In a crisis, societal needs take precedence over a patient’s best interests. Triage guidelines, however, differ on whether limited resources should focus on maximizing lives or life-years. Choosing between these two approaches has implications for neonatology. Neonatal units have ventilators, some adaptable for adults. This raises the question of whether, in crisis conditions, guidelines for treating extremely premature babies should be altered to free-up ventilators. Some adults who need ventilators will have a survival rate higher than some extremely premature babies. (...) But surviving babies will likely live longer, maximizing life-years. Empiric evidence demonstrates that these babies can derive significant survival benefits from ventilation when compared to adults. When “triaging” or choosing between patients, justice demands fair guidelines. Premature babies do not deserve special consideration; they deserve equal consideration. Solidarity is crucial but must consider needs specific to patient populations and avoid biases against people with disabilities and extremely premature babies. (shrink)

Most bioethicists and professional medical societies condemn the practice of ?slow codes.? The American College of Physicians ethics manual states, ?Because it is deceptive, physicians or nurses should not perform half-hearted resuscitation efforts (?slow codes?).? A leading textbook calls slow codes ?dishonest, crass dissimulation, and unethical.? A medical sociologist describes them as ?deplorable, dishonest and inconsistent with established ethical principles.? Nevertheless, we believe that slow codes may be appropriate and ethically defensible in situations in which cardiopulmonary resuscitation (CPR) is likely (...) to be ineffective, the family decision makers understand and accept that death is inevitable, and those family members cannot bring themselves to consent or even assent to a do-not-resuscitate (DNR) order. In such cases, we argue, physicians may best serve both the patient and the family by having a carefully ambiguous discussion about end-of-life options and then providing resuscitation efforts that are less vigorous or prolonged than usual. (shrink)

In current American medical practice, autonomy is assumed to be more valuable than human life: if a patient autonomously refuses lifesaving treatment, the doctors are supposed to let him die. In this paper we discuss two values that might be at stake in such clinical contexts. Usually, we hear only of autonomy and best interests. However, here, autonomy is ambiguous between two concepts—concepts that are tied to different values and to different philosophical traditions. In some cases, the two values (that (...) of agency and that of authenticity) entail different outcomes. We argue that the comparative value of these values needs to be assessed. (shrink)

In most children’s hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians (...) about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children’s hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are ethics committee meetings, Nursing Ethics Forum, ethics Brown Bag workshops, PICU ethics rounds, Grand Rounds, NICU Comprehensive Care Rounds, Palliative Care Team case conferences, multidisciplinary consults in Fetal Health Center, and ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of “core competencies” than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple “moral spaces” in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set out to do than in the role of the typical hospital ethics consultant today. (shrink)

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of the consent (...) form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

Many scientists and doctors hope that affordable genome sequencing will lead to more personalized medical care and improve public health in ways that will benefit children, families, and society more broadly. One hope in particular is that all newborns could be sequenced at birth, thereby setting the stage for a lifetime of medical care and self‐directed preventive actions tailored to each child's genome. Indeed, commentators often suggest that universal genome sequencing is inevitable. Such optimism can come with the presumption that (...) discussing the potential limits, cost, and downsides of widespread application of genomic technologies is pointless, excessively pessimistic, or overly cautious. We disagree. Given the pragmatic challenges associated with determining what sequencing data mean for the health of individuals, the economic costs associated with interpreting and acting on such data, and the psychosocial costs of predicting one's own or one's child's future life plans based on uncertain testing results, we think this hope and optimism deserve to be tempered.In the analysis that follows, we distinguish between two reasons for using sequencing: to diagnose individual infants who have been identified as sick and to screen populations of infants who appear to be healthy. We also distinguish among three contexts in which sequencing for either diagnosis or screening could be deployed: in clinical medicine, in public health programs, and as a direct‐to‐consumer service. Each of these contexts comes with different professional norms, policy considerations, and public expectations. Finally, we distinguish between two main types of genome sequencing: targeted sequencing, where only specific genes are sequenced or analyzed, and whole‐exome or whole‐genome sequencing, where all the DNA or all the coding segments of all genes are sequenced and analyzed.In a symptomatic newborn, targeted or genome‐wide sequencing can help guide other tests for diagnosis or for specific treatment that is urgently needed. Clinicians use the infant's symptoms (or phenotype) to interrogate the sequencing data. These same complexities and uncertainties, however, limit the usefulness of genome‐wide sequencing as a population screening tool. While we recognize considerable benefit in using targeted sequencing to screen for or detect specific conditions that meet the criteria for inclusion in newborn screening panels, use of genome‐wide sequencing as a sole screening tool for newborns is at best premature. We conclude that sequencing technology can be beneficially used in newborns when that use is nuanced and attentive to context. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

