# Bioethics/Introduction

no in order to approach some of the ethical dilemmas in contemporary clinical medicine. Major ethical systems - Kantian, utilitarian, virtue-centered, and care-oriented - all impact on contemporary bioethical discourse.
Some of the questions addressed by bioethics include: When should life-sustaining treatments like breathing machines or feeding tubes be started, continued or stopped? What should family members and health to participate in their own health care decisions?
Some specific fields of bioethics are summarized below:

#### Medical Ethics and the Law

This field concerns the relationship between clinical bioethics and the law that has evolved as clinical care has become increasingly complex with new medical technologies. It emphasizes legal theories and principles concerning ethical issues in the context of clinical care. Topics include advance directives, proxy decision-making, issues of consent and confidentiality, withholding and withdrawing care, the definition of death, mental competence and related matters.

#### Ethics of Research and Experimentation

This field concerns the principles of clinical and experimental research ethics and the regulation of research practices, particularly from the perspectives of the Nuremberg code and the Helsinki declaration. Topics include: scientific and research integrity; research with adult and pediatric human subjects; informed consent; vulnerable study populations; privacy and confidentiality of research and clinical records; conflicts of interest; research on animals; and research in third world nations.

#### Ethical Issues in Death and Dying

This field concerns the ethical issues associated with care of the terminally ill and with death issues more generally. Topics include: death; the definition and diagnosis of brain death; chronic vegetative states; loss of personhood; right-to-life/right-to-die; euthanasia; infanticide; physician-assisted suicide; palliative care; pain management; quality of life and related issues.

#### Ethical Issues in Health Care Allocation and Government Policy

This field concerns issues related to access to health care resources and on ways of understanding the issues of fairness and justice on an institutional system such as health care. Various models of paying for health care services and the ethical issues inherent in such systems, particularly in settings of limited resources are an important theme. Topics include: use of surrogates, transplantation policy, problems of financing, the allocation of resources, and experimentation.

#### Ethical Issues of Human Reproduction

This field concerns the various philosophical, legal and ethical issues dealing with human reproduction and considers differing philosophic and ethical positions relating to human reproduction. Topics include genetic engineering, reproductive technologies such as artificial insemination and in vitro fertilization, cloning, sanctity of life, the notion of family, etc.

#### Religion and Bioethics

This field concerns the various philosophical and ethical considerations of different religious faiths in the particular context of bioethics. Issues include: similarities and differences between religious faith and reasoned justification, the role of faith in morality and ethics, and the relationship of certain established faith traditions (e.g., Christianity, Judiasm, Islam) to particular issues in clinical and experimental medicine.

#### Ethical Relationships and the Health Care Team

This concerns the role of and relationships between various members of the health care team, focusing on their roles and responsibilities and how they influence decision making and communication regarding ethical issues. Issues concern the appropriate ways to resolve interpersonal difficulties such as challenging or disobeying a superior, reporting or stopping inappropriate behavior, and expressing moral or ethical judgments.

#### Bioethics Committees and Consulting

This field concerns the workings of hospital and university bioethics committees, institutional review boards, and bioethics consultants, focusing on understanding of nature, purpose and structure of these committees and of the role of bioethicists in such committees. National and international guidelines dealing with experimentation with human subjects, especially the Nuremberg code, are considered.

#### Ethical Issues in Genetics

This field concerns the bioethical issues present in the rapidly developing area of genetic technology, including the nature and methods of DNA analysis, the concept of genetic disease, genetic testing / screening for various diseases, genetic engineering of plants, animals and humans, and cloning. Social policy issues related to genetically modified foods are also important concerns.
* Autonomy, Informed Consent and the Death of Therapeutic Privilege: Lessons Learned from the Jehovah’s Witnesses
* Principlism
* Bioethics and Moral Theory
* Utilitarianism

## PRINCIPLISM

One particulary popular approach to the analysis of bioethical problems is sometimes known as the “Georgetown School” of bioethics, named after Georgetown University where much of the early work on bioethics originated. This approach to bioethics emphasizes the principles of autonomy (respecting the decisions of autonomous persons), justice (fairness in the distribution of benefits and risks), nonmalfeasance (the duty to avoid causing harm); and beneficence (the duty to provide benefits and to balance benefits against risks). This approach is sometimes also known as "principlism".
“There are a set of principles or ideals which people use as a common ground for bioethics. They include the autonomy of individuals to make choices, while respecting the choices of others, justice. In all things we do, the ideal is to avoiding doing harm, and trying to do good” (Macer, 1999). Each of the following principles plays a key role in the composition of bioethics: respect, beneficence, justice, and do no harm. Individuals have autonomy (the right to make ones own decisions about their own actions freely and without concern) and we should respect people for the simple reason that they are counterparts to our health community. Beneficence is defined as having benefits that are proportionate to risks. For example, in researching treatments for a certain health problem, potential side effects should be weighed against the potential benefits and the weight distribution should be somewhat of an equal balance. Justice is seen as the even distribution of risks/benefits throughout the general public. In biomedical research, groups should potentially benefit and/or potentially be exposed to risk at the same rate of other groups unless there is some factor that justifies unequal distribution. And lastly, there is the principle of do no harm. This principle is quite clear in that certain ideas should not be presented nor should experiments/treatments be performed if we know that they will ultimately produce harm.

