Jane Johnson

Innovative surgery: the ethical challenges

Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special features of both surgery and innovation.

Implementing a One Health approach to emerging infectious disease: reflections on the socio-political, ethical and legal dimensions

Background‘One Health’ represents a call for health researchers and practitioners at the human, animal and environmental interfaces to work together to mitigate the risks of emerging and re-emerging infectious diseases (EIDs). A One Health approach emphasizing inter-disciplinary co-operation is increasingly seen as necessary for effective EID control and prevention. There are, however, socio-political, ethical and legal challenges, which must be met by such a One Health approach.DiscussionBased on the philosophical review and critical analysis of scholarship around the theory and practice of One Health it is clear that EID events are not simply about pathogens jumping species barriers; they are comprised of complex and contingent sets of relations that involve socioeconomic and socio-political drivers and consequences with the latter extending beyond the impact of the disease. Therefore, the effectiveness of policies based on One Health depends on their implementation and alignment with or modification of public values.SummaryDespite its strong motivating rationale, implementing a One Health approach in an integrated and considered manner can be challenging, especially in the face of a perceived crisis. The effective control and prevention of EIDs therefore requires: (i) social science research to improve understanding of how EID threats and responses play out; (ii) the development of an analytic framework that catalogues case experiences with EIDs, reflects their dynamic nature and promotes inter-sectoral collaboration and knowledge synthesis; (iii) genuine public engagement processes that promote transparency, education and capture people’s preferences; (iv) a set of practical principles and values that integrate ethics into decision-making procedures, against which policies and public health responses can be assessed; (v) integration of the analytic framework and the statement of principles and values outlined above; and (vi) a focus on genuine reform rather than rhetoric.

Ethical challenges of innovative surgery: a response to the IDEAL recommendations

1–3 addresses some but not all these concerns. Here, we build on this important work by identifying gaps that warrant further attention and by making additional suggestions for dealing with the ethical challenges associated with surgical innovation. The most obvious source of patient harm is physical, with the potential for increased mortality and morbidity from innovations compared with standard treatment. This concern is supported by historical reports in which innovative surgery has generated harm—eg, by routine episiotomy, treatment of peptic ulcer disease with gastric freezing, and early eff orts to artifi cially sustain circulation with implant devices. 4 Although technologies might be independently safe and eff ective, their combination could generate unanticipated problems—eg, a major innovation in gastrointestinal surgery, laparoscopic cholecystectomy, resulted in a substantial increase in biliary injuries. 5 Noneff ective treatments also generate potential harms, since surgery itself is not benign; ancillary risks arise from infection and anaesthesia, and the commitment to surgical intervention could mean other treatment options are foreclosed. Even if new procedures are deemed safe and eff ective, the learning curves associated with innovative treatments heighten risks to patients while a surgeon obtains competency in such procedures. Additionally, there can be burdens for patients and their families that are caused by innovative surgery, which go beyond physical diffi culties, and include fi nancial and psychological hardship. 4

Joint issues – conflicts of interest, the ASR hip and suggestions for managing surgical conflicts of interest

BackgroundFinancial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.DiscussionWe identify financial and nonfinancial conflicts of interest experienced by surgeons, hospitals and regulators in the ASR case. These conflicts may have impacted surgical advice, decision-making and evidence gathering with respect to the ASR prosthesis, and contributed to the significant harms experienced by patients in whom the hip was implanted. Drawing on this case we explore shortcomings in the standard responses to conflicts of interest – disclosure and recusal. We argue disclosure is necessary but by no means sufficient to address conflicts of interest. Using the concept of recusal we develop remedies including second opinions and third party consent which may be effective in mitigating conflicts, but their implementation introduces new challenges.SummaryDeployment of the ASR hip is a case of surgical innovation gone wrong. As we show, there were multiple conflicts of interest involved in the introduction of the ASR hip into practice and subsequent attempts to gloss over the mounting body of evidence about its lack of safety and effectiveness. Conflicts of interest in surgery are often not well managed. We suggest strategies in this paper which can minimise the conflicts of interest associated with surgical innovation.

