Five international consensus statements on concussion in sports have been published. This commentary argues that there is a strong need for a new approach to them that foregrounds public health expertise and patient-centered guidance. Doing so will help players, parents and practitioners keep perspective about these potentially life-altering injuries especially when they recur.

Research on AIDS involving human subjects poses in stark form a familiar dilemma: Can the demands of a rigorous scientific research design be met without violating the rights or harming the interests of research subjects? The dilemma is especially troubling in the early phases of drug research, when promising medications showing some signs of success in combatting this fatal disease must be tested for safety and efficacy. The research design using randomized controlled trials, in which an experimental drug is tested against a placebo, highlights the dilemma. Although the use of this research design does not pose the only ethical problem for AIDS research, it is perhaps the most dramatic. Related ethical issues include the question of when an experimental drug that holds out the only present hope may be released for general use; who should be selected to receive experimental drugs that are in short supply; how much information should be released about safety and efficacy while a clinical trial is still in progress; and what factors determine the appropriateness of early termination of a study.

Hospitals long ago shed their role as alms houses for the poor. What vestiges remain of the early American hospital are the tax-exempt, nonprofit hospital form and a general perception that hospitals, as charitable institutions, owe a duty to their communities. The appropriateness of the nonprofit hospital tax exemption has long been debated, and many theories have been advanced to justify the tax exemption of nonprofit hospitals. In a growing number of jurisdictions, however, state and local authorities have gone beyond the theoretical debate and are challenging the tax exemption of their nonprofit hospitals. For various reasons, efforts are afoot to capture greater community benefit from nonprofit hospitals.

At the heart of such challenges is the debate over the nature and extent of the duty charitable institutions owe to their communities. A demand is growing for nonprofit hospitals to earn their tax exemptions by benefiting their communities in concrete ways. Some have been stripped of their tax-exempt status by local authorities or pressured to make payments in lieu of taxes. A number of states have recently implemented initiatives in an attempt to make hospitals more accountable for their community benefits. Many hospitals are responding to this heightened scrutiny in a proactive way, by voluntarily documenting community benefits. A number of nonprofit hospitals and hospital associations are cooperating with—or even sponsoring—state legislation in this area.

The United States, unlike all other industrialized nations, does not have a comprehensive public system for financing health care. Nevertheless, the magnitude of America's public health care financing effort is remarkable. Of the one trillion dollars the United States spent on health care in 1996, almost half, $483.1 billion, was spent by public programs. In 1995, Medicare—our social insurance program for persons over sixty-five and the long-term disabled—overed 37.5 million Americans; Medicaid—our program for indigent elderly and disabled persons and indigent children and their families—covered 36.3 million. In 1996, Medicare and Medicaid spent $203.1 and $147.7 billion, respectively. The payment policies of these massive public health care programs have a profound effect on the provision of health care.

Many of the recipients of Medicare and Medicaid suffer pain. In 1994, 376,200 Americans over age sixty-five died of cancer. Virtually all of these would have been Medicare recipients, and as many as 70 percent of them died in unrelieved pain. Nearly four million Americans over sixty-five endured the pain of inpatient surgery in 1995, again nearly all of whom were Medicare recipients.

In recent debates surrounding World Health Organization (WHO) reform, international lawmaking has received unprecedented attention as a future priority function of the Organization. Although WHO's constitutional lawmaking authority was historically neglected and even resisted by WHO and its Member States until the adoption of its first treaty a decade ago, the widespread consensus in favor of a central role for lawmaking in visions of a reformed WHO reflects the crystallization of contemporary approaches to global health governance. Today it is widely recognized that the trends toward globalization that have restricted the capacity of sovereign states to protect health through unilateral action alone have made innovative mechanisms to promote global cooperation and coordination, including international lawmaking, an essential component of governance of public health.

