bluuebunny/crossref_metadata_2025 huggingface dataset:
Women in Clinical Trials: Are Sponsors Liable for Fetal Injury?
Authors: Sandomire Hazel
Published: June 2007

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ fears of a variety of catastrophes which contributed to closing the doors of clinical trials for women.

This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed.
Tuberculosis and AIDS: Epidemiologic, Clinical, and Social Dimensions
Authors: Selwyn Peter A.
Published: June 2007

In little more than a decade, the AIDS epidemic has exerted a profound effect on morbidity and mortality among young adults and children in many parts of the world. One of the more dramatic aspects of AIDS is that it seems to have arisen almost spontaneously as a new epidemic, spreading rapidly within at-risk populations in a way that is unprecedented for the serious infectious diseases of recent memory. Tuberculosis, on the other hand, had only recently been considered a disease of historical importance but of diminishing relevance to current public health priorities, especially in industrialized countries. Over the past decade, however, and in parallel with the AIDS epidemic, there has been a resurgence of tuberculosis in many of the same populations most affected by HIV infection. This has had important implications for clinical practice, public health, and the development of appropriate health policy. A number of elements have converged to promote the development of HIV-related tuberculosis, including biologic, social, and environmental factors. These will be discussed both to provide a context for understanding the relationship between the two epidemics, and as a basis for suggesting strategies for tuberculosis control in the AIDS era.
Seek and Hide: Public Health Departments and Persons with Tuberculosis, 1890–1940
Authors: Rothman Sheila M.
Published: June 2007

In 1882 Koch discovered the tubercle bacillus and transformed both the medical and the social history of tuberculosis and the experiences of those who contracted it. For the first time, the absence or presence of the bacillus made it possible to define, in Koch’s terms, “the boundaries of the diseases to be understood as tuberculosis.” And for the first time the sick became subject to oversight and discrimination.

Prior to Koch’s discovery, tuberculosis, or as it was then called, consumption, was considered a hereditary and non-contagious disease, albeit a very deadly and persistent one. Over the first half of the nineteenth century, it was responsible for one out of every five deaths. It crossed all boundaries of geography, social class, age, and sex affecting residents in rural as well as urban areas, the prosperous as well as the poor, the young even more notably than the old, females more often than males. Physicians assumed a familial predisposition existed (as in the case of insanity); following the precepts of humoral medicine, they postulated that the disease originated in “irritations” whose sources were to be found in the interaction of an inherited constitution with a particular lifestyle and environment.
The Resurgence of Tuberculosis in the United States: Societal Origins and Societal Responses
Authors: Sidel Victor W. , Drucker Ernest , Martin Steven C.
Published: June 2007

Planning of effective responses to the recent resurgence of tuberculosis in the United States, and particularly in New York City, requires review of our knowledge of (1) the factors that led to the decline of tuberculosis in the U.S. and other countries during the nineteenth and the first three-quarters of the twentieth century, and (2) the recent changes in these same factors and the rise of new factors that have contributed to its resurgence. Because the analysis of the impact of all of these factors in both the remote and the recent past is controversial, it is important to use a well-defined framework to organize the analysis. The framework we will use is shown in Table 1. To the classic epidemiologic triad of Agent, Host and Environment it adds the category of Health Services. In this paper we redefine both the classic and new categories using current disciplines and concepts applicable to tuberculosis.
The Economic Impact of Tuberculosis in Hospitals in New York City: A Preliminary Analysis
Authors: Arno Peter S. , Murray Christopher J.L. , Bonuck Karen A. , Alcabes Philip
Published: June 2007

There is a nationwide resurgence of tuberculosis (TB) in the country’s urban centers; New York City stands at the forefront of this resurgence. The root causes are increased homelessness, drug addiction and poverty, all symbols of deteriorating social and economic conditions in the city. The inadequate level of public health resources devoted to TB has also contributed to its spread. Still, even with these factors, it is questionable whether the escalating number of TB cases in this country would have occurred without the reservoir of immunosuppressed persons, who are less resistant to the disease, created by the AIDS epidemic. The fear and urgency of this public health crisis, which has been emerging since the beginning of the last decade, are fueled by the rise of TB strains resistant to the first-line drugs and by the disease’s contagiousness.
Science, Law, and the Search for Truth in the Courtroom: Lessons from Daubert v. Merrell Dow
Authors: Bertin Joan E. , Henifin Mary S.
Published: June 2007

