The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)

The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.

In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA organizations use to conduct (...) their evaluations and considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy. (shrink)

Svirsky, Howard, and Berman address the U.S. Food and Drug Administration ’s oversight of tobacco products, the newest major area of regulation Congress assigned to the FDA. They discus...

Gene therapies to treat sickle cell disease are in development and are expected to have high costs. The large eligible population size — by far, the largest for a gene therapy — poses daunting budget challenges and threatens to exacerbate health disparities for Black patients, who make up the vast majority of American sickle cell patients.

We discuss the role of prior authorization (PA) in supporting patient-centered care (PCC) by directing health system resources and thus the ability to better meet the needs of individual patients. We begin with an account of PCC as a standard that should be aimed for in patient care. In order to achieve widespread PCC, appropriate resource management is essential in a healthcare system. This brings us to PA, and we present an idealized view of PA in order to argue how (...) at its best, it can contribute to the provision of PCC. PA is a means of cost saving and as such it has mixed success. The example of the US demonstrates how implementation of PA has increased health inequalities whereas best practice has the potential to reduce them. In contrast, systems of universal coverage, like those in Europe, may use the cost savings of PA to better address individuals' care and PCC. The conclusion we offer therefore is an optimistic one, pointing towards areas of supportive overlap between PCC and PA where usually the incongruities are most evident. (shrink)

State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a risk, it (...) is not a problem unique to Medicaid, since private insurance programs have also implemented closed formularies. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

A grandfather clause is a provision whereby an old rule continues to apply to some existing situation while a new rule applies to all future cases. This paper focuses on the use of grandfather clauses in health technology appraisals (HTAs) issued by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. NICE provides evidence‐based guidance on healthcare technologies and public health interventions that influence resource allocation decisions in the National Health Service (NHS) and the broader public (...) sector in England and Wales. In this context, a grandfather clause is included when NICE does not recommend treatment with a given technology. The grandfather clause provides an exemption from the general recommendation for patients who have already started treatment with the technology in question, before the publication of the NICE guidance. In this paper we first lay out the contexts in which grandfather clauses occur in NICE guidance, and then consider ethical arguments against and in support of grandfather clauses and the continuation of treatment. We argue that NICE’s current practice of automatic inclusion of a grandfather clause is ethically problematic and unfair. While the inclusion of a grandfather clause may be appropriate and justified in specific cases, we argue that inclusion of such a clause should be considered as part and parcel of the decision making process on a case by case basis, rather than adopted as the default. (shrink)

Misinformation is a serious concern for societies across the globe. To design effective interventions to combat the belief in and spread of misinformation, we must understand which psychological processes influence susceptibility to misinformation. This paper tests the widely assumed – but largely untested – claim that emotionally provocative headlines are associated with worse ability to identify true versus false headlines. Consistent with this proposal, we found correlational evidence that overall emotional response at the headline level is associated with diminished truth (...) discernment, except for experienced anger which was associated with increased truth discernment. The second set of studies tested a popular emotion regulation intervention where people were asked to apply either emotional suppression or emotion reappraisal techniques when considering the veracity of several headlines. In contrast to the correlation results, we found no evidence that emotion regulation helped people distinguish false from true news headlines. (shrink)

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

Patient and public involvement (PPI) has gained widespread support in health research and health policy circles, but there is little consensus on the precise meaning or justifications of PPI. We argue that an important step towards clarifying the meaning and justification for PPI is to split apart the familiar acronym and draw a distinction between patient and public involvement. Specifically, we argue that patient involvement should refer to the practice of involving individuals in health research or policy on the basis (...) of their experience with a particular condition, while public involvement should refer to the practice of involving individuals in health policy or research based on their status as members of a relevant population. Analyzing cases from the UK, Australia, and the USA, we show how our proposed distinction can deliver much needed clarity to conversations on PPI, while guiding the development and evaluation of future PPI‐based policies. (shrink)

This letter responds to the essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines,” by Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman, in the special report “Time to Rebuild: Essays on Trust in Health Care and Science,” in the September‐October 2023 issue of the Hastings Center Report.

