Bioethics.pdf

Bioethics I, II, III TRANSCRIPTIONS BATCH 2016

AY 2012 – 2013 COMPILED BY MARIE MAE PANTOLLA BATCH 2016

SUBJECT: COPY PASTE BY: BATCH 2016

BIOETHICS MARIE MAE PANTOLLA

BIOETHICS 1 The course involves the study of the fundamental concepts of general ethics and the foundations of Bioethics. Here, students are made aware of their moral responsibilities as Christians as they exercise their profession. It is emphasized that as medical students, they should know where decisions are based in order to be ethical and Christian-oriented physicians. The course also includes related values and virtues that are necessary for the enhancement of morality in the practice of medicine. ELGA The expected lasallian graduate’s attributes (ELGA) are: • Ethically competent • Ethically efficient • Imbued with the spirit of faith • Virtuous • Reveres life: promotes and defends life • Respectful towards the human person • Compassionate and safe physician • Ethically responsive • Just • Responsible for oneself and responsible to others/patients • Respectful to human rights • Effective communicator INTRO TO BIOETHICS OBJECTIVES 1. 2. 3. 4.

To define the different ethical sciences To identify the similarities of the ethical sciences To differentiate the ethical sciences from one another To determine the scope of Bioethics

ETHICS That branch of philosophy that studies and draws conclusions of the degree of goodness and badness of human actions and conduct in relation to the purposes of human living. CHRISTIAN ETHICS That branch of theology which studies, in the light of human reason and of Christian Faith, the guidelines man must follow to attain his final goal. BIOETHICS Is the systematic study of human conduct in the areas of life sciences and of health care, insofar as that conduct is examined from the view point of moral values and principles

Bioethics goes beyond ethical issues in medicine to include ethical issues in: • Public health • Population concerns • Genetics • Environmental health • Reproductive practice and technologies • Animal health and welfare and the like ISSUE AREAS IN BIOETHICS 1. The rights and duties of patients and health professionals. 2. The rights and duties of research subjects and researchers; 3. The formulation of public policy, guidelines for clinical care and biomedical research. WHY IS THERE A NEED TO STUDY BIOETHICS? 1. there is a physician-patient relationship 2. the physician is a healer of another’s body 3. the physician does not have a total right and/or obligation over the patient 4. the physician must be guided by principles 5. the physician must be able to decide on certain actions/procedures without prejudice to the patient HUMAN ACTS OBJECTIVES: 1. To define human act 2. To differentiate human act from act of man 3. To analyze the nature of the human act 4. Describe the kinds of voluntary acts 5. To describe the effects of voluntary acts 6. Indentify the impairments of human acts or to voluntariness 7. To judge the imputability of a human act HUMAN ACTS Actions that proceed from insight into the purpose of one’s doing and from consent of free will VOLUNTARY ACT • perfect – an act performed with full knowledge and full consent of the will • imperfect – knowledge and/or consent are not full or lacking • actual – the act that proceeds from the present deliberation of the will • virtual – the act is placed by a previous deliberation that still persists in its effect EFFECT OF THE VOLUNTARY ACT • Positive – the effect comes from an action that is done (committed) • Negative – the effect comes from an action that is not done (omitted) • Direct – the effect is intended in itself • Indirect – the effect is not intended but merely permitted as the inevitable result of an object directly willed

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IGNORANCE • Invincible Ignorance – one is not able to dispel/remove the ignorance by a reasonable diligence • Vincible Ignorance – the ignorance can be removed by reasonable diligence but it is not removed due to negligence or bad will Principles: 1. Invincible Ignorance takes away or prevents the human act from being voluntary in regard to that which is not known. So, a human act coming from invincible ignorance is not voluntary in its cause. 2. Vincible Ignorance does not take away the voluntariness but diminishes voluntariness INATTENTION • an actual, momentary privation of knowledge Principles: 1. if a person does not attend at all to what he is doing, he does not accomplish a human act. 2. if a person is only half-attending to what he is doing, he performs an imperfect human act. ERROR 1. the origin of error may be traced from: – deficient education – influence of bad company – misleading mass media 2. 3. 4.

man is challenged to overcome the errors and search for the truth. man must be able to reach views based on sound reasons. man, as an individual, must fight against errors, and the community must help one another to resist error.

PASSION OR CONCUPISCENCE • a movement of the sensitive appetite which is produced by good or evil apprehended by the imagination Concept: • there is no connotation of evil • God has endowed man with these appetites which pervade his whole sensitive life • they are instruments for the self-preservation of the individual and the whole human race • passions become evil only if their force is not controlled by reason • man has the urgent duty to check his sensitive appetites Division: • antecedent – precedes the action of the will and at the same time induces the will to consent • consequent - follows the free determination of the will and is either freely admitted and consented to or deliberately aroused Principles: 1. antecedent passions always lessen voluntariness and sometimes preclude it completely because it hinders the reflection of reason and weakens its attention, at the same time, it strongly entices one to action and entices the will to consent. The more intensive concupiscence is, the weaker the intellect and will become. 2. consequent passions are either good or bad because they are either freely admitted and consented to or deliberately aroused. They are voluntary in themselves. FEAR • the shrinking back of the mind on account of an impending evil

Concept: • this kind of fear is intellectual fear as distinguished from the fear arising from the senses which is one of the passions • intellectual fear does not generally escape the control of the mind and will • generally it leaves the person free • the evil that causes the fear may threaten the affected person or those associated with him Principles: 1. fear does not destroy the voluntary character of an action but it usually lessens the merit or guilt 2. even though an action done out of fear has an involuntary aspect, it holds that a person does so by a decision of his will and therefore performs a human act. 3. grave fear – caused by a grave evil which one cannot easily escape from – usually excuses from the obligations of divine or human laws. The reason for this is that moral impossibility excuses from the compliance with such laws. VIOLENCE • a compulsive influence brought to bear upon one against his will by some extrinsic agent Concept: • violence is not caused by moral force but only by the compulsive force of some physical or psychic agent • while internal resistance of the will is essential for violence, external resistance is not always called for Division: • absolute – if the will dissents totally and resists as best it can and is meaningful • relative – if the will dissents only partially or weakly and is perhaps deficient in its external resistance, too Principles: • absolute violence excludes any voluntariness. • relative violence does not impair voluntariness completely but lessens it DISPOSITIONS AND HABITS 1. Disposition – an inclination that one has to certain ways of action and conduct which have their roots in one’s character an inherited propensities 2. Habit –the facility or easiness and readiness of acting in a certain manner acquired by repeated acts Principles: 1. a deliberately admitted habit does not lessen voluntariness, and actions resulting there from are voluntary at least in their cause; person is responsible if he consents by free decision to the habit. 2. an opposed habit lessens voluntariness and sometimes precludes it completely.

NORMS OF MORALITY Objective Norm – Moral Law Subjective Norm – Conscience MORAL LAW OBJECTIVES:  To identify the objective norm of morality  To define the different laws  To differentiate the different laws from one another  To explain the nature of moral law  To explain the nature of natural law  To explain the nature of human law  To determine and justify the obligations towards the laws  To judge a human action according to the moral law

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LAW -

ANY DIRECTIVE OR RULE OF ACTIVITY

MORAL LAW A DIRECTIVE RULE OF OBLIGATORY, GENERAL, AND STABLE CHARACTER, ORDERING MAN’S ACTIVITY TOWARD THE ULTIMATE END. DIVISION OF MORAL LAW (hierarchical order):

Divine Law Natural Law Human Law

Moral Law Includes: – obligatory demands – recommendations – common laws which concern all men or groups of men – personal commands which result from an individual call addressed to an appointed person – counsels – permission CHARACTERISTICS OF A GENUINE MORAL LAW: GOOD and HOLY A genuine moral law must be good and holy because the moral law MUST GUIDE human activity to contribute to the REALIZATION OF THE FINAL GOAL of human history and of creation and that it should prevent man from obstructing the attainment of this end. CHARACTERISTICS OF A GENUINE MORAL LAW: GOOD and HOLY PRINCIPLES: • a norm which does not contribute to the final end has no moral force binding the will. • a norm which results in the frustration of the ultimate good is morally evil and its observance unlawful. The Moral Law is based on the ORDER OF BEING • Action follows being 1. a thing acts according to its nature. 2. the nature of a thing is the cause, while the action is the effect. The Moral Law is based on the ORDER OF BEING • Application of this axiom to man’s activity 1. man’s moral obligation must be derived from and measured by the nature of his being. 2. God is the ultimate norm of moral law since He created everything. 3. the laws emerging from man’s nature have their origin in the Creator’s designs. 4. the task of Christian Ethics is to recognize man as he really is in his true nature and with all his essential relations and to derive therefrom the moral laws which are to direct his activity. NATURAL MORAL LAW IS THAT MORAL ORDER WHICH ARISES FROM THE FULL REALITY OF HUMAN NATURE AND WHICH CAN BE RECOGNIZED BY MAN’S REASON, INDEPENDENT OF POSITIVE DIVINE REVELATION. “full reality of human nature” spiritual – the effects of Christ’s saving work comprises all the ends designed in the physical, psychical and spiritual inclinations and

aspirations of human nature inclusive of the ultimate end “full reality of human nature” The ends here refer to existential ends, and these are/include: 1. self-preservation which includes bodily integrity and social respect 2. self-perfection physically and spiritually which includes: a) development of one’s faculties for the improvement of the conditions of life, and b) provision for one’s economic welfare by securing the necessary property or income 3. broadening of experience and knowledge 4. procreation and education of children 5. interest in the spiritual and material welfare of one’s fellowmen as human persons equal in value 6. social organizations to promote common utility which consist in the maintenance of peace and order and in the opportunity for all to attain full human existence by sharing proportionately in the welfare of society 7. promotion of cultural progress and creative evolution of the world 8. the knowledge and worship of God and the ultimate fulfillment of man’s destiny through union with Him “recognized by man’s reason” the medium is reason alone but this does not exclude the influence of grace. PROPERTIES OF THE NATURAL LAW 1. Universality 2. Immutability 3. indispensability UNIVERSALITY – the natural law binds all people at all times in all places – no one is superior to the guidelines which show man the way – no one is beyond good and evil – no one is free from the obligation of fulfilling the duty to obey and abide with this law – the most universal principle of the natural law is: GOOD MUST BE DONE AND EVIL MUST BE AVOIDED. What is good and worthy of man’s desire? The following are guidelines: 1. the golden rule 2. maintain and promote your bodily and mental life. 3. maintain and promote social coexistence 4. give to everyone what is his due IMMUTABILITY INDISPENSABILITY – no one is dispensed from the natural law from the side of human authority – there may be a suspension of the natural law but such suspension always demands an expressed positive divine revelation HUMAN LAW IS AN ORDINANCE OF REASON FOR THE COMMON GOOD, PROMULGATED BY HIM WHO HAS THE CARE OF THE COMMUNITY. Reasons for the necessity of human law 1. to make clear the requirements of the natural law and the divine positive law for everybody 2. to enforce obedience at least to those demands of the moral law which are of greater value for the common good. 3. to determine the moral law more precisely when several possibilities of fulfilling it are open to men.

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OBJECT OF THE HUMAN LEGISLATION  The direct object of human law is the common welfare/good  Human legislation is supposed to create favorable conditions for man’s life in the religious, cultural, social and economic aspects.  Human legislation has to safeguard the common good by protecting the moral culture of the community, its interior peace, security, social justice, and human rights. 4 conditions that a regulation may become the object of a law 1. the content of the law must be morally permitted. 2. the content of the law must be just – the lawgiver must not go beyond his jurisdiction – the law must not restrict the rights of the subjects – the law must distribute burdens and privileges equally and according to the capacities of the subjects – new penal laws cannot be extended to past actions 3. the law must be physically and morally possible. – the law must be within the forces and means of a person – the command of the law can be done with no great difficulty 4. the law must be useful and of benefit for the common good MORAL OBLIGATION TOWARDS THE LAW: PRINCIPLES: 1. on the nature and gravity of the moral obligation – just laws bind in conscience by reason of their intrinsic necessity and justice – anyone who violates a just law is in conscience bound to submit to a just punishment – a punishment is just if it measures up to the importance of the law for the common welfare 2. on the extent of the moral obligation – the subject has the moral obligation to acquire by sufficient means a knowledge of the law – the subject is obliged to use the ordinary means which are absolutely necessary for the observance of the law – the subject is bound to remove or anticipate obstacles which make the observance of the law proximately impossible, if this can be done without great inconvenience CESSATION 1. of the obligation towards the law: – when one ceases to be subject of the law – when one is invincibly ignorant of the law – when there is a physical impossibility – when there is a moral impossibility – a dispensation – a privilege 2. of the law: – through the act of a legislator or through contrary customs – a new law abrogates a former law if it expressly states it, or if it is directly contrary to the old law – the purpose of the law ceases to exist CONSCIENCE Conscience judges on the morality of a concrete action commanding to do what is good and to avoid what is evil OBJECTIVES:  To identify the subjective norm of morality  To describe what is conscience  To distinguish the division of conscience  To identify the kinds of conscience

 

To demonstrate the obligation towards conscience To judge a human action according to the dictate of conscience

The Concept of Conscience:  It is not a theoretical or scientific knowledge of moral values and of good and evil, but  It shows to man what his nature is and what the divine Spirit requires of him as his personal obligation and then leads him to perceive the binding force of these requirements.  In most cases, the judgment of conscience is not reflexive but spontaneous. The judgment of conscience is expressly reflected upon especially in instances of doubt, or of resistance and disobedience to the dictates of conscience.  It concerns a person’s concrete action in a concrete situation.  It formulates general moral principles concerning the morality of human actions in the abstract without relation to the concrete activity of a person here and now. The Dictate of conscience Contains 2 Elements:  the judgment on the morality of a concrete action which a person intends to perform or has performed, and  the command and obligation that what is recognized as good must be done and what is recognized as evil must be avoided. The obligation is categorical. It is not only right to follow it, it is obligatory to do so. Antecedent Conscience the judgment on the morality of an action and the obligation to perform it or omit it is passed before the action is done. This conscience commands, exhorts, permits or forbids. Consequent Conscience evaluates a deed already done or omitted. This conscience approves, excuses, reproves or accuses. Right Conscience the moral judgment agrees with the objective norm of morality Erroneous Conscience the moral judgment disagrees with the objective norm of morality. This can be: a.

b.

vincibly erroneous – it dawns on man that his moral outlook might not be entirely sound or he is aware of being careless and irresponsible in his decision invincibly erroneous – the person has no awareness of the possibility of error

Other Kinds of Erroneous Conscience: 1. Perplexed 2. Lax 3. Scrupulous

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Perplexed when confronted with two alternative precepts, it fears sin in whatever choice it makes. This is a disturbed conscience. There is a disturbance of the capacity to form a judgment Lax -

judges a thing to be lawful when it is actually unlawful, moral when actually immoral, light or venial sin when actually serious or mortal sin.

Scrupulous judges something to be sinful when actually it is not, or something to be grievous or moral when actually light or venial Certain Conscience passes judgment without fear or error Doubtful Conscience uncertain concerning the morality of an action WE MUST HAVE A RIGHT AND DELICATE (SENSITIVE) CONSCIENCE PRESERVING OURSELVES INTACT WITH CLEAR AND VIGILANT DISCERNMENT OF THE GOOD AND EVIL. The VINCIBLY ERRONEOUS CONSCIENCE Before a person with this kind of conscience may act: 1. he must remove his erroneous state by searching the truth; if this is not possible because he is unable to do so, 2. He must postpone the action; if the action cannot be postponed, 3. He must follow the safer line of action. THE PERPLEXED CONSCIENCE The line of actions to be taken is: 1. if the decision can be delayed, postpone the action to obtain information and deliberate; if the decision cannot be postponed, 2. One must choose what appears to be the lesser evil; if still this is impossible to settle/do, 3. Either of the alternatives may be done Principles: 1. If this line of action is observed, there is no formal sin because it is impossible for the person to escape both alternatives of the perplexing situation; 2. If this line of action is not observed, the person may be guilty of formal sin because nothing was done to correct the error. The DOUBTFUL CONSCIENCE the line of actions to be done: 1. the action must be postponed until certainty is reached; If the doubt cannot be solved directly, 2. one may make a presumption PRESUMPTION - a conjecture where the GREATER RIGHT COMMONLY LIES and the lesser injustice is to be feared REFLEX PRINCIPLES WHERE PRESUMPTION STANDS 1. In doubt, presumption stands on the side of the superior. 2. In doubt, stand for the validity of the act. 3. In doubt, amplify the favorable and restrict the unfavorable. 4. In doubt, presumption stands for the usual and the ordinary. BINDING FORCE OF CONSCIENCE 1. MUST BE OBEYED:  Certain  Invicibly Erroneous  Right  Unaware Lax 2. MUST NOT BE OBEYED:

3.

 Aware Lax MUST NOT BE OBEYED UNTIL SOME CLARIFICATION IS OBTAINED, BUT ONE MAY ACT IF CLARIFICATION CANNOT BE OBTAINED AND THE DECISION HAS TO BE MAKE IMMEDIATELY:  Vincibly Erroneous  Perplexed  Doubtful

FREEDOM OF CONSCIENCE There is a strict obligation to follow one’s certain conscience; correspondingly, one has the right to act according to one’s conscience. The restrictions of the freedom of conscience is when it happens that the dictate of conscience runs in conflict with the demands of the common welfare. SOURCES OF MORALITY OBJECTIVES: 1. To explain the meaning of “sources of morality” 2. To enumerate the sources of morality 3. To explain each of the sources of morality 4. To determine how the elements affect the morality of a human act 5. To judge a human act according to the sources of morality SOURCES OF MORALITY Sources defining the morality of human acts these are the elements in the human act which determine its morality. These elements are called sources of the morality of human acts because the human act derives its morality from their agreement or disagreement with the moral norm. These sources are: OBJECT CIRCUMSTANCES INTENTION OBJECT Object of the human act is the effect which an action primarily and directly causes. It is always and necessarily the result of the act, independent of the circumstances or of the intention. It is generally regarded as the primary source for the judgment on the morality of an act. Effect of the Human Act is: 1. the physical, biological changes which an act brings about; 2. The impact of the act on rights and claims of persons, whether of other persons or of the agent himself, and the changes the act brings about in this sphere. To determine the OBJECT of a specific action: 1. look into the matter the act is concerned with and the existing rights and claims of persons to this matter; 2. Define the changes which are to be brought about primarily and directly. CIRCUMSTANCES These are the particulars of the concrete human act which are not necessarily connected with its object, These CIRCUMSTANCES are: WHO WHAT WHERE WITH WHAT MEANS WHY HOW WHEN

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The CIRCUMSTANCES can alter the morality of human acts for better or for worse. They can influence the morality of a human act.

CARDINAL VIRTUES: considered as “hinges” on which the whole moral life turns

INTENTION / END This is the reason for which the agent undertakes an act. The agent performs the action for the sake of this end/intention which he expects to achieve. The INTENTION/END can modify the morality of an act in similar ways as circumstances do.

PRUDENCE disposes a man to discern correctly what measures he must take to realize the exigencies of a virtue in concrete circumstances JUSTICE to give what is due FORTITUDE courage to stand/defend what one believes TEMPERANCE gentleness; benevolence; moderation

VIRTUE A habit that gives both the inclination and the power to do readily what is morally good. OBJECTIVES: 1. To define virtue 2. To explain the concept of virtue 3. To specify the fundamental requirements for virtue 4. To define, enumerate and explain the meaning of the requirements of the theological virtues 5. To define, enumerate and explain the meaning and requirements of the cardinal virtues 6. To apply the concept of virtue in medical practice 7. To enumerate and explain the meaning of the virtues of a physician

VIRTUE IN MEDICAL ETHICS Virtue as lived morality or a lived dimension of morality, refers to a gathering of personal motives, feelings and dispositions for a consistent lived expression of a virtue. “Becoming A Good Doctor” by James F. Drane p. 157 Virtue is the personal appropriation of values made with the help of reason Ibid., p. 164 VIRTUE OF BENEVOLENCE Connected with diagnosis and prognosis it is the character trait which disposes the doctor to carry out beneficent acts It refers to the commitment or will to carry out medical acts according to the highest ethical standards It refers to wishing a patient well or being disposed to attend to the patient’s needs

Fundamental Requirements for Virtue 1. moral knowledge – some insight and knowledge of the value it endeavors to realize – education, instructions, formation 2. prudence – cautious deliberation – to look carefully into the concrete circumstances 3. love of moral value – the beauty and goodness of the moral value must be deeply sensed and truly loved – deepening and faithful pursuance of the right fundamental option 4. dominion over the passions – moderating restraint Theological Virtues: • Faith • Hope • Charity Theological Virtue - God is the  immediate object LOVE / CHARITY is the most exalted, the most fundamental and universal of all virtues 



can co-exist with: o failures that result from weaknesses: wrong attitudes which result from deficient insight into the real demands of the moral value cannot co-exist with: o bad habit; o fully deliberate adherence to a serious vice

VIRTUE OF TRUTHFULNESS Connected with medical communication it is the disposition to tell the truth, not only once but several times over; The habit of telling the truth even when it is not convenient or does not serve a personal convenience; It disposes the doctor to prepare patients for full participation in decision-making regarding their own lives VIRTUE OF RESPECT Connected with decision-making it is the trained attitude or disposition to reverence those free acts by which patients carry out their best interests It disposes the doctor to handle differences with the patient with sensitivity, avoiding deceit or manipulation VIRTUE OF FRIENDLINESS Connected with inevitability of feelings; affective dimension there is pleasure in one another’s company, confidences are shared, and there is an exchange of benefits; Feelings are shared and intimacies revealed appropriate only within this relationship Affectionate relationship - controlling personal hostility Understanding - looking beyond the patient’s acts, words and behavior and seeing the interior world of thoughts and feelings Forgiving

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VIRTUE OF RELIGION Connected with the idea that doctors are priests Reflection on the awesome dimensions of his work Recognition of what is “transcendent” in the patient (the mystery of life) Commitment to serving patients struggling with life’s meaning Treating the patient as Christ would “Other” - directed; the “other” is the patient It keeps doctors from confusing themselves with God, and from falling into the temptation of moral self-righteousness It is the reality of God that keeps creatures aware of “their place”. FUNDAMENTAL BIOETHICAL PRINCIPLES 1. Sanctity and Inviolability of Life 2. Human Dignity 3. Autonomy 4. Stewardship and Accountability 5. Totality SANCTITY AND INVIOLABILITY OF HUMAN LIFE OBJECTIVES: 1. To explain the meaning of the principle of sanctity and inviolability of human life 2. To evaluate the bases for this principle 3. To formulate the general rule system bearing on the sanctity and inviolability of human life 4. To apply the principle in given cases or situations 5. To judge violation or non-violation of the principle in given cases. SANCTITY OF LIFE Interpreted as to mean that each individual, regardless of the state of health, is not to be used as means, and is to be treated with dignity because he is valuable. 

