The BiDil affair brought once again to the fore questions of race and medicine. As discussed in other essays in this collection, the emergence of BiDil as the first medication approved and marketed for treating specific racial groups raises important questions for medicine and society: How are race and ethnicity framing our understanding of health and illness? Should treatment decisions be based on the race and ethnicity of patients? Should we encourage the development of race-specific medical treatments in order to reduce health disparities? Or is this approach dangerous, and can it lead to unwanted consequences including racial stigmatization? These questions are not new, and since the introduction of race as a scientific construct in the late-19th century, race has played an important part in the history of medicine, most notoriously during World War II and the Holocaust. Yet the identification of race medicine with Nazi science tends to obscure the vast use of race as a medical construct by a wide range of medical scientists and practitioners across the political spectrum. In many instances, racial minorities were preoccupied with race medicine in order to promote the health of their own communities. One such group was that of Jewish physicians.

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.

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 (CDC) and multi-disciplinary partners. Each of the action agenda papers deals with one of the four core elements of public health 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 policy makers and practitioners — in all jurisdictions and all relevant sectors and disciplines — with responsibilities for all-hazards emergency preparedness.

Advancing and protecting the public's health depends upon the coordination of actions by many, diverse partners. For effective public health preparedness, there must be effective coordination of legal tools and law-based strategies across local, state, tribal, and federal jurisdictions, and also across sectors such as public health, health care, emergency management, education, law enforcement, community design, and academia.

Just over ten years ago, the first human trials of virtual colonoscopy, or computed tomography (CT) colonography, were performed. CT colonography (CTC), as it is now called, is a low radiation dose CT examination of the abdomen and pelvis following bowel purgation cleansing and insuflation (inflation) of the colon and rectum. High spatial resolution CT datasets of the abdomen and pelvis are obtained while the patient is lying in the prone and supine positions, with the entire procedure lasting about ten minutes. The resulting images are interactively reviewed on a dedicated computer workstation using 2D multiplanar images and 3D endoluminal displays of the colon. Over the past decade, rapid technological advancements in image acquisition, 3D display techniques, colonic insuflation, and stool tagging (i.e., labeling of stool with ingested radio-opaque contrast) have occurred, which have greatly improved the ability of CT colonography to detect colorectal polyps and cancer.

Incidental research findings, as defined in this symposium’s consensus paper, are unexpected findings discovered in the course of research but “beyond the aims of the study.” These include findings generated by research methodology, such as imaging or genetic analysis, findings related to clinical screening for inclusion or exclusion, or direct observations of physical abnormalities or behavior. Decisions about managing incidental research findings involve important ethical considerations regarding a researcher’s obligations to provide care, minimize harms, and respect research participants’ wishes. When the research participant is a child, the triadic relationship between the researcher, child participant, and parent makes these considerations more complicated. (See Figure 1.)

A typical discussion around health reform in the U.S. focuses on how the nation can most effectively and efficiently extend insurance coverage to the rising number of people who have none. Furthermore, discussions about health care reform typically are centered on times of normalcy, when the health care system is not overly taxed and there is the luxury of time to think about everyday matters of health and health care, including health care services needed to prevent illness, treat conditions, and address individual emergencies. But in light of the lessons learned over the past decade, it is also essential to consider how any reformed health care system will react to and mitigate the consequences of a public health emergency.

This is one of four interrelated action agenda papers resulting from the National Summit on Public Health Legal Preparedness convened in June 2007 by the Centers for Disease Control and Prevention and nineteen multi-disciplinary partner organizations. Each of the action agenda papers deals with one of the four core elements of public health 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.

This paper focuses on the fourth core element: information that can be used in shaping and applying law as a public health tool, specifically in the context of public health emergencies.

Patients belonging to ethnic, racial, and religious minorities have been all but excluded from the legal academy’s ongoing conversation about informed consent. Perhaps this is just as well, since the conversation appears to have concluded that the doctrine has failed to serve as a meaningful regulation of clinical relationships. Informed consent does not operate in practice the way it was intended in theory. More than a decade ago, Peter Schuck noted the “informed consent gap” that distinguishes the “proper” law of informed consent “on the books” from the actual consent law in action, and called for a more contextualized approach to informed consent. Susan Wolf later called for a systemic approach to informed consent in order to accommodate multiple decision points in the managed care setting. Some reformers have sought enhancements to expand the doctrine.

If we want to understand the allure of pharmaceuticals, we need to look beyond both medical efficacy and profit motives. The success (or failure) of a drug depends not only on these, but also on how it mobilizes prior conceptions of identity. The extent to which a drug is taken — or talked about — is related to commodity properties that exceed the physiological and the economic. In implicit contrast to the discussions of BiDil elsewhere in this collection, I explore how the links between race and pharmaceuticals can be both unstable and generative even when the drug in question is old and generic. By attending closely to an encounter around generic thiazide outside of a medical or marketing context, I show that although pharmaceuticals can seem to rely on scientific data and marketing for their power, they are, in fact, also subject to claims on many more registers that cannot quite subsume or refute each other.

