Medicine and Health Sciences Commons^™

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 …

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.

Just Compensation: A No-Fault Proposal For Research-Related Injuries, Leslie Meltzer Henry, Megan E. Larkin, Elizabeth R. Pike

Faculty Scholarship

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been …

Respect And Dignity: A Conceptual Model For Patients In The Intensive Care Unit, Leslie Meltzer Henry, Cynda Rushton, Mary Catherine Beach, Ruth Faden

Faculty Scholarship

Although the concept of dignity is commonly invoked in clinical care, there is not widespread agreement—in either the academic literature or in everyday clinical conversations—about what dignity means. Without a framework for understanding dignity, it is difficult to determine what threatens patients’ dignity and, conversely, how to honor commitments to protect and promote it. This article aims to change that by offering the first conceptual model of dignity for patients in the intensive care unit. The conceptual model we present is based on the notion that there are three sources of patients’ dignity—their shared humanity, personal narratives, and autonomy—each of …

Finding Fault?: Exploring Legal Duties To Return Incidental Findings In Genomic Research, Elizabeth R. Pike, Karen H. Rothenberg, Benjamin E. Berkman

Faculty Scholarship

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must …

Setting The Stage: Enhancing Understanding Of Bioethical Challenges With Theatre, Karen H. Rothenberg

Faculty Scholarship

Theatre provides a dynamic platform to reflect upon the ethical, legal, and social implications of medical innovations and the powerful impact on personal and professional relationships. This article explores the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities, to aid in the understanding of the bioethical challenges we face today and to place them in an historical and societal context. Four plays are discussed that reflect the ethical and legal context of their eras and reveal significant ethical challenges for us to consider.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone

Faculty Scholarship

This Article examines how new technologies generate privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is …

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Faculty Scholarship

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Probiotics: Finding The Right Regulatory Balance, Diane E. Hoffmann, Claire M. Fraser-Liggett, Frank B. Palumbo, Jacques Ravel, Karen H. Rothenberg, Virginia Rowthorn

Faculty Scholarship

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated.

Environmental And Occupational Interventions For Primary Prevention Of Cancer: A Cross-Sectorial Policy Framework, Carolina Espina, Miquel Porta, Joachim Schüz, Ildefonso Hernández Aguado, Robert V. Percival, Carlos Dora, Terry Slevin, Julietta Rodriguez Guzman, Tim Meredith, Philip J. Landrigan, Maria Neira

Faculty Scholarship

Nearly 13 million new cancer cases and 7.6 million cancer deaths occur worldwide each year; 63% of cancer deaths occur in low and middle-income countries. A substantial portion of all cancers are attributable to carcinogenic exposures in the environment and the workplace.

The objective of this study was to develop an evidence-based global vision and strategy for the primary prevention of environmental and occupational cancer.

The study concluded that opportunities exist to revitalize comprehensive global cancer control policies by incorporating primary interventions against environmental and occupational carcinogens.

Neurotechnologies At The Intersection Of Criminal Procedure And Constitutional Law, Amanda C. Pustilnik

Faculty Scholarship

The rapid development of neurotechnologies poses novel constitutional issues for criminal law and criminal procedure. These technologies can identify directly from brain waves whether a person is familiar with a stimulus like a face or a weapon, can model blood flow in the brain to indicate whether a person is lying, and can even interfere with brain processes themselves via high-powered magnets to cause a person to be less likely to lie to an investigator. These technologies implicate the constitutional privilege against compelled, self-incriminating speech under the Fifth Amendment and the right to be free of unreasonable search and seizure …

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale, Elizabeth A. Reilly, Jeffery Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Dialogues, Dilemmas, And Disclosures: Genomic Research And Incidental Findings, Lynn W. Bush, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Genes And Plays: Bringing Elsi Issues To Life, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Ethical complexities surround the promise of genomic technology and the power of genetic information as they alter conceptions of identity and dynamics within personal and professional relationships. Creative approaches such as dramatic vignettes offer a unique analytical stage for imagining the bioethical past and future. Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine. Although the scientific landscape shifts, concerns expressed in theatre from 50 years ago parallel many contemporary ELSI (ethical, legal and social implications) issues, highlighting the ongoing struggle to appreciate the impact of emerging genetic technologies on relationships. To …

Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Transformative innovations in medicine and their ethical complexities create frequent confusion and misinterpretation that color the imagination. Placed in historical context, theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped -- and been shaped by -- personal and professional relationships. The drama of these human interactions is powerful and has the potential to generate fear, create hope, transform identity, and inspire empathy -- a vivid source to observe the complex implications of translating research into clinical practice through …

Accountable Care Organizations In The Affordable Care Act, Frank Pasquale

Faculty Scholarship

No abstract provided.

