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040430P - THE CONCEPTUAL BASIS FOR RESOLVING ETHICAL CONTROVERSIES IN MEDICAL DECISIONS

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Paper presented at a seminar on medical ethics at the National Heart Institute, Kuala Lumpur on 30th April 2004 by Prof Dr Omar Hasan Kasule, Sr. MB ChB (MUK), MPH, DrPH (Harvard)


ABSTRACT
European ethical theories and ethical principles are characterized by inconsistency and lack of uniformity because of their European historical background. The paper presents an alternative ethical theory based on defining five purposes of medicine. It also presents 5 ethical principles that help resolve conflicts between the 5 purposes. The 5 purposes read together with the 5 principles provide a robust and consistent system for resolving virtually all problems that arise in medical decisions. Medical intervention is supposed to achieve 5 purposes: morality, health, progeny, intellect, and property. These 5 purposes must be protected, preserved, and promoted. The 5 principles are: intention, certainty, harm, difficulty, and precedent. Practical applications are discussed. The purpose of morality underlies physician values, disclosure and truthfulness, privacy, confidentiality, and fidelity. The principle of intention underlies informed consent,

1.0 BACKGROUND TO EUROPEAN MEDICAL ETHICS
1.1 THE RISE OF ETHICS
Secularized European law denies moral considerations associated with ‘religion’. Its failure to solve issues in modern medicine that required moral considerations led to the birth of the discipline of medical ethics. However the new discipline was unclear neither law enforced by courts nor morality enforced by religious authority. Concern with moral issues in medicine increased in the recent past due to new medical technology and increase in moral violations by medical practitioners.

1.2 EUROPEAN ETHICAL DOCTRINES
The following international declarations covered legal medical issues from a European world-view: Declaration of Geneva, International Code of Medical Ethics, Declaration of Tokyo, Declaration of Oslo, and Declaration of Helsinki. In 1976 Beauchamps and Childress wrote authoritatively about ethical theory and ethical principles. They listed 4 basic European ethical principles: autonomy, beneficence, non malefacence, and justice. They listed eight European ethical theories none of which can on its own explain all ethical or moral dilemmas. These theories can be listed as the utilitarian consequence-based theory, the Kantian obligation-based theory, the rights-based theory based on respect for human rights, the community-based theory, the relation-based theory, and the case-based theory.

According to the utilitarian consequence-based theory, an act is judged as good or bad according to the balance of its good and bad consequences. Utilitarianism means attaining the greatest positive with the least negative. This theory has a problem in that it can permit acts that are clearly immoral on the basis of utility. The obligation-based theory is based on Kantian philosophy. Immanuel Kant (1724-1804) argued that morality was based on pure reasoning. He rejected tradition, intuition, conscience, or emotions as sources of moral judgment. The problem with the Kantian theory is that it has no solution for conflicting obligations because it considers moral rules as absolute. The rights-based theory is based on respect for human rights of property, life, liberty, and expression. The individual is considered to have a private area in which he is master of his own destiny. The problem of the rights-based theory is that emphasis on individual rights creates an adversarial atmosphere. According to the community-based theory, ethical judgments are controlled by community values that include considerations of the common good, social goals, and tradition. This theory repudiates the rights-based theory that is based on individualism. The problem with this theory is that it is difficult to reach a consensus on what constitutes a community value in today’s complex and diverse society. The relation-based theory gives emphasis to family relations and the special physician-patient relation. For example a moral judgment may be based on the consideration that nothing should be done to disrupt the normal functioning of the family unit. The problem of this theory is that it is difficult to deal with and analyze emotional and psychological factors that are involved in relationships. The case-based theory is practical decision-making on each case as it arises. It does have fixed philosophical prior assumptions.