We stand on the edge of change. The Republican coalition is frayed, and its trusty issues — slash taxes, cut programs, deregulate industry, preach morals — have worn thin. Will the Democrats seize the opportunity and capture the political system? Or will Republicans refresh themselves and win a new lease on power? The contest will center on clashing visions and competing programs; since national health insurance is perhaps the Democrats’ signature program, health reform will be, once again, at the eye of the political storm.

Public discourse on race-specific medicine typically erects a wall between the scientific use of race as a biological category and the ideological battle over race as a social identity. Scientists often address the potential for these therapeutics to reinforce a damaging understanding of “race” with precautions for using them rather than questioning their very development. For example, Esteban Gonzalez Burchard, an associate professor of medicine and biopharmaceutical sciences at the University of California, San Francisco, states, “We do see racial differences between populations and shouldn’t just close our eyes. Unfortunately, race is a politically charged topic, and there will be evildoers. But the fear should not outweigh the benefit of looking.” Although it is recognized that ideology influences the social meaning of race, it is usually assumed that there is a separate, prior scientific understanding of race that is not contaminated by politics.

It has been pending in Congress for twelve years, despite the support of the last two presidential Administrations and the National Institutes of Health. It has been the subject of extensive affirmative lobbying by academic medical centers, pharmaceutical and biotech companies, genetic disease advocacy groups, and civil rights organizations. It has overcome vehement objections by employers and insurers. Its final passage, however, has been thwarted by a few Congressional leaders, who have prevented enactment despite overwhelming bipartisan support in both houses of Congress.

Based on this legislative history, one could not help but assume that the Genetic Information Nondiscrimination Act (GINA) is a revolutionary piece of legislation that, if finally enacted, would provide extensive, effective, and comprehensive protection against genetic discrimination in health insurance and employment Unfortunately, such an assessment would be incorrect. Indeed, GINA may be a case of too much ado about too little.

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings (IFs) in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research.

With rapidly expanding technological capacity, research has outpaced the existing infrastructure of ethical and regulatory guidance. In the area of incidental findings (IFs), this is particularly true.

The regulations under which most Institutional Review Boards (IRBs) operate were established over 25 years ago and have not been substantially altered in the intervening years. The technology available today that creates the opportunity for IFs was not conceived of, or considered, in the crafting of those regulations. Therefore, little guidance can be derived directly from these regulations. Rather, aspects of existing ethical guidance and regulations can be adapted to assist IRBs and researchers in dealing with issues surrounding IFs.

I come from a medical family. My father and uncle were physicians, and my father also chaired a department at a West Coast medical school for over 30 years. I am sure I got my interest in teaching from him. My brother is a physician and is currently the safety and quality officer of a Canadian province. My mother operated the last non-automated medical laboratory in my state. I have always understood what sacrifices are made by health care professionals, and I think I have managed to learn a bit about their motivations as well.

I was in private practice for ten years with litigation firms, and the last five years of that time I worked for a firm that specialized in professional liability defense and health law.

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident.

We are well into the political season that guarantees the election of a new president. Actually, this season, the election cycle began in November 2006, as soon as the off-year election ended. Not surprisingly, health care and reforming health care are major issues for the election — although somewhat less important than they were before late 2007.

I use the phrase “not surprisingly” because there are easily understandable reasons why health care tends to be an election issue whenever we are electing a new president. One obvious reason is that, for several decades, we have been plagued by sizeable numbers of people without health insurance and even more importantly, by unsustainable increases in health care spending and substantial numbers of people experiencing patient safety and clinical appropriateness problems. I regard the unsustainable spending and safety and quality problems as especially important because they affect all of us — not just the 15% of the population that is without health insurance.

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients.

Magnetic resonance imaging (MRI) and functional MRI (fMRI) are important tools for neuroscience research because of their capability for investigating both the structure and function of the brain. The fMRI image extends traditional anatomical imaging of the MRI to include maps of human brain function. The ability to observe brain function opens an array of opportunities to research brain organization, neurological status, and neurosurgical risk. Neurological research is, thus, burgeoning. For example, Columbia University currently has several ongoing protocols investigating fMRI’s future role in neurosurgical planning, pain management, and understanding the physiological basis for neurological disorders as well as cognitive and perceptual events. One can imagine research proposals, both important and trivial, on such topics as whether brain imaging can shed light on the nature of dreams, memory, speech development, love, anger, or addiction.