Bioethicists Call For Caution in Use of Rare Experimental Fetal Therapy

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.


See Also:

Robert H. Levi Leadership Symposium 2017: Navigating the Ethical Tensions in Patients’ Requests for Innovative Therapies

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

NEWS ADVISORY: A Clinician’s Guide to Managing Moral Distress

September 12, 2013

To: Reporters, editors, broadcasters and producers

Subject:
Johns Hopkins nurse-bioethicist discloses rising concerns about the toll of “moral distress” among nurses and physicians caring for seriously and terminally ill people in the era of health care reform.

Background:
As health care reform takes shape in the U.S., vast amounts of attention have been given to the fact that more and more people with pre-existing illnesses will have access to professional care to relieve their physical and emotional suffering. Far less public attention has been given to the nurses and physicians who provide that care, and the authors of a recent study say there is evidence that many already experience serious “moral distress” that may interfere with their own health and their efforts on behalf of seriously ill and dying patients.

“Studies and case histories suggest that clinicians may experience feelings such as empathy, tenderness, sadness, remorse, shame or anger in response to perceived conflicts in values, interpersonal disagreements and institutional constraints,” says Cynda Rushton, PhD, RN, FAAN, a nurse ethicist specializing in palliative and end-of-life care. Rushton is the Anne and George L. Bunting Professor of Clinical Ethics, a joint faculty position at Johns Hopkins’ School of Nursing and Berman Institute of Bioethics.

In a pair of articles published in the Journal of Palliative Medicine, Rushton and her colleagues explain how a clinician’s physical and emotional experience of moral distress can be detrimental to the patient and themselves, and how by learning to stabilize their own nervous system and emotional reaction, they can respond in a more principled, compassionate manner.  The authors propose a framework for “creating a healthy work environment supporting clinicians to practice with integrity” and reducing the toll on caregivers and patients alike.

“Conflicts of conscience are common among clinicians, particularly involving the care of patients at the end of life,” they write. For example, “some… may have concluded it was unconscionable to participate in [care] that caused disproportionate suffering and pursue goals perceived as unattainable.”

The authors add, “Clinicians struggling to address the dissonance between what they are doing and their professional roles often express this conflict as a lament of ‘why are we doing this?’ Coupled with an experience of injustice on behalf of the patient and/or broader society, this conflict can lead to unhealthy emotional arousal and moral distress. Acting against informed moral judgment creates a conflict of conscience by abandoning, consciously or unconsciously, convictions, ethical values or norms, and/or personal integrity.”

Interview Opportunity:
Rushton is available to discuss the proposed framework, which, the team writes, “offers a promising approach to designing interventions that help clinicians mitigate the detrimental consequences of unregulated moral distress and to build the resilience necessary to sustain themselves in clinical service.”

“Like their patients,” the team adds, “clinicians suffer as they attempt to fulfill their ethical obligations and maintain their integrity as individuals and professionals,” and there are “instances when the balance of benefit and burden that patients must tolerate to live longer becomes untenable.”

Rushton also can put the issue in the context of an aging population, a health care system confronted with serious change and cost issues, and ever-increasing attention to end-of-life decision-making and the limits of life-sustaining treatments.

# # #

Media Contact:
Leah Ramsay
202.642.9640
lramsay@jhu.edu