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Perspectives in Biology and Medicine

Scott H Podolsky
Eric Topol's The Patient Will See You Now: The Future of Medicine is in Your Hands (2015) depicts a medical future in which the patient-doctor relationship is upended in the context of easily acquired and shared big data and the increasing computing power necessary to analyze such data. A chief obstacle to this future, in Topol's rendering, is the entrenched paternalism of the medical profession. But Topol's thought-provoking assessment misses other key potential obstacles to the rational and equitable implementation of this (or any) medical future and would benefit from a more nuanced telling of the history of attempts to empower patients in this country...
2018: Perspectives in Biology and Medicine
Rebecca L Walker
Philosophical approaches to animal research have typically asked whether nonhuman animals have rights that would prohibit such research or whether the benefit of such research on the whole balances out the harms to animals. The professional ethics approach instead promotes compliance with regulatory norms that aim to support science progress. In Voracious Science and Vulnerable Animals: A Primate Scientist's Ethical Journey (2016), John Gluck struggles with issues that relate to each of these ethical frameworks, but the notion of an ethical "journey" also raises questions of character that are underdeveloped in animal research ethics...
2018: Perspectives in Biology and Medicine
Matthew William McCarthy, Diego Real de Asua, Ezra Gabbay, Joseph J Fins
A growing demand for transparency in medicine has the potential to strain the doctor-patient relationship. While information can empower patients, unrestricted patient access to the electronic medical record may have unintended consequences. Medical documentation is often written in language that is inaccessible to people without medical training, and without guidance, patients have no way to interpret the constellation of acronyms, diagnoses, treatments, impressions, and arguments that appear throughout their own chart...
2018: Perspectives in Biology and Medicine
Margaret C Hayden, Stephen D Brown
This article compares a six-week fetus to a brain-dead boy to illustrate multiple inconsistencies and flaws in various prominent frameworks for determination of death by neurological criteria ("brain death"). The authors critically examine the biological and normative assumptions that distinguish these ethically ambiguous "marginal states" at the beginning and end of life and find no consistent biological or ethical criteria that coherently define the fetus as alive and the boy as dead. The authors note important contradictions in how medicine, bioethics, and society treat these marginal states, despite their striking biological and philosophical similarities, and conclude that these contradictions are ultimately untenable...
2018: Perspectives in Biology and Medicine
Wendy Lipworth, Cameron Stewart, Ian Kerridge
The term innovation is frequently used as a justification for allowing clinicians to offer unproven autologous stem cell-based interventions (SCBIs) to their patients. Proponents of this kind of innovation (which we refer to as "clinical innovation") argue that physicians should be free to administer whatever interventions they choose, and informed consumers should be free to receive them. This article refutes the notion that clinician autonomy and consumer demand are a sufficient justification for offering patients unproven autologous SCBIs...
2018: Perspectives in Biology and Medicine
Tereza Hendl
Australia has a booming market of unproven autologous stem cell- based interventions (SCBIs) for a wide range of medical conditions. Multiple SCBIs are provided in private practices outside of formal clinical trials. Some defend the provision of unproven SCBIs on grounds of patient choice. This essay interrogates this argument for patient choice and explores patients' vulnerabilities in clinical practice with autologous SCBIs. While all patients are inherently vulnerable, the regulatory framework for autologous stem cells in Australia exacerbates the problems associated with inherent vulnerabilities and generates situational and pathogenic vulnerabilities...
2018: Perspectives in Biology and Medicine
Tsung-Ling Lee, Tamra Lysaght
Demands from patients, health-care professionals, and industry to streamline the market approval process for promising new therapies has prompted the introduction of programs that can provide more rapid access to stem cell-based products before evidence of safety and efficacy has been demonstrated in clinical trials. These products may be approved for marketing under "conditional authorizations," while uncertainty around safety and efficacy is reduced through the collection of clinical data in observational trials or registries...
2018: Perspectives in Biology and Medicine
Christine Hauskeller
Current European regulations hinder the compilation of the evidence that would be required to bring safe and effective autologous stem cell-based interventions (SCBIs) into standard clinical care. European agencies have expanded their regulations to cover all new SCBIs and research. They establish demanding conditions for cell retrieval, processing, and application. Drawing on empirical sociological findings from the implementation of the first phase III stem cell clinical trial in Europe, this article examines ethical problems effected by that policy, such as that the costs of bringing treatments to market means new autologous SCBIs may remain untested and that this plays in favor of the growing direct-to-consumer market, and that the research pathways in regenerative medicine and the role of clinician-scientists in developing new treatments are restricted, because the regulations are biased to enable specific SCBIs that are of interest to industry...
2018: Perspectives in Biology and Medicine
Douglas Sipp
The direct-to-consumer marketing of stem cells for unproven therapeutic uses has grown rapidly in the United States in recent years. This development is surprising since the marketing and distribution of human cell-based medical products is stringently regulated in the US. This essay describes ambiguities, gaps, and inconsistencies in the current regulatory system that have enabled such businesses to thrive. In addition to directly challenging the authority of the Food and Drug Administration (FDA) over autologous cell-based products in the courts, stem cell marketing firms have also identified and exploited regulatory loopholes, such as the same surgical procedure exception, which exempts from FDA oversight human cell-based products that are harvested and reimplanted in a single procedure...