  

Life is holy because God is the origin of life and the ultimate guarantor of the sanctity of human life; Because man’s life comes from God he belongs directly and exclusively to Him; One must respect one’s own life and the life of others not only because of this; Because of man’s eternal destiny

HUMAN LIFE the fundamental ethical value MORAL INTEGRITY the absolute ethical value General Rule System Bearing on the Sanctity of Life 1. Survival and integrity of the human species – man ought to work towards his own survival 2. Survival and integrity of family lineage 3. Integrity of bodily life – the basic right to life 4. Integrity of personal, mental and emotional individuality – the right to be oneself 5. Integrity of personal bodily individuality – integrity of the human body CONCLUSION: Man’s life is holy because it comes from God and has an eternal destiny. INVIOLABILITY OF LIFE Because life is holy it cannot be violated HUMAN DIGNITY OBJECTIVES: 1. To explain the meaning of the principle of human dignity 2. To evaluate the bases for this principle

3. 4. 5. 6. 7.

Co-relate this principle with sanctity and inviolability of life To determine the scope of reference of human dignity To explain respect for human dignity in the dimensions of personhood To apply the principle in given cases/situations To judge the violation or non-violation of the principle in given cases.

HUMAN DIGNITY The dignity of the human person is the STRUCTURAL NUCLEUS OF ETHICS 



In the sense that moral life is basically the actualization of what it means to be a person in relation to other persons and sentient beings. RESPECT for the dignity of all persons and each person is the necessary condition for all morally good attitudes and acts.

BASES OF THE DIGNITY OF THE HUMAN PERSON 1. Every human person is crated in His image and likeness. 2. Every human person is endowed with intelligence to know and a free will to decide/choose. 3. The creation of the human soul is a direct action of God. 4. Every human person is called into existence in relation to God. 5. Each human person is unique and irreplaceable. 6. Each human person is called to maturity and eternal life. SCOPE OF REFERENCE OF HUMAN DIGNITY Respect for the dignity of the human person should be: 1. Concrete 2. Universal 3. Egalitarian 4. Absolute 5. Partisan in favor of those who suffer from dehumanizing situations Respect for the dignity of the human person should be: CONCRETE  In the sense that it refers not to abstract human nature, but to concrete and actual human beings immersed in complexed and conflictive historical realities UNIVERSAL  that it applies to all persons, going beyond geographical and political boundaries EGALITARIAN  In that it affirms the equality of all human persons in dignity, rejecting all discrimination, whether this be based on race, religion, sex, ideology, generation, social class or any other arbitrary criterion ABSOLUTE  Because it is inherent in human persons precisely as persons, and not for what they possess, nor for what they can give, nor for their physical, intellectual and social capabilities, but for what they are --- persons  The human person is valuable most of all because he is a person; he is an end in himself and should never be used or manipulated as a mere means for another end PARTISAN IN FAVOR OF THOSE WHO SUFFER FROM DEHUMANIZING SITUATIONS  in the sense that it has a preferential option in practice in favor of the liberation of those human beings whose humanity has been disfigured by dehumanizing situations – the oppressed, the destitute and other marginalized persons

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 Human dignity  entails respecting the human person in all the concrete dimensions of his personhood: 1. his / her corporeity 2. his / her social nature 3. his / her reason and liberty CORPOREITY Human beings exist corporeally. The biological bodies and the bases for their human consciousness, and thus for their personhood, and so participate in the dignity of the human person Social Nature Human persons are by nature social; they live together and interact with other persons in society. Within society, the rights and responsibilities of persons should be recognized, and as persons they should be active participants in social and cultural life in a relation of equality with other persons. REASON AND LIBERTY Human persons are characterized by reason and liberty, and are thus called to realize themselves responsibly as persons. They should be active and responsible subjects of their own lives. Consequently, they have a right to access to information that affects them. Liberty of human persons must be respected as long as its exercise does not violate/injure the rights of other persons. AUTONOMY One has the moral right to choose and follow one’s own plan of life OBJECTIVES: 1. To explain the meaning of the principle of autonomy 2. To describe the assets of autonomy 3. To identify the role of the health professional in helping the patient make an autonomous choice 4. To co-relate this principle with the principle of stewardship 5. To apply the principle in given cases/situations 6. To judge the violations and no-violation of the principle in given cases. IMPLICATIONS OF AUTONOMY 1. This does not mean absolute freedom to do anything as one wishes; 2. To act morally, man still has to follow the guidelines of moral law and conscience; 3. One has a right to determine what will be done to him; 4. One has a duty not to constrain another’s autonomous choices and actions; 5. Human beings should be treated with dignity; 6. Human beings should be allowed to make decisions for themselves. POSITIVE ASSETS OF AUTONOMY 1. Autonomy enhances a person’s worth and self-image 2. It protects a person from being used or abused by others 3. In health care it develops a mature therapeutic alliance between health care professional and patient. VIOLATIONS OF THE PRINCIPLE OF AUTONOMY  Actions performed that constrain a person’s capacity to make a decision;

Actions performed that constrain a person’s capacity to act according to his decision

NON-VIOLATIONS OF THE PRINCIPLE OF AUTONOMY  When a person expresses his autonomous wish to waive consent or delegate authority to others. The physician’s delegated prerogative refers to the authority of a physician over his patient as an authority delegated to him by the patient  When respecting a person’s autonomy competes with other moral principles THE ROLE OF THE HEALTH PROFESSIONAL The health professional should help the patient make his/her autonomous choice and act on it by: 

   

providing him/her with the information necessary to weigh the reason for his/her opinion; stating his/her own convictions and clearly explaining the reason for this opinion; not exercising coercion, manipulation, undue influence, or irrational persuasions; respecting the patient’s autonomous choice; withdrawing from the case and helping the patient find another health professional who might be more successful in these particular situations when the health professional thinks it is impossible to help the patient.

STEWARDSHIP/ACCOUNTABILITY Man is not the independent lord of his life but only a steward subject to the sovereignty of God, and he is responsible for it because he is accountable to God. Man’s bodily life is entrusted to his freedom STEWARDHIP AND ACCOUNTABILITY OBJECTIVES: 1. To explain the meaning the principle of stewardship and accountability 2. To analyze man’s responsibility 3. To detect dangers and risks 4. To distinguish different kinds of prerogatives 5. To determine the moral obligations in prerogatives 6. To co-relate this principle with human dignity 7. To apply the principle in given cases/situations 8. To judge the violation and non-violation of the principle in a given case STEWARDSHIP  Man is accountable in the way he uses his autonomy/freedom and in the way he respects and maintains his own (and that of others’) dignity.  (Prudent) stewardship means seeing that the powers entrusted to people are gifts and that the true meaning of these powers is to be found in respecting the dignity of everyone and everything.  Man must use his freedom responsibly, in conformity with the ends which are set forth by the inclination of his own nature as a rational being. DANGERS AND RISKS  Earthly life lies constantly exposed to many dangers. But human life is altogether impossible without a free risk of bodily loss in the quest for life’s meaning. Excessive concern about bodily risks is not acceptable.  It is a matter of weighing values or ideals, and a question of prudence;  The expected benefit must be proportionate to the risk. The greater the love with which man risks his life, and the higher the service rendered

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for the common good or for a particular fellowman, the purer is the witness to faith, hope and love, and so the more justifiable the risk. Absolute Prerogative - One is said to have ABSOLUTE PREROGATIVE in a thing when it is essentially subordinated to one’s final end, and has become the object of one’s lawful rights. Prerogative “for use” - That restricted power which a man has, whereby he has some right to use the thing, but with certain restriction, which are imposed by the higher rights of others. Delegated Prerogative  Is the authority or power given by the patient to his doctor by virtue of the patient’s right and obligation as an individual to preserve his health and bodily integrity. Prerogative in Human Life 1. Man has, at most, only a “prerogative for use” over human life 2. Absolute prerogative in human life is an exclusively divine prerogative TOTALITY OBJECTIVES: 1. To explain the meaning of the principle of totality 2. To determine the scope of the principle 3. To co-relate this principle with the principles of the human dignity, stewardship and autonomy 4. To apply this principle to given cases/situation 5. To judge the violations and non-violations of this principle in a given case PRINCIPLE OF TOTALITY The principle states that all the parts of the human body as parts, are meant to exist and function for the good of the whole body, and are thus naturally subordinated to the good of the whole body Implications of the Principle of Totality  When some part or function becomes detrimental to the good of the whole body, it is in accord with right order to remove such a part or to suppress its function;  Justified mutilation is limited or has restrictions

9

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SY 2011-2012

Subject: Bioethics Topic: Beneficience Lecturer: Dr. Melchor Vrias Date of Lecture: 29 July 2011 Transcriptionist: Gluttinoids Pages: 3

 You would need other to ask help from other physicians.  Referral is also an obligation of the physician

BENEFICENCE  

  

One has the obligation to help others further their important and legitimate interests. The term beneficence refers to actions that promote the wellbeing of others. In the medical context, this means taking actions that serve the best interests of patients. One of the obligations of the physician and other health care professionals is TO DO GOOD and to do everything to benefit the patient Not absolutely good, there are some risks in every procedure that are unavoidable Always do good as a physician

Implications of Beneficence 1. There is an obligation to confer benefits that is, doing or promoting good, and actively to prevent and remove harm or evil.  The physician should be able to identify both the benefits and harm that could be brought about by the procedure/treatment  The treatment should be more beneficial than harmful to the patient.  As a student, we should be mindful for we have all the preparations, to be able to discern in the future what is good and what is harmful. 2. There is an obligation to weigh and balance the possible good against the possible harm.  There is always a certain degree of harm in every procedure you perform in your patient.  Make sure that the benefits outweighs the harm  Recommend something that is better or more beneficent The impossibility of doing all good - this arises from limitations of: 1. The nature of time and space  Doctors hold many clinics and manages many patients in different places and hospitals  Distance limitation – the physician will not be able to attend a patient may be if he is at home or at different place 2. One’s own limitations.  Limitations of a physician depends on the physician's expertise or specialization.

3. The state of the art in a given area as well as the availability of state of the art tools.  Limited by equipment and facilities  If assigned in a barrio, there are limitations in terms of diagnostic test a physician can request as well as th availability of medications 4. One’s obligation to avoid evil  Sometimes we cannot avoid evil in the course of the treatment o Ex: Adverse effects of drugs are inevitable, but the drug is necessary and will do more good than harm  The physician must inform the patient or the significant other about the risks (both known and unknown risk) Beneficence  Doing good and avoiding evil is NOT simply a question of principles but of practical wisdom of knowledge, skills, and common sense weighing the relevant aspects of the factual and social situation as well as the concrete meaning of human dignity in a particular time and space  You have to weight certain aspects, such as the patients social situations, how the treatment affects the relatives, the patient per se and the meaning of his dignity in a particular time and place  In doing good, consider the dignity of the patient.  Always treat patient as a Human Being o E.g: In a brain dead patient, the relatives may say to continue treatment.. But the doctor must explain that continuing with the treatment can be harmful.

SPECIFICATION OF BENEFICIENCE 

The things necessary for the person to remain human and maintain dignity are the top of the list of goods to be done.  It would be more important for the patient to die with dignity especially in terminal cases. For instance, they would rather die at home than stay in the hospital. 1

patients, in this case the employees, as indicated by the company Limits of Specification 1. Talent  It is a matter of situations in which the effort to do good/better or to preserve the good may conflict with the good of other human beings o As physicians, sometimes you really want to do good, but keep in mind that the patient and his relatives have the right to choose, this includes their choice to refuse the treatment. o So no matter how much you want to do good, the obligation to do good is over ridden when the patient or the relatives doesn’t want to continue with the treatment. o Betterment of Patient < Betterment of the Family - Ex. when treatment is expensive & would bankrupt the patient’s family – patient forgoes treatment)  There is tension between respecting freedom and securing what a health care professional may consider the best interests of the patient. o Medical benificence can come in conflict with the autonomy of the patient. o You may know what is best for the patient, but the patient's autonomy dictates that he doesn't want to continue with the treatment. o Autonomy of the patient shall prevail, given that the patient is competent. 2. Most goods that we have to do are specified by: a. Law  Law: patient’s right  Law of child’s abuse – Doctors are required to report child abuse. b. Custom  Some customs and principles limit your obligation to do good o Custom includes tawas, can't take a bath during menstrual periods. o Religion – Cannot do blood transfusion on Jehova’s witnesses; one religion forbid medical intervention c. Relationship and Roles  doctor-patient relationship, patientrelative relationship, patient-spouse relationship can be limiting d. Agreements  Agreements like contracts.  Example, company physicians are limited by the fact that they should disclose certain information regarding his

PATIENT’S GOOD  Take the following into consideraration because patients use one or combination of these goods in making a decision: 1. The Ultimate Good  The meaning and destiny of human existence;  The positions taken with reference to relationships with other human beings, the world and God;  The “ultimate concern” – the one to which we turn for final justification of our acts if all secondary or intermediate reasons fail  If the other good fail this would be our last resort, to turn to our Creator.  This value supersedes the biomedical good and the patient’s view of his own good 2. The Biomedical Good  The good that can be achieved by medical intervention into a particular disease state;  The statement of what can be achieved based on strictly scientific and technical assessment  Ultimate good supercedes the medical good  The good that is usually used by health care professionals o The biomedical good is the basis of the physicians on why a patient should follow the decisions of the physician 3. The Patient’s View of his Own Good: His Best Interest  The patient’s subjective assessment of the quality of life the intervention might produce;  Whether of not this quality of life is consistent with the patient’s life plan and goals;  The patient’s life plan is highly personal  The choices that are to be made according to his life plan may run counter to biomedical good or what the physician thinks is a good life for the patient.  The initial good the patient use  If an information is disclosed, this good is used when the patient is making a decision.  If the probable result of the treatment is in conflict with the patient's life plan and goals, the patient may not adhere with the treatment. 4. The Good of the Patient as a Human Person  The good that is grounded in his capacity as a human person to reason, to choose and to express those choices in speech with other humans;  Freedom to choose  This value supersedes the biomedical good and the patient’s view of his own good

2

PATERNALISM  Involves acting without consent. Or even overriding the patient’s wishes, wants or actions, in order to benefit the patient or at least to prevent harm to the patient  Physicians used this principle before  Physicians can overlook the autonomy and rights of the patient.

sometimes competent, sometimes not) you may constrain them by giving sedative to calm them and make them competent 2.

If the Health care professional overrules the patient for the convenience or profit of the provider  Example: Like nurses in a hurry in shifting and give a drug immediately, some drugs are painful when administered in fast rate, it's not paternalism because the provider has other obligation to do and not to give care and compassion to the patient, this is inhumane at times.

3.

If the health care professionals refuses to go along with the patient’s wishes because these wishes are against the conscience or professional standard of the provider, and vice versa.  If the patient has the right to refuse treatment, the physician also has right to refuse a patient.  This occurs when the patient is noncompliant because he/she doubts the physician as a competent professional.  This doesn't apply in emergency cases though, a physician can't refuse a patient in an emergency case

Two (2) Elements of Paternalis 1. The absence of consent or over-riding of consent 2. The beneficent motive  The welfare of the patient Types of Paternalism 1. Strong Paternalism  Also called extended paternalism  The health care provider attempts to override the wishes of a competent person 2. Weak Paternalism  Also called limited or restricted paternalism  Consent is missing or the health care provider overrules or overrides the wishes of an incompetent or a doubtfully competent patient.  Doubtfully competent patient: alcohol/ drug intoxicated patient, in sedatives, effect of illness ( high-grade fever, depression)  Sometimes called cooperative paternalism when one of its purposes is to restore the person’s competence so that the patient may give informed consent.  Example: Over-ride by giving IV fluid and IV antipyretic to lower the fever making the patient competent again and making them capable to make competent decisions Strong paternalism is ethically rejected if:  The competence of an individual to make decisions for another competent individual would require both knowledge of the other person’s values and of all the factors influencing their lives.  Health care professionals do not have the right to enforce value and judgments to the patients on the grounds that the “doctor knows best”  It would be a rare health care professional who knew all the factors influencing the life of the patient. - Unless the patient tells you “bahala ka na Doktor”. However, you still need to inform the patient. It is NOT Paternalism 1. When the health care provider acts to prevent the patient from causing serious injury to others.  Ex: psych patients, though incompetent (especially waning patients,who are

Paternalism is justified: 1. If the harm is prevented from occurring or the benefits provided to the patient outweigh the loss of independence and the sense of invasion caused by the interference. 2. If the person's condition seriously limits his/her ability to choose autonomously. 3. If the interference is universally justified under relevantly similar circumstances.  Example: sedatives can be given to violent patients, restraining restless patient (tied to railings), this is universally justified and may do without the consent of the patient Rule of thumb involving Paternalism:  Decisions about health, life and death are not merely medical decisions but involve the good of the society and the good of third parties, as well as the values of the patient.  Consider that it is not only the physician who decides, also consider the value and situation of the patient (socially, emotionally...) End of Transcription

"Your life is the manifestation of your dream; it is an art. And you can change your life anytime if you aren't enjoying the dream. Dream masters create a masterpiece of life; they control the dream by making choices.”

3

SY 2011-2012

Subject: Bioethics Topic: Cooperation Lecturer: Dr. Melchor V. G. Frias Date of Lecture: September 9, 2011 Transcriptionist: Polkadots Pages: 2

Cooperation • Any physical or moral concurrence with a principal agent in a sinful deed. (principal agent: attending physician) * In Medicine, unlike in other circumstances, cooperation means a negative thing. • The participation of more than one person in the same immoral or criminal action. • Circumstances may arise in which a man is associated, to a greater or lesser degree, with someone else in a situation which is contrary to right order. • Depends on the degree of participation in the medical practice Types of Cooperation 1. Formal Cooperation • When one externally concurs in the sinful deed of another and at the same time internally consents to it. • When one takes part in the immoral action of another while at the same time adopting the evil intention of his associate. • If the intention of the anesthetist is the same as that of the surgeon in an illicit operation (e.g. contraceptive sterilization), the cooperation of the anesthetist is called formal cooperation. * one internally consents to and physically agrees to do the action • Always wrong, sinful or immoral • The cooperator is equally guilty with the principal agent. 2. Material Cooperation • When one externally concurs in the sinful deed of another without internally consenting to it. • Generally illicit, since the evil of sin should not be supported by any means, but on the contrary, opposed and suppressed * Participation in a situation such as when one is forced to do the action or one didn’t actually know what was being done (ergo, without intention). However, if you know that an act is wrong, you should refuse to do it because even if you refuse, your practice should not be threatened. 2 types of Material Cooperation 2.1 Immediate Material Cooperation • When one concurs in the sinful deed or evil act itself. • When one person actually performs the immoral action in cooperation with another

person. • Almost always sinful or immoral. • If the surgeon and the assistant are both engaged in actually aborting the fetus, the cooperation of the assistant is said to be immediate material cooperation. • Usually translates into formal cooperation. * exception: when one is being threatened, such as when the action is done at gun point or in resident training, when threatened of training termination (in this case you can refuse and report about the threatening to the administration) 2.2 Mediate Material Cooperation • When one provides means and other help for the sinful deed or evil act without joining the evil act itself. • Concurrence in the sinful action of another not, however, in such a way that one actually does the act with the other or concurs in the evil intention of the other but, while merely doing something which is good or indifferent in itself, the action also supplies an occasion of sin to another, i.e. supplies some assistance, means, or preparation for the sinful action of another. *Example: a circulating nurse who prepares the equipment and facilities for surgery--she is just doing her job, which is good/indifferent in itself. I this case, the gravity of her participation is less than the people actually involved, eg, the2nd assistant (junior intern) who did the retraction, but greater than for example, the institutional worker who just wheeled in the patient to the OR. • The morality of mediate material cooperation is to be sought using the principle of double effect: 1. Good effect-- one’s own freedom of action, plus the value of doing this or that action not wrong in itself. 2. Evil effect -- usually has a double aspect: (1) one’s action constitutes an occasion of sin for someone else; (2) there may be some evil coming upon a third party (patient) as a result of the action. Norms for Material Cooperation • Permissible if 2 conditions are verified: 1. The act by which cooperation is rendered may not be sinful in itself. 2. There should be a sufficient cause for granting an assistance which is to serve an evil purpose. *For the circulating nurse, she is just doing his/her job and doing her job is not wrong in itself. Also, she may not

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be aware that an illicit operation (e.g. abortion) will be done. • In estimating the sufficiency of the reason for material cooperation, consider: 1. The gravity of the other’s sin. * abortion vs. contraceptive surgery 2. The closeness of the cooperation to the sinful act. (proximate or remote) * proximate: assisting resident vs. junior intern vs. circulating nurse remote : do not actually participate on the action but provide some help for fulfillment of procedure 3. The indispensability of the cooperation. (necessary or unnecessary) * for example: retraction during the surgical procedure by junior intern --the surgery can be done without that help. 4. One’s obligation to prevent the wrong-doing * if the action is wrong, the obligation of the doctor to prevent the wrongdoing is higher than that of the nurse

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BIOETHICS)II) TOPIC:!CONFIDENTIALITY!

! OBJECTIVES:! ! Explain!the!aim,!meaning!and!implications!of! Confidentiality,! ! Differentiate!the!types!of!Obligatory!Secrets,! ! Explain!the!exceptions!to!Confidentiality,! ! Apply!the!principle!in!given!situations,! ! Judge!what!is!ethically/unethically! acceptable!as!the!principle!is!applied!in!given! situations! ! Fundamental)aim:! ! To!foster!communication!of!important,! sometimes!intimate!information!which!will! help!a!health!care!professional!aid!a!patient.! ! To!foster!trust!in!the!physicianKpatient! relationship.! " Excludes!unauthorized!persons!from! gaining!access!to!patient!information! " Requires!persons!who!have!such! information!legitimately!refrain!from! communicating!it!to!others! ! If)confidentiality)is)broken,)relationships)are)at) stake:) ! PatientKphysician! ! Patient!&!all!other!healthcare!providers! ! Reputation!of!physician!in!community! ! Physician!&!other!patients! ) If)confidentiality)is)broken,)the)following)could) be)threatened:) ! Privacy! ! Personal!autonomy! ! Decision!making!process!for!physician!and! patients! ! Patient’s!responsibility!for!his!own!health! ! Public!health!values) ) ) Confidentiality)is)concerned)with)keeping) secrets:) ! Secret)–!knowledge!which!a!person!has!a! right!or!obligation!to!conceal! ! The!obligation!to!keep!secrets!arises!from!the! fact!that!harm!will!follow!if!the!knowledge!is! revealed.! ! ) Three)types)of)Obligatory)Secrets:) ! Natural!Secret! ! Promised!Secret! ! Professional!Secret! ! NATURAL)SECRET) ! The)information)involved)is)by)its)nature) ) harmful)if)revealed) " There!is!obligation!to!avoid!harming! ) others!unless!there!is!proportionate!) reason!for!risking!or!permitting!the! ) harm.! ) ! ! ! ! !

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" Sometimes!the!harm!that!comes! from!concealing!a!natural!secret! outweighs!the!harm!that!is!being! avoided.! ! PROMISED)SECRET) ! Knowledge)that)has)been)promised)to) be)concealed.) " Generally,!the!promise!has!been! exacted!because!the!matter!is!also! a!natural!secret.! " The!evil!of!revealing!the!secret! arises!from!the!harmful!effects!of! breaking!promises.! " The!secret!may!be!revealed!if!the! good!to!be!attained!offsets!the!evil! that!results.! ! PROFESSIONAL)SECRET) ! Knowledge)which,)if)revealed,)will) harm)not)only)the)professional’s)client,) but)will)do)serious)harm)to)the) profession)and)to)the)society)which) depends)on)that)profession)for) important)services.) " The!consequences!should!patients! lose!faith!in!the!confidentiality!of! their!dealings!with!the!health!care! system!can!be!very!harmful.! " The!condition!of!the!patient’s!body! is!private!and!is!shared!only!with! those!he!chooses!to!help!him,!but! not!with!anyone!else.!

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" There!is!an!implied! promise!to!keep!the! secret!by!virtue!of!the! profession.!

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Exceptions)to)confidentiality) ! Those!commanded!by!statute! law! ! Those!arising!from!legal! precedent! ! Those!arising!from!a!particular! patientKprovider!relationship! ! Those!due!to!proportionate! reasons) ! *********************************************! NMMAIKBATCH!2016! ) )

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BIOETHICS)II) TOPIC:!ETHICS!IN!RESEARCH! !

OUTLINE:)! I.)ETHICS)IN)RESEARCH)! ! General!Ethical!Guidelines!! ! General!Bioethical!Principles!! ! Basic!Elements!of!Research!Ethics!! ! Ensuring!Quality!Ethical!Research!! ! Ethical!Considerations!in!a!Research/Study! Protocol!! ! Authorship!! II.)ETHICAL)BREACHES)IN)SCIENTIFIC)RESEARCH)! ! Scientific/Research!Misconduct!! ! Dealing!with!Misconduct! !

ETHICS'IN'RESEARCH'

! GENERAL)ETHICAL)GUIDELINES)FOR)HEALTH) RESEARCH! ! Health!research!involving!human!subjects! includes!research!on!identifiable!human! material!or!identifiable!data![Principle!1!–! Declaration!of!Helsinki,!2004]!! ! Considerations!related!to!the!wellKbeing!of! the!human!subject!should!take!precedence! over!the!interests!of!science!and!society! [Principle!1!–!Declaration!of!Helsinki,!2004]! ! It!is!the!duty!of!the!researcher!to!protect!the! life,!health,!privacy!and!dignity!of!the!human! subjects!and!to!safeguard!scientific!integrity!! ! GENERAL)BIOETHICAL)PRINCIPLES)! ! All!research!involving!human!participants! should!be!conducted!in!accordance!to!four! basic!ethical!principles:!! " Respect)for)persons)! # Autonomy,!which!requires!that! those!who!are!capable!of! deliberations!about!their! personal!goals!should!be!treated! with!respect!for!their!capacity! for!selfKdetermination!! # Protection)of)persons)with) impaired)or)diminished) autonomy,!which!requires!that! those!who!are!dependent!or! vulnerable!be!afforded!security! against!harm!or!abuse!! ! " Beneficence)! # Ethical!obligation!to!maximize! possible!benefits!and!to! minimize!possible!harm!and! wrongs!! ! " NonPMaleficence)! # [do!no!harm]!holds!a!central! position!in!the!tradition!of! medical!ethics!and!guards! against!avoidable!harm!to! research!participants!! !

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" Justice)! # Requires!that!cases!considered! to!be!alike!be!treated!alike,!and! that!cases!considered!to!be! different!be!treated!in!ways!that! acknowledge!the!difference!!

!! ELEMENTS)OF)RESEARCH)ETHICS)! ! Informed)Consent)! " For!all!biomedical!research! involving!humans,!there!must!be!a! voluntary!informed!consent!of!the! prospective!subject!! " Waiver!of!informed!consent!is!to! be!regarded!as!uncommon!and! exception,!and!must!in!all!cases!be! approved!by!an!ethics!review! committee![Guideline!4!–!Council! for!International!Organizations!of! Medical!Science!(CIOMS),!2002]!! ! ! Risk,)Benefits)and)Safety)! " Health!research!is!only!justified!if! there!is!a!reasonable!likelihood! that!the!populations!in!which!the! research!is!carried!out!to!stand!to! benefit!from!the!research!results! [Principle!19!–!Declaration!of! Helsinki,!2004]!! ! ! Community)! " Conclusion!or!termination!of!the! research!care!activity!should!not! preclude!the!possibility!of! administering!extended! community!care![Bhutta,!2000]!! ! ! Privacy)and)Confidentiality)! " Every!precaution!should!taken! to!respect!the!privacy!of!the! participant!and!the! confidentiality!of!the! participant’s!information!! ! ! Disclosure)of)Research)Results)! o Must)occur)when)ALL)of)the)ff) apply:! " The!findings!are!scientifically! valid!and!confirmed!! " The!findings!have!significant! implications!for!the!subject’s! health!concerns!! " The!course!of!action!to! ameliorate!or!treat!these! concerns!is!readily!available! when!research!results!are! disclosed!to!its!subjects!! ! ! !

! ! Standard)of)Care)! " Particular!needs!of!the!community! and!medically!disadvantaged!must!be! recognized!in!determining!the! standard!of!care!that!must!be! provided!them!as!research!subjects!! ! ! Compensation)of)Research)Subjects)! " Compensation!given!to!subjects!for! costs/expenses!incurred!in!taking!part! in!a!study;!free!medical!services!and! compensation!for!the!inconvenience! and!time!spent!should!not!be!so!large! as!to!induce!the!prospective!subjects! to!consent!to!participate![Guidelines!7! –!CIOMS,!2002]!! ! ! Subjects)groups)that)require)special) considerations)! " Some!populations!require!special! protections!because!of!characteristics! or!situations!that!render!them! vulnerable!! ! ! Absence)of)Direct)Benefit)! " Risk!from!research!interventions!that! do!not!hold!out!the!prospect!of!direct! benefit!for!the!individual!subject! should!be!no!more!likely!and!no! greater!than!the!risk!attached!to! routine!medical!or!psychological! examination!of!such!persons!! ! ENSURING)QUALITY)RESEARCH)! ! Role)of)the)Ethics)Review)Committee)! " Review!the!scientific!merit!and!ethical! acceptability!of!any!research!involving! human!participants!! ! ! Research)Protocol)! " Should!adequately!address!the!four! ethical!principles!and!should!be! sufficiently!detailed!to!serve!as! documentation!of!the!study! ! ! Qualifications)of)Investigators)! " Persons!engaged!in!health!research! involving!human!subjects!should!be! scientifically!qualified!! ! ! Protections)of)the)Environment)and) BioSafety)! " In!conduct!of!biomedical!or!behavioral! research,!appropriate!caution!shall!be! exercised!to!avoid!harm!or!damage!to! the!environment![Principle!12!–! Declaration!of!Helsinki,!2004]!! ! ! Welfare)of)Animals)! " In!regards!to!the!use!of!animals!for! research,!animal!investigators!shall! abide!by!RA!No.!8485K!Animal!Welfare!! !

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Act!of!1998!and!its! implementing!rules!and! regulations!! ! ! National)Ethical)Guidelines)for) Health)Research)2006:)! " Special)Ethical) Guidelines:)) # Clinical!trials!on!drugs,!devices! and!diagnostics!! # Herbal!medicine!research!! # Complementary!and!alternative! medicine!research!! # Epidemiological!research!! # Social!and!behavioral!research!! # Research!involving!traumatized! populations!! # HIV/AIDS!research!! # Research!on!assisted! reproductive!technology!! # Genetic!research!including! stem!cell!research!! ! ! International)Guidelines)! " World!Medical!Association’s! Helsinki!Declaration!of!1964! (revised!and!amended!in!1975,! 1983,!1989,!1996,!and!2000)!! " The!WHO!Council!of! International!Organizations!of! Medical!Sciences!(CIOMS)!2002!! " The!International!Conference!on! Harmonization!Good!Clinical! Practice!Guidelines!(1996)!!

! ETHICAL)CONSIDERATIONS)IN)A) RESEARCH/STUDY)PROTOCOL)! ! Provision!for!management!of!adverse! reactions/effects!! ! Stopping!of!the!study!in!case!harmful! effects!are!demonstrated!! ! Potential!benefits!outweigh!potential! harm![literature!review,!previous!trials,! records]!! ! Indemnification)) " Amount!and!methods!of! reimbursement!of!trialKrelated! expenses!of!study!participants!! " Guarantee!of!medical! care/financial!indemnification!of! study!participants!in!case!of! trialKrelated!injuries!! ! Informed)Consent)! " English!or!Tagalog;!dependent!of! location!! " Who!may!solicit!consent?!Who! may!give!consent?!! " Statement!that!the!study!is! investigative!in!nature!! " Specify!number!of!participants!in! the!study!! !

" Express!the!purpose/objective!of!the! study!! " Disclose!probability!of!random! assignment!to!treatment!and!trial! treatments!! " Explain!the!procedure!of!the!study! including!all!invasive!procedures!! " Expected!duration!of!subject’s! participation!including!followKup! visits!! " Benefits!to!the!subject!! " Alternative!procedure/course! treatment!that!may!be!available!! " Disclose!risk,!discomforts!and! inconveniences!associated!with!the! study!! " Responsibilities!of!the!subject!! " Statement!of!voluntary!participation!! " Study!participants!have!the!option!to! withdraw!from!the!study!anytime!! " Guarantee!of!confidentiality!! " Circumstances/reasons!for!the! termination!of!the!subject’s! participation!! " Statement!regarding!indemnification!! " Contact!person!! ! AUTHORSHIP)! ! There!is!no!universally!agreed!definition!of! authorship.!As!a!minimum,!Authors!should! take!responsibility!for!a!particular!section!of! the!study!! ! All!persons!designated!as!“authors”!should! QUALIFY!for!authorship!! ! Should!have!participated!sufficiently!in!the! work!to!take!PUBLIC!RESPONSIBILITY!for! the!content!! ! ! Who)Qualifies?! )(Substantial!contribution!to):)! " Conception!and!design;!or!analysis! and!interpretation!of!the!data!! " Drafting!the!article!or!revising!it! critically!for!important!intellectual! content!! " Final!approved!of!the!version!to!be! published!! ! ! Who)does)Not)Qualify?! " Participation!solely!in!acquisition!of! funds! " Just!collection!of!data! " General!supervision!! " Performing!statistical!tests! " No!‘laundry!list’! " No!‘gift’!authorship! ! ! Group)or)corporate)author) " Multicentre!trials/research! " Should!fully!meet!the!criteria!for! authorship! )

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" NonKqualified!can!be!listed!in!!!!!!!!! acknowledgement!or!in! appendix!!!(with!permission)) " Order!of!authorship!to!be! decided!jointly!(first!24!+!last! one!if!>25!listed!in!Medline)! " Watch!out!for!“personality”! influence! ! ! Who)and)what)comes)under) ‘Acknowledgement’?) " Those!that!do!not!qualify!for! authorship!like!general!support! by!departmental!chair! " Those!rendering!technical!help,! or!financial!and!material!support! " Relationships!that!may!pose!a! conflict!of!interest!e.g.,!financial! relationships!with!the!industry! " Others!like!scientific!adviser,! critical!review!of!study!proposal,! data!collection!or!participation! in!clinical!trial! ! ****************************************! )

INTEGRITY'AND'ETHICAL'BREACHES'IN' SCIENTIFIC'RESEARCH' '

OBJECTIVES:! ! Identify!specific!situations!of! breaches!in!integrity!and!ethics! in!scientific!research.! ! Define!specific!situations!of! breaches!in!integrity!and!ethics! in!scientific!research.! ! Discuss!appropriate!actions!in! dealing!with!breaches!in!the! integrity!and!ethics!of!scientific! research.! ! Introduction:) ! It!is!essential!to!define!and!develop!best! practice!in!the!integrity!and!ethics!of! scientific!research.! ! The!crucial!aim!is!to!find!practical!ways! of!dealing!with!the!issues.! ! Intellectual!honesty!ought!to!be!actively! encouraged!and!used!to!inform! publication!ethics!and!avoid! misconduct.! ! Guidelines!should!be!developed!–! advisory!rather!than!prescriptive!!!!!!!!!!!!!!!!!!!!!!!!!!!! [The!COPE!Report,!2003]) ! Serious!ethical!breaches!occur!in!at! least!1.0%!of!all!clinical!researches.! ! Issues!are!identified!and!reported!by:! " Anonymous)callers:!33.0%! " Whistle)blowers)at)study)site:! 33.0%! " Ethics)committee)and/or) sponsor:)20.0%![Gitanjali,! 2003]!

! ! Behaviour!by!a!researcher!that!falls!short!of! good!ethical!and!scientific!standards.! ! Significant)misbehaviour)that:!! " Improperly!appropriates!the! intellectual!property!of!others,! " Impedes!the!progress!of!research,!! " Risks!corrupting!the!scientific!record! " Risks!compromising!the!integrity!of! scientific!practices.! ! Misrepresentation) " Fraud! " Omission!of!facts! ! Misappropriation) " Plagiarism! " Use!of!confidential!information!from! review!of!manuscript!or!grant! application! ! Interference) " Obstruct!research!of!another!by! damaging!/!taking!away!research! related!property!of!another!–! apparatus,!reagents,!writings,!data!etc.! ! FRAUD) ! Descriptive/Analytic)Study)or) Experimentation) " Planning!K!stealing!idea! " Conduct!K!fabrication! " Statistics!K!manipulation!of!data! " Reporting!K!suppression!of!negative! findings![Gitanjali!B,!2003]! ! ! Publication) " Gift!authorship! " Duplicate!or!repetitive!publications! " Failure!to!publish! ! ! Study)Design)and)Ethical)Approval!! " Good!Research!should!be!well!justified,! well!planned,!appropriately!designed,! and!ethically!approved.!To!conduct! research!to!a!lower!standard!may! constitute!misconduct.! " ! ! Data)Analysis) " Data!should!be!appropriately!analyzed,! but!inappropriate!analysis!does!not! necessarily!amount!to!misconduct.! Fabrication!and!falsification!of!data!do! constitute!misconduct.! ! ! Authorship) " As!a!minimum,!authors!should!take! responsibility!for!a!particular!section!of! the!study.! ! ! Redundant)or)Duplicate)Publication) " Publication!of!a!paper!that!overlaps! substantially!with!one!already!published! in!print!or!electronic!media.! " When!2!or!more!papers,!without!full! cross!reference,!share!the!same! hypothesis,!data,!discussion!points,!or! conclusions![The!cope!report,!2003]!! !

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" When)is)a)Secondary) Publication)acceptable?) # Articles!that!need!to!reach!the! widest!possible!audience!or!are! intended!for!a!different!group! of!readers! # Competing!manuscripts!based! on!the!same!study! $ Differences!in!analysis!or! interpretation! $ Differences!in!reported! methods!or!results! # Competing!manuscripts!based! on!the!same!database! [IMCJE,2008]! ! ! Failure)to)Publish) " Failure!to!report!findings!of!any! carefully!done!study!of!an! important!question,!relevant!to! readers,!whether!the!results!for! the!primary!or!any!additional! outcome!are!statistically! significant.! ! PLAGIARISM) ! Unreferenced!use!of!others’!published! and!unpublished!ideas,!including! grant!applications,!and!submission! under!“new”!authorship!of!a!complete! paper.! ! It!may!occur!at!any!stage!research.! ! It!applies!to!print!and!electronic! versions.![Gitanjali!B,!2003];! [The!COPE!Report,!2003]! ! Copying!word!for!word! ! Paraphrasing! ! Quoting!based!on!secondary!sources! ! Taking!ideas!without!citation! ! Putting!one’s!name!to!work!written!by! another! ! DEALING)WITH)SCIENTIFIC)MISCOUNDUCT) PRINCIPLE) ! The!general!principle!confirming! misconduct!is!intention!to!cause!others! to!regard!as!true!that!which!is!not!true! ! The!examination!of!misconduct!must! focus,!not!only!on!the!particular!act!or! omission,!but!also!on!the!intention!of! the!individual.! ! Deception!may!be!by!intention,!by! reckless!disregard!of!possible! consequences,!or!by!negligence.! ! Codes!of!practice!may!raise!awareness.! ! DEALING)WITH)SCIENTIFIC)MISCOUNDUCT) INVESTIGATING)MISCONDUCT) ! Editors!are!ethically!obligated!to! pursue!the!case.! ! It!is!for!the!editor!to!decide!what!action! to!take.![The!COPE!Report,!2003]! ! !

) ! DEALING)WITH)SCIENTIFIC)MISCONDUCT) ! ! Monitoring! ! ! Audit! ! ! Ethics!committee!overview! ! ! Regulatory!inspection) ! ) ! ! International) ! " Office!of!Research!Integrity!in!US!to! ! investigate!allegations!of!research! ! misconduct! ! " Committee!of!Publication!Ethics!(COPE)! ! guidelines!on!good!publication!practice! ! " ICH!–!GCP!guidelines!for!clinical!trials! ! ! ! ! Philippines) ! " Training!workshops! ! " Philippine!Ethical!Guidelines!for! ! Biomedical!Research! ! " National/Institutional!ERBs! ! ! ! ************************************************! ! NMMAIKBATCH!2016! ! ) ! ! ! ) ! ) ! ) ! ) ! ! ! ! ) ! ) ! ) ! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) ! ) !

BIOETHICS)II)

! ! ! ! ! Why)tell)the)truth?! " There!is!evidence!that!patients’!–! coping!skills!are!enhanced,! cooperation!with!treatment!is! increased,!levels!of!anxiety!are! reduced.!KEll!et.!al.,!1989! " Patients!have!the!right!to!the! truth.! ! ! The)Right)to)the)Truth! " Informed!Consent! " Truth!by!Purchase! " Important!NonKmedical! Decisions! ! Truth)Telling) ! Given!the!contextual!complexity!of! truth!telling,!ethical!concerns!regarding! information!disclosure!demand! sensitivity,!thoughtfulness,!and!skillful! communication!from!clinicians,! patients,!and!ethicists.!! ! **********************************! NMMAIKBATCH!2016! ! !

TOPIC:)TRUTH!TELLING! )

OBJECTIVE:! ! Define!and!explain!truthfulness!and!truth! telling!in!the!practice!of!medicine,! ! Explain!reasonable!expectation!of!the!truth! and!the!factors!that!affect!it,! ! Explain!patients’!right!to!the!truth,! ! Apply!the!principle!in!given!situations,! ! Judge!what!is!ethically/unethically! acceptable!as!the!principle!is!applied!in!given! situations! ! Truthfulness)in)Ethics) ! A!fundamental!human!value,!a!basic!ethical! principle,!a!moral!virtue!allied!to!justice.!The! virtue!of!veracity!inclines!persons!to!manifest! both!in!their!lives!the!convictions!of!their! minds.)) ! Truthfulness)in)Bioethics) ! As!autonomous!and!relational!human!beings,! patients!and!their!families!have!a!right!to! information.! ! Generally)summed)up)in)two)commands:! " Do)not)Lie) # “If!you!communicate!do!not!lie”! " You)must)communicate)with)those) who)have)a)right)to)the)truth) # “You!must!communicate,!if!the! other!person!has!a!right!to! communication.”!! ! TRUTHFULNESS) ! Lying) " Speech!against!mind! # If!you!communicate!something! at!odds!with!what!you!believe! to!be!true! # Falsehood) KSpeech!against!the!mind!in! those!circumstances!in!which! the!other!has!a!“reasonable! expectation!of!!!the!truth.”! ! ! Reasonable)Expectation)of)the)Truth! " Expectations)vary)according)to) these)factors:) # Place!of!communication! # Roles!of!communicators! # Nature!of!the!truth!involved! ! ! Why)tell)a)lie?) " Belief!that!disclosure!can!set!off!a! destructive!interplay!of!psychological! and!physical!processes!that!result!in! worsening!of!patients’!conditions.! " The!power!of!suggestion!can! exacerbate!pain!and!side!effects! unnecessarily.! ! ! ! !

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BIOETHICS)II)

! ! TOPIC:!PRINCIPLE!&!ISSUES!IN!PEDIATRICS! ! ! ! OBJECTIVES:! " Helps!train!them!in!decisionK ! Explain!principles/issues!in!Pediatrics,! making.! ! Apply!the!principle/issue!in!given!situations,! " Achieves!compliance!and! ! Judge!what!is!ethically/unethically! cooperation.!! acceptable!as!the!principle/issue!is!applied!in! ! Having!a!voice!in!deciding!reinforces! given!situations.! his!sense!of!himself!as!a!person!and! ! helps!prepare!him!for!the!independent! PRINCIPLES)AND)ISSUES)IN)PEDIATRICS) decision!maker!he!will!someday!be.! ! Making!Decisions! ) ! Telling!the!Truth! ADOLESCENT)AGEPSPECIFIC)VALUES) ! Relating!to!Patients! ! What)are)a)person’s)“real’)values)and) ) goals?) PARENT’S)RIGHTS) ! What)weight)should)be)given)to)ageP ! The!Foundation!of!Parent’s!Rights:! specific)values?) " Historical!precedent:!rights!of!parents! ! Adolescent!choices!are!typically! over!children!are!grounded!on!the! characterized!by!what!might!be!called! property!rights!of!fathers.! ageKspecific!values.! " They!are!the!ones!charged!by!society! ! Values!that!are!held!only!during!the! with!responsibility!for!the!welfare!and! teenKage!years!or!given!high!priority! upK!bringing!of!children.! only!during!that!time.! " Parents!are!the!people!who!live!most! ! Concern)with)body)image) directly!with!consequences!of!their! ! Acceptance)by)peers) child!rearing.! ! Striving)for)independence) " Parents!have!a!genetic!tie!to!their! ! Hold)little)appeal)for)parents!–!likely! children.! to!weigh!longKterm!benefits!heavily! " Parents!make!the!bestKqualified! than!shortKterm!unpleasant! decision!makers.! experiences.! " The!intimacy!of!family!life!is!among! ! Temporary!–!children!outgrow!them! the!greatest!personal!values.! and,!in!their!own!adulthood,!will!most! ! likely!repudiate!them.! ! Limit)of)parent’s)rights) ! May!be!retained!into!adulthood!–!but! " Criteria!for!child!abuse/neglect.! for!good!reasons,!not!out!of! " Certain!life!threatening!situations! developmental)need.! ! ! CONSULTING)THE)CHILD) ! ISSUE:) ! Are)children)competent)to)make)decisions)) " !!!The!adolescent’s!preference! for)themselves?) should!be!overridden!when!it! " Not!fully!rational! conflicts!with!typically!adult! " Not!mature! judgments!of!value.! " Not!experienced! # One!cannot!assume! ! universality!of!adult!values.! ! Children’s)lack)of)competence)can)be) # Adolescents!may!not!adopt! challenged:) typical!values! " Decision!making!is!a!developmental! # The!best!one!can!do!is!appeal! process! to!typical!adult!values!–! " Children!generally!make!the!same! “reasonable!person”!standard! treatment!choices!as!adults! ! ISSUE:) " Decision!making!is!dependent!on!life! " !!!Choosing!for!adolescents!against! experience! their!wishes!assumes!that!their! ! own!stated!preferences!are!not! ! Voluntariness)in)consulting)children) their!“real”!values.! " The!patient!as!a!child! # Some!adolescents!do!know! " Pressures!from!parents! what!adult!values!they!will! " The!doctor!as!a!friend! adopt.! o For)assent)to)be)genuine,)there)must)be) # Some!adolescents!have!goals! the)possibility)of)dissent.) that!require!commitment!and! ) narrow!choices.! ! Benefits)in)trying)to)get)child)assent) ! " Helps!them!see!the!reasons!for!the! ! medical!decision.! ! " Provides!a!model!for!human!relationships.! ! !

! # Let!adolescents!choose!for! themselves!or,!if!parental! consent!is!needed,!use!the! subjective!standard!for! substituted!judgment.! ! ! Difficult!judgments!must!be!made!by!the! wouldKbe!paternalist!about!the!seriousness! of!an!adolescent’s!life!plan!and!the!relation! between!medical!choices!now!and!the! possibility!of!fulfilling!that!plan!in!the!future.! ! We!need!a!better!justification!to!impose!adult! ageKspecific!values!of!adolescents,!especially! when!these!values!do!not!lead!to!choices!that! are!irrational!in!the!sense!of!being! incompatible!with!the!adolescent’s!own! perceived!life!goals.! ! INFORMING)PARENTS) ! Why)tell)the)truth?) ! Physician’s)point)of)view) " Truth!telling!is!a!protection! " Builds!trust!/!good!patientKdoctor! relationship! ! ! Parents’)point)of)view)) " Correct!and!full!information!is!a! necessity! " Psychological!benefit! ) ! Delaying)or)Withholding) " Reasons!must!stem!from!concern!for! the!parent!or!child!and!not!the! doctor’s!own!personal!reasons.! " If!the!information!may!affect!a! parent’s!decision,!then!it!is!wrong!to! withhold!or!delay!it.!! " Treating!without!parental!consent!or! withholding!truth!from!parents! # Emergency!situations! # Information!may!do!serious! harm! ! TELLING)THE)CHILD) ! Is!Benevolent!Deception!about!serious!illness! acceptable!or!justified?) " As!long!as!they!are!not!in!conflict!with! good!medical!practice.! " As!long!as!they!do!no!harm! ! ! Reasons)for)Telling) " Accepting!this!principle!suggests!some! conditions!under!which!it!might!be! justified!to!tell!the!child!the!truth!even! against!parents’!wishes.! " Will)not)telling)be)more)harmful?) " What)will)benefit)the)child?) " Will)not)telling)do)more)good)than) harm?) ) ! Lying)to)Children) " Why!is!it!that!we!consider!it!justified! or)even!required!to!lie!to!children!in! situations!where!! !

! We!would!think!it!wrong!to!lie!to!adult! patients?! !

" )))Lying)to)Children)–) Justifications:) # All,!or!almost!all!lying!to! children!is!seen!as!benevolent! deception.! # To!protect!them,!prolong!their! innocence!and!get!them!to!do! things!that!will!benefit!them.! # Because!one!does!not!trust! their!judgment! # Because!their!experience!is! limited!and!their!goals!are! short!term.! ! " !!!Denying!children!the!truth! always!harms!them!to!some! degree!by!slowing!their!progress! toward!developing!their!own! autonomy.! " !!!Some!benevolent!deceptions!in! medicine!may!not!be!harmful,! but!some!can!do!harm,!and! trying!to!decide!the!balance!of! benefit!to!harm!or!vice!versa!is!a! helpful!and!morally!appropriate! way!to!decide!questions!of! telling!the!truth!to!a!child.! ! LOYALTY)TO)PARENTS) ! The!doctorKpatient!relationship!is!built! on!mutual!trust!! " Parents’!trust!in!the! pediatrician!promotes:! # Honesty!and!cooperation! # Confidence!to!accept!the! medical!help!that!their!child! needs! ! When)are)Pediatricians’)obligations) to)parents)legitimately)overridden) by)other)obligations?) ! The!pediatrician’s!first!loyalty!is!to)the) child! ! Pediatricians!owe!loyalty!to!parents!by! virtue!of!their!status!as!guardians!of! their!children!and!this!status!is! conferred!by!the!state.! ! When!parents!do!not!fulfill!their! responsibility,!they!lose!their!status!as! guardians!and!thus!lose!their!claim!to! the!loyalty!of!pediatricians.! ! Situations!that!present!clear!and! imminent!serious!danger!to!the!child’s! life!or!wellKbeing,!whether!posed!by! parents!directly!or!by!conditions!that! the!parents!cannot!correct,!demand!that! pediatricians!put!into!motion!whatever! is!required!to!protect!the!child!! ! ! ! !

) ! ! In)cases)of)clear)danger,)the)pediatrician’s) ! loyalty)is:) ) " First!to!the!child! ) " Second!to!the!state! ! " Third!to!the!parents! ) ! ) SAYING)NO) ! ! Patients!do!have!legitimate!claims!on! ! physician’s!time,!energy,!and!attention.!But! ! what)limits)may)a)physician)set)against) ! Parents?)! ! " The!ultimate!case!of!setting!limits!is!to! ) refuse!parent’s!request!to!treat!their!child.! ! " The!ultimate!test!of!a!physician’s!right!to! ! say!no!may!come!at!the!end!of!life.! ! ! ) ! Are)there)circumstances)where)the) ) pediatrician)should)take)the)initiative)and) ) refuse)to)treat?) ) " If!treatment!is!futile!and!inhumane! ) " If!it!causes!significant!suffering!to!the! ) child) ) ) ! There!is!no!obligation!to!treat!if!the!treatment!is! ) futile,!even!if!it!causes!the!child!no!suffering!or! ) harm.! ) ! Parents!cannot!demand!useless!or!inappropriate! ) treatment.!However,!there!might!be!good!reasons! ) for!not!refusing:! " For!the!parents’!sake! ) " For!organ!donation!! ) ! ) ********************************************! ! NMMAIKBATCH2016! ! ) ! ! ! ! ! ! ) ) ! ! ! ) ! ! ! ! ! ! ! ) ) ! ! ! ) ) ! ! ! ! ! ! !

JUSTICE Julius Ceazar H. Reyes, MD, DPSA December 13, 2013; 8:00 – 10:00 AM Bioethics OUTLINE  Ethical principles  Justice  3 principles of justice  Theories of justice

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 Rules and principles that govern the distribution of social benefits and burdens  Condition of scarcity and competition  Material principles of distributive justice  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  The Right to Health Care: Decent minimum of Health Care  One-tiered system  Distribution is based on needs; needs are met by equal access to basic services  Two-tiered system  Better services might be made available for purchase at personal expense

ETHICAL PRINCIPLES    

Utilitarian Libertrian Egalitarian

Respect for autonomy Beneficence Non-maleficence Justice

JUSTICE  Moral rightness based on ethics, rationality, law, national law, religion or equity  Act of being just or fair  Formal principle (Aristotle): equals must be treated equally, unequal must be treated unequally

3 PRINCIPLES OF JUSTICE  Allocation of resources  Triage  Distributive justice 1. Allocation of resources  hospital beds  As a doctor, you must choose what to prioritize first

THEORIES OF JUSTICE 1. Utilitarian

2. Triage  It is applied when there is too many patients in one hospital  The doctor will decide who will or will not be treated  Doctors as gatekeepers to determine treatment  Greatest good for greatest number  One's contribution to society or "social worth"  Military or civilian disaster:  Those who cannot be expected to survive even with treatment  Those who will recover without treatment  The priority group, those who need treatment in order to survive

 A theory in normative ethics holding that the proper course of action is the one that maximizes utility, specifically defined as maximizing happiness and reducing suffering  Maximizing value  Trade-offs & balances

 to benefit those who are genuinely in need 2. Libertarian  Economic benefits must be in proportion to one’s contribution to the production of those benefits

3. Egalitarian  To make more equal the unequal situation of naturally disadvantaged members  Distinction between UNFAIR and UNFORTUNATE

3. Distributive justice  Which of the available drugs will you prescribe  How many drugs will you prescribe -END-

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Transcriber/s: Eliza Marie Herrera Formatting: Nicxz Icaro Editor/s: Nicxz Icaro, Craig Angelo Reyes

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 1 of 1

BIOETHICAL PRINCIPLES IN OBSTETRICS 1-2 Julius Ceazar H. Reyes MD, DPSA December 6 & 13, 2013; 8:00 – 10:00 AM, 8:00 – 9:00 AM Bioethics OUTLINE PART 1  Procreation  Two principles of procreation  Conjugal act  Perspectives of conjugal act  Unitive  Procreative

PART 2  Prenatal Diagnosis  Legitimacy and criteria of therapeutic procedures of human embryo  Principles in pregnancy

PART 1 PROCREATION  The process by which an organism produces others of its biological kind  The sexual activity of conceiving and bearing biological offspring

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TWO PRINCIPLES OF PROCREATION 1.

It requires the part of the spouse responsible collaboration with the fruitful love of God.

 Responsibilities of the spouses: 1) Know and understand their sexuality  The man or husband is aware that he is a man and the wife is aware that she is a woman. 2) Know and understand the unity of marriage  When a man and a woman enter marriage, they become one. 3) Know and understand their personality  You cannot enter a marriage without knowing yourself or your spouse’s personality. 4) Know and understand their duties with their children  It does not mean that just because a man and a woman enters marriage they may keep on procreating without knowing that they have duties towards their children such as education or quality of life.  Is it okay to have a lot of children? Yes, as long as the parents are capable of providing their children with their basic rights (education, food and shelter, etc.)

Transcriber/s: Gladys Hulipas Formatting: Nicxz Icaro Editor/s: Nicxz Icaro, Craig Angelo Reyes

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The gift of human life must be actualized in marriage through the specific and exclusive acts of husband and wife in accordance with the laws inscribed in their persons and in their union. Actualization of marriage is where the concept of procreation or sexual intercourse comes in. This is a requirement in marriage. It is not gratifying if a woman refuses to have sexual intercourse with her husband in the context marriage, but there is a proper way to this. The refusal of sexual intercourse becomes grounds for annulment. When we say specific and exclusive, there must be no one else but the husband and wife. (No extras!)  It has to be in accordance with the natural laws and nature of marriage.  Within marriage, the child has to be born inside a “legitimate union”. A child has to be born in the context of marriage to be considered legitimate. Being legitimate is the right of the child. A child born from live-in partners is still considered illegitimate, but if they marry the child may be considered legitimate.  Legitimacy is important even in laws of society, for the dignity of the human person. A child born in the context of marriage has more dignity that a child born out of the context of marriage.

CONJUGAL ACT  The act of sexual intercourse between two opposite sexes

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THE COMMUNION OF PERSONS IN MARRIAGE AND THE CONJUGAL ACT William E. May A man and woman become husband and wife when they “give” themselves to one another in and through the act of irrevocable personal consent that makes them to be spouses. And in consenting to marriage, to being husband and wife, they consent to all that marriage implies and therefore the consent implicitly to the conjugal act, the act “proper and exclusive to spouses.” In and through the conjugal act husband and wife literally become “one flesh”, “one body.” In and through this act they come to “know” each other in a unique and unforgettable way, and they come to know each other precisely as male and female in their masculinity and femininity.

Entering marriage means that the spouses are giving consent to perform intercourse. “… The man does not force himself upon the woman, but gives himself in a receiving manner. The woman does not simply submit herself to the man, but receives him in a giving manner.” -Robert Joyce PERSPECTIVES OF CONJUGAL ACT  UNITIVE = “love giving”  Husband and wife render mutual help and service to each other through an intimate union of their persons and their actions  It will not end after sexual intercourse and must go beyond that  Husband and wife see their “self-worth” by being loved  Husband and wife share intimacy  Intimacy does not only refer to physical closeness, it is when one becomes willing to be vulnerable to each other  PROCREATIVE = “life giving”  This is why the church is against contraception because in contraception, the procreative power of conjugal act in marriage is abolished  The natural ordination of the conjugal act towards the creation of human life (“matrimonial right”)  The result is another human life.  By principle, human life will start when the sperm of the father will meet the ovum of the mother. Any insult or attack to that human life is unethical and immoral.  In abortion, we destroy human life which is the product of the conjugal act. Hence abortion is immoral and unethical. CASE 1 R.M., a 21 year old female, sought consult at the outpatient department for amenorrhea. Pregnancy test was done revealing a positive result. So the patient was requested for vaginal ultrasonography and revealed a left ovarian pregnancy approximately 7 weeks AOG. She was immediately brought to the operating room and underwent direct oophorectomy.  Was the decision of the physician acceptable?  Technically, the obstetrician should not have immediately proceeded with the oophorectomy; the ectopic pregnancy at this point has no risk or danger to the mother.

Transcriber/s: Gladys Hulipas Formatting: Nicxz Icaro Editor/s: Nicxz Icaro, Craig Angelo Reyes

 What the obstetrician may have done is to monitor the progress of the pregnancy until the pregnancy reaches the age of viability, and then oophorectomy may be performed. If the fetus does not survive upon reaching the age of viability, let the fetus die the natural way.  If the at some point the mother experiences bleeding or rupture, then you may perform oophorectomy even if the fetus is not viable. CASE 2 X.M., 16 year old G1P0, 16 weeks AOG, was diagnosed with endometrial cancer stage 4. As the patient’s attending obstetrician, you informed her on the risk of harmful effects of chemotherapeutic drugs to the fetus. However, if chemotherapy will not be given, there is a greater chance that the mother will die.  If you’re the obstetrician, who will you choose? Will you proceed with chemotherapy and let the baby die? Or delay the management and let the mother die eventually?  Both the life of the mother and fetus is of equal reverence/value.  There is no direct answer. You are not supposed to choose whether the life of the mother or the life of the fetus. You may delay the treatment; wait for the age of viability. Once the fetus is at the age of viability, deliver the baby, institute the chemotherapeutic treatment to the mother; if the baby will not survive outside the mother, let the baby die the natural way. In that way, you are not choosing between the mom and the baby.  If the management is very urgent and must be given immediately, use the Principle of Double effect. You may institute the chemotherapeutic agents in this case provided that your intention is to cure and not to terminate the pregnancy. But if the intention is to institute therapy and eventually terminate the therapy, that is bad.

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 2 of 3

PART 2 PRENATAL DIAGNOSIS

PRINCIPLES IN PREGNANCY

 Prenatal diagnosis must respect the life and integrity of the embryo and the human fetus and must be directed towards its safeguarding or healing as an individual.  If the prenatal diagnosis will destroy the integrity of the embryo, then the management is not justified, unacceptable or immoral.  Prenatal diagnosis is opposed to the moral law when it is done with the thought of possibly inducing an abortion due to malformation or congenital anomalies or hereditary illness.  For example, during the prenatal diagnosis, you were able to diagnose the fetus would have anencephaly; do not terminate the pregnancy. Proceed with the pregnancy, deliver the baby and let the baby die the natural way. But do nothing to terminate the pregnancy.

 PRINCIPLES OF INVIOLABILITY OF LIFE  No one has the right to end someone’s life  Physicians cannot terminate the life of a patient because they have no right.  When in doubt, always side with life.  Always apply this principle in obstetrics.  PRINCIPLES OF DOUBLE EFFECT  Criteria for evaluating the permissibility of acting when one’s otherwise legitimate act will also cause an effect one would normally be obliged to avoid  Always applicable in obstetrics especially when the life of the mother and the life of the fetus is at risk.  BOTH LIVES ARE EQUAL IN VALUE  The mother’s life and the fetus’s life are of equal importance  As much as possible, save both lives  WHICH LIFE IS TO BE SAVED?  There is no direct answer.  For as long as both lives can be saved, then save the mother and the fetus.

LEGITIMACY AND CRITERIA OF THERAPEUTIC PROCEDURES OF HUMAN EMBRYO

 NATURE OF DISORDER OR TRAUMA  If you were able to assess that one will really not survive, then that is the only time that you may choose.

 Strictly therapeutic  If the therapeutic efficacy of the management is questionable, do not institute that therapy to the mother.  Explicit objective is healing of maladies (chromosomal defects)  If a therapeutic management would be able to solve the chromosomal defect, then carry on as long as it is strictly therapeutic and would not destroy the integrity of the embryo.  Directed to the true promotion of the personal well-being of an individual  Does not harm the integrity of the embryo.  Does not worsen the embryo’s condition of life  Delicate and particular precaution in embryonic life are called for

CASE A 16 week pregnant mother went to the emergency room because of massive bleeding or spotting. Ultrasound showed that there is a separation of the placenta and the implantation site (placenta previa). The mother is already hypotensive upon reaching the ER. Will you terminate the pregnancy?  The first step is to manage the hypotension. The fetus cannot be delivered because it is not yet at the age of viability (20 weeks).  Improve the condition of the mother.  Assess the condition of the fetus. If there is only partial separation, do conservative management. If more than 50% of the placenta is separated, then you may remove the product of conception -END-

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D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 3 of 3

BIOETHICS IN SURGERY Malen M. Gellido, MD, FPCS, FACS January 10, 2014; 8:00 – 10:00AM Bioethics OUTLINE  Mutilation  Surgery  Principle of totality  Principle of double-effect  Non-maleficence/beneficence  Autonomy/informed consent

MUTILATION

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Maim or distort (Livy) Amputate (Ovid) Diminish or lessen (Cicero) The act of depriving a limb, member or important part; deprival of an organ (Dorland’s medical dictionary)  The removal of an organ or the suppression of its function

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Elective surgery Therapeutic surgery Palliative surgery Incidental surgery Suppression or excision of a healthy organ

 Example #1: Removal of an appendix

 Example #2: Mastectomy

SURGERY  Entails a positive invasion of the body’s integrity  Surgery = Mutilation  By virtue of principle of totality, it is morally acceptable PRINCIPLE OF TOTALITY  The parts of a physical entity, as parts, are ordained to the good of the physical whole. Since this good of the whole is the fundamental reason of, and reason for, the existence of the parts,  There is no violation of right order in the destruction of the parts, when this is necessary for the whole  All parts of the human body are meant to exist and function for the good of the whole body, and are thus naturally subordinated to the good of the whole body.  Therefore, when some part or function becomes detrimental to the good of the whole body, it is morally acceptable to remove such part or to suppress its function.

Transcriber/s: Nicxz Icaro Formatting: Nicxz Icaro Editor/s: Craig Angelo Reyes

PRINCIPLE OF DOUBLE EFFECT  Often invoked to explain the permissibility of an action that causes a serious harm, such as the death of a human being, as a side effect of promoting some good end  Example #1  A pregnant woman with uterine cancer has to undergo surgery to remove the uterus. The good effect is that the mother may be cured with the removal of the uterus but the bad effect is the termination of the baby.  The act itself is good which was the removal of the cancerous uterus, the good effect and not the evil effect is the one intended by the agent

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 Example #2  A patient terminally ill from cancer has metastasis to the bones which is causing extreme excruciating pain. Usual doses of analgesics is no longer effective. Morphine, which is an opioid used to relieve intense or chronic severe pain, was given to relieve the patient from suffering regardless of the incremental dosage.  Example #3  A patient bleeding from gastric ulcer, vomiting blood, and in hypotensive shock. He had myocardial infarction a few weeks before. If operated, chances of dying is 90%. The bleeding has to be stopped immediately by doing surgery FOUR CONDITIONS:  The act itself is good or indifferent  The good effect and not the evil effect is the one directly intended by the agent  The good effect is not produced by the evil effect. The good effect must follow from the action at least as immediately as the harmful effect  There is proportionate reason for permitting the foreseen evil to occur  Example #1  Performing a surgery to remove a life-threatening uterine cancer from a pregnant woman may be permitted, since the action is not evil in itself, even though it may cause death of the fetus.  Example #2  Giving increasingly high doses of morphine in terminally ill patients to relieve suffering, even though this might bring about end of life. PRINCIPLE OF NON-MALEFICENCE  “Primum non nocere” –“first do no harm”  One ought not to inflict evil or harm  Related to the following human rights:  Right not to be killed  Right not to have bodily injury or pain inflicted  Right not to have one’s confidence revealed AUTONOMY/INFORMED CONSENT AUTONOMY  The moral right to choose and follow one’s own plan of life  Freewill, Free to choose anything you want to do INFORMED CONSENT  The willing and uncoerced acceptance of a medical intervention by a patient after adequate disclosure by the health professional of the nature of the intervention, its expected risks, benefits and alternatives available  Signing of consent form is just signing and NOT securing. The act of securing a consent from the patient is the actual communication between the doctor and the patient. The signing is just an evidence that the patient really consented. Transcriber/s: Nicxz Icaro Formatting: Nicxz Icaro Editor/s: Craig Angelo Reyes

ELEMENTS OF INFORMED CONSENT: 1. Disclosure of information 2. Comprehension of information  Explain all the details of the nature of disease, urgency of the treatment, treatment options, recent publications, benefits, costs 3. Voluntariness  Patient is not coerced (scared by the surgeon)  Do not force the patient to agree on the procedure if he/she is not willingly consenting 4. Competence  Consent given voluntarily by the patient himself  If patient is incompetent, legal guardian or immediate family member is the one to be asked for consent. NOTE: ALL SURGERIES NEED INFORMED CONSENT

ELECTIVE SURGERY  Not urgent surgery or Scheduled at own convenience or leisure  Cosmetic surgery 1. May be done:  if the risk is low  if the functional integrity is maintained  even if the other organs that are affected by the removal are rendered functionless secondary to a more important surgery 2. May not be done:  if the risk is high  if it does benefit the patient  if there is no medical usefulness THERAPEUTIC SURGERY 1. Since it is a necessary surgery, because it is curative, then it should be done. 2. Informed consent is necessary  Examples:  Colon cancer: colectomy  Appendicitis: appendectomy  Breast cancer: mastectomy PALLIATIVE SURGERY  Relieve symptoms 1. Since it is not designed to prolong life but make the patient more comfortable (the condition cannot be cured), it is an optional surgery. 2. Informed Consent is necessary 3. If proper disclosure of information has been made and the patient still requests it, it may be done but always weigh the benefits and the risks.  Example #1  Bleeding gastric cancer with gastric outlet obstruction, the cancer obstructed the pylorus and food cannot proceed to the duodenum. Surgery is done for the patient to enjoy the pleasure of eating food normally and not by tube.

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 Example #4  Colectomy, removal of the right side, patient also has asymptomatic gall stones, since the part is already opened might as well remove the gallbladder but still ask for an informed consent from a family member if the patient is incompetent or if not anticipated.

UNNECESSARY SURGERY 1. It is unethical to perform surgery with no real medical indication but which might be undertaken for some unworthy motive such as financial gain or face-saving. 2. A surgeon is culpable when, because of inability or lack of knowledge to preserve or repair an injury, performs an amputation/mutilation rather than ask for assistance or make a referral. 3. Although it would be easier to amputate, the surgeon is bound to conserve as much as possible a part, or all of the part of the body that is injured.

SUPPRESSION OR EXCISION OF A HEALTHY ORGAN  Justifiable if the normal organ exercises an influence on another diseased organ  Example #5  Hormonal treatments are usually used in breast cancer which works by blocking the effects of estrogen on breast cancer tumor cells. Since ovaries produce estrogen, removal of the ovaries may be an option. However, it is only effective or advised for pre-menopausal women

 Example #2  Cholecystectomy (surgical removal of gallbladder). If a patient with gall stones is asymptomatic, 90% does not progress to cholecystitis so usually the gallbladder is not removed. A doctor should not scare or force the patient to have a surgery if it’s not medically necessary. INCIDENTAL SURGERY 1. The removal of the part of the body does not pose a serious threat to the patient’s life. 2. It is done during the course of a main surgery. 3. The part removed has no integral function in the body. 4. The part removed enhances physical appearance.

CLINICAL CASES 1. Incidental Appendectomy 2. Strictly Elective Appendectomy  No symptoms involve but insisted on having it remove 3. Elective Tonsillectomy 4. Circumcision of the Newborn  Not unnecessary nor incidental 5. Oophorectomy in breast cancer  There are Pro’s and Con’s since hormonal medications may also be taken

 Example #3  Gynecologist will remove mucinous tumor of ovaries, but these are notorious for involving the appendix, so even if the appendix is normal looking they will ask them to remove it.

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BIRTH REGULATION Rev. Fr. Danilo Tiong December 20, 2013; 8:00 – 10:00 AM Bioethics OUTLINE  Birth regulation  Responsible parenthood  Contraception

BIRTH REGULATION SOME ETHICAL CRITERIA TO TAKE INTO ACCOUNT FOR THE ACTUAL MORAL DISCERNMENT REGARDING BIRTHREGULATION: 1. The exercise of responsible parenthood should be such as to respect human life.  This does not mean you have to be PRO-life but RESPECT LIFE because it’s coming from God  The fundemental bioethical principle is SANCTITY and INVIOLABILITY to life (Reverence or respect for human life) 2. The moral evaluation of the various methods of contraception should be made not from an excessively biological point of view of human sexuality, but from a complete vision of marriage and human love.  Regulating birth is not just physical or biological but also spiritual or moral  We cannot separate sexual love from human love because it’s a part of it. When we look at a person, when he/she acts according to that love. It is the whole thing of himself including his own sexuality. Sexuality is not gender, it is the whole sexual makeup of the entire person, how he looks at things, perceive things, relate with people and with God.  When we talk about Human love were talking about a responsible human love, real sexual love, mature love, complete love not just love that see in the streets or hear in songs  Marriage is not just having a child; it’s only a part of it. Marriage is when two people in complete mature love come together and decide to be together for life because they decide that the other would be the parent of his/her children coming from a real love and as part of sexuality. It starts with sex, starts with attraction but ends up with something.  Sexual intercourse may have its end, what remains is the real love.  Marriage is not a sacrifice; marriage is a gift of oneself because of a supplying love in which you want that person to be the parent of your child and to live with him/her for the rest of your life. 3. From the technical point of view, none of the available methods of contraception satisfies all the criteria for an ideal method.  There would be no ideal method  One method may be effective for one couple but not for the other  There should be openness between husband and wife

Transcriber/s: Eliza Marie Hererra Formatting: Nicxz Icaro Editor/s: Nicxz Icaro, Craig Angelo Reyes

4. The morally acceptable use of contraceptive methods should be the result of the free and responsible discernment of the spouses  When the spouses discern: they talk, they dialogue about their fertility, they talk about their sexual love together, and they talk about themselves.  What if after discerning the couple agreed to use the pills? it still depends on the circumstances they are in or situation, their health, social status and many things. The spouses should keep in mind that their mutual self-giving and the resulting procreation should be an expression of authentic personal love  It’s not only biological, not only ligation, pills or family planning. It should be coming expression of authentic personal love, from that authentic personal love, they discuss, and they discern and talk.  Their mutual self-giving, specially the physical, should be intimate and sacred. And from that sacredness and intimacy, the resulting procreation should be there for an expression of authentic personal love. Children are expression of authentic personal love.

RESPONSIBLE PARENTHOOD  The right and duty of increasingly humanized population ethically entails the principle of responsible parenthood, with the corresponding need for family planning. Children should be the product of the mature and responsible love of married couples.  Right and duty cannot be separated  Responsible parenthood is a principle and not a means for contraception.  When we talk of responsible parenthood it might imply the number of children or spacing of birth  The term responsibility should echo the fundamental bioethical principle of STEWARDSHIP and ACCOUNTABILITY  Responsible parenthood is not family planning; family planning is a part of responsible parenthood.  Family planning is NOT a necessity.  Society has the obligation to create adequate conditions for the exercise of responsible parenthood by the spouses.  Society must create adequate conditions. Society including government should not fight but should give proper respect on how other people look at these things.

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 The actions of the community should respect the dignity of the human person and the value of personal decisions.  If a particular couple has a particular decision, we don’t condemn them.  Includes both the dignity of the spouses and of the unborn  Personal decisions are valuable which include the decisions of the spouses after proper discussion and are therefore respected  “The product of human reproduction is not a potential person but a person with potentials”

CONTRACEPTION  The deliberate prevention of conception.  The essential action of contraceptive methods is to prevent fertilization by precluding the meeting of ovum and spermatozoa.

 The spouses have the obligation to make the ultimate ethical discernment regarding the exercise of their fecundity, taking into consideration  The orientation of conjugal love toward fecundity  The various values which are involved  Religious, cultural, social, family & moral values  The circumstances of their situation.  Don't plan on having 6 children if you can't provide them food adequately  Why have only one child when you can raise 3? This plan may arise from personal selfish reasons  Spouses should consider monetary and social situation

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HUMAN SEXUALITY 1-2 Danilo A. Ballesteros, MD, MBAH, DPPS February 7 & 14, 2013; 8:00 – 10:00 AM Bioethics OUTLINE     

PART 1  Importance of sexuality  Sexual morality  Sex  Sexuality  Sexual orientation  Sexual Identity  Gender  Gender identity  Meaning of human sexuality  Old testament  New testament

Man’s sexual constitution in general Nature of sexual love Purpose of sexual love Social aspect of sexual love Christian Attitude Towards Sex and Sexuality  Fields of modesty  Principle of personalized sexuality PART 2  Principal values of human sexuality  Encyclical letters, papal lecture

PART 1 IMPORTANCE OF SEXUALITY  The human person is so deeply influenced by his sexuality that this latter must be regarded as one of the basic factors shaping human life  The person’s sex is the source of the biological, psychological and spiritual characteristics which make a person male or female, and thus are extremely important in the maturation and socialization of the individual  Moral corruption is on the increase  Boundless exaltation of sex  Teachings, moral norms and habits faithfully preserved have been called into doubt  The Sources of Moral Knowledge  Conscience SEXUAL MORALITY CONVENTIONAL SEXUAL MORALITY  Sex is morally legitimate only within the bounds of marriage Defense:  Social utility  A stable family life is absolutely essential for the proper raising of children and the consequent welfare of society as a whole  Natural law theory  Actions are morally appropriate insofar as they accord with our nature and end as human beings and morally inappropriate insofar as they fail to accord with our nature and end as human beings  Procreation is the natural purpose or end of sexual activity THE LIBERAL VIEW  Reject as unfounded the conventionalist claim that non-marital sex is immoral  Reject the related claim that sex is immoral if it cuts off the possibility of procreation  Nor are willing to accept the claim that sex without love is immoral Transcriber/s: Eliza Marie Hererra, Nicxz Icaro Formatting: Nicxz Icaro Editor/s: Craig Angelo Reyes

 There are important moral restrictions on sexual activity  It is morally objectionable to the extent that it is incompatible with a justified moral rule or principle  Infliction of personal harm SEX  Two common designations: 1. The biological aspect of one’s personhood, the individual’s biological makeup based on the appearance of genitals 2. Genital behavior, i.e. What we think, feel and do sexually SEXUALITY  It encompasses both sex, i.e. who we are and what we think, feel and do sexually, as well as the meanings given to sex.  “What our body means to us, how we understand ourselves as a woman or as a man, the way we feel comfortable in expressing affection – those are part of our sexuality… Un this broadest sense, sexuality is how we make sex significant” (Whitehead and Whitehead 1989:45)  It does not necessarily include genital intercourse or related sexual practices. SEXUAL ORIENTATION  Sexual orientation refers to the emotional and erotic preference for the category of people – heterosexual, homosexual, or bisexual – how an individual prefers to relate sexually or intimately. SEXUAL IDENTITY  Sexual identity refers to the individual, gay, lesbian, or bisexual. “Self-identification” is the operative word which is indicative of whether the individual considers him-/herself as male or female.  Sexual identity is related to but different from gender identity

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GENDER  A socially constructed designation. GENDER IDENTITY  This refers to the individual’s subjective sense of being a man or woman. It is the individuals inner sense of self as a man or woman SEXUAL LOVE IS:  Exalted as a human value  Willed by the Creator  Wholly good LIMITATION OF SEXUAL LOVE:  An easy, unpreoccupied enjoyment of sexual love and its spontaneous regulation by the instincts of human nature.  The fallen state of man cannot be ignored REALITY OF HUMAN SEXUALITY:  Its creative powers of enriching love  Its eroding forces of dehumanizing abuse CHRISTIAN VIEW OF SEXUALITY:  God created man male and female (principle of differentiation)  The woman is a human person like Adam (principle of equality)  The original goodness of sexuality (principle of value) MEANING OF HUMAN SEXUALITY BIBLICAL VIEW – OLD TESTAMENT  Gen 1:27 “God created man… created them.”  Man is God’s image  Differentiated in two sexes  The entire man is created good. Sexuality, as a gift of God, is wholly acceptable.  Man’s nature must primarily be understood from the nature of God, and not from the nature of the animal. BIBLICAL VIEW – NEW TESTAMENT  Jesus Christ treated women equally with men  The early church was concerned with self-control and discipline in sexual life  Fornication and adultery are listed as vices and are condemned (I Thes.4:4-8; I Cor. 6:9 ff.)  Christians must sanctify their bodies and sexuality because they are the temples of the Holy Spirit (I Cor. 6:13-20)  Married people are to maintain mutual love for each other (I Peter 3:1-7). And there is parallelism between the bond that unites Christ with the Church and the bond of marriage (Eph. 5:21-33).  There is a recommendation of virginity.

Transcriber/s: Eliza Marie Hererra, Nicxz Icaro Formatting: Nicxz Icaro Editor/s: Craig Angelo Reyes

THE PURPOSE OF SEXUALITY:  Procreation (Gen. 1:28)  Mutual companionship (Gen. 2:18) and to complete (completion) each other (the sexes) (Gen. 2:21 ff.) The completion of each other is both biological and spiritual.  This completion and mutual companionship culminates in the mutual self-giving by which they form so intimate a union that they can be called “one flesh”. (Gen. 2:24) BECAUSE OF SIN:  State of integrity is lost  The entire order of creation is disturbed  The relationship of the sexes is disturbed  The carefree naturalness of the sexes in their mutual relationship is lost.  Sexuality is experienced as a vulnerable possession which man must protect against abuse by others and also by himself MAN’S SEXUAL CONSTITUTION IN GENERAL  Man and woman complement each other. Any contempt of the other sex is unfounded conceit and ultimately an offense of the Creator  The erotic is a marvellous and creative power in man. But its force can be terrifying. When sexual desires and genital satisfaction are detached from the totality of eros and human love, evil can be revealed.  Only when integrated in the totality of man’s being is sexuality good, amiable and constructive. NATURE OF SEXUAL LOVE  The attraction and love of the sexes finds its expression in the act of sexual love.  Sexual love aims at a partner of the other sex. Every other form of sexual actuation is:  Incomplete  Directed to the beloved  Immature  To be able to have sexual desire or fulfillment with another sex and to be able to love the opposite sex with one’s whole being  Perverse  Outside of what is natural  Pleasure is not the purpose/aim of sexual function. Pleasure is the divinely instituted allurement of human beings to use their sexual powers and thereby to maintain and to propagate life.  J. Grundel: “Sexuality cannot and may not become purely the means to private satisfaction of instinct nor a sort of easily available drug. It gives man a goal beyond himself.”

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PURPOSE OF SEXUAL LOVE 1. Propagation of mankind through procreation of children.  This is the innate, ultimate purpose of man’s sexual faculties  This is the nature-ordained end of sexuality  It includes education of children 2. A means to express mutual love  Expresses mutual love and esteem  Deepens the intimate unity of husband and wife  Truly a human action that signifies and promotes the mutual self-giving  If a person accepts this act in its whole significance and value as suited and intended for the procreation of children he/she will be ready for such intimate love only with a partner whom he/she would like to be the father/mother of his/her possible child 3. Creates a community 4. Mutual love is enhanced and more perfectly achieved when man and woman are bound together by a permanent union of common life. SOCIAL ASPECT OF SEXUAL LOVE 1. Since sexuality orders a man toward other human beings and since its complete actualization involves a partner, in necessarily affects the social life of a community scholar 2. Nobody can arbitrarily use another for the satisfaction of one’s own sexual desires. He/She has to respect the rights of the partner:  To his/her body  To the free disposition of him-/herself  To a treatment worthy of a person  To responsible care 3. Sexual relations give life to children who are the future of the community. A sound family life is an essential condition for the guarantee of a healthy youth. 4. Human sexuality possesses specific qualities which demand a control of its energies for social living

Transcriber/s: Eliza Marie Hererra, Nicxz Icaro Formatting: Nicxz Icaro Editor/s: Craig Angelo Reyes

CHRISTIAN ATTITUDE TOWARDS SEX AND SEXUALITY  The Christian attitude towards sex and sexuality is RESPECT AND REVERENCE.  The nature of SHAME in the realm of sexuality is fundamentally that of a protective instinct, built in by nature between a person and his fellow  The moral virtue which disposes a man to meet the demands of shame in the realm of sexuality is MODESTY.  Modesty is a readiness to keep away from all dangers rising against a person’s sexual integrity. Modesty is the protection and custodian for chastity.  FIELDS OF MODESTY  Conversation  Literature/reading  Media (TV, radio, movie theatre)  Looks touches  Fashion (dress)  Chastity is the moral force which keeps order in the sphere of sexual activity.  Chastity is not only continence but is an attitude of reverence for the mystery of life and for the personal dignity of the partner.  Chastity shapes and orders the sexual powers in such a way that they are truly able to serve the human relation of conjugal partnership and the social need of the propagation of the community PRINCIPLE OF PERSONALIZED SEXUALITY  The gift of sexuality must be used in keeping with its intrinsic, indivisible, specifically human teleology.  It must be a loving, bodily, pleasurable expression of the complementary, permanent self-giving of a man and a woman to each other which is open to fruition in the perpetuation and expansion of this personal communion through the family they responsibly beget and educate  Sex is a search for sensual pleasure and satisfaction, releasing physical and psychic tensions  Sex is a search for completion of the human person through an intimate personal union of love expressed by bodily union  Sex is a social necessity for the procreation of children and their education in the family so as to expand the human community and guarantee its future beyond the death of individual members  Sex is a symbolic mystery

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PART 2 PRINCIPLE OF PERSONALIZED SEXUALITY  The gift of sexuality must be used in keeping with its intrinsic, indivisible, specifically human teleology  It must be a loving, bodily, pleasurable expression of the complementary, permanent self-giving of a man and a woman to each other which is open to fruition in the perpetuation and expansion of this personal communion through the family they responsibly beget and educate.

ENCYCLICAL LETTERS, PAPAL LECTURES  Humanae vitae  Encyclical Letter of His Holiness Pope Paul VI on the Regulation of Birth  Evangelium vitae  Encyclical Letter of the Supreme Pontiff John Paul II on the Value and Inviolability of Human Life  Theology of the human body  Pope John Paul II

PRINCIPAL VALUES OF HUMAN SEXUALITY  Sex is a search for sensual pleasure and satisfaction, releasing physical and psychic tensions  Sex is a search for completion of the human person through an intimate personal union of love expressed by bodily union  Sex is a social necessity for the procreation of children and their education in the family so as to expand the human community and guarantee its future beyond the death of individual members  Sex is a symbolic mystery SEX OUTSIDE MARRIAGE IS ETHICALLY WRONG  Selfish pursuit of pleasure apart from love  Casual or promiscuous relations  May express love but not a committed love involving true self-giving  Adultery or premarital sex may be committed, but practiced in a way contradictory to its natural fulfillment in the family  May be committed, but practiced in a way contradictory to its natural fulfillment in the family

HOW HEALTH CARE PROFESSIONALS CAN HELP  Provide for an understanding of the unitiveprocreative meaning of sexuality in marriage  Provide information on essential biological facts on sexual differences and equality, pregnancy and birth  Provide information on why people have a need for children and on problems of sterility and the limits on the right to have children  Provide information on the problems of responsible parenthood in present-day society, natural family planning methods and alternative methods and ethical evaluation of all birth regulation methods  Explain the rights of the unborn child  Discuss the problems of genetic defects and the supportive attitude toward defective persons and consider problems in psychosocial development

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CONFLICT-OF-INTEREST: DOCTORS AND THE PHARMACEUTICAL INDUSTRY by Angelica D Francisco, MD

DEPRESSION-SEROTONIN THEORY LOW SEROTONIN LEVELS  DEPRESSION ANTIDEPRESSANTS • SELECTIVE SEROTONIN REUPTAKE INHIBITORS, SSRI

2010 WebMD “ Rate your risk for depression: could you be depressed?” 10Qs “I feel sad or down most of the time”; “I feel tired almost everyday”; “I have trouble concentrating”; “I feel worthless or hopeless”

ANSWER “NO” LOWER RISK: YOU MAY BE AT RISK FOR MAJOR DEPRESSION

DEPRESSION-SEROTONIN THEORY ZOLOFT “Zoloft may help correct the chemical imbalance of serotonin in the brain.”

DEPRESSION-SEROTONIN THEORY PAROXETENE (PAXIL ) “If you have experienced some of these symptoms of depression nearly everyday, for at least 2 weeks, a chemical imbalance could be to blame.”

Objectives • To identify the key ethical challenges in the relationship between health professionals and the pharmaceutical industry • To define a conflict-of-interest situation and describe why such situations are especially troubling in medical practice

Doctors and the Pharmaceutical Industry “… AN INHERENT CONFLICT OF INTEREST BETWEEN THE LEGITIMATE BUSINESS GOALS OF MANUFACTURERS AND THE SOCIAL, MEDICAL AND ECONOMIC NEEDS OF PROVIDERS AND THE PUBLIC TO SELECT AND USE DRUGS IN THE MOST RATIONAL WAY.”

(WHO Europe, 1993)

Conflict-of-Interest “A person is in a conflict of interest situation if he/she is in a relationship with another in which s/he has a moral obligation to exercise her judgment in that other’s service and, at the same time, s/he has an interest tending to interfere with the proper exercise of judgment in that relationship.” (Davis, 1982)

Key Ethical Principles 1. Respect for autonomy -informed decision-making 2. Non-maleficence -”do no harm” 3. Beneficence - maximum benefit 4. Justice -distributive fairness

PHYSICIAN’S FIDUCIARY DUTY TO PROMOTE PATIENTS’ WELFARE ABOVE ALL ELSE 1. BE LOYAL TO PATIENTS 2. ACT IN THEIR PATIENTS’ INTERESTS 3. MAKE THEIR PATIENTS’ WELFARE THEIR FIRST CONSIDERATION 4. KEEP PATIENT INFORMATION CONFIDENTIAL

The revenues of the 12 largest pharmaceutical manufacturers on the Fortune 500 list range from $67.2 billion (Pfizer) to $5.5 billion (Celgene). Source: http://www.drugchannels.net/2014/06/profits-in-2014-fortune-500.html

GSK FINED USD3 Bn, 2012 • GlaxoSmithKline fined $3bn after bribing doctors to increase drugs sales • Sales reps in the US encouraged to mis-sell antidepressants Paxil and Wellbutrin and asthma treatment Advair

Simon Neville The Guardian, Tuesday 3 July 2012

GSK FINED USD3 Bn, 2012 •

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•

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Psychiatrists and their partners were flown to five-star hotels, on allexpenses-paid trips where speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving, golf, fishing and other extra activities arranged by the company. GSK held eight lavish three-day events in 2000 and 2001 at hotels in Puerto Rico, Hawaii and Palm Springs, California, to promote the drug to doctors for unapproved use. Those who attended were given $750, free board and lodging and access to activities including snorkelling, golf, deep-sea fishing, rafting, glassbottomed boat rides, hot-air balloon rides and, on one trip, a tour of the Bacardi rum distillery, all paid for by GSK. Air fares were also covered for doctors and spouses, in most cases, and speakers at the event were paid $2,500 each. Simon Neville The Guardian, Tuesday 3 July 2012

Another Glaxo Scandal In China: Bribing Docs To Prescribe Meds? • Glaxo sales reps allegedly provided doctors with speaking fees, cash, dinners and paid trips in return for prescribing various drugs. The allegations, the paper writes, were made by an anonymous tipster, who sent emails to the Glaxo board, senior execs and compliance officers earlier this year. • One example: sales reps there urged doctors to prescribe the Lamictal epilepsy drug to patients with bipolar disorder, which is an unauthorized use and one patient became seriously ill, writes the paper, which reviewed some of the documents. Glaxo acknowledged an adverse event occurred, but maintained it was not due to off-label marketing. June 2013 Source: http://www.drugs.com/news/another-glaxo-scandal-china-bribing-docs-prescribe-meds-45062.html

NEWER NOT NECESSARILY BETTER…

“Disease mongering” • Payer L. “to inflate a common condition to the level of pathology” “trying to convince essentially well people that they are sick, or slightly sick people that they are very ill.” • R. Moynihan. EDUCATION AND DEBATE Selling sickness: the pharmaceutical industry and disease mongering. Commentary: Medicalization of risk factors BMJ 2002; 324 • Joseph Lister, Listerine & halitosis Dossey L. Creating Disease: Big Pharma and Disease Mongering. Huffington Post http://www.huffingtonpost.com/dr-larry-dossey/big-pharma-health-care-cr_b_613311.html

“Disease mongering” • Taking a normal function and implying that there’s something wrong with it and that it should be treated • Describing suffering that isn’t necessarily there • Defining as large a proportion of the population as possible as suffering from the disease • Defining a condition as a deficiency disease or as a disease of hormonal imbalance • Recruiting doctors to spin the message • Using statistics selectively to exaggerate the benefits of treatment • Promoting the treatment as risk-free • Taking a common symptom that could mean anything and making it sound as if it is a sign of a serious disease Dossey L. Creating Disease: Big Pharma and Disease Mongering. Huffington Post http://www.huffingtonpost.com/dr-larry-dossey/big-pharma-health-care-cr_b_613311.html

“Disease mongering” • • • • • • • • • •

ERECTILE DYSFUNCTION FEMALE SEXUAL DYSFUNCTION BIPOLAR DISORDER ATTENTION DEFICIT HYPERACTIVITY DISORDER RESTLESS LEG SYNDROME OSTEOPOROSIS SOCIAL ANXIETY DISORDER (SOCIAL SHYNESS IRRITABLE BOWEL SYNDROM BALDING AGING

Dossey L. Creating Disease: Big Pharma and Disease Mongering. Huffington Post http://www.huffingtonpost.com/dr-larry-dossey/big-pharma-health-care-cr_b_613311.html

“Disease mongering” • INCIDENCE OF CONDITION HAS BEEN EXAGGERATED IN PURSUIT OF CORPORATE PROFITS • PSYCHOLOGICAL COSTS • FINANCIAL COSTS • PERSONAL/SOCIAL COSTS

Dossey L. Creating Disease: Big Pharma and Disease Mongering. Huffington Post http://www.huffingtonpost.com/dr-larry-dossey/big-pharma-health-care-cr_b_613311.html

Influence of pharma on physicians • 8 out of 10 received gifts, usually free food at their workplace • 8 out of 10 received free medicine samples • 4 out of 10 had their expenses paid to attend meetings and conferences • 3 out of 10 were paid consultants, on a company speakers bureau or advisor board Source: Campbell, 2007

Non-traditional forms of marketing

Physicians and “Gifts” • GIFTS, FREE MEALS, TRAVEL SUBSIDIES, SPONSORED TEACHINGS, SYMPOSIA • OBJECTIVE: …TO IDENTIFY THE IMPACT ON THE KNOWLEDGE, ATTITUDES AND BEHAVIOR OF PHYSICIANS

Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

Physicians and “Gifts” • INCREASING REQUEST OF PHYSICIANS FOR ADDING THE DRUGS TO THE HOSPITAL FORMULARY • CHANGES IN PRESCRIBING PRACTICES • DRUG COMPANY SPONSORED CME HIGHLIGHTED THE SPONSOR’S DRUGS

Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

Physicians and “Gifts” • ATTENDING SPONSORED CME EVENTS AND ACCEPTING FUNDING FOR TRAVEL OR LODGING FOR ATTENDING SYMPOSIA WERE ASSOCIATED WITH INCREASED PRESCRIPTION RATES OF THE SPONSOR’S MEDICATION • ATTENDING PRESENTATIONS GIVEN BY PHARMACEUTICAL REPRESENTATIVE SPEAKERS WERE ASSOCIATED WITH NONRATIONAL PRESCRIBING. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000 Jan 19;283(3):373-80.

Gift Economy • • • • •

Coffee mugs, free lunches Pen lights Knap sacks Stethoscopes Pocket textbooks

“… few doctors accept that they themselves have been corrupted. Most doctors believe that they are quite untouched by the seductive ways of industry marketing; that they are uninfluenced by the promotional propaganda they receive; that they can enjoy a company’s ‘generosity’ in the form of gifts and hospitality without prescribing its products. The degree to which the profession, mainly composed of honourable and decent men/women, can practice such self deceith is quite extraordinary. No drug company gives away its shareholders’ money in the act of disinterested generosity.” Rawlins, 1984

Effect of free samples on Rx

If promotion did not affect treatment decisions, would pharmaceutical companies pour billions of dollars into marketing targeting professionals, i.e. MDs, each year?

• Codes of conduct for pharmaceutical companies developed by industry organisations tend to be voluntary but are often backed up by complaints procedures • Most such codes prohibit companies from giving doctors inducements to prescribe their products • Many doctors' organisations offer guidance about commercially funded researchJournal editors have issued a statement aimed at preventing suppression of unfavourable findings • Guidance on good publication practice for pharmaceutical companies was lacking until recently • Dialogue between the interested parties is needed before further guidance on the doctor-industry relationship is issued BMJ. 2003 May 31; 326(7400): 1196–1198.doi: 10.1136/bmj.326.7400.1196PMCID: PMC1126055 How to dance with porcupines: rules and guidelines on doctors' relations with drug companies Elizabeth Wager, publications consultant1

Merck ordered to pay $321 million criminal fine for illegally marketing Vioxx painkillerThursday, April 26, 2012 by: Ethan A. Huff

Drug giant Merck & Co., creator of the human papillomavirus (HPV) vaccine Gardasil, has been ordered by a federal judge in Boston, Mass., to fork over $321 million in criminal fines for illegally marketing Vioxx, a dangerous painkiller drug that was pulled from the market in 2004 because taking the drug doubles a patient's risk of having a heart attack or stroke.Learn more:

http://www.naturalnews.com/035690_Merck_Vioxx_marketing.html

Patients’ Attitudes on Gifts to MDs Sample: 486 Patients Type of Gift

Percent Awareness

“Not alright”

87

7.6

Ballpens

55.3

17.5

Medical books

34.6

16.9

Infant formula

28.6

44.2

Dinner at a restaurant

22.4

48.4

Coffee maker

13.8

40.7

Free drug sample

Blake RL Jr, Early EK. Patients' attitudes about gifts to physicians from pharmaceutical companies. J Am Board Fam Pract. 1995 Nov-Dec;8(6):457-64.

Patients’ Attitudes on Gifts to MDs • 32.5% DISAPPROVE OF MDs ACCEPTING PAYMENT BY PHARMACEUTICAL COMPANY OF MEDICAL CONFERENCE EXPENSES • 28-43% DISAPPROVED OF MDs ATTENDING SOCIAL EVENTS SPONSORED BY PHARMACEUTICALS • 70% BELIEVED GIFTS INFLUENCE MDs PRESCRIBING MEDICATIONS • 64% BELIEVED GIFTS TO MDs INCREASE MEDICATION COSTS

Patients’ Attitudes on Gifts to MDs CONCLUSION APPROVAL RATES WERE HIGH FOR GIFTS CONSIDERED TO BE TRIVIAL OR THAT HAVE POTENTIAL VALUE TO PATIENT CARE; DISAPPROVAL RATES WERE RELATIVELY HIGH FOR GIFTS THAT HAVE SOME MONETARY VALUE BUT HAVE LITTLE OR NO BENEFIT TO PATIENTS. OPINIONS ABOUT GIFTS WERE RELATED TO PERCEPTION OF EFFECTS ON PRESCRIBING BEHAVIOR AND COSTS.

PHAP CASES: TOP FIVE INQUIRIES

Categories

Particulars

EC Ruling

Remarks

1. CME

Request to allow sponsorship of conferences in Boracay and other venues deemed to be entertainment and relaxation sites

Committee cannot grant a waiver of any existing rule in the present code. PHAP would like to preserve the integrity of the healthcare profession by avoiding any undue perception of influence by the pharmaceutical industry on their prescribing habits and Section 13.0 of the Code is one of the many safeguards established for such intention.

The ruling is also in consonance with the emerging global trend.

PHAP CASES: TOP FIVE INQUIRIES

Categories 2. Independence of Healthcare Professionals

Particulars Clarification on donation of appliances, etc. to clinics of doctors

Remarks EC Ruling Clinics are not considered institutions and hence, equipment or appliances cannot be loaned or donated.

PHAP CASES: TOP FIVE INQUIRIES

Categories 3.Promotional/ Educational / Materials

Particulars Clarification re applicability of Sec. 4.5.4 as well as Circular 065-05

EC Ruling Rulings are applicable only to prescription or ethical drugs and not on OTC. However, OTC advertising is allowed on condition that adverse effects are also mentioned in the promotional materials.

Remarks

PHAP CASES: TOP FIVE INQUIRIES

Categories 4. Post Marketing Surveillance

Particulars Request to consider adjusting the investigator’s fee for the conduct of the post marketing surveillance from P1k to P5k

EC Ruling Remarks EC did not find justification to grant the request.

PHAP CASES: TOP FIVE INQUIRIES

Categories 5. Gift-giving guidelines

Particulars Whether companies can give gifts during the holiday season.

Remarks EC Ruling Reiterated Nov. 10, 2010 guideline , which stated, “recognition of and in due respect to the Philippine Medical Association Code, the Committee advised to follow the PMA rule on gifts. In this case, no contributions or gifts should be given to physicians to avoid compromising their policy on this matter.

However, since the PMA does not apply to other healthcare professionals, we enjoin you to please be guided of the existing ruling under the PHAP Code.”

BMJ. 2003 May 31; 326(7400): 1196–1198.doi: 10.1136/bmj.326.7400.1196PMCID: PMC1126055 How to dance with porcupines: rules and guidelines on doctors' relations with drug companies Elizabeth Wager, publications consultant1

American Medical Student Association’s PharmFree Pledge “I AM COMMITTED TO THE PRACTICE OF MEDICINE IN THE BEST INTEREST OF PATIENTS AND IN TH PURSUIT OF AN EDUCATION THAT IS BASED ON THE BEST AVAILABLE EVIDENCE, RATHER THAN ON ADVERTISING OR PROMOTION. I, THEREFORE, PLEDGE TO ACCEPT NO MONEY, GIFTS OR HOSPITALITY FROM THE PHARMACEUTICAL INDUSTRY; TO SEEK UNBIASED SOURCES OF INFORMATION AND NOT RELY ON INFORMATION BY DRUG COMPANIES; AND TO AVOID CONFLICTS OF INTEREST IN MY MEDICAL EDUCATION. (AMSA, 2001)

ASSIGNMENT READ ARTICLES BY: • Brennan TA, etal. Health Industry Practices that Create Conflicts of Interest • Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. • Moynihan R. Who pays for the pizza?

ASSIGNMENT Position paper: Choose …. “There is no ethical conflict in physicians receiving gifts/money from pharmaceutical companies.” OR “It is ethically unacceptable for physicians to accept gifts/money from pharmaceutical companies.”

ASSIGNMENT • 2 pages, font arial/calibri 11, 1.5 space • 1” margins • Submit on: 7October 2014 (Faculty Rm, 3rd F)

References • • • •

• • •

Angell, M. The truth about drug companies. How they deceive us and what to do about it. 2004 Blake RL Jr, Early EK. Patients' attitudes about gifts to physicians from pharmaceutical companies. J Am Board Fam Pract. 1995 Nov-Dec;8(6):457-64. Goldacre B. Bad Pharma. Harper Collins Publishers, 2012. Health Action International. Understanding and Responding to Pharmaceutical Promotion: A Practical Guide http://www.haiweb.org/10112010/DPM_ENG_Final_SEP10.pdf Quan SF. , Do You Have A Minute? The Dilemma Posed by Physician Interaction with the Pharmaceutical Industry J Clin Sleep Med. 2007 June 15; 3(4): 345–346 Rodwin MA. Medicine, Money & Morals: Physicians’ Conflicts of Interests. Oxford University Press, 1993 Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000 Jan 19;283(3):373-80.

END-OF-LIFE CARE Paul Dexter C. Santos, MD, FPCP, FPSMO October 13, 2014; 10:00 AM – 12:00 NN Bioethics III OUTLINE  Case 1  Brain States  Brain Death  Artificial Nutrition/Hydration (ANH)  Brain Death and Organ Donations  Case 2  Medical Futility  Case 3  Withdrawing/Withholding Life-Prolonging Treatments  Euthanasia and Assisted Suicide  Allowing to Die  Case 4  Terminally Ill  Case 5  Challenging Autonomy  Advanced Directives

CASE 1 A 45 year old man had a motorcycle accident last year and is presently in a permanent vegetative state. He is dependent on a feeding tube where he is being fed and hydrated. He has been in this state for more than 12 months and the family is experiencing “caregiver fatigue”. The family members know that there is really no chance of the patient returning to previous functionality and productivity and they made a court appeal if they can already remove the feeding tube.

a) What is the condition known as the “permanent vegetative state”? b) What will be your opinion with regards to the withdrawal of the feeding tube? Please defend your answer. c) Is ARTIFICIAL NUTRITION AND HYDRATION (ANH) comprise proportionate (ordinary) or disproportionate (extraordinary) treatment?  There is no wrong answer as it is still a subject of debate BRAIN STATES  MCS: Minimally Conscious State  State of wakefulness  Fluctuating awareness of self and environment  Potential for re-activation or “emergence” being able to do or be able to respond to stimuli

Transcriber: Nicxz Icaro Formatting: Ro-Janna Jamiri Editor: Craig Angelo Reyes

 PVS: Permanent Vegetative State  Unable to interact with the environment, “eyes-open” state (vs. COMA which is a “closed-eyes” state)  Cannot be classified as conscious  COMA NA DILAT  Permanent if > 3months after an anoxic injury or >12months following traumatic injury  Anoxic – no oxygen to the brain for 30minutes or more  Patients with cardiorespiratory arrest  Brain Death  Irreversible cessation of all brain function (cortical and brain stem)  EEG – flat line  Legally dead  Cardiac Death  Cessation of cardiac physical and electrical activities  In the advent of advanced life support systems, it is difficult to base the actual occurrence of death with cardiac death  Brain death = actual death BRAIN DEATH  Clinical determination  Absence of cortical function:  Unresponsive and unarousable  Absence of brain stem function:  Absent reflexes (gag, papillary, corneal), no spontaneous breathing  EEG: No brain activity  In the clinics, usually doctors rely on clinical like the PE findings and the like ARTIFICIAL NUTRITION/HYDRATION (ANH)  As per the Catholic Church  Is an ORDINARY treatment and IS MANDATORY  Life prolonging measures should not be given IF THEY ARE INEFFECTIVE  In CASE 1 – ANH can prolong the life of the patient as per doc; family should also be considered in decision making  For some dying patients, ANH may increase the discomfort  Bloating  Abdominal cramps  Diarrhea  In these situations, doctors should carefully evaluate and communicate with the patient and relatives  In these situations, ANH may not be given since it contributes to the discomfort of the patient

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 TERRI SCHIAVO Case  Ruled to be in permanently vegetative state after anoxic brain injury  Long legal battle in the US which eventually resulted in a decision to remove the feeding tube in 2005  Husband wants tube removed but the family (parents and siblings) countered  Florida court agreed to remove feeding tube March 18, 2005  George Bush signed an emergency law on March 21, 2005 allowing the parents of Terri to appeal the court’s decision  Schiavo died March 31, 2005 BRAIN DEATH AND ORGAN DONATIONS  Importance of knowing the time of brain death is for organ donation  Those who are brain dead but whose circulation is supported by artificial means, can be approached for the possibility of organ donation  Obtaining consent from relatives should be done in a humane and empathic manner  May be present in some living wills SUMMARY  FOR ANH  Should not be removed since it is an ordinary treatment that can provide nourishment to the patient.  But still depend on the morality of the individuals involved and the legality of the process in the country

CASE 2 An 85 year old male with stage IV lung cancer went to the emergency room for difficulty breathing. His Xray showed multiple lung masses and nodules occupying aggregately about 70% of his lungs. He also developed severe sepsis from a concomitant pneumonia and his kidneys are failing due to the infection. At this time, the patient will require intubation with mechanical ventilation, and hemodialysis from a strictly medical point of view. The relatives of the patient said “do everything” despite the doctors stating the incurable state of the cancer.

a) As a relative, what further information would you require from the doctor to help you in making decisions?  Pros and cons of the treatment  Cost of treatment  Survival and success rates b) As a doctor, what treatment goals would you set for the patient?  Palliative – support or minimize the discomfort, treatment of other symptoms c) Would you strongly recommend mechanical ventilation and hemodialysis? Why or why not?  YES – since the family stated to do everything, and as long as the family can sustain the treatment financially

Transcriber: Nicxz Icaro Formatting: Ro-Janna Jamiri Editor: Craig Angelo Reyes

MEDICAL FUTILITY  Hippocrates: “Refuse to treat those who are overmastered by their disease, realizing that in such cases, medicine is powerless”  Clinical action serving no useful purpose in attaining a specified GOAL for a given patient  GOALS should be established:  Cure or palliation?  Keep alive or return to full functionality  Goals to be discussed with patient and relatives  Important to SPECIFY THE GOAL to the RELATIVE  Example: Goal for intubation is to provide oxygenation  If for palliation, specify to the relative that it will not make the patient well and go back to work

CASE 3 A 70 year old male has multi-drug resistant staphylococcal pneumonia and has stayed at the intensive care unit for 2 weeks. He is on mechanical ventilator and inotropic drugs to maintain his blood pressure. All possible antibiotics were already used and the patient is not responding to treatment. The blood pressure is declining despite maximum inotropic support, and his level of oxygenation is dropping despite full oxygen support. He is mostly unconscious but can be awaken for short periods. His family is contemplating on stopping inotropic support and mechanical ventilation.

a) Will stopping mechanical ventilation and inotropic support constitute euthanasia? b) Are these measures (inotropic, mechanical ventilation) considered extraordinary measures to prolong life?  Inotropic – disproportionate c) c. Would you agree in discontinuing these treatments? WITHDRAWING/WITHHOLDING LIFE PROLONGING TREATMENTS  Withdrawing  An act of commission  Decide and commit to discontinue an ongoing treatment  Withholding  An act of omission  Treatment is not given in the first place  Legally, there’s no legal difference (BMA 1999)  Ordinary (proportionate) means vs. extra-ordinary (disproportionate) means of sustaining life  No obligation for doctors to provide disproportionate, ineffective or even experimental treatment  Withdrawing disproportionate treatment – NOT CONSIDERED EUTHANASIA since the disease will take the natural course

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 2 of 3

 BIOETHICAL PRINCIPLES  Beneficence: acting in the best interest of the patient  Non-Maleficence: first do no harm  Autonomy: patient’s right to choose or refuse treatment  Justice: decision of who gets what treatment

EUTHANASIA AND ASSISTED SUICIDE  Taking deliberate action to end a life of another person on compassionate grounds  The primary objective is to achieve the death of the person and not merely allowing death to occur  Illegal in most countries  Legal: NETHERLANDS, BELGIUM, SWITZERLAND  Church: euthanasia is a homicide act which no end can justify  Maximize pain management, hospice care and psychological counseling  DIGNITAS CLINIC, SWITZERLAND

CASE 5 A 75 year old man who was a chronic smoker has been living with emphysema for the past 7 years. The past 6months, he has been dependent on oxygen at home, but would still have difficulty breathing even on light movements. The past week, he called his lawyer to write down his will and advanced directives. His will states that if ever his breathing becomes severely labored, he would not want intubation and mechanical ventilation to be done. And if ever his heart and circulation stops, he would not want CPR to be done. One day, he slipped while inside the bathroom and went unconscious after hitting his head on the floor. His wife brought him to the emergency room. The doctors advised intubation and mechanical ventilation to control the swelling of the brain due to the trauma. Intubation has a good chance of saving the patient’s life. The patient’s wife brought up the will that no intubation should take place.

 Sir Edward Downes and wife Joan  Conductor – BBC Philharmonic Orchestra  Died July 10, 2009 via assisted suicide at the Dignitas Clinic in Switzerland  Suffered from progressive deafness and blindness  Lady Downes had Stage IV pancreatic cancer

ALLOWING TO DIE  It is the condition or the disease that causes the death of the person, not the deliberate acts of the doctor  Discussed in the context of medical futility and withholding of extra-ordinary means of prolonging life

a) What will you do in this situation? Defend your answer.  Respect the will  Proceed with the intubation since the circumstance is different from what is stated in the will

CASE 4 A 45 year old male lawyer is diagnosed with Stage IV pancreatic cancer. You told him that though the disease is incurable by modern medicine, treatment can still be given to control cancer spread and add a few to several months to his overall survival. After a long discussion, he decided not to take any form of treatment whatsoever and just let the disease take its course.

CHALLENGING AUTONOMY  If the person is not capable of reasoning  If other people believe that the person is misinformed  If the decision of the person is not in accordance to his known values and beliefs  Patient’s decision should not be overturned just because it does not conform with societal norms (autonomy will be meaningless)

a) As his physician, are you obliged to convince him to undergo treatment?  Obliged to give information not to convince b) He was admitted several months later due to lung and liver failure due to spreading cancer. This time he asks you to “do everything” and invokes his right to self-determination and autonomy. What will you do?  Can do in the context of the situation  Give goals, treatment options and outcomes

ADVANCED DIRECTIVES  Advanced decision are legally binding  Must be made by an adult who is well informed  Validity of long standing advanced refusals may be questioned if treatment options are substantially different  Consider if circumstances are different from what is stated in the will  If there is no written will and the patient becomes incapacitated to decide, then the “presumed wishes” of the patient have to be implemented (doctrine of substituted judgment)

TERMINALLY ILL  When the state of one’s health deteriorates to an irreversible and fatal condition  Right to life… right to death with dignity

-ENDTRANSCRIPTION DETAILS BASIS REMARKS

Latest PPT + IDK 2014 Editor’s note: Wala.

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Transcriber: Nicxz Icaro Formatting: Ro-Janna Jamiri Editor: Craig Angelo Reyes

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 3 of 3

MATERNAL-FETAL CONFLICTS IN BIOETHICS 1 Maria Carmelita J. Nadal-Santos, MD, FPOGS November 5, 2014; 9:45 AM – 11:30 AM Bioethics III OUTLINE  Disclosure  Termination of Pregnancy  Is Termination of Pregnancy Morally Acceptable?  Abortion  Erroneous Justifications

DISCLOSURE  Any facility identified as Catholic assumes with this identification the responsibility to reflect in its policies and practices the moral teachings of the Church  NOT A MATTER OF OPINION  The medical profession is always at the SERVICE OF LIFE  Many moral problems of relevance today stems from conflicts arising from the life of the mother and the fetus In telenovelas, characters are always given the option to choose between the mother and the baby, but in real life, this is not really an option. So yung mga nasa drama na nagsasabing wala tayong magagawa at kailangan mamili kay mommy at kay baby is wrong because the rights of the baby is totally and completely the same as the rights of the mother, the same rights each and every one of us has.

TERMINATION OF PREGNANCY There is always a bad connotation when you say “termination of pregnancy” but it is actually only a terminology that says to put an end to pregnancy. There is no moral responsibility. It only means to stop the pregnancy from progressing, regardless of the age of gestation. It can be medical (use of drugs), operative or surgical.

 Putting an end to the progression of pregnancy  To stop the pregnancy from progressing  Regardless of the age of gestation  Covers different methods  Medical, operative or surgical procedures IS TERMINATION OF PREGNANCY MORALLY ACCEPTABLE?  IT DEPENDS ON THE SITUATION WHEN DOES IT BECOME ACCEPTABLE?  When you say acceptable, it is RIGHT  It is not acceptable if you’re not at peace with your conscience or if it’s only considered acceptable because it is what the majority does

Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

WHEN DOES IT BECOME ILLICIT?  LICIT is morally acceptable; if it is ILLICIT, it becomes erroneous or illegal  When you say when it becomes morally illicit?  It is asking the question “Kailan hindi nagiging tama?” or “When does it become morally bad?”  It becomes acceptable (acceptable means you are free of moral responsibilities and it is the right thing to do) if:  INTRAUTERINE CONDITIONS become unfavorable for the developing fetus to continue specially if the fetus has reached the period of viability.  If the conditions inside the mother’s womb make it dangerous for the fetus to stay longer and the fetus is already viable, then there is no sense to prolong the pregnancy, so terminate the pregnancy. The decision becomes easier when the fetus is already viable.  In cases of:  Pre-eclampsia  Since the intrauterine conditions are not good for the fetus, you terminate and prepare the fetus. Give antenatal steroids, antihypertensive medications, so on and so forth.

 Oligohydramnios  Terminate the pregnancy. No need for resuscitation, such as intraamnionic infusion or any other heroic methods because the baby is already viable.

 Premature rupture of membranes  The danger in dealing with PROM are the intrauterine infections or chorioamnionitis The late Dra. Ferrolina once told Dra. Nadal, “Carrie, mabuti ng ilabas mo ng buhay kesa mamatayan ka sa loob ng tiyan. Pagnilabas mo yang premature, problema ng pedia. Pero pag namatay yan sa loob ng nanay, ikaw ang may kasalanan niyan.” [HAHAHA. WHAT AN ADVICE :))]

MATERNAL INDICATIONS  Hemorrhagic conditions in pregnancy  i.e. Placenta previa – You cannot do anything with placenta previa. You are faced with a placenta totally covering the internal os. You cannot predict when the mother will contract or when she will have internal hemorrhage. If the baby is viable, terminate. There is no need for the mother to bleed to death. Opt for elective cesarean section instead, terminate right away and don’t wait for the full 39 weeks gestation period. At times, the pregnancy is terminated if there is already sonographic signs of fetal maturity and if the fetal weight is good.

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 1 of 7

 Medical conditions  i.e. Eclampsia  Tonic-clonic seizure is an indication for termination of pregnancy because the intrauterine conditions are no longer favorable.

 Termination of pregnancy becomes morally illicit when it is willed as the principal end or as a means to an end as in direct induced abortion. WHEN DOES LIFE BEGIN?  FERTILIZATION  At the level of the fallopian tube pa lang, life na yan.  Biological and genetic truth  Genetic code of the fertilized ovum is DISTINCT from that of the father and of the mother (totally different human being) ARE YOU CONVINCED OF THIS FACT? ARE YOU CONVINCED ENOUGH THAT YOU CAN MAKE A STAND FOR IT? (If you answer yes, it should not only come from the mouth but from the heart. Naks naman!)

 A FUTURE DOCTOR WHO IS COMMITTED WITH THE CONVICTION TO PROTECT AND DEFEND LIFE (conception to natural death)  You have to realize from the depths of your heart that fertilization and life is synonymous because you will be giving advice to people about the implications. Are you a doctor who will prescribe contraceptives? Because that is the implication of contraceptives, they prevent ovulation. But if you will look at the prescribing information, it is not 100% anovulation. What becomes of the 2-3%? There is fertilization. “Human life must be respected and protected absolutely from the moment of conception. From the first moment of his existence, a human being must be recognized as having the rights of a person – among which are inviolable right of every innocent being to life.” ~Congregation for the Doctrine of the Faith, DONUM VITAE  “You have to guide your family, friends, loved ones and every soul around you on what is the right thing to do because you want to be morally upright doctors, di ba? Being a doctor is a gift and you have to use it wisely, correctly, giving glory to God, who is the source of our life. It is God’s love who is giving us this wonderful experience, this wonderful life.” ~Dra. Nadal

ABORTION  Termination of a pregnancy at any time after fertilization and before viability of the fetus  Abortion is until 20 weeks; beyond 20 weeks, it is not termed as abortion anymore  An aborted embryo should be respected as deceased human person and should be blessed if requested or permitted by the family.

Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

CLASSIFICATION OF ABORTION a) Spontaneous b) Induced / Direct / Provoked / Intentional / Artificial / Voluntary c) Indirect Abortion d) Threatened Abortion e) Inevitable Abortion f) Therapeutic Abortion

A. SPONTANEOUS ABORTION  Accidental / involuntary / ovular / causal  Occurs as a result of natural causes:  Involuntary  No moral value  Free from any human responsibility  “Nakunan”  There is no dilemma with regard to spontaneous abortion

B. INDUCED / DIRECT / PROVOKED / INTENTIONAL / ARTIFICIAL / VOLUNTARY ABORTION  Results from voluntary human intervention purpose is to terminate pregnancy  You become accessory to the crime even if you only give an advice or if, for example, the patient asks you to buy “pampalaglag” at Quiapo and you don’t refuse, then you are already an accessory. If a patient comes to you for advice, that is the golden opportunity to advice the patient on what to do. Not to condemn them for their acts, but to understand and help them.

 Directly willed as the principal end, or as a means to an end, regardless of whatever means.  The intention is there, para malaglag. That is morally unacceptable.  ALWAYS IMMORAL  An excommunication is attached to those directly responsible for creating the decision and implementing the decision to induce abortion  Life threatening conditions, resulting from this type of abortion, will be treated in the hospital but said treatment shall not be deemed as approval of such abortions.  If treated, it is because the mother is also a patient, a human being in need of treatment  The mother will be referred for counseling. DIRECT / INDUCED ABORTION  Can be LEGAL or ILLEGAL and CRIMINAL  LEGAL  Is what civil law permits in certain cases, not punishing those who perform it (Singapore, USA, Japan, China)  This is NOT SYNONYMOUS WITH LICIT (which is not being punishable by the law)  Coincides with the so called THERAPEUTIC ABORTION

D L S H S I M e d i c i n e B a t c h 2 0 1 6 | 2 of 7

Legality is not the same with being morally upright. There will be no repercussions from the law but it will not save you from being responsible for your actions. These legal abortions at times coincide with what is so called the therapeutic abortion. It may sound good because that means you’re treating the mother, but it is actually a form of induced abortion.

 ILLEGAL  Prescribed and prohibited by civil law  CRIMINAL  Punishable by law  In our country, it is illegal and is punishable by law. PURPOSE OF CLEARING CONFUSION  At the level of public opinion, to identify [and differentiate] the LICIT with the LEGAL  DIRECT ABORTION IS ALWAYS ILLICIT and NO HUMAN LAW can make it good or legitimate to justify it, because the right to life comes directly from God and not from the parents, nor from society, nor from any other authority  No matter how much you look at it, to kill the life of another being, especially one without defenses, is always irrevocably and undeniably wrong. Minsan, kung sino pang tama, siya pa yung nahihiya. Kahit ikaw na lang ang nagiisa, kapag tama ka, wagi ka pa din, because at the end of our life, we will be judged according to what we’ve decided and what we’ve done with your life. At the end of the day, you can face God and you can say. “Lord, I have loved you and I have defended you.” Because it is God working in us that should prevail.

“Life must, from its conception, be safeguarded with the greatest care; abortion and infanticide are abominable crimes.” ~Gaudium et spec, no. 51 cf. no 27  Total respect for human life and condemnation of direct/induced abortion is NOT confined to Christians  It is conviction and a rule of conduct shared by non-Christians, founded on what a PERSON is and should be  The right of life comes from God, not from parents or from society. Dra. Nadal once had a patient, currently pregnant at the time, who was a G9008 who wanted to have the baby aborted. Dra. Nadal advised her patient that had her parents not been generous with her, then she would not be here at all. Having a baby may be expensive but the happiness they give parents is priceless. Some say, “dugo pa lang naman yan doc eh, walang laman.” Knowing that life begins with fertilization, you know that life is already there.

Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

C. INDIRECT ABORTION  Foreseen but merely permitted, side effect of a procedure which is directed toward some good end and legitimate purpose  Is not wanted nor sought directly  It lacks voluntariness, the essential characteristic by which a man becomes responsible for his acts.  It is rather the consequence of an unavoidable circumstantial accident  In cases of ectopic pregnancy, the dangerously pathologic part of the mother may be removed and the loss of the embryo is indirect or incidental to the surgery  Remove the dangerously pathologic part of the mother, which is the fallopian tubes, regardless of which part. It may be removed and the loss of the life of embryo is indirect and incidental to the surgery. Dra. Nadal once had a case wherein the patient came in because of right lower quadrant pains. There was an adnexal mass with cardiac activity, but because of the Principle of Double Effect, knowing that the patient will not survive knowing that the fallopian tube cannot facilitate the growing embryo, will you subject the patient to emergency laparotomy right away, knowing that the cardiac activity of the baby is still there? Yes, because if you don’t, it will rupture and cause hemorrhage on the mother. Transfusion would have to be done, which would endanger the mother’s life more. You are not trying to abort the baby directly, but because it would eventually abort and the fallopian would rupture, you can already proceed to do laparotomy. The evil effect there is the removal of the growing embryo, but the good effect is that you saved the life of the mother from extensive hemorrhage. The intention is good because ectopic pregnancy is aborted even if nothing is done.

 Another example is the removal of bleeding cancerous uterus because you cannot do anything. The mother is tremendously bleeding, the fetus will eventually abort so remove it.  Human life is beset with conflicts of values because there are actions which aside from producing a good effect, cause an unwanted evil effect which are inseparable.  “Principle of double effect”  Intention of the agent is morally good, the evil effect is foreseen and permitted but not wanted, is avoided in so far as possible  Removal of a bleeding, cancerous uterus in a pregnant woman D. THREATENED ABORTION  Signs and symptoms of premature expulsion of a non-viable fetus (bleeding, cramps)  No moral problem, but by how long must a mother go in terms of bed rest? General inactivity?  Principle of Charity  Mother is obliged to undergo this sacrifice to try to preserve the pregnancy as long as there is real hope of saving the infant  Mothers and fathers can be very heroic!

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Dra. Nadal once had a patient with incompetent cervix. Cerclage was done and the patient has to be in complete bed rest because if the uterus will contract, it will dilate the cervix and can tear up the cervix, leading to bleeding. Dra. Nadal did the cerclage 12 weeks AOG after ultrasound with viable fetus. The husband asked her how long the patient has to be in bed rest, to which she answered until the patient gives birth. The husband was concerned who will do the household chores. During one of the check-up (sa house ng patient kasi complete bed rest), she saw the husband heating water for him to bathe his wife. So you see, if you marry the right person, it is heaven made. So the principle of charity here is that the mother is obliged to undergo this sacrifice to try to preserve the pregnancy as long as there is real hope to save the infant. The problem with induced abortion is because they are not ready to have a family secondary to premarital sex. The bottom line is when you love the person you have to love them as a person with dignity. Don’t allow the relationship to be at the level of sex. You have to control your sexual appetites, because if not, that will result to unwanted pregnancy that will destroy your innate self because that is abuse of yourself, just like taking drugs. Sex is not supposed to be left and right. It has to be controlled because you have this innate dignity. Do you agree? Sabi nila, if you cannot do the act in front of your parents, then don’t do it. Set limitations so that the standard is set and you avoid temptations. No matter how strong you are, if you put yourself in that situation, sabi nga nila, “I am but human.”

E. INEVITABLE ABORTION  Abortion cannot be prevented anymore  Membranes are ruptured, minimal to profuse vaginal bleeding (depending on the placental separation or attachment)  Moral difficulty:  It is not morally acceptable if the fetus is not dead.  It is also not morally acceptable to hasten the inevitable abortion  Ensure minimal bleeding, vital signs of the mother are stable, conservative management – letting nature take its place  In cases wherein the obstetrician rightfully judges separation of the placenta so irrevocably progressed, to empty the uterus in an attempt to save maternal life, fetal death is neither sought nor intended for F. THERAPEUTIC ABORTION  The current permissive legislature considers as an indication for abortion any pregnancy which endangers the life of the mother  Risks to life of the mother is anything that affects the physical or even psychological health of the mother  Aside from the physical, they may also say that they are not yet ready to become a mother.  Undoubtedly pregnancy can occasionally aggravate maternal health to such a degree as to endanger her life but INTENSIVE OBSTETRIC CARE has allowed may pregnancies to continue in spite of complications “To save the life of the mother is a lofty goal, but to directly kill her baby as means to achieve this is not permissible.” ~Pope Pius XII, Address, Oct 29, 1951 Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

ERRONEOUS JUSTIFICATIONS PSYCHOLOGICAL WELL-BEING  Little basis  Psychiatrists know well that modern therapy can solve any psychiatric problem precipitated by pregnancy  Abortion has caused a lot of mental disturbances  “The women for whom abortion is justified are the very same ones who carry the highest risk of mental disorders once abortion is performed” ~WHO Dra. Nadal had a patient who wanted to have induced abortion and no matter how much she tried to persuade her, she went ahead with it. After that she had some sort of postpartum psychosis because every night she would hear a baby crying. Psychological trauma would affect them more.

FREEDOM TO DECIDE FOR ONE’S BODY  Feminists’ outcry:  “My body belongs to me”  They believe that the fetus as a mere appendage of the mother’s body which can be removed according to her free decision  The new human being in her womb possesses its own genetic apparatus distinct from that of the mother.  She may have the right to her body but not over the unborn who is another human being and not just a part of her own RAPE OR INCEST  Reason why some hospitals justify giving morning-after pills  Abortion does not necessarily remove nor reduce the trauma; on the contrary it increases it  To kill the innocent to atone for the fault of the father is always illicit *Who among you thinks or agrees that the rapist should be punished by death? Then why kill the innocent child? The fetus has no reason to pay with his death for the sin of his father. He is innocent.

EUGENICS (Greek, “EUGENESIA”, “to engender well”)  To procreate healthy offspring (positive) and avoid the birth of defective offspring (negative)  Prenatal diagnostic tests:  Amniocentesis  Chorionic villi sampling  Ultrasound  It becomes illicit, when selective induced abortion is intended  A diagnosis of malformation or hereditary disease must not be equated with a death sentence  Life is valued not for its normality nor future productivity but for its intrinsic dignity -ENDBut wait… There’s more.

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MATERNAL-FETAL CONFLICTS IN BIOETHICS 2 Maria Carmelita J. Nadal-Santos, MD, FPOGS November 10, 2014; 10:00 AM – 12:00 NN Bioethics III OUTLINE    

Principles of Inviolability of Human Life Principles of Double Effect Ectopic Pregnancy Bioethical Considerations in Specific Conditions:  Chorioamnionitis  Eclampsia  Hemorrhages of Pregnancy  Hydatidiform Mole  Cancer

PRINCIPLES OF INVIOLABILITY OF HUMAN LIFE  Destruction of one life CANNOT become a mere means to saving the life of the other  Each life is equally important with its own dignity PRINCIPLES OF DOUBLE EFFECT  Choosing a decision that produces a good effect (intention is morally good) but there is an inseparable unwanted evil effect which is foreseen and permitted but NOT wanted and is avoided as much as possible  So the thing here is that the evil effect is unwanted but you allow it because it will eventually happen but you do not intend – you are not the cause, you are not the reason why it is happening it’s just the effect

WHICH LIFE IS TO BE PREFERRED? WHICH LIFE IS TO BE SAVED?  Maternal and fetal life are treated with equal reverence and the inviolability of each is equally respected  Example: Mother with uterine cancer, not bleeding, needing chemotherapy 12 weeks AOG. What will you do? The life of the mother at this point in time is not at stake, thus giving chemotherapy which is fetotoxic is already giving preference to the mother so there is violation of the rights and the life of the baby. In 14 weeks AOG with uterine cancer, do you think the baby can survive?  Answer: Yes, it can progress and can turn out to be a mature human being- it is very easy for us to decide in preferring the mother especially if the pregnancy would still need a very long time but if you are guided with the principle that each life is valuable then you would consider otherwise. Ang common na iniisip ng tao ay kapag baby yan pwede na, kasi ang preferred ay nanay, total ang intention ay mabuti – MALI!!!  Unless the life of the mother is threatened like in placenta previa, especially if the baby is premature, so you don’t have any choice. As long as you prefer the baby you are not morally responsible for it.

BIOETHICAL CONSIDERATIONS IN SPECIFIC CONDITIONS ECTOPIC PREGNANCY  Any gestation developing outside the uterus  Implantation of the ovum in the fallopian tube presents a SERIOUS pathological situation  RUPTURE  SHOCK  DEATH  Utilizing the PRINCIPLE OF DOUBLE EFFECT  Dangerous maternal tissue may be surgically removed, the loss of the fetus is indirect incidental to the surgery  It is a SECONDARY ABDOMINAL PREGNANCY  Moral aspect – it must be permitted to advance if possible to viability  Actual crisis of DANGEROUS HEMORRHAGE  Surgical intervention to control the bleeding is permissible provided NO DIRECT ATTACK is made on the fetus  If there is bleeding then do blood transfusion and try to be conservative as much as possible  If there is minimal bleeding and the vital signs are stable, then you allow the pregnancy to continue  If there is tremendous hemorrhage threatening the life of the mother, then you can intervene right away; but in ectopic pregnancy, since there is no possibility that the life of the baby reach viability, so you could already intervene  The same principles apply to other types of ectopic pregnancy of ovarian and cervical pregnancies. CHORIOAMNIONITIS  PROM occurring before viability of the unborn child is accompanied by the threat of INTRAUTERINE INFECTION  No moral issue – if viable fetus  DELIVER  MORAL DILEMMA  Fetus is not viable  Serious infection  Maternal and Fetal  It is ideal to continue the pregnancy until viability  Antibiotics to control infection  Medical intervention to hasten fetal lung maturity  Diagnostics:  Blood tests, fetal surveillance studies (ultrasound)

 The moral approach to maternal-fetal conflicts is toward medical or surgical intervention which offer to achieve both maternal and fetal safety Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

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EXAMPLE: 22 weeks AOG, ruptured bag of water what will you do? Answer: Don’t deliver right away. You have to do your diagnostics – do CBC. Try as much as possible to control infections by giving antibiotics and try to give dexamethasone or steroids for fetal lung maturity. Also, do your fetal surveillance studies. Prepare an Intensive Neonatal Care / environment that would offer a better chance of survival than the baby be left alone to survive in the infected uterus. Or in some cases, transfer to a perinatology hospital Advice that Dra. Nadal gave to her Colleague: If the parents really want to deliver the patient in 29 weeks old, then they should transfer into higher perinatal center who has a better success rate than our hospital. If they don’t want to continue with the pregnancy then okay but refer so that the fetus has bigger chance of survival. It’s not a matter of losing money because you refer but a matter of exhausting all possible help to the parents and to the baby. Even if you end up losing the patient, it is okay as long as you were able to give the best care to the baby available here in the Philippines.

“If the available intensive neonatal care is judged to be incapable of prolonging the extra-uterine life of the baby for any considerable length of time, it is clear that the emptying of the uterus, even to avert serious danger for the mother, would simply be a direct abortion which the fact that the infant is going to die anyhow would neither justify nor change.” ~Thomas J. O’Donnel, SJ -No matter how young the baby is, we give life to the unborn.-

ECLAMPSIA  Begins with uncontrolled hypertensive condition of the mother  Growing increase in number of elderly gravida  Poor prenatal care  Poor compliance in medicines (superstitions, poverty) When is the best time to have baby? In Doc’s opinion, it is after residency so that we can graduate on time and concentrate daw.  BUT FIRST GET MARRIED WITH THE RIGHT PERSON!!! 

 Some obstetrical texts advise immediate termination of pregnancy even when there is no hope that the fetus can survive outside the uterus.  Such procedure is viewed as DIRECT ABORTION and in violation of the uniquely divine prerogative of absolute dominion over human life  Like the mere presence of convulsion in 22 weeks AOG, you cannot terminate the pregnancy because such intervention is tantamount in doing direct abortion because we could still control convulsion.  The PRINCIPLE OF DOUBLE EFFECT CANNOT BE USED HERE because the evil effect (removal of the fetus) is directly willed since it is envisioned as a necessary means to produce the good effect (control of eclampsia). HEMORRHAGES OF PREGNANCY  Conservative and expectant management when possible to achieve both maternal safety and fetal salvage  With the use of ultrasound, we can already diagnose early the presence of placenta previa , so at early age we could already advise to go on bed rest, to be closely monitored by an obstetrician and she will be prepared early enough that she needs to be delivered in the hospital.  Use the PRINCIPLE OF DOUBLE EFFECT  What is Important is the moral distinction between DIRECT AND INDIRECT ABORTION  To DIRECTLY kill the fetus or to uproot it from its site of implantation is never morally acceptable EXAMPLE: 15 weeks AOG with fear of hemorrhage, not bleeding, and was diagnosed with placenta previa. If you do outright hysterectomy, it is tantamount to direct abortion. However, if a 24 weeks AOG mother is bleeding, vital signs are deteriorating, need to transfuse volumes of blood. Do you think it is justifiable to be conservative? No. It is justifiable to deliver the baby right away. Looking for a stress reliever? No problem.

 If left untreated can result in MATERNAL DEATH and FETAL DEATH  Pulmonary edema  Cardiac arrest  Cerebral hemorrhage  Hypoxia  No moral difficulty if unborn child is viable  TERMINATE PREGNANCY  MORAL ASPECT  If eclampsia occur before the fetus is viable:  Control hypertension  Control convulsions  Monitor organ function  Fetal surveillance studies  Prepare NICU, neonatal intensivist (if in case that you cannot control the hypertension and convulsion) Last push. Go get ‘em.  Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

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ABRUPTIO PLACENTA  Degree of separation of placenta varies from slight (harmless) to complete (fetal distress to fetal death) to maternal death  MORAL ASPECT  If maternal hemorrhage is mild, not endangering the mother’s life and fetus is not viable  expectant management  No steps can be taken which would indirectly expose the life of the fetus to any considerable danger

PLACENTA PREVIA  After viability, uterus may be emptied  Preparation  Give steroids  Prepare NICU  PRAY  Prepare the intensivist HYDATIDIFORM MOLE  Expectant management when diagnosed with the presence of a living fetus (Incomplete Hmole)  For complete H-mole, you evacuate right away using your suction curettage  Evacuation, by dilatation and suction curettage, hysterectomy or hysterotomy are morally acceptable and indicated with a fetal death in utero, regardless of the stage of pregnancy

Using ultrasound with color Doppler studies, we can know if the baby needs immediate delivery or not. If in the initial ultrasound is already severe and the baby is in danger, deliver the baby right away.

 ELEMENT OF PROPORTION in the PRINCIPLE OF DOUBLE EFFECT  There should be a due proportion between the good that is intended and the evil that is permitted.  To avert a slight danger from the mother (hemorrhage) by a procedure which would expose the fetus to considerable danger would violate this proportion  The ideal thing here is that the proportion is not balance  There should be more good than evil

CANCER  Extirpation of a cancerous uterus in a pregnant woman as in indirect abortion  For example, the mother needs chemotherapy and the baby is very far from viability and you allow chemotherapeutic agents knowing that it is fetotoxic, so it is indirect abortion and the principle of double effect cannot be applied in this situation.

EXAMPLE 1: 21 weeks AOG with vaginal spotting in placenta previa, knowing that spotting is tolerable, would you terminate pregnancy? No, because the bleeding is minimal and can still be controlled. EXAMPLE 2: A patient with cervical cancer, 20 weeks AOG, massive bleeding, vital signs deteriorating, and no blood available, what will you do? If it is possible to transfer the patient to a hospital equipped with a better blood transfusion and neonatal center. But in 20 weeks AOG, you can already terminate the pregnancy. When maternal life is in danger from hemorrhage it is normally permissible to try to control the bleeding even if it is foreseen that this will result in fetal death. Based on the PRINCIPLE OF DOUBLE EFFECT, the good effect (directly willed) here is the control of hemorrhage, while the evil effect (not directly willed, foreseen) is fetal death is a side effect of the attempt to control the hemorrhage. THERE IS NO MORAL ISSUE HERE. Removal of dead fetus can be done at any stage of development, and the ideal mode of delivery in this case is vaginal.

-ENDTRANSCRIPTION DETAILS BASIS REMARKS

Latest PPT + IDK 2014 RECORDINGS + NOTES + DEVIATIONS 8-10% CREDITS Editor’s note: I opted to combine both lectures because of reasons. ‘Nuff said. Good luck, Batch 2016!  Thank you to all transcribers, formatters and editors for all subjects! And again, congrats JFT champions!  #PeoplesChampBatch2016

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Transcriber: Reichell Brebonia, Nicxz Icaro, Gladys Hulipas Formatting: Craig Angelo Reyes Editor: Craig Angelo Reyes

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BIOETHICAL ISSUES AND GUIDELINES IN PEDIATRICS AND QUALITY OF LIFE Melchor Victor G. Frias IV, MD, MSc, FPPS December 1, 2014; 08:00 AM – 10:00 AM / 10:00 AM – 12:00 NN Bioethics III OUTLINE A. Bioethical Guidelines and Issues in Pediatrics: Impaired Newborns  Guidelines on To Treat or Not to Treat  Guidelines on Initiating Versus Withdrawing Treatment  Issues  Philippine Ethical Guidelines in the Immediate Care of Extremely Premature and Extremely Low Birth Weight Neonates

B. Key Facts on Disability and Health  Definition  Guidelines  Issues

A. BIOETHICAL GUIDELINES AND ISSUES IN PEDIATRICS: IMPAIRED NEWBORNS 1. GUIDELINES ON TO TREAT OR NOT TO TREAT MODERN MEDICAL TECHNOLOGY:  May be life saving  May present ethical dilemmas  Most of these medical technologies may be scarce, therefore the principle of justice comes in, which discerns the benefit of these medical technologies given to premature babies

 May be risky and costly  Risks are involved due to some procedures that are invasive and mostly expensive

 Generates issues that cause agony and disagreements among:  Physicians/pediatricians/neonatologists  Medical staff  Parents  Ethicists IN EMERGENCY SITUATIONS, TREAT  Emergency situation:  Unanticipated and life threatening  A sudden referral in the emergency room or in a delivery room with a premature baby

 Lack of immediate treatment will increase risk to health  Treatment is needed to alleviate physical pain or discomfort  Time is important; when there has been no opportunity to assess the infant and resuscitation will sustain life, TREAT  Without the time that you can buy, then there is no opportunity for you to assess the patient. In any situation where there is uncertainty regarding the diagnosis and prognosis, treat the patient.

 In general, NICU policy is posited on a presumption in favor of treating infants.  When you are in the NICU as a junior intern, you are part of the team. When you are not sure of the prognosis of a particular infant, especially if the patient is premature, then the goal is to resuscitate. Just because the baby is already unconscious and with no signs of heartbeat and respiration, you don’t stop there. When confronted with such a patient, you resuscitate.

Transcriber: Nicxz Icaro Formatting: Craig Angelo Reyes Editor: Sarah Livelo

 The burden of proof is on the proponent of not treating  An advantage of viewing the immediate treatment of newborns as emergency is that emergency treatment is always acceptable, even without parental consent.  Once you satisfy all the criteria for emergency, you won’t need to consult for parental consent.  Immediate treatment can buy time to clarify diagnosis and prognosis, and to inform and consult with parents. 2. GUIDELINES ON INITIATING VERSUS WITHDRAWING TREATMENT INITIATING VERSUS WITHDRAWING TREATMENT  It used to be thought that initiating treatment meant a commitment to continued treatment.  Physicians were too cautious in using artificial life support  Psychological difference  Moral difference CLEARLY FUTILE TREATMENT IS NOT MORALLY REQUIRED  If medical care is clearly beneficial, the infant should always be treated; but if treatment will be clearly futile or will only prolong dying, it is justified to withhold it  Treatment is futile in terms of the infant’s survival  The medical condition of the infant should be the sole criterion for with-holding treatment  Treatment is also futile if the infant has some physical impairment incompatible with life, which is uncorrectable

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IF TREATMENT IS NOT MEDICALLY INDICATED THERE IS NO MORAL OBLIGATION TO TREAT  Treatment is not medically indicated if the pediatrician/physician, according to reasonable medical judgment, determines that any of these conditions exists: 1. The infant is chronically and irreversibly comatose  You may need the help of a neurologist at this point. 2. Treatment would merely prolong dying  In this case, if the patient is proven to be brain dead, at this point he is already dead. There may be heart and lung function but the brain is not functioning. 3. Treatment would not be effective in correcting all of the life threatening conditions.  You may have multiple congenital anomalies in a particular infant 4. Treatment would be futile in terms of physical survival 5. Treatment would be virtually futile and inhumane  In general, there is no obligation to treat on the remote chance of success, especially when the treatment would produce severe and prolonged suffering. MEDICALLY INDICATED TREATMENT MAY NOT BE WITHHELD.  Medically indicated treatment:  Whatever is likely to be effective in ameliorating or correcting all life threatening conditions  If it is uncertain that medical care will be beneficial, treatment is not necessarily required  If treatment is withheld, the infant’s disability should not be the basis of withholding treatment *In cases of disagreements or uncertainty about whether or not treatment is required, a bioethics committee should be consulted.

WITHHOLDING/WITHDRAWING LIFE SUSTAINING TREATMENT  The attending physician (AP) should assume the primary responsibility for coordinating communication among those involved in considering to limit or withdraw therapy.  The AP or family may initiate the discussion and decide concerning withholding or withdrawing life support measures in the presence of the following: 1. Patient’s condition is terminal and death is imminent 2. Patient is irreversibly comatose or in persistent vegetative state and there is no hope for improvement 3. The burden of treatment far outweighs the benefit  Every surrogate/family is obliged to use proportionate means to preserve the child’s health

Transcriber: Nicxz Icaro Formatting: Craig Angelo Reyes Editor: Sarah Livelo

 A surrogate may decide to forego disproportionate means of preserving life.  In children, life support measures may be necessary to permit full evaluation of the patient’s condition; these interventions should not be withheld during evaluation.  The free and informed consent made by a surrogate/family concerning the use or withdrawal of life sustaining procedures should always be respected and complied with unless contrary to the child’s best interest and/or Catholic moral teaching.  No patient should be discharged against medical advice without the initiation of discussions with the surrogate/family and appropriate review by the medical team. 3. ISSUES MAY TREATMENT BE WITHHELD IF PARENTS REQUEST IT?  NO, if it clearly benefits the infant/child and there is no clear indication of futility.  YES, if it is clearly futile. SHOULD TREATMENT BE CONTINUED WHEN PARENTS REQUEST IT, EVEN IF THE MEDICAL STAFF CONSIDER IT FUTILE?  NO, when it causes more significant suffering to the infant/child and it is already futile.  YES, if it is for the sake of the parents.  YES, if it is for organ donation. MAY FUTILE TREATMENT BE CONTINUED FOR THE PURPOSE OF FUTURE KNOWLEDGE?  For better care for premature & impaired infants  Boundaries between treatment and research become blurred  Non-therapeutic research on infants and children is never morally required IS FOOD, WATER, AND PALLIATIVE CARE ALWAYS REQUIRED?  Depending on the clinical circumstances, nutrition and hydration may be considered medical treatment.  The child should not be made to suffer needlessly.  Nutrition and hydration should be provided to all patients; as long as this is of sufficient benefit to outweigh the burdens involved to the patient/family, medically assisted nutrition and hydration should also be given. ARE COSTS AND USE OF RESOURCES RELEVANT FACTORS IN NON-TREATMENT DECISIONS?  There is no set value on life or an upper limit on expenditures for life-sustaining treatment.  If treatment is virtually futile and prognosis for a minimally good quality of life is very poor, one may end/withdraw treatment. WHEN NON-TREATMENT IS GENERALLY ACCEPTED  There is brain death.  The child is in a persistent vegetative state and there is virtually no hope of recovery  Treatment is clearly futile.

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4. PHILIPPINE ETHICAL GUIDELINES IN THE IMMEDIATE CARE OF EXTREMELY PREMATURE AND EXTREMELY LOW BIRTH WEIGHT NEONATES  Good medical practice favors initiation of lifesustaining medical treatment until the clinical situation is confirmed and ethical concerns, if any, are clarified.  If postnatal assessment differs from antenatal assessment, recommendations to parents may be changed accordingly.  Factors to consider in decision-making are fetal and immediate neonatal conditions, including available resources  In cases of extremely premature and extremely low birth weight, especially in hospital with scarce resources.  All decisions should be based on both parents’ and the attending physician’s assessment of what is in the best interest of the neonate  Parents’ involvement in decision-making is mandatory  In cases of conflict between the parents and the attending physician, the decision must be for the good of the newly-born infant, beginning with the respect of his right to life.

 When the concerned parties fail to reach a consensus, the matter can be referred to the Hospital Ethics Committee. GUIDELINES IN AGGRESSIVE CARE  Full resuscitative measures should be made available to all live newly born; non-initiation of resuscitation may be considered, however, when such is deemed futile, as in: 1. Presence of lethal anomalies or 2. Birth weight less than or equal to 400 grams and postnatal gestational assessment less than 24 completed weeks.  Resuscitation of newly born infants other than (1) and (2) may be stopped after 15 minutes, when cardiorespiratory function has not been restored. GUIDELINES IN PALLIATIVE CARE  When the decision not to continue aggressive care is reached, every effort must be made to offer comfort care such as human contact, providing warmth, oxygen, hygiene, fluids and nutrition; adequate support for the grieving process should be made available and coordinated accordingly.

B. BIOETHICAL GUIDELINES AND ISSUES IN QUALITY OF LIFE 1. DEFINITION  The experience of life as viewed by the patient  i.e. how the patient, not the parents or health care providers, perceives or evaluates his or her existence  In pediatrics, it is difficult to determine the quality of life, so we must get as much as we can from the patient’s parents or primary guardian. 2. GUIDELINES THREE SITUATIONS WHERE ONE CAN FOREGO LIFESUSTAINING MEDICAL TREATMENT A. THERE IS BRAIN DEATH:  Even though heart-lung function can be sustained artificially, where there is no brain function, there is no life and that is the end of treatment.  Clinical Criteria for Brain Death  Fixated pupils  Absent oculo-vestibular response  Absent corneal reflex  Apnea with PCO2 >60mmHg  Isoelectric EEG and ECG  No behavioral or reflex response stimuli that imply function above the level of the foramen magnum B. THE CHILD IS IN A PERSISTENT VEGETATIVE STATE AND THERE IS VIRTUALLY NO HOPE OF RECOVERY:  There is little, if any, controversy that it is not required, legally and morally, to sustain life functions for such a child.  For example, a child with SSPE stage 4  There’s no more hope anymore, but parents still wants to continue treatment. Transcriber: Nicxz Icaro Formatting: Craig Angelo Reyes Editor: Sarah Livelo

C. TREATMENT IS CLEARLY FUTILE:  It will be easier to justify non-treatment when survival is unlikely than when treatment is futile relative to improved status. LIFE-SUSTAINING MEDICAL TREATMENT (LSMT)  LSMT encompasses all interventions that may prolong the life of patients  Ventilators or respirators, organ transplantation, dialysis  Antibiotics, insulin, chemotherapy, nutrition and hydration provided IV/by tube “FOREGO”  Refers to both stopping a treatment already begun as well as not starting a treatment  It is futile  You may say forego if you do not want to initiate the treatment or if you want to withdraw the treatment.

3. ISSUES ARGUMENTS AGAINST QUALITY OF LIFE  Human life is of unqualified value  Life is better than death, but in some patients, death is better than life.  For example: generalized paralyze patient but very conscious.  To one life worth living and another not is to deny the essential equality of all people, to discriminate against some, and to devalue what is sacred  Judging QOL implies valuing some lives more than others and this is morally wrong because all human life is equally valuable  Implication: The difference between the value of life and the value of human life

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 “The value of life” vs. “The value of human life” – Biological life vs. Biographical life  Some say biographical life is more important than biological.  For those against quality of life, they will choose biological life  Medical staff, family and relatives are included in decision-making.  Parents usually choose biological life, because the life of their child is always important.  Judging QOL in the context of refusing treatment implies that not all life is good and that sometimes death may be better than life  But this is not true; life is always good and death is always bad by comparison  A rational person would always choose life over death.  The Slippery Slope Argument  If we allow refusal of treatment for those just above a vegetative state, it will be easier to begin to allow less severe stages

ARGUMENTS FOR QUALITY OF LIFE  Some lives are so unbearable that to continue them is wrong in itself  Some recommend consideration of quality of life, the best interest of the infant, the interests of the family members, and issues of futility  Human life is sacred, but not an absolute good  Utilitarian argument  Cure-oriented medical treatment may be withdrawn if and when the patient and family determine that the burdens of treatment outweigh the possible benefits  The “best interests” standard is based on quality of life considerations and the child’s potential for human relationships  For infants, a patient-centered quality of life approach based on the potential for human relationship associated with the infant’s medical condition. CONFLICTS AND ISSUES  Refer to the Hospital Bioethics Committee -END-

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MORAL ASPECTS OF SURGERY 1-2 Renato Cirilo A. Ocampo, MD, FPCS, FACS January 12, 2015; 8:00 AM – 10:00 AM / 10:00 AM – 12:00 NN Bioethics III OUTLINE  Ghost Surgery  Sexual Reassignment  Organ Transplantation  Types of Transplantation  Criteria for Transplantation  Determination of Death

GHOST SURGERY  Surgery in which the patient is not informed of, or is misled, as to the identity of the operation surgeon  Someone does the surgery in behalf of the other surgeon (an “appointed" surgeon)  Someone who has not examined the patient  Someone the patient has not yet met  Originally, the term “ghost surgery” referred to a practice whereby an unqualified physician would, often with the consent of the hospital, call a qualified surgeon to the operating room to perform a procedure  The ghost surgeon is likely to be excluded in the pre- and post op-care period of a patient  For example, a pregnant woman’s cervix is 9-10 cm dilated but her OB is not around  This is NOT ghost surgery because this case is an emergency  The patient should not have to pay the same operation fee since it is not her primary OB

BASES OF THE IMMORALITY OF GHOST SURGERY 1. The patient has the right to know and select the surgeon to whom he is to entrust his life.  It is against the BASIC RIGHT OF AUTONOMY  Example: Gusto ko si Doc Gellido ang mag-oopera sakin kasi I TRUST HIM <3 2. The moral evil is the attendant justice which is likely to befall the patient.  The moral evil in ghost surgery lies in ATTENDANT INJUSTICE  Justice is giving the patient what he deserves, what is due to him  What the patient paid for should be given to them 3. Professional fees  The referring surgeon has no right to it because he/she did not perform it!  The ghost surgeon has no total right to it because he is an accomplice!  This is for medical service! 4. The ghost surgeon is likely to be excluded from the pre-operative examination and the postoperative care, and this is likely to be detrimental to the patient 5. It seriously militates against the common good  You’re more likely to be liable legally  Because this is injustice, deceitful, etc. Transcriber: Nicxz Icaro Formatting: Craig Angelo Reyes Editor: Sarah Livelo

SURGERY AND RESIDENCY TRAINING  In recent years, a great deal of controversy has centered on the role of residents in the operating room  Allowing residents in teaching hospitals to perform surgical procedures under the supervision of attending surgeons  This is a “disguised” form of ghost surgery  Conversely, how will we train them if they do not perform the procedure?  Hospital training programs with residents performing for consultants is the most common form of ghost surgery  The number one suspicion for ghost surgeons are the residents  If the guidelines are not properly implemented, the residency training program is a disguise, like a form of ghost surgery particularly involving private patients (if the consultant does not want to do the operation especially at night when they are sleeping, he would give it to the residents)

GUIDELINES 1. An operating surgeon is the performing surgeon  As such, his duties and responsibilities go beyond mere direction, supervision, guidance, or minor participation. 2. The operating surgeon may be assisted by residents or other surgeons 3. With the consent of the patient, the operating surgeon may delegate the performance of certain aspects of the operation to his assistants provided this is done under participatory supervision  Therefore, HE MUST SCRUB!  Importantly, dapat alam ng pasyente na may assistance; nakalagay sa informed consent yung mga pangalan ng assistant/s 4. Full disclosure to the patient is necessary if the resident or other physician is to perform the operation under non-participatory supervision  In cases when the attending doctor cannot make the operation  Primary doctor should be informed of the details in the OR  For example, the resident calls you up habang nasa event kang malayo. OB ka kunyari, tapos fully dilated na yung pasyente! Crowning na! Sure na hindi ka aabot! Explain to patient that this is an emergency and somebody must fill in because the doctor is not yet there. DISCLOSURE IS IMPORTANT. If the patient requests for another doctor instead, respect the request.

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THE SURGEON’S OBLIGATION TO THE PATIENT REQUIRES HIM TO PERFORM THE OPERATION 1. Within the scope of authority granted by the consent of the operation.  For example: If the appendix was taken out in a CS operation, the surgeon may be liable and should not ask for additional fee

2. In accordance with the terms of the contractual relationship 3. With complete disclosure of facts relevant to the need and performance of the operation. 4. Utilizing his best skill 5. If a resident is to operate upon and take care of the patient, under the general supervision of an attending surgeon who will not participate actively, the patient should be so informed and consent thereto 6. It is unethical to mislead a patient as to the identity of the doctor who performs the operation.

SEXUAL REASSIGNMENT HERMAPHRODISM 1. Medical and scientific tests should be done to determine which is the more predominantly determined sex  Considerations:  External genital morphology  Internal genital morphology  Chromosomal sex  Gender role 2. In cases where there is a total equivocal sex identification  The approach may be either towards either sex  Choice of sex depends on the individual  In the case of infants or minors (to a certain age), the parents determine after consultation with specialists SEXUAL REASSIGNMENT SURGERY  Is it ethical to perform a surgery whose purpose is to make a male look like a female or a female to appear male? Is it medically appropriate?  Sexual reassignment surgery (SRS) violates basic medical and ethical principles and is therefore not ethically or medically appropriate  The term “sexual reassignment surgery” is in itself problematic  Implies that the sexual identity is assigned at birth and can actually be surgically reassigned, in which the DNA already says otherwise  “I’m a woman locked up in man’s body, I want to be a woman.”  They should be evaluated by a psychiatrist if they meet the criteria for sexual reassignment; siyempre, kailangan baguhin boses mo, kailangang tanggalin ung testicles and penis, then form it as an artificial vagina/clitoris, they have to take estrogen meds.  Argh, it’s complicated.

 Sex is written on every cell of the body and can be determined through DNA testing; it cannot be changed

Transcriber: Nicxz Icaro Formatting: Craig Angelo Reyes Editor: Sarah Livelo

 It violates the principle of non-maleficence (“primum non nocere” or “first do no harm”), as it mutilates a non-diseased body  Being “trapped in the bodies of the wrong sex” is an irrational belief (a delusion or a disordered perception of self)  It does not accomplish what it claims; it does not change a person’s sex and does not provide benefits IT IS MORALLY UNACCEPTABLE BECAUSE: 1. Since it is not definitely established that the problem is biological, the procedure is not a cure  Is there a pathologic lesion that tells you that the person is gay? None. So there is no biological basis. They are perfectly male, so it’s very psychological.

2. The procedure is an attempted palliation which is drastic, destructive and irreversible 3. Surgical sex change does not solve the person’s existential problem; it is primarily a case of psychotherapy  There is no evidence that gender identity confusion that is contrary to the anatomical structures is inborn; any attempt to change this through by surgical means, forever dooms the individual’s chances in overcoming sexual and psychological difficulties, and it does not cure the problem.

4. Such mutilation involves a total lack of due stewardship of human life and integrity of the human person 5. There is no solid agreement that such procedure does much good and help to the individual 6. There can be ambiguity about really wanting it

ORGAN TRANSPLANTATION TYPES OF TRANSPLANTATION 1. Living donors (usually related to the recipient) 2. Dead/cadaver Donors (declared brain-dead or clinically dead)

1. LIVING DONORS  Requires:  Consent from donor  Functional integrity of the body is maintained  Absence of immediate adverse effect (proportionate risk)  Charity as the motive for organ donation justifies the risk and the loss of anatomical integrity  Organ donation is not an obligation  Usually has good prognosis 2. DEAD/CADAVER DONORS  Respect and reverence are due to the remains of a human being  Sacredness of human life  Respect for the dead body signifies respect for human life  Respect for the author of life  Respect for the dead person’s relative  Culture and tradition should also be respected  Consent from the deceased before death or consent from the family if there is no will is needed  Make sure that the donor is truly dead  If he is not and you declare him to be, it is considered murder

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CRITERIA FOR CESSATION OF BRAIN FUNCTION 1. Irreversible coma 2. No spontaneous respiration and response to apnea test for 6 minutes 3. Absence of the following brainstem reflexes  Papillary, corneal, gag, and caloric tests

CRITERIA FOR TRANSPLANTATION 1. There is a serious need on the part of the recipient that cannot be fulfilled in any other way.  Needs and concerns  Worth of the transplant expenses and personnel involved  Establishing the death of the donor  Can be a criminal offense if the patient donor is not yet dead  The transplant surgeon is usually not part of the team that declares a patient “clinically dead”

EXCLUSIONS TO THE ABOVE CRITERIA 1. Drug and metabolic intoxication 2. Hypothermia 3. Children (18 years old and below) 4. Shock

2. The functional integrity of the donor as a human person will not be impaired even though anatomical integrity may suffer  Anatomical integrity

PHILIPPINE CRITERIA FOR BRAIN DEATH  Irreversibility is recognized when the evaluation discloses that: a) The cause of coma is established and is sufficient to account for the loss of brain function. b) The possibility of recovery of any brain function is excluded. c) The cessation of brain function persists for at least 24 hours of observation and therapy.

 Material or physical integrity of the human body

 Functional integrity  The systematic efficiency of the human body

3. The risk taken by the donor as an act of charity is proportionate to the good resulting for the recipient.  The motive for donating is charity  Only limited harm to the donor 4. The donor’s consent is free and informed  The donor comes over, not driven by poverty or ignorance to donate his organ, and sometimes, this is like coercion due to certain circumstances (no money for living) that provoked them just to sustain their living conditions; therefore, this is not really free  Living Donor  Has been informed of the benefits for him  Has been informed of the risks he takes as a donor  Has signed the free and informed consent form 5. The recipients for the scarce organs are selected justly  Need for a policy  Need to determine “just selection”  Wealth is not a basis or a determinant with who receives an organ  Transplant surgeon should never be involved in the transaction of procuring/obtaining the organ; it becomes immoral

ORGAN DONORS POLICY A. Living Donors  Registration in donor centers (should be fully competent adults)  Screening of all donors  Education; free and informed consent  Identification B. Cadaver Donors  Free and informed consent of relatives, advance directives  Brain death criteria C. Recipients (when deciding who gets the organ)  Utilitarian Principle  The one who needs it more gets the organ  Egalitarian Principle  First come, first served (first one to lose their organ function is the one given)  Social Work or Merit  This is decided by value of judgment D. No monetary compensation except for burial expenses or attendant surgery  No negotiations are allowed in exchange for an organ E