## BIOETHICS AND MORAL THEORY

Central to bioethics is moral theory. Moral theory can be approached from many viewpoints [1]. The deontological approach to morality (from the Greek word deon, or duty) is based on specific obligations or duties. These can be positive (such as to care for our family) or negative (such as not to steal). This approach is also sometimes called nonconsequentialist since these principles are held to be obligatory regardless of any good or bad consequences of that might result. For example, it is wrong to kill even if it results in great benefit.
Philosophers have subdivided deontological theories into a number of categories, of which the concept of the “categorical imperative” developed by the 18th-century German philosopher Immanuel Kant is the best known. He said that we must “treat people as an end, and never as a means to an end”, by which he meant that we should always treat people with humanity and dignity, and never use individuals as “mere instruments” as a means to our own happiness. Another version of the categorical imperative is: "Always act in such a way that the maxim of your action can be willed as a universal law." Other deontological approaches include “duty theory” (defining duties to God, duties to oneself, and duties to others), “rights theory” (concerned with rights that all people have, and which the rest of us must respect), and a more recent theory developed by W.D. Ross, which emphasizes prima facie duties.
The consequentialist approach to moral theory determines moral responsibility by weighing the consequences of one’s actions. According to the consequentialist view, correct moral actions are determined by a cost-benefit analysis concerning the consequences of an action.
Several subtypes of consequentialism have been proposed: (1) the view that an action is morally correct if its consequences are more positive or favorable than negative to the person performing the action (ethical egoism), (2) the view that an action is morally correct if the consequences of that action are more positive than negative to everyone except the person doing the action (ethical altruism), and (3) the view that an action is morally correct if the action’s consequences are more positive than negative to everyone (utilitarianism).
Any good moral theory should have a set of traits that defines them as being good. These characteristics are needed to avoid a number of philosophical flaws that might otherwise occur. These include: bias, cultural imperialism / cultural ideology, prejudice, racism, sexism and other defects in logic and thinking. I would hold that the following are desirable traits of any good moral theory. (1) It should be consistent – i.e., yielding similar results in similar settings. (2) It should be universal - i.e., if the theory applies to one individual, then it should apply to all individuals. (3) It should be intuitive – i.e., the theory fits our moral intuition.
Other individuals might add other characteristics to this list, such a need for the theory to be understandable by nonphilosophers (certainly a requirement for any practical theory), or the need for the theory not to be based on any religious teachings (although I feel that this is already covered by my requirement (2) above). Others might add the requirements of being time-invariant (that the principles hold true over time) and trans-cultural (that the principles apply to all cultures), but I view these also as being covered by requirement (2). Still others might state that any moral theory must respect all forms of human life, no matter how degraded., while animal rights advocates might emphasize that a moral theory must necessitate respect for all sentient life forms, not just humans. Finally, Princeton’s Professor Peter Singer would likely take issue with my third requirement that a moral theory be intuitive – his moral positions are often taken to be unintuitive and repugnant when first explained, especially in the matters of euthanasia and infanticide, although he makes his case forcefully and lucidly in his many writings.
Professor Paul Taylor, well-known for his writings in the domain of environmental ethics, argues that six characteristics are necessary for a philosophical principle to be a moral rule: (1) generality, (2) universality, (3) priority, (4) disinterestedness, (5) publicity, and (6) substantive impartiality. While his focus is on environmental ethics as opposed to bioethics, it can be seen that his views are substantially similar to mine once the meaning of the terms he uses are fully understood [2].
Beauchamp and Childress offer a number of useful notions on morality in the first chapter of their classic bioethics text [3], but their focus is not on developing a list of specific characteristics as, for example, Taylor has done. Still, their second chapter discusses this matter at some length, introducing requirements of clarity, coherence, completeness, simplicity, explanatory power, justificatory power and practicability. Finally, with respect to people's personal beliefs in the development of a good ethical theory, as discussed in requirement (3) above, a good moral theory should be intuitive with respect to existing beliefs, but only when the personal beliefs meet the other requirements of consistency, time-invariance etc. as discussed above.

#### Sources

[1] Internet Encyclopedia of Philosophy, http://www.utm.edu/research/iep/
[2] Taylor P. "On Taking the Moral Point of View," Midwest Studies in Philosophy, III (1978), 35-61
[3] Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th Ed. New York: Oxford University Press, 1994

## UTILITARIANISM

Why does the moral theory of Utilitarianism seem to falter when it is applied to questions of social or individual justice?
Utilitarianism is a school of philosophical thought frequently identified with the writings of Jeremy Bentham and John Stuart Mill. In more recent years it has undergone a number of refinements, such as “Preference Utilitarianism”, advocated by Professor Peter Singer. Classical Utilitarianism advocates the principle of providing “the greatest happiness to the greatest number” as the basis for assessing the morality of various actions, while “Preference Utilitarianism” advocates the principle of meeting the preferences of the greatest number of people. Thus good variously consists in providing maximal happiness (or satisfying people's preferences, in the case of Preference Utilitarianism) and the rightness of an action depends directly or indirectly on its yielding such outcomes.
However, while Utilitarianism has had a strong influence of the intellectual landscape of philosophical discourse and, in particular, in ethical theory, Utilitarianism is often seen to falter when it is applied to questions of social or individual justice. In particular, Utilitarianism sometimes violates common-sense notions of justice. Because Utilitarianism seeks to maximize the total amount of a particular “utility” (like happiness or preferences) over an entire society or social group, it seeks whichever arrangement achieves maximum utility. But such an arrangement might be achieved by distributing benefits and burdens in a way that violates common notions of justice. For instance, the use of slaves might greatly help maximize the net happiness in a society, but common-sense notions of justice almost always take slavery to be wrong (with apologies to both Aristotle and Thomas Jefferson, who were both great intellectuals yet were slave owners).
Another serious criticism of Utilitarianism is that under the goal of maximizing happiness or some other utility, the wishes and desires of sadists and perverts are lumped in with the wishes and desires of everyone else when an overall determination of utility is made. By espousing a system in which the satisfaction of all desires are to be maximized, Utilitarianism can end up violating our intuitive precepts of natural justice.
John Rawls takes the position that we must reject Utilitarianism and instead develop a deeper understanding of what is right and wrong as a basis for making ethical decisions. What is needed, Rawls argues, is moral theory with justice at its core. That being said, other philosophers have proposed extensions to the classical utilitarian model to deal with some of the limitations identified above. One example is “Negative Utilitarianism”, a moral philosophy aimed at producing the least amount of suffering throughout the world.