On June 28, 1993, the United States Supreme Court ruled on the admissibility of expert scientific opinion and evidence in federal court cases. The importance of the case can be measured by the interest it stimulated. The scientific community turned out in particular force to register its views. At the heart of the controversy was a debate over the nature of scientific knowledge and its relation to law. More than any other Supreme Court case in recent memory, the amici seemed to view the Daubert case both as posing a potential challenge to basic scientific premises and as an opportunity to reclaim a lost prerogative to determine how science is applied in courts.
Waiting for Reform: Developments in the Law of Health Care Access and Finance: 1992–1993
Authors: Jost Timothy S.
Published: June 2007

The last year, June 1992 through September 1993, has seen a great deal of ferment with respect to access to and financing of health care in the United States. The elections of 1992 portend dramatic changes in the American health care system, and vigorous debate regarding both expansion of access to health care and transformation of the health care financing system is taking place at the federal and the state levels. In fact, however, the time period covered here produced remarkably few changes in the law, particularly at the federal level. The one piece of Medicare and Medicaid legislation passed by Congress in the fall of 1992, H.R. 11, was vetoed by President Bush immediately after the election. The Omnibus Budget Reconciliation Act (ORBA) of 1993 contained a host of minor adjustments to the Medicare and the Medicaid programs, but only the Medicaid asset transfer provisions and extensions to the self-referral provisions of the fraud and abuse laws, discussed below, are of import to us.
Recent Developments in Health Law
Authors:   American Journal of Law & Medicine
Published: June 2007

In American Dental Association v. Martin, the United States Court of Appeals for the Seventh Circuit reviewed a challenge to a rule of the Occupational Safety and Health Administration (OSHA). In December, 1991, OSHA passed a standard to protect health care workers from viruses transmitted by blood—bloodborne pathogens—including the hepatitis B virus (HBV) and the human immunodeficiency virus, the virus known to cause AIDS. Three health care organizations, whose members are dentists, medical personnel firms, and home health employers, petitioned the court to review OSHA's rule.

The Occupational Safety and Health Act was passed to assure employees that they would have as safe and healthy a working environment as feasible. Congress sought to ensure this by vesting the Secretary of Labor for Occupational Safety and Health with the authority to promulgate mandatory safety and health standards. In promulgating standards concerning toxic materials or harmful physical agents, the secretary sets rules that most adequately assure that an employee will not suffer a material impairment of health or functional capacity while performing work-related duties.
Policy Issues and Imperatives in the Use of Opioids to Treat Pain in Substance Abusers
Authors: Joranson David E. , Gilson Aaron M.
Published: June 2007

A great deal has been learned in the past fifteen years from the study of pain mechanisms. More recently, the relief of pain has begun to receive much needed attention as well. Although most, if not all, acute and cancer pain can be relieved, recent evidence shows that inadequate treatment of pain is still common among the general population—even for pain due to cancer. Inadequate treatment of cancer pain is even more likely if the patient is a member of an ethnic minority, female, elderly, or a child. Evidence also suggests that substance abusers are at risk for poor pain treatment.

A number of barriers which involve problems of knowledge, attitudes, and laws and regulations affect health care professionals, patients, and the health care system; collectively, they contribute to the inadequate treatment of pain.
Drug Utilization Review: A Description of Use for a Medicaid Population (Maryland) 1986–1994
Authors: Baylis Richard D.
Published: June 2007

A relatively healthy forty-six-year-old woman with mild hypertension receives a prescription for an antihypertensive medication. One of the medication's adverse effects is its potential to cause severe depression. Four months later, she is diagnosed with anxiety, an early manifestation of depression. An antianxiety drug is prescribed, but her anxiety worsens. Her physician then diagnoses her as having a depressive disorder, and prescribes a new antidepressant medication. She is still on the same antihypertensive.

