Health Law and Policy Commons^™

A Critique Of Expertise For Health Law, Aziza Ahmed

Faculty Scholarship

A health justice approach requires a progressive critique of expertise. This article considers two recent high-profile cases – the mask mandate and medication abortion -- to understand how we should think the mobilization of expertise in the context of public health law. Following from this, the article offers news ways to better understand how to think of the relationship between health law, expertise, and politics.

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.

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 …

Abortion Experts, Aziza Ahmed

Faculty Scholarship

The COVID-19 pandemic, and the overturning of Roe v. Wade,¹ has intensified the fight for access to medication abortion. ² As state governors put emergency orders into place limiting health care provisions to essential services, some also limited access to abortion, designating it a nonessential service. ³ In the face of these challenges, women's health advocates, in keeping with prior advocacy, have called for greater access to medication abortion.⁴ The increased reliance on telemedicine during the COVID-19 pandemic provides new possibilities for the provision of abortion medication that do not rely on a patient engaging in-person at a …

Trust, Brutality, And Human Dignity: How “Partial Birth Abortion” Helps Shape American Biopolitics, George J. Annas

Faculty Scholarship

In this Article, I explore how nearly continuous public rhetorical challenges to abortion in the political realm first led the public and the courts to turn away from a particular abortion procedure (intact dilation and extraction, also known as partial-birth abortion) which political agitators labeled as “barbaric” and then to view physicians who performed abortions not as legitimate professionals, but simply as “abortionists,” and sometimes as evil “Frankensteins.” “Abortionists” use no “medical judgment” and are unworthy of deference by state legislatures, Congress, or the courts when deciding how or when to perform an abortion. The concentration on the welfare of …

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. …

Health Reform Reconstruction, Lindsay F. Wiley, Elizabeth Mccuskey, Matthew B. Lawrence, Erin C. Fuse Brown

Faculty Scholarship

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades and calls for reconstruction. For more than a half-century, a cramped "iron triangle" ethos has constrained health reform conceptually. Reforms aimed to balance individual interests in cost, quality, and access to health care, while marginalizing equity, solidarity, and public health. In the iron triangle era, reforms unquestioningly accommodated four legally and logistically entrenched fixtures - individualism, fiscal fragmentation, privatization, and federalism - that distort and diffuse any reach toward social justice. The profound racial disparities and …

Title 42, Asylum, And Politicising Public Health, Michael Ulrich, Sondra S. Crosby

Faculty Scholarship

President Biden has continued the controversial immigration policy of the Trump era known as Title 42, which has caused harm and suffering to scores of asylum seekers under the guise of public health.1 The Centers for Disease Control and Prevention (CDC) ordered the policy in March 2020 with the stated purpose of limiting the spread of the coronavirus into the U.S.; though, CDC and public health officials have admitted this policy has no scientific basis and there is no evidence it has protected the public.2,3 Instead, the impetus behind the policy appears to be a desire to keep out or …

Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines, Kevin Outterson

Faculty Scholarship

Antibacterial medicines should be foundational for modern medicine—a key part of the infrastructure of contemporary practice. Recently, however, antibacterials have struggled commercially. Even with “push” incentives (grants paid before regulatory approval), antibacterials have failed on the market because revenues are tied to volume sold. There are policy initiatives under way in the United States and United Kingdom that explore paying for exceptional antibacterials with “pull” incentives (paid after regulatory approval) by delinking the payments from volume via other payment formats such as market entry rewards and subscriptions. This article discusses these initiatives but also proposes an expected net present value …

Gendered Complications Of Covid-19: Towards A Feminist Recovery Plan, Naomi Cahn, Linda C. Mcclain

Faculty Scholarship

COVID-19 exposed the limitations in the current economic system on public and private support for gender equity and the intersecting impact of gender, race, and class in that lack of support. Women of color, particularly those who are Black, Latina, or Native American, were at the intersection of the inequities in the pandemic economy. The catalogue of COVID-19’s impact covers all aspects of women’s lives: work, family, education, health, reproduction, mental and physical well-being, and leisure. This Article argues that COVID-19 has complex implications for gender equality and gender equity as state and local governments, the federal government, and private …

Medicaid Waivers, Administrative Authority, And The Shadow Of Malingering, Nicole Huberfeld

Faculty Scholarship

From 2018 through 2020, HHS approved state Medicaid demonstration waivers to impose new eligibility conditions such as work requirements, connecting current “personal responsibility” rhetoric and historical suspicion of malingering. The Biden administration reversed course but advocated to the Supreme Court for expansive administrative discretion. This approach supports health equity now but could enable reemergence of restrictive health policies down the road.

