The World Health Assembly (WHA) adopted the new International Health Regulations (IHR) on May 23, 2005. The new IHR represent the culmination of a decade-long revision process and an historic development for international law and public health. The new IHR appear at a moment when public health, security, and democracy have become intertwined, addressed at the highest levels of government. The United Nations (UN) Secretary-General Kofi Annan, for example, identified IHR revision as a priority for moving humanity toward “larger freedom.” This article analyzes the new IHR and their implications for global health and security in the 21st century.

The WHA instructed the WHO Director-General (DG) to revise the IHR in 1995 because the Regulations did not provide an effective framework for addressing the international spread of disease. Doubts about the IHR's effectiveness had, however, been present long before 1995. The critiques identified the narrow scope of the regulations (applying only to a small number of infectious diseases), the lack of compliance by states, and the absence of a strategy for responding to rapid changes in public health's global economic and technological environments.

After years of near total neglect, the problem of childhood obesity is now in the limelight. Terms like “epidemic,” “crisis,” and “emergency” are used frequently when describing the trend. Progress is defined with strong language (e.g., the need for a “war” on obesity) and fueled by statistics such as the observation that this generation of children will be the first to live shorter lives than their parents. Multi-disciplinary journals such as the Journal of Law, Medicine & Ethics have dedicated symposiums to the issue, and conferences have been convened not only by health professionals but by government agencies, the food industry, and even professionals who market to children. The seriousness of childhood obesity is no longer in doubt, and finally attention has turned to the more complex question – what must be done?

“Relying on Science, Romney Files Death Penalty Bill.” With that headline, a press release on April 28, 2005 announced that Massachusetts Governor Mitt Romney was seeking to reintroduce by legislation the death penalty that the state's Supreme Judicial Court ruled unconstitutional in 1984. The remainder of the text left little doubt that science was a major basis for the governor's action. The press release quoted Romney as saying that the bill provided a “gold standard for the death penalty in the modern scientific age.” Positing a symmetry that will be questioned below, Romney also declared, “Just as science can free the innocent, it can also identify the guilty.” The bill itself deferred to science by calling for corroborating scientific evidence, multiple layers of review, and a novel “no doubt” standard of proof. By raising the required standard of evidence and by restricting the class of capital crimes, the proposed law hoped to correct the defects of other death penalty statutes.

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, physicians promote patients’ interests by prescribing products off label.

Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits.

Broadband internet access is a super-determinant of health that plays an important role in healthcare and public health outcomes. Laws and policies shape implementation and use of broadband for healthcare and public health. Connecting broadband and telehealth laws with their health impacts, through legal epidemiological research, enables states to make evidence-based decisions to improve health outcomes for underserved populations.

The obesity epidemic among children and adolescents in the United States continues to worsen. The most recent analysis of data from the National Health and Nutrition Examination Survey showed that the prevalence of overweight among children and adolescents – defined as a Body Mass Index (BMI) at or above the 95th percentile on gender-specific BMI-for-age growth charts developed by the Centers for Disease Control and Prevention (CDC) – increased significantly between 1999-2000 and 2003-2004. Over this period, the prevalence of overweight among children and adolescents aged 2-19 increased 23% – from 13.9% to 17.1%. In 2003-2004, 18.8% of children aged 6-11 and 17.4% of adolescents aged 12-19 were overweight. Roughly comparable proportions of each age group were considered to be at risk of becoming overweight (BMI equal to or higher than the 85th percentile and less than the 95th percentile).

Advance care directives for health care have been promoted as a way to improve end-of-life decision making. These documents allow a patient to state, in advance of incapacity, the types of medical treatments they would like to receive (a living will), to name a surrogate to make those decisions (a durable power of attorney for health care), or to do both. Although studies have shown that both physicians and patients generally have positive attitudes about the use of these documents, relatively few individuals have actually completed one.

What underlies this discrepancy between attitudes and behavior with regard to advance care directives? One obvious explanation is lack of access. Emanuel et al. estimated that approximately 90 percent of the population desire an advance care directive, and they pointed to access as the major barrier. Yet interventions that increase accessibility have typically failed to yield more than a 20 percent completion rate. Thus, it appears that access is not the sole determinant of advance care directive completion.

When making decisions for adults lacking decision-making capacity and having no discernable preferences, widespread support exists for using the Best Interests Standard. For example, the President's Council on Bioethics supports this view in its publication, Taking Care: Ethical Caregiving in Our Aging Society. The President's Council maintains that decision-makers should seek the best available care for incapacitated adults, yet clarifies the best care does not always extend biological life for the longest time and advocates careful attention to comfort care and pain control. Their recommendations for making medical decisions for incapacitated adults match guidelines by American Academy of Pediatrics (AAP) committees and by the U.K’.s Nuffield Council on Bioethics report for making medical decisions for children and infants.