A seventy-two-year-old man is given furosemide and digoxin to control a mild case of congestive heart failure and hypertension. Because furosemide deletes potassium from the body, his physician also places him on a potassium supplement. Six months later, the physician tells the patient to stop taking the furosemide and prescribes an angiotensin converting enzyme (ACE) inhibitor. An effect of ACE inhibitors is to reduce the body's excretion of potassium thereby reducing the digoxin's effectiveness.
Medical Education for Pain and Addiction: Making Progress toward Answering a Need
Authors: Schnoll Sidney H. , Finch James
Published: June 2007

Pain is one of the most frequent presenting symptoms for patients who come to a physician's office. Despite the frequency of this presentation, little consistent, systematic information is provided to medical students or physicians about the treatment of pain. In addition, relatively little information is given about the recognition and prevention of drug abuse and about how to prescribe analgesics rationally to minimize the chances for abuse. This lack of educational preparation for both pain and addiction contributes to significant fear and inability on the part of health professionals to diagnose and treat both conditions. It creates a barrier of fear to prescribe adequate doses of pain medications for patients who present with both acute and chronic pain problems. Inadequate medicating can be caused by the physician's overriding worry about creating addiction in a patient. Morgan has called this problem “opiophobia.”
Finding Common Ground: The Necessity of an Integrated Agenda for Women's and Children's Health
Authors: Chavkin Wendy , Breitbart Vicki , Wise Paul H.
Published: June 2007

During the past decade, a new term has entered the medical/legal lexicon : maternal-fetal conflict. Implicit in the terminology is the assumption that a pregnant woman and her fetus have separate and competing rights. This concept has stimulated extensive legal and ethical debate, primarily in the context of medical interventions (cesarean sections and blood transfusions) forced on unwilling pregnant women, and in corporate efforts to bar fertile women from hazardous jobs. On one side of the debate are the proponents of the future child's right to be born of sound mind and body, and society's interest in the delivery of healthy newborns. On the other side, are advocates of a woman's right to reproductive autonomy, bodily integrity, due process, confidential medical treatment, and freedom from gender discrimination. Neither side has challenged the formulation of the problem, or has examined its permeation into public health policy.
Doing All They Can: Physicians Who Deny Medical Futility
Authors: Swanson Jeffrey W. , Van McCrary S.
Published: June 2007

Why do some physicians continue to treat patients who are clearly dying or persistently unconscious, while others consider medical intervention to be futile past a certain point? No doubt, medical decisions vary in part because clinical information is often ambiguous in individual cases and because it may support more than one reasonable interpretation of a patient's chances for survival or improvement if a particular treatment is administered. Also, cases vary considerably to the extent that a patient's or a family member's preferences for treatment are communicated, understood, and implemented. But, beyond these contingencies, patients at the end of life may receive more, less, or different treatment because physicians themselves are social actors, individuals who bring to bear on their clinical decisions a variety of personal attitudes, values, concerns, and interests. Legal defensiveness, religious vitalism, authoritarianism, intolerance of ambiguity, and other traits may influence physicians’ behavior, but each may be concealed under the rubric of what is “medically indicated” or “medically appropriate.”
Toward a Duty to Report Clinical Trials Accurately: The Clinical Alert and beyond
Authors: Glass Kathleen Cranley
Published: June 2007

Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. But do investigators and others who are responsible for disseminating information have any obligation to divulge adequately the results of clinical trials to practitioners so that the latter might offer the choice of appropriate care to their patients? Can incomplete disclosure of trial outcomes result in harm to patients? If this is the case, what possible avenues are available to avoid such harm?
Baby K: Medical Futility and the Free Exercise of Religion
Authors: Post Stephen G.
Published: June 2007

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.
Creating Practice Guidelines: The Dangers of Over-Reliance on Expert Judgment
Authors: Kane Robert L.
Published: June 2007

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.
Medical Decision Making and People with Disabilities: A Clash of Cultures
Authors: Longmore Paul K.
Published: June 2007

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.
An Economic Analysis of the Joint Purchasing Safety Zone
Authors: Blair Roger D. , Herndon Jill Boylston
Published: June 2007

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.
The Legal Subtext of the Managed Care Environment: A Practitioner's Perspective
Authors: Gosfield Alice G.
Published: June 2007

For a health lawyer in private practice, the substance of any discussion of managed care turns on the developments in the health care marketplace. Without a doubt, the industry is rapidly moving from one frame of reference to a radically different one. It is no surprise then, that, in consulting me, my clients want to know what is and what will be, not what should be. They want at least to survive, if not be successful, in the whirlwind of restructuring that offers no clear choices, no clear outcomes, and significant legal liabilities if they do not perform effectively.

What I want to address in this article is how the consolidation of medical practices and the integration of delivery structures has outpaced the legal system's ability to regulate or guide the emerging health care market. This gap leaves physicians without proper legal guidance on how to balance their duties to their patients and their contractual obligations to managed care organizations (MCOs). A brief review of the case law to date highlights some of the legal and ethical issues that arise for physicians who practice in this environment.
Moral Justice and Legal Justice in Managed Care: The Ascent of Contributive Justice
Authors: Morreim E. Haavi
Published: June 2007

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 ofFox 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.
Managed Care as Regulation: Functional Ethics for a Regulated Environment
Authors: Johnson Sandra H.
Published: June 2007

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.
Beyond “Genetic Discrimination”: Toward the Broader Harm of Geneticism
Authors: Wolf Susan M.
Published: June 2007

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.
Conflicts in the Biotechnology Industry
Authors: Greely Henry T.
Published: June 2007

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.
Ethical Issues Raised by Needle Exchange Programs
Authors: Loue Sana , Lurie Peter , Lloyd Linda S.
Published: June 2007

United States public health experts have long expressed concern about the prevalence of the human immunodeficiency virus (HIV) among injection drug users (IDUs). The United States has the largest reported IDU population in the world: 1.1 to 1.5 million. Recent estimates from the Centers for Disease Control and Prevention (CDC) suggest that 50 percent of incident HIV infections occur among IDUs, with additional infections occurring among their sex partners and offspring. More than 33 percent of new AIDS cases occur in IDUs, their sexual partners, and their children. Almost one half of all women diagnosed with AIDS in the United States are IDUS. Many of the remaining infected women were infected as a result of sex with a male IDU.

While public health agencies, legislators, community leaders, and religious groups have engaged in vigorous debate over the merits of needle exchange programs (NEPs) as an intervention to reduce HIV transmission, the programs, some legal and some illegal, have been implemented in fifty-five cities across the country.
Developing Public Policy for Sectarian Providers: Accommodating Religious Beliefs and Obtaining Access to Care
Authors: Boozang Kathleen M.
Published: June 2007

The market changes sweeping the U.S. health care industry have a distinctive impact on communities that rely on religiously affiliated health care providers. When a sectarian sponsor subsumes multiple providers, its assertion of religious beliefs can preclude the provision of certain health care services to the entire community. In addition, the sectarian provider's refusal to offer certain services may violate state certificates of need, licensing, Medicaid managed care, or even professional liability law. This situation challenges both the provider and the state: the provider seeks adherence to religious law, and the state seeks compliance with its law and citizens access to health care.

I propose that the state attempt to ameliorate tensions between civil and religious laws through negotiated accomodation. This concept encourages the sectarian institution to reassess its mission in the current market and to identify alternative avenues of health care delivery that will preserve patients' access to care without excessively diluting religious identity or beliefs.
Remedies for Human Subjects of Cold War Research: Recommendations of the Advisory Committee
Authors: Mastroianni Anna , Kahn Jeffrey
Published: June 2007

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.

In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974.
Contemporary Transplantation Initiatives: Where's the Harm in Them?
Authors: Price David P.T.
Published: June 2007

Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation (EV) and use of nonheart-beating donors (NHBDs). Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol (the Exeter Protocol), in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol (the Pittsburgh Protocol). The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain (for example, at Leicester General Hospital), Italy, France, Spain, Japan, and the United States (for example, the Regional Organ Bank of Illinois).
Writing the Rules of Death: State Regulation of Physician-Assisted Suicide
Authors: Schwartz Jack
Published: June 2007

If the Supreme Court affirms either Compassion in Dying v. State of Washington or Quill v. Vacco, state legislatures will be presented with a new and unwelcome task: regulating physician-assisted suicide (PAS). This article focuses on the states task of specific policy making in light of the due process reasoning in Compassion in Dying and the equal protection reasoning in Quill. Policy makers must try to predict whether a particular regulation would in practice achieve its intended objective. They must also try to predict whether the regulation would survive constitutional review if challenged. Finally, they must consider the extent to which they could, or should, maintain two different regulatory regimes: a more permissive one for decisions to forgo life-sustaining medical treatments, and a more restrictive one for decisions to obtain a prescription for a lethal dose of medication. This last issue will be especially challenging if the equal protection analysis in Quill prevails.
Guidelines for Physician-Assisted Suicide: Can the Challenge Be Met?
Authors: Coleman Carl H. , Fleischman Alan R.
Published: June 2007

The question of legalizing physician-assisted suicide (PAS) has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.

