Physician prescribing practices contributed to the US opioid epidemic, leading to increased regulation of opioid prescribing. In some instances, prescribers are unscrupulous or corrupt. They are criminally investigated and subject to prosecution. Less egregious opioid prescribing infractions are addressed through state medical licensing boards. At stake are physicians’ licenses to practice medicine.

The case of clinical trials for convalescent plasma during COVID-19 illustrates important lessons for realizing public sector approaches to biomedical research and development. These lessons, centering on mission, transparency, and spillover effects, can be translated to wider efforts to develop a “public option” for clinical trials.

Payers have shaped the healthcare system in the United States as fee-for-service has facilitated a care model that prioritizes volume over the sake of patient care. This worsens health disparities, especially in safety net facilities where ancillary social work is both necessary clinically and completely uncompensated. Using concepts from Iris Marion Young’s Responsibility for Justice, it can be concluded that payers have a moral responsibility for reimbursing social care to address historical injustices. In this article, I describe the ethical hazards in paying for social care and propose a way to finance this through value-based payments.

Reliance upon fossil fuels and limited greenspace contribute to poor indoor and outdoor air quality and adverse health outcomes, particularly in communities of color. This article describes justice-informed public health and legal interventions to increase access to greenspace and accelerate the transitions to renewable energy and away from gas appliances.

I applied to law school as a means to an end. To “fix the system,” to make a difference, to advocate for meaningful change that improves health and well-being of others. Charity Scott accomplished, in her academic career, what I have not. At least thus far, I have chosen to follow a different path, dipping in and out of my original mission. Charity, by contrast, was focused and centered, never deviating from her integrity, purpose, kindness, advocacy, and brilliance. She gracefully married the intellectual enterprise of legal education with an unwavering mission to improve individual lives — of students, colleagues, clients, practitioners, and public servants. She was among pioneers in the health law field. She pioneered the medical-legal partnership model. She made a difference.

In the initial wave of the opioid crisis, uninformed prescribing practices and lax oversight were the drivers of opioid addiction and death. Although opioid prescriptions have decreased by 44.4 percent between 2011-2020,1 the number of deaths linked to prescription opioids has decreased only marginally.2 The marked fall in opioid prescribing without a concomitant reduction in opioid-related deaths suggests that an at-risk population continued to receive prescription opioids, whether directly or indirectly, from a medical professional. Currently, illicitly manufactured fentanyl (IMF) is the culprit for the majority of the approximately 81,000 annual opioid-related deaths.3 This finding has been misleadingly used to suggest that prescription opioids for chronic pain are no longer (and never were) a relevant concern,4 while the reality is that their lethal consequences are simply dwarfed by the marked rise in IMF deaths.5

As Steve Kaminshine said in his comments at the symposium honoring Charity Scott, I was recruited to come to Georgia State University as a “Law and Bioethics” scholar who had spent more than sixteen years shuttling between an office in a hospital and another in a law school. But when I first visited Georgia State Law, I did not know that more than ten years earlier Charity Scott had spent the better part of an academic year living and breathing clinical ethics at Grady Memorial Hospital.1 Because of her usual habit of immersion in all learning experiences, in that year Charity gained more insight into how hospitals work and how physicians behave when they are knee deep in their professional milieu of life and death decision-making than many full-time bioethics academics do in a career. For the rest of her career Charity kept one foot well planted in the medical context, as an advisor in problems of research ethics, as a teacher in her own medical-legal partnership structured around real-life clinical problems, and as an ethical analyst who could never be accused of mouthing a mantra of phrases, the “vacuous incantation of abstract principles”2 that might pass for bioethics discourse in some circles.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.

Public health laws and policies are uniquely able to mitigate the adverse and inequitable health impacts of climate change. This article summarizes some key considerations in developing such laws and policies and a variety of approaches local public health departments are using to increase climate resilience and health equity.