## EQUITY ISSUES IN HEALTH CARE

In offering medical services there are often two kinds of health care systems to consider. First, in many countries there is a public system (funded primarily by taxes) that is usually accessible yet often limited in its resources. Then there is often also a private health care system, funded primarily via payments by private insurance or by occasional private individuals paying cash. Some countries have a predominantly public health care system (for instance, the Canadian system is almost entirely public, except for cosmetic procedures and the like), while some countries like the USA have a predominantly private health care system. The British system has both a public National Health Service as well as a thriving private system that has arisen in the face of the many shortcomings present in the National Health Service.
While resource limitations are a problem with all health systems, the problem is usually far worse in the public systems funded through taxation. As a result, many individuals involved in health policy research are seeking to determine which clinical services are most valuable and appropriate and which ones are of more limited value. Their motivation is to make the best use of public funds by only offering those procedures known to be most effective, and not offering procedures that are of very limited or no benefit.
The fact is that some common medical practices have no rational clinical basis in the sense that they provide no benefit relative to the potential risks. Perhaps the best known example is that of newborn circumcision, which is still carried out in 27% of Canadian newborn boys [1]. Other practices such as “female circumcision” can be frankly mutilating and even downright harmful, yet may be considered acceptable or even desirable in some cultures [2]. In a public health care system with limited resources, it makes sense either not to offer such procedures (in the case of male circumcision) or to explicitly forbid them when they are obviously harmful (as in the case of female circumcision). This is not to suggest that all clinically unnecessary procedures should always be unavailable – only that they should not be offered by the public health care system funded by tax money.
The Oregon Health Plan (OHP) [3] has been widely heralded as a landmark innovation in public health care policy that rations public medical resources by a system of prioritizing funding for health care. This is done through a process of systematically ranking publicly offered medical services, an approach that has drawn substantial international interest as a rational model of medical resource allocation.
In 1989, Oregon enacted legislation to provide basic health care to all residents on Medicaid, their public health care system. This required that services be prioritized to determine what would or would not be covered – effectively establishing a rationing plan. To do this, the Oregon legislature created a Health Services Commission charged with producing a list of health care services ranked in priority “according to comparative benefits of each service to the entire population being served.” They heard testimony of numerous panels of physicians from every specialty and assessed how well each treatment that might be offered affected quality of life. From this they established a “cost-effectiveness value” for each “condition-treatment pair”. The final product was a priority list of 709 condition-treatment pairs in ranked order. Based on the available state funds, a line was drawn on the list - any treatment above the line was covered; any treatment below the line was not. This turned out to be at the 587th condition-treatment pair.
While the Oregon system is not without its critics [4], the plan strikes me as a particularly fair and rational approach based on a process of public consultation coupled with clinical efficacy research. I would advocate this model as a good starting point for meeting the various needs and demands of a diverse population. This is not to suggest that the plan would necessarily apply to all residents – only those getting publicly-funded health care would be participate, and wealthier individuals with private insurance would participate in a different (more generous) plan.
Finally, there are a number of practices that are harmful to patients to the extent that they should be forbidden even when well-meaning individuals sometimes seek them. These include the previously mentioned practice of female circumcision, a number of dangerous quack remedies [5], and possibly the practice of euthanasia. Deciding which ineffective or potentially harmful practices should be tolerated (as we do with male circumcision), and which ones should be forbidden (as with female circumcision) is not always an easy task, but application of the principle of nonmalfience is certainly one approach that has special merit. Still, the principle of nonmalfience may sometimes be in direct conflict with the principle of patient autonomy in the cases of patients seeking ineffective or dangerous treatments. In my book, the principle of nonmalfience takes absolute priority. After all, was it not Hypocrites who said “First do no harm.”

#### References

[1] Patrick Sullivan. Infant's death another nail in circumcision's coffin, group says. CMAJ 2002 167: 789-a
[2] E. H. Kluge. Female circumcision: when medical ethics confronts cultural values. CMAJ 1993 148: 288-289.
[3] A. McPherson. The Oregon plan: rationing in a rational society. CMAJ 1991 145: 1444-1445.
[4] Jonathan Oberlander, Theodore Marmor, and Lawrence Jacobs. Rationing medical care: rhetoric and reality in the Oregon Health Plan. CMAJ 2001 164: 1583-1587.
[5] For more information on potentially harmful quack remedies, visit www.quackwatch.com. This site is operated by a retired psychiatrist, Dr. Stephen Barrett, and is filled with hundreds of reports on dubious products, services and theories, all presented in a highly engaging manner. I particularity recommend the section “Cheers and Jeers from Quackwatch Visitors” where Dr. Barnett places his fan mail and his hate mail.

