Race is becoming an increasingly common lens through which biomedical researchers are studying the relevance of genes to group predispositions that may affect disease susceptibility and drug response. These investigations contravene decades of research in the natural and social sciences demonstrating that social categories of race have little genetic significance. Nevertheless, a resounding debate has ensued over the utility of race in biomedical research — particularly as new drugs claiming to serve particular racial populations enter the marketplace. Now that the Food and Drug Administration (FDA) has approved BiDil as the first race-specific treatment despite conflicting evidence and unsettled debates, is there a way for federal regulators to promote research that may address minority health concerns without giving undue credence to the dangerous idea that social understandings of race are genetically relevant? It may be useful for the FDA to turn to an area with experience negotiating such dilemmas — constitutional law — and its approach — strict scrutiny — to help guide when and under which circumstances government should give effect to racial categories in biomedicine.

A community's abilities to promote health and maximize its response to public health threats require fulfillment of one of the four elements of public health legal preparedness, the capacity to effectively coordinate law-based efforts across different governmental jurisdictions, as well as across multiple sectors and disciplines. Government jurisdictions can be viewed “vertically” in that response efforts may entail coordination in the application of laws across multiple levels, including local, state, tribal, and federal governments, and even with international organizations. Coordination of legal responses to public health emergencies also may involve a horizontal dimension comprising numerous and diverse sectors, such as public health, public and private health care, emergency management, education, law enforcement, the judiciary, and the military.

Although responses to many acute health threats can implicate multiple jurisdictions and sectors, the jurisdictional and sectoral dimensions of legal preparedness are complex and may vary substantially by the nature of a threat, its geographic and geopolitical extent, and the operational response demanded.

The question of why women, in consultation with their physicians, should choose hormone therapy (HT) in response to menopause represents a renewed controversy at the beginning of the new century. Conflicting messages regarding the health risks and benefits of HT have been conveyed in the mainstream media, especially information in the media regarding the results of large-scale studies of the health impact of hormone therapy. Women who have been on one or another of the hormone replacement regimes have been forced to reconsider continuing on HT. Doctors who suggest these hormones to their patients are somewhat confused, as are perimenopausal women who are considering HT. Pharmaceutical companies that produce these compounds are worried, and public health officials are on the defensive.

Media coverage of HT research has been extensive. In particular, two large-scale studies, one here in the U.S. (the Women's Health Initiative, or WHI) and the other in Great Britain, have recently cast a negative light on the use of hormone therapy, after years of routine prescription of HT for menopausal women.

Extensive media coverage of the nation’s response to its obligation to furnish health care for service members wounded in current overseas conflicts in Iraq and Afghanistan has elevated public consciousness of the importance of the U.S. military and veteran’s health care systems to a level not seen since the end of the Vietnam War. The number of casualties of U.S. military engagements has varied in each specific conflict and is a direct result of both the type of battle and the military’s ability to handle battlefield injuries (see Table 1).

Debates over health care reform often focus on the appropriate role for the government in health care. Much less attention is paid to defining the respective roles of the states and the federal government. Yet, in the American political system, the basic issue of federalism has profound implications.

The question for the nation is which aspects of health policy should reflect national, uniform standards, and which should vary according to local conditions, values, and preferences. Economic mobility and the desire for efficiency militate for national uniformity and federal standards. By contrast, state policies can be more closely tailored to local economic conditions and can reflect local values regarding matters such as the appropriate role of government.

Information is the fourth core element of public health legal preparedness and of legal preparedness for public health emergencies specifically. Clearly, the creation, transmittal, and application of information are vital to all public health endeavors. The critical significance of information grows exponentially as the complexity and scale of public threats increase.

Only a small body of organized information on public health law existed before the 21st century: a series of landmark books published beginning in 1926 by Tobey, Grad (1965), and Wing (1974); model public health laws published as early as 1907; systematic reviews of original research studies published in the 1990s; and a small but growing number of articles published in public health journals and law reviews.

With the new century came new public health law programs and activities at the Centers for Disease Control and Prevention (CDC), in public health professional associations, and in numerous non-profit and academic organizations.