1.3 INCOSISTENCY OF EUROPEAN ETHICS
Europeans have a problem dealing consistently with moral issues after removing religion from public life over the past 5 centuries of secularism. The 3 European approaches to ethical analysis are: normative (what ought to be done) or practical (what most people do), and non-normative (what is actually going on). Morality became communal consensus about what is right and what is wrong. Thus ethics became relative and changeable with change of community values. European law does not follow a consistent moral guideline. It does not automatically ban all what is immoral and does not automatically permit all what is moral. Lack of one coherent European theory of ethics is because of the historical background. During the Roman Empire a marriage of convenience held between Judeo-Christian concepts and pagan Greco-roman concepts. The marriage was strained by a partial return of Europeans to their Greco-Roman heritage and marginalization of the Christian Church starting with the renaissance and reformation through the enlightenment, modernism and now post modernism. In these circumstances it was difficult to define one coherent European ethical theory.

2.0 THE 5 PURPOSES OF MEDICINE
2.1 PROTECTION OF MORALITY
Protection of morality essentially involves religious practice in the wide sense that every human endeavor is a form of worship. Thus medical treatment makes a direct contribution to religion by protecting and promoting good health so that the worshipper will have the energy to undertake all the responsibilities of worship. A sick or a weak body can perform none of the acts of worship properly. Balanced mental health is necessary for intellectual competence needed to distinguish between the moral and the immoral. Thus medical treatment of mental disorders thus contributes directly to morality.

2.2 PROTECTION OF LIFE
The primary purpose of medicine is to fulfill the second purpose of protecting health and life. Medicine cannot prevent or postpone death since such matters are in the hands of the creator alone. It however tries to maintain as high a quality of life until the appointed time of death arrives. Medicine contributes to the preservation and continuation of life by making sure that the nutritional functions are well maintained. Medical knowledge is used in the prevention of disease that impairs human health. Disease treatment and rehabilitation lead to better quality health.

2.3 PROTECTION OF PROGENY
Medicine contributes to the fulfillment of this function by making sure that children are cared for well so that they grow into healthy adults who can bear children. Treatment of infertility ensures successful child bearing. The care for the pregnant woman, perinatal medicine, and pediatric medicine all ensure that children are born and grow healthy. Intra-partum care, infant and child care ensure survival of healthy children. Protection of progeny assures continuation of the human species.

2.4 PROTECTION OF THE MIND
Medical treatment plays a very important role in protection of the mind. Treatment of physical illnesses removes stress that affects the mental state. Treatment of neuroses and psychoses restores intellectual and emotional functions. Medical treatment of alcohol and drug abuse prevents deterioration of the intellect. The intellect is the distinguishing criterion of humans from animals. When humans lose their intellect they are not different from animals.
  
2.5 PROTECTION OF WEALTH
The wealth of any community depends on the productive activities of its healthy citizens. Medicine contributes to wealth generation by prevention of disease, promotion of health, and treatment of any diseases and their sequelae. Communities with general poor health are less productive than a healthy vibrant community. The principles of protection of life and protection of wealth may conflict in cases of terminal illness. Care for the terminally ill consumes a lot of resources that could have been used to treat other persons with treatable conditions. The question may be posed whether the effort to protect life is worth the cost. The issue of opportunity cost and equitable resource distribution also arises.

3.0 PRINCIPLES OF MEDICINE
3.1 THE PRINCIPLE OF INTENTION
The Principle of intention comprises several sub principles. The first sub principle is that each action is judged by the intention behind it calls upon the physicians to consult their inner conscience and make sure that their actions, seen or not seen, are based on good intentions. The second sub principle is that what matters is the intention and not the literal interpretation. It rejects the wrong use of data to justify wrong or immoral actions. The third sub principle states that means are judged with the same criteria as the intentions. It  implies that no useful medical purpose should be achieved by using immoral methods.

3.2 THE PRINCIPLE OF CERTAINTY
Medical diagnosis does cannot reach the legal standard of absolute certainty. Treatment decisions are best on a balance of probabilities. Each diagnosis is treated as a working diagnosis that is changed and refined as new information emerges. This provides for stability and a situation of quasi-certainty without which practical procedures will be taken reluctantly and inefficiently. Existing assertions should continue in force until there is compelling evidence to change them. Established medical procedures and protocols are treated as customs or precedents. What has been accepted as customary over a long time is not considered harmful unless there is evidence to the contrary. All medical procedures are considered permissible unless there is evidence to prove their prohibition. Exceptions to this rule are conditions related to the sexual and reproductive functions. All matters related to the sexual function are presumed forbidden unless there is evidence to prove permissibility. The exception for sexual or reproductive functions is because of their crucial role in ensuring survival and continuation of the human species.

