Pediatricians provided expert testimony that, in the case of Baby K, provision of ventilator support goes beyond accepted standards of care for anencephalic infants and so is medically futile. This argument, however reasonable, does not persuade those who believe in the absolute value of even a fraction of human life. In Baby K, court records indicate that Ms. H, Baby K's mother, persistently adheres to the sanctity-of-life principle on religious grounds.

While I think that quality-of-life considerations have a role in medical decision making, those who reject such considerations must be respected. This article makes the following claims, on behalf of religious dissenters: (1) the Baby K case should be interpreted in light of the freedom of religion guaranteed in the First Amendment (“Congress shall make no law respecting an establishment of a religion, or prohibiting the free exercise thereof”); (2) religious beliefs should not be trivialized in clinical ethics, even if reason, not belief, is the language of the public forum; (3) the time-honored free exercise clause (“or prohibiting the free exercise thereof ”) is essential to the American experiment in liberty and should not be overridden in the name of a concept as vague as futility; and (4) free exercise of religion deserves serious discussion in the futility debate, and significant religious accommodation must be included in any hospital or societal futility policies. In the concluding section, issues are raised regarding the balance between religious consideration and resource allocation.

The current explosion of genetic knowledge and the rapid proliferation of genetic tests has rightly provoked concern that we are approaching a future in which people will be labeled and disadvantaged based on genetic information. Indeed, some have already suffered harm, including denial of health insurance. This concern has prompted an outpouring of analysis. Yet almost all of it approaches the problem of genetic disadvantage under the rubric of “genetic discrimination.”

This rubric is woefully inadequate to the task at hand. It ignores years of commentary on race and gender demonstrating the limits of antidiscrimination analysis as an analytic framework and corrective tool. Too much discussion of genetic disadvantage proceeds as if scholars of race and gender had not spent decades critiquing and developing antidiscrimination theory.

Indeed, there are multiple links among race, gender, and genetics. Dorothy Roberts has discussed the historical links between racism and genetics, while she and others have begun to map connections between gender and genetics.

How ought we to understand the sources and limits of the authority of family members to make health care decisions for their decisionally incapacitated relatives? This question is becoming increasingly crucial as the population ages and the power of medical technology waxes. It is also becoming increasingly contested, as faith in advance directives shows signs of waning, and the moral complexities of intimate relationship become more theoretically patent.

This last point—the newly visible moral richness of intimate relationship—provides this paper with its field. I am interested in probing the images of the relationship between self and other, particularly self and intimate other, that seem presupposed by some leading attempts to determine the basis for proxy decision-making authority, and what constraints it must observe. In the light of both recent work in the philosophy of mind and considerations closer to common experience, the reigning images seem too slight to support the weight of current practices and beliefs about proxy authority; supplanting them with images more faithful to our experience will have implications for our practice with proxies.

Several prominent cases have recently highlighted tension between the interests of individuals and those of the broader population in gaining access to health care resources. The care of Helga Wanglie, an elderly woman whose family insisted on continuing life support long after she had lapsed into a persistent vegetative state (PVS), cost approximately $750,000, the majority of which was paid by a Medi-gap policy purchased from a health maintenance organization (HMO). Similarly, Baby K was an anencephalic infant whose mother, believing that all life is precious regardless of its quality, insisted that the hospital where her daughter was born provide mechanical ventilation, including intensive care, whenever respiratory distress threatened her life. Over the hospital's objections, courts ruled that aggressive care must be provided. Much of Baby K's care was covered by her mother's HMO policy. In the 1993 case of Fox v. HealthNet, a jury awarded $89 million to the family of a woman whose HMO had refused, as experimental, coverage for autologous bone marrow transplant in treating her advanced breast cancer.

Analysis in bioethics has relied primarily on the identification and application of general principles and on the examination of particular paradigmatic cases. Principalism and casuistry depend on an assumption of generalizability; that is, that learning and insights gained from an understanding of the principles or the case may be effectively applied to other similar situations. For the most part, the particular characteristics of the institutional setting have not played a central role in these approaches. It would appear, then, that what has been learned in the context of one health care setting is transferable, with some few adjustments, to another.

The institutional context does make both a practical and a substantive difference, however, and shifting ethical analyses from one context to another has sometimes proven difficult. This has been so, for example, in the context of nursing home care.

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.

The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Resource finitude, cost containment, and a purchaser monopsony market have created public concern-about the moral and legal responsibility for quality assurance in health plans. Resource allocation and standards of care represent a clash of moral values in intensive care treatment. This essay advances a procedural model, based on legislation passed in Oregon, that could govern the incorporation of private sector health insurance plans in Oregon to assure democratic input from consumers, providers, and employers into a limited vision of individual entitlement to consume futile or inappropriate care in intensive care units (ICUs). The model, which I call the Oregonian ICU, presumes that rationing of care is implicit and not publicly disclosed under managed care. It focuses on maximizing the quality of limited benefits available in the basic managed care insurance tier. Limitations to futile and inappropriate care are developed on the basis of morally weighted prognostic scoring systems that inform the creation of negotiated private sector contracts.