In Phillip Kerr’s 1994 spellbinding novel A Philosophical Investigation, the medical test to which the protagonist refers is a functional brain scan based on positron emission tomography (PET). It is used to run large studies of male and female brains and, following a lead suggested by animal studies, has been used to identify rare cases of human male subjects who lack the ventral medial nucleus (VMN). This nucleus, in the experiment (and the story), is hypothesized to inhibit the activity of the sexually dimorphic nucleus (SDN), a preoptic area of the male brain believed to be a repository of male aggressive response. Prior research, we learn from the plot, shows that 3 in 100,000 human males are VMN-negative. Thirty percent of those affected are believed to be in prison or to have a criminal record; 70% are believed to stabilize levels of aggression by producing increased levels of estrogen. Identities of subjects participating in the brain scan studies are protected through the conversion of real names to those of famous figures of the past — Bertrand Russell, Charles Dickens. Those for whom results are unfavorable are recontacted, and they are offered counseling.

The standards for medical education in the United States now go above and beyond traditional basic science and clinical subjects. Bioethics, health law, and health economics are recognized as important parts of translating physicians’ technical competence in medicine into effective research, administration, and medical care for patients. The Liaison Committee on Medical Education (LCME), which establishes certification requirements for medical schools, requires all medical schools to include bioethics in their curricula. Furthermore, issues such as the growth of genetic testing, end-of-life decision making for a burgeoning elderly population, confidentiality in the era of electronic medical records, and allocation of scarce medical resources make bioethics training clearly necessary for physicians. Although 16 percent of the United States GDP is devoted to health care, the LCME does not currently mandate training in health law or health economics. Furthermore, as the Schiavo case and HIPAA remind us, legal directives influence medical practice in areas such as billing, confidentiality, and end-of-life care.

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling (1865-1936) penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.

Over 100 years have passed since this poem was written, yet the ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

As everybody knows, advances in medicine and medical technology have brought enormous benefits to, and created vexing choices for, us all – choices that can, and occasionally do, test the very limits of thinking itself. As everyone also knows, we live in the age of consultants, i.e., of professional experts who are ready, willing, and able to give us advice on any and every conceivable question. One such consultant is the medical ethics consultant, or the medical ethicist who consults.

Medical ethics consultants involve themselves in just about every aspect of health care decision making. They help legislators and judges determine law, hospitals formulate policies, medical schools develop curricula, etc. In addition to educating physicians, nurses, and lawyers, amongst others, including medical, nursing, and law students, they participate in clinical decision making at the bedside.

As this nation embarks on new efforts to reform the U.S. health system, we face a critical unfinished agenda from the mid- 1960s: persistent racial, ethnic, and socioeconomic disparities in health and health care. Medicaid, Medicare, and Community Health Centers — public programs with very different legislative histories and financing mechanisms — were the first federally funded, nationwide efforts to improve health care access for low-income and elderly Americans. Members of racial and ethnic minority groups also greatly benefited from these efforts because recipients of federal funds, such as Medicare, were required to comply with the newly passed Civil Rights Act of 1964, which barred racial discrimination. Unquestionably, government played a major role in the gains in health care access that have occurred in the last half century. Yet today all Americans do not have the same opportunities for health, access to care, or quality of care when they receive it.

The BiDil controversy in America coincides with a renewed interest in the linkages between race and therapeutics, whether in the medical history of the United States itself, or in the colonial world. During the colonial era in South Asia, many anthropological and medical researchers conducted research which compared the European and “colonial” body, contrasting everything from blood composition to brain weight between the races of the Indian Empire. This, as Mark Harrison has shown, was fundamentally a phenomenon of the 19th century, arguing that “[i]t was only after 1800 that racial identities came to be fixed and that India was viewed with terror, as a reservoir of filth and disease.” Racist attitudes in British Indian colonial medicine are not hard to discover. They underpinned, for instance, campaigns to improve the appallingly high maternal and infant mortality rates in which the blame was placed squarely upon the women and the indigenous midwives who delivered them rather than the poverty in which they lived. As such, Peers Dimmock, a professor of gynecology and obstetrics at the Calcutta Medical School, opened his address to the First Indian Medical Congress in 1894 with a diatribe against “the unclean and repulsive traditionary [sic] methods of the native midwives.”

The question of how to handle incidental findings (IFs) has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging (MRI) scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search should be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise.

This paper is one of the four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness (Summit) convened in June 2007 by the Centers for Disease Control and Prevention and multi-disciplinary partners. Each of the action agenda papers deals with one of the four core elements of legal preparedness: laws and legal authorities; competency in using those laws; coordination of law-based public health actions; and information. Options presented in this paper are for consideration by policymakers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.