Clinical ethics consultation service remains undeveloped in developing countries. It is recognised that its introduction poses challenges. Malaysia, a multicultural society with diverse religions, values and perceptions further complicate the introduction of formal clinical ethics consultation service. Clinicians attending a national congress workshop completed a Strengths–Weaknesses–Opportunities–Threats analysis. The aim was to gain insight into clinician’s expectations and promote initiatives leading to the introduction of clinical ethics consultation service. Clinicians agree that clinical ethics consultation service can improve quality of care, reduce (...) healthcare costs and advocate for patients and providers. The analysis highlighted constraints in sufficient critical mass of relevant expertise and restricted opportunities for training. The opportunities lie in education, curriculum development and availability of dedicated proponents. Cultural barriers, limited resources, lack of awareness, differenc... (shrink)

Policies and position statements regarding decision-making for extremely premature babies exist in many countries and are often directive, focusing on parental choice and expected outcomes. These recommendations often state survival and handicap as reasons for optional intervention. The fact that such outcome statistics would not justify such approaches in other populations suggests that some other powerful factors are at work. The value of neonatal intensive care has been scrutinized far more than intensive care for older patients and suggests that neonatal (...) care is held to a higher standard of justification. The relative value placed on the life of newborns, in particular the preterm, is less than expected by any objective medical data or any prevailing moral frameworks about the value of individual lives. Why do we feel less obligated to treat the premature baby? Do we put newborns in a special and lesser moral category? We explore this question from a legal and ethical perspective and offer several hypotheses pertaining to personhood, reproductive choices, “precious children,” and probable evolutionary and anthropological factors. (shrink)

The growth of managed care was accompanied by concern about the impact that changes in health care organization would have on the doctor-patient relationship. We now are in a “post-managed care era,” where some of these changes in health care delivery have come to pass while others have not. A re-examination of the DPR in this setting suggests some surprising results. Rather than posing a new and unprecedented threat, managed care was simply the most recent of numerous strains on the (...) DPR that have occurred throughout the century. These strains are a constant, inevitable consequence of the varying needs and concerns of patient and physicians as they seek to balance their desires for a certain type of DPR with their simultaneous desire for other aspects of care such as lower costs, greater technological sophistication, and improved outcomes. (shrink)

Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, and (...) health policy discuss if age should guide rationing decisions. (shrink)

There is an inconsistency in the ways that doctors make clinical decisions regarding the treatment of babies born extremely prematurely. Many experts now recommend that clinical decisions about the treatment of such babies be individualized and consider many different factors. Nevertheless, many policies and practices throughout Europe and North America still appear to base decisions on gestational age alone or on gestational age as the primary factor that determines whether doctors recommend or even offer life-sustaining neonatal intensive care treatment. These (...) policies are well intentioned. They aim to guide doctors and parents to make decisions that are best for the baby. That is an ethically appropriate goal. But in relying so heavily on gestational age, such policies may actually do the babies a disservice by denying some babies treatment that might be beneficial and lead to intact survival. In this paper, we argue that such policies are unjust to premature babies and ought to be abolished. In their place, we propose individualized treatment decisions for premature babies. This would treat premature babies as we treat all other patients, with clinical decisions based on an individualized estimation of likelihood that treatment would be beneficial. (shrink)

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)

It is astoundingly difficult—and may not be desirable—to be rational about decisions to let our babies die. Parents in these situations are caught in a maelstrom of overpowering and often contradic...

