Topic: Public Health Ethics

Can Physicians Working in Detention Facilities Uphold Their Hippocratic Oath?

Berman Institute faculty Nancy Kass and Len Rubenstein, along with Paul Spiegel of the Bloomberg School of Public Health’s Center for Humanitarian Health, have published “Can Physicians Work in US Immigration Detention Facilities While Upholding Their Hippocratic Oath?”in the Aug. 30 online edition of JAMA Viewpoint.

The authors state that medical ethics “have been strikingly consistent from Hippocrates to modern-day guidance. Whatever the future of US immigration policy, decent and humane treatment of children, as well as all other detainees, and preservation of the independence of physicians and other health professionals to meet patients’ medical and psychological needs are essential. Now is not a time to change the commitments, reputation, and integrity of physicians and the medical profession.”

The authors put forward a number of concrete steps that should be taken to ensure appropriate treatment of individuals receiving medical care in Health and Human Services (HHS) facilities run by the Office of Refugee Resettlement (ORR). They include:

  • “Health care professionals should insist on and adhere to clinical independence to ensure they are able to provide the highest standards of care that are in the best interests of the patient. This independence also demands that physicians and other health care professionals are not subject to retribution for reporting … about their evaluations of conditions of detention that impede their patients’ health and the availability of quality medical care.”
  • “There needs to be an independent health oversight body that monitors all aspects of preventive and curative health services, outcomes, and standards in DHS and ORR/HSS immigration detention facilities, assesses health care practitioners’ ability to uphold their primary professional obligations, and issues timely recommendations. The proposed independent oversight body should be completely insulated from government interference and be granted full access to all DHS and ORR/HSS detention facilities, their personnel, and patient medical records at any time.”
  • DHS and ORR/HHS should be required to report on a regular basis how they are meeting their own and international standards for each facility for which they are responsible. While Customs and Border Patrol, Immigration and Customs Enforcement, and ORR standards exist, they should be assessed independently to ensure they are sufficient and meet international standards. Furthermore, their responses to the independent health oversight organization should also be made public.”

Nancy Kass is the Phoebe R. Berman Professor of Bioethics and Public Health and the Berman Institute’s Deputy Director for Public Health. Len Rubenstein is core faculty at the Berman Institute and the Director of the Program on Human Rights, Health and Conflict at the Bloomberg School’s Center for Public Health and Human Rights. Paul Spiegel is Director of the Center for Humanitarian Health at the Bloomberg School.

Newly Published Oxford Handbook of Public Health Ethics Provides Sweeping and Authoritative Review of Field 

Representing the culmination of a multi-year scholarly effort, this month’s publication of The Oxford Handbook of Public Health Ethics provides for the first time a sweeping and authoritative review of public health ethics, with faculty from the Johns Hopkins Berman Institute of Bioethics taking a leading role in its creation.

The Handbook’s three editors include Jeffrey Kahn, Andreas C. Dracopoulos Director of the Berman Institute, and Nancy Kass, Vice Provost for Graduate and Professional Education, and Phoebe R. Berman Professor of Bioethics and Public Health at Johns Hopkins. Berman faculty wrote 23 of the book’s chapters and edited 11 of its 15 sections. Faculty from the Bloomberg School of Public Health wrote an additional 11 chapters.

While medical ethics has a rich history dating back thousands of years, an explicit focus on public health ethics is much more recent.  And as public health seeks to gain increasing benefits for populations—from improving diets and vaccination rates to reducing injuries and violence—critical questions that focus on how far the reach of public health intervention should go, and how to ensure that public health benefits are realized by all become increasingly critical to address.

Vexing ethics issues are inherent in all aspects of public health practice and policy. They exist in top-of-the-news stories like infectious disease outbreaks and vaccine hesitancy, health disparities, and in more routine assessments of population health needs, data collection, program evaluation, and policy development. They may be distinctive or shared across diverse fields, such as environmental health, nutrition programs and policy, injury prevention, communicable and noncommunicable diseases, and reproductive health.

“Public health practitioners and policymakers face questions of ethics routinely in their work, and they must navigate sometimes competing responsibilities to the public with other important values such as privacy, autonomy, and prevailing cultural norms,” wrote the editors, who also include Anna Mastroianni, Professor of Law at the University of Washington School of Law and Associate Director of the university’s Institute for Public Health Genetics.

The score of topics and range of perspectives the Handbook offers ensures it will be an indispensable guide to the state of public health ethics today, both in the United States and globally, and a valuable resource for practitioners, policymakers, researchers, scholars and students.