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 …

Effects Of Political Versus Expert Messaging On Vaccination Intentions Of Trump Voters, Christopher Robertson, Keith Bentele, Beth Meyerson, Alexander Wood, Jacqueline Salwa

Faculty Scholarship

To increase COVID-19 vaccine uptake in resistant populations, such as Republicans, focus groups suggest that it is best to de-politicize the issue by sharing five facts from a public health expert. Yet polls suggest that Trump voters trust former President Donald Trump for medical advice more than they trust experts. We conducted an online, randomized, national experiment among 387 non-vaccinated Trump voters, using two brief audiovisual artifacts from Spring 2021, either facts delivered by an expert versus political claims delivered by President Trump. Relative to the control group, Trump voters who viewed the video of Trump endorsing the vaccine were …

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 …

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 …

Your Health Is In Your Hands? Us Cdc Covid-19 Mask Guidance Reveals The Moral Foundations Of Public Health, Cecília Tomori, Aziza Ahmed, Dabney P. Evans, Benjamin Mason Meier, Aparna Nair

Faculty Scholarship

In the second year of the COVID-19 pandemic, US public health policy remains at a crossroads. The US Centers for Disease Control and Prevention’s (CDC’s) May 28, 2021 guidance, which lifted masking recommendations for vaccinated people in most situations, exemplifies a troubling shift — away from public health objectives that center equity and toward a model of individual personal responsibility for health. CDC Director Rochelle Walensky emphasized that "your health is in your hands," undermining the idea that fighting COVID is a "public" health responsibility that requires the support of institutions and communities. The social impacts of this scientific guidance, …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

Faculty Scholarship

Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Standard Racism: Trying To Use “Crisis Standards Of Care” In The Covid-19 Pandemic, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Lowering the standard of care in a pandemic is a recipefor inferior care and discrimination. Wealthy whitepatients will continue to get “standard of care” medi-cine, while the poor and racial minorities (especiallyblack and brown people) will get what is openlydescribed as substandard care rationalized by the asser-tion that substandard care is all that we can deliver tothem in a crisis. (IOM 2009) Paul Farmer’s experiencein responding to the Ebola outbreak in West Africa is ashocking, if extreme, example of how dangerous topatients this practice is. White patients were treatedwith the US standard of care, including transfer to theUS for treatment, …

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 …

Designing An Independent Public Health Agency, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

We believe that Congress should act on a bipartisan basis to fix U.S. public health institutions. Legislators could decide to merely buttress current institutions, as former commissioners have suggested be done for the FDA.1 Alternatively, legislators could consider a broad reorganization of public health functions and create a superagency, whose purview would include everything from the approval of drugs and devices to the maintenance of national stockpiles of protective equipment.

Medical Cannabis And The Age Of Majority, Katharine B. Silbaugh

Faculty Scholarship

This Essay considers whether commercial cannabis retailers are adequately constrained in the sale of cannabis to 18- to 21-year-olds. It examines the intersection of the medical cannabis market, recreational cannabis market, and underlying status law regulating late adolescents aged 18 to 21. Because the age of majority licenses full medical decision-making, an 18-year-old can access medical cannabis but not recreational cannabis or alcohol. This Essay proceeds on the assumption that medical cannabis is a construct that has eased the process of achieving a legalized commercial cannabis market. The ambiguity around medical claims is comfortable in the libertarian soil of cannabis …

Marijuana Legalization And The Role Of The Massachusetts Legislature, Sean J. Kealy

Faculty Scholarship

The public is often frustrated when Congress or their state legislature is not responsive to their policy priorities. This was especially true during the effort to legalize marijuana in Massachusetts. The legislature consistently refused to take up the issue despite public support. Legalization advocates ultimately bypassed the legislature by turning to the ballot-initiative process on three occasions: first to decriminalize possession of small amounts of marijuana, then to legalize medical marijuana, and most recently to legalize recreational marijuana. After the electorate legalized recreational marijuana, the legislature further frustrated advocates, first by delaying implementation of key parts of the law and …

The Boston Medical Center Immigrant Task Force: An Alternative To Teaching Immigration Law To Health Care Providers, Sondra S. Crosby, Lily Sonis, George J. Annas

Faculty Scholarship

As healthcare providers engage in the politics of reforming and humanizing our immigration and asylum “system” it is critical that they are able to refer their patients whose health is directly impacted by our immigration laws and policies to experts who can help them navigate the system and obtain the healthcare they need.

Addressing Public Health’S Failings During Year One Of Covid-19, George J. Annas, Sandro Galea

Faculty Scholarship

By almost any measure, public health fell short during 2020. In retrospect, the list of what public health professionals, including federal and state public health officials, public health practitioners, and academics, could have done better is easy to articulate, and has already been the subject of angry books about the disasterous responses to the pandemic in Europe and the US [1,2]. It falls to all of us to pause, reflect, and ask: how do we move forward? We have five suggestions.

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 …

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 …

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 Need For A Strong And Stable Federal Public Health Agency Independent From Politicians, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

The COVID-19 pandemic has revealed the precariousness of federal public health institutions in the United States, and how disastrously things can go when those institutions are undermined by political forces. Such institutions can be disbanded, underfunded, populated with incompetent political hacks, manipulated, or sidelined. As a field, public health in particular needs some political space, given that it requires deep scientific expertise and needs to communicate to the public clearly, reliably, and with authority to engender trust. Key public health agencies, such as the Centers for Disease Control and Prevention (CDC) in particular, should be buttressed against future political encroachment, …

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 …

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.