Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

OBJECTIVE: The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations. SUMMARY BACKGROUND DATA: Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and risks pose challenges for regulation. High-profile implantable device failures have fuelled concerns about the level of clinical evidence needed for market approval. Calls for more rigorous evaluation lack clarity about what kind of evaluation is appropriate, and are commonly interpreted as meaning more randomized controlled trials (RCTs). These are valuable where devices are genuinely new and claim to offer measurable therapeutic benefits. Where this is not the case, RCTs may be inappropriate and wasteful. METHODS: Starting with a set of ethical principles and basic precepts of clinical epidemiology, we developed a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable. RESULTS: The algorithm clearly defines a group of devices where an RCT is deemed necessary, and the associated framework indicates that an IDEAL 2b study should be the default clinical evaluation method where it is not. CONCLUSIONS: The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.

Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives.

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Four types of gender bias affecting women surgeons and their cumulative impact.

Women are under-represented in surgery, especially in leadership and academic roles, and face a gender pay gap. There has been little work on the role of implicit biases in women's under-representation in surgery. Nor has the impact of epistemic injustice, whereby stereotyping influences knowledge or credibility judgements, been explored. This article reports findings of a qualitative in-depth interview study with women surgeons that investigates gender biases in surgery, including subtle types of bias. The study was conducted with 46 women surgeons and trainees of the Royal Australasian College of Surgeons. Maximum variance sampling strategies ensured a comprehensive set of perspectives. Data were analysed using iterative thematic analysis to document and classify forms of gender bias experienced by the participants, including implicit bias and epistemic injustice. It found four types of bias affecting women surgeons: (1) workplace factors such as access to parental leave and role models; (2) epistemic injustices-unfair assessments of women surgeons' credibility by patients and colleagues; (3) stereotyped expectations that they will carry out more of surgery's carework, such as meeting the emotional needs of patients and (4) objectification. Implicit biases arose in each category. Given that many of the biases identified in this study are small, are harmless on their own and are not necessarily under anyone's conscious control, important questions arise regarding how they cause harm and how to address them. I draw on theoretical work on cumulative harm to answer these questions.

Ethics and the cardiac pacemaker: more than just end-of-life issues.

For many years, ethical debate about pacemakers has focused on whether and under what circumstances they may be turned off in end of life care. Several other important ethical issues have been neglected, perhaps because the dilemmas they pose for cardiologists are not so immediate. These include: potential conflicts of interest, particularly those arising from the role of industry employed allied professionals (IEAPs) in pacemaker care; unanticipated impacts of commercial competition and the device improvement cycle; risks associated with remotely accessible software; equity in access to healthcare; and questions about reuse of explanted pacemakers in low and middle income countries. This paper analyses these issues in order to facilitate a more comprehensive approach to ethics and the cardiac pacemaker. Cardiologists should be aware of all of these issues and contribute to ongoing discussions about how they are resolved.

Device representatives in hospitals: are commercial imperatives driving clinical decision-making?

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: (1) impacts on healthcare costs, (2) the outsourcing of expertise and (3) issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

Addressing Deficits and Injustices: The Potential Epistemic Contributions of Patients to Research.

Patient or public involvement (PPI) in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research (generating knowledge), and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients' experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker's idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research.

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.

Consent to innovative treatment: No need for a new legal test.

The provision of advice prior to medical treatment raises the perennial question of how much information is sufficient and how can patients truly understand the nature of the risks and benefits of any proposed treatment? This issue is potentially heightened in the context of innovative treatment where health care providers themselves do not know the full range of risks and benefits and thus cannot hope to communicate these to the patient. This potential issue in turn raises the question of whether or not there needs to be a specific legal framework around consent to innovative treatment. This article draws together the findings of a study into innovation in surgery and an analysis of the existing legal framework to demonstrate that while concerns around consent to innovative treatment are valid they are not unique and apply equally to the provision of all health care. The article concludes that to suggest a framework which specifically addresses innovative treatment would be to add an artificial and unnecessary formality to any pre-treatment consultation. In short, the current legal framework adequately addresses the concerns raised by the surgeons in the study and there is no need for a new legal test.

Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice.

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new." CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.

Identifying surgical innovation: a qualitative study of surgeons' views.

OBJECTIVE: This study explores how surgeons define innovation, critically examines and evaluates these views, and uses the findings to develop practical criteria for identifying surgical innovation for ethical and regulatory purposes. BACKGROUND: Surgical innovation is crucial for progress in surgery, but can be harmful to patients and difficult to identify and therefore support appropriately. Current attempts to define surgical innovation lack precision, and do not give enough guidance to identify innovations in practice. This study is the first to give an account of surgeons' own views about defining innovation. METHODS: This qualitative study involved interviews with 18 Australian surgeons. Participants provided examples of innovation and distinguished innovation from variations in practice and from research. Data were collected using audio-recorded semistructured interviews. The data were coded using a template and analyzed to develop a thematic account of innovative surgery in practice. RESULTS: There was no uniform view about innovation, but participants identified 5 features of surgical innovation that distinguish it from variations: newness or novelty; degree of change; level of risk; impact; and requiring formal processes. There was no agreement on the distinction between innovation and research. CONCLUSIONS: Drawing on surgeons' own views is important for the development of a practical definition of surgical innovation. We have used a critical analysis of surgeons' own views as the basis for defining the core features of innovation. A precise definition of innovation will assist surgeons to identify and manage innovation and thereby enhance patient safety.

Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals.

BACKGROUND: Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect. DISCUSSION: In this paper we investigate justifications for placebo-controlled surgical trials and suggest three measures for strengthening their ethical acceptability. We argue that, given the extent, irreversibility and cost of surgical interventions, there is a need for the best possible evidence about their efficacy. In some cases, the strongest evidence will be from placebo-controlled surgical trials, especially where interventions are for outcomes (such as pain) that are likely to elicit a placebo response. In the second part of the paper, we propose three specific measures to increase the ethical acceptability of placebo-controlled surgical trials. The first is structured consultation with the relevant patient community about the risks and benefits of particular placebo-controlled surgical trials. The second seeks to address the therapeutic misconception through the use of educational materials, informed by patient consultation. Finally, we argue for ethical consideration of non-surgeon clinicians who are necessarily involved in the delivery of placebo-surgical interventions. SUMMARY: If there is no appropriate surgical comparator and the risks can be reduced to the absolute minimum (given the type of placebo procedure required), and the research has the support of the relevant patient community, there may be grounds for judging that the potential benefits of specific placebo-controlled surgical trials outweigh the risks. If so justified, the ethical acceptability of placebo-controlled surgical trials can be enhanced through using educational measures to address participant vulnerability, and by recognizing clinicians who are necessary participants in the research.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine.

ABSTRACTThis paper examines potential ethical and legal issues arising during the research, development and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detrimental to best personalizing treatment decisions in the clinic.