#### Appendix

The International Society for Equity in Health (www.iseqh.org) seeks to “promote equity in health and health services internationally through education, research, publication, communication and charitable support.” It is concerned with exactly the sort of questions that have been raised here: How does one ensure fairness in access to health care resources? What procedures should not be made publicly available in a socialized health care system? How do we deal with cultural and economic factors that impact on the demand for health care services? They begin by offering two working definitions:
Equity in Health: The absence of systematic and potentially remediable differences in one or more aspects of health across populations or population groups defined socially, economically, demographically, or geographically.
Inequity in health: Systematic and potentially remediable differences in one or more aspects of health across populations or population groups defined socially, economically, demographically, or geographically.
Also, the journal for the society, the International Journal for Equity in Health (http://www.equityhealthj.com), features a small number of articles that are helpful to address these issues. These and other sources identify a number of questions that need answering:
* How is fairness in a health care system to be assessed?
* Should health equity be measured at the individual or the group level?
* To what extent are health status inequalities sensitive to the type of health measure used?
The interested reader is referred to these resources for more information.

## DISTRIBUTIVE JUSTICE

"In a situation of unmet need, with patients dying daily for the want of a donor liver, what is fair to all patients is to have approximately the same opportunity of receiving a donor liver." Jeffrey Crippin MD, Baylor University
Beauchamp and Childress (4th Edition, page 228) discuss various standards of fairness in the context of distributive justice. These are:
* To each person an equal share
* To each person according to need
* To each person according to effort
* To each person according to contribution
* To each person according to merit
* To each person according to free-market exchanges
These standards of fairness may be explored in the context of three commonly described models of distributive justice:
* Egalitarian model - where individuals have equal access to goods and services
* Utilitarian model - where goods and services are provided to those who are likely to benefit the most
* Libertarian model - where individuals rights and resources govern access to goods and services
Which model one agrees with most will depend to some extent on whether one views health care as a right (implying a right to universal access to health care), views health care as a need (where people with the greatest need have highest priority and people with similar needs treated similarly ), or views health care as a market commodity.
Let us now consider the words of Dr. Crippin: "In a situation of unmet need, with patients dying daily for the want of a donor liver, what is fair to all patients is to have approximately the same opportunity of receiving a donor liver." While a single sentence of this kind is usually inadequate to express a complex philosophical position, Dr. Crippin’s statement appears to be an expression of an Egalitarian model. In this model of social justice, one gives equal consideration to all interests while treating everyone as equals. As a result, individuals in need have equal access to goods and services. Note also that when Beauchamp and Childress write “To each person an equal share” they are invoking an Egalitarian model of medical services.
Notice that Crippin does not explicitly emphasize the degree of need in his statement. He does not say: "In a situation of unmet need, with patients dying daily for the want of a donor liver, what is fair to all patients is to have those individuals in greatest need to be given priority over those patients with a lesser need." Such an approach would reflect a Utilitarian model, in which medical resources are provided on the basis of maximal medical benefit.
In the Libertarian model medical services are merely a market commodity subject to free-market conditions, and a fair distribution of medical resources occurs as long as they are distributed without force or fraud in a free-market economy. When Beauchamp and Childress write “To each person according to free-market exchanges” they are invoking a Libertarian model of medical services.
One common view is that any ethically appropriate model for organ allocation must take into account issues related to benefit and need., and that those patients who both have a strong need for a transplant and will strongly benefit from a transplant should get priority over patients with either less of a need or who would be expected to obtain less of a benefit. This is a Utilitarian viewpoint based primarily on clinical factors. And, in fact, this is more or less how things are done in the real clinical world. For instance, according to the American Medical Association [1] criteria for organ allocation include:
* The likelihood of benefit to the patient;
* The impact of treatment in improving the quality of the patient’s life;
* The duration of benefits;
* The urgency of the patient’s condition; and
* In some cases, the amount of resources required for successful treatment
This particular set of criteria for organ allocation appears to me to be a particularly well thought out set of Utilitarian principles that is superior to the simpler Egalitarian model advocated by Crippin in that if takes into factors like benefit, quality of life and urgency that are not explicitly addressed by the Egalitarian model. I would cast my vote for this approach.
Reference
[1] http://www.ama-assn.org/ama/pub/article/2036-2387.html

## MEDICAL FUTILITY THEORY

Starting Point: The Case of Helga Wanglie
Helga Wanglie broke her hip in December 1989 after a fall in her home. She was 86. She was treated in hospital and moved to a nursing home, but a month later she was readmitted for respiratory complications and needed to be placed on a ventilator. Attempts to wean her were unsuccessful. As a result, she was transferred to a long-term care facility that specialized in ventilated patients. While there, she suffered a cardiac arrest with anoxia that resulted in severe, irreversible brain damage. She remained in a persistent vegetative state. Meanwhile, she also remained in a state of permanent ventilator dependency.
Because of her dismal prognosis, the medical staff suggested that her family consider termination of treatment. However, the family decided against any withdrawal of care, as she was apparently heard to have said "If anything happens to me, I want everything done". The matter went to court. In its decision, the court rejected the hospital's position and turned over full guardianship to Helga's 87 year-old husband. Helga Wanglie died of multisystem organ failure on July 4, 1991. Medical bills totaled approximately $750,000 [1-3].
If one were searching for a case to use for starting a classroom discussion on futile care theory, this case would be an excellent starting point. Few clinicians would disagree that Helga Wanglie’s case was completely hopeless, and almost all would also agree that there would be no clinical value in continuing extraordinary measures such as mechanical ventilation. Yet Helga Wanglie’s husband fought for continued treatment of his wife despite these facts. His conflict with the medical profession highlights many of the issues involved in futile care ethics.

