In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within the guidelines there (...) are eight domains to the provision of palliative care. This article focuses on the last, but very significant Domain 8—Ethical and Legal Aspects of Care. (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)

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)

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.

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...

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)

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)

In this issue, Macklin and Natanson examine some of the controversies that arise in randomized clinical trials (RCTs). They are particularly concerned that researchers may misrepresent novel interv...

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 ethical principles articulated in the Belmont Report and the regulatory oversight of research based on those principles seem to have served society well. Before Belmont, there were numerous egregious violations of research ethics. Since Belmont, there seem to be fewer—though good data are lacking.A central pillar of the Belmont framework is that a bright line must be drawn between medical practice and biomedical research. The Report stated that to qualify as practice, the following conditions must be satisfied: the purpose (...) of an intervention is to provide diagnosis, preventive treatment, or therapy; the intervention is designed solely to enhance the well-being of an individual... (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...

This book examines the many ethical issues that are encountered in the Pediatric Intensive Care Unit. It supports pediatricians, nurses, residents, and other providers in their daily management of critically ill children with the dilemmas that arise. It begins by examining the evolution of pediatric critical care, and who is now impacted by this advancing medical technology. Subsequent chapters explore specific ethical concerns and controversies that are commonly encountered. These topics include how to conduct end-of-life discussions with families facing a (...) myriad of challenging choices. It goes on to explore the concept of futility, and what that does and does not mean in the pediatric ICU setting. Controversial subjects such as children as organ donors, particularly using donation after cardiac death, in addition to issues surrounding the declaration of brain death are covered. Additional chapters address resource allocation, and also analyze the use of long-term technology in chronically critically ill children. Chapters include case examples with guidance on how to work through similar difficulties and decision-making. While this book is specifically targeted for care providers at the ICU bedside, it is also of benefit to medical students, students in bioethics, practicing ethical consultants and families who are dealing with critically ill children. (shrink)

The doctors were frustrated. They could see only two options. Neither was very desirable. They could stop the ventilator and let the baby die. Or they could do a tracheostomy and start preparations to discharge him on a ventilator. The parents wanted a third option. They kept hoping that their baby would get better. The doctors were pretty sure that that wasn't going to happen.

It has become increasingly difficult to place a value on the work that doctors do. Yet fiscal pressures have lead to economic incentives for performing certain kinds work instead of others. So the question arises: what are the ethics and consequences of trying to objectively compare the many services physicians offer?

What are we to make of Henrietta Lacks? After dying at a young age more than half a century ago, she has now become immortal twice—once biologically, and once culturally.She was first immortalized when cells from her cervical biopsy were cultured and became the first immortal cell line. The idea that this made Lacks herself immortal illustrates the dangerous temptations of genetic reductionism and literary license. Such literary license is illustrated by the title of Rebecca Skloot’s remarkable 2011 bestselling book (...) about Lacks and her cells. Skloot wrote a treatise that is at once a detective novel, an analysis of the conundrums of research ethics, a call for health system reform, and an exploration of racism in... (shrink)

“Facts don’t come with their own meaning attached.” Tzvetan Todorov Alex John London is frustrated by the commonly encountered situation of doctors thinking that they know what is bes...

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)

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)

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)

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)

There is a moment in The Immortal Life of Henrietta Lacks that brought tears to my eyes. Henrietta Lacks is the woman whose cervical tumor gave rise to a cell line—brand named HeLa—that became quite useful in many important lines of biomedical research. When the book’s author, Rebecca Skloot, tracks down Lacks’s descendents in a Baltimore ghetto, they are not doing well. Zakariyya, the youngest of her children, has had the toughest life. He was born after his mother’s cancer was (...) already widespread, and she died shortly after his birth. He has drifted in and out of the military and in and out of jail. A moody and violent man, he once killed a man over a girl by stabbing him in the chest with a kitchen knife. Skloot .. (shrink)

The dust-jacket photo of Eric Cassell portrays him as a magician. He wears a dark suit, a bow tie, and big dark-rimmed glasses. His head is tilted down; his forehead is massive; his eyes are intense. It is an interrogating look that is crucial to the central theme of his most recent books, The Nature of Healing: The Modern Practice of Healing and The Nature of Clinical Medicine: The Return of the Clinician.