Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and (...) federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing. (shrink)

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration. An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, (...) physicians promote patients’ interests by prescribing products off label.Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”. (shrink)

Volume 20, Issue 6, June 2020, Page 17-19.

The ethics of long-term Extracorporeal Membrane Oxygenation (ECMO) use, especially when organ recovery appears highly unlikely and the patient does not qualify for organ transplantation, are compli...

Formal training in clinical ethics must become a central part of residency curricula to prepare practitioners to manage the ethical dimensions of patient care. Residency educators must ground their teaching in an understanding of the conceptual, biomedical, and psychosocial aspects of the important ethical issues that arise in that field of practice. Four aspects of professional competence in clinical ethics provide a useful framework for curricular planning. The physician should learn to: (1) recognize ethical issues as they arise in clinical (...) care and identify hidden values and unacknowledged conflicts; (2) think clearly and critically about these issues in ways that lead to ethically justifiable courses of action; (3) apply those practical skills needed to implement an ethically justifiably course of action; and (4) judge when the management of a clinical situation requires consultation with individuals or institutional bodies with additional expertise or authority. We argue that these practical goals can be accomplished with a relatively modest emphasis on the theoretical aspects of medical ethics. (shrink)

Rereading Renée C. Fox's “A Sociological Perspective on Organ Transplantation and Hemodialysis,” published in 1970, one is likely to be struck more by continuity than by change. The most pressing of the social, policy, and ethical concerns that Fox raised remain problematic fifty years later. We still struggle with scientific and clinical uncertainty, with the boundary between experimentation and therapy, and with the cost of organ replacement therapies and disparities in how they are allocated. We still have an imperfect understanding (...) of transplant immune responses. We still debate when a potential donor “actually” dies, and we still seem to think better empirical criteria could harmonize the diverse religious, cultural, and socioeconomic values of patients, providers, third‐party payers, and policy‐makers. Organ transplantation was for Fox both a particular case unfolding in time and an entryway for discussing the difficult moral questions presented by many new medical technologies in a context of high demand and limited resources. (shrink)

Previous papers on ethics consultation in medicine have taken a positivistic approach and lack critical scrutiny of the psychosocial, political, and moral contexts in which consultations occur. This paper discusses some of the contextual factors that require more careful research. We need to know more about what prompts and inhibits consultation, especially what factors effectively prevent house officers and nonphysicians from requesting consultation despite perceived moral conflict in cases. The attitudes and institutional power of attending medical staff seem important, especially (...) where innovative interventions raise ethical questions. Ethics consultants also need to address the thorny problems of the origin(s) of the consultant's authority, whistleblowing, conflicts of interest that affect the consultant, persistently poor communications in hospitals, systemic inequity in the availability or quality of services for some, and the standing of the consultant's recommendations, including their appearance in the patient's medical record. (shrink)

The American Journal of Bioethics, Volume 11, Issue 10, Page 15-16, October 2011.

While procurement of organs from donors who are not "brain dead" does not appear to pose insurmountable moral obstacles, the social practice may raise questions of conflict of interest. Non-heart-beating organ donation opens the door for pressure on patients or families to forgo possibly beneficial treatment to provide organs to save others. The combined effects of non-heart-beating donation and organ shortages at major transplant centers brought about by the 1991 United Network for Organ Sharing (UNOS) local-use organ allocation policy created (...) potential conflicts, including the fact that candidates for organs become potential donors far more frequently than previously. Hospitals with a major emphasis on transplantation have economic and academic interests that may have been hurt by the relative organ shortage. Some may view non-heart-beating organ donation as a way to restore weakened programs and thus unconsciously compromise recognition of problems associated with non-heart-beating donation. (shrink)

In the twenty-first century, decisions to withhold or withdraw life-supporting measures commonly precede death in the neonatal intensive care unit without major ethical controversy. However, caregivers often feel much greater turmoil with regard to stopping medical hydration and nutrition than they do when considering discontinuation of mechanical ventilation or circulatory support. Nevertheless, forgoing medical fluids and food represents a morally acceptable option as part of a carefully developed palliative care plan considering the infant’s prognosis and the burdens of continued treatment. (...) Decisions to stop any form of life support should focus on the clinical circumstances, not the means used to sustain life. (shrink)

The experiences of individuals with intersex conditions include considerable abuse at the hands of medical personnel. Despite changes in expert opinion about full disclosure of the nature of each patient’s condition and recommendations to defer cosmetic surgical interventions, we do not know how much actual practice has changed over several decades. Moreover, discrepancies continue between the views of who have these conditions and medical practitioners, especially about preventing cancer and retaining gonads for the purpose of providing “natural” hormone production. We (...) have insufficient data to resolve these different perspectives. (shrink)

Volume 19, Issue 7, July 2019, Page 69-71.

Professionals in transplantation medicine have a particularly difficult task that most other healthcare professionals in the United States do not have to face explicitly. That is, the transplanters control the use of scarce solid organs. Because they invariably have more than one patient who might benefit from a new kidney (or liver, heart, etc.), they cannot focus single-mindedly on their duty to each and every patient as if no other patient mattered. In the case at hand, the patient has had (...) more than one of a life-sustaining organ. At some centers, one, perhaps two, previous organs would count as After that, the patient has had her chances and it is time to move on to others. Moreover, some believe the patient in this case has contributed to the current problem by inadequate care of the gifts she has been given. (shrink)

In his response to our treatment of the medical excuse, Spital claims that we offer a flawed analysis of the practice of offering excuses to potential living organ donors. Spital's criticisms help sharpen our position and more clearly lay out the issues. In what follows, we address each of his concerns and replies and clarify our earlier analysis.