The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing p...

Public health agencies regularly survey randomly selected anonymous students to track drug use, sexual activities, and other risk behaviors. Students are unidentifiable, but a recent project that i...

Using medical advances to enhance human athletic, aesthetic, and cognitive performance, rather than to treat disease, has been controversial. Little is known about physicians? experiences, views, and attitudes in this regard. We surveyed a national sample of physicians to determine how often they prescribe enhancements, their views on using medicine for enhancement, and whether they would be willing to prescribe a series of potential interventions that might be considered enhancements. We find that many physicians occasionally prescribe enhancements, but doctors hold (...) nuanced and ambiguous views of these issues. Most express concerns about the potential effects of enhancements on social equity, yet many also believe specific enhancements that are safe and effective should be available but not covered by insurance. These apparently contradictory views might reflect inherent tensions between the values of equity and liberty, which could make crafting coherent social policies on medical enhancements challenging. [Supplementary materials are available for this article. Go to the publisher's online edition of American Journal of Bioethics for the following free supplemental resource(s): An additional table (Table 5) referred to on p. 5]. (shrink)

The threat of bioterrorism, the emergence of the SARS epidemic, and a recent focus on professionalism among physicians, present a timely opportunity for a review of, and renewed commitment to, physician obligations to care for patients during epidemics. The professional obligation to care for contagious patients is part of a larger "duty to treat," which historically became accepted when 1) a risk of nosocomial infection was perceived, 2) an organized professional body existed to promote the duty, and 3) the public (...) came to rely on the duty. Physicians' responses to epidemics from the Hippocratic era to the present suggests an evolving acceptance of the professional duty to treat contagious patients, reaching a long-held peak between 1847 and the1950's. There has been some professional retrenchment against this duty to treat in the last 40 years but, we argue, conditions favoring acceptance of the duty are met today. A renewed embrace of physicians' duty to treat patients during epidemics, despite conditions of personal risk, might strengthen medicine's relationship with society, improve society's capacity to prepare for threats such as bioterrorism and new epidemics, and contribute to the development of a more robust and meaningful medical professionalism. (shrink)

Some individuals facing dementia contemplate hastening their own death: weighing the possibility of living longer with dementia against the alternative of dying sooner but avoiding the later stages of cognitive and functional impairment. This weighing resonates with an ethical and legal consensus in the United States that individuals can voluntarily choose to forgo life‐sustaining interventions and also that medical professionals can support these choices even when they will result in an earlier death. For these reasons, whether and how a terminally (...) ill individual can choose to control the timing of their death is a topic that cannot be avoided when considering the dementia trajectory. With a focus on the U.S. context, this landscape review considers the status of provisions that would legally permit people facing dementia to hasten death with appropriate support from medical professionals. This review can be used to plan and guide clinical and legal practitioner discussion and policy development concerning evolving questions not fully covered by existing medical decision‐making provisions. (shrink)

Patients and physicians often perceive the current health care system to be unfair, in part because of the ways in which coverage decisions appear to be made. To address this problem the Ethical Force Program, a collaborative effort to create quality improvement tools for ethics in health care, has developed five content areas specifying ethical criteria for fair health care benefits design and administration. Each content area includes concrete recommendations and measurable expectations for performance improvement, which can be used by (...) those organizations involved in the design and administration of health benefits packages, such as purchasers, health plans, benefits consultants, and practitioner groups. (shrink)

Responses to public health emergencies can entail difficult decisions about restricting individual liberties to prevent the spread of disease. The quintessential example is quarantine. While isolating sick patients tends not to provoke much concern, quarantine of healthy people who only might be infected often is controversial. In fact, as the experience with severe acute respiratory syndrome (SARS) shows, the vast majority of those placed under quarantine typically don't become ill. Efforts to enforce involuntary quarantine through military or police powers also (...) can backfire, stoking both panic and disease spread. Yet quarantine is part of a limited arsenal of options when effective treatment or prophylaxis is not available, and some evidence suggests it can be effective, especially when it is voluntary, home-based and accompanied by extensive outreach, communication and education efforts. Even assuming that quarantine is medically effective, however, it still must be ethically justified because it creates harms for many of those affected. Moreover, ethical principles of reciprocity, transparency, non-discrimination and accountability should guide any implementation of quarantine. (shrink)

Volume 19, Issue 6, June 2019, Page 30-31.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep (...) this “essential industry” producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry’s implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities. (shrink)

Volume 20, Issue 10, October 2020, Page W4-W7.