3.3 THE PRINCIPLE OF INJURY
Medical intervention is justified on the basis of the principle that injury, if it occurs, should be relieved. An injury should not be relieved by a medical procedure that leads to an injury of the same magnitude as a side effect. In a situation in which the proposed medical intervention has side effects, we follow the principle that prevention of a harm has priority over pursuit of a benefit of equal worth. If the benefit has far more importance and worth than the harm, then the pursuit of the benefit has priority. Physicians sometimes are confronted with medical interventions that are double edged; they have both prohibited and permitted effects. The guidance of the Law is that the prohibited has priority of recognition over the permitted if the two occur together and a choice has to be made. If confronted with 2 medical situations both of which are harmful and there is no way but to choose one of them, the lesser harm is committed. A lesser harm is committed in order to prevent a bigger harm. In the same way medical interventions that are in public interest have priority over consideration of individual interest. The individual may have to sustain a harm in order to protect public interest. In the course of combating communicable diseases, the state cannot infringe the rights of the public unless there is a public benefit to be achieved. In many situations, the line between benefit and injury is so fine that the physician has to rely on conscience to reach a solution since no empirical methods can be used.

3.4 PRINCIPLE OF HARDSHIP
Medical interventions that would otherwise be prohibited actions are permitted under the principle of hardship if there is a necessity. Necessity legalizes the prohibited. In the medical setting a hardship is defined as any condition that will seriously impair physical and mental health if not relieved promptly. Hardship mitigates easing of legal rules and obligations. Committing the otherwise prohibited action should not extend beyond the limits needed to preserve the Purpose of the Law that is the basis for the legalization. Necessity however does not permanently abrogate the patient’s rights that must be restored or recompensed in due course; necessity only legalizes temporary violation of rights. The temporary legalization of prohibited medical action ends with the end of the necessity that justified it in the first place. This can be stated in al alternative way if the obstacle ends, enforcement of the prohibited resumes. It is illegal to get out of a difficulty by delegating to someone else to undertake a harmful act.


3.5 THE PRINCIPLE OF CUSTOM or PRECEDENT
The standard of medical care is defined by custom. The basic principle is that custom or precedent has legal force. What is considered customary is what is uniform, widespread, and predominant and not rare. The customary must also be old and not a recent phenomenon to give chance for a medical consensus to be formed.

4.0 REGULATIONS OF PHYSICIAN CONDUCT
4.1 VALUES, COMPETENCE, AND RESPONSIBILITY
The values explained below arise from fulfilling the purpose of morality. The physician-patient is based on brotherhood. The physician must maintain the highest standards of justice. He should also follow the following guidelines: good intentions, avoiding doubtful things, leaving alone matters that do not concern him, loving good for others, causing no harm, giving sincere advice, avoiding the prohibited, doing the enjoined acts, , renouncing greed, avoiding sterile arguments, respect for life, basing decisions and actions on evidence, following the dictates of conscience, righteous acts, quality work, guarding the tongue, avoiding anger and rage, respecting transgressing God’s limits, consciousness of God in all circumstances, performing good acts to wipe out bad ones, treating people with the best of manners, restraint and modesty, maintaining objectivity, seeking help from God, and avoiding oppression or transgression against others. The physician should be professionally competent, balanced, have responsibility and accountability. He must work for the benefit of the patients and the community.

4.2 DISCLOSURE AND TRUTHFULNESS
As part of the professional contract between the physician and the patient, the physician must tell the whole truth. Patients have the right to know the risks and benefits of medical procedure in order for them to make an autonomous informed consent. Deception violates fidelity. If disclosure will cause harm it is not obligatory. Partial disclosure and white or technical lies are permissible under necessity. Disclosure to the family and other professionals is allowed if it is necessary for treatment purposes. Physicians must use their judgment in disclosure of bad news to the patient.

