Research Area: Research Ethics

Remembering Daniel Callahan

By Ruth Faden

It is with profound sadness and a deep sense of gratitude that we mark the passing of Daniel Callahan, who died on Tuesday, July 16th, just two days shy of his 89th birthday.

Callahan was without question one of the founders and intellectual giants of the field of bioethics. Over the course of an extraordinary career, Callahan wrote 47 books, 17 solo-authored. Nine of his books won national prizes; all took difficult topics to new levels of scrutiny and insight, and many expanded the horizons of bioethics inquiry. Callahan’s most recent book, for example, The Five Horsemen of the Modern World (Columbia University Press, 2016) explored climate change, food, and water as well as chronic illness, and obesity.

In the 1970s and 80s, when I was coming of age in bioethics, it is no exaggeration to say that Dan defined much of what was, and still is, the best of bioethics. His commitment to interdisciplinary inquiry, to rigorous engagement with opposing viewpoints, and to seeking solutions to complex problems was like a magnet to me and others that were looking for a way to make a difference in ethics and public policy.

For many in bioethics, Dan was an extraordinary mentor, advocate and friend who took genuine pleasure in the accomplishments of others. I will never forget one letter I received when I was appointed chair of a presidential committee in the 1990s. It was incredibly supportive and encouraging, a “you can do this” kind of note, signed “an anonymous admirer”. It took me barely a nano-second to deduce that the note was from Dan (who sweetly ‘fessed up in a phone call, replete with more words of encouragement and support).

Dan has inspired so many of us in bioethics in so many ways. A true public intellectual, Dan’s prodigious, probing scholarship remains unmatched in its unique combination of rigor and accessibility. Many of Dan’s insights and arguments will remain vital and vibrant well into the future.

But for all of his extraordinary scholarly accomplishments, Dan Callahan’s legacy will perhaps most be defined by the co-founding and flourishing of the Hastings Center.

At the celebration of the Berman Institute’s 10th anniversary we honored the first recipient of the Harvey M. Meyerhoff Leadership in Bioethics Award. A global civic leader, long-time trustee of the Johns Hopkins University, and member and chair of the Berman Institute Board, Harvey (Bud) Meyerhoff played a major role in the founding and success of the Berman Institute. In establishing the Meyerhoff Leadership Award the intent was to honor people who, like Bud Meyerhoff, exemplify extraordinary leadership, specifically within or in support of the field of bioethics.

The selection committee had no difficulty agreeing on who the first recipient of the Meyerhoff Leadership Award should be.

I can think of no one who better represents the ideals of leadership in the field of bioethics than Dan Callahan. In fact, the story of contemporary biomedical ethics cannot be accurately told without identifying the central role of both Dan and the Hastings Center.

In the late 1960s, Dan foresaw the need for an organization that could engage in systematic intellectual study of the ethical issues raised by the new technological medicine and the broader impact of this new medicine on culture. Serving as the director or president of the Hastings Center for its first 27 years, Dan helped guide the Center from a one-room entity in the basement of his house (supported by a small gift from his mother) into a major center for bioethics scholarship and public engagement.

Today the legacy of Dan Callahan, lies not only in the quality of Hasting Center’s own research projects and of Dan’s own scholarship, but also in the numerous other bioethics scholars and centers that Dan has helped spawn in the United States, Europe, and Asia.

All of us in bioethics are deeply indebted to Dan Callahan. Dan will be sorely missed but his voice and his presence will be ever with us.

 

Image: By Chip Porter – www.thehastingscenter.org, CC BY 3.0

Cynda Rushton Named to Nurse Researcher Hall of Fame

Berman Institute faculty member Cynda Rushton has been selected for induction into the Sigma Theta Tau International Honor Society of Nursing (Sigma) 2019 International Nurse Researcher Hall of Fame. Professor Rushton was chosen for significant contributions to the nursing profession and her sustained research efforts to improve the care and health of people, specifically in the areas of aging and nursing ethics.

As Anne and George L. Bunting Professor of Clinical Ethics at the Berman Institute and the Johns Hopkins School of Nursing, Rushton, PhD, RN, FAAN, focuses on moral suffering and resilience of clinicians, and designing cultures of ethical practice. In 2014, she co-led the first-ever National Nursing Ethics Summit to prepare a blueprint for nursing ethics in the 21st century, and in 2016, an initiative to help nurses transform morally distressing experiences into moral resiliency.

Her most recent work has been designing, implementing, and evaluating the Mindful Ethical Practice and Resilience Academy (MEPRA) to train nurses challenged with patient suffering, resource allocation, and other ethical situations to respond with integrity. She is author and editor of a new book Moral Resilience: Transforming Moral Suffering in Healthcare (Oxford University Press).

“Ethical practice is the bedrock of nursing, and we are at a pivotal junction in health care that demands that we reorient toward our moral compass,” says Rushton. “My work has been supported by so many peers and mentors along the way, which has helped make this honor a reality. I am humbled and grateful to have been selected as part of this distinguished group of nurses.”

Rushton will be inducted at Sigma’s 30th International Nursing Research Congress in Canada, July 2019.

A version of this article was first published by the JHSON.

Apply: Genomics & Society Mentorship Program

Summer Internship Dates: May 26 – August 3, 2019

Application Deadline: Early February, 2019.
Applicants will be informed of their status by March 1.

6 slots available for Summer 2019 cohort

Open to undergraduate students interested in the ethics of research, clinical care and/or public health, the Johns Hopkins Genomics and Society Mentorship Program begins with a 10-week Summer Internship Program (SIP) through the Johns Hopkins School of Medicine. The Johns Hopkins SIP provides summer research experience to underrepresented minorities, students from economically disadvantaged and underserved backgrounds, and students with disabilities. Through the Mentorship Program, these students will gain experience doing research centered on ethical, legal and social implications (ELSI) of genomics.