There are three broad ethical issues related to handling public health emergencies. They are the three R's - rationing, restrictions and responsibilities. Recently, a severe shortage of annual influenza vaccine in the US, combined with the threat of pandemic flu, has provided an opportunity for policy makers to think about rationing in very concrete terms. Some lessons from annual flu vaccination likely will apply to pandemic vaccine distribution, but many preparatory decisions must be based on very rough estimates. What ethical (...) principles should guide rationing decisions, what data should inform these decisions, how to revise decisions as new data emerge, and how to implement rationing decisions on the ground are all important considerations. In addition, ethicists might be able to help policy makers think through the importance of international cooperation in surmounting global rationing dilemmas and to accept the inevitable responsibilities of government in making and implementing rationing decisions. (shrink)

Volume 20, Issue 7, July 2020, Page 75-77.

*The views in this article are the author's alone and should not be construed as policy statements of the American Medical Association.

* Disclaimer: The views expressed are the author's own. This article should not be construed as representing policies of the American Medical Association.

The three primary ethical challenges in preparing for public health emergencies - addressing questions of rationing, restrictions and responsibilities - all entail confronting uncertainty. But the third, considering whether people and institutions will live up to their responsibilities in a crisis, is perhaps the hardest to predict and therefore plan for. The quintessential example of a responsibility during a public health emergency is that of health care professionals' obligation to continue caring for patients during epidemics. Historically, this 'duty to treat' (...) has sometimes gone unrecognized or ignored, but it has also famously been adhered to, including during the recent SARS epidemic. And non-crisis examples of health professionals working in the face of personal risk are very common. The duty to treat should be circumscribed by several considerations, including the levels or risk and benefit at issue, the degree of public reliance on health professional action, and the nature of the individual health professional's acceptance of greater than usual risk. Examining the professional duty to treat and the legitimate questions it raises can provide insight into other actors' responsibilities. Public health ethics as well as professional ethics can help frame answers to some key questions: How strong are ethical responsibilities during crises? To whom do they apply? Should they be more explicit - and hence more circumscribed - or less explicit and hence largely aspirational? And how can public health policies encourage responsible actions? (shrink)

Recent arguments over whether certain public health interventions should be mandatory raise questions about what counts as a "mandate." A mandate is not the same as a mere recommendation or the standard of practice. At minimum, a mandate should require an active opt-out and there should be some penalty for refusing to abide by it. Over-loose use of the term "mandate" and the easing of opt-out provisions could eventually pose a risk to the gains that truly mandatory public health interventions, (...) such as childhood vaccines, have provided over the last 50 years. Already, confusion about what counts as a mandate, and about what criteria should be used to determine when a public health intervention should be implemented as a mandate, has led to some inappropriate public policy decisions. For instance, by any reasonable criteria, the yearly influenza vaccine should be mandatory for health care workers. To enforce this mandate, those who refuse vaccination should be required to sign a waiver, and patients - especially those at high risk from flu - should be informed when they receive care from unvaccinated practitioners. (shrink)

*The views expressed are the author's own. This article should not be construed as representing policies of the American Medical Association.

*The views represented are the author's alone and should not be construed as representing policies of the American Medical Association.

