Medical and surgical innovations are sometimes attempted in effort to save lives. Some innovations ultimately prove beneficial (e.g., umbilical cord blood transplant for several conditions), and others diffuse prematurely into practice causing substantial harm (e.g., bone marrow transplantation for breast cancer). While professional groups offer guidelines for responsible innovation, public attention can inflate patients’ expectations; there is little guidance regarding how to manage such desperate situations in an ethically sound way.
The public symposium event of this Levi symposium focuses on the general issue of innovation. The working group session addresses a pressing current problem: whether to use amnioinfusion (instilling fluid into the pregnant uterus) for fetal renal agenesis (absence of kidneys), a fatal condition unless treated. Approximately, one in 3000 pregnant women and their partners learn that their fetus has renal agenesis. The condition is fatal because functioning fetal kidneys are essential for lung development.
In 2014, a Johns Hopkins obstetrician reported the innovative use of amnioinfusion for renal agenesis to stimulate fetal lung development. The infant was born prematurely and dialysis was used as a bridge to renal transplant that recently occurred at 2 years of age. This story quickly reached the media, fueled in part because the infant’s mother is a prominent politician. Subsequently, Johns Hopkins receives requests almost weekly from pregnant women for this experimental treatment. Other centers are eager to replicate this single success story and plan to offer amnioinfusion even though it has not been scientifically validated and may result in substantial harms.
Physicians clearly want to offer hope to parents, yet amnioinfusion entails serious medical and ethical concerns. Unanswered scientific questions involve accuracy of fetal diagnosis, procedure-related complications for the pregnant woman and fetus, and long term outcomes. In addition to such concerns arising from beneficence, there are ethical questions about informed consent and justice.
This Levi Symposium will meet the urgent need for discourse about this innovation before widespread uptake, which may be detrimental despite stakeholders’ aspirations.
Goals of the symposium and working group session:
- A consensus paper outlining medical, ethical and policy implications of amnioinfusion; and
- A blueprint for a multicenter study of amnioinfusion
- Jean Anderson, MD
- Ahmet Baschat, MD
- Jaime Herrera Beutler (R-WA 3rd District)
- Jessica Bienstock, MD, MPH
- Renee Boss, MD, MHS
- Timothy Bunchman, MD
- Niraj Desai, MD, FACS
- Elena Gates, MD
- Aviva Goldberg, MD, MA
- Paul Grimm, MD
- Leslie Meltzer Henry, JD, PhD, MSc
- Christine Hertenstein
- Eric Jelin, MD
- Emily Johnson, MD
- Anna Mastroianni, JD, MPH
- Mark Mercurio, MD, MA
- Alicia Neu, MD
- Lawrence M. Nogee, MD
- William J. Polzin, MD
- Steven J. Ralston, MD, MPH
- Ronald Ramus, MD
- Megan Kasimatis Singelton, JD, MBE, CIP
- Michael Somers, MD
- Jeremy Sugarman, MD, MPH, MA
- Karen Wang, MD