A friend once told me I was wasting my time writing about cross-cultural perspectives on the beginnings of life. “Your work is interesting for its curiosity value,” he said, “but fundamentally worthless. What happens in other cultures is totally irrelevant to what is happening here.” Those were discouraging words, but as I followed the American debates about the beginnings and ends of life, it seemed he was right. Anthropologists have written a great deal about birth and death rites in other societies and about non-western notions of personhood, but to date our findings have had little impact on American policy, ethics, or law. The recognized experts on contentious topics such as abortion and euthanasia tend to come from the fields of philosophy, bioethics, theology, law, and biology, but rarely from the social sciences. I was a bit surprised, therefore, to be invited to address the Thomas A. Pitts Memorial Lectureship on “Defining the Beginning and the End of Human Life.”

How can the abortion issue be resolved? Many believe that the issue can be resolved if, and only if, we can determine when human life begins. Those opposed to abortion choice typically say that human life begins at conception. Many who favor abortion choice say that we will never know when human life begins. The importance of the when-does-human-life-begin issue is not so much argued for as it is taken to be self-evident. Furthermore, belief that this issue is fundamental is taken for granted – at least outside of philosophy – by many of the people who seem to disagree about almost everything else concerning abortion. It has been my experience that – with rare exceptions – even those who insist that the issue of abortion should focus on the interests of pregnant women believe that this focus is warranted because fetuses are either not yet fully alive or not yet fully human.

Embryonic stem cell research is morally and politically controversial because the process of deriving the embryonic stem (ES) cells kills embryos. If embryos are, as some would claim, human beings like you and me, then ES cell research is clearly impermissible. If, on the other hand, the blastocysts from which embryonic stem cells are derived are not yet human beings, but rather microscopic balls of undifferentiated cells, as others maintain, then ES cell research is probably morally permissible. Whether the research can be justified depends on such issues as its cost, chance of success, and numbers likely to benefit. But this is an issue for any research project, not just ES cell research. What makes the debate over ES cell research controversial is that it, like the debate over abortion, raises “questions that politicians cannot settle: when does human life begin, and what is the moral status of the human embryo?” This paper looks at several theories of moral status and their implications for embryo research.

The definition of death is one of the oldest and most enduring problems in biophilosophy and bioethics. Serious controversies over formally defining death began with the invention of the positive-pressure mechanical ventilator in the 1950s. For the first time, physicians could maintain ventilation and, hence, circulation on patients who had sustained what had been previously lethal brain damage. Prior to the development of mechanical ventilators, brain injuries severe enough to induce apnea quickly progressed to cardiac arrest from hypoxemia. Before the 1950s, the loss of spontaneous breathing and heartbeat (“vital functions”) were perfect predictors of death because the functioning of the brain and of all other organs ceased rapidly and nearly simultaneously thereafter, producing a unitary death phenomenon. In the pretechnological era, physicians and philosophers did not have to consider whether a human being who had lost certain “vital functions” but had retained others was alive, because such cases were technically impossible.

Most contributors to the debate about brain death, including Dr. James Bernat, share certain assumptions. They believe that the concept of death is univocal, that death is a biological phenomenon, that it is necessarily irreversible, that it is paradigmatically something that happens to organisms, that we are human organisms, and therefore that our deaths will be deaths of organisms. These claims are supposed to have moral significance. It is, for example, only when a person dies that it is permissible to extract her organs for transplantation.

It is also commonly held that our univocal notion of death is the permanent cessation of integrated functioning in an organism and that the criterion for determining when this has occurred in animals with brains is the death of the brain as a whole – that is, brain death. The reason most commonly given for this is that the brain is the irreplaceable master control of the organism's integration.

On August 9, 2001, President George W. Bush delivered a statement that would have a great effect on bioethics policy in the United States. The President stated his belief that human life is a sacred gift from the Creator, expressed his strong opposition to any type of human cloning, and announced a policy of restricting federal funds for embryonic stem cell research to studies on stem cell lines already in existence at the time of his statement. He also announced his intention to create the President's Council on Bioethics (PCB), headed by Leon Kass, “to monitor stem cell research, to recommend appropriate guidelines and regulations, and to consider all of the medical and ethical ramifications of biomedical innovation.” On November 28, 2001, President Bush formally created the PCB, which began its deliberations the following January.

In ethical literature associated with controversies at the beginning and end of human life, there is often a two-part structure: first, basic facts about the topic are presented in a more or less descriptive format, then there is the ethics or policy.

Protecting the public's health has recently regained prominence in political and public discussions. Threats of bioterrorism following September 11, 2001 and the deliberate dissemination of anthrax later that fall, the reemergence of novel or resurgent infectious diseases, (such as the West Nile Virus, SARS, influenza, avian flu) and rapid increases in diseases associated with sedentary lifestyles, poor diets, and smoking (e.g., heart disease, diabetes, cancer) have all raised the profile of public health. The U.S. government has responded with increased funding, reorganization, and new policies for the population's health, safety, and security. Politicians and the public more clearly understand the importance of law in improving the public's health. Recognizing that many public health laws have not been meaningfully reformed in decades, law- and policy-makers and public health practitioners have focused on the legal foundations for public health. Laws provide the mission, functions, and powers of public health agencies, set standards for their (and their partners’) actions, and safeguard individual rights.