Changes in healthcare financing increasingly rely upon patient cost-sharing to control escalating healthcare expenditures. These changes raise new challenges for physicians that are different from those that arose either under managed care or traditional indemnity insurance. Historically, there have been two distinct bases for arguing that physicians should not consider costs in their clinical decisions—an “aspirational ethic” that exhorts physicians to treat all patients the same regardless of their ability to pay, and an “agency ethic” that calls on physicians to (...) be trustworthy advisors to their patients. In the setting of greater patient cost-sharing, physicians' aspiration and agency roles increasingly conflict. Satisfactorily navigating the new terrain of consumer-driven healthcare requires physicians to consider these two roles and how they can best be reconciled so as to maximize quality of care while respecting the heterogeneity of patients' financial resources and willingness to pay. (shrink)

A commentary on “Were There ‘Additional Foreseeable Risks’ in the SUPPORT Study?,” by Henry J. Silverman and Didier Dreyfuss; “SUPPORT: Risks, Harms, and Equipoise,” by Robert M. Nelson; “The Controversy over SUPPORT Continues and the Hyperbole Increases,” by Alan R. Fleischman; and “SUPPORT and Comparative Effectiveness Trials: What's at Stake?,” by Lois Shepherd, all in the January‐February 2015 issue.

It used to be futile to try to save babies born at 23 weeks. It isn’t anymore. It used to be futile to try to keep patients with end-stage congestive heart failure alive. It isn’t anymore. Futility is a moving target. Thus, it is not surprising that doctors, patients, and families often disagree about which treatments are efficacious or futile, appropriate or inappropriate, obligatory or obligatorily withheld. The goalposts keep moving. Yesterday’s impossibility is today’s routine. Why should a patient believe (...) a doctor who says that treatment is futile, inappropriate, or likely to cause more harm than good? Could it just mean that the doctors are unwilling to try everything that is available? When... (shrink)

Dominic Wilkinson suggests that one of Schubert’s songs has relevance for neonatologists today. In the song, Schubert suggests that death sometimes comes as a friend. Wilkinson ponders whether the song has a message for doctors and parents, who sometimes struggle to figure out whether death is an enemy or a friend to a dying baby. Wilkinson reflects on the case of baby ‘Hal’, who was born with serious cardiomyopathy. Hal’s parents and doctors disagree about whether to withdraw life-support. Through his (...) recreations of their discussions, Wilkinson shows how hard it is to confront—and maybe even welcome—death for a child. While adults often frame their own decision to forego life-sustaining treatment with thoughts that they have lived a good life, death in childhood can seem unfair because it robs the child of their opportunity to live a good or completed life. Much as we try, we cannot really imagine what a critically ill neonate experiences or desires. We have very little insight into Hal’s interests or subjective experience. Without direct access to the child’s experience, it is impossible to know whether, like an adult, a child would choose to allow death to occur. We cannot verify the claim that the child’s death was good in the sense that it was good for them. Wilkinson proposes that a prolonged dying process …. (shrink)

Written with poignancy and compassion, Do We Still Need Doctors? is a personal account from the front lines of the moral and political battles that are reshaping America's health care system. Using compelling firsthand experiences, clinical vignettes, and moral arguments, John D. Lantos, a pediatrician, asks whether, as we proceed with the redesign of our health care system, doctors will -- or should -- continue to fulfill the roles and responsibilities that they have in the past. Interspersing moving personal stories (...) of his young patients suffering from AIDS, cancer, and other chronic or terminal illnesses with his own stirring dilemmas of truth telling, creative navigation of HMO bureaucracy, and reflections on the identity crisis of medical education, Dr. Lantos reveals how changes in out health care system and new technologies are fostering new ways of understanding and responding to illness. He taps into the public's sense of wanting doctors and hospitals to do something other than what they do now and the frustrating disagreement about what they should do in the future. (shrink)

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more deliberative, explicit, (...) and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety‐net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community‐based care, and fully staff hospitals and clinics on nights and weekends. (shrink)

Spceial Care explores the moral and legal issues in neonatal intensive care. It is an urgently needed entry in the current discussions of treatment for badly damaged babies.