#### Medical Futility Theory

The concept of futility has had historic importance in medicine. According to Drane and Coulehan [4], for Hippocratic physicians, attempting a futile treatment was a display of ignorance. They also note that contemporary ethical standards published by the Council on Ethical and Judicial Affairs of the American Medical Association (AMA) show continuity with this tradition: "Physicians should not provide or seek compensation for services that are known to be unnecessary or worthless." Drane and Coulehan recognize, however, that patients and their families may not agree:
‘Traditionally, applying the principle that physicians do not provide treatments when the interventions at their disposal do not produce medical benefits has been relatively straightforward. However, with the growing importance of patient autonomy and informed consent in treatment decisions, ethicists must now balance this principle with the principle of patient self-determination.‘
‘A patient's right to choose or refuse treatment is limited by the physician's right (and duty) to practice medicine responsibly. Bizarre or destructive choices made by a patient are not sacrosanct simply because the patient made them. In some cases, physicians may choose not to act on patient decisions that appear to be unreasonably destructive.’
‘Physicians also have a right to refuse to provide futile treatments (i.e., interventions that might be physiologically effective in some sense but cannot benefit a patient). Patients themselves have a right to provide input into what would constitute a "benefit" for them, but physicians should be able to decide when a particular treatment is futile based on their knowledge of the treatment's effects and its likely impact on a patient's quality of life.’
Ethical principles dealing with medical futility can be developed based on the traditional bioethical principle of beneficence, as well based on traditional physician values identified above. Under the principle of beneficence, which directs physicians to apply their skill and knowledge only for the good of their patient, physicians should not provide treatment known not to produce clinical benefits. Some authors go further. For example, McGee et al. [5] state: “Withholding futile treatments supports the ethical principles of both nonmaleficence (do no harm) and beneficence (relieve suffering).” Finally, the Catholic Health Association of the United States has issued a statement of principles on the issue that emphasizes similar principles.
Modern arguments against futile care generally center on two issues. First, futile care has no possibility of achieving a good outcome and serves only to prolong death. No physical or spiritual benefit comes from such care. Futile care also prolongs the grieving process and frequently raises false hope. Also, futile care can be very difficult on caregivers, who may see themselves as forced to act against the best interests of their patient [6,7].
Secondly, in a setting of limited resources, futile care involves the expenditure of resources that could be used by other patients with a good likelihood of achieving a positive outcome. This second argument would appear to be strong in those nations with socialized health care systems.

#### Families Seeking Futile Care

The above not withstanding, families occasionally seek to ensure that their loved ones get heroic or extraordinary care even in the absence of any likelihood of clinical benefit. However, in most of these cases the family eventually comes to realize that there is no possibility of a good outcome from such efforts, and end up agreeing with the clinical team. But not always.
One famous case is that of Baby K, an anencephalic infant. The infant’s mother wanted the hospital to continue with advanced supportive care (primarily ventilatory support) against the wishes of the clinical team, and sought legal support for her position. Ms. H. knew of her baby's condition from the second trimester of her pregnancy, but, motivated by a strong religious conviction that "all life is precious" and that God alone should decide how long the baby would live, she remained adamant that Baby K. be kept alive as long as possible.
The hospital’s position was that such care would be futile. At the trial [Matter of Baby K. 16 F.3d 590 (4th Cir. 1994), n. 9 at 598.], expert testimony was given to demonstrate that provision of ventilator support for anencephalic infants goes beyond the accepted standard of care. The legal team for Baby K's mother adhered to a religious sanctity-of-life principle as the basis for their case. In the end, in a particularly controversial decision, the U. S. District Court ruled that the hospital caring for Baby K must put her on a mechanical ventilator whenever she had trouble breathing. In particular, the court interpreted the Emergency Medical Treatment and Active Labor Act (EMTALA) to require continued ventilation for the infant. The wording of this act requires that patients who present with a medical emergency must get "such treatment as may be required to stabilize the medical condition" before the patient is transferred to another facility. The court took the position that "it is beyond the limits of our judicial function to address the moral or ethical propriety of providing emergency stabilizing medical treatment to anencephalic infants. We are bound to interpret federal statutes in accordance with their plain language..." As a result of the decision, Baby K was kept alive much longer than most anencephalic babies, living to age 2 ½ .
The cases of Baby K and Helga Wanglie vividly demonstrate how family and clinical caregivers may sometimes see matters very differently. Such differences usually reflect very different philosophical vistas, and cannot always simply be dismissed as being based on ignorance on the part of the family. For instance, some people take the “santity of life” argument to its extreme, arguing that all efforts to sustain life should be made wherever clinically possible, no matter how degraded that life may be. While much has been written to refute this position (see, for instance, the writings of Peter Singer [8]), such (usually always secular) counterarguments generally have little or no impact on individuals invoking such arguments based on personal religious beliefs.
Some other individuals may argue that clinical care should be a market commodity that one should be able to purchase just like cruise vacations or luxury automobiles, as long as the purchaser of the clinical services has the necessary funds and as long as other patients are not being denied access to clinical resources as a result. In this model, Helga Wanglie should be able to get ICU care until funding vanished.
In my view, this market-oriented viewpoint is either naïve or wrong in several respects. First, in almost all such cases the funding comes from insurance carriers, who must avoid “wasting” funds to ensure that adequate funds are available for other clients. Secondly, competition for ICU resources can be intense, and providing ICU care to patients who will not benefit from them only makes access more difficult for patients for which ICU care would prove to be clinically beneficial. Finally, to view clinical care is a mere market commodity or service is to detach it from its underlying dignity and humanity.

