Medicine in the marketplace: clinician and patient views on commercial influences on assisted reproductive technology.

RESEARCH QUESTION: What are the views and experiences of patient and expert stakeholders on the positive and negative impacts of commercial influences on the provision of assisted reproductive technology (ART) services, and what are their suggestions for governance reforms? DESIGN: Semi-structured interviews were conducted with 31 ART industry experts from across Australia and New Zealand and 25 patients undergoing ART from metropolitan and regional Australia, between September 2020 and September 2021. Data were analysed using thematic analysis. RESULTS: Expert and patient participants considered that commercial forces influence the provision of ART in a number of positive ways - increasing sustainability, ensuring consistency in standards and providing patients with greater choice. Participants also considered commercial forces to have a number of negative impacts, including increased costs to government and patients; the excessive use of interventions that lack sufficient evidence to be considered part of standard care; inadequately informed consent (particularly with regard to financial information); and threats to patient-provider relationships and patient-centred care. Participants varied in whether they believed that professional self-regulation is sufficient. While recognizing the benefits of commercial investment in healthcare, many considered that regulatory reforms, as well as organizational cultural initiatives, are needed as means to ensure the primacy of patient well-being. CONCLUSIONS: The views expressed in this study should be systematically and critically examined to derive insights into how best to govern ART. These insights may also inform the design and delivery of other types of healthcare that are provided in the private sector.

Perspectives on non-financial conflicts of interest in health-related journals: A scoping review.

The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review. nfCOI were discussed most commonly in empirical (22%; 42/190), theoretical (15%; 29/190) and "other" studies (18%; 34/190) - including commentary, perspective, and opinion articles. nfCOI were addressed frequently in the research domain (36%; 68/190), publication domain (29%; 55/190) and clinical practice domain (17%; 32/190). Attitudes toward nfCOI and their management were divided into two distinct groups. The first larger group claimed that nfCOI were problematic and required some form of management, whereas the second group argued that nfCOI were not problematic, and therefore, did not require management. Despite ongoing debates about the nature, definition, and management of nfCOI, many articles included in this review agreed that serious consideration needs to be given to the prevalence, impact and optimal mitigation of non-financial COI.

Informing existing technology acceptance models: a qualitative study with older persons and caregivers.

New technologies can help older persons age in place and support their caregivers. However, they need to be accepted by the end-users to do so. Technology acceptance models, such as TAM and UTAUT and their extensions, use factors like performance expectancy and effort expectancy to explain acceptance. Furthermore, they are based on quantitative methods. Our qualitative study investigates factors fostering and hindering acceptance among older persons and their caregivers for a variety of assistive technologies, including wearables, ambient sensors at home with and without cameras and social companion robots. The goal of this paper is twofold: On the one hand, it investigates the factors of technology acceptance models in a qualitative setting. On the other hand, it informs these models with aspects currently overlooked by them. The results reveal that performance expectancy and effort expectancy are relevant for acceptance. We also find that reliability, anxiety around technology and different social aspects have an influence on acceptance of assistive technology in aged care for all end-user groups. Our findings can be used to update current technology acceptance models and provide in-depth knowledge about the currently used factors.

Moral justification for the use of 'add-ons' in assisted reproductive technology: experts' views and experiences.

RESEARCH QUESTION: What factors do assisted reproductive terchnology (ART) providers take into account when they make decisions about offering 'add-ons'? DESIGN: A qualitative analysis of interviews with 31 ART professionals, focusing on their views and experiences in relation to add-ons, including the factors that are considered when doctors make decisions about their use. RESULTS: The participants reported that a range of considerations are taken into account when it comes to justifying the use of a particular add-on in a given circumstance, including the likelihood of benefit and harm, patients' perceived psychological needs and preferences, and organizational expectations. Importantly, patient preferences, psychological factors and low risk of harm appear to be stronger motivations than increasing the likelihood of a live birth or the desire to innovate. CONCLUSIONS: These findings suggest that it cannot be taken for granted that add-ons and innovation are closely linked. One possible response to this would be regulatory reform; for example, only allowing 'unproven' add-ons to be used in the context of formal scientific evaluation. Alternatively, it could be made clear that add-ons that are not undergoing formal evaluation have more in common with other therapies lacking a clear evidence base, such as complementary and alternative medicines, than with conventional medical practice. Practices in relation to add-ons may also require a focus on the responsibilities of corporations, and the standards applying to purveyors of consumer goods and services.

