Virtually all Americans are part of the health care system. They may be patients, health professionals, employers providing benefits, insurers, medical manufacturers, regulators, innovators, or investors. Each has a stake in this burgeoning sector of the United States economy, and each may be critically affected, in multiple and diverse ways, by changes to the system under health reform. As health care expenditures continue to rise, it is increasingly important to understand where these expenditures go and the factors that drive these cost increases. This article examines health care expenditure patterns, considering both the “usual suspects” that frequently are cited as spending drivers, as well as certain significant dynamics that may be the main contributors to rising costs. We conclude that in order to successfully contain costs, health reform will need to address these underlying factors.

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely.

In a recent discussion about how scientific knowledge might potentially change our understanding of the nature and extent of human genetic, cultural, or biological variation, the sociologist David Skinner identified two competing visions of the future: one that was decidedly dystopian, which conjured up a “re-racialized” future, and an opposing utopian future in which the potential for racialized thinking might be finally overcome. We can situate the ongoing debates about the congestive heart failure drug BiDil, approved by the Food and Drug Administration (FDA) for use only by African Americans, in relation to these differing future prospects.

When the FDA announced its approval of BiDil in June 2005, it located the drug, and perhaps the future of pharmaceutical development, within a particular vision of the future, heralding BiDil as “representing a step toward the promise of personalized medicine.” The discourse of “personalized medicine” can be characterized as part of a utopian future, one in which clinicians will be able to make increasingly individualized decisions based on each patient’s genetic makeup so that the drugs they take will be those that work best for them.

Current discussions of so-called “enhancement” technologies immediately involve matters of definition, because the distinctions between enhancement and therapy invite ambiguity. Therapy is generally defined as the prevention or cure of disease, or as the restoration or approximation of return to normal physiological function. Enhancement is defined as the alteration of individual (or group) characteristics, traits, and abilities (both health- and non-health-related) beyond a measurable baseline of normal function. Both notions rely on shared understandings of disease and illness, which depend in turn on the ways that we conceptualize and operationalize judgments of normalcy. Both notions have therefore generated significant controversy among philosophers of medicine, with the result that blanket distinctions between therapy and enhancement appear unlikely to convince everyone.

This paper provides an overview of recent US Department of Health and Human Services (HHS) initiatives and efforts — under the leadership of the General Counsel, the Secretary, and the President — regarding legal preparedness for public health emergencies. In addressing this topic, the paper focuses on four core elements comprising public health legal preparedness:

1. (1) effective legal authorities to support necessary public health activities;

2. (2) competencies of public health professionals to know and then to apply those laws;

3. (3) coordination of the application of laws across jurisdictions (local, state, tribal, federal, and international) and across multiple sectors; and

4. (4) information and best practices in public health law.

A physician-investigator conducting brain imaging research to study the pathophysiology of depression detects a suspicious finding in a healthy volunteer that suggests a possible brain tumor. Must the investigator disclose this finding to the research subject? Further, is there a duty to ensure that brain scans performed to answer research questions are evaluated clinically to identify potential health problems? If so, what in the nature of the investigator-subject relationship gives rise to such an obligation?

Investigators and Institutional Review Boards (IRBs) commonly struggle with the question of how to address incidental findings — that is, “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study.” A working group convened by the National Institutes of Health has recommended that brain imaging research studies should establish protocols for handling incidental findings. However, there is little ethical guidance available to steer such efforts, and practices appear to vary widely. Although several articles have catalogued the ethical dilemmas surrounding incidental findings, with the exception of seminal work by Henry Richardson and Leah Belsky on the more general topic of researchers’ obligations to provide ancillary clinical care to research subjects, systematic ethical analysis of the incidental findings problem is lacking.

In most other nations, insurance for medical care is called sickness insurance, and it covers sick people. In the United States, we have “health insurance,” and its major carriers — commercial insurers, large employers, and increasingly government programs — strive to avoid sick people and cover only the healthy. This perverse logic at the heart of the American health insurance system is the key to reform debates.