#### The Case Against Medical Futility Theory

Are there, then, any potential problems with futile care theory? Could it be that the issues are not be as cut and dried as the clinical community would have it?
In this respect, it is helpful to consider matters from the perspective of those who disagree with the traditional clinical view regarding futile care. For Helga Wanglie and her husband, all human life - even a degraded and permanently unconscious human life – is still taken to be valuable, regardless of any considerations of quality of life. Similarly, the mother of Baby K no doubt saw her infant’s life as infinitely valuable, even if incapable of a conscious existence.
One criticism of futile care theory is that the caregivers sometimes see things only from the perspective of their training, and thus seek to be the only decision-makers in these matters. However, as noted by Weijer and Elliott [9], for clinicians to be the sole decision-makers in these situations amounts to saying to families, "Your values don't count."
Weijer and Elliott [9] go on to note that different viewpoints concerning the goals of treatment may form the basis for disagreements between families and clinicians:
“… judgments of futility make sense only in relation to a specified goal: an intervention may be futile if the aim is to cure an underlying disease but effective if the aim is to keep the patient alive. Yet in the most controversial cases in which futility is invoked the disagreement between doctors and families is not about the probability that an intervention will work but about the goals that it will serve.”
“… the concept of medical futility is a tarbaby. It cannot do what it is asked to do, and trying to force the issue won't produce a solution; it will produce a mess. When patients or families demand treatment that is unlikely to produce a good outcome doctors ought to disclose carefully the treatment options, the likely outcomes, and the probabilities of attaining those outcomes. Clearly, both the doctor's judgment and that of the patient (or family) are essential to the decision making process. … This can be achieved only by an open and frank dialogue. Invoking futility ensures, if anything, that this will not occur.”
Another problem confronting futile care theory is that invoking the principle of futility is sometimes direct conflict with the principle of patient autonomy. As the case of Helga Wanglie illustrates, when families make end-of-life decisions in conflict with caregivers, and the case ends up in courts, the courts are often strongly influenced by concerns for patient's right to autonomy. As Weijer and Elliott note [9]: “Futility is not the ethical trump card that some would like it to be.”
Another problem with futile care theory is that even defining the notion of clinical futility can be challenging. McGee et al [5] emphasize that various definitions are used in the literature:
“The term medical futility has been used to describe life-or-death situations in which proposed treatments will fail to prolong quality life, achieve the patient's key goals for medical care, achieve a critical physiologic effect on the body, or result in a therapeutic benefit for the patient. Another definition of futility states that "if a treatment merely preserves permanent unconsciousness or cannot end dependence on intensive medical care, the treatment should be considered futile." In an attempt to give a quantitative definition of futility, some have suggested that treatments with less than a 1% chance of benefiting patients should be considered futile.”
The Ethics Committee of The Society of Critical Care Medicine has attempted to clarify the concept of futility with a policy statement. They emphasize, among other things, that care that is extremely unlikely to be beneficial is not necessarily futile in nature [10]. They write:
“Treatments should be defined as futile only when they will not accomplish their intended goal. Treatments that are extremely unlikely to be beneficial, are extremely costly, or are of uncertain benefit may be considered inappropriate and hence inadvisable, but should not be labeled futile. Futile treatments constitute a small fraction of medical care. Thus, employing the concept of futile care in decision-making will not primarily contribute to a reduction in resource use. Nonetheless, communities have a legitimate interest in allocating medical resources by limiting inadvisable treatments. Communities should seek to do so using a rationale that is explicit, equitable, and democratic; that does not disadvantage the disabled, poor, or uninsured; and that recognizes the diversity of individual values and goals. Policies to limit inadvisable treatment should have the following characteristics: a) be disclosed in the public record; b) reflect moral values acceptable to the community; c) not be based exclusively on prognostic scoring systems; d) articulate appellate mechanisms; and e) be recognized by the courts. Healthcare organizations that control payment have a profound influence on treatment decisions and should formally address criteria for determining when treatments are inadvisable and should share accountability for those decisions.“
Finally, futility theory may be challenged on a statistical basis. While scenarios like providing ICU care to the brain dead patient or the anencephalic patient when organ harvesting is not possible or practical are easily identifiable as being completely futile, many other situations usually taken to be futile are far less clear. For instance, should surgeons attempt a heroic clinical rescue in a 99 year old unconscious patient with a ruptured abdominal aortic aneurysm, even though survival with a good outcome would be so very unlikely as to warrant publication of the case as a clinical case report? Various bleak clinical scenarios will vary in their degree of futility. For instance, when elderly patients sustain large third degree burns, mortality is almost guaranteed. This is similarly true for elderly patients sustaining massive trauma. But in many of these cases it can still be very difficult to accurately predict outcome [11, 12].
As Weijer and Elliott note:
“… problems will arise with any criterion that allows doctors to rely solely on their own experience. Their recollections are biased towards cases with a poor outcome. Moreover, doctors' judgments about individual cases are not accurate enough to allow them to claim reliably that a given person has (for instance) less than a 1% chance of responding to treatment. While the agreement of several colleagues about a prognosis may improve the judgment's reliability, support from the literature may be lacking. Even if empirical data exist on a particular intervention, the vast majority of "negative" clinical trials have a sample size that is too small to provide strong enough evidence to rule out a small treatment effect.”