What moral weight should patient-led demand have in clinical decisions about assisted reproductive technologies?

Evidence suggests that one reason doctors provide certain interventions in assisted reproductive technologies (ART) is because of patient demand. This is particularly the case when it comes to unproven interventions such as 'add-ons' to in vitro fertilisation (IVF) cycles, or providing IVF cycles that are highly unlikely to succeed. Doctors tend to accede to demands for such interventions because patients are willing to do and pay 'whatever it takes' to have a baby. However, there is uncertainty as to what moral weight should be placed on patient-led demands in ART, including whether it is acceptable for such demands to be invoked as a justification for intervention. We address this issue in this paper. We start by elucidating what we mean by 'patient-led demand' and synthesise some of the evidence for this phenomenon. We then argue that a doctor's professional role morality (PRM) yields special responsibilities, particularly in commercialised healthcare settings such as ART, because of the nature of professions as social institutions that are distinct from markets. We argue on this basis that, while there may be reasons (consistent with PRM) for doctors to accede to patient demand, this is not always the case. There is often a gap in justification between acceding to patient-led demands and providing contested interventions, particularly in commercial settings. As a result, acceding to demand in such settings needs a strong justification to be consistent with PRM.

Therapeutic misunderstandings in modern research.

Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade-offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the 'therapeutic misconception'. The evolution of the clinical trials landscape, including greater integration of clinical trials into healthcare and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience. Using cancer clinical trials as an exemplar, we describe how methodological changes in early- and late-phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re-examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation.

Hope and Exploitation in Commercial Provision of Assisted Reproductive Technologies.

Innovation is a key driver of care provision in assisted reproductive technologies (ART). ART providers offer a range of add-on interventions, aiming to augment standard in vitro fertilization protocols and improve the chances of a live birth. Particularly in the context of commercial provision, an ever-increasing array of add-ons are marketed to ART patients, even when evidence to support them is equivocal. A defining feature of ART is hope-hope that a cycle will lead to a baby or that another test or intervention will make a difference. Yet such hope also leaves ART patients vulnerable in a variety of ways. This article argues that previous attempts to safeguard ART patients have neglected how the use of add-ons in commercial ART can exploit patients' hopes. Commercial providers of ART should provide add-ons only free of charge, under a suitable research protocol.

The silent world of assisted reproduction: A qualitative account of communication between doctors and patients undergoing in vitro fertilisation in Australia.

CONTEXT: In vitro fertilisation (IVF) is now a common assisted reproductive technology (ART) procedure globally, with 8 million children alive today having been conceived utilising IVF. For many patients, IVF is a difficult experience with many discontinuing treatment because of emotional, relationship and financial stress, or intolerable physical side effects of hormone treatments. DESIGN AND PARTICIPANTS: A qualitative study, in which 31 professionals and 25 patients from the ART sector in Australia were interviewed. The interviews were analysed using codebook thematic analysis. RESULTS: Our data indicates there are 'silences' within the therapeutic relationship of IVF, which may limit the capacity for patients to prepare emotionally, financially, or medically for the procedure, and may contribute to psychological distress and dissatisfaction with care. These 'silences' include what the patient 'is not told' by their clinician or 'does not hear' and what the patient feels they 'cannot say'. DISCUSSION: Drawing upon the work of Jay Katz, Charis Thompson, and Miles Little on 'silences' and performance in clinical practice, we argue that although IVF is a complex and multifaceted procedure that is often conducted in a commercial setting, the clinical and therapeutic relationship between doctor and patient remains pivotal to the experiences of patients. The 'silences' within this relationship may impact negatively on decision-making, and on the delivery and experience of care. CONCLUSIONS: Careful attention to the realities of IVF treatment in the clinic room (and awareness of the performances that hide them) should allow for more present and compassionate care. Such care may leave patients more satisfied with their experience and their choices, regardless of treatment outcomes. PATIENT OR PUBLIC CONTRIBUTION: This article draws on interviews with patients who had undergone or were currently undergoing IVF, as well as a range of representatives from the ART community (including reproductive medicine specialists, general practitioners, fertility nurses, counsellors, administrators in ART businesses and embryologists).