When should doctors seek protective custody to override a parent’s refusal of potentially lifesaving treatment for their child? The answer to this question seemingly has different answers for different subspecialties of pediatrics. This paper specifically looks at different thresholds for physicians overriding parental refusals of life-sustaining treatment between neonatology, cardiology, and oncology. The threshold for mandating treatment of premature babies seems to be a survival rate of 25–50%. This is not the case when the treatment in question is open heart (...) surgery for a child with congenital heart disease. Most cardiologists would not pursue legal action when parents refuse treatment, unless the anticipated survival rate after surgery is above 90%. In pediatric oncology, there are case reports of physicians requesting and obtaining protective custody for cancer treatment when the reported mortality rates are 40–50%. Such differences might be attributed to differences in care, a reasonable prioritization of quality of life over survival, or the role uncertainty plays on prognoses, especially for the extremely young. Nonetheless, other, non-medical factors may have a significant effect on inconsistencies in care across these pediatric subspecialties and require further examinations. (shrink)

Neonatal intensive care units (NICUs) and medical intensive care units (MICUs) are both very expensive. The cost-effectiveness of NICUs has been extensively evaluated, as has the long-term outcomes of subpopulations of NICU patients. NICU treatment is among the most cost-effective of high-tech interventions. And most patients do well. There are fewer evaluations of cost-effectiveness in the MICU and almost no long-term outcome studies. Policymakers who scrutinize expensive high-tech interventions would do well to study the examples found in the NICU.

I am currently caring for a child named Priscilla who is ventilator-dependent and whose care confronted me with questions of justice. Priscilla was born at the County Hospital after a normal pregnancy to a 17-year-old single mother. At birth, she was noted to have some dysmorphic features: widely spaced eyes, low-set ears, and a cleft palate. Her chest X-ray showed hypoplastic ribs and scapulae. Her chromosome studies were normal. Eventually, a diagnosis of a rare dwarfing syndrome campomelic dysplasia – was (...) made. (shrink)

I was recently invited to talk about ethics with the staff of a level‐three neonatal intensive care unit. They presented a case featuring a full‐term baby born by emergency caesarean‐section after a cord prolapse that caused prolonged anoxia. Her initial pH was 6.7. She was intubated and resuscitated in the delivery room. Her Apgar score remained at 1 for ten minutes. Further evaluation over the next two days revealed severe brain damage. Her prognosis was dismal.The doctors recommended a do‐not‐resuscitate order. (...) The parents agreed. The doctors suggested a gastrostomy tube. The parents disagreed. Instead, they requested that fluid and nutrition be discontinued. The emotions in the room, as we started to discuss the case, were strong and discordant. Eventually, the conversation wound down. They turned, expectantly, to the visiting bioethicist. (shrink)

In this paper, we examine healthcare organizations’ responses to high profile cases of doctor–parent disagreement. We argue that, once a conflict crosses a certain threshold of public interest, the stakes of the disagreement change in important ways. They are no longer only the stakes of the child’s interests or who has decision‐making authority, but also the stakes of public trust in healthcare practitioners and organizations and the wide scale spread of medical misinformation. These higher stakes call for robust organization‐level responses. (...) There are responsible and thoughtful ways for healthcare organizations to directly engage with these cases. Hospitals should seek an alliance with the parents around the goal of public discussion and utilize web‐based platforms to provide the public with information about medical conditions, experimental treatments, and how clinical ethics deliberation in hospitals works. We outline five important lessons for healthcare organizations to keep in mind when responding to such cases. Approached with care, these cases could become “teachable moments” for both healthcare organizations and society. (shrink)

