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.

Futile treatment. Do not resuscitate (DNR). These terms and the thoughts they evoke may be unfamiliar to families with ill children. Similarly, laws, such as the Americans with Disabilities Act or the Emergency Medical Treatment and Active Labor Act, are probably unfamiliar. Yet these terms and laws, and, more important, their implications, are part of a new world of health care into which more families are thrust—the world of wrenching and complicated decisions.

Although the number of these situations is increasing and even predictable, the infrastructure of support services for families dealing with these medical decisions for seriously ill children has not been adequately addressed or developed. Parents know that some children are born with or develop serious illnesses and die. Amid absorbing large amounts of new information and interpreting the parameters and implications of what they are learning about their child's condition, families are forced by circumstances to assess—and to act on—their most critical, and perhaps previously unexamined, values.

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.

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.

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.

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?

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer (although an insurance company or other third party may be retained to administer the claim payment process).

Discussions about the role of practice guidelines and the strength of the evidence on which they are based should begin with a set of more basic questions: What is the function of such guidelines and what forces shape their use?

At least two forces can be seen behind the press for guidelines. On the one hand, guidelines can be used to improve the quality of care by raising the general level of practice to meet at least the standards set by experts. At the other, they become vehicles for cost containment.

By international standards, the United States spends a disproportionate share of its gross domestic product on health care. The majority of spending increases are traceable to the growth in technology. Whether couched as a concern that resources could be better used to provide other parts of the population with more effective health care or as a general concern that money spent on health might be better used for other social goods, a notion exists that less is better.

To achieve lower medical spending with as little reduction as possible in good outcomes, practitioners and policy makers alike have been experimenting with the use of practice guidelines. These guidelines both recommend certain types of therapies and proscribe others in the treatment of patients with particular conditions. This paper explores the question of whether guidelines which do reduce total resource costs of medical care to a population will (1) be feasible and (2) produce “acceptable” results. The definition of acceptable is part of the policy problem, so it will be left open for a while, but the question of which outcomes match with which levels of resource cost will form the positive basis for the normative judgment of “acceptability.”

In response to increasing use of practice guidelines in medicine, physicians have focused their attention on how these guidelines can restrict their medical practices. However, guidelines not only restrict physician discretion, but they also limit the treatment options available to patients. As a result, treatments which patients consider beneficial may not be recommended; for example, some hysterectomies for abnormal uterine bleeding, and cataract surgery in patients with dementia. When guidelines are used to determine which medical treatments a health care organization or insurer will cover, these recommendations become restrictions. Thus far, guidelines have been developed without adequate attention to the impact that their restrictive use has on diverse patient values.

Two significant tensions in current medical ethics relate to the inclusion of patient values in practice guidelines. First, a tension exists between the traditional paternalistic model of care, in which the physician judges unilaterally which treatments will benefit the patient, and the more recent autonomy model, in which the physician elicits the individual patient's health values to determine which treatments will be beneficial.

In discussions of medical decision making as it applies to people with disabilities, a major obstacle stands in the way: the perceptions and values of disabled people (particularly disability rights advocates and disabled social scientists) and of many nondisabled people (particularly health care professionals, ethicists, and health policy analysts), regarding virtually the whole range of current health and medical-ethical issues (treatment decision making, health care access and health care rationing, medical costcontainment, and assisted suicide), seem frequently to conflict with one another. This divergence in part grows out of the sense, common among people with disabilities, that their interactions with “the helping professions,” medical and social service professionals, are adversarial. But those differences of opinion also stem more basically from a clash of fundamental values.

This paper addresses, in historical perspective, the ways in which the status of persons with disabilities as a stigmatized minority group affects medical decision making. It also examines the efforts of disability rights activists to prevent discrimination against persons with disabilities in current medical culture. Finally, it raises questions about how the rights of people with disabilities will fare as new care standards are developed and implemented.

Even with thirty years of academic experience under his belt, nothing could have prepared the medical school department chairman for the unexpected and protracted course of events that would follow his allegations of scientific misconduct against an associate professor in his department. In this actual case of scientific misconduct whistleblowing, the university allowed the accused professor to resign, but the chairman persisted in seeking a full investigation of the matter. Under the direction of the Office of Scientific Integrity (OSI) of the Department of Health and Human Services (DHHS), the institution eventually reopened the investigation, and concluded that the accused professor had fabricated and falsified data, and had plagiarized the unpublished method of other investigators. Thereafter, the professor agreed to a voluntary exclusion from receiving federal funds for a period of three years.

Despite the fact that the chairman's allegations proved true, his involvement as a “whistleblower” entailed consequences that censured rather than encouraged his behavior.