Research Area: Science and 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

Berman Institute Director Named to International Commission

Jeffrey Kahn, Andreas C. Dracopoulos Director of the Berman Institute and Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, has been appointed to an international commission convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the Royal Society of the U.K., with the participation of science and medical academies around the world, to develop a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical applications of human germline genome editing. The framework will identify a number of scientific, medical, and ethical requirements that should be considered, and could inform the development of a potential pathway from research to clinical use – if society concludes that heritable human genome editing applications are acceptable.

Prof. Kahn has served on numerous state and federal advisory panels. He is currently chair of National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy, and has previously chaired its committee on the Use of Chimpanzees in Biomedical and Behavioral Research (2011); the committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights (2014); and a committee on the Ethical, Social, and Policy Considerations of Mitochondrial Replacement Techniques (2016).  He also formerly served as a member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee.

The commission is the latest action from the international science community to address issues around human genome editing.  It follows the Second International Summit on Human Genome Editing in Hong Kong – convened last November by the U.S. National Academies, the Royal Society, and the Academy of Sciences of Hong Kong. The topic became a focus of global attention when a scientist from China revealed at the summit that as a result of his research, twins had been born whose embryonic genomes had been edited. The scientist was widely condemned by the global scientific community for violating long-standing scientific principles and ethical norms.

The commission will:

  • identify the scientific issues – as well as societal and ethical issues, where inextricably linked – that must be evaluated for any possible clinical application of germline genome editing;
  • identify protocols and preclinical validation for evaluating the potential for off-target effects, mosaicism, and any potential long-term side effects that may result;
  • discuss ways to assess the balance between potential benefits and harms of germline editing applications to a child and to subsequent generations;
  • design appropriate protocols for obtaining patient consent and ethical approval from review committees, and for satisfying requirements of regulatory authorities;
  • assess possible mechanisms for long-term monitoring of children born with edited genomes; and
  • outline research and clinical characteristics that would form part of an oversight structure, including defining criteria for heritable genome editing, monitoring any clinical use, and bringing forward concerns about human experiments.

The commission will hold public meetings and an international workshop, and will also issue a call for public input to inform their work.  The commission’s final report is expected to be issued in the spring of 2020.

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”

Alan Regenberg, MBE

Alan is also engaged in a broad range of research projects and programs, including the Berman Institute’s science programs: the Stem Cell Policy and Ethics (SCOPE) Program; the Program in Ethics and Brain Sciences (PEBS-Neuroethics); and the Hinxton Group, an international consortium on stem cells, ethics and law; and the eSchool+ Initiative. Recent research has focused on using deliberative democracy tools to engage with communities about their values for allocating scarce medical resources like ventilators in disasters like pandemics. Additional recent work has focused on ethical challenges related to gene editing, stem cell research, social media, public engagement, vaccines, and neuroethics. (Publications)