Faculty Bibliography

Innovative surgery is defined as a novel procedure, a significant modification of a standard technique, or a new application of an established technique. Although innovation is a crucial part of improving patient care in plastic surgery, there are various ethical considerations and dilemmas in performing unvalidated techniques and procedures, especially for non-life-threatening indications. The aim of this study was to gain a better understanding regarding the motivations and ethical considerations of plastic surgeons in their decision to perform innovative operations. An anonymous, institutional review board-approved, online survey was sent to members of the American Society of Plastic Surgeons and other international plastic surgeons worldwide. The survey asked respondents to rank various factors that influence their decisions to perform innovative plastic surgery, both reconstructive and aesthetic, on a five-point Likert scale. Seven hundred thirty-three of 26,028 plastic surgeons (response rate, 2.9 percent) responded to the survey. Although similar factors were considered to be important for both reconstructive and aesthetic operations, only approximately 50 percent of respondents considered institutional review board approval to be an important factor when considering innovation in both reconstructive (50 percent) and aesthetic surgery (51 percent), suggesting that respondents do not consider innovation a form of research that ought be subject to standard research protections. Overall, the authors' survey suggests that more effort must be extended to ethical training in plastic surgery to create a stronger professional atmosphere regarding innovation and, possibly, to the creation of a more formal group charged with oversight of innovation.

As the field of vascularized composite allotransplantation (VCA) continues to evolve and technological approaches improve, VCA programs must focus on promoting greater consistency in psychosocial assessment across programs to support the equitable selection of patients. Based on a summary of published reports of VCA, we address the ethical considerations raised by the present heterogeneity of approaches to psychosocial assessment, including weighing risks and benefits, informed consent and the role of decisional capacity, and potential or perceived bias in the assessment process. We propose transparency of process across the field and encourage VCA programs to work collaboratively to share approaches to psychosocial assessment both pre- and post-transplant to promote health equity.

In this article, we present a report from a national meeting titled, "Evolving Issues of Vascularized Composite Allotransplantation-A Symposium on Ethics, Policy, and Reimbursement Issues," which convened in September 2017. We discuss the maturation of vascularized composite allotransplantation from an emerging technology to becoming an extension of clinical practice for select patients with complex reconstructive needs. Viewpoints and action items were presented by and discussed among the 70+ clinicians, researchers, policymakers, ethicists, healthcare administrators, and third-party payers who attended the symposium with the goals of implementing a collaborative roadmap for vascularized composite allotransplantation growth, evaluation, and sustainability by establishing a unified plan to help address concerns of the public, policymakers, and healthcare finance. We review the current status of vascularized composite allotransplantation in clinical practice and summarize symposium discussions regarding ethical considerations, reimbursement, payer strategies, and standardization of data collection.

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Despite the prodigious medical literature on cancer care, some patients rely on celebrity narratives as frameworks for understanding their experiences of cancer and as benchmarks for decision making. Regardless of whether these narratives are appropriate sources of health information for patients, it has been shown that celebrity narratives influence patterns of care. Three cases-John McCain, Angelina Jolie, and Jimmy Carter-are presented to illustrate how media coverage of cancer can have unforeseen consequences on individual patients exposed to these kinds of stories. For this reason, clinicians should become familiar with these narratives and comfortable with discussing how celebrity narratives can shape patients' views and decisions.

Constantin Reliu had been working for twenty years as a cook in Turkey when he returned to his hometown of Barlad, Romania, to discover that, there, he was dead. His former wife had, unbeknownst to him, at some point during his stay in Turkey registered him as deceased in Romania. He has since been living a legal nightmare trying to prove to Romanian authorities that he is, in fact, alive. Reliu is not alone in finding out that the legal system is not as attuned to physiological activity or biological assessment by doctors in determining death as one might think. If one starts with the assumption that death is a purely biological concept, solely the province of doctors, Reliu's story seems entirely unrelated to the concept of death in the medical context. A brain scan would not lead to a reversal of his being assessed as dead. The story is a reminder, however, that how death is used is not just biological, and therefore that the standard of death even in the clinic must answer to cultural considerations. Values, the law, and custom matter a great deal in determining who is alive and who is not, whether in the courtroom, the coroner's office, or the clinic.

Zika virus (ZIKV) infection has been associated with Guillain-Barré Syndrome (GBS). Roughly 60% of people in countries such as the U.S. live in areas at risk for seasonal spread of ZIKV. ZIKV belongs to a class of diseases that is not typically seen in hospital settings across the U.S. and Europe. We describe the case presentation, management, and treatment of ZIKV infection complicated by GBS. A 64-year-old woman with recent travel to the Dominican Republic presented with rash followed by an acute, ascending polyneuropathy consistent with GBS. She was confirmed to have an acute ZIKV infection by detection of ZIKV nucleic acid by reverse transcription-polymerase chain reaction. She met Brighton Collaboration criteria level 1 evidence for GBS. She received two courses of intravenous immunoglobulin and slowly improved, though still had weakness at discharge. More research is needed to identify the pathophysiology behind ZIKV-associated GBS and its optimal treatment. Prevention is fundamental to limiting infection and spread of ZIKV.

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.