2018: Perspectives in Biology and Medicine
Leigh Turner
Hundreds of businesses and clinics in the United States are engaged in direct-to-consumer marketing of unproven and unlicensed stem cell-based interventions. This essay provides an overview of this marketplace, examines advertising techniques companies use to draw clients and legitimate marketing claims, and summarizes the roles the Food and Drug Administration (FDA) and other agencies are supposed to play in regulating the direct-to-consumer marketplace for stem cell interventions. The essay also reviews federal regulations, describes how many businesses selling purported "stem cell treatments" appear to violate these standards, and considers ethical issues and harms associated with widespread promotion of unapproved stem cell products...
2018: Perspectives in Biology and Medicine
Tamra Lysaght, Jeremy Sugarman
No abstract text is available yet for this article.
2018: Perspectives in Biology and Medicine
A A Eduard Verhagen
Requests for life-prolonging treatments can cause irresolvable conflicts between health-care providers and surrogates. The Multiorganization Policy Statement (Bosslet et al. 2015) with recommendations to prevent and manage these conflicts creates a good opportunity to examine how end-of-life decisions are made in Dutch neonatal intensive care units and how medical futility is defined. The Dutch equivalent of medical futility in the context of NICU care has grown and developed rather independently, within the typical legal, ethical, and cultural framework of Dutch society...
2018: Perspectives in Biology and Medicine
Robert M Veatch
In response to the criticism of Schneiderman and colleagues (2017) that two recent policy statements of professional medical organizations referred to some medical treatment that were traditionally called "futile" by the terms "inappropriate" or "potentially inappropriate," this critique accepts their claim challenging these terms as being hopelessly ambiguous. However, this critique rejects the conclusion they all share that clinicians or hospitals should have the unilateral authority to refuse to provide treatments that will plausibly achieve the end that the patient or surrogate is pursuing...
2018: Perspectives in Biology and Medicine
Connie M Ulrich
Futility is a term that is distressing for many, but it is a concept that merits revisiting for its normative, empirical, and ethical value in understanding end-of-life issues. Ethical concerns surrounding aggressive care and the suffering of patients at end of life are frequently cited as significant ethical issues within institutional settings, leading to clinicians' moral distress. The author responds to the essay on "The Abuse of Futility" by Schneiderman, Jecker, and Jonsen (2017), who support the continual use of futility language with patients and families...
2018: Perspectives in Biology and Medicine
Robert D Truog
Debate about the concept of medical futility is often polarized around two views. One is that futility is simply an acknowledgment of the limitations of modern medicine, a corollary of the fact of human mortality. The other is that futility is a judgment that is always grounded in a particular set of values, and that medical professionals have no right to impose their value judgments on patients and families who do not share their perspective. This essay argues that these dichotomous views can be reconciled by appreciating the importance of the context in which the dialogue occurs...
2018: Perspectives in Biology and Medicine
Thaddeus Mason Pope
The primary objective of this article is to defend the vocabulary in the Multiorganization Policy Statement. The Multiorganization Statement narrows but does not abolish the term futility. Rather, it offers a richer and more precise vocabulary that facilitates better ethical decision-making. The secondary objective of this article is to defend the continuing utility of the terms and concepts "quantitative futility" and "qualitative futility" defended by Schneiderman, Jecker, and Jonsen (2017)...
2018: Perspectives in Biology and Medicine
Michael Nair-Collins
Conflicts between providers and patients or their families surrounding end-of-life care are both regrettable and extremely challenging, interpersonally and ethically, for all involved. These conflicts often implicate the concept of medical futility. The concept of futility is too often conflated with distinct concepts that are more ethically salient, including the fiduciary responsibility to assess surrogate decision-making, and distributive justice. By distinguishing these concepts from futility, it becomes clear that there are some situations in which forgoing life-sustaining treatment over objection is permissible, and perhaps even obligatory...
2018: Perspectives in Biology and Medicine
Cheryl Misak
The argument in this paper is that the position of Schneiderman, Jecker, and Jonsen (2017) suffers from the very flaws of which they accuse the Multiorganization Policy Statement, and that all the ethical and conceptual arguments speak in favor of the collaborative, deliberativist position that underlies the Multiorganization Statement. That position is that we should abandon self-sealing definitions of futility, which disguise the value judgments inherent in them, in favor of the evolving, collaborative process of decision-making...
2018: Perspectives in Biology and Medicine
Laura Miller-Smith
Futility has wrongly been applied over the past decades to clinical scenarios where treatment disputes exist, but where true physiological futility is not certain. This particularly applies to the pediatric critical care arena, where a major source of ethical debate and moral concern surrounds decisions about appropriateness of treatment, and not necessarily futility. In the pediatric intensive care unit, Schneiderman and colleagues' (2017) definitions of quantitative and qualitative futility are rarely applicable...
2018: Perspectives in Biology and Medicine
Franklin G Miller
Judgments of futility are always relative to some goal. In light of that proposition, continued treatment for those diagnosed as "brain dead" is not necessarily futile.
2018: Perspectives in Biology and Medicine
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