Search

The article discusses a 2024 study on the attitudes of patients 65 years and older on the use of routine clinical data in making treatment decisions. Results show participants' interest in such data and in how drugs work for them, and their concerns on confounders like populations' similarity of conditions with them, and on common minor side effects. Also noted are participants' common view that their physicians determine the evidence's applicability to them, and recommend a medication.

Building trust in public health agencies like the US Food and Drug Administration (FDA) has become a key government priority. Understanding the roots of FDA mistrust is important if the agency is to develop targeted messaging and reforms aimed at building confidence in the agency. We conducted a survey of 2,021 respondents in the US probing attitudes toward the FDA. The primary outcome was FDA trust, defined as the mean score that each respondent assigned to the FDA across four prespecified axes: (1) competence and effectiveness; (2) commitment to acting in the best interests of the American public; (3) abiding by the rules and regulations set forth by policy or law; and (4) expertise in health, science, and medicine. On multivariable ordinal logistic regression, FDA mistrust was associated with female gender (odds ratio [OR] = 0.74, 95% confidence interval [CI] 0.62–0.88), rural community (OR 0.85, 95% CI 0.75–0.96), conservative political views (OR 0.77, 95% CI 0.74–0.81), worse self‐reported health (OR 0.89, 95% CI 0.80–0.98), lower satisfaction with health care received (OR 0.63, 95% CI 0.56–0.71), less attention to health and science news (OR 0.72, 95% CI 0.64–0.80), and not having children under the age of 18 (OR 0.72, 95% CI 0.60–0.86). These findings underscore the challenges faced by US political leaders in convincing a heterogeneous American public to trust the FDA. The FDA should develop and deploy targeted outreach strategies to populations with lower levels of trust and strengthen internal processes that minimize biases and ensure sound decision‐making. [ABSTRACT FROM AUTHOR]

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper – developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting – seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny. [ABSTRACT FROM AUTHOR]

This article analyzes differences in prescription drug pricing transparency practices among 3 Organisation for Economic Co-operation and Development member nations: the United Kingdom, Germany, and Canada. Specifically, this article compares these countries' policies on list and net price disclosures and on how international reference pricing is used to evaluate merits and drawbacks of different pricing transparency approaches. Finally, the article summarizes what policymakers in the United States should learn from these comparisons. [ABSTRACT FROM AUTHOR]

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." [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Debate about whether and when to accommodate patient requests for concordant clinicians should consider evidence. This article examines how existing evidence could be used to interpret or inform ethical arguments about whether to accommodate such requests. Studies on patient-clinician concordance yield mixed and inconclusive results. Concordance might contribute to increased patient satisfaction and trust, but these results are not consistent and could be the result of clinicians' communication skills. Given this evidence and the risk of social harm in honoring concordance requests, this article argues that patients' concordance requests should be honored only when health care services would be denied to a patient, such as in a case of a clinician's conscientious objection to providing a service. All other requests should be scrutinized for a reasonable ethical justification. [ABSTRACT FROM AUTHOR]

Context: Vaccine hesitancy is associated with political and institutional distrust, but there is little research on how people's trust responds to political events. We revisit the fall of 2020 when evaluation of new COVID-19 vaccines collided with an impending national election. Drawing on a political Bayesian perspective, we assess abrupt changes in attention to political events and test hypotheses on subpopulation response: (1) partisan, (2) educational, and (3) ethnic and racial., Methods: Analysis of daily changes in news reporting and social media use in 2020, combined with detailed analysis of two-large scale surveys fielded at the time, focusing on questions of COVID-19 vaccine hesitancy and safety concerns about COVID-19 vaccines., Findings: Vaccine hesitancy in the US spiked from late August to early October 2020. We identify several plausible triggers for this spike, all pertaining to the FDA and electoral politics. Heightened vaccine hesitancy occurred among Democrats, Asian and Black citizens, as well as college-educated respondents. Turbulence mainly affected those who were initially most trusting in government and vaccines. Asian-American vaccine confidence recovered; that of Black Americans did not., Conclusions: Electoral politics may destabilize citizen assumptions about vaccine authorization and boost uncertainty, thereby undermining public willingness to take approved vaccines., (Copyright © 2024 by Duke University Press.)

During the Trump administration, members of Congress and the administration proposed the introduction of international reference pricing (IRP) to Medicare in order to reduce US drug spending by benchmarking prices to those in other countries. Many other countries currently use IRP. We examined how US policy proposals compare with the implementation of IRP in the countries that would be referenced by the United States. Nearly two-thirds of comparator countries use IRP but also use other price negotiation strategies. The congressional proposal was most like the approach used by other countries, while the Trump administration's proposals took an uncommon approach to IRP by not adopting additional pricing strategies. DISCLOSURES: This work was supported by Arnold Ventures, which provided overall funding but was not involved in conception, design, or conduct of this work. Kesselheim provides guidance to the Massachusetts Health Policy Commission on its prescription drug price review process under a contract to Brigham and Women's Hospital but does not receive personal funding for this work. Rand has nothing to disclose.