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. (shrink)

Nicholas Makins proposes that doctors should take a deferential attitude towards their patients’ preferences when making decisions, and this includes their risk attitudes.1 He grounds this proposal in the principles of autonomy and beneficence. Makins appears to hold autonomy as a good in and of itself, and so for him it follows that deferring to patients must also be good. He also seems to hold that the satisfaction of personal preferences inevitably leads to improved well-being, and so deferring to patients’ (...) risk attitudes upholds the principle of beneficence. Unfortunately, Makins explicitly avoids defining well-being. His account seems to ignore the possibility of an objective measure of health that could contravene patient preferences, and therefore, challenge a deferential approach. While it is true that medicine is replete with complex decisions and significant uncertainty which require value judgements to navigate, it is not true medicine is purely about satisfying preferences. Patient preferences should always guide clinical decisions, but it seems to me Makins is making the far stronger claim that a doctor should act as a substitute decision-maker of sorts, doing their best to make the decision as if they were the patient themselves. I would contend this is not a good idea, as it would clearly impact a doctor’s …. (shrink)

Almost any medicine can be purchased online from abroad. Many high-income countries permit individuals to import medicines for their personal use. However, those who import medicines face the risk of purchasing poor-quality products that may not work, or that may even harm them. Many people are willing to accept this risk for the opportunity to purchase more affordable medicines. This is especially true of individuals from low socioeconomic backgrounds who already struggle to afford the medicines they need if they are (...) not subsidised by insurers or if copayments are high. As medicine prices and out-of-pocket healthcare spending continue to climb, the online marketplace provides an important alternative for individuals in high-income countries to source medicines. In this article, I argue that doctors have a responsibility to help patients access medicines online and I propose a framework that can be used to facilitate responsible personal importation. (shrink)

Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may be but to possible (...) futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations. (shrink)

The debate about whether misoprostol should be distributed to low resource communities to prevent post-partum haemorrhage, recognised as a major cause of maternal mortality, is deeply polarised. This is in spite of stakeholders having access to the same evidence about the risks and benefits of misoprostol. To understand the disagreement, we conducted a qualitative analysis of the values underpinning debates surrounding community distribution of misoprostol. We found that different moral priorities, epistemic values, and attitudes towards uncertainty were the main factors (...) sustaining the debate. With this understanding, we present a model for ethical discourse that might overcome the current impasse. (shrink)

Cancer is a major burden on populations and health systems internationally. The development of innovative cancer medicines is seen as a significant part of the solution. These new cancer medicines are, however, expensive, leading to limited or delayed access and disagreements among stakeholders about which medicines to fund. There is no obvious resolution to these disagreements, with stakeholders holding firmly to divergent positions. Access to cancer medicines was recently explored in Australia in a Senate Inquiry into the Availability of New, (...) Innovative, and Specialist Cancer Drugs in Australia. We analysed the resultant Senate Report to identify competing stakeholder values. Our analysis illustrates that there are four main “goods” prioritized by different stakeholders: 1) innovation, 2) compassion, 3) equity, and 4) sustainability. We observe that, with the exception of sustainability, all of these “goods” put pressure on payers to provide access to cancer medicines more quickly and based on less rigorous evaluation processes. We then explore the consequences of giving in to such pressure and suggest that deconstructing the implicit values in calls for “enhanced access” to cancer medicines is necessary so that more nuanced solutions to the challenge of providing access to these high cost medicines can be found. (shrink)

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present (...) a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner. (shrink)

Wiggins and Wilbanks (2019) present citizen science as a range of “models” that fall under the rubric of public participation. They seem to have accepted what they call the “‘populist rhetoric’ tha...

While ethics and evidence‐based medicine are often viewed as separate domains of inquiry and practice, what we know influences what we can ethically justify doing, and what we see as our moral obligations shapes the way we interpret evidence. The boundaries between the moral and epistemic spheres become particularly blurred when the health of people is at stake and even more so when no “officially” recommended medical intervention is available to help a patient in need. The treatment of major hemorrhages (...) using recombinant factor VIIa (rFVIIa), which was originally approved under orphan drug legislation to treat hemophilia, is a case in point.Following reports in the late 1990s that rFVIIa was success­fully used to stop bleeding in gunshot trauma, there was much excitement about its potential to help patients with uncontrolled bleeding in other clinical settings, leading to wide‐spread off‐label use of the drug. In recent years, new evidence has raised questions about the off‐label use of rFVIIa for severe bleeding. Nonetheless, while some clini­cians are now adamantly opposed to prescribing rFVIIa for massive bleed­ing, many remain determined to continue the practice. This raises the question: why do clinicians have such variable responses to the same body of evidence?We analyzed the debate around off‐label use of rFVIIa and character­ized its main conceptual features and tensions. We did not seek to provide a normative analysis as to whether the evidence supports the case for off‐label prescribing, nor did we try to provide a historical analysis of how attitudes and clinical practice have changed. Rather, we sought to make visible the moral and epistemic values underpinning stakeholders’ opinions and practices. On the basis of our analysis, which is described in this ar­ticle, we suggest that debates such as those surrounding rFVIIa will not be resolved simply by conducting more studies and that, therefore, there is also a need for conceptual and pro­cedural frameworks that more sys­tematically incorporate values into clinical policy‐making. (shrink)

In their article, van Gils Schmidt and Salloch defend the claim that physicians have a duty to protect the climate. The logic of the argument in broad terms is that (i) there is a relationship between climate change and the burden of disease, (ii) the healthcare sector is a significant emitter of global greenhouse gasses, thereby enhancing the burden of disease and (iii) since doctors are advocates of health and stakeholders in the healthcare sector, they have a duty to respond (...) to climate change. The authors recognise the ‘ethical basis for the claim of healthcare professionals having a special responsibility in climate change is far from being obvious’. The theoretical framework they choose for making this tentative link more apparent is Korsgaard’s theory of practical identities. The main argument of the authors seems to be that practical identities are pluralistic—a person can identify as a physician and environmentalist simultaneously—and the normative positions attributable to these identities may come into conflict. More than that, they claim that being an environmentalist is increasingly becoming …. (shrink)

Conflicts of interests are typically divided into those that are financial and those that are not. While there is general agreement that financial COIs have a significant impact on decisions and need to be declared and managed, the status of non-financial COIs continues to be disputed. In a recentBMJfeature article it was proposed that religious beliefs should be routinely declared as an interest. The article generated over 41 responses from the medical community and health researchers, which put forward diverse and (...) opposing views. In this paper, we analyse the discourse to shed further light on the reasons put forward for and against declaring religious beliefs. We argue for a middle path in which only material beliefs should be declared, and then only when there are no extenuating circumstances. To this end, we present a framework to help evaluate the materiality of interests that can be used for both financial and non-financial interests. (shrink)

Effective evaluation of any activity requires, first, that we understand what its objectives are, and second, that we can define and measure these objectives. For instance, a publicly listed compan...

A commentary on “Ethics and Evidence in Medical Debates: The Case of Recombinant Activated Factor VII,” by Narcyz Ghinea, Wendy Lipworth, Ian Kerridge, Miles Little, and Richard O. Day, in the March‐April 2014 issue.