Citing uncertainties about the risks and benefits of an experimental therapy for fetuses whose kidneys do not develop, bioethicists at Johns Hopkins and a team of medical experts are calling for rigorous clinical trials in the use of a potential treatment, known as amnioinfusion.
The article, published ahead of print in Obstetrics & Gynecology, calls for a better look at the ethical issues related to this novel intervention, which was driven by a well-publicized birth from 2012; the child is still alive. The authors, who include those among all relevant disciplines, have identified 10 key categories of ethical issues relevant to this novel intervention: potential risks and benefits, clinical care compared with innovation compared with research, counseling of expectant parents, consent, outcome measures, access and justice, conflicts of interest, effects on clinicians, effects on institutions and long-term societal implications.
Bilateral renal agenesis occurs in 2.88 per 10,000 live births. This means that about 1,100 pregnancies are affected by this condition annually in the United States. The condition has been considered uniformly fatal because, without functioning kidneys, the fetus’ lungs also do not fully develop. However, serial prenatal amnioinfusions might be able to overcome problems with lung development. The treatment consists of infusing saline solution into the amniotic sac to allow the lungs to develop. The idea is to support the fetus so that, after birth, the baby can undergo dialysis and ultimately kidney transplantation.
Yet, these infusions may also pose risks to the mother and may cause premature birth. Since this intervention is still experimental, careful research must be done to assess the safety and efficacy of the procedure. Additionally, families must receive proper counseling on their options. Those faced with the diagnosis of bilateral renal agenesis also have pregnancy termination and expectant management with palliative care, as well as experimental interventions, to consider.
“It is important that expectant parents considering an intervention do so by enrolling in a formal clinical trial,” says Jeremy Sugarman, Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins University School of Medicine and the deputy director for medicine of the Berman Institute of Bioethics at The Johns Hopkins University. “This way the decisions and experiences of the families, patients and physicians can be captured so we can find out if the intervention is safe and effective.”
The bottom line, says Sugarman, is the need for long-term multicenter research involving those who choose serial amnioinfusions and those who do not, so that physicians can properly inform and counsel families about treatment options and likely outcomes for their fetuses.
Sugarman, Jeremy MD, MPH; Anderson, Jean MD; Baschat, Ahmet A. MD; Herrera Beutler, Jaime BA; Bienstock, Jessica L. MD, MPH; Bunchman, Timothy E. MD; Desai, Niraj M. MD; Gates, Elena MD; Goldberg, Aviva MD, MA; Grimm, Paul C. MD; Henry, Leslie Meltzer JD, PhD; Jelin, Eric B. MD; Johnson, Emily MSN, RN; Hertenstein, Christine B. MGC; Mastroianni, Anna C. JD, MPH; Mercurio, Mark R. MD, MA; Neu, Alicia MD; Nogee, Lawrence M. MD; Polzin, William J. MD; Ralston, Steven J. MD, MPH; Ramus, Ronald M. MD; Singleton, Megan Kasimatis JD, MBE; Somers, Michael J. G. MD; Wang, Karen C. MD; Boss, Renee MD, MHS. Ethical Considerations Concerning Amnioinfusions for Treating Fetal Bilateral Renal Agenesis. December 4, 2017; Published Online Ahead of Print
Ms. Javitt has served as an adjunct professor of law at the University of Maryland School of Law, where she has taught Food and Drug Law and Genetics and Law, and at the Johns Hopkins School of Public Health, where she co-taught Health Law and Regulation. She was a Greenwall Fellow in Bioethics and Health Policy at Johns Hopkins and Georgetown Universities. She was an Associate at Covington & Burling in Washington, D.C., where she specialized in FDA regulatory issues. She served as law clerk to the Honorable Gary L. Taylor, U.S. District Court, Central District of California. She has written on a variety of science regulatory and legal issues on topics including direct-to-consumer advertising of genetic testing and FDA regulation of biotechnology. She holds the Juris Doctor (J.D.), cum laude, from Harvard Law School, a Masters of Public Health (M.P.H.) from the Johns Hopkins University and a B.A., magna cum laude, Phi Beta Kappa, from Columbia College.
JD, Harvard Law School
MPH, Johns Hopkins University
BA, Columbia College
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At the University of Minnesota, Kahn was an associate and then full professor in the Department of Medicine, where he held the Maas Family Endowed Chair in Bioethics. He held additional faculty appointments in the Philosophy Department, Clinical Research Graduate Program, School of Public Health, and Institute of Public Affairs, and he was a faculty fellow in the law school. During his 15-year tenure leading Minnesota’s Center for Bioethics, he founded the Association of Bioethics Program Directors, serving as its inaugural president from 2006 to 2010. He is also an elected fellow of the Hastings Center.
Kahn is a renowned leader in bioethics whose work explores the intersection of ethics and health and science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies. During his more than 25-year career, he has been consistently funded to carry out groundbreaking interdisciplinary bioethics research. Most recently, the NIH awarded him and co-principal investigator Gail Geller a four-year, $4.15 million award to launch a Center of Excellence in Ethical, Legal, and Social Implications of Genomic Uses in Infectious Diseases and Epidemics.
Kahn has served on numerous state and federal advisory panels. He is currently chair of the National Academy of Medicine’s Board on Health Sciences Policy. He previously chaired the Institute of Medicine’s Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, the Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights, and the Committee on Ethical and Social Implications of Mitochondrial Replacement Techniques. He also served on the NIH Recombinant DNA Advisory Committee.
He has published more than 115 articles in the bioethics and medical literature and is the co-author of Contemporary Issues in Bioethics and Beyond Consent: Seeking Justice in Research. He speaks widely around the world on a range of bioethics topics, in addition to frequent media outreach. From 1998 to 2002, he penned the biweekly “Ethics Matters” column on CNN.com.
Kahn has been engaged in numerous activities across Johns Hopkins. He is chair of the Public Interest Investment Advisory Committee, he co-chaired search committees for a Bloomberg Distinguished Professor and the Bunting Professor in Clinical Ethics in the School of Nursing, and he has served on university-wide faculty advisory committees on digital education and MOOCs.