The Handbook provides an authoritative review of public health ethics in topics including genetics, violence, pandemics, global issues and many more. The 73 chapters are organized into 15 sections, each prefaced with an original essay by a leading scholar highlighting the ethics issues in that particular area of public health. Two sections are dedicated to the conceptual foundations, ethical tensions, and ethical frameworks of and for public health and how public health does its work. The 13 sections that follow are arranged topically, examining ethics considerations across the broad expanse of public health.

Chapters by Berman Institute-affiliated authors include:

Anne Barnhill

Claire Davis

Mike DiStefano

Ruth Faden

Jessica Fanzo

Gail Geller

Leslie Meltzer Henry

Nancy Kass

Carleigh Krubiner

Michelle Huckaby Lewis

Debra Mathews

Maria Merritt

Maggie Moon

Brendan Saloner

Andrew Siegel

Holly Taylor (completed contribution while on Berman Institute faculty, now at Dept. of Bioethics, Clinical Center, National Institutes of Health)

For more than a decade, the Oxford University Press’ Handbook series has published cutting-edge research by the world’s leading scholars across more than a dozen disciplines. Each volume offers an authoritative and state-of-the-art survey of current thinking in a particular subject area. The Oxford Handbook of Public Health Ethicsfills a critical gap, joining previously published Oxford Handbooks devoted to a wide range of related areas,including Bioethics, Clinical Research Ethics, Reproductive Ethics, Psychiatric Ethics, and Animal Ethics.

The Oxford Handbook of Public Health Ethicshas just been released in print by Oxford University Press. Individual chapters are also available online through Oxford Handbooks Online.

Viewing Drug Shortages as a Public Health Crisis

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. However, shortages in the drugs which make up the backbone of many proven and life-saving pediatric oncology regimens have become commonplace in the United States, with far-reaching consequences. In a paper published in the March 4 JAMA Pediatrics, Berman Institute professor Yoram Unguru and colleagues explore the causes and impacts of drug shortages, and call for government intervention to address this growing public health crisis.

“Typically we only get one chance to cure disease. If that opportunity is missed, it is rare we are able to cure childhood cancer,” says. Dr. Unguru. “Direct consequences of drug shortages include increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths.”

“At the height of the shortages, a survey of medical oncologists found that a staggering 83% of oncologists weren’t able to prescribe their preferred chemotherapy agent. More than 75% had to make a major change in treatment such as choosing a different treatment regimen or substitute different drugs during the treatment. And over 40% had to delay the start of treatment. Two surveys of childhood cancer specialists, in 2015 and in 2017 , found that two out of three pediatric oncologists reported that their patients’ clinical care was compromised by the shortages.”

Dr. Unguru and his co-authors argue that the U.S., like many other countries already have, should establish an essential medicines list. As defined by the WHO, essential medicines satisfy the priority health care needs of the population. Medicines included in the essential medicines listare both clinically effective and cost effective and are to be available within the context of functioning health systems at all times in adequate amounts and dosage forms, with assured quality and at an affordable price.The current WHO Essential Medicines List for Children includes 18 chemotherapy agents and 4 supportive care medicines.

“It may shock you to hear, but over the past 2.5 years, nearly two-thirds of these essential medicines for children with cancer have been or are currently in short supply in the U.S.  In fact, at this time, 5 of the 18 essential medicines, nearly 30%, are in short supply in the U.S.,” said Dr. Unguru.

Dr. Unguru is a pediatric hematologist/oncologist with joint faculty appointments at The Herman and Walter Samuelson Children’s Hospital at Sinai and The Johns Hopkins Berman Institute of Bioethics, where he is a Core Faculty member. He is also an Assistant Professor in the Johns Hopkins School of Medicine. Dr. Unguru is a member of the Children’s Oncology Group, and leads a multidisciplinary, transnational working group examining the ethical and policy implications of chemotherapy shortages in childhood cancer.

Vaccine Guidance Gains Global Attention

Health and Bioethics Experts: “The treatment of pregnant women in vaccine research
and deployment is unacceptable. Business as usual simply cannot continue.”

New Report Lays out Recommendations for Policymakers, Researchers, and Global Health Organizations on Including Pregnant Women in Epidemic Vaccine Development and Deployment

Even as health care responders valiantly battle the ongoing Ebola outbreak in the Democratic Republic of Congo, one highly vulnerable group is being denied a potentially life-saving vaccine: pregnant and lactating women. This and other recent epidemics of Zika, Lassa Fever, and Hepatitis E have shown how infectious disease outbreaks can severely – and at times uniquely – affect the health of pregnant women and their offspring. Despite a significantly higher risk of serious disease and death, vaccines against these devastating diseases are rarely developed and approved for pregnant women.