Focusing on sick people versus healthy people might seem a strange way to view the coverage issue. Most discussions of insurance categorize people into other groupings: the insured versus the uninsured; Caucasian whites versus other racial and ethnic groups; men versus women; poor and low-income people versus everybody else; children, adults, and the elderly; or citizens versus immigrants and undocumented aliens. More recently, health researchers have begun talking about “vulnerable populations,” using most of the same demographic groupings and adding other illness-inducing factors such as social isolation, stress, and impoverished neighborhoods. But as I will show, insurance plans now use premiums, cost-sharing, and other design features in ways that indirectly divide each of these groups into the sick and the healthy, to the detriment of the sick. By shifting the costs of illness onto people who use medical care — that is, sick people — market-oriented reforms of the last few decades have eroded insurance in the name of strengthening it.

In 2000, researchers from the Human Genome Project (HGP) proclaimed that the initial sequencing of the human genome definitively proved, among other things, that there was no genetic basis for race. The genetic fact that most humans were 99.9% the same at the level of their DNA was widely heralded and circulated in the English-speaking press, especially in the United States. This pronouncement seemed proof that long-term antiracist efforts to de-biologize race were legitimized by scientific findings. Yet, despite the seemingly widespread acceptance of the social construction of race, post-HGP genetic science has seen a substantial shift toward the use of race variables in genetic research and, according to a number of prominent scholars, is re-invoking the specter of earlier forms of racial science in some rather discomfiting ways. During the past seven years, the main thrust of human genetic research, especially in the realm of biomedicine, has shifted from a concern with the 99.9% of the shared genome — what is thought to make humans alike — towards an explicit focus on the 0.1% that constitutes human genetic variation. Here I briefly explore some of the potential implications of the conceptualization and practice of early 21st century genetic variation research, especially as it relates to questions of race.

Not much work has been done on Hindu bioethics other than by a select few scholars and medical doctors. Professor Cromwell Crawford, author of Dilemmas of Life and Death: Hindu Ethics in a North American Context and Hindu Ethics for the Twenty-first Century, for example, is well known in the field of Hindu bioethics. Others scholars include Dr. Uma Mysorekar, who is a gynecologist as well as the president of the board of trustees of the Ganesha Temple of Flushing New York. She has published several short pieces on Hindu bioethics, and has even been interviewed by PBS for their “Religion and Ethics” program. Dr. H. L. Trivedi, director of the Institute of Kidney Diseases and Research Center at the Civil Hospital Campus in Ahmedabad, India, is also prominent. His pithy paragraph in Transplant Proceedings on Hinduism and organ transplantation is cited with enormous frequency on the Internet and elsewhere. These thinkers, however, are unequivocally wrong in their position that Hinduism supports organ transplantation, and, more importantly, that it offers any coherent or systematic bioethics whatsoever.

Physically and intellectually, man is not the same as a million years ago. This “improvement” in humans has occurred over a period of time and not as a result of any outside biotechnical intervention. So, the question is what is the need now? The fine line between what can be done technically and what should be done morally is the reason for biomedical ethics. What is the nature of man, and what is his relationship with his creator and his environment? Whose interest (man, God, and environment) are we as scientists and physicians to guard? What are the rights of the unborn, and who protects those rights? While seeking medical treatment for infertility and reconstructive surgery for a malformation or genetic manipulation for a genetic disease might perhaps be appropriate and recommended, is it also appropriate to create a super healthy, super human with genetic manipulation? If so, then are we embarking on the path of ethnic cleansing of humans of lesser ability, and is it appropriate to discriminate? In this paper, such questions and concerns are discussed from an Islamic perspective.

Public health legal preparedness begins with effective legal authorities, and law provides a key foundation for public health practice in the United States. Laws not only create public health agencies and fund them, but also authorize and impose duties upon government to protect the public's health while preserving individual liberties. As a result, law is an essential tool in public health practice and is one element of public health infrastructure, as it defines the systems and relationships within which public health practitioners operate.

For purposes of this paper, law can be defined as a rule of conduct derived from federal or state constitutions, statutes, local laws, judicial opinions, administrative rules and regulations, international codes, or other pronouncements by entities authorized to prescribe conduct in a legally binding manner. Public health legal preparedness, a subset of public health preparedness, is defined as attainment of legal benchmarks within a public health system.