Human reproductive cloning has become the most palpable example of the globalization of science. Throughout the world, events and conjectures in the media, such as the birth and death in the United Kingdom of the cloned sheep Dolly and projects to clone human beings by Korean scientists, by members of the Canadian-based Raelian cult, and by the Italian physician Antinori in an undisclosed country, have galvanized the political will of individual countries to ban human reproductive cloning.

Yet, international attempts to harmonize policies in the area of biomedical ethics and human research, such as the 1997 Council of Europe’s Convention on Human Rights and Biomedicine, and most recently, the United Nations’ efforts to adopt an international convention against human reproductive cloning, have been insufficient to trigger a substantial global policy design process on issues relating to these new technologies.

Over the past decades the mortality rate in the United States has decreased and life expectancy has increased. Yet a number of recent studies have drawn Americans attention to the fact that racial and ethnic disparities persist in health care. It is clear that the U.S. health care system is not only flawed for many reasons including basic injustices, but may be the cause of both injury and death for members of racial and ethnic minorities.

In 2002, an Institute of Medicine (IOM) report requested by Congress listed more than 100 studies documenting a wide range of disparities in the United States health care system. This report found that people belonging to racial and ethnic minorities often receive lower quality of health care than do people of European descent, even when their medical insurance coverage and income levels are the same as that of the latter.

In the fall of 2001, the need for a vigorous and effective public health system became more apparent than it had been for many decades. With the advent of the first widescale bioterrorist attack on the United States, the government's obligation to respond and take steps to protect the public health became self-evident.

Also obvious was the need for of an effective partnership between federal, state, and local officials. Local officials are almost always on the front lines of the struggle against bioterrorism. They are the first to recognize a suspicious case and to provide testing and treatment for the affected population. At the same time, state officials are needed to support and coordinate local efforts, providing an expertise that may be lacking in many communities, especially smaller ones.

But few would doubt that the federal government has a key role to play. The Centers for Disease Control and Prevention (CDC) is expected to lead the epidemiological investigation and provide expertise on how to cope with diseases that remain unfamiliar to most physicians.

The conflict between pregnant women freely using cocaine and the well-being of fetuses presents a difficult social problem. Since 1985, at least 200 women, in thirty states, have been criminally prosecuted for using illicit drugs or alcohol during pregnancy. Such policies enjoy considerable public and political support. Nonetheless, treatment programs that include referral to law enforcement officials raise serious ethical and legal issues for hospitals and health care providers. In this paper, we assess the development of one medical university's controversial treatment program for pregnant women addicted to cocaine.

In October 1989, the Medical University of South Carolina (MUSC) instituted a new program, called the Interagency Policy on Management of Substance Abuse During Pregnancy (Interagency Policy), designed “to ensure appropriate management of patients abusing illegal drugs during pregnancy.” This program required some pregnant women to seek drug counseling and prenatal care under the threat of criminal sanctions.

A recurring lesson in the debate about forgoing life-sustaining treatment for patients with neurologic syndromes is the need to understand the medical realities in such cases. Those of us in the neurological sciences spend a great deal of time working with these cases on a daily basis—trying to define the medical facts and educate ourselves, the public, and the courts. This article will discuss the medical and neurological facts regarding patients with severe and permanent neurological impairment, focusing only on one form of medical treatment: artificially administered nutrition and hydration. The concern of this paper is not the patient's wishes, the family's wishes, or the decision-making role of other key players, but the medical conditions in which it is ethically appropriate to withdraw or withhold artificial fluids and nutrition.

Three years ago I first surveyed state court decisions and laws governing the withholding or withdrawal of medical treatment. The decision of the United States Supreme Court in Cruzan v. Director, Missouri Department of Health on June 25, 1990, makes it timely to review again state law developments because a majority of the Court announced in Cruzan that it will leave to the states the question of what legal requirements may be imposed on decisions to discontinue treatment for incompetent patients. Justice Rehnquist, writing for the majority, explained that the Court's deference to state decision-making is grounded in the fact that “state courts have available to them for decision a number of sources—state constitution, statutes, and common law—which are not available to US.” Although the opinion makes clear that Missouri might have authorized the family of Nancy Cruzan to decide to terminate medical treatment for her, a majority of the Supreme Court refrained from holding that Missouri is constitutionally required to do so.

