On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” (defined as, “the age of the unborn child as calculated from the fertilization of the human ovum”) and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment (1) she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or (2) it is necessary to preserve the life of an unborn child.”

There is an old saw in health policy that everyone wants health care that is good, fast, and cheap — but it’s impossible to have more than two of these at one time.

A similar bit of folk wisdom seems intuitively true for the development and testing of new pharmaceutical products. The public is in a bind. We want breakthrough drugs, and fast. But we also want these drugs to be affordable, thoroughly tested, safe, and effective. It seems we can’t have it all.

In this paper, we will not claim that one can have it all — but that we can do far better than we are at present. First, we review extensive data on contemporary problems in the design, conduct, and analysis of industry-sponsored clinical trials. Finding major issues that have been solidly documented over more than a decade, we provide many examples of the multifarious ways in which industry-funded trials have been manipulated to raise the likelihood of producing industry-friendly results.

The quality of end-of-life care in this country is often poor. There is abundant literature indicating that dying individuals do not receive adequate pain medication or palliative care, are tethered to machines and tubes in a way that challenges their dignity and autonomy, and are not helped to deal with the emotional grief and psychological angst that may accompany the dying process. While this is true for individuals in many settings, it seems to be especially true for individuals in nursing homes. This is somewhat puzzling given that (1) considerable resources have been devoted to bringing public attention to this problem, (2) we have the knowledge and expertise to provide such care, and (3) we have a government-financed benefit that covers this type of care - the Medicare hospice benefit (MHB).

While utilization of hospice care has increased during the last decade, there is considerable evidence that hospice care remains underutilized particularly in the long term care setting.

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of Medicine’s (IOM’s) landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress.

What was really going on in the Baby K case? Many people have posed that or similar questions to me when I have been introduced as the attorney for Baby K's mother. In a nutshell, the courts in Baby K ruled that a hospital is required to provide emergency medical care to an anencephalic baby at the mother's request. In this paper, I provide some insights into the factors that underlie the litigation and the legal issues decided by the courts. In my view, this case involved a myriad of legal questions, religious principles, power struggles, and health care resources arguments that could arise in other contexts.

The intense and extensive debate over human embryonic stem cell (hESC) research has focused primarily on the moral status of the human embryo. Some commentators assign full moral status of normal adult human beings to the embryo from the moment of its conception. At the other extreme are those who believe that a human embryo has no significant moral status at the time it is used and destroyed in stem cell research. And in between are many intermediate positions that assign an embryo some degree of moral status between none and full. This controversy and the respective positions, like the abortion controversy, is by now well understood, despite the lack of progress in resolving it. I have argued briefly elsewhere that early embryos do not have significant moral status, but I do not want to reenter that debate here. Instead, I want to focus on an issue that has had relatively little explicit and separate attention, but is likely to loom larger in light of the Obama administration’s partial lifting of the Bush administration’s restriction on the embryos that can be used in stem cell research that receives federal funding.

Is there anything ethically wrong with surrogate motherhood? Many people confess their inability to articulate their opposition in rational terms, yet they feel uneasy. The practice arouses negative emotions ranging from mild distaste to revulsion. Others say there is nothing wrong, in principle, with surrogate motherhood. It is a way of helping infertile women fulfill a fundamental human longing and, therefore, should be permitted and even facilitated. Many who are not fundamentally opposed to surrogacy nonetheless maintain that the practice ought to be regulated, in order to prevent abuses and to provide a mechanism for resolving conflicts that may develop in particular cases.

Surrogacy arrangements have been condemned by Roman Catholic spokesmen, in a legal brief by a conference of bishops in New Jersey, and by the Vatican in a statement issued by the Pope in March 1987. Feminists have denounced the practice, using rhetoric rather than argument, with the slogan woman as vessel. A group of wormen who agreed to bear children under surrogacy contracts has convened to speak out against such arrangements.

Military reproductive health policies affect large numbers of women. In 2006 servicewomen numbered nearly 350,000 and comprised 14.5% of active-duty forces and 17.4% of the reserve force. In addition, approximately 165,000 female dependents of active duty military personnel and 157,000 female dependents of reserve duty personnel are between the ages of 12 and 22 and are eligible for military health care services. Dependents of military personnel are eligible for military health care coverage until age 21, or up to the age of 23 if considered a full-time student.

About 10% of active duty female servicemembers become pregnant each year. Pregnant servicewomen are considered non-deployable and are usually not assigned to overseas commands. Pregnant women in the Army, the service branch with the greatest number of women on active duty, can choose to remain on active duty, request temporary leave from service, or request separation from service. Separation options include either discharge, honorable or uncharacterized depending on rank, or transfer to individual ready reserve.

