Today, public health regulation at all levels faces unprecedented challenges both at home and abroad. The September 11, 2001 attacks on New York and Washington, D.C., by the Al Qaeda terrorist network and the anthrax bioterrorism that followed shortly thereafter have put public health regulation at the forefront of homeland security. The anthrax scare, in particular, has greatly tested the American public health system, calling into question whether the United States and its component states and localities are prepared to handle a major outbreak of infectious disease, such as smallpox, in a future bioterrorist action. While the response of public health agencies was commendable, especially in light of the magnitude of the assaults, it is manifestly clear that the American public health system will be hard pressed to meet similar challenges that may lie ahead.

The events of fall 2001 follow a period of major challenges for public health. The AIDS pandemic has killed millions of people throughout the globe, especially in Africa and other parts of the developing world.

In August 2000, Arthur Matas and his colleagues de scribed a protocol in which their institution began to accept as potential donors, individuals who came to the University of Minnesota hospital offering to donate a kidney to any patient on the waiting list. Matas and his colleagues refer to these donors as nondirected donors by which is meant that the donors are altruistic and that they give their organs to an unspecified pool of recipients with whom they have no emotional relationship. This paper represents an ethical and policy critique of the nondirected donation protocol that was implemented at the University of Minnesota in August 1999. Specifically, I address the ethical questions: Whether altruistic living solid organ donations by strangers (nondirected donations) should be permitted? And if so, What are appropriate ethical guidelines for such donations?

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction (e.g., craving, impaired control, and compulsive use) cannot be observed in non-drug-dependent humans, it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans.

Zoning laws determine what types of land uses and densities can occur on each property lot in a municipality, and therefore also govern the range of potential environmental and health impacts resulting from the land use. Zoning regulations are the most ubiquitous of the land use laws in the United States, as well as in many other countries. As such, they have far-reaching effects on the location of noxious uses, and any concomitant environmental or human health impacts.

Zoning has enormous implications, in general, for shaping our environment, and because changes to zoning are made through a political process, it has possibilities for abuse. One zoning expert stated:

The purpose of this article is to re-visit how rationing is defined for a health-care context, Two reasons justify returning to this topic. First, the variability as to how rationing has been defined in the legal, medical, and philosophical literature justifies a careful examination to identify its critical features. Second, I believe that if the definitions typically employed in the literature, several of which are discussed below, are compared to those that would be offered by the American public, ethically weighty dissimilarities would be apparent. Disparate characterizations are worrisome because serious “disconnections” between policymakers’ understandings, rhetoric, and priorities and those of the general public are more likely.

Lainie Ross, in her article in this issue, criticizes on ethical grounds a number of factors in the University of Minnesota program that allows unrelated strangers to donate kidneys for transplant. I have to admit that when the transplant center at the University proposed allowing the practice of what came to be called nondirected donation, I was skeptical about a number of the same issues that trouble Dr. Ross. But as my colleagues and I examined and discussed the ethics of such a plan, along with the risks to prospective donors, their possible motivations, and the logistics of performing the surgeries under conditions of anonymity between donor and recipient, among other factors, we came to believe that such donations can be ethically acceptable. As a product of frequent meetings over the course of a year in advance of the first nondirected donation, we set out to craft a process that would first and foremost meet the test of an ethical approach to organ donation and transplant, the description of which was published in the New England Journal of Medicine in August 2000.

As Jonathan Mann observed, the problem of AIDS-related stigma is inextricably bound to issues of health, human rights, and the law. Such stigma translates into feelings of fear and hostility directed at people with HIV. It finds expression in avoidance and ostracism of people with HIV, discrimination and violence against them, and public support for punitive policies and laws that restrict civil liberties while hindering AIDS prevention efforts. Being the target of stigma inflicts pain, isolation, and hardship on many people with HIV, while the desire to avoid it deters some from being tested for HIV, seeking treatment, or practicing risk-reduction.

An ongoing debate among legal scholars and public health advocates is the role of litigation in shaping public policy. For the most part, the debate has been waged at a conceptual level, with opponents and proponents arguing within fairly well-defined boundaries. The debate has been based either on speculation of what litigation could achieve or on ideological grounds as to why litigation should or should not be used this way. With the exception of Rosenberg's study of how litigation shaped policy in civil rights, abortion, and environmental matters, there is almost no empirical support for either position.

In recent years, the most ardent proponents of litigation as public policy have been public health advocates. Perhaps out of frustration with the inability to achieve desired public health goals through the legislative branch of government, public health advocates have pursued litigation as an alternative strategy. Beginning with tobacco class action litigation in the early 1990s and continuing with litigation against gun manufacturers at the end of that decade, public health advocates have waged a veritable litigation assault aimed at changing how public health policy is formed.

Criminal law is one of the regulatory tools being used in the United States to influence risk behavior by people who have HIV/AIDS. Several different types of laws have been or could be used in this way These include:

• HIV-specific exposure and transmission laws — i.e., laws that explicitly mention and exclusively apply to conduct by people with HIV;

• public health statutes prohibiting conduct that would expose others to communicable diseases and/or sexually transmitted diseases (STDs); and

• general criminal laws governing attempted murder and assault.

Jeffrey Kahn and I agree that organ donation by altruistic strangers is acceptable, and that the organ procured this way ought to be allocated equitably. Our agreement in principle, however, is challenged in the details of its application. Specifically, I want to focus on three issues raised by Kahn that merit further discussion: whether relationships matter; how kidneys should be allocated; and the ethical acceptability of the expanded donor pool.

