Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Following the confirmation of U.S. Supreme Court Justice Brett Kavanaugh in one of the most sensational jurisprudence events of the modern era, we examine potential repercussions across multiple themes in public health, law, and policy stemming from his ideology and the confirmation process.

The use of decision-making capacity assessments (DMCA) in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved. One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician's duty to obtain consent: in short, consent is needed for an assessment of one's ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative.

Compulsory psychiatric treatment is the norm in many Western countries, despite the increasingly individualistic and autonomous approach to medical interventions. Community Treatment Orders (CTOs) are the singular best example of this, requiring community patients to accept a variety of interventions, both pharmacological and social, despite their explicit wish not to do so. The epidemiological, medical/treatment and legal intricacies of CTOs have been examined in detail, however the ethical considerations are less commonly considered. Principlism, the normative ethical code based on the principles of autonomy, beneficence, non-maleficence and justice, underpins modern medical ethics. Conflict exists between patient centred commentary that reflects individual autonomy in decision making and the need for supported decision making, as described in the Convention on the Rights of Persons with Disabilities (CRPD) and the increasing use of such coercive measures, which undermines this principle. What appears to have been lost is the analysis of whether CTOs, or any coercive measure in psychiatric practice measures up against these ethical principles. We consider whether CTOs, as an exemplar of coercive psychiatric practice, measures up against the tenets of principalism in the modern context in order to further this debate.

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and so should not influence one's access to donated livers. They argue instead that livers should be allocated in accordance with the equal opportunity principle, according to which US residents who are equally sick should have the same opportunity to receive a liver, regardless of where they live. In this paper, we examine a central premise of the argument for the equal opportunity principle, namely, that geographic location is a morally arbitrary basis for allocating livers. We raise some serious doubts regarding the truth of this premise, arguing that under certain conditions, factors closely associated with geographic location are relevant to the allocation of livers, and so that candidates' geographic location is sometimes a morally non-arbitrary basis for allocating livers. Geographic location is morally non-arbitrary, we suggest, since by taking it into account, the UNOS may better fulfill its central goals of facilitating the effective and efficient placement of organs for transplantation and increasing organ donation.

Each decade since 1979, the Healthy People initiative establishes the national prevention agenda and provides the foundation for disease prevention and health promotion policies and programs. Law and policy have been included in Healthy People objectives from the start, but not integrated into the overall initiative as well as possible to potentially leverage change to meet Healthy People targets and goals. This article provides background on the Healthy People initiative and its use among various stakeholder groups, describes the work of a project aiming to better integrate law and policy into this initiative, and discusses the development of Healthy People 2030 — the next iteration of health goals for the nation. Lessons from the preliminary stages of developing Healthy People by the HHS Secretary's Advisory Committee (Committee) on National Health Promotion and Disease Prevention Objectives for 2030 and a Federal Interagency Workgroup will be included. Efforts by the Committee focused on the role of law and policy as determinants of health and valuable resources around health equity are also shared. Finally, the article discusses ways that law and policy can potentially be tools to help meet Healthy People targets and to attain national health goals.

In the Winter 2017 edition of JLME, Dr. Carson outlined an economic approach to the epidemiology of HIV transmission within the gay community, with a special emphasis on mobile apps. His conclusion is that HIV transmission amongst the gay community constitutes a collective action problem, which is resolved by the social norm of using a condom. This article critiques Dr. Carson's approach from an economic perspective. By utilizing classic law and economic theory, this article will argue that HIV transmission may not, in fact, constitute a collective action problem in economic terms, and that instead condom use as a method of disease protection in theory can arise from purely rational, market driven actions. To do so, it borrows from transactional theory of information asymmetry to show the potential to alert counterparts as to serostatus. This conclusion provides an important supplement to Carson: rather than social norms being the core driver in condom usage to prevent HIV, instead condom use may arise solely as a result of rational, private decision making arising from market signaling. The article then critiques its own findings to demonstrate that it is unclear whether Carson's argument or the argument in this paper is, indeed, correct — which may represent a limitation in the analytical techniques advanced.

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research.

Brain organoid research raises ethical challenges not seen in other forms of stem cell research. Given that brain organoids partially recapitulate the development of the human brain, it is plausible that brain organoids could one day attain consciousness and perhaps even higher cognitive abilities. Brain organoid research therefore raises difficult questions about these organoids' moral status – questions that currently fall outside the scope of existing regulations and guidelines. This paper shows how these gaps can be addressed. We outline a moral framework for brain organoid research that can address the relevant ethical concerns without unduly impeding this important area of research.

When Congress passed HIPAA, it did not intend to constrain public health's data sharing in the same way as clinical or payers. In fact, HIPAA recognizes data sharing with public health as a matter of national priority and shields this function from its reach. However, a health department may offer services that bring it within HIPAA's purview, such as running a Children's Health Insurance Program or a laboratory that bills electronically. When this is the case, HIPAA requires all information and departments be subject to HIPAA unless the public health authority chooses to hybridize. Health departments might re-assess their coverage and elect to become a hybrid entity, thereby restricting HIPAA to only where required and removing barriers to information sharing with communities.

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

To help eliminate perinatal HIV transmission, the US Department of Health and Human Services recommends against breastfeeding for women living with HIV, regardless of viral load or combined antiretroviral therapy (cART) status. However, cART radically improves HIV prognosis and virtually eliminates perinatal transmission, and breastfeeding's health benefits are well-established. In this setting, pregnancy is increasing among American women with HIV, and a harm reduction approach to those who breastfeed despite extensive counseling is suggested. We assess the evidence and ethical justification for current policy, with attention to pertinent racial and health disparities. We first review perinatal transmission and breastfeeding data relevant to US infants. We compare hypothetical risk of HIV transmission from breastmilk to increased mortality from sudden infant death syndrome, necrotizing enterocolitis and sepsis from avoiding breastfeeding, finding that benefits may outweigh risks if mothers maintain undetectable viral load on cART. We then review maternal health considerations. We conclude that avoidance of breastfeeding by women living with HIV may not maximize health outcomes and discuss our recommendation for revising national guidelines in light of autonomy, harm reduction and health inequities.

This manuscript summarizes the most common barriers to effective administrative preparedness and how to surmount them through the use of promising practices, strategies, and NACCHO developed resources focused on addressing unique jurisdictional requirements and needs.