Topic: Genetics

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.

Gail Geller, ScD, MHS

In addition to her work in genetics, Dr. Geller’s other substantive areas of scholarship include the use of complementary and alternative medicine (CAM), the role of palliative care in chronic diseases, and the medical socialization process. She received one of the highly coveted NIH “challenge” grants to explore the integration of palliative care in the management of children, young adults and families affected by chronic, life-threatening disorders (muscular dystrophy and sickle cell disease). She received a prestigious Kornfeld Fellowship to explore the intersection of bioethics and CAM. She has served as co-director of the educational component of the Johns Hopkins CAM Center, ethics representative on the Data Safety & Monitoring Board of the National Center for Complementary & Alternative Medicine (NCCAM), and adjunct faculty at the Tai Sophia Institute in their Master’s Program in Transformative Leadership and Social Change. For 15 years, she co-directed the required Integrative Medicine course for Hopkins medical students, and the Healer’s Art elective. Several of the grants onwhich she has served as PI, Co-PI or Co-I have focused oncultivating respect, trust, empathy, wonder, and tolerance forambiguity among current and future health professionals. The unifying themes that animate her work are communication and decision-making under conditions of uncertainty, and the intrapersonal, interpersonal and social/cultural forces that influence moral development, attitudes and behavior.

Dr. Geller also has longstanding interests in ethics education. She served as Co-Deputy Director of the Greenwall Fellowship Program in Bioethics & Health Policy until 2012, and now, as the Berman Institute’s Director of Education Initiatives, she oversees the Hecht-Levi Fellowship Program in Bioethicsand the Masters in Bioethics . Dr. Geller has occupied several educational leadership positions in the SOM. She was involved in the revision to the undergraduate medical curriculum that took place in 2009. Currently, she co-directs the “culture of medicine” core theme which includes horizontal strands of particular relevance to ethics, professionalism and social justice. In addition, she directs the Scholarly Concentrationcalled the HEART (Humanism, Ethics, and the ‘Art’ ofMedicine), teaches in the “Medical Humanities & Social Medicine” elective, serves on the Advisory Board for the Center for Medical Humanities & Social Medicine, and directs the Program in Arts, Humanities & Health. She is a member of the School of Medicine’s Admissions Committee.

Dr. Geller has served on the Board of Directors of the American Society for Bioethics & Humanities, the scientific review panel for the ELSI Program (Ethical, Legal and Social Issues) at NIH’s National Human Genome Research Institute, the Advisory Board of the Center for Genetics Research Ethics and Law (CGREAL) at Case Western Reserve University, and the IOM Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials. She was a Consultant to the Ethics Working Group of the National Children’s Study, the Informed Consent Working Group of the Secretary’s Advisory Committee on Genetic Testing (SACGT), the CDC’s Program in Public Health Genetics, and the Presidential Advisory Committee on Human Radiation Experiments. She is a Fellow of the Hastings Center.

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.

Michelle Huckaby Lewis, MD, JD

Dr. Lewis received a BA degree in English and History from Stanford University before earning her JD degree from Vanderbilt University School of Law. After law school, she worked on Capitol Hill as a Legislative Assistant for Congressman Bob Clement from Tennessee. While working on Capitol Hill, she was appointed to the White Task Force on Health Care Reform during the Clinton Administration. She served on work groups related to Health Insurance Reform and Medical Malpractice Reform. Dr. Lewis then attended Tulane University School of Medicine and received her MD degree. She completed a residency in Pediatrics at the David Geffen School of Medicine at UCLA. She completed the Robert Wood Johnson Clinical Scholars Program at Johns Hopkins University and the Greenwall Fellowship Program in Bioethics and Health Policy at Johns Hopkins University and Georgetown University.

Jeremy Greene, MD, PhD

Greene’s most recent book, Generic: The Unbranding of Modern Medicine, narrates the history of generic drugs as a means of exploring problems of similarity and difference in modern medicine. Generic drugs are never fully identical to the brand name products they imitate. Rather, their claims to being ‘the same’ lies in proof that they are similar enough in ways that matter to be functionally interchangeable. As the market for generic substitutes has grown–from only 10% of the American pharmaceutical market in 1960 to nearly 80% by 2010–so too have epistemological and epidemiological conflicts over how one can prove that generics are truly equivalent to their brand-name counterparts. These debates over generic drugs reveal fundamental conflicts over what it means to practice rational medicine, and what role consumers, physicians, insurers, and others should have in defining that rationality.

He has begun work on a new project, Medicine At a Distance, which examines how changing expectations of instantaneous communications through electric, electronic, and digital media transformed the nature of medical knowledge. Most histories of medical technology focus on heroic diagnostic and therapeutic innovations–like X-rays and artificial hearts–which stand as visible symbols of medical modernity. His research is focused on recapturing how more mundane technologies of communication enabled and altered the production, circulation, and consumption of medical knowledge, from telegraph to text pager, telephone to telemedicine, fax machine to Facebook. This work is supported by a Faculty Scholars Fellowship from the Greenwall Foundation.

Karen H. Rothenberg, JD, MPA

Professor Rothenberg is a leading national expert on legal issues in health care. Over the last two decades she has focused her research primarily on the ethical, legal and social implications of genetic testing and research, including the legislative approaches to genetic information in the health insurance and employment context, the impact of genetic research on racial and ethnic populations and women’s health care, and the use of genetic information in the courtroom. Professor Rothenberg is co-editor of the book Women and Prenatal Testing: Facing the Challenges of Genetic Technology and co-author of five articles on genetics and public policy that have been published in the journal Science, the most recent of which is “Judging Genes: When Should Judges Admit or Compel Genetic Tests?” Her other numerous publications cover diverse research interests including the role of gender in health care, AIDS, research ethics, the right to forego treatment, emergency care, and new reproductive technologies. She has testified before federal and state legislatures on a wide range of issues, including the U.S. House of Representatives’ Genetic Information Nondiscrimination Act.

Professor Rothenberg has served on the Maryland Stem Cell Research Commission since its inception in 2006 (Chair from 2008-2010) and Co-Chaired the 2009 World Stem Cell Summit. She is a past president of the American Society of Law, Medicine and Ethics and former co-editor-in-chief of the Journal of Law, Medicine & Ethics. During sabbaticals and IPA leaves from the law school, she has worked at the NIH in the Office of Research on Women’s Health, the National Institute for Child Health & Human Development (NICHD) and NHGRI. She has served on the NICHD Institutional Review Board and has been a member of the NIH Recombinant DNA Advisory Committee, the National Action Plan for Breast Cancer, and numerous NIH panels on prenatal care, the recruitment and retention of women in clinical studies, and the ethical, legal and social implications of genetics.

She received both a B.A., magna cum laude and Phi Beta Kappa, from Princeton University and an M.P.A. from Princeton’s Woodrow Wilson School of Public and International Affairs. She earned a J.D. from the University of Virginia School of Law where she was a member of the Order of the Coif.