The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the American Society of Law, Medicine & Ethics (ASLME) to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.

This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief.

The Centers for Disease Control published its long awaited guidelines for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients on July 12, 1991. The guidelines recommend voluntary HIV and HBV testing of all health care workers performing exposure-prone invasive procedures. Special safeguards are applicable to any worker who is infected with HIV or the most virulent form of hepatitis B—i.e., hepatitis B e antigen positive (HBeAg). HIV or HBsAg-positive health care workers should not carry out exposure-prone invasive procedures unless an expert panel has approved and provided individualized guidance, and the patient is informed about the HCW's serological status.

Characteristics of exposureprone procedures include digital palpitation of a needle tip in a body cavity or the simultaneous presence of the worker's fingers and a sharp instrument in a poorly visualized or confined anatomic site.

Restructured health care reimbursement systems and new requirements for nonprofit hospitals are transforming the U.S. health system, creating opportunities for enhanced integration of public health and health care goals. This article explores the role of public health practitioners and lawyers in this moment of transformation. We argue that the population perspective and structural strategies that characterize public health can add value to the health care system but could get lost in translation as changes to tax requirements and payment systems are rapidly implemented. We urge public health leaders to take a more active role in hospital assessments of community health needs and evaluation of the patient outcomes for which providers are accountable.

The February 1997 announcement of the birth of Dolly, the sheep cloned from a mammary cell of an adult ewe, has drawn attention to the growing ability to select, alter, or otherwise manipulate the genome of offspring. Prior to Dolly, ethical discussion of genes in reproduction had focused on negative selection: carrier screening, prenatal diagnosis, and abortion or embryo discard. After Dolly, ethical debate will have to consider the direct or positive use of genetic selection or alteration technology.

The principal use of genetic selection techniques in human reproduction (reprogenetics) likely will be to treat or prevent disease in offspring. In the future, however, such techniques might also be used to enhance or even diminish expected characteristics of progeny. Techniques to accomplish these goals are likely to include: selection of the nuclear genome, as occurs in somatic cell cloning; chromosomal transplants; or direct insertion or deletion of specific genes.

Corporations, through their products and behaviors, exert a strong effect on the wellbeing of populations. Public health practitioners and academics have long recognized the harms associated with some corporations’ products. For example, firearms are associated with approximately 30,000 deaths in the United States each year1 and over 200,000 deaths globally. Motor vehicles are associated with about 40,000 deaths in the United States each year and over 1.2 million deaths globally. Tobacco products kill about 438,000 people each year in the United States5 and about 4.9 million people worldwide. In addition to producing unsafe or harmful products, some corporations behave in ways that negatively impact the public’s health, such as marketing alcohol to youth and other vulnerable populations. Given these observations, one can conclude that it is possible to quantify the public health impact of individual industries, such as firearms, motor vehicles, tobacco, and alcohol. Health professionals can then target these individual industries to prevent or lessen the harms they cause.

Here's what was sitting on my desk on my first day of work for Senator Jack Danforth last summer:

August 19

Liz-

Here is something you can start on when I am in Wyoming. Maybe you could begin pulling together some thoughts and material. Perhaps someone at YDS could give you some help. However, please don't attribute any conclusions to me as I have none.

What are the ethics of extending the length of life?

We cannot artificially end life (thou shalt not kill), but how about artificially extending life? Is that always good, sometimes good?

Is it good to extend the life of a senile 90 year old who wears diapers? How about “neonatal care”—for a baby who would otherwise die? What's the difference in these two cases, or should we have a difference?

In ethics, is keeping people alive the highest good? Should our priority be to keep people breathing?

Is it “playing God” to make distinctions on the basis of quality of life? Do we owe a lesser degree of care to the comatose patient than someone else?

Global Cumulative Treatment Analysis (GCTA) is a novel clinical research model combining expert knowledge, and treatment coordination based upon global information-gain, to treat every patient optimally while efficiently searching the vast space that is the realm of cancer research.

With the many changes occurring in today's healthcare organizations, patients are increasingly equipped with a vast quantity of health care data and being more included in the healthcare decision-making process. The new approach we propose incorporates a new patient-organization framework that examines relevant historical, legal and ethical elements within the doctrine of informed consent in addition to examining the role of new healthcare organizations' obligations to include data to support addressing issues such as population health, health outcomes and health disparities within the informed consent. There is a growing consensus among healthcare professionals that using an evidencebased organizational informed consent framework to improve the informed consent process can lead to better comprehension, health outcomes, transparency and improved patient trust and retention overall.

Using an implementation science framework, we detail how a national system for covering both standard and telemedicine laboratory testing would support a national PrEP program. Implementation strategies that will facilitate success include minimizing provider burden through uncomplicated billing systems and minimizing patient burden through centralized, online access systems. We anticipate that providing telemedicine and in-person laboratory testing options will optimize PrEP care by making it less burdensome, leading to cost-effective healthcare and improved population health.

