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.

A recurring lesson in the debate about forgoing life-sustaining treatment for patients with neurologic syndromes is the need to understand the medical realities in such cases. Those of us in the neurological sciences spend a great deal of time working with these cases on a daily basis—trying to define the medical facts and educate ourselves, the public, and the courts. This article will discuss the medical and neurological facts regarding patients with severe and permanent neurological impairment, focusing only on one form of medical treatment: artificially administered nutrition and hydration. The concern of this paper is not the patient's wishes, the family's wishes, or the decision-making role of other key players, but the medical conditions in which it is ethically appropriate to withdraw or withhold artificial fluids and nutrition.

Epidemiology is the study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control of health problems.

Several terms used in this definition require discussion. “Study” encompasses (a) observations in public health practice, e.g. to investigate outbreaks of food poisoning, identify the source of an epidemic, trace contacts of sexually transmitted diseases; (b) hypothesis-testing observational studies using cross-sectional, cohort and casecontrol methods; and (c) experiments such as randomized controlled trials, in which there is intervention as well as observation, usually with the aim of evaluating a preventive, diagnostic or therapeutic regimen or procedure. “Distribution” refers to time sequences, places of occurrence, and persons affected. “Determinants” are all the physical, biological and behavioral factors that can influence health. “Health-related states or events” include diseases, injuries, deaths, behaviors such as tobacco addiction, and reactions to preventive, diagnostic or therapeutic regimens or procedures.

The process of dying, ultimately, is an experience that will be common to us all. Considering the current trends in health care, I would guess that most of us give more than a passing thought to how that final phase of life will be played out on a personal level. Undoubtedly, that image is shaped by our attitudes and experiences. In addition each of us recognizes that we have had or are likely to have an impact on the dying in our role as family or friend, health care provider or interpreter of the legal or ethical issues. As a member of a hospice team, I have personally cared for hundreds of terminally ill patients, and based on these experiences, I present the following observations regarding the process of dying, with and without feeding and fluid by tube.

J.R. was a successful business executive until AIDS intervened; within an eight month period, he was forced to give up both his position and independence because of severe peripheral neuropathy which left him minimally functional and in constant pain.

The Nuremberg Code of 1947 is often taken to mark the beginning of the modern age of ethical codes for medical and health-related research with human subjects. The 1947 Code was fashioned in response to inhumane medical experimentation revealed at the Nuremberg War Crimes Tribunal. The fact that, prior to 1939, Germany had an ethical code for human research in medicine that appears sensitive and sophisticated even by current standards indicates that codes in themselves do not assure ethical conduct. Nevertheless, calls continue for the preparation of codes of conduct to guide the exercise of ethical judgment in health-related research.

Medical research concerned with individual subjects as such now possesses codes or guidelines at many levels, including funding agency, research institutional, national and international levels. The World Medical Association's Helsinki Code is now in its fourth version, and the Guidelines proposed in 1982 by the World Health Organization affiliate, the Council for International Organizations of Medical Sciences (CIOMS) is about to be revised to take account of a decade of significant developments.

A recent case report described a 62-year-old woman who had suffered a stroke and subsequently had global aphasia, hemiplegia, and could not respond consistently to yes-no questions. She remained hospitalized for four years and throughout this period was irritable, uncooperative, and often refused food. Her care providers considered it very likely that she was depressed and treated her with antidepressant medication, but these drugs did not have beneficial effect.

Her situation subsequently deteriorated. She refused food and water to a greater extent and lost 22 pounds over one month. At that time electroconvulsive therapy was instituted. Thereafter, presumably responding to electroconvulsive therapy, she became pleasant and cooperative and drank and ate heartily.

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.

Imagine, if you will, a place where health, hospitalization, education, military, employment, law enforcement, housing, tax and financial records, as well as disease registries and the data sources for the census, vital statistics, and all aspects of people's private activities, are meticulously kept, fully linked together, and easily accessible to qualified researchers. What is that place? Epidemiologists’ heaven.

Of course, formidable problems face epidemiologists trying to reach heaven. The data sources on many aspects of our lives are incomplete and the means of linking them are typically nonexistent or partial at best. But even if the data all existed, there would be a further “catch”: epidemiologists would probably find themselves facing great obstacles in gaining access to the data.

Epidemiologists sometimes think of “ethics” as the source of those obstacles, which are believed to be embodied in the federal rules for the protection of research subjects—colloquially called 45 CFR Part 46—especially as they are interpreted by some institutional review boards (IRBs).

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 persons recognizes 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) and non-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.

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.

With the Nancy Cruzan decision, the post-Reagan Supreme Court continued recreating America's legal landscape by transferring traditional rights from its citizens to state legislatures and state officials. Attorneys Bopp and Marzen see Cruzan as a cause for celebration. The more common view is that it is a hollow acceptance of the technological imperative that requires all Americans to engage in extensive damage control. Given the composition of the Court, constituted by President Ronald Reagan to overrule Roe v. Wade, Bopp and Marzen correctly note that the result in Cruzan was “practically inevitable.” But its inevitability does not make its consequences any more desirable than the devastation caused by an inevitable tornado or tidal wave. This article summarizes the Cruzan case and suggests ways to contain its potentially destructive force.

To a Western audience the terms “people” and “people's perspective” could appear somewhat perplexing. Technically, every person belongs to the class of “people”; hence, to talk of “people's perspective” seems to make an artificial division within one monolithic group. This ostensibly artificial division reflects a reality that necessitates it. In a Third World context, the term “people” has a fairly distinct connotation. It is not just a majority which is governed by a system that gives all people a minimal quality of life and allows them a meaningful participation in the political process. In a Third World context “people” are a “mass”—a faceless body of massive energy to be manipulated and kept domesticated in the interest of the powerelite. It is a power-bloc that is threatening as well as inescapable.

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.

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.

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.