Changing institutional and government practices so that we have vaccines to offer pregnant women in an epidemic is one of 22 long overdue recommendations contained in the new report Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, issued in December 2018 by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy. The report, aiming to ensure that pregnant women are no longer excluded from receiving vaccines against emerging infectious diseases, has received widespread media attention, including:

“The self-perpetuating cycle of excluding pregnant women from research and from the benefits of vaccination must end,” said Carleigh Krubiner, a lead author of the report jointly appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development. “With global efforts now underway to develop a range of vaccines against devastating epidemic threats, we have to make sure pregnant women are on the agenda, so they will never again be left unprotected in the face of future outbreaks.”

The report lays out concrete steps for equitably addressing the needs of pregnant women in public health preparedness, vaccine research and development, and the deployment of vaccines during epidemics. Its recommendations include:

  • During an epidemic, the default should be to offer vaccines to pregnant women—not the reverse.
  • Vaccines that can be safely given to pregnant women need to be developed. For these vaccines, evaluation in pregnancy needs to occur as early in the clinical development process as possible.
  • During an epidemic, decisions about whether pregnant women will be offered vaccines should consider not only any potential risks of the vaccine but also, and importantly, the risks pregnant women and their babies face if vaccine is denied.
  • All decisions about inclusion or exclusion of pregnant women should be informed by those with the relevant expertise in maternal and neonatal health as well as in vaccinology and virology.
  • The perspectives of pregnant women themselves should inform vaccine research and deployment decisions that may mean life or death for them and/or their babies.

The full recommendations are available at http://vax.pregnancyethics.org/prevent-guidance.

“The way we have treated pregnant women in vaccine research and deployment is utterly unacceptable. Business as usual cannot be permitted to continue,” said Ruth R. Faden, a lead author of the report and founding director of the Johns Hopkins Berman Institute of Bioethics. “Ensuring that pregnant women affected by outbreaks have safe and effective vaccines is not only a matter of justice and health equity, it’s also critical to the public health response.”

That pregnant women affected by the ongoing Ebola crisis in the Democratic Republic of the Congo are not being offered vaccine demonstrates how urgent and serious the consequences are of the status quo exclusions of pregnant women from vaccine research and delivery. In recent UNICEF interviews, pregnant women “clearly articulated that they wanted to choose whether to be vaccinated or not.”  As one woman said, ‘now there is no option, you just send us to death.’”

“As we continue to develop new vaccines against pathogens with serious and often lethal consequences in pregnancy, pregnant women must be on the agenda every step of the way,” said Ruth A. Karron, a lead author of the report and director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative at Johns Hopkins Bloomberg School of Public Health. “We simply can’t continue to fail pregnant women as we develop new vaccines against emerging threats.  We need to generate an evidence base for safe and effective use of these vaccines during pregnancy.”

To read the full report visit vax.pregnancyethics.org/prevent-guidance. In conjunction with the report release, PREVENT has also released a video that discusses the risks of the status quo, and describes why urgent action is needed. You can watch the video at vax.pregnancyethics.org.

PREVENT is a grant-funded project led by faculty at Johns Hopkins University alongside co-investigators at Georgetown University and the University of North Carolina at Chapel Hill, with external contributions from Working Group Members. The PREVENT Project is funded by the Wellcome Trust (203160/Z/16/Z).

 

Leslie Meltzer Henry, JD, PhD

Professor Henry provides expert commentary for federal and local agencies, organizations, and the media. She has served as a bioethics consultant to the Department of Defense and has presented before panels of the Department of Health and Human Services, the Food and Drug Administration (FDA), and the National Institutes of Health Bioethics Advisory Committee. Professor Henry has provided written commentary for the Mid-Atlantic Ethics Committee Network, and she has been quoted in media outlets including the Atlantic, the Wall Street Journal, CNN, ABC, NPR, the Chronicle of Higher Education, Forbes, and the Baltimore Sun.

Professor Henry is a co-investigator on a project focused on addressing the ethical and legal challenges of conducting research with pregnant women during public health emergencies, like the Zika crisis, where there is an urgent need to attend to the health needs of pregnant women and their offspring.  She is also a member of PHASES, a research team aiming to develop ethically and legally acceptable strategies for conducting research about HIV treatment and prevention during pregnancy.

Prior to joining the faculty, Professor Henry completed a post-doctoral fellowship in bioethics and health policy at Johns Hopkins School of Public Health and Georgetown Law Center, clerked for the Honorable Judith Rogers of the U.S. Court of Appeals for the District of Columbia Circuit, was a fellow in the National Institutes of Health’s Office of Human Subjects Research, and was founder and Editor-in-Chief of the Yale Journal of Health Policy, Law, and Ethics.