Can old drugs learn new tricks? Achieving registration and public subsidy listing for off-patent medicines with novel therapeutic applications.

With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.

How therapeutic advances have transformed the medical landscape: a primer for clinicians.

Novel medicines are entering the market rapidly and are increasingly being used alone or in combination to treat illnesses of every sort. While transforming the lives of many patients, these new therapies have also forced us to reconsider the way we evaluate, use and fund medicines. This article offers a primer to help practitioners understand how the therapeutic landscape is changing and how this might impact the evidence generation, access to interventions, patient experience and quality of care.

Going the Distance : Ethics of Space and Location on Accessing Reproductive Services in Australia.

Qualitative studies on assisted reproductive technology commonly focus on the perspectives of participants living in major metropolises. In doing so, the experiences of those living outside major cities, and the unique way conditions of spatiality shape access to treatment, are elided. In this paper, we examine how location and regionality in Australia impact upon access and experience of reproductive services. We conducted twelve qualitative interviews with participants residing in regional areas across Australia. We asked participants to discuss their experience with assisted reproduction services and the impacts of location on access, service choice, and experience of care, and analysed the data using reflexive thematic analysis, as outlined by Braun and Clarke (2006, 2019). Participants in this study reported that their location impacted the services available to them, required considerable time in travel, and reduced continuity of care. We draw on these responses to examine the ethical implications of uneven distribution of reproductive services in commercial healthcare settings which rely on market-based mechanisms.

When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials.

Many factors influence patients' decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer. While this is not surprising, it is potentially problematic if patients fail to recognise the distinction between research and clinical care (a phenomenon known as the 'therapeutic misconception'). This is becoming increasingly problematic as clinical trial designs become more complex, as clinical trials become more embedded in routine clinical care, and as trials are increasingly used by patients and clinicians to access new diagnostic platforms and therapies. We outline some of these recent trends, focusing on the cancer clinical trials landscape as this provides a good case study of the phenomenon. We conclude by making preliminary suggestions that changes to the consent process, perhaps using 'dynamic consent' platforms, might help to mitigate the therapeutic misconception and note the need for further research to guide strategies for improving communication and decision-making.

Clinical innovation ethics frameworks: A systematic narrative review.

BACKGROUND: It is common for doctors to engage in clinical innovation-i.e. to use novel interventions that differ from standard practice, and that have not yet been shown to be safe or effective according to the usual standards of evidence-based medicine-in the belief that this will benefit their patients. Clinical innovation is currently poorly defined and lacks cohesive oversight mechanisms. METHODS: A systematic narrative review, with the aim of identifying areas of similarity and divergence in innovation ethics frameworks developed across different medical specialties. RESULTS: 47 articles were included in the review. Few ethical issues raised by the ethics frameworks appear to be unique to distinct areas of practice. While variations exist in the oversight mechanisms suggested, these are again not specific to areas of practice, but rather reflect either cautious or more permissive attitudes towards clinical innovation. CONCLUSIONS: There is considerable overlap amongst ethics frameworks developed for use in diverse areas of practice. This reflects a tendency to treat innovative interventions in each area of practice as "exceptional" and a failure to develop "higher order" frameworks such as those that have been developed for research. Those involved in the oversight of clinical innovation need to aim for a balance between exceptionalism and harmonisation.

Situating commercialization of assisted reproduction in its socio-political context: a critical interpretive synthesis.