The ethical debate on embryo research, particularly on whether to destroy human embryos for stem cell research, is sometimes said to involve a confrontation between religion and science. The claim is misleading at best. Ironically, religious claims have not infrequently been invoked by those who support human embryonic stem cell research, who have said that such research will enable us to “answer the prayers of America’s families” or present us with “the biblical power to cure.” And even religious organizations (as well as scientists and ethicists who share some of their concerns on this issue) have often made the case against the ethical acceptability of this research relying on science, and on general ethical considerations that transcend religious divisions. The Catholic Church, in particular, maintains that the ethical norm against directly taking the life of any innocent human being can be understood and embraced by people of good will, with or without religious faith, and that the application of this norm to the present controversy depends on an understanding of some basic facts about early human development.

Molecular genetic testing has increasingly been incorporated into clinical medicine, and this trend is likely to accelerate in the future. The introduction of genetic testing into medical practice is beginning to collide head on with patents that claim ownership of correlations between human genetic variants and predisposition to disease, response to therapeutic drugs, and susceptibility to pharmacologic side effects. Patent holders or licensees of genes, genetic variants, and their genotype-phenotype correlations are already using the threat of litigation to monopolize genetic tests for important well-known syndromes like Duchenne Muscular Dystrophy and inherited breast and ovarian cancer, in addition to a host of less commonly discussed conditions.

In the face of escalating Medicaid costs and anticipated reductions in federal Medicaid spending, states are increasingly converting from fee-for-service (FFS) to managed health care systems. The interrelated issues of enrollment and auto-assignment are fundamental to the overall success or failure of Medicaid managed care programs. The purpose of this article is to suggest how policy makers, consumer advocates, and providers should address these issues. My major premise is that implementation of managed care will proceed more smoothly if states adopt enrollment strategies that promote voluntary selection of health plans by Medicaid consumers, minimize the likelihood of auto-assignment, and mitigate the negative consequences of mandatory assignment of consumers to managed care organizations (MCOs).

States seeking to implement Medicaid managed care must apply for a waiver from the secretary of the Department of Health and Human Services (DHHS). Two different types of waivers are available to implement Medicaid managed care.

Employers of all types, including group practices, health maintenance organizations (HMOs), and university and other hospital practices, commonly include noncompetition clauses in physician employment contracts. The clauses only apply in the event physicians leave their employers, and typically only limit activities in relatively narrow geographic areas. Consequently, physicians often agree to the clauses without much thought or analysis. This is a mistake, as the clauses may have broad adverse ramifications for both physicians and patients.

This article identifies the standard components of noncompetition clauses, addresses the ethical and practical concerns they raise, and reviews recent court decisions on point. The article concludes that despite public policy concerns, courts can and often do enforce the clauses. The purpose of the article, therefore, is to increase physicians’ awareness of the potential impact of these clauses, and to encourage physicians to carefully consider whether to accept contracts that contain them, or at the very least to negotiate for the least restrictive terms possible.

This article seeks to outline a viewpoint on the study of the legal, ethical and policy considerations raised by DNA tests and databases (from here on, DNA usages). It does not delve into the specifics involved. It outlines a way of thinking that has proven productive elsewhere1 and seems promising in dealing with DNA usages in the United States, but little more. Given that this essay is about a communitarian approach that draws on specific communitarian values, I turn next to briefly present the approach here followed.

Communitarianism is a social philosophy that maintains that society should articulate what is good, and asserts that such articulations are both necessary and legitimate. Communitarianism is often contrasted with classical liberalism, a philosophical position that holds that individuals should formulate their idea of good on their own. Communitarians examine the ways shared conceptions of the good (values) are formed, transmitted, justified, and enforced.

A great deal of discussion and debate has centered around the right of a terminally ill patient to refuse life-sustaining treatment. The statement of policy found in Idaho's recent Natural Death Act summarizes many of these issues:

The legislature finds that adult persons have a fundamental right to control decisions relating to the rendering of their medical care, including the decisions to have life sustaining procedures withheld or withdrawn in instances of a terminal condition.

The legislature further finds that modern medical technology has made possible the artificial prolongation of human life beyond natural limits.

The legislature further finds that patients suffering from terminal conditions are sometimes unable to express their desire to withhold or withdraw such artificial life prolongation procedures because of the progress of the disease process which renders the patient comatose or unable to communicate with the physician.

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA), a major piece of health care reform legislation. This comprehensive legislation includes provisions that focus on prevention, wellness, and public health. Some, including authors in this symposium, question whether Congress considered public health, prevention, and wellness issues as mere afterthoughts in the creation of PPACA. As this article amply demonstrates, they did not.

This article documents the extent of congressional consideration on public health issues based on personal experience working on the framework for health care reform — specifically, my experience as a Fellow for a member of the Health Subcommittee of the Senate Finance Committee from 2008-2009. I also include a review of congressional activity in the United States House of Representatives. Analysis of the congressional meetings and hearings reveals that Congress had a deep understanding about the critical need to reform the U.S. public health and prevention system.

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.