One expert's framing of the mission of public health may help improve understanding of the range of hazards for which to be legally prepared. These hazards include urgent realities — such as chronic disease, injury, disabilities, conventional communicable diseases, and an aging and obese population — and urgent threats, such as pandemic influenza, natural disasters, and terrorism.

The Physician Orders for Life-Sustaining Treatment (POLST) Paradigm is designed to improve end-of-life care by converting patients’ treatment preferences into medical orders that are transferable throughout the health care system. It was initially developed in Oregon, but is now implemented in multiple states with many others considering its use. Accordingly, an observational study was conducted in order to identify potential legal barriers to the implementation of a POLST Paradigm. Information was obtained from experts at state emergency medical services and long-term care organizations/agencies in combination with a review of relevant state law. Legal analysis of survey responses and existing laws identified several potential state legal barriers to a POLST Paradigm implementation. The most potentially problematic barriers are detailed statutory specifications for out-of-hospital DNR (do not resuscitate) protocols (n = 9 states). Other potential barriers include limitations on the authority to consent to forgo life-sustaining treatments (n = 23 states), medical preconditions (n = 15), and witnessing requirements (n = 12) for out-of-hospital DNR protocols.

This paper is one of the four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness (Summit) convened in June 2007 by the Centers for Disease Control and Prevention, and multi-disciplinary partners. Each of the action agenda papers deals with one of the four core elements of legal preparedness: laws and legal authorities; competency in using those laws; and coordination of law-based public health actions; and information.

This action agenda offers options for consideration by those responsible for or interested in ensuring that public health professionals, their legal counsels, and relevant partners understand the legal framework in which they operate and are competent in applying legal authorities to public health emergency preparedness.

Competencies are critical to an individual's ability to make effective legal response to all-hazards public emergencies.

Magnetic resonance imaging (MRI) is a noninvasive imaging tool that utilizes a strong magnetic field and radio frequency waves to visualize in great detail organs, soft tissue, and bone. Unlike conventional x-rays (including computed tomography [CT]), there is no exposure to ionizing radiation and at most field strengths (generally below 7 Tesla) the procedure is considered safe for nearly every age group. Because it is non-invasive (i.e., does not break the skin or harm the body) and possesses excellent spatial resolution (down to millimeters), the use of MRI as a research tool has increased exponentially over the past decade. Uses have ranged from add-ons to a clinical study (e.g., after scanning a child who has fallen from a bicycle, the radiologist might do an extra sequence to explore ways of obtaining higher resolution images) to studies of brain development in typically developing children. In addition, a major effort has been made in recent years to use MRI to study brain function (so-called “functional MRI” [fMRI]). Because the clinical utility of fMRI has not yet been realized, fMRI is still considered highly exploratory, and we cannot yet identify incidental findings of a functional (as opposed to structural) nature.

During World War II, scientists funded by the United States government conducted mustard gas experiments on 60,000 American soldiers as part of military preparation for potential chemical warfare. One aspect of the chemical warfare research program on mustard gas involved race-based human experimentation. In at least nine research projects conducted during the 1940s, scientists investigated how so-called racial differences affected the impact of mustard gas exposure on the bodies of soldiers. Building on cultural beliefs about “race,” these studies occurred on military bases and universities, which became places for racialized human experimentation.

Health care depends on people. It is the health workforce — doctors, nurses, pharmacists, lab technicians, and nursing assistants, to mention a few — that, in large measure, determine the quality and effectiveness of any health enterprise. The nature of the health workforce was integral to the health care reform debates of the early 1990s and will surely be central in proposals to improve the quality, accessibility, and cost of U.S. health care in the future. Therefore, as we enter a new period of health reform deliberations and as we face the inevitability of an aging population, it is important to consider the problems and potential remediation necessary for the health workforce of the future. This article focuses particularly on physicians and nurses while recognizing the importance and frequently parallel concerns that arise across all health care disciplines. Understanding how the composition, capacity, and activities of a health care workforce must change as part of health reform requires an understanding of the context in which health professionals practice. What are the factors that govern health care today, and what are their impact on the health workforce?

Information technology is considered a potentially transformative element in the field of health care by payers, providers, vendors, and consumers alike. Because of this transformative potential, health information technology (HIT) adoption is viewed by many as a key component of health system reform. HIT is in its earliest stages, with diffusion of the technology still relatively limited; at the same time, there is growing awareness of its potential to affect the operation of the entire health care system as a result of the vast amount of information that will become available to both health professionals and patients.