Each year, infection with Human Papillomavirus (HPV) leads to millions of abnormal Pap smears and thousands of cases of cervical cancer in the US. Throughout the developing world, where Pap smears are less common, HPV is a leading cause of cancer death among women. So when the international pharmaceutical giant Merck developed a vaccine that could prevent infection with several key strains of HPV, the public health community was anxious to celebrate a major advance. But then marketing and lobbying got (...) in the way. Merck chose to pursue an aggressive lobbying campaign, trying to make its new vaccine mandatory for young girls. The campaign stoked public mistrust about how vaccines come to be mandated, and now it's not just Merck's public image that has taken a hit. The public health community has also been affected. What is the lesson to be learned from this story? Public health communication relies on public trust. (shrink)

The Centers for Disease Control and Prevention (CDC) recently recommended that HIV screening should become routine for all adults in the United States. Implicit in the CDC proposal is the notion that pre-test counseling would be more limited than at present, and that written informed consent to screening would no longer be required. If widely implemented, routine testing would mark a tremendous shift in the US HIV screening strategy. There are a number of considerations used to determine what screening tests (...) should be routine, and HIV fits the bill in almost every regard. Yet the stigma associated with HIV infection remains, making the CDC's recommendation highly controversial. Will minimizing requirements for pre-test counseling and special written informed consent lead to unexpected or unwanted HIV testing, or do these stringent counseling and consent requirements needlessly scare people away? Will widespread and routine testing be associated with declining stigmatization, or will it drive some patients away from seeking desperately needed health care? These are high stakes questions, and we're about to find out the answers. (shrink)

As we write, U.S. cities and states with extensive community transmission of Covid‐19 are in harm's way—not only because of the disease itself but also because of prior and current failures to act. During the 2009 influenza pandemic, public health agencies and hospitals developed but never adequately implemented preparedness plans. Focused on efficiency in a competitive market, health systems had few incentives to maintain stockpiles of essential medical equipment. Just‐in‐time economic models resulted in storage of only those supplies needed then. (...) At the same time, global purchasing in search of lower prices reduced the number of U.S. suppliers, with hospitals dependent on foreign companies. There is still a possibility that the pandemic will be manageably bad rather than unmanageably catastrophic in this country. Immediate, powerful, and sustained federal action could make the difference. (shrink)

With this issue, we begin a regular feature on bioethics and public health. We welcome Matthew K. Wynia, M.D., M.P.H., Director of the Institute for Ethics of the American Medical Association as our new Contributing Editor. If you have comments or suggestions regarding this feature, please email us at manuscript@ bioethics.net.

The term “Electronic Health Records” means something different to each of the stakeholders in health care, but it always seems to carry a degree of emotional baggage. Increasingly, EHRs are advertized as a nearly unmitigated good that will transform medical care, improve safety and efficiency, allow better patient engagement, and open the door to an era of cheap, effective, timely, and patient-centered care. Indeed, for some EHR proponents the benefits of adopting them are so obvious that adoption has become an (...) end in itself. But for others — and especially for a number of skeptical practitioners and patients — EHR is a code word that portends the corporate transformation of health care delivery, the loss of patient privacy, the demand that patients bear more responsibility in health care, and the unreflective takeover of the health care system by people who do not understand medical care or how health care relationships unfold. (shrink)

Anne Barnhill focuses her article in this issue on the American Medical Association's ethics policy governing clinical use of placebos, but the implications of her analysis are deeper, touching on how physicians should make judgments about which interventions to offer patients in the process of shared decision‐making. The bottom line is that, even if an undisclosed placebo might be marginally more effective for a particular patient in the short term, over the long haul the integrity of the patient‐physician relationship relies (...) on doctors being honest with their patients. Even when it comes to placebos, honesty remains the best policy. (shrink)

The American Journal of Bioethics, Volume 11, Issue 7, Page 1-2, July 2011.

Since physicians began to formally professionalize in the 19th century, we have sought to set ourselves apart from other occupations through the adoption (and variable enforcement) of codes of ethi...