The discovery of the molecular structure of deoxyribonucleic acid (DNA) and the science of molecular biology have profoundly changed medicine’s diagnostic capability and promise to transform the therapeutic realm. When some genetic disorders are diagnosed, physicians can intervene for prevention or treatment. While the basic structure of DNA is the same for all human beings, no two individuals, other than identical twins (or cloned individuals), have the same DNA sequence. This discovery has had important repercussions in the criminal justice system, where DNA can serve as an identification tool.

At the crossroads of these different uses of DNA, there are great concerns about potential misuses of genetic information. Preventing disease, curing illness, and convicting criminals are all seen as worthwhile uses of the technology, but concerns of potential misuse in medicine or in the criminal justice system are not unfounded. A 1998 American Medical Association (AMA) study showed that 68 percent of patients had fears that their genetic test results would be used against them by their employers or insurers. Others, pointing to racial profiling, have suggested that we may now face genetic profiling.

The relationship between law and a population’s health is complex and poorly understood. To the extent that scholarship exists on the subject, it has usually focused on epidemics that are concentrated in relatively vulnerable, marginalized communities. Often, individual behaviors are assumed to play a major role in the epidemiology of these diseases. Perhaps, as a result, these illnesses become stigmatized and the object of coercive laws, which in turn become the subject of litigation, legal debate, and ultimately scholarly analysis. Thus, to the extent that U.S. legal scholars have thought about public health in the last 30 years (and they seldom have), they have generally done so in the context of tuberculosis (TB), intravenous drug abuse, and a handful of similar conditions. Likewise, Jonathan Mann’s own appreciation of the importance of human rights to public health emerged in the wake of his work with HIV, which is perhaps the prototypical stigmatized disease.

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of access to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate.

There is perhaps no duty more fundamental to American government than the protection of the public's health, safety, and welfare. On September 11, 2001, this governmental duty was severely tested through a series of terrorist acts. The destruction of the World Trade Towers in New York City and a portion of the Pentagon in Washington, D.C., presented many Americans with a new, visible reality of the potential harms that terrorists can cause. The staggering loss of lives (estimated from 2,600 to 2,900) damaged the national psyche in ways far exceeding the physical scars to American institutions.

As horrific as the images of destruction and loss of human lives may be, events that unfolded after September 11 revealed another dreaded, and potentially more catastrophic, threat to Americans sense of security and public health: bioterrorism. Unlike terrorists that use bombs, explosives, or other tools for mass destruction, a bioterrorist's weapon is an infectious agent.

Biomedical advances of the past 20 years have stimulated a renewed interest in medical ethics. Transplantation of multiple human organs, implantation of artificial devices, advances in genetics, and stem cell research are a few of the medical procedures and discoveries that have awakened in both professionals and the public an awareness that medical discoveries often raise important ethical and societal issues. Today, members of the medical profession face issues that did not seem so pressing to their predecessors, and physician conduct in response to many of these issues involves decision-making based on ethical principles. Issues of informed consent, gifts from pharmaceutical companies, and patient rights to privacy were not of great concern to most physicians a generation ago. However, these and other topics that involve a physician's ethical conduct have become increasingly pertinent to the practice of medicine.

A renewed emphasis on ethics has been voiced by leaders in the field of medicine.

The Dutch experience has influenced the debate on euthanasia and death with dignity around the globe, especially with regard to whether physician-assisted suicide and euthanasia should be legitimized or legalized. Review of the literature reveals complex and often contradictory views about the Dutch experience. Some claim that the Netherlands offers a model for the world to follow; others believe that the Netherlands represents danger, rather than promise, and that the Dutch experience is the definitive answer regarding why we should not make active euthanasia and physician-assisted suicide part of our lives.

Having investigated the Dutch experience for a number of years, in the summer of 1999 I went to the Netherlands to visit the major centers of medical ethics as well as some research hospitals, and to speak with leading figures in euthanasia policy and practice. This essay commences by providing some background information on the practice of euthanasia and on the legal framework, and then reports the main answers to my first question: Why the Netherlands?

The provision of police services and the suppression of crime is one of the first functions of civil government. Article 3 of the Universal Declaration of Human Rights speaks of a right to “security of person.” “The term ‘police’ traditionally connoted social organization, civil authority, or formation of a political community—the control and regulation of affairs affecting the general order and welfare of society,” including the protection of public health. Civil dispute resolution is also an important part of a system that moves people away from self-help and toward reliance on collectively constituted, peaceful channels for working out problems.

A safe and secure environment is tied to health. Research in social epidemiology suggests that a shared sense of security from physical violence and interference with property can contribute to better community health.

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers.

Before September 11, 2001, a mass-casualty terrorist attack on American soil was generally considered a remote possibility. Similarly, before October 4, 2001—the first confirmed case of anthrax caused by intentional release — widespread bioterrorism seemed implausible. Among the arguments that such a biological artack was unlikely included: the lack of a historical precedent; the technological and organizational challenges to acquiring and weaponizing a biological agent; and the almost universal moral opprobrium that would certainly accompany the use by terrorists of such a weapon. In the wake of September 11th and October 4th, however, many are reconsidering the likelihood of a large-scale bioterrorist attack against civilians.

The Centers for Disease Control and Prevention (CDC) defines bioterrorism as the intentional release of viruses, bacteria, or toxins for the purpose of harming or killing civilian. One measurement of the public health system's level of bioterrorism preparedness is the quality and distribution of laws mandating the reporting of diseases caused by certain biological agents.