Opening The Industry Playbook: Myths And Truths In The Debate Over Bpa Regulation, Thomas Mcgarity, Rena I. Steinzor, Matthew Shudtz, Lena Pons

Faculty Scholarship

For the last two decades, scientists have amassed evidence that bisphenol A (BPA) poses a threat to human health. Although scientists have targeted BPA as a public health concern, plastics industry lobbyists have attempted to thwart the efforts of federal, state, and local authorities to reduce exposure to BPA. This paper reviews the major arguments advanced by the plastics industry and debunks them as “myths” that public health officials must reject. The five topics covered include: the myth of scientific consensus on safety; the myth that only studies complying with “Good Laboratory Practices” guidelines are adequate for making regulatory decisions; …

The Hippocratic Myth: Why Doctors Are Under Pressure To Ration Care, Practice Politics, And Compromise Their Promise To Heal, Frank Pasquale

Faculty Scholarship

Not many policymakers or scholars can write with the authority of Gregg Bloche. Bloche is not only a law professor, but a physician, who knows his way around a hospital. Throughout The Hippocratic Myth, Bloche cements his authority in the mind of the reader by relating stories of his experience as a clinician. In each of these stories, his humane and insightful approach as psychiatrist shines through. I do not say this to imply that Bloche uses his book to brag about his own abilities. Rather, these fluently-written passages strike one as the work of one of those rare practitioners …

Prosecuting Doctors For Trusting Patients, Deborah Hellman

Faculty Scholarship

In an escalating phase of our country’s war on drugs, doctors treating patients in pain are being prosecuted for drug trafficking under the Controlled Substances Act. While doctors surely can be guilty of drug trafficking when they sell drugs for money, lately some doctors have been prosecuted for violations of a statute that requires knowingly distributing or dispensing controlled substances in an unauthorized manner for simply being willfully blind to the fact that their patients were reselling the drugs. While willful blindness may be an apt substitute for knowledge in the traditional drug courier scenario, doctors in these cases are …

Physicians Who Break The Law, Diane E. Hoffmann

Faculty Scholarship

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …

The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

Over a quarter of a century has passed since health care ethics committees (HCECs) in the United States received legal recognition as alternatives to the courts in resolving conflicts related to patient end-of-life care. By the mid to late 1980s HCECs had been established in over half of U.S. hospitals and had received a certain legitimacy in the health care system. Given their age and growth one could characterize them developmentally as emerging from adolescence and establishing themselves in young adult-hood. As a result, we might expect that they would have resolved the identify crisis characterizing the adolescent years. Yet, …

Book Review: "Human Dignity And Bioethics: Essays Commissioned By The President's Council On Bioethics, Leslie Meltzer Henry

Faculty Scholarship

The President’s Council on Bioethics frequently invokes -- but never defines -- the notion of human dignity in its reports on caregiving, stem-cell research, cloning, assisted reproduction, and biomedical enhancement. This article argues that the Council employs the language of dignity so loosely in its policy recommendations that the word is often nothing more than a rhetorical trump card to reject policies at odds with the Bush administration’s perspective. This article examines how the Council uses the word dignity; explores competing philosophical, theological, and political understandings of the word; and suggests ways in which a more productive dialogue about dignity's …

Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz

Faculty Scholarship

No abstract provided.

Oy Canada! Trade's Non-Solution To "The Problem" Of U.S. Drug Prices, Daniel Gilman

Faculty Scholarship

Price disparities—price “differentiation” or “discrimination”—in pharmaceuticals markets have, in recent years, been the subject of much discussion. Price sensitivity should come as no surprise: Medicines play an increasingly important role in healthcare, while pharmaceuticals prices continue to rise. When prices vary greatly within markets or between neighboring markets, the pressure towards arbitrage is clear. This paper considers the question whether the re-importation of medicines from Canada or the EU is well advised and argues that it is not. First, we might reasonably question the extent to which we wish, as a matter of policy, to manage pharmaceuticals pricing; among other …

Undesirable Implications Of Disclosing Individual Genetic Results To Research Participants, Leslie Meltzer Henry

Faculty Scholarship

The bioethics and legal community are divided over whether investigators who conduct biomedical research are ethically and/or legally obligated to disclose incidental genetic findings to research participants. This paper argues that the justification for disclosure rests on the mistaken view that principles of beneficence, respect, reciprocity, and/or justice require researchers to offer participants individual genetic results. Whereas these principles and others obligate physicians to share individually relevant results with patients with whom they share a fiduciary relationship in the clinical care setting, they do not similarly obligate investigators to share such information with participants in the research setting. Furthermore, proposals …

Achieving The Right Balance In Oversight Of Physician Opioid Prescribing For Pain: The Role Of State Medical Boards, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

No abstract provided.

Whose Duty Is It Anyway?: The Kennedy Krieger Opinion And Its Implications For Public Health Research, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

In this article, the authors discuss the Maryland Court of Appeals decision in the case of Grimes v. Kennedy Krieger Institute, Inc. and its implications for the tort duty owed by researchers, in particular public health researchers, to their subjects. The Opinion resulted from two lawsuits alleging lead poisoning of children enrolled in a study conducted by the Kennedy Krieger Institute, a world renown pediatric research and treatment facility. The opinion shocked the research establishment with its scathing characterization of researchers and its apparent holding that in Maryland a parent cannot consent to the participation of a child in "nontherapeutic …