Medicine and Health Sciences Commons^™

The Rise And Fall Of A Reproductive Right: Dobbs V. Jackson Women’S Health Organization, Carol Sanger

Faculty Scholarship

Although the phrase “Post-Roe Era” is still used by those who want to underscore the loss wrought last June by Dobbs v. Jackson Women’s Health Organization, it is only a matter of time before the present state of reproductive constitutionalism solidifies into the more authoritarian “Dobbs Era.” In these early days of transition, states are still figuring out what they want the legal status of abortion to be, ever since Dobbs overruled both Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, thus tossing the issue of abortion’s legality back to the states for …

The Nih-Moderna Vaccine: Public Science, Private Profit, And Lessons For The Future, Christopher J. Morten

Faculty Scholarship

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

The Covid Ceiling: Super-Moms Are Struggling, Verónica Gonzales-Zamora

Faculty Scholarship

COVID Ceiling is the unique combination of identity, discipline, and academic work requirements with care crisis and public health crisis that is contributing to the current and soon larger wave of mental health crises.

Getting Real: The Maryland Healthcare Ethics Committee Network’S Covid‑19 Working Group Debriefs Lessons Learned, Norton Elson, Howard Gwon, Diane Hoffmann, Adam M. Kelmenson, Ahmed Khan, Joanne F. Kraus, Casmir C. Onyegwara, Gail Povar, Fatima Sheikh, Anita J. Tarzian

Faculty Scholarship

No abstract provided.

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 …

Extending Postpartum Medicaid: State And Federal Policy Options During And After Covid-19, Jamie R. Daw, Emily Eckert, Heidi Allen, Kristen Underhill

Faculty Scholarship

The United States is facing a maternal health crisis with rising rates of maternal mortality and morbidity and stark disparities in maternal outcomes by race and socioeconomic status. Among the efforts to address this issue, one policy proposal is gaining particular traction: extending the period of Medicaid eligibility for pregnant women beyond 60 days after childbirth. The authors examine the legislative and regulatory pathways most readily available for extending postpartum Medicaid, including their relative political, economic, and public health trade-offs. They also review the state and federal policy activity to date and discuss the impact of the COVID-19 pandemic on …

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

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 …

The Southern Hospitals Report, Elizabeth Reiner Platt, Katherine M. Franke, Candace Bond-Theriault, Amy Littlefield

Faculty Scholarship

When research for this report was first initiated, it was intended to answer a narrow question: is abortion care restricted at historically Protestant hospitals in the U.S. South? Strict limits on access to abortion at Catholic hospitals — and the ways in which this can obstruct and delay even emergency medical care — are already well documented in legal and medical literature and news media. In contrast, restrictions at Protestant hospitals have not been extensively studied and are not well understood. Our research sought to fill this gap in knowledge. We focused on the U.S. South because Catholic hospitals are …

A One Health Framework To Estimate The Cost Of Antimicrobial Resistance, Chantal Morel, Richard Alm, Christine Ardal, 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 …

Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …

Reconciling Environmental Justice With Climate Change Mitigation: A Case Study Of Nc Swine Cafos, D. Lee Miller, Ryke Longest

Faculty Scholarship

For thirty years, the swine industry has externalized severe environmental and health harms onto poor communities of color in Eastern North Carolina. This “Big Pig” problem is caused by the confinement, consolidation, and concentration of industrial hog operations within the low, flat, and economically marginalized Coastal Plain. Big Pig’s rise was not inevitable. As recently as 1982, more than 11,000 small swine farms freckled nearly all of North Carolina’s 100 counties. Then came the “boom” of consolidation and industrialization that transformed hog production into a highly consolidated and vertically integrated industry.

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Abortion Talk, Clare Huntington

Faculty Scholarship

Public service announcements routinely note that one in eight women will be diagnosed with breast cancer. Advocates frequently invoke the twenty percent wage gap between men and women. And educational groups often cite the (more contested) statistic that one in five women will be sexually assaulted during college. But there is another data point not regularly part of public conversation: nearly one in four women will have an abortion by the age of forty-five. The widespread — but largely secret — practice of terminating pregnancies is what Carol Sanger wants us to talk about. As much as possible.