Over the next 15 years, the government-funded human genome project will map and sequence each of the human cell’s estimated 100,000 genes. The project’s first fruits will be a vast quantity of information about genetic disease. This information will contribute to the design of quicker, cheaper and more accurate tests for identifying deleterious genes in individuals. Because genetic conditions are often regarded as “immutable, heritable taints that intrinsically implicate the bearer’s identity,” overly-deterministic interpretations of genetic information can readily distort genetic risk and become enshrined in institutional policies of social isolation and discrimination.

Biobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns. These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt. Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce legal norms. The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent.

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.

In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts.

In July 2013, parents in Ohio objected to their 21-year-old son becoming an organ donor. Elijah Smith was involved in an accident and pronounced dead using neurological criteria. The organ procurement organization (OPO) went to court and argued that because the young man was brain dead and because his driver's license indicated that he wished to be a donor, the court should allow them to use his organs. The mother argued that her son did not understand what he was signing when he signed his license and that his signature did not reflect an informed decision. The court disagreed with her, saying that he had indicated a wish to donate his organs and that no one but Elijah could revoke that wish. His organs were removed.

Elijah's mother suspected that he did not understand what he was signing. She might have been right, given what we know about the process for obtaining permission for organ donation and the limited public understanding of brain death.

Many activities concerning the unknown involve the potential for risk, and clinical research is no exception. Some research participants experience correlative benefit; others do not. When the participants are adults, as in Phase I trials with healthy volunteers, we rely on a highly individualistic decision-making process based on autonomous choice. This assumes that the ability to make voluntary, competent, informed choices, evaluating the risks and benefits from a personal perspective, offers the best protection for research participants. Rightly or wrongly, we depend heavily on informed consent for protection. We have further refined our post-Nuremberg ethical principles by requiring that safety and toxicity of drugs and devices be first assessed on the least vulnerable. In addition, we assume Institutional Review Boards (IRBs) will screen out protocols involving an inappropriate level of risk.

In the summer of 1998, the Wisconsin State legislature amended its child protection laws. Under new child abuse provisions, Wisconsin judges can confine pregnant women who abuse alcohol or drugs for the duration of their pregnancies. South Dakota enacted similar legislation almost simultaneously. The South Dakota statute requires mandatory drug and alcohol treatment for pregnant women who abuse those substances and classifies such activity as child abuse. In addition, the South Dakota legislation gives relatives the power to commit pregnant women involuntarily for two days; a court order can place the pregnant women in custody for up to nine months. These recent legislative “successes” follow scores of failed attempts by legislators in other states to establish fetal protection laws aimed at women who use and abuse drugs and alcohol during pregnancy.

The problem of harmful, unnecessary and neglected pain has been studied extensively in many health care settings over the past decade. Research has documented the incidence of untreated pain, and scholars and advocates have given the problem several names: “public health crisis,” “oligoanalgesia, and “moral failing,” among them. Articles have identified a litany of now familiar “obstacles” or “barriers” to effective pain relief. Each of these individual obstacles or barriers has been the subject of targeted remedial action in at least some context.

The checklist approach to improving care for patients in pain, however, is likely to have only limited effect. What really appears to be operating is a complex ecosystem that supports ambivalence, denial, and even suspicion of the circumstance of patients in pain and efforts to treat them. Pain relief in emergency medicine, a relatively new setting for the study of challenges to treating pain, provides a revealing context for viewing discrete obstacles to effective pain management in medicine as part of an integrated environment into which patients with pain enter for treatment.

In August 2001,just after President Bush announced his stem cell funding policy and the creation of a new Presidents Council on Bioethics PCB), the new chair of the PCB, Leon Kass, set out his philosophy for constructing public bioethics bodies: There are several ways of running commissions, he said. One is to stack it with your people, make them homogenous, and force a consensus. Another is to make them heterogeneous, so that you can only come to the lowest common denominator. We re not going to adopt either . We are going to allow the debate to be developed and heard.

Now, three years, sixteen meetings, and five reports later, there are nagging questions about whether this council indeed has allowed the debate to be developed and heard. And the charge of politicizing public bioethics to a degree heretofore unknown and stifling the voices of dissenting members comes not from the political left but from President Bushs own appointees, including one scientist who was dismissed from further service.

How to respond justly to the dangers persistent violent offenders present is a vexing moral and legal issue. On the one hand, we wish to reduce predation; on the other, we want to treat predators fairly. The central theme of this paper is that it is difficult to achieve both goals without compromising one of them, and that both are being seriously undermined. I begin by explaining the legal theory, doctrine and practice governing dangerous offenders (DO) and demonstrate that the law leaves a gap in the ability to confine them. Next I explore the means by which the law has overtly or covertly sought to fill the gap. Many of these measures, especially the new form of civil commitment for sexual predators, dangerously conflate moral and medical categories. I conclude that pure preventive detention is more common than we usually assume, but that this practice violates fundamental assumptions concerning liberty under the American constitutional regime.

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.