#### References, Sources and Notes

* In re the conservatorship of Helga M. Wanglie, No. PX-91-283, District Probate Division, 4th Judicial district of the County of Hennepin, State of Minnesota.
* http://web.archive.org/19990824232320/www.geocities.com/HotSprings/Oasis/2919/cases.html
* http://www.missouri.edu/~philwb/wanglie.html
* James F. Drane, PhD, & John L. Coulehan, MD . The Concept of Futility. Patients Do Not Have a Right to Demand Medically Useless Treatment. Health Progress 1993. http://www.chausa.org/PUBS/PUBSART.ASP?ISSUE=HP9312&ARTICLE=B
* McGee DC. Weinacker AB. Raffin TA. The patient's response to medical futility. Archives of Internal Medicine. 160(11):1565-6, 2000 Jun 12.
* Ronald M. Perkin, MD. Stress and Distress in Pediatric Nurses: The Hidden Tragedy of Baby K. http://www.llu.edu/llu/bioethics/update12_2.htm
* For a somewhat different view from that of Perkins (above) consider the perspective of Dagi. Dagi argues against making the emotional needs of the caregiver an overriding consideration in clinical ethics, arguing that the claim of health care workers to be a professional “places legitimate constraints on the extent to which they may be permitted to have their needs and wants influence the ethical dialectic.” T. F. Dagi, "Compassion, Consensus, and Conflict: Should Caregivers' Needs Influence the Ethical Dialectic?" The Journal of Clinical Ethics 3 (1992): 214-18.
* Peter A. Singer. Rethinking Life and Death: The Collapse of Our Traditional Values. St. Martin's Griffin (New York) 1994
* Weijer C. Elliott C. Pulling the plug on futility. BMJ. 310(6981):683-4, 1995 Mar 18.
* The Ethics Committee of the Society of Critical Care Medicine. Consensus statement of the Society of Critical Care Medicine's Ethics Committee regarding futile and other possible inadvisable treatments. Crit Care Med. 1997;25:887-891.
* Dawson NV, Arkes HR. Systematic errors in medical decision making: judgement limitations. J Gen Intern Med 1987; 2:183-7.
* Poses RM, Bekes C, Copare FJ, Scott WE. The answer to "What are my chances, doctor?" depends on whom is asked: prognostic disagreement and inaccuracy for critically ill patients. Crit Care Med 1989; 17:827-33.

## VIRTUE IN HEALTH CARE

"Virtue is harder to be got than a knowledge of the world; and, if lost in a young man, is seldom recovered." John Locke
Wisdom is knowing what to do next; virtue is doing it. David Star Jordan
According to the Internet Encyclopedia of Philosophy [1] “virtue theory is the view that the foundation of morality is the development of good character traits, or virtues”. According to this model, a person is good or virtuous to the extent that he or she has virtues and lacks vices. Another way of looking at the matter is to state that there are certain ideals, such as the pursuit of excellence or dedication to the common good, which we should strive for and which permit the full development of our humanity. Virtues may be viewed as attitudes or character traits that enable us to develop this potential.
The virtues of everyday life include generosity, fidelity, self-control, honesty, truthfulness, integrity, bravery, courage, justice, patience, prudence, fortitude, tolerance, and countless others. In fact, some virtue theorists have identified over 100 virtuous character traits.
However, different social groups may emphasize different “virtue sets”. For instance, the Boy Scout virtues are “ trustworthy, loyal, helpful, friendly, courteous, kind, obedient, cheerful, thrifty, brave, clean and reverend” [2]. By contrast, some other social groups (Satanists and Hell’s Angels members come to mind) would not consider all of these character traits to be virtuous [3]. Indeed one man’s virtue may be another man’s vice, as in the often-used term “generous to a fault”.
Minogue details five virtues [4] that are associated with medicine. He holds these to be:
* Compassion
* Courage
* Tolerance
* Honesty
* Faithfulness (or Fidelity, or Loyalty)
Missing in this list is a trait that most patients want above all in a physician or nurse – competence. The importance of professional competence as a virtue has been emphasized elsewhere. For instance, the College of Human Medicine at Michigan State University has developed a set of “desirable professional attributes” that are used as examples of “professional virtue” for guiding medical students [5]. These attributes fall into six categories:
* Competence
* Honesty
* Compassion
* Respect for Others
* Professional Responsibility
* Social Responsibility
While there is considerable overlap in these lists (for instance, both lists include compassion and honestly as desirable traits, and Minogue’s “tolerance” trait is similar to the “respect for others” trait in the College of Human Medicine list), the differences are nonetheless striking. Also, some individuals do not regard “courage” as an especially important trait in clinical practice, except in the context that exercising honesty and responsibility in hostile settings can sometimes require considerable courage. Some individuals would argue that both these lists should be combined to make a list of virtues for physicians. The combined list one might then propose would be:
* Competence
* Honesty
* Compassion
* Respect for Others
* Professional Responsibility
* Social Responsibility
* Courage
* Loyalty
Yet it is also appropriate to consider even more virtues that might apply, such as resourcefulness, patience, integrity, wisdom and prudence. To the extent that these traits overlap with the list above it is not necessary to explicitly list them. Still, they are important clinical virtues.
One interesting issue is whether the traits of the virtuous physician and the traits of the virtuous nurse are similar. Many individuals would argue that they are indeed similar, that there are no more differences between the traits of the virtuous physician and the traits of the virtuous nurse then there are between the virtuous traits of the various medical specialties. There are, of course, differences between what nurses and physician do, just as there are differences between the various medical specialties do. But perhaps these differences are so great that different sets of virtues are necessarily implied. Both groups have the same goals in mind for their patient, and both groups share a similar clinical worldview. The fact that one group frequently implements orders from the other is not, in my view, an overriding issue. Nor perpahs should one regard it as particularly relevant that nurses are often said to come from a tradition of caring, while physicians are often said to come from a tradition of science and reason. The reality is that both traditions are major influences on both nurses and physicians in today’s clinical world.