The presence of the Tuskegee Syphilis Study was palpable at the June 16, 2005, Food and Drug Administration’s (FDA) Advisory Committee meeting on BiDil, a heart medication from the pharmaceutical company NitroMed that sought approval as the first race-specific drug. So ubiquitous is the restless and unsettled spirit of Tuskegee that it continues to hover over the African American public and the biomedical research/health care provider communities more than three and a half decades after the actual study “died.” No one invoked the word “Tuskegee” in that dimly lit meeting room as BiDil gained the Advisory Committee’s approval. Yet its power was exerted even when it was not named. The FDA Committee’s chairman, Cleveland Clinic cardiology chief Steven Nissen, acknowledged this after the committee met: “We were putting [Tuskegee]…to rest.”

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.

For most of the first two decades after the enactment of the Employee Retirement Income Security Act of 1974 (ERISA), health policymakers did not seem to recognize the full impact that ERISA would have on regulation of health insurance and health care coverage. Perhaps the early court decisions in which the courts clarified that states could regulate insurance companies and the products they sold to ERISA plan sponsors gave them false comfort that because Congress appeared to recognize the role of the states in regulating insurance, ERISA might have only a tangential impact on health care reform efforts.

The popular press plays an important role in science communication, both reflecting and shaping public attitudes about particular issues and technologies. It is a key source of health information and can help to frame public debates about science and health care controversies. Given this powerful role, there has long been a concern that media representations of genetics are overly simplistic and inappropriately deterministic in tone. If true, media representations may hurt collective deliberations about science issues and misinform the public regarding the relevance of genetics in a variety of contexts — including the relevance of genetics and biology to the existing social categories of “race.”

In what follows, I draw on things I have found in Japanese discussions of bioethics in order to clarify some aspects of the ethics of biotechnological enhancement. In doing so it will, I hope, become evident that what we might call a “religious” component is in Japan somewhat differently construed than in the contexts with which we are more likely to be familiar in North America. And in the end an attempt will be made here to show that the materials considered give us all – not just the Japanese – reasons for going forward with biological enhancement technologies only on condition that extreme caution be exercised. The fast-moving, oncoming traffic in this domain ought to be forced, these materials suggest, to come up to a caution-demanding signal – not a green light but one that is unambiguously amber. Caution and perhaps even a full stop appear to be in order.

As we write this paper in spring 2008, many are hopeful that November’s election will open the door to some form of comprehensive health care reform. In all likelihood, we will elect a president who has campaigned to a greater or lesser extent on promises of improving access to health care, improving quality, and reducing costs. Equally important, it seems likely that the 111th Congress is preparing to undertake meaningful health care reform. And perhaps most important, despite recent attention to energy issues and the economy, opinion polls consistently show that the American public continues to rank health care as one of the two or three most important domestic issues in the fall elections and supports comprehensive health care reform.

There are countless variations on this theme. The call can come from one of your own physicians who was called by the investigator. Your physician may or may not be well informed on what the reported finding about Disease Y means or how to respond. DNA testing can reveal more than susceptibility to disease. People can learn that they do not have the biological connections — parentage or evidence of ethnic origin — that they thought they did.

Colleagues who serve on the Institutional Review Board (IRB) in my institution tell me that they currently do not permit “cold calls” of the type portrayed in the opening paragraph. Such direct contacts have, however, occurred in the past, with or without the blessing of an IRB. Sharing findings with the individual’s physician, who is then supposed to serve as a learned and wise intermediary, is not without problems either, given that many physicians understand little about complex genetics. Yet the very existence of this project on managing incidental findings in research demonstrates that some people believe that some research findings ought to be available to participants.

Among the many components of legal preparedness for public health emergencies is the assurance that the public health workforce and its private sector partners are competent to use the law to facilitate the performance of essential public health services and functions. This is a significant challenge. Multiple categories of emergencies, stemming from natural disasters to emerging infectious diseases, confront public health practitioners. Interpreting, assessing, and applying legal principles during emergencies are complicated by the changing legal environment and differences in governmental organization of emergency management functions. While law and legal competencies are essential to routine public health practices, once government declares a state of public health emergency or disaster, the legal landscape changes. Typical legal responses to protect the public's health may no longer be the norm. Public health practitioners, legal counsel, health care partners, and others need to be able to assess changing laws and policies and apply them in real-time.

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.