What should be the role of an institutional ethics committee (IEC) in resolving conflict concerning patient care decisions in the neonatal intensive care unit (NICU)? This question takes on added importance in light of recent court decisions which suggest that IEC deliberations may serve as persuasive evidence in court, of proposed state regulations that would establish an IEC as an alternative to judicial review, and of recent Joint Commission on Accreditation of Healthcare Organizations (JCAHO) guidelines that require an institutional policy on limitation or withdrawal of treatment to include a specified mechanism for resolving conflict. Unfortunately, despite these developments, prospective case consultation remains one of the most controversial and poorly understood aspects of IEC functions. Questions and concerns persist about the relation the IEC has and should have to actual decisions in specific cases.

We briefly examine the clinical, organizational, and regulatory complexity of the NICU environment and suggest five potential sources of uncertainty, disagreement, and conflict among parent(s) and NICU staff.

Discussion of the ethics of forgoing medically provided nutrition and hydration tends to focus on adults rather than infants and children. Many appellate court decisions address the legal propriety of forgoing medically provided nutritional support of adults, but only a few have ruled on pediatric cases that pose the same issue.

The cessation of nutritional support is implemented most commonly for patients in a permanent vegetative state (often referred to as persistent vegetative state (hereinafter “PVS”)). An estimated 4,000 to 10,000 American children are in the permanent vegetative state, compared to 10,000 to 25,000 adults. Yet the dearth of literature, case reports, and court decisions suggests that physicians and families of pediatric patients stop medically provided nutrition or seek court orders much less frequently.

Only 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to the samples. This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples.

A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information (such as family history and cholesterol levels), and, if so, whether this means that it should receive special legal protection.

Authority is an uneasy, political notion. Heard with modern ears, it calls forth images of oppression and power. In institutional settings, authority is everywhere present, and its use poses problems for the exercise both of individual autonomy and of responsibility. In medical ethics, the exercise of authority (along with power) has been located on the side of the physician or the health care institution, and it has usually been opposed by appeal to patient autonomy and rights. So, it is not surprising, though still ironic, that ethics consultation, which develops from this patient rights-dominated ethic, should itself bring forth questions of authority. Nonetheless, it does.

Insofar as authority has been discussed in ethics consultations, it has been understandably approached from the broad perspective of legitimation and power, which are common themes in social and political treatments of authority. These treatments have dominated twentieth-century discussions of authority, which primarily view authority as legitimate power.

As a consequence of the problems caused by genetic discrimination, federal and state law makers are being pressured to pass a legislative remedy. A primary question is whether the Americans with Disabilities Act of 1990 (ADA) applies to (1) individuals with a potentially disabling genetic disorder who are pre-symptomatic or asymptomatic and may never become ill and to (2) healthy individuals who are carriers of genetic conditions. At present, this question has relevance principally for individuals with the genotype for single gene disorders, like Huntington disease and hemochromatosis, and to asymptomatic carriers of single gene disorders such as cystic fibrosis. Although many such single gene conditions exist, the total incidence of these conditions in the U.S. population is less than 0.4 percent. However, the question concerning the applicability of the ADA will become increasingly important because genetic tests will almost certainly be developed in the near future for common multifactorial diseases like diabetes, heart disease, and certain forms of cancer.

In 1982, the President's Commission produced its report on human gene therapy. One of that report's recommendations was to expand the Recombinant DNA Advisory Committee (RAC) to the National Institutes of Health to include a subcommittee on human gene therapy. In 1984, the Human Gene Therapy Subcommittee was established, and in 1989 it produced a document—“Points to Consider for Protocols for the Transfer of Recombinant DNA into Human Subjects”—that stated the RAC's position on what sorts of protocols it would approve.

In assessing the impact of the President's Commission report, Alexander Capron wrote,

The Genetic Privacy Act (GPA) is a comprehensive effort to protect individuals from unauthorized analysis of their DNA and from unauthorized disclosure of information resulting from genetic analysis. Irrespective of merit, every bill must survive legislative scrutiny. This is a considerable challenge, particularly for a bill as complex and far-reaching as the GPA. To illustrate my point, I describe the fate of two bills introduced into the Maryland Senate in 1995 by Senator Jennie Forehand. The first, also entitled the Genetic Privacy Act (S. 645), was a slightly modified version of the model legislation prepared by Annas, Glantz, and Roche. After a hearing, the bill received a 9-2 unfavorable vote from the Economic and Environmental Affairs Committee. The second was a much shorter bill, DNA Testing – Informed Consent and Confidentiality (S. 707), which simply stated that “DNA analysis may only be performed with the informed consent of the person being analyzed” and that the results of such analysis “are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person being tested.” This bill had a hearing but was never put to a vote by the Judicial Proceedings Committee. My principal aim is to examine the testimony on these bills. I will conclude with some suggestions about accomplishing the goals of genetic privacy legislation.

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions.

It is undeniable that health care costs have been increasing at an alarming rate. During the ten-year period between 1983 and 1993, the medical care component of the Consumer Price Index (CPI) rose at an average annual rate of 10 percent while the overall CPI increased by only 4.5 percent per year. These dramatic increases have obvious societal implications. For those without health insurance, a serious illness may mean personal bankruptcy. For those with health insurance coverage, premiums are rising while coverage is shrinking. Employers are struggling to continue providing health insurance to their employees. Irrespective of whose fault it really is, much of the blame has been directed at health care providers.

Faced with mounting criticism regarding the costs of delivering health care, the industry struck back. It claimed that collaboration—not competition—was necessary to reduce health care costs and improve efficiency, but that antitrust uncertainty deterred such collaborative efforts.

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work done since 1990 at the Institute of Medicine (IOM) and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic?