A Rejoinder, Barak D. Richman, Steven L. Schwarcz

Faculty Scholarship

No abstract provided.

Bad Apples Or A Rotten Tree: Ameliorating The Double Pandemic Of Covid-19 And Racial Economic Inequality, Nathalie Martin

Faculty Scholarship

Black Lives Matter signs pepper our rural, middle class neighborhood. The lawn signs raise a fundamental question: if Black Lives Matter, what will it take to reverse the longstanding trend that has left many dead and so many others, perhaps all others, suffering? What will it take to create some semblance of equality and equity across racial lines in America?

Part I of this essay discusses race and Covid 19. It reviews and updates statistics on Covid deaths and race, and discusses some of the reasons for the racial disparities in Covid deaths. Part II briefly reviews the stratification of …

Following The Money: The Aca’S Fiscal-Political Economy And Lessons For Future Health Care Reform, William M. Sage, Timothy M. Westmoreland

Faculty Scholarship

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship …

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Jonathan J. Darrow, Christopher Robertson, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

Medical Marijuana: Implications Of Evolving Trends In Regulation, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

Social Solidarity In Health Care, American-Style, Erin C. Fuse Brown, Matthew B. Lawrence, Elizabeth Mccuskey, Lindsay F. Wiley

Faculty Scholarship

The ACA shifted U.S. health policy from centering on principles of actuarial fairness toward social solidarity. Yet four legal fixtures of the health care system have prevented the achievement of social solidarity: federalism, fiscal pluralism, privatization, and individualism. Future reforms must confront these fixtures to realize social solidarity in health care, American-style.

Paying For Unapproved Medical Products, Kelly Mcbride Folkers, Alison Bateman-House, Christopher Robertson

Faculty Scholarship

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some expenses borne by private payers, some by public payers, some covered as charity care, and some paid out of pocket by patients. A separate question is off-label use, in which an approved medical product is used for an unapproved indication. In this article, we focus on a narrower issue: what entities …

Desnatada: Latina Illumination Of Breastfeeding, Race, And Injustice, Jasmine Gonzales Rose

Faculty Scholarship

In Skimmed: Breastfeeding, Race, and Injustice, Andrea Freeman brilliantly explains how racism results in lower breastfeeding rates by Black mothers,¹ which in turn results in poorer health outcomes--including higher mortality rates--for Black babies.² She provides four primary reasons for this phenomenon: (1) the history and legacy of slavery, (2) the imposition of racist gender stereotypes on Black women, (3) racially-targeted formula promotion by manufacturers and hospitals, and (4) government benefits and employment policies that obstruct poor people's ability to breastfeed. The first two of these reasons are particularly devastating: the legacy of slavery and misogynoiristic³ stereotypes …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Struggle For The Soul Of Medicaid, Nicole Huberfeld, Sidney Watson, Alison Barkoff

Faculty Scholarship

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the “soul” of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

The Limits Of Medical X-Pertise: Gender Markers In A Pandemic, Heron Greenesmith, Andy Izenson

Faculty Scholarship

The world changed drastically in 2020. The pandemic has far reaching consequences, and so too do the current civil rights movements and the struggle for gender justice and liberation. This Article seeks to describe a moment in time, a moment of doubt of how one 's gender and race will predict one 's ability to survive the pandemic-not simply COVID-19, but the pandemic writ-large and all the wrenches it has thrown into the health-care machine. How do those of us standing at the edge of a gender revolution navigate these waters? Will our health be the price we pay for …

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 …

Kob Interviews Joshua Kastenberg About Constitutional Rights During Covid-19, Joshua Kastenberg, Brittany Costello

Faculty Scholarship

No abstract provided.

The Affordable Care Act: Up For A Final Vote?, Wendy K. Mariner

Faculty Scholarship

For more than a decade, the minimum essential coverage requirement, commonly known as the individual mandate, has been a key point of controversy over the ACA, symbolizing ideological and political disagreements over government assistance to low-income populations, federal regulation of private industry, and the legacy of President Obama. 26 U.S.C. §5000A(a) requires everyone (with exceptions) to be covered by a private or public health benefit program meeting ACA standards. 26 U.S.C. §5000A(b) requires those who are not so covered to pay a fee (“shared responsibility payment”) to the Treasury. 26 U.S.C. §5000A(c) sets forth the amount of that fee.

Introduction: Health And Human Rights, George J. Annas

Faculty Scholarship

The American health care industry is killing us, and the casualties are mounting daily. Instead of saving lives, it is more often taking them, and not only by failing to seriously confront the coronavirus pandemic and racism in the industry, but also by the way health care is financed.

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

Faculty Scholarship

Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

Have The Aca’S Exchanges Succeeded? It’S Complicated, David K. Jones, Sarah H. Gordon, Nicole Huberfeld

Faculty Scholarship

The fight over health insurance exchanges epitomizes the rapid evolution of health reform politics in the decade since the passage of the Affordable Care Act. The ACA's drafters did not expect the exchanges to be contentious; they would expand private insurance coverage to low- and middle-income individuals who were increasingly unable to obtain employer-sponsored health insurance. Yet, exchanges became one of the primary fronts in the war over Obamacare. Have the exchanges been successful? The answer is not straightforward and requires a historical perspective through a federalism lens. What the ACA has accomplished has depended largely on whether states were …

Border Babies — Medical Ethics And Human Rights In Immigrant Detention Centers, Sondra S. Crosby, George J. Annas

Faculty Scholarship

Providing decent medical care for families in U.S. detention centers near the Mexican border has become exceedingly difficult over the past 2 years. Trauma was inflicted on migrants to deter others from attempting to enter the United States. A cornerstone of deterrence was the “zero tolerance” policy that forcibly separated children from their parents at the border. Photographs of children confined in cages horrified Americans, who demanded that the policy be rescinded. It was, but family separations continue and have been made even worse by the Migrant Protection Protocol (MPP) — which the U.S. Supreme Court will most likely review …

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

Rationing Crisis: Bogus Standards Of Care Unmasked By Covid-19, George J. Annas

Faculty Scholarship

After the spectacular failure to apply acceptable triage methods to evacuate patients from a flooded Memorial Hospital during Hurricane Katrina, preparedness planning was intensified (Fink Citation2013). Regarding physicians and hospitals, two approaches got the most attention: (1) diluting the legal “standard of care” for physicians and hospitals so they would be immune from lawsuit for negligent acts during a crisis (“crisis standards of care”); and (2) developing triage protocols for scarce resource allocation. Both can be considered crude works in process. Nonetheless, in the midst of the greatest national crisis since 9/11, I think it is time to declare …

Trade Mark Licensing And Covid-19: Why Fashion Companies Have A Duty To Comply With Their Legal Obligations, Irene Calboli

Faculty Scholarship

For the past several months, Covid-19 has dominated the intellectual property (IP) debate. Most discussions have focused on the implications of patent protection on access to treatments against the virus and a hopefully soon to be found vaccine. In these remarks, I would like to focus on another Covid-19 crisis making headlines across the world and partially related to IP: millions of workers in the garment industry in developing countries have been fired or furloughed as fashion companies have cancelled orders due to plunging sales since the pandemic’s beginning. Famous Western groups such as Inditex (Zara), C&A, Target, and Marks …