The World Health Assembly (WHA) adopted the new International Health Regulations (IHR) on May 23, 2005. The new IHR represent the culmination of a decade-long revision process and an historic development for international law and public health. The new IHR appear at a moment when public health, security, and democracy have become intertwined, addressed at the highest levels of government. The United Nations (UN) Secretary-General Kofi Annan, for example, identified IHR revision as a priority for moving humanity toward “larger freedom.” This article analyzes the new IHR and their implications for global health and security in the 21st century.

The WHA instructed the WHO Director-General (DG) to revise the IHR in 1995 because the Regulations did not provide an effective framework for addressing the international spread of disease. Doubts about the IHR's effectiveness had, however, been present long before 1995. The critiques identified the narrow scope of the regulations (applying only to a small number of infectious diseases), the lack of compliance by states, and the absence of a strategy for responding to rapid changes in public health's global economic and technological environments.

To circumvent objections that the death penalty was “cruel and unusual punishment” and therefore a violation of the Eighth Amendment to the Constitution, advocates proposed lethal injection and the involvement of physicians to overcome the negative perceptions associated with the death penalty, and to increase public acceptability of the practice. Initiated in 1982, lethal injection is now the primary method of execution in 37 of the 38 states with the death penalty. “To be exact, this method has been used to kill 788 of the 956 men and women who have been executed in the United States since 1976, when the death penalty was reinstated by the Supreme Court.” More recently, of the 191 executions performed in the United States since 2001, 189 have been by lethal injection.

This “medicalization” of the death penalty has ignited a debate, by those within the medical profession and by others outside it, about the appropriateness of physicians participating in executions.

Increasing reports of financial entanglements involving scientist and industry have led some to question the neutrality of research results. In December 2003, a story in the Los Angeles Times shocked readers by exposing several cases of NIH scientists embroiled in serious financial conflicts of interest.1 It was revealed, for example, that senior NIH official Stephen Katz was a paid consultant to Schering AG, a German pharmaceutical company with which he was involved in conducting clinical trials. In a similar case, John Gallin, director of the NIH's Clinical Center, was discovered to have co-authored an article on a company's gene-transfer technology, while being paid as a consultant to a subsidiary of the same company. Jeffrey Schlom, director of the National Cancer Institute's Laboratory of Tumor Immunology and Biology, helped direct NIH-funded studies examining wider use for a particular cancer drug while serving as a consultant whose highest-paying client was looking to genetically engineer that drug.

The use of restraints on psychiatric patients has long been criticized, and the need for self-restraint of professionals in response to new technologies has been documented from the nineteenth century. Since the middle ages, when leprosy disappeared from civilized society, individuals with a “deranged mind” came to occupy the public space of outcast once reserved for the leper. This diminished social status conflicts with the ethical precept of respect for all patients and the need for humane treatment within the clinical care setting. Psychiatric patients may be presented as a physically dangerous presence in clinical care facilities. New technologies may seem to offer a solution to the problem of balancing the safety of staff with the ethical requirement to treat patients with respect and attention to their medical needs. The Taser, promoted as a safe method of law enforcement, has received notoriety in at least one case involving restraint of psychiatric patients.

Few areas of health law practice present as many quandaries for the ethical health lawyer as health care fraud and abuse. The activities addressed by the anti-fraud laws – such as payment for referrals and submission of false claims – not only have a direct impact on the financial viability of the federal health care programs, but go to the heart of the ethical behaviors expected of those who transact business with the government. The severe consequences of violating these proscriptions include significant monetary penalties, ineligibility to participate in the federal health care programs, and even imprisonment. It is no wonder, then, that compliance with the fraud and abuse laws is a key consideration in any health care venture. At the same time, ethical considerations make this area of health law particularly vexing for counsel, raising numerous challenges that include how to balance the strategic goals of current clients against the interests of future clients and whether to advise clients to self-report potential violations even when illegal intent may not easily be shown.

The Open Access Movement maintains that all scientific and scholarly literature should be available to all for free via the Internet. This concept is not new. Some scholars trace its roots as far back as 1963 when “hypertext” was first introduced. Although the Open Access Movement may have originated more than fifty years ago, it has been fueled by more recent events, including the unremitting escalation of journal subscription prices over the last two decades, resulting in massive cancellations of journals by academic libraries; the ubiquitous nature of the Internet and the parallel explosion of electronic resources; and the desire of authors to find a new publishing model which continues to offer the benefits of peer review while providing for more rapid publication and wide-spread distribution than the current labor-intensive, time-consuming model.

The Open Access Movement has resulted in a number of online repositories devoted to legal analysis and policy. This column explores the genesis of the movement, its value to researchers and policymakers, and provides an overview of the two principal open access products in the legal arena.

In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration (FDA) and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act (PDUFA), which effected, among other changes, an increased number of reviewers, a higher review load for each reviewer, and the implementation of “user fees” from companies submitting drugs for review. While many have posited that the lack of safety in some FDA-approved drugs was caused by the enactment of PDUFA, the results of a recent study from the Tufts Center for the Study of Drug Development have indicated that there is no statistically significant correlation between the number of drugs recalled for safety and the enactment of PDUFA.