For reasons of consistency, fairness, and compassion, this guidance should be applied to all people lacking decision-making capacity. Uniform guidelines, however, would be incompatible with a policy for infants based on the Child Abuse Prevention and Treatment Act (CAPTA) amendments, widely known as the “Baby Doe” Rules.

The relationship between sociology and bioethics has been an uneasy one. It has been described as contentious and adversarial, and at least some of the sociologists who have ventured into the territory of medical ethics report back on unfriendly natives. This bioethical ill will toward sociology is not without cause. Sociologists have been quite critical of what they call (with not-so-subtle pejorative overtones) the bioethical project.

Two decades ago - when bioethics was just getting up on its organizational feet - Renée Fox and Judith Swazey leveled the charge of cultural myopia against bioethics, noting that this myopia generally manifests itself in the form of systematic inattention to the social and cultural sources and implications of its own thought. They go on to say ifbioethics is an indicator of the general state of American ideas, values, and beliefs, of our collective self knowledge, and our understanding of other societies and cultures - then there is every reason to be worried about who we are, what we have become, and where we are going

For over 100 years, the field of contemporary public health has existed to improve the health of communities and populations. As public health practitioners conduct their work – be it focused on preventing transmission of infectious diseases, or prevention of injury, or prevention of and cures for chronic conditions – ethical dimensions arise. Borrowing heavily from the ethical tools developed for research ethics and bioethics, the nascent field of public health ethics soon began to feel the limits of the clinical model and began creating different frameworks to guide its ethical challenges. Several public health ethics frameworks have been introduced since the late 1990s, ranging from extensions of principle-based models to human rights and social justice perspectives to those based on political philosophy. None has coalesced as the framework of choice in the discipline of public health. This paper examines several of the most-known frameworks of public health ethics for their common theoretical underpinnings and values, and suggests next steps toward the formulation of a single framework.

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration (FDA), to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.

In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration.

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features (adaptivity, flexibility, monitoring, responsiveness, reflexivity, and inclusiveness) and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders acquire a common substantive orientation.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly to include analysis of DNA collected from humans that has implications for human health (even if the purpose of the study is not medical). This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings.

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public health and the distinctions, for example, between public health and clinical care, and public health and health promotion.

In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities.

Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to the samples. This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples.

A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information (such as family history and cholesterol levels), and, if so, whether this means that it should receive special legal protection.

It is now well recognized that the United States is a consumer-driven society. Private consumption comprises a rising fraction of GDP, advertising is proliferating, and consumerism, as an ideology and set of values, is widespread. Not surprisingly, those developments are not confined to adults; they also characterize what some have called “the commercialization of childhood.” Children are more involved than ever in media, celebrity, shopping, brand names, and other consumer practices. At the core of this change is children's growing role as independent consumers. In recent years, children's access to income has risen markedly, and they have gone from being purchasers of cheap plastic goods and a few select food items (e.g., candy) to being a major market for a diverse set of goods and services, including foodstuffs. Unofficial estimates suggest that children aged four to twelve spent a reported $6.1 billion in purchases from their own money in 1989, $23.4 billion in 1997, and $30 billion in 2002, for a total increase of four hundred percent.

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.

The definition of death is one of the oldest and most enduring problems in biophilosophy and bioethics. Serious controversies over formally defining death began with the invention of the positive-pressure mechanical ventilator in the 1950s. For the first time, physicians could maintain ventilation and, hence, circulation on patients who had sustained what had been previously lethal brain damage. Prior to the development of mechanical ventilators, brain injuries severe enough to induce apnea quickly progressed to cardiac arrest from hypoxemia. Before the 1950s, the loss of spontaneous breathing and heartbeat (“vital functions”) were perfect predictors of death because the functioning of the brain and of all other organs ceased rapidly and nearly simultaneously thereafter, producing a unitary death phenomenon. In the pretechnological era, physicians and philosophers did not have to consider whether a human being who had lost certain “vital functions” but had retained others was alive, because such cases were technically impossible.

In 2010, in connection with the Patient Protection and Affordable Care Act (Obamacare), the United States Congress passed the Physician Payment Sunshine Act. This legislation requires pharmaceutical companies, medical device companies, and other manufacturers of medical supplies to collect information on their payments to physicians, beginning on August 1, 2013, and to annually report this information to the Centers for Medicare and Medicaid Services (CMS), beginning on March 31, 2014. All payments of over $10 are to be reported and aggregate payments of more than $100 to a single physician in a single year must also be reported.