Bioethics is taking an institutional turn, where organizations are being taken seriously as moral agents. Within US healthcare, this is difficult to do without confronting “the market” as a highly influential context for organizational behavior. In the 1990s, pioneering thinkers such as David Mechanic,1 Brad Gray, and Mark Schlesinger2 undertook a first round of organizational ethics scholarship focused on how market forces influence health insurer behavior — motivated by a particular concern for health maintenance organizations (HMOs).3 And more recently, owing partly to a transfer of financial risk4 to healthcare delivery organizations,5 rapid consolidation within health system markets,6 and the pronounced uptick in physician employment,7 the behavior of healthcare delivery organizations is also being assessed in relation to market forces.

In this article, we examine the relationship between the World Health Organization International Health Regulations (IHR) and human rights and its implications for IHR reform, considering the evolution of human rights in the 2005 IHR, the role of human rights in IHR reforms and the implications of these reforms in key domains including equity and solidarity, medical countermeasures, core capacities, travel restrictions, vaccine certificates, social measures, accountability, and financing.

Our paper examines what is required to protect and promote effective public discussion and policy development in the current climate of divisive disagreement about many public policy questions. We use abortion as a case example precisely because it is morally fraught. We first consider the changes made by Dobbs, as well as those which led up to the Dobbs decision, accompany it, and follow from it.

We compared study characteristics of randomized controlled trials funded by industry (N=697) to those not funded by industry (N=835). RCTs published in high-impact journals are more likely to be blinded, more likely to include a placebo, and more likely to post trial results on ClinicalTrials.gov. Our findings emphasize the importance of evaluating the quality of an RCT based on its methodological rigor, not its funder type.

Effective climate change resilience in local communities must center each community’s unique challenges and essential role in developing climate resilience strategies. This article will discuss recent developments by the federal government that align with a community-centered approach, and how Community Health Workers can influence the outcomes.

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.

The authors consider the legal and ethical considerations of offering a time-limited trial of a potentially non-beneficial intervention in the setting of patient or surrogate requests to pursue aggressive treatment. The likelihood of an intervention’s success is rarely a zero-sum game, and an intervention’s risk-to-benefit ratio may be indiscernible without further information (often, a matter of time).

This pilot study is the first formal exploration of the concept of “Organizational Professionalism” (OP) among health system leaders in high-performing healthcare organizations. Semi-structured key informant interviews with 23 leaders from 8 healthcare organizations that were recipients of the Malcolm Baldrige National Quality Award (MBNQA) or Baldrige-based state quality award programs explored conceptualization, operationalization, and measurement of OP. Further exploration and understanding of OP in healthcare organizations has the potential to establish and sustain professional and ethical organizational cultures that bolster trust through the sound implementation of laws, policies, and procedures to support the delivery of high-quality patient care.

More than twenty-five years after the first signs of potential harm, the US remains locked in the grip of an opioid epidemic, with more Americans dying from overdoses than ever before.1 Diversion of prescription opioids plays an important role in opioid-related harms. Much of the scientific and public health focus on diversion has been on end-users, given how commonly non-medical prescription opioid use occurs, as well as the proportion of individuals who report that their source of non-medical opioids was friends or family. However, diversion of opioids, as well as their rampant oversupply, can be discerned higher up the supply chain, including among wholesalers, pharmacies and rogue prescribers whose behavior may trigger well-described “flags” warranting further evaluation and action.

To evaluate how study characteristics and methodological aspects compare based on presence or absence of industry funding, Hughes et al. conducted a systematic survey of randomized controlled trials (RCTs) published in three major medical journals. The authors found industry-funded RCTs were more likely to be blinded, post results on a clinical trials registration database (ClinicalTrials.gov), and accrue high citation counts.1 Conversely, industry-funded trials had smaller sample sizes and more frequently used placebo as the comparator, used a surrogate as their primary outcome, and had positive results.

In recent years, the Minnesota Attorney General’s Office and the Minnesota Department of Health have cultivated a productive partnership to strengthen the state’s multidisciplinary response to overlapping health equity and social justice issues. This article describes shared efforts in three areas: post-conviction justice, drug overdose, and human trafficking/exploitation.