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.

Our society is obsessed with health. At every second, everywhere, we are surrounded and overwhelmed by distressing calls on how vital it is to adopt a healthy lifestyle. While incorporating a healthy diet and physical exercise into our routines are the foremost commandments, everything from tobacco to refined sugars, trans fat, excessive alcohol, caffeine, and even eggs are declared public evils. Yet there is hope: medicines will save us! And indeed medicines exist available for all kinds of human afflictions. There are pills to help you relax and forget about stress, while some others, on the contrary, can keep you miraculously alert. There are pills that heal your most unbearable pains, physical or emotional, wherever their location — the head, back, quadriceps, heart, or soul. Though they may cause your stomach to burn, that is easily remedied by taking a complementary pill that will neutralize your stomach acidity with only some minor and negligible side effects elsewhere. There are also magic pills that promise you happiness, by giving you the power to thrive and the endurance to conquer the world. They ignite your hunger for achievement, but also for extra sugar and saturated fat.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.

Health equity can be defined as the absence of disadvantage to individuals and communities in health outcomes, access to health care, and quality of health care regardless of one’s race, gender, nationality, age, ethnicity, religion, and socioeconomic status. Health equity concerns those disparities in public health that can be traced to unequal, systemic economic, and social conditions. Despite significant improvements in the health of the overall population, health inequities in America persist. Racial and ethnic minorities continue to experience higher rates of morbidity and mortality than non-minorities across a range of health issues. For example, African-American children with asthma have a seven times greater mortality rate than Non-Hispanic white children with the illness. While cancer is the second leading cause of death among all populations in the U.S., ethnic minorities are especially burdened with the disease.

What does unethical behavior look like in everyday professional practice, and how might it become the accepted norm? Examinations of unethical behavior often focus on failures of individual morality or on psychological blind spots, yet unethical behaviors are generated and performed through social interactions across professional practices rather than by individual actors alone. This shifts the focus of behavioral ethics research beyond the laboratory exploring motivation and cognition and into the organizations and professions where unethical behavior is motivated, justified, enabled and supported in specific social contexts. For instance, when pharmaceutical firms fund academic research, how do the funding arrangements intersect with individual behaviors that are typical in academic research? In turn, how do academic-industry interactions affect scientific norms, particularly those involving compliance with rules, regulations, and ethical codes of conduct? A social organization approach to ethics allows us not only to examine ethics in practice, but also to tease apart unethical behaviors that might operate on an unreflective level and become accepted as “just the way it is.”

Following the widespread occurrence of birth defects from the use of thalidomide to treat nausea during pregnancy in the 1960s and 1970s, the Food and Drug Administration (FDA) became particularly vigilant about the use of therapeutic agents during pregnancy and in women of childbearing potential. The FDA developed a list that categorizes an agent according to the known (and potential unknown) risks to a fetus. The drug thalidomide falls into Category X: agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh the benefits of use during pregnancy.

Another Category X drug is isotretinoin, commonly known by its trade name Accutane. Isotretinoin is an oral medication prescribed for severe recalcitrant, nodular acne in patients who are unresponsive to conventional therapy. Isotretinoin has been available since 1982, and it remains the only effective treatment for this condition.

Informed consent is a basic ethical and legal requirement for human subjects research. The U.S. federal regulations governing research on human subjects stipulate general requirements for informed consent. Investigators are required to disclose to prospective subjects material information about the purpose, procedures, and likely consequences of the study, among other things. However, investigators sometimes employ deception for methodological reasons. In order to keep subjects’ responses unbiased, investigators deceive subjects about such things as the fact that they are taking part in research, the purpose of the research, the research interventions or interactions, or the likely consequences of those interventions or interactions. When investigators deceive subjects about such aspects of a study, the study fails to meet these general requirements for informed consent.