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.

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.

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.

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.

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.

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.

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review.

Importance: Developing more and better diagnostic and therapeutic tools for central nervous system disorders is an ethical imperative. Human research with neural devices is important to this effort and a critical focus of the National Institutes of Health Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Despite regulations and standard practices for conducting ethical research, researchers and others seek more guidance on how to ethically conduct neural device studies. This article draws on, reviews, specifies, and interprets existing ethical frameworks, literature, and subject matter expertise to address 3 specific ethical challenges in neural devices research: analysis of risk, informed consent, and posttrial responsibilities to research participants. Observations: Research with humans proceeds after careful assessment of the risks and benefits. In assessing whether risks are justified by potential benefits in both invasive and noninvasive neural device research, the following categories of potential risks should be considered: those related to surgery, hardware, stimulation, research itself, privacy and security, and financial burdens. All 3 of the standard pillars of informed consent-disclosure, capacity, and voluntariness-raise challenges in neural device research. Among these challenges are the need to plan for appropriate disclosure of information about atypical and emerging risks of neural devices, a structured evaluation of capacity when that is in doubt, and preventing patients from feeling unduly pressured to participate. Researchers and funders should anticipate participants' posttrial needs linked to study participation and take reasonable steps to facilitate continued access to neural devices that benefit participants. Possible mechanisms for doing so are explored here. Depending on the study, researchers and funders may have further posttrial responsibilities. Conclusions and Relevance: This ethical analysis and points to consider may assist researchers, institutional review boards, funders, and others engaged in human neural device research.

Evidence for personalised medicine: mechanisms, correlation, and new kinds of black box.

Personalised medicine (PM) has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells (iPSCs) so as to make individualised treatment predictions. We compare this strategy to two main PM strategies-stratified medicine and computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies-a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system.

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.

They Know How to Work It, That's Their Focus in Life: The Complex Role of Industry Representatives in Surgical Innovation.

Relationships between health care providers and industry can generate conflicts of interest with their attendant harms. However, the types of relationships that involve conflicts of interest have often been understood narrowly as material ones between individual clinicians and industry. In research we undertook with surgical teams, we found the role of industry representatives has become normalized in the context of surgical innovation. In this article, we report the findings of our study and unpack the features of both surgery and innovation which contribute to the scope and normalization of industry involvement. We argue that these relationships generate significant ethical challenges and conclude by commenting on how our conceptualization of the situation might inform change.

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.

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.

What Pacemakers Can Teach Us about the Ethics of Maintaining Artificial Organs.

One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software-particularly software that can be remotely accessed-in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered.