bluuebunny/crossref_metadata_2025 huggingface dataset:
Quality of Life and Non-Treatment Decisions for Incompetent Patients: A Critique of the Orthodox Approach
Authors: Dresser Rebecca S. , Robertson John A.
Published: June 2007

Since the Quinlan decision in 1976, courts and legislatures have made substantial progress in defining rules to govern nontreatment of dying and debilitated patients. For example, the right of the competent patient to refuse necessary care is now widely established, and the legality of withdrawing respirators and even nutrition and hydration from permanently unconscious patients is increasingly recognized.

More difficult questions arise, however, when the patient is neither competent nor permanently unconscious, but instead is in a conscious, severely demented and debilitated state, with experiences that appear quite limited. Thousands of patients in this condition are cared for in private homes, hospitals, and nursing homes, the victims of stroke, senility, Alzheimer's disease, and other illnesses. Even though they usually require only low-tech, minimally supportive care, such patients can impose great stress on their families and high financial costs on the health care system.
The Linares Affair
Authors: Lantos John D. , Miles Steven H. , Cassel Christine K.
Published: June 2007

On August 2, 1988, 6-month-old Samuel Linares aspirated a balloon at a birthday party and was unconscious and blue when his father, Rudolfo, found him. Nine months later, his father used a gun to keep medical staff at bay while he disconnected the respirator keeping his comatose son alive. Mr. Linares ignited much soul-searching among pediatricians, lawyers, and ethicists about treatment decisions for profoundly damaged children.

Public discussion of the ethics of forgoing life support in pediatric care moves like a pendulum betweeen fear of inappropriately allowing children to die and fear of unrestrained life-supporting technology. In the early 1970s, physicians’ and theologians challenged accepted tenets of law and ethics by proposing that pediatricians should allow critically ill or severely disabled babies to die without the most aggressive use of technology. By 1982, Baby Doe caught the nation's moral imagination and raised the possibility that withholding or withdrawing life-sustaining procedures amounted to sanctioned infanticide. This concern led to restrictions on the right of parents and doctors to decide to discontinue treatment. Public sympathy for Mr. Linares suggests that the pendulum may be swinging back toward a less restrictive public policy about forgoing life-sustaining treatment in children.
Legal Advice, Moral Paralysis and the Death of Samuel Linares
Authors: Nelson Lawrence J. , Cranford Ronald E.
Published: June 2007

Legal advice lies close to the death of Samuel Linares, closer than it usually does to the deaths of the many who die every day in American hospitals. Samuel's parents wanted the attending physician to disconnect the ventilator of their permanently unconscious son and allow him to die, something they saw as right for their son and their family. But this never happened. Samuel was not allowed to meet the death he hadsonarrowly avoided in August of 1988 when he accidentally swallowed a balloon and choked. He did not die uneventfully after his parents and the clinicians caring for him had carefully deliberated about the personal, ethical and professional propriety of stopping the ventilator and made a responsible decision about his fate.

Instead, Rudy Linares had to ward off nurses and security guards with a handgun until he disconnected his son's ventilator and held him in his arms until he died. According to the attending physician, Dr. Goldman, “There was noethical difference of opinion here.The physicians agreed that the child was in an irreversible coma and would not recover. There was no medical opposition to removing the ventilator.What we faced was a legal obstacle.” (Emphasis added.)
The Values History: An Innovation in Surrogate Medical Decision-Making
Authors: Lambert Pam , Gibson Joan McIver , Nathanson Paul
Published: June 2007

In the United States we prize our freedom as individuals to make our own decisions, however unwise they might seem to others. This devotion to the principle of autonomy (from the Greek “autos” meaning self and “nomos” meaning rule) is obvious in our legal system as well as in a variety of social rules and customs that govern our daily lives.

Difficulties arise, however, when we lose, either temporarily or permanently, the capacity to make our own decisions. Ideally we would have planned ahead for possible incapacity in order to retain control over the future course of our lives. Unfortunately the ideal situation rarely exists. Most of us avoid anticipating the possibility of our own incapacity, and by implication, loss of control. Until recently attention has not been paid to developing and supplying accessible and understandable information about advance directives that could assist us in such planning. And most of us still prefer (or at least resort to) informal, often uninformed, family decision-making arrangements.
Trends in Guardianship Reform: Implications for the Medical and Legal Professions
Authors: Hommel Penelope A. , Wang Lu-In , Bergman James A.
Published: June 2007

In recent years, there has been a slow but dramatic change in society's attitudes toward persons with disabilities—an evolution away from traditional paternalistic approaches which foster dependency, toward policies focused on maximizing the potential for autonomy and independence among individuals of limited capacity. This change is clearly reflected in efforts across the country to revise state guardianship statutes. This article analyzes significant trends in these reform efforts, and highlights important practice implications for physicians and attorneys whose practices include serving persons who are limited in their capacity to make informed decisions.
Financial Planning for Health Care in Older Age: Implications for the Delivery of Health Services
Authors: Regan John J.
Published: June 2007

The 1980s have witnessed mounting concern among older adults and policy makers about the ability of people to maintain control over health care decisions in later life. Laws authorizing living wills, durable powers of attorney, and family consent for incompetent patients have proliferated throughout the states. Even the United States Supreme Court finally entered the arena as it pondered the fate of Nancy Cruzan in the face of Missouri's refusal to authorize the withdrawal of the nasogastric tubes which keep her alive. The challenge of translating personal autonomy in health care into legal rights has captured the attention of legislators and courts alike. What began as an isolated decision in the Quinlan case in 1976 has become a torrent of lawmaking action by 1990.

Staying in control of health care arrangements in later life, however, embraces much more than refusing or terminating life-sustaining treatment. Mechanisms for financing health care services often determine the quality of the older person's life and the extent to which the individual retains autonomy over the myriad details of daily life.
Pertussis Vaccine Litigation in Three Countries
Authors: Campbell Colin L.
Published: June 2007

The purpose of this paper is to review the nature and extent of pertussis vaccine litigation in Great Britain, Canada and the United States. It is not intended to deal in detail with the medical or scientific controversy that surrounds this vaccine except to the extent necessary to explain the litigation.

In order to understand what has been called by some a growth industry for lawyers, one must have a basic understanding of the nature of the disease and the nature of the vaccine and know something about the neurological development of the young child.

The disease whooping-cough (pertussis) is well known as an acute and distressing infection of the respiratory tract. Although less frequent in recent years, it has been a disease relatively common in infant children.

The disease is caused by a bacterium known asBordetella pertussis, which produces catarrhal coughing that results in repetitive, explosive or paroxysmal coughing.
Rationing and Professional Autonomy
Authors: Agich George J.
Published: June 2007

The effort to control inflation of the cost of health care in the United States in recent years has focused on a strategy of introducing competition by encouraging prospective payment systems such as DRGs and HMOs. Changes associated with these new payment systems have engendered a debate that has been conducted partly in terms of medical ethics. Because they tend in various ways to provide physicians with incentives to reduce medical costs, prospective payment systems have been alleged to create ethical conflicts for physicians. The obligation to practice cost-effective medicine is said to conflict with the obligation of physicians under the traditional professional view of medical ethics to provide the best care to patients without regard to cost or other matters. At bottom is the concern that the net effect of these changes will be to force physicians to ration medical services. Not only will patients suffer thereby, but professional authority will be weakened as efficiency protocols and various bonuses or inducements alter the norms of clinical decision-making.
Courts, Gender and “The Right to Die”
Authors: Miles Steven H. , August Allison
Published: June 2007

Public policy with regard to decisions to forgo life-sustaining medical care has dramatically changed over 15 years. Courts, legislatures, and professional bodies recognize a patient's right to refuse treatment despite civic or medical values that favor prolonging life. The United States Supreme Court has taken up this issue on an appeal of Missouri's Supreme Court decision ordering tube feeding for comatose Nancy Cruzan over her family's objections. The right to refuse life-sustaining treatment exemplifies a changing accommodation between controversial personal choices and the values our society holds collectively. As with other civil rights issues to come before the Court, the courts embody the very cultural canon they critique and redefine.

While the relevance of the American tenet of individualism to the “right to die” (properiy, the “righi to refuse life-sustaining treatment”) is well recognized, the role of our culture's view of gender in these decisions is not appreciated.
Euthanasia: The Collision of Theory and Practice
Authors: Robinson Jane
Published: June 2007

As a nurse and policy analyst, my interest in the subject of active euthanasia lies in the practical consequences of formal policy (for example, ethical guidelines), as well as the consequences of having no formal policy, for therapeutic practice.

The basic assumption underpinning this paper is that policy decisions in the area of euthanasia cannot be simply ‘read off’ from any theoretical body of knowledge, but rather such decisions are always grounded in particular situations and social relationships. In this, I concur with Reedy, Minogue, and Sterk, who argue that:

The task of theoretical ethics is to arrive at knowledge. The task of clinical ethics is to arrive at a decision. The two activities are quite distinct and yet functionally related. The “right thing to do” in a clinical situation is much more a negotiated process than a deduction from the same theory.
Soviet Psychiatry and Human Rights: Reflections on the Report of the U.S. Delegation
Authors: Bonnie Richard J.
Published: June 2007

For more than 20 years, the Soviet Union has been charged with confining political and religious dissidents in psychiatric hospitals for other than medical reasons. The repressive use of psychiatric hospitalization has been primarily associated with the maximum security “special hospitals,” operated by the Ministry of Internal Affairs, to which dissidents have been committed after being found mentally nonresponsible for political crimes. In 1977, the World Psychiatric Association (WPA) condemned the Soviet Union for such abuses, and six years later the Soviet All-Union Society of Neuropathologists and Psychiatrists resigned from the WPA rather than face almost certain expulsion. Soviet psychiatric officials repeatedly denied these charges of political abuse and refused to permit international bodies or psychiatrists from other countries to see the patients and psychiatric hospitals in question.

In the spring of 1989, however, the Soviet government allowed an official delegation of psychiatrists and forensic experts from the United States to interview patients, selected by the delegation, in whose cases hospitalization was believed to have been politically motivated.
The HIV-Infected Health Care Professional: Public Policy, Discrimination, and Patient Safety
Authors: Gostin Larry
Published: June 2007

Three years ago, I was invited by the Hastings Center to prepare a position paper asserting that patients had the right to be protected against exposure to HIV in health care settings. Believing, rather naively I fear, that I was being asked to defend the rights of patients, I happily accepted. My paper examined such areas as the patient's right to be informed if her surgeon was HIV-infected, along with the prevailing professional duty of health care providers to protect patients from avoidable harms.

When I arrived at the debate forum, I looked up to see my friends—humane public health officials, civil libertarians, and AIDS activists—on the other side of the table. It dawned on me that the debate was not about patients’ rights at all, but about restricting the employment rights of HIV-infected health care professionals. Still, I argued at that time, and have continued to assert in the Centers for Disease Control review process, that HIV-infected health care professionals ought to refrain from the practice of seriously invasive procedures.
Discrimination and Disability: The Challenges of the ADA
Authors: Parmet Wendy E.
Published: June 2007

Last July 26, amidst much fanfare, President Bush signed the Americans with Disabilities Act of 1990 (the “ADA”). The Act, which President Bush aptly called “the world's first comprehensive declaration of equality for people with disabilities,” breaks new ground. Seeking to ensure the dignity and legal equality of an estimated 43 million disabled Americans, the Act is both broad and visionary. Regulating areas as diverse as transportation, employment, communications, health care and public accommodations, it suggests a new understanding on the part of Congress about the nature of discrimination. It also both answers and raises numerous questions about the role of law in the face of disease and disability.

The ADA is modeled upon many prior laws, most especially the Rehabilitation Act of 1973. Included in the Rehabilitation Act are several provisions ancestral to the ADA. Secs. 501 and 503 of the Rehabilitation Act place affirmative obligations on the federal government and its contractors to employ the disab1ed.
Advance Directives: Where are We Heading afterCruzan?
Authors: Rouse Fenella
Published: June 2007

On June 25, 1990 the U.S. Supreme Court ruled for the first time in a right to refuse medical treatment case. The court's holding (by a majority of five of the nine justices) was essentially as follows: The right to liberty, which is explicitly mentioned in the Constitution, encompasses a person's decision to reject life-sustaining treatment; competent people are entitled to reject life-support and states are therefore prohibited from preventing people from making that choice. States may, however, regulate the exercise of the right, to ensure that the decision to stop treatment is indeed what the patient would have wanted. Asking for “clear and convincing evidence” of an incompetent patient's wishes (which means a demonstration that the person herself deliberately and thoughtfully made the decision in advance, or perhaps formally appointed someone else to make that decision for her) is a legitimate form of regulation by the state: It furthers the quest for what the person would have wanted and protects incompetent individuals from decisions made by others which might be influenced by the others’ interest instead of being based solely on what the individual would have wanted.
Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards
Authors: Mehlman Maxwell J.
Published: June 2007

For the better part of the last decade, the major goal of health care policy has been to reduce health care costs. This has raised fears that the quality of care may suffer, as providers cut corners in response to cost containment pressures from the government and other third-party payers.

These concerns over quality in turn have increased interest in the complex systems that monitor and regulate health care quality. Three main questions have been raised about the ability of the quality assurance systems to assure the quality of care. First, they may not be sufficiently effective, especially given the threat to quality posed by efforts to contain costs. For example, quality assurance has been criticized for focusing on a small number of aberrant physicians and hospitals—a so-called “bad apples” approach—rather than on improving the overall quality of care and for failing to identify more than a handful of the poor quality providers believed to exist.
Waging a War on Drug Users: An Alternative Public Health Vision
Authors: Gostin Larry
Published: June 2007

This article returns to a war waged for the better part of this century-between the theories of punishment and rehabilitation in impeding the drug epidemic. Today, the terms of the war are recast as supply-side policies based upon law enforcement, destroying crops in source countries, interdiction and increased sentencing, and demand reduction based upon prevention, education and treatment.

The war on drugs has reached a feverish pitch. New policies and statutes have tightened the grip of supply-side policies, with images of battle and hate-mongering which go beyond the vilified drug lords and governments which harbor them, to the middle men, the dealers, and even the users. The in-vogue policies of user accountability and zero tolerance make it acceptable to direct the state's formidable powers at drug dependent persons themselves. Drug dependent persons have profound physical and psychological problems, and are primarily concentrated in poor, minority urban areas.
Recent Developments in Abortion Law in Industrialized Countries
Authors: Boland Reed
Published: June 2007

The last several years have witnessed a growing intensity in the debate over abortion in the United States. Although the issue has never been far from the public eye, with the Supreme Court's decision in Webster v. Reproductive Health Services in 1989, it assumed a new urgency as it appeared more possible that the Court might reverse Roe v. Wade, the 1973 case guaranteeing a woman a right to an abortion. Moreover, this urgency was not confined to the United States. The same several years also saw an increase in abortion-related legal developments in other industrialized countries of the world: Belgium, Canada, Romania, and Bulgaria significantly liberalized abortion laws; England made changes that take notice of recent medical knowledge on fetal survival and fetal handicap; France became the first country in the world to approve the potentially revolutionary abortion drug RU 486; and Ireland reaffirmed its opposition to abortion.
Life and Death Choices after Cruzan
Authors: Gostin Larry
Published: June 2007

This issue of Law, Medicine & Health Care on life or death choices, so skillfully put together by Alexander Capron and based on ASLM's conference last September chaired by Professor Capron and Joanne Lynn, grew out of the Supreme Court's decision in Cruzan v. Director, Missouri Department of Health.

At the time of the Supreme Court decision Nancy Cruzan was in a persistent vegetative state (PVS), a condition in which a person exhibits motor-reflexes but evinces no indications of significant cognitive function. Nancy Cruzan's biological existence was being sustained by the provision of technological feeding and hydration. Hospital employees refused, without court approval, to honor her parents’ request to withdraw artificial nutrition and hydration.
Remarks on the Judge's Role and Moral Certainty
Authors: Kessler Gladys
Published: June 2007

First, I am a trial judge on D.C. Superior Court—a court of general jurisdiction. Thus, my personal experiences and approach are grounded in the intense and heart-rending world of live testimony and real human beings—not the rarefied appellate atmosphere of cold transcripts and brilliant analytical arguments.

To put some of my remarks in context, and to present a totally atypical situation which raises all the analytical issues of Cruzan, I would like to describe a real case—one that I actually tried—about 10 years ago, involving a committed patient at St. Elizabeths Hospital—a large local hospital for the mentally ill. I will call him Vladimir—he was a real person, not a faceless mental patient. Vladimir had escaped from the repressiveness and brutality of pre-Glastnost Russia—to the freedom of the West. Sometime after locating in America and working here, he became mentally ill and was hospitalized.
Cruzan: Facing the Inevitable
Authors: Bopp James , Marzen Thomas J.
Published: June 2007

When the United States Supreme Court upheld the decision of the Missouri Supreme Court that it was not in the best interests of Nancy Cruzan to die of dehydration and malnutrition by withholding from her food and fluids provided by tube the result was deplored by many legal and popular commentators.

The criticism suggested a wide range of values and reasoning that were reflected in the various briefs filed in the U.S. Supreme Court in support of reversing the Missouri court decision. The objections might be placed in three categories: the medical, the legal, and the ethical.

The medical rationale for reversal of the Missouri Supreme Court categorized provision of food and fluids by tube as a “medical treatment” and, hence, subject to practices that pertain to forgoing other, more obvious forms of medical treatment, such as use of respirators or chemotherapy.
A Judge's Perspective: The New York Rulings
Authors: Wachtler Sol
Published: June 2007

After I was named Chief Judge of New York State, a position previously occupied by one of the noblest of jurists, Benjamin Cardozo, I went up to look at my new chambers and there was my new desk—the desk that had been used by Benjamin Cardozo. And I said to a friend of mine, “Just think of it, I will be seated and be using and will have Benjamin Cardozo's desk.” And he said, “Yes, but remember, 50 years from today, it will still be Benjamin Cardozo's desk.” We have through the likes of Benjamin Cardozo inherited a jurisprudential history in New York State.

The question that we now grapple with is a question which many states have had to face and the decisions from the state courts are diverse and often controversial. We were all waiting for the United States Supreme Court, that fountain of wisdom, to set the guidelines, so that we would have a standard to which we would look and adhere.
Between Isolation and Intrusion: The Patient Self-Determination Act
Authors: McCloskey Elizabeth
Published: June 2007

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?
The Role of State Legislatures after Cruzan: What Can—and Should—State Legislatures Do?
Authors: Rouse Fenella
Published: June 2007

In Cruzan, the Supreme Court held that the refusal of treatment is a constitutionally protected right and that the methods for permitting its exercise should be crafted by the laboratory of the states. In June 1990, when the court ruled, there already existed a large and complex body of law concerned with the refusal of treatment which differed, sometimes considerably, from state to state. Generally, withholding or withdrawing life-sustaining treatment has been accepted by the states, but different systems of justification have been used.

Competent people are able to make decisions to refuse any form of medical treatment, regardless of their medical condition; competent people can also prepare written instructions describing the medical treatment they would want to receive in the future if incompetent, which have been endorsed by both state courts and legislatures.
Why I Don’t Have a Living Will
Authors: Lynn Joanne
Published: June 2007

For a dozen years, my clinical practice has been largely with dying patients, my academic pursuits have focused on medical ethics, and my public service has been mostly at the interface of medicine and law. One would think that I would have “done the right thing” long ago and signed a living will. I have not. This essay is meant to illuminate my reasons. Some of my reasons may apply to others, and I will also mention some concerns that affect others but not me. However, I do not oppose the growth and development of advance directives. Rather, I hope to open the public and professional discussion of how to make decisions for incompetent adults in order to include more varieties of formal and informal advance directives and to force policy-makers to consider how to make decisions for incompetent adults who have no advance directives.

As a physician, I do use advance directives, both formal and informal, with many patients in all of my clinical settings.
Medical Staff Credentialing: A Prescription for Reducing Antitrust Liability
Authors: Peters Brian M. , Maneval Wendy Cherner
Published: June 2007

In the past ten years, the medical staff credentialing process has become a veritable antitrust minefield. The number of antitrust lawsuits brought by physicians and other health practitioners who have been denied medical staff appointment, reappointment, or whose clinical privileges have been terminated, restricted or otherwise diminished has escalated dramatically. Battles have been, and continue to be, waged in medical staff credentialing committees, hospital board rooms and, ultimately, in the courts over appointment and reappointment procedures, the criteria applied, and the procedures for hearings and appeals. Although aggrieved physicians also sue on other legal theories, antitrust lawsuits are particularly complex, expensive and time-consuming to defend and pose the risk of considerable monetary loss if a defendant is held liable. In addition, antitrust lawsuits may have deleterious public relations effects, impairing a hospital's reputation in the community and its credibility in its business dealings.
CDC Guidelines on HIV or HBV-Positive Health Care Professionals Performing Exposure-Prone Invasive Procedures
Authors: Gostin Larry
Published: June 2007

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.
Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics
Authors: Gostin Larry
Published: June 2007

Ethical principles for the protection of human subjects in clinical research are now well recognized, and rooted in the inherent worth and dignity of the individual.

Respect for personsrecognizes people as autonomous agents and requires that their choices be observed. For persons who are not fully autonomous, the principle of respect for persons requires that they are protected from risks and adverse consequences of research, even sometimes excluded from research.

Beneficence(do good) andnon-maleficence(do no harm) are complementary ethical principles that impose affirmative duties on researchers to maximize any benefits for subjects and minimize any risks. Thus, researchers must go beyond mere respect for a person's choices. The researcher must be vigilant to ensure that the subject receives all possible benefits and avoids all possible harms from participating in the research.
Informed Consent: Some Challenges to the Universal Validity of the Western Model
Authors: Levine Robert J.
Published: June 2007

This paper presents first an account of informed consent as it is envisioned and ethically grounded in the Western world. Next there is a discussion of why the Western model is unsuitable in much of the remainder of the world where the concept of “person” differs substantially from that of Western societies. This is followed by some comments on the current controversy on whether ethical standards should be regarded as universally applicable or, rather, whether some degree of ethical and cultural relativism is to be regarded as legitimate. After providing preliminary responses to some questions posed by the Conference Programme Committee, the paper concludes with a proposal for a procedural approach to the resolution of problems with informed consent.
The American, British and Dutch Responses to Unlinked Anonymous HIV Seroprevalence Studies: An International Comparison
Authors: Bayer Ronald , Lumey L.H. , Wan Lourdes
Published: June 2007

With the identification of HIV as the etiological agent responsible for AIDS in 1984, it became clear that an understanding of the dimensions of the epidemic would require more than a careful detailing of the incidence and prevalence of overt symptoms of AIDS. To enable public health authorities to target and evaluate preventative interventions and plan for the health care services that would be required in the future as the infected progressed to symptomatic conditions, knowledge of the incidence and prevalence of HIV infection was critically needed.
Confidentiality: The Protection of Personal Data in Epidemiological and Clinical Research Trials
Authors: McCarthy Charles R. , Porter Joan P.
Published: June 2007

Lilienfeld and Lilienfeld have defined epidemiology as “the study of the distribution of a disease or physiological condition in human populations and of the factors that influence this distribution.” Epidemiology is an eclectic discipline, utilizing statistics, sociology, and biology of the study of disease populations. Epidemiological studies can help explain the etiology of a specific disease; they can evaluate the consistency of epidemiologic data with etiological hypotheses and provide a basis for developing or evaluating preventive procedures and public health practices.

The consultation for the Development of International Guidelines for Epidemiological Research and Ethical Review Procedures assembled in Geneva in November 1990 offered basic principles that should apply to epidemiological and clinical research. The principles provide the basis for discussion here.

Providing protection for the rights and welfare of two categories of research subjects in epidemiologic research must be a matter of serious concern to those who design, conduct and disseminate findings of epidemiological research.
“They Will Put it Together/and Take it Apart”: Fiction and Informed Consent
Authors: Nixon Lois LaCivita , Wear Delese
Published: June 2007

In his compelling poem, “Talking to the Family,” physician poet John Stone describes the presentation of unbearable news, the death of a mother, to the awaiting family holding the now-motherless infant. First the physician puts on his white coat and reveals the death to the family. Then he takes off the coat, drives home, and replaces a light bulb in the hall. In seven short sentences the reader is drawn into a barren description of tragedy that seems cold and methodical. In line eight, the center of the poem, a single-line stanza thuds heavily, mimicking the message he bears: “I will tell them.”
Mistakes and Fraud in Medical Research
Authors: Friedman Paul J.
Published: June 2007

Violations of the ethical canons of research have been reported with increasing frequency in recent years. Nowhere have the reported incidents been so numerous or so troubling or attracted so much Congressional attention as in biomedical research. Research ethics, once “something everyone agrees about,” has become the subject of disagreement now that issues of culpability and enforcement are demanding attention. How to distinguish mistakes from fraud has stopped being theoretically obvious and has become a practical problem.

Defining culpable research misconduct has proved to be controversial. Good definitions are a prerequisite for intelligent discourse and sensible regulations. Regulations based on unclear or misdirected definitions stimulate resistance, hostility and evasiveness. The case in point is the definition of what it is that a research institution must investigate and report to the appropriate federal funding agency if allegations of misconduct are received.
The Morality of Physician-Assisted Suicide
Authors: Weir Robert F.
Published: June 2007

In March, 1989, 12 physicians published an article on the provision of care to hopelessly ill patients. Unfortunately, many of the substantive points in that article received insufficient attention from readers because the authors call for appropriate, continually adjusted care for terminally ill patients was overshadowed by a portion of the document in which ten of the authors agreed that “it is not immoral for a physician to assist in the rational suicide of a terminally ill person.”

In June, 1970, Jack Kevorkian, a retired pathologist in Michigan, gained international media attention by enabling Janet Adkins, a woman in the early stage of Alzheimer's disease, to terminate her life with the help of his “suicide machine.” The features of the case were so unusual that physicians, ethicists, and attorneys in health law who were interviewed by journalists were unanimous in judging this particular act of physician-assisted suicide deplorable.
Hospice Care as an Alternative to Euthanasia
Authors: Miller Robert J.
Published: June 2007

The same concerns that have led society to consider euthanasia as an option for relieving the suffering of the dying led to the development of the hospice movement. How effectively has hospice care met these needs, and is there still a need for euthanasia? Is the hospice approach to death an alternative to euthanasia, compatible with euthanasia, or euthanasia in another form? Do those health care workers who are drawn to providing hospice care favor or oppose euthanasia?

Hospice care developed out of a sense of frustration with the treatment of the dying, and as a reaction against the abuses of an impersonal high-technology approach to patients. There was institutional denial of death which made it impossible to integrate death into the lives of people. Due to neglect, many patients were under-treated with little attention paid to relieving pain or dealing with their or their families’ psychosocial needs.
Voluntary Euthanasia and the Risks of Abuse: Can We Learn Anything from the Netherlands?
Authors: Battin Margaret
Published: June 2007

In the United States’ quite volatile public debates over the legalization of voluntary active euthanasia and physician-assisted suicide, much has been made of the risk of abuse. Indeed, it was probably fears of abuse that contributed more than any other single factor to the 1991 defeat of the United States’ first ballot test of legalizing euthanasia, the state of Washington's Initiative 119—despite prior state and national polls suggesting the measure would pass. Opponents of Initiative 119, which would have legalized physician-performed euthanasia or physician-provided aid in suicide when voluntarily requested by competent terminally ill patients with less than six months to live, variously claimed that the legislation would encourage greedy family members to pressure patients into choosing death, that unscrupulous physicians would kill patients who became unattractive to treat, that cost-cutting pressures from hospitals, insurers, and other institutions would force patients into death, and that race-, age-, and handicap-prejudice would take an especial toll among vulnerable groups.
Updating RU 486 Development
Authors: Baulieu Etienne-Emile
Published: June 2007

RU 486 is a synthetic drug with antisteroid hormone properties, synthesized by the Roussel-Uclaf Company, Paris, France, which owns a world-wide patent for all uses.

I have summarized the story of RU 486's discovery, testing and use in the Journal of the American Medical Association, in Science? and in a book entitled The Abortion Pill, also published in French as Génération Pilule.

Based on antiprogesterone action, RU 486 was first approved in France for voluntary pregnancy interruption (VIP), within the framework of the abortion law, as a medical method to replace the instrumental technique in use when the law was passed in 1975. Registration of RU 486 was obtained in September 1988.
RU486 in France and England: Corporate Ethics and Compulsory Licensing
Authors: Boland Reed
Published: June 2007

Prospects for the introduction of RU486 into the United States in the foreseeable future are not good. Despite the drug's proven value in inducing abortion safely and effectively in early pregnancy without the need of surgery or anesthesia and its potential value in the treatment of many other diseases, it has been held hostage by the controversy over abortion. Because of opposition to abortion from the current administration and the threat of boycotts by antiabortion groups, Roussel-Uclaf, the drug's manufacturer, has expressed its resolve not to become embroiled in the abortion debate and has postponed indefinitely plans to market RU486 in the United States.

The contrast between this situation and that accompanying the introduction of RU486 into France and England, the two countries where it has so far been approved, is striking. Rather than blocking access to RU486, the governments of these countries moved forward expeditiously with testing and approval of the drug.
Patents and the Supply of Therapeutic Products
Authors: Hayhurst William L.
Published: June 2007

Grants of exclusive rights to inventors are not a modern phenomenon. In some early civilizations such grants were at the pleasure of the ruler. In 1474 the senate of the Republic of Venice introduced what is believed to be the first law that provided a systematic procedure for obtaining patents for inventions. That system disappeared with the decline of the Venetian Republic. During the 17th and 18th centuries the English developed a system which has survived in its fundamentals, and that system has been adopted, with variations, by the great majority of countries. The justification for the system is the encouragement that it provides to invest in research and development and to publish one's accomplishments rather than try to preserve secrecy.
Ethics Committees and Due Process
Authors: Fletcher John C.
Published: June 2007

Susan Wolf, in an important article on hospital or institutional ethics committees (IECs) and due process, writes:

Ethics committees are in a due process wasteland. There is no indication that committees regularly offer patients any of the basic procedural protections such as notice, an opportunity to be heard, a chance to confront those in opposition, receipt of a written determination and a statement of reasons, and an opportunity to challenge that determination. Ethics corninittees may seek the decisive power of the Adjudicatory Model, while using the process of the Consultation Model. This is the worst of both worlds—the committee wields great influence over the treatment decision but accords no protection for the patient's rights.

There are few data upon which to draw to disagree with Wolf's first claim about a due process “wasteland.” I suspect that it is mostly true, although one can observe, as I do, that Susan Wolf has omitted a great deal of evolution concerning ethics consultation in her article.
Ethics Committees, Organ Transplantation and Public Policy
Authors: Dickens Bernard M.
Published: June 2007

It has recently been observed that in the United States hospital ethics committees have passed through their infancy and that, even though they may not yet have come of age, they have entered their adolescence. Accordingly, they must increasingly expect to be held to account for their conduct, and be prepared for others to anticipate not only that they can be self-reliant but that their communities may rely on them to undertake several functions of public significance. The claim that they have grown beyond their infancy remains contentious in the U.S., and is unlikely to be made of Canadian hospitals ethics committees with the same confidence. It is not too early, however, to anticipate a time when Canadian committees too may be considered capable of performing acts that are of considerable public importance, particularly concerning hospital policies on organ transplantation.
Do Those Who Cannot Speak Really Have a Voice?
Authors: Dew Betty
Published: June 2007

Joseph Finelli, after a heart transplant, is being artificially maintained by medications and a gastrostomy tube (G-tube). He is not brain dead nor in a persistent vegetative state. In my role as court-appointed Guardian ad Litem (GAL-court investigator), it appears to me that Mr. Finelli is being treated against his stated goals and values. After applying the substituted judgment factors, I recommend the withdrawal of the medication which sustains his life. His family adamantly opposes my position.