Electronic health records for patients, personal health records , have become increasingly popular among policy makers and purchasers, but uptake among patients and physicians has been relatively slow. PHRs have varying uses that might make them more or less appealing to different stakeholders. The three core uses for PHRs — promoting communication, data use, and patient responsibility — each raises a set of potential practical and financial dilemmas. But some ethical concerns are also at play, some of which are rarely (...) recognized as values-based barriers to the use of PHRs. Recognizing these ethical issues, and addressing them explicitly in PHR design and policy making, would help PHRs to achieve their promise. (shrink)

How should the field of bioethics grapple with a history that includes ethicists who supported eugenics, scientific racism, and even Nazi medicine and also ethicists who created the salutary policy and practice responses to those heinous aspects of medical history? Learning humility from studying historical errors is one path to improvement; finding courage from studying historical strengths is another, but these can be in tension. This commentary lays out these paths and seeks to apply them both to a contemporary challenge (...) facing the field: why hasn't bioethics been more at the forefront of efforts to address inequities in health and health care? (shrink)

Volume 20, Issue 4, May 2020, Page 73-75.

The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors. We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements with the recommendations of (...) the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions. (shrink)

The participation of physicians in the atrocities of the Holocaust exposed vulnerabilities in medicine’s moral commitment to patients’ best interests that every health professional should recognize. Teaching about this history is challenging, as it is extremely complex and there are no common standards for what basic historical facts students in health professions training programs should learn. Nor is there guidance on how these historical facts can or should be related to contemporary ethical issues facing health professionals. To address these problems, (...) we propose a set of core historical facts about health professional involvement in the Holocaust that every student in a health professional training program should learn. We then identify three ethical lessons from the Holocaust that are pertinent today as physicians struggle to maintain their moral compass and earn the trust of patients and the public: 1) The lesson of commitment to science; maintaining balance between reason and skepticism in the search for truth, The lesson of clinical detachment; maintaining balance between necessary professional distance with a commitment to humanism and intimacy with patients, and 3) The lesson of competing loyalties; maintaining balance in upholding medicine’s multiple responsibilities, including to individual patients and the larger community. Embedding these facts and lessons into the education of health professionals is challenging yet critically important. Today’s physicians struggle with some of the same ethical tensions as did German physicians in the Nazi era, albeit in a much-attenuated fashion. Awareness of these tensions and taking active measures to maintain them in balance are necessary components of humanistic health care, which should be an integral part of health professional training programs. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 53-55, September‐October 2021.

1The opinions contained in this article are those of the authors and should not be construed as policies of the American Medical Association.

The non-governmental organizations (NGOs) that assume the bulk of emergency care during large-scale disasters in the developing world must expend considerable time and resources to ensure donations to sustain their field operations. This long-standing dilemma for the humanitarian community can create a competitive environment that: • Compromises the delivery and quality of services,• Allows the effectiveness of operations to be compromised by a lack of cooperation and collaboration,• Disrupts the timely and accurate coordination and analysis of outcome measures that• Undermines (...) the long-term capacity of indigenous aid organizations. (shrink)

Patients and physicians often perceive the current health care system to be unfair, in part because of the ways in which coverage decisions appear to be made. To address this problem the Ethical Force Program, a collaborative effort to create quality improvement tools for ethics in health care, has developed five content areas specifying ethical criteria for fair health care benefits design and administration. Each content area includes concrete recommendations and measurable expectations for performance improvement, which can be used by (...) those organizations involved in the design and administration of health benefits packages, such as purchasers, health plans, benefits consultants, and practitioner groups. (shrink)

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical (...) trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. (shrink)

There is an old saw in health policy that everyone wants health care that is good, fast, and cheap — but it’s impossible to have more than two of these at one time.A similar bit of folk wisdom seems intuitively true for the development and testing of new pharmaceutical products. The public is in a bind. We want breakthrough drugs, and fast. But we also want these drugs to be affordable, thoroughly tested, safe, and effective. It seems we can’t have (...) it all.In this paper, we will not claim that one can have it all — but that we can do far better than we are at present. First, we review extensive data on contemporary problems in the design, conduct, and analysis of industry-sponsored clinical trials. Finding major issues that have been solidly documented over more than a decade, we provide many examples of the multifarious ways in which industry-funded trials have been manipulated to raise the likelihood of producing industry-friendly results. (shrink)

*Disclaimer: The views expressed are the author's and should not be ascribed to the American Medical Association.