As support for PAS grows, it becomes increasingly likely thatthe practice will be legalized in at least some statesin the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted.
Physician-Assisted Suicide, Hospice, and Rituals of Withdrawal
Authors: Bartholome William G.
Published: June 2007

As I write, I hear that Dr. Jack Kevorluan has delivered another victim to the emergency room of his local Michigan hospital. Why do physicians and terminally ill patients feel we need to change the law with respect to assisted suicide when a rogue pathologist, who has been stripped of his medical license, is allowed to pursue his appetite for providing his clients with inhalation treatments of carbon monoxide gas? If no court will convict this outlaw, what makes the physicians and patients who brought Compassion in Dying v. State of Washington and Quill v. Vacco fear that any court would ever convict a licensed physician of assisting in a suicide when he/she writes one of her established patients a prescription for a short-acting barbiturate? Moreover, it is not even clear that laws against assisted suicide in most jurisdictions were ever intended to apply to the actions of licensed physicians. Nonetheless, the plaintiffs in the Second and Ninth Circuit Courts of Appeals were clearly seeking some kind of redress, some kind of protection from potential legal claims they feared might be made against them.
Assisted Suicide: The Challenge to the Nursing Profession
Authors: Kjervik Diane K.
Published: June 2007

Nursing prides itself on a commitment to caring for patients and their families. Daily, nurses support patients and their families as they face life-threatening disease and injury and help them through the painful decisions to initiate or remove ventilators, artificial nutrition and hydration, and other life-sustaining technology.

The opinions of the Second and Ninth Circuit Courts of Appeals, inCompassion in Dying v. State of WashingtonandQuill v. Vauo, strike at the heart of the nursing value system. If the United States Supreme Court upholds either opinion, physicians will be legally allowed to help patients die, and nurses will be called on to assist with this process, just as nurses have assisted with electroconvulsive treatment, abortion, and other controversial procedures. Advanced practice nurses (APNs), who are licensed to prescribe drugs, may also be allowed by law to assist patients to end their own lives.
Appropriate Management of Pain: Addressing the Clinical, Legal, and Regulatory Barriers
Authors: Lo Bernard , Rothenberg Karen H. , Vasko Michael
Published: June 2007

Adequate treatment of pain is essential to alleviate suffering, yet studies show that patients with terminal or serious illness receive inadequate pain relief. In the case of terminally ill patients, adequate palliation of pain may be likely to reduce requests for physician-assisted suicide. This issue of the journal addresses barriers to effective pain relief and suggests how treatment of pain can be improved. The symposium features the Pain Relief Act, which is designed to provide practitioners who prescribe controlled substances for pain with protection from inappropriate legal sanctions. The Act is the product of the Project on Legal Constraints on Access to Effective Pain Relief, whose principal investigators were Nancy Neveloff Dubler, LL.B., Sandra H. Johnson, J.D., LL.M., Robert J. Levine, M.D., and Benjamin W. Moulton, J.D., M.P.H.

The Project was supported by the Mayday Fund and the Emily Davie and Joseph S. Kornfeld Foundation.
Narratives on Pain and Comfort: Mary's Story
Authors: McQuillan Robert J.
Published: June 2007

Mary was angry. Youre going to take my pain medications away, aren't you? These were the first words she spoke as I walked into the examining room. Mary had a complex medical history, beginning with a back injury in 1988 that led to several surgical procedures, multiple injections of local anesthetic and corticosteroids, and placement of a dorsal column stimulator, none of which provided significant relief of her pain. Crippled by severe and sharp pain in her lower back and left leg, she had sought help from several physicians, and had most recently been referred to me specifically, as she put it, to take away the pain medications.