Maria Merritt, PhD

HONORS AND AWARDS

  • Hastings Center Fellow, elected December 2020
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01: classroom), 4th term 2016-17, 2015-16, 2014-15, 2012-13, and 2011-12; (221.616.81: online), 4th term 2017-18 and 2016-17; and as principal instructor of Ethics in Global Health Practice (604.603.86), 2018-19.
  • Student Assembly Special Recognition Award for Outstanding Commitment to Student Success, 2017
  • Principal Investigator, NIH award number 1R01AI114458-01A1, 2015-19, “Assessing Social Justice in Economic Evaluation to Scale up Novel MDR-TB Regimens” (award issued by National Institute of Allergy and Infectious Diseases)
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01), 4th term 2015-16; 2014-15; 2012-13; and 2011-12
  • Co-Investigator, NIH award number 1R01AI085147-01A1, 2010-14, “Ancillary Care in Community-Based Research: Deciding What to Do” (PI Holly A. Taylor; award issued by National Institute of Allergy and Infectious Diseases)
  • Greenwall Faculty Scholars Program in Bioethics career development award, 2009-12, “Researchers’ Obligations in Community-Based Research: Resolving Dilemmas of Care”
  • Faculty Innovation Fund, 2007-08, Johns Hopkins Bloomberg School of Public Health, “Ancillary Care in Public Health Intervention Research in Resource-Limited Settings: Researchers’ Practices and Decision-Making”(Co-PI Holly A. Taylor)
  • Faculty Fellow, Edmond J. Safra Foundation Center for Ethics, Harvard University, 2005-06
  • Postdoctoral Fellow, Department of Clinical Bioethics, National Institutes of Health, 2000-02
  • Rhodes Scholar, Oxford University, 1987-90

Vaccinating Pregnant Women Against Ebola

In a STAT News opinion piece, Johns Hopkins University experts, including our Ruth Faden, argued it is unfair to deny pregnant and lactating women the experimental Ebola vaccine if they wish to take it, given the great risk the virus poses to those who are exposed to it.

“From a public health perspective and an ethical perspective, the decision to exclude pregnant and lactating women is utterly indefensible,” they wrote.

The authors are members of Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group, which has brought together an international team of experts in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research to provide specific recommendations developed to address this critical gap in vaccine research and development and epidemic response. This group recognizes that excluding pregnant women from efforts to develop and deploy vaccines against emerging threats is not acceptable.

Nancy E. Kass, ScD

Dr. Kass is coeditor (with Ruth Faden) of HIV, AIDS and Childbearing: Public Policy, Private Lives (Oxford University Press, 1996).

She has served as consultant to the President’s Advisory Committee on Human Radiation Experiments, to the National Bioethics Advisory Commission, and to the National Academy of Sciences. Dr. Kass currently serves as the Chair of the NIH Precision Medicine Initiative Central IRB; she previously co-chaired the National Cancer Institute (NCI) Committee to develop Recommendations for Informed Consent Documents for Cancer Clinical Trials and served on the NCI’s central IRB. Current research projects examine improving informed consent in human research, ethical guidance development for Ebola and other infectious outbreaks, and ethics and learning health care. Dr. Kass teaches the Bloomberg School of Public Health’s course on U.S. and International Research Ethics and Integrity, she served as the director of the School’s PhD program in bioethics and health policy from its inception until 2016, and she has directed (with Adnan Hyder) the Johns Hopkins Fogarty African Bioethics Training Program since its inception in 2000. Dr. Kass is an elected member of the Institute of Medicine (now National Academy of Medicine) and an elected Fellow of the Hastings Center.

Travis N. Rieder, PhD

Travis’ work tends to fall into one of two, quite distinct research programs. The first concerns ethics and policy questions about sustainability and planetary limits. Much of this research has been on issues in climate change ethics and procreative ethics with a particular focus on the intersection of the two – that is, on the question of responsible procreation in the era of climate change.  His publications have appeared in several journals on this topic, as well as in a short book with Springer, entitled Toward a Small Family Ethic (2016). He also works on food ethics related to climate change and sustainability, and is currently a member of the Global Food Ethics and Policy team, focusing on ethical issues concerning high-emissions food, in particular animal-sourced foods.

The second, and much newer, research program concerns ethical and policy issues surrounding America’s opioid epidemic. In this area, Travis has published an essay in Health Affairs concerning physician responsibility for safely weaning patients off prescription opioids, and co-authored a National Academy of Medicine Perspective Paper on Physician Responsibility in combating the opioid crisis.

In addition to his more scholarly writing, Travis is firmly committed to doing bioethics with the public, and to that end writes and interviews regularly for the popular media; his work has appeared in very many high-impact publications, including The Guardian, Washington Post, NPR’s All Things Considered, New Republic, and IFLScience. He writes regularly for The Conversationand blogs occasionally at The Huffington Post and the Berman Institute Bioethics Bulletin.