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …

Trauma, Depression, And Burnout In The Human Rights Field: Identifying Barriers And Pathways To Resilient Advocacy, Sarah Knuckey, Margaret Satterthwaite, Adam Brown

Faculty Scholarship

Human rights advocates often confront trauma and stress in their work. They are exposed to testimony about heinous abuses; work in insecure locations; visit physical sites of abuse; review forensic, photographic, and video evidence; directly witness abuses; experience threats; and can also suffer detention, be attacked, or be tortured themselves. Such exposure risks adversely impacting the wellbeing and mental health of advocates. While the human rights field is diverse and work varies widely, most – if not all – advocates are likely directly or indirectly exposed to potentially traumatic events or material in the course of their work. The degree …

If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

Ethicists who oppose compensating kidney donors claim they do so because kidney donation is risky for the donor’s health, donors may not appreciate the risks and may be cognitively biased in other ways, and donors may come from disadvantaged groups and thus could be exploited. However, few ethical qualms are raised about professional football players, who face much greater health risks than kidney donors, have much less counseling and screening concerning that risk, and who often come from racial and economic groups deemed disadvantaged. It thus seems that either ethicists—and the law—should ban both professional football and compensated organ donation, …

Error Disclosure Training And Organizational Culture, Jason M. Etchegaray, Thomas H. Gallagher, Sigall K. Bell, William M. Sage, Eric J. Thomas

Faculty Scholarship

Objective. Our primary objective was to determine whether, after training was offered to participants, those who indicated they had received error disclosure training previously were more likely to disclose a hypothetical error and have more positive perceptions of their organizational culture pertaining to error disclosure, safety, and teamwork.

Methods. Across a 3-year span, all clinical faculty from six health institutions (four medical schools, one cancer center, and one health science center) in The University of Texas System were offered the opportunity to anonymously complete an electronic survey focused on measuring error disclosure culture, safety culture, teamwork culture, and intention to …

Procedural Due Process And Intramural Hospital Dispute Resolution Mechanisms: The Texas Advance Directives Act, Thaddeus Pope

Faculty Scholarship

Increasingly, clinicians and commentators have been calling for the establishment of special adjudicatory dispute resolution mechanisms to resolve intractable medical futility disputes. As a leading model to follow, policymakers both around the United States and around the world have been looking to the conflict resolution provisions in the 1999 Texas Advance Directives Act (TADA).

In this article, I provide a complete and thorough review of the purpose, history, and operation of TADA. I conclude that TADA is a commendable attempt to balance the competing goals of efficiency and fairness in the resolution of these time-sensitive, life-and-death conflicts. But TADA is …

Repugnance Management And Transactions In The Body, Kieran Healy, Kimberly D. Krawiec

Faculty Scholarship

Researchers have made progress in understanding the role of repugnance in transactions involving the human body. Yet, often, the focus remains on exchange between individuals and how they mentally cope (or not) with repugnance. But these exchanges also entail a “vertical” dimension in which organizational and state actors both directly manage repugnance and also limit the repugnance management tools available to the marketplace. Analyzing repugnance and its management as an organizational and regulatory problem, in addition to an individual one, suggests that a single, harmonized system of exchange in bodily goods is unlikely to emerge with the passage of time.

Organ Entrepreneurs, Kieran Healy, Kimberly D. Krawiec

Faculty Scholarship

The supply of human organs for transplantation might seem an unlikely place to begin thinking about entrepreneurship. After all, there is no production market for human organs and, with the surprising exception of Iran, legal rules around the world make the sale of human organs for transplantation a criminal offense. Yet entrepreneurs have been present throughout the history of organ transplantation — a history of the active exploration, innovation, and management of a potentially very controversial exchange at the seemingly clear boundaries that separate giving from selling, life from death, and right from wrong.

This article explores the role of …

Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman

Faculty Scholarship

The rise of blockbuster pharmaceutical acquisitions has prompted fears that unprecedented market concentration will weaken competition. Two of the most prominent concerns focus on the upstream and downstream ends of the pharmaceutical industry: (1) the concern that these mergers will concentrate the market for discovery and will therefore lead to fewer discoveries; and (2) the concern that merging large marketing, sales, and distribution forces will strengthen the hands of select pharmaceutical manufacturers and weaken downstream competition. Having considered potential dynamic effects in the industry and conducted a series of preliminary interviews with knowledgeable observers, though, this Article argues that neither …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

Drinking From The Data Well: Response To Gamete Donor Anonymity And Limits On Numbers Of Offspring: The Views Of Three Stakeholders, Martha M. Ertman

Faculty Scholarship

No abstract provided.

Access To Essential Medicines In African Countries: An Introduction, Peter G. Danchin, Diane Hoffmann

Faculty Scholarship

No abstract provided.

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Aziza Ahmed, Sienna Baskin, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.