Not that the pain medications had afforded Mary a normal life by any stretch of imagination. She was taking eight to ten moderate strength opioid tablets per day in an effort to decrease her pain. She was not active, choosing to spend most of her time at home. She had quit her job shortly after the work-related accident. In fact, the workman's compensation board is still disputing her claim, and this dispute took a toll on Mary.
Narratives on Pain and Comfort: Casey's Story
Authors: Gabb Jay
Published: June 2007

Pain can be a body-wrenching curse. Yet it is often a life-defining and supporting blessing!

Pain is a distinct physiological event, yet it is also an emotional, social, spiritual, and economic force. Pain in its more destructive form alters lives, changes relationships, and disrupts families.

Quality pain management should not be just a pharmacological response to a medical situation; it must also be a theological, ethical, and societal response to human need. Appropriate pain management is a gift to both the receiver and the provider. As a parish priest, a supervisor of pastoral services, and an ethics resource specialist, I have seen many pain-filled situations that have involved multiples of these dimensions.

Born in 1969, Casey died in 1995, just a few months after his twenty-sixth birthday. Casey was an intelligent, charismatic college student, strong in religious faith, who had few problems … at least until one day in the summer of 1994. That day he began to suffer extreme pain in his lower stomach and bowels.
Pain Management: Texas Legislative and Regulatory Update
Authors: Ralston David L.
Published: June 2007

My purpose is to provide an update on recent Texas regulatory and statutory changes adopted , since the passage in Texas of the Intractable Pain Treatment Act in 1989 (Pain Act) (see Table l). First, I describe the rules adopted by the Texas State Board of Medical Examiners (TSBME) that authorize physicians to prescribe opioids for the treatment of pain (Pain Rules) (see Table 2). Second, I detail recent statutory changes that pertain to education of physicians and medical students about pain treatment. All of these changes attempt to create a better legal environment for the treatment of chronic pain in Texas.

Before describing the Pain Rules adopted in Texas, the question Why adopt rules, rather than simply ask TSBME to issue a policy statement? must be answered. Many states, most notably California, have issued policy statements that clarify for physicians the parameters within which they may treat pain? Policy statements, unlike administrative regulations, do not have the force of law.
Improving Pain Management through Policy Making and Education for Medical Regulators
Authors: Joranson David E. , Gilson Aaron M.
Published: June 2007

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical boards and the pain management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief.
Cancer Genetic Susceptibility Testing: Ethical and Policy Implications for Future Research and Clinical Practice
Authors: Wilfond Benjamin S. , Rothenberg Karen H. , Thomson Elizabeth J. , Lerman Caryn
Published: June 2007

Genetic testing for cancer susceptibility is an application of biotechnology that has the potential both to improve the psychosocial and physical wellbeing of the population and to cause significant psychosocia1 and physical harms. In spite of the uncertain value of genetic testing, it has captured the interest of biotechnology companies, researchers, health care providers, and the public. As more tests become feasible, pressure may increase to make the tests available and reimbursable. Both the benefits and harms of these tests lie not as much in the tests themselves, as in their power to predict or alter the future. The value of the tests does not derive from the information per se, but from the ability to communicate effectively the information to patients and providers, and the behavioral responses of patients, providers, and others to this information.
Medical Record Confidentiality Law, Scientific Research, and Data Collection in the Information Age
Authors: Turkington Richard C.
Published: June 2007

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery system would be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure.
Privacy and Confidentiality Practices for Research with Health Information in Canada
Authors: Hagey Janet
Published: June 2007

Health information by its nature is personal and sensitive. At the same time, significant public value has resulted from research with health records about determinants of health and effective provision of health services. In Canada, certain legislation and processes have been established to balance the individual's right to privacy and the public good associated with analysis of health information.

My purpose is to describe privacy and confidentiality practices in Canada with respect to access to health data for research purposes. I provide an overview of the Canadian health care system and the legislative framework used to regulate research related to health information and Canada's major national data bases. Then I describe the confidentiality and privacy policies and procedures of Statistics Canada, of the Canadian Institute for Health Information (CIHI), and of health policy research organizations in three provinces. I conclude with comments on some current issues in health information in Canada.
Decisionally Impaired Persons in Research: Refining the Proposed Refinements
Authors: DeRenzo Evan G.
Published: June 2007

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically permissible to involve persons in research who are too decisionally impaired to provide their own consent.

It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections.
Introduction: Legal and Regulatory Issues in Pain Management
Authors: Johnson Sandra H.
Published: June 2007

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.