Visit the Program webpage for more information and to apply.

Berman Faculty share response to human gene editing claims

A renegade. But not a charlatan.

That was the opinion of a group of Berman Institute faculty about He Jiankhi, the Chinese scientist who claims to have used the gene-editing tool CRISPR to edit the embryos of twin girls that he said were born last month.

In the wake of He’s announcement, the Berman Institute held a Dec. 10 panel discussion, “Ethics, Policy, and Human Genome Editing—What’s Now? What’s Next?” for the faculty and students of the JHU School of Medicine’s Institute of Genetic Medicine (watch below).

Berman Institute Director Jeffrey Kahn was in Hong Kong to attend the Second International Summit on Human Genome Editing when the news of He’s actions broke.

“If true as reported – and He, who has now vanished from sight, has not published any data that would confirm his action – this would be an extremely premature and ethically problematic experiment in creating genetically modified children,” said Kahn.

Kahn was joined on the panel by Debra Mathews, who gave a brief scientific introduction to genetic modification, and Jeremy Sugarman, who outlined a number of the ethical issues raised by He’s actions, including lack of oversight, the possibility of off-target effects, the informed consent of the parents, the prospect of genetic enhancement raised by He’s actions, and the need for responsible follow-up, among others.

The panel stated that He’s actions would be illegal in many countries, including the United States, and that recent developments suggest that Chinese authorities are investigating their legality in his native country.  Such an experiment also violates the recommendations in the international consensus report issued in 2017.

“The creation of these gene-edited children violates virtually every existing guideline, policy, norm, and value surrounding the use of this technology,” said Kahn, who was interviewed by numerous media outlets about He’s actions, including the Washington Post, NPR, and Vox.

Kahn said that the Berman Institute would continue to organize programs and provide additional ongoing response about the bioethical implications of human gene editing.

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).

 

Prof. Unguru Decries Drug Shortages

Calling access to essential medicines a basic human right, Berman Institute professor Yoram Unguru made a compelling argument for the United States Food & Drug Administration to establish an Essential Medicines List, as a first step in ensuring that the population has access at all times, and in sufficient amounts, to medicines that satisfy their priority health care needs.

Speaking at a Nov. 27 Washington, DC, meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” convened in cooperation with the U.S. FDA, Dr. Unguru explained that shortages of vital drugs have harmed countless patients, been implicated in patient deaths between 2010-2012, and had a lasting detrimental impact on clinical research, threatening researchers’ ability to achieve meaningful progress in improving the lives of children with cancer.

“Typically, we only get one chance to cure children with cancer. If that opportunity is missed, it’s rare that we are able to cure them of their disease,” said Dr. Unguru.

“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, one in 2015 and again just last year, found the two out of three pediatric oncologists reported that their patients’ clinical care was compromised by the shortages.”

View Dr. Unguru’s full comments here.

The purpose of the Nov. 27 meeting was to give stakeholders including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages and to make recommendations for actions to prevent or mitigate drug shortages.

Dr. Unguru called on the FDA to join many other countries throughout the world in adopting the World Health Organization’s essential medicines list (EML). As defined by the WHO, essential medicines: “Satisfy the priority health care needs of the population. Medicines included in the EML are both clinically effective and cost effective and are to be available at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.”

The current WHO Essential Medicines List for Children includes 18 chemotherapy agents and 4 supportive care medicines.

“This 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.

He has appeared, among other places, in the New York Times and on NPR to discuss allocation of scarce children’s cancer-treating drugs.

“Given the continued shortages of drugs, especially generic injectable drugs that are essential to the treatment of children with cancer, the United States should create an EML for pediatric oncology drugs,” Dr. Unguru said.

“Ultimately, what is needed is greater involvement by government.  Congress must grant federal authorities the ability to ensure that patients in need have access to medications.  Children with cancer should not have to continue to suffer because of inaction and a lack of will; they deserve better.”

2018-19 Seminar Series

Leading bioethics scholars from around the world lecture on vital issues in the field at our biweekly Seminar Series. Lectures, held at lunchtime, are free and open to the public.

2018-2019 Berman Institute Seminar Series
Seminars are video recorded and posted on our YouTube channel.

Upcoming Seminars

May 13, 2019
Holly Fernandez Lynch, JD, MBE
“Evaluating IRB Quality and Effectiveness”
Seminar Details
Feinstone Hall

Past Seminars

September 24, 2018.
Jonathan Moreno, PhD
“Bioethics is Advocacy: Is That So Wrong?”

October 8, 2018
Travis Rieder, PhD
“Bioethics, Pain Medicine, and America’s Opioid Crisis”

October 29, 2018
Matteo Bonotti, PhD
“Opportunity Pluralism and Children’s Health”

November 12, 2018
Peter Buxtun
“Marked Men: In Case You Didn’t Know about Tuskegee”

February 11, 2019
Alex John London, PhD
“Ethical and Regulatory Issues With Autonomous Vehicles”

March 11, 2019
David S. Jones, MD, PhD

March 25, 2019
Marion Danis, MD
“Engaging the Public in Setting Health Care Priorities”

April 8, 2019
Brian Carter, MD
Hutzler-Rives Memorial Lecture: “Insights from patienthood: A pediatrician and bioethicist’s reflections on pediatric palliative care”

April 22, 2019
Effy Vayena, PhD
“Digital Health Ethics: The Systemic Oversight Approach”