4.3 PRIVACY AND CONFIDENTIALITY
Privacy and confidentiality are often confused. Privacy is the right to make decisions about personal or private matters and blocking access to private information. The patient voluntarily allows the physician access to private information in the trust that it will not be disclosed to others. This confidentiality must be maintained within the confines of the Law even after death of the patient. In routine hospital practice many persons have access to confidential information but all are enjoined to keep such information confidential. Confidentiality includes medical records of any form. The patient should not make unnecessary revelation of negative things about himself or herself. The physician can not disclose confidential information to a third party without the consent of the patient. Information can be released without the consent of the patient for purposes of medical care, for criminal investigations, and in the public interest. Release is not justified without patient consent for the following purposes: education, research, medical audit, employment or insurance.

4.4 FIDELITY
The principle of fidelity requires that physicians be faithful to their patients. It includes: acting in faith, fulfilling agreements, maintaining relations, and fiduciary responsibilities (trust and confidence). It is not based on a written contract. Abandoning the patient at any stage of treatment without alternative arrangements is a violation of fidelity. The fidelity obligation may conflict with the obligation to protect third parties by disclosing contagious disease or dangerous behavior of the patient. The physician may find himself in a situation of divided loyalty between the interests of the patient and the interests of the institution. The conflict may be between two patients of the physician such as when maternal and fetal interests conflict. Physicians involved in clinical trials have conflicting dual roles of physicians and investigators.

4.5 INFORMED CONSENT
Informed consent is derived from the Principle of Intention. No medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence. The patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias their decision-making. The patient must be free and capable of giving informed consent. Informed consent requires disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient, recommendation of the physician on the best course of action, decision by the patient, and authorization by the patient to carry out the procedures. The patient is free to male decisions regarding choice of physicians and choice of treatments. Consent can be by proxy in the form of the patient delegating decision making or by means of a living will.

Valid consent must be voluntary, informed, and by a person with capacity to consent. It involves explaining the procedure contemplated, making sure the patient understands, and offering the patient a choice. Consent is limited to what was explained to the patient except in an emergency. Refusal to consent must be an informed refusal (patient understands what he is doing). Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court. Doubts about consent are resolved in favor of preserving life. Spouses and family members do not have an automatic right to consent. A spouse cannot overrule the patient’s choice. Advance directives, proxy informed consent by the family are made for the unconscious terminal patient on withholding or withdrawal of treatment. Physician assisted suicide, active euthanasia, and voluntary euthanasia are illegal. A do not resuscitate order (DNR) by a physician could create legal complications. The living will has the following advantages: (a) reassuring the patient that terminal care will be carried out as he or she desires (b) providing guidance and legal protection and thus relieving the physicians of the burden of decision making and legal liabilities (c) relieving the family of the mental stress involved in making decisions about terminal care. The disadvantage of a living will is that it may not anticipate all developments of the future thus limiting the options available to the physicians and the family. The device of the power of attorney can be used instead of the living will or advance directive. Decision by a proxy can work in two ways: (a) decide what the patient would have decided if able (b) decide in the best interests of the patient. Informed consent is still required for physicians in special practices such as a ship’s doctor, prison doctor, and doctors in armed forces. Police surgeons may have to carry out examinations on suspects without informed consent.

4.6 CONSENT OF THE INCOMPETENT
Competent children can consent to treatment but cannot refuse treatment. The consent of one parent is sufficient if the 2 disagree. Parental choice takes precedence over the child’s choice. Courts can overrule parents. Life-saving treatment of minors is given even if parents refuse. Parental choice is final in therapeutic or non-therapeutic research on children. Mental patients cannot consent to treatment, research, or sterilization because of their intellectual incompetence. They are admitted, detained, and treated voluntarily or involuntarily for their own benefit, in emergencies, for purposes of assessment, if they are a danger to themselves, or on a court order. Suicidal patients tend to refuse treatment because they want to die. Nutrition, hydration, and treatment can be withdrawn in a persistent vegetative state since the chance of recovery is low. There is no moral difference between withholding and withdrawing futile treatment. Labor and delivery are emergencies that require immediate decisions but the woman may not be competent and proxies are used. Forced medical intervention and cesarean section may be ordered in the fetal interest. Birth plans can be treated as an advance directive.