Joseph Finelli is a 57-year-old Italian-American Catholic husband and father of four adults. Mr. Finelli was an “extremely active” man. He enjoyed training dogs, hunting, running, and was an “avid” biker. Debilitating congestive heart failure eventually confined his activities to walking ten steps at a time. Surrendering his active life produced pronounced depression.
Physicians and Futile Care: Using Ethics Committees to Slow the Momentum
Authors: Brennan Troyen A.
Published: June 2007

The subject of physician efforts to limit care by unilaterally withholding particular therapies, even if the patient, or the family of an incompetent patient, wishes continued care, plays an increasingly prominent role in discussions of clinical medical ethics. Some providers have described a professional duty to define the futility of care, and to act on the determination of futility even in the face of the patient’s, or a surrogate’s, resistance. This aggressive stance has gained intellectual momentum and may be percolating down into clinical practice.

Given the history of the medical profession's diffident attitude toward patients’ rights and its reliance on well-meaning paternalism, the notion that doctors should determine futility and limit access to specific interventions must be carefully scrutinized. Indeed, the emergence of two other themes in health policy and ethics, in particular the living will/power of attorney initiative on the one hand and the open discussion of rationing care in Oregon on the other, tends to undermine the key rationales for physician control over futile care.
Drawing a Line between Killing and Letting Die: The Law, and Law Reform, on Medically Assisted Dying
Authors: Gostin Lawrence O.
Published: June 2007

Traditional medical ethics and law draw a sharp distinction between allowing a patient to die and helping her die. Withholding or withdrawing life sustaining treatment, such as by abating technological nutrition, hydration or respiration, will cause death as surely as a lethal injection. The former, however, is a constitutional right for a competent or once-competent patient, while the latter poses a risk of serious criminal or civil liability for the physician, even if the patient requests it.
U.S. Health Care Coverage and Costs: Historical Development and Choices for the 1990s
Authors: Bovbjerg Randall R. , Griffin Charles C. , Carroll Caitlin E.
Published: June 2007

American health policy today faces dual problems of too little coverage at too high a cost. The mix of private and public financing leaves about one seventh of the population without any insurance coverage. At the same time, the coverage Americans do have costs an ever-larger share of our country’s productive capacity. The U.S. pays well above what other countries pay and what many people, health plans, businesses, and governments want to pay. This “paradox of excess and deprivation” results from the incremental approach the U.S. has taken to promoting incompatible policy goals of increasing health insurance coverage and medical quality while trying to control costs, without squarely confronting tradeoffs. This essay examines the record of incremental developments and draws lessons for current efforts at reform.
Recent Developments in Antitrust Law and Their Implications for the Clinton Health Care Plan
Authors: Jacobs Michael S.
Published: June 2007

Although the details of the Clinton health care plan have yet to emerge from the continuing policy debate over the shape and size of the administration’s reform measures, one thing has become increasingly clear. Several recent developments in antitrust law will have important implications for what the plan will permit and how it will work.

By all accounts, the broad outline of the administration’s plan revolves around the development of large and powerful consumer groups who, with the help of sophisticated, government-established intermediaries, will presumably purchase health care wisely and well. This alliance of massed consumer purchasing and government information-gathering will, it is hoped, produce a health care market more in competitive balance than the current version, which is widely regarded as dominated by powerful providers who dictate terms to small, uninformed buying groups.
Reproductive Freedom and Violence against Women: Where are the Intersections?
Authors: Heise Lori L.
Published: June 2007

There isn’t much understanding in some marriages. My sister has six [children] and another has eight. I said to one of them that she shouldn’t have any more. And she said “What can I do? When my husband comes home drunk, he foxes me to sleep with him.” And that is what happens to a lot of women. And if the women don’t do it, the men hit them, or treat them badly. Or the men get jealous and think their wives are with other men.

—Rene, a 29-year old Peruvian woman

Gender violence is a major yet often underrecognized obstacle to reproductive choice. In both the abortion rights movement in the United States and the reproductive health movement globally, the “enemy” of self-determination and choice is usually seen as imposing from the top down. In the North, it is the government—through the courts, the legislature, and bureaucratic rulemaking—that threatens to “take away” women’s reproductive autonomy. The image is one of the public sphere invading that which is private—of the state interfering with a woman’s right to control her own body.