A recent American Academy of Pediatrics (AAP) clinical report states that it is an acceptable option for pediatric care clinicians to dismiss families who refuse vaccines. This is a clear shift in guidance from the AAP, which previously advised clinicians to “endeavor not to discharge” patients solely because of parental vaccine refusal. While this new policy might be interpreted as encouraging or recommending dismissal of vaccine-refusing families, it instead expresses tolerance for diverse professional approaches. This is unlike the earlier guidance, (...) which promoted a unified response to vaccine refusal. In fact, the resolution (which was presented at the AAP’s Annual Leadership Forum) that led to this clinical report also calls on the AAP “to continue to support pediatricians who continue to provide health care to children of parents who refuse to immunize their children.” However, the shift toward embracing dismissal as an acceptable response to vaccine refusal may erode professional solidarity. Pediatricians are clearly divided on this question; most do not dismiss vaccine-refusing families. By declaring that dismissal is an acceptable option, the AAP has sanctioned a practice that may be unfair to the many clinicians who do not dismiss these families. Clinicians who adopt a policy of dismissal toward families who refuse vaccines might impose burdens on colleagues who remain willing to offer care to those families, and their actions might show insufficient commitment to the efforts of their profession to promote health for all children. (shrink)

Providing care for a baby born at 24 weeks of gestation in a neonatal intensive care unit is one of the most expensive medical treatments in the United States today. The cost can easily run over $300,000 for one baby. Furthermore, many extremely premature babies who survive are left with chronic diseases or disabilities that require further medical expenses and other specialized services throughout childhood or throughout life. When all these expenditures are totaled up, it can seem that neonatal intensive (...) care is just not worth it.Concerns about the cost-effectiveness of NICUs have led to persistent critical scrutiny of these specialized units by physicians, economists, and epidemiologists. These analysts have examined NICUs and the patients in them in order to determine whether there are subpopulations of babies for whom neonatal intensive care is so demonstrably ineffective or so costly that it should not be provided. Such examinations have been carried out in many different countries, at many times over the last 30 years, and have analyzed outcomes for babies by gestational age, birthweight, and illness severity. (shrink)

Star Trek scripts have often grappled with dilemmas of medical ethics. The most explicitly medical-ethics-oriented Star Trek episode is named, aptly enough, “Ethics.” The script was written by Sara Charno and Stuart Charno, authors of two other Star Trek episodes. “Ethics” first aired on 2 March 1992. In the fall of 1992, we began to use this “Ethics” episode to motivate discussions in our first-year medical students’ course on medical ethics and the doctor-patient relationship. We asked students to write essays (...) addressing one of the many ethical dilemmas posed by the episode. Over the years, the episode has become a tradition. Both students and instructors find the formulation of dilemmas in the context of a science-fiction story to be both liberating and stimulating. In this essay, we will discuss this particular episode in some detail and then provide a brief synopsis of other episodes that might be used in ethics courses in a similar way. (shrink)

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.” ). By contrast, the Office of Human Research Protections, (...) in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.”.In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible. (shrink)

Many babies with trisomy 13 and 18 die in the first year of life. Survivors all have severe cognitive impairment. There has been a debate among both professionals and parents about whether it is appropriate to provide life-sustaining interventions to babies with these serious conditions. On one side of the debate are those who argue that there is no point in providing invasive, painful, and expensive procedures when the only outcomes are either early death or survival with severe cognitive impairment. (...) Others suggest that, although mortality is high and cognitive impairment universal, babies with these conditions have an acceptable quality of life. In this paper, we will discuss both points of view. We will review the ways in which these conditions are portrayed in pediatrics textbooks and on social media sites that offer support to parents. We will then suggest an appropriate way to deal with clinical decisions for babies with these trisomies. (shrink)

Five years ago, remarkable animal experiments on artificial womb technology (AWT) at Children’s Hospital of Philadelphia (CHOP) got us thinking about the ethical for premature babies. We recognized...

Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...