The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these (...) duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health research resources. (...) Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

This article tells the story of the oil and gas origins of the Gaia hypothesis, the theory that the Earth is a homeostatic system. It shows how Gaia’s key assumption—that the climate is a fundamentally stable system, able to withstand perturbations—emerged as a result of a collaboration between the theory’s progenitor, James Lovelock, and Royal Dutch Shell in response to Shell’s concerns about the effects of its products on the climate. The article explains how Lovelock elaborated the Gaia hypothesis and (...) gave it evidential depth through a series of Royal Dutch Shell-funded research projects meant to identify organisms whose biological activities might double as climate-regulating mechanisms. The article goes on to show how this research subsequently laid the foundation for a distinct genre of climate change denialism, in which corporations sowed doubt not by denying the phenomenon of global warming but by naturalizing it. (shrink)

_K. al-Manām_ by Ibn Abī al-Dunyā is a compendium of 350 Muslim dream narratives in Arabic. The English introduction examines the function of dreams in classical Arabic literature with a focus on dreams as a means of edification.

Two of the most influential theories about scientific inference are inference to the best explanation and Bayesianism. How are they related? Bas van Fraassen has claimed that IBE and Bayesianism are incompatible rival theories, as any probabilistic version of IBE would violate Bayesian conditionalization. In response, several authors have defended the view that IBE is compatible with Bayesian updating. They claim that the explanatory considerations in IBE are taken into account by the Bayesian because the Bayesian either does or should (...) make use of them in assigning probabilities to hypotheses. I argue that van Fraassen has not succeeded in establishing that IBE and Bayesianism are incompatible, but that the existing compatibilist response is also not satisfactory. I suggest that a more promising approach to the problem is to investigate whether explanatory considerations are taken into account by a Bayesian who assigns priors and likelihoods on his or her own terms. In this case, IBE would emerge from the Bayesian account, rather than being used to constrain priors and likelihoods. I provide a detailed discussion of the case of how the Copernican and Ptolemaic theories explain retrograde motion, and suggest that one of the key explanatory considerations is the extent to which the explanation a theory provides depends on its core elements rather than on auxiliary hypotheses. I then suggest that this type of consideration is reflected in the Bayesian likelihood, given priors that a Bayesian might be inclined to adopt even without explicit guidance by IBE. The aim is to show that IBE and Bayesianism may be compatible, not because they can be amalgamated, but rather because they capture substantially similar epistemic considerations. 1 Introduction2 Preliminaries3 Inference to the Best Explanation4 Bayesianism5 The Incompatibilist View : Inference to the Best Explanation Contradicts Bayesianism5. 1 Criticism of the incompatibilist view6 Constraint - Based Compatibilism6. 1 Criticism of constraint - based compatibilism7 Emergent Compatibilism7. 1 Analysis of inference to the best explanation7. 1. 1 Inference to the best explanation on specific hypotheses7. 1. 2 Inference to the best explanation on general theories7. 1. 3 Copernicus versus Ptolemy7. 1. 4 Explanatory virtues7. 1. 5 Summary7. 2 Bayesian account8 Conclusion. (shrink)

Epistemic injustice sits at the intersection of ethics, epistemology, and social justice. Generally, this philosophical term describes when a person is wrongfully discredited as a knower; and within the clinical space, epistemic injustice is the underlying reason that some patient testimonies are valued above others. The following essay seeks to connect patterns of social prejudice to the clinical realm in the United States: illustrating how factors such as race, gender identity, and socioeconomic status influence epistemic credence and associatively, the quality (...) of healthcare a person receives. After describing how epistemic injustice disproportionately harms already vulnerable patients, I propose a narrative therapy intervention. This intervention can help providers re-frame their relationships with patients, in such that they come to view patients as valuable sources of unique knowledge. Though I identify this intervention as a valuable step in addressing clinical epistemic injustice, I call upon medical educators and practitioners to further uplift the voices, perspectives, and stories of marginalized patients. (shrink)

Journal of Political Philosophy, EarlyView.

Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists’ views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists’ normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists’ views do not align (...) with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population—less diverse even than other academic disciplines—suggesting far more work needs to be done to build an inclusive field. (shrink)

There has been considerable puzzlement over how to respond to higher-order evidence. The existing dilemmas can be defused by adopting a ‘two-dimensional’ representation of doxastic attitudes which incorporates not only substantive uncertainty about which first-order state of affairs obtains but also the degree of conviction with which we hold the attitude. This makes it possible that in cases of higher-order evidence the evidence sometimes impacts primarily on our conviction, rather than our substantive uncertainty. I argue that such a two-dimensional representation (...) is naturally developed by making use of imprecise probabilities. (shrink)

Psychological studies show that the beliefs of two agents in a hypothesis can diverge even if both agents receive the same evidence. This phenomenon of belief polarisation is often explained by invoking biased assimilation of evidence, where the agents’ prior views about the hypothesis affect the way they process the evidence. We suggest, using a Bayesian model, that even if such influence is excluded, belief polarisation can still arise by another mechanism. This alternative mechanism involves differential weighting of the evidence (...) arising when agents have different initial views about the reliability of their sources of evidence. We provide a systematic exploration of the conditions for belief polarisation in Bayesian models which incorporate opinions about source reliability, and we discuss some implications of our findings for the psychological literature. (shrink)

Hierarchical Bayesian models (HBMs) provide an account of Bayesian inference in a hierarchically structured hypothesis space. Scientific theories are plausibly regarded as organized into hierarchies in many cases, with higher levels sometimes called ‘paradigms’ and lower levels encoding more specific or concrete hypotheses. Therefore, HBMs provide a useful model for scientific theory change, showing how higher‐level theory change may be driven by the impact of evidence on lower levels. HBMs capture features described in the Kuhnian tradition, particularly the idea that (...) higher‐level theories guide learning at lower levels. In addition, they help resolve certain issues for Bayesians, such as scientific preference for simplicity and the problem of new theories. *Received July 2009; revised October 2009. †To contact the authors, please write to: Leah Henderson, Massachusetts Institute of Technology, 77 Massachusetts Avenue, 32D‐808, Cambridge, MA 02139; e‐mail: [email protected]. (shrink)

BackgroundFunctional neurodiagnostics could allow researchers and clinicians to distinguish more accurately between the unresponsive wakefulness syndrome and the minimally conscious state. It remains unclear how it informs surrogate decision-making.ObjectiveTo explore how the next of kin of patients with disorders of consciousness interpret the results of a functional neurodiagnostics measure and how/why their interpretations influence their attitudes towards medical decisions.Methods and SampleWe conducted problem-centered interviews with seven next of kin of patients with DOC who had undergone a functional HD-EEG examination at (...) a neurological rehabilitation center in Germany. The examination included an auditory oddball paradigm and a motor imagery task to detect hidden awareness. We analyzed the interview transcripts using structuring qualitative content analysis.ResultsRegardless of the diagnostic results, all participants were optimistic of the patients’ meaningful recovery. We hypothesize, that participants deal with the results of examinations according to their belief system. Thus, an unfavorable evaluation of the patient’s state had the potential to destabilize the participant’s belief system. To re-stabilize or to prevent the destabilization of their belief system, participants used different strategies. Participants accepted a “positive” HD-EEG result since it stabilized their belief system.ConclusionWe hypothesize, that a group of next of kin of patients with DOC deals with functional neurodiagnostics results on the basis of the result’s value and their high hope that the patient will recover meaningfully. A psychological mechanism seems to moderate the impact of functional neurodiagnostics on surrogate treatment decisions. (shrink)

Hierarchical Bayesian models (HBMs) provide an account of Bayesian inference in a hierarchically structured hypothesis space. Scientific theories are plausibly regarded as organized into hierarchies in many cases, with higher levels sometimes called ‘para- digms’ and lower levels encoding more specific or concrete hypotheses. Therefore, HBMs provide a useful model for scientific theory change, showing how higher-level theory change may be driven by the impact of evidence on lower levels. HBMs capture features described in the Kuhnian tradition, particularly the idea (...) that higher-level theories guide learning at lower levels. In addition, they help resolve certain issues for Bayesians, such as scientific preference for simplicity and the problem of new theories. (shrink)