Impure Politics and Pure Science: Efficacious Ebola Medications Are Only a Palliation and Not a Cure for Structural Disadvantage

Caplan and colleagues (2015) present a strong argument for using alternative trial designs for experimental treatments for Ebola virus disease (EVD). This argument is, of course, not new. There is a significant body of work in the philosophy of medicine that highlights the moral authority given to randomized controlled trials (RCTs) and the fact that RCTs are often chosen not because these are needed but because people simply do not recognize that they can get evidence that is just as useful from other trial designs (Kerridge 2010). Disciplines Education | Social and Behavioral Sciences Publication Details Degeling, C., Johnson, J. & Mayes, C. (2015). Impure Politics and Pure Science: Efficacious Ebola Medications Are Only a Palliation and Not a Cure for Structural Disadvantage. The American Journal of Bioethics, 15 (4), 43-45. This journal article is available at Research Online: http://ro.uow.edu.au/sspapers/3817

Vulnerable Subjects? The Case of Nonhuman Animals in Experimentation

The concept of vulnerability is deployed in bioethics to, amongst other things, identify and remedy harms to participants in research, yet although nonhuman animals in experimentation seem intuitively to be vulnerable, this concept and its attendant protections are rarely applied to research animals. I want to argue, however, that this concept is applicable to nonhuman animals and that a new taxonomy of vulnerability developed in the context of human bioethics can be applied to research animals. This taxonomy does useful explanatory work, helping to pinpoint the limitations of the 3Rs/welfare approach currently adopted in the context of animal experimentation. On this account, the 3Rs/welfare approach fails to deliver for nonhuman animals in experimentation because it effectively addresses only one element of their vulnerability (inherent) and paradoxically through the institution of Animal Ethics Committees intended to protect experimental animals in fact generates new vulnerabilities that exacerbate their already precarious situation.

Addressing Within-Role Conflicts of Interest in Surgery

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest are transparency and recusal, which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation.

Justice and Surgical Innovation: The Case of Robotic Prostatectomy

Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about whether to publicly fund access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long-term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations.

The First Shared Online Curriculum Resources for Veterinary Undergraduate Learning and Teaching in Animal Welfare and Ethics in Australia and New Zealand

Simple Summary There is a need for teaching Animal Welfare and Ethics in veterinary schools and we are developing online resources to meet this need. In this paper we describe how we prioritized the development of these resources by polling experts in the field. Abstract The need for undergraduate teaching of Animal Welfare and Ethics (AWE) in Australian and New Zealand veterinary courses reflects increasing community concerns and expectations about AWE; global pressures regarding food security and sustainability; the demands of veterinary accreditation; and fears that, unless students encounter AWE as part of their formal education, as veterinarians they will be relatively unaware of the discipline of animal welfare science. To address this need we are developing online resources to ensure Australian and New Zealand veterinary graduates have the knowledge, and the research, communication and critical reasoning skills, to fulfill the AWE role demanded of them by contemporary society. To prioritize development of these resources we assembled leaders in the field of AWE education from the eight veterinary schools in Australia and New Zealand and used modified deliberative polling. This paper describes the role of the poll in developing the first shared online curriculum resource for veterinary undergraduate learning and teaching in AWE in Australia and New Zealand. The learning and teaching strategies that ranked highest in the exercise were: scenario-based learning; a quality of animal life assessment tool; the so-called ‘Human Continuum’ discussion platform; and a negotiated curriculum.

The controversy over vertebroplasty: an analysis of the debate and proposals for a way forward.

This paper examines the ongoing and often heated debate about the merits or otherwise of percutaneous vertebroplasty as a treatment for painful osteoporotic vertebral fractures. In spite of the proliferation of research on this topic there is no agreement over its indications, safety or efficacy. We discuss the ethical issues which arise when new medical interventions such as vertebroplasty are introduced and make suggestions of relevance not just to the case of vertebroplasty, but to the introduction of innovative procedures generally.