BACKGROUND: In many countries, ART service provision is a commercial enterprise. This has benefits, for example, creating efficiencies and economies of scale, but there are also concerns that financial imperatives can negatively impact patient care. The commercialization of ART is often conceptualized as being driven solely by the financial interests of companies and clinicians, but there are in fact many complex and intersecting socio-political demands for ART that have led to, sustain and shape the industry. OBJECTIVE AND RATIONALE: To use the academic and policy discourse on the commercialization of ART to build a theoretical model of factors that influence demand for ART services in high-income countries in order to inform potential policy responses. SEARCH METHODS: We searched electronic databases for journal articles (including Web of Science, Scopus, PubMed) and websites for grey literature, carried out reference chaining and searched key journals (including Human Reproduction, Fertility and Sterility). The terms used to guide these searches were 'assisted reproductive technology' OR 'in vitro fertilization' AND 'commerce' OR 'commercialisation' OR 'industry' OR 'market'. The search was limited to the English language and included articles published between 2010 and 2020. We used an established method of critical interpretive synthesis (CIS) to build a theoretical model of factors that influence demand for ART services in high-income countries. We developed initial themes from a broad review of the literature followed by iterative theoretical sampling of academic and grey literatures to further refine these themes. OUTCOMES: According to contemporary academic and broader socio-political discourse, the demand for ART has arisen, expanded and evolved in response to a number of intersecting forces. Economic imperatives to create sustainable national workforces, changing gender roles and concerns about the preservation of genetic, national/ethnic and role-related identities have all created demand for ART in both public and private sectors. The prominence given to reproductive autonomy and patient-centred care has created opportunities to (re)define what constitutes appropriate care and, therefore, what services should be offered. All of this is happening in the context of technological developments that provide an increasing range of reproductive choices and entrench the framing of infertility as a disease requiring medical intervention. These socio-political drivers of demand for ART can be broadly organized into four theoretical categories, namely security, identity, individualization and technocratization. LIMITATIONS REASONS FOR CAUTION: The primary limitation is that the interpretive process is ultimately subjective, and so alternative interpretations of the data are possible. WIDER IMPLICATIONS: Development of policy related to commercial activity in ART needs to account for the broad range of factors influencing demand for ART, to which commercial ART clinics are responding and within which they are embedded. STUDY FUNDING/COMPETING INTERESTS: This work was supported by a National Health and Medical Research Council Ideas Grant (APP1181401). All authors declare that they have no conflict of interest in relation to this work.

A New Priority Pathway for Biologicals in Australia: Contextualising and Evaluating the Proposed Reforms.

This section examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

An Archeology of Corruption in Medicine.

Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar within churches and other ostensibly beneficent institutions, and it happens within medicine and the pharmaceutical industries. Corrupt behavior reduces trust, costs money, causes injustice, and arouses anger. Yet it persists, despite all efforts since the beginnings of societies. People who act corruptly may lack conscience and empathy in the same way as those with some personality disorders. Finding ways to prevent corruption from contaminating beneficent organizations is therefore likely to be frustratingly difficult. Transparency and accountability may go some way, but the determined corruptor is unlikely to feel constrained by moral and reporting requirements of this kind. Punishment and redress are complicated issues, unlikely to satisfy victims and society at large. Both perhaps should deal in the same currency-material or social-in which the corrupt dealing took place.

Moral Lacunae in the Management of Dual Agency Dilemmas Comment on "Dual Agency in Hospitals: What Strategies Do Managers and Physicians Apply to Reconcile Dilemmas Between Clinical and Economic Considerations?"

Waitzberg and colleagues' participants articulate a wide range of strategies to manage tensions between clinical and economic obligations. There are, however, three notable absences in the data. First, all strategies described by participants are underpinned by the assumption that clinical (and associated administrative) practices need to either align with economic considerations or be made more compatible with them. Second, the dual agency dilemma was framed exclusively as existing at the level of the health care institution, with little attention paid to obligations to broader health systems. Third, there was no evidence of critical questioning of the priorities of the hospitals in which participants work. These absences do not render the strategies used by Weitzberg and colleagues' participants morally "wrong," but they do suggest that people who are deeply embedded in a system might fail to recognise the full range of moral concerns and moral possibilities.