In lieu of an abstract, here is a brief excerpt of the content:Conflicts—and Consensus—about Conflicts of Interest in MedicineMatthew K. Wynia and Bette–Jane Crigger*This fascinating collection of essays about individual experiences of conflict of interest leaves little doubt that physicians remain divided about the importance, impact and meaning of conflicts of interest in their work. These essays offer differing views about what conflicts of interest look and feel like “on the ground” and about whether specific conflicts of interest are bad, (...) just a fact of life, or maybe even good.Conflict, Conflict EverywhereThese essays situate conflict of interest in a variety of contexts: the treatment recommendations a physician makes for an individual patient; the relationship between teaching physician and medical student or practicing physician and health care organization; the interaction between academic researchers and industry collaborators or professional bodies and industry supporters. In this, the narratives taken together reflect the scope of concern about conflict of interest in medicine familiar in the literature. In his classic 1993 essay, Dennis Thompson noted that concerns about conflict of interest encompass issues of physician self–referral, risk sharing between physicians and health care institutions, gifts from industry, hospital purchasing practices, as well as sponsored research and research with patients (Thompson 1993). To that list have subsequently been added relationships with industry in medical education at all levels, physicians’ service as consultants to industry or members of industry speakers bureau, and development of clinical practice guidelines (Lo & Fields 2009).That almost none of these essays draw attention to some widely publicized situations of conflict of interest—for example, gifts to physicians or the provision of drug samples—should, we think, be seen more as an artifact of the authors’ varied individual experiences than as a failure by the authors to engage key concerns in the ongoing professional and public debate. It could also be that the authors, asked to submit personal stories, assumed that yet another essay about the ‘traditional’ issues in the conflicts of interest literature would be seen as redundant, routine or even boring. Or, there is the tantalizing possibility that the absence of some of the more familiar conflicts from these narratives is the early fruit of efforts to address these traditional issues through policies governing interactions between physicians and industry promulgated by academic medical centers and health systems, medical specialty societies, and industry.One significant area of concern that has emerged in recent years is conflict of interest in the development of clinical practice guidelines. E.g., Choudry et al. 2002; Sniderrman & Furberg 2009; Guyatt et al. 2010. Although none of the essays in this [End Page 101] collection address it head on, Perlmutter touches on several key issues. His depiction of how an FDA committee process limited the input he was able to provide as an expert, undermined his potential to contribute to the professional dialogue, and raised concerns about the objectivity of the drug approval process echoes concerns about objectivity, the role of expert opinion, and the presence on guideline development panels of individuals with financial interests in the recommendations to be developed that have been explored at some length in the literature, most recently by the Institute of Medicine in reports on evidentiary standards (Eden et al 2011) and principles for guideline development (Graham et al. 2011).Conflict of Interest or Dual Agency?Several essays set out physicians’ experience in navigating situations of diverging expectations. Bierut, for example, reflects on the disjunction between the goals and products of academic researchers and commercial sponsors. She saw herself advancing basic knowledge and was forced to grapple with the reality of sponsors’ goals to advance commercial ends as well. Nagldinne and Mikulec each recall struggles to reconcile their obligation to exercise professional judgment on behalf of patients with the demands of health care organizations focussed also on the bottom line. Cruz–Flores attests to the challenge of making recommendations for care when one is both a practicing clinician and a clinical investigator engaged in research that might offer benefit to a patient for whom there are limited options.Thompson defined conflicts of interest as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of... (shrink)

Reading Alfandre and colleagues’ compelling paper in this issue of the Journal—in which the authors outline a useful process for navigating the ethics of “contingency” standards of care—brou...