#### Notes

* http://www.utm.edu/research/iep/
* More information is available at http://www.scouting.org
* More information is available at http://www.churchofsatan.com
* Source: http://www.acsu.buffalo.edu/~fescobar/337H/lecture10.htm
* More information is available at http://www.chm.msu.edu/chmhome/index.htm

## BIOETHICS AND TOBACCO

Tobacco is a legal product and smoking it is a legal practice, at least in most locales. Yet it is understood by all to be unhealthy and a cause of/contributing factor to several diseases leading to disability and death. One interesting question is whether the life-long smoker's right to national health insurance (such as the US Medicare system) to cover the treatment of lung cancer should be forfeited because of this self-destructive behavior.
According to the World Health Organization one out of every two long-term smokers will ultimately be killed by tobacco [1]. They note that “in developed countries, half will be killed in old age, after age seventy, but the other half will be killed in middle age, before age seventy, and those who die from smoking before age seventy will lose more than 20 years of life expectancy”. In the USA, a 1998 study by Leonard Miller, professor of social welfare at the University of California Berkeley and Dorothy Rice, professor emeritus of health economics at the UCSF School of Nursing found that “smoking-related Medicaid costs amount to $12.9 billion per year, or $322 billion in 25 years without inflation”, a figure that they noted “does not include the financial impact of cigarette smoking on Medicare or private insurance companies” [2].
About 75% of Americans do not smoke, yet everyone pays for the cost of treating tobacco-related illnesses via higher insurance premiums and taxes. Many people argue that it is not fair that non-smokers have to pay many billions of dollars in health insurance premiums and taxes for the medical treatment of smokers. Given the well-established link between long-term tobacco use and lung cancer, this has led some individuals to suggest that life-long smokers should be denied Medicare or Medicaid health insurance coverage for the treatment of lung cancer.
However, such a policy may be both impractical and unethical.
First, while there is no doubt that health care costs are higher for smokers, the extra health care costs to Medicare and Medicaid associated with smoking can be recovered simply by increasing the price of cigarettes. This would be a particularly effective alternative to denying Medicare services to smokers, since there is strong data to suggest that raising the cost of cigarettes is one of the most effective ways of reducing consumption.
Secondly, tobacco smoking is hardly the only form of self-destructive behavior. Other self-destructive practices that one might focus one include the following:
* excessive alcohol consumption
* not wearing seatbelts while driving
* participation in unsafe sexual practices
* excessive food consumption leading to morbid obesity
* use of dangerous recreational drugs such as cocaine or heroin
* participation in dangerous sports without sufficient attention to safety issues
In the interests of fairness, if one were to deny Medicare services to smokers, it would also be necessary to deny Medicare services to individuals who sustain clinical insults as a result of other self-destructive behavior. It should be apparent that this would be a logistical nightmare.
Third, if life-long smokers on Medicare health insurance should be denied coverage for the treatment of lung cancer, they should also be denied coverage for other diseases strongly linked to smoking: coronary heart disease, cerebrovascular disease, peripheral vascular disease, emphysema, chronic obstructive pulmonary disease, bladder cancer, and even age-related macular degeneration (AMD), a leading cause of blindness.
Fourth, the US government has not made a concerted effort to reduce tobacco use. Industry commentators often point out that there is an incestuous relationship between the tobacco industry and US government. While the idea of regulating tobacco use and creating a "smoke-free" society remains a popular dream in Washington, the reality is that the federal government and the 50 states eagerly consume a steady flow of sin taxes generated by the sale and consumption of tobacco products. Furthermore, and most amazingly, Washington continues to subsidize the growth of tobacco. Some critics suggest that the US federal government should clean up its own house first before implementing draconian Medicare policies of the nature suggested.
Fifth, there are many causes of lung cancer besides tobacco smoking, and some forms of lung cancer (e.g. small cell cancer) are not related to smoking at all. Radon exposure, exposure to asbestos, and even dietary factors may account for many cases of lung cancer. In fact, the only form of lung cancer that is unequivocally linked to smoking is squamous cell carcinoma.
Finally, medicine has a humane tradition of being nonjudgmental and caring for all regardless of social worth or social standing. Public policy should reflect this. Some critics suggest that setting into place a policy whereby a life-long smoker's access to Medicare for the treatment of lung cancer should be forfeited is inhumane in the extreme. Such action says to the patient that he or she is unworthy of our clinical attention, and is in clear violation of the principle of beneficence.

#### References

[1] TOBACCO – HEALTH FACTS. WHO Fact Sheet No 221. April 1999. http://www.who.int/inf-fs/en/fact221.html
[2] http://www.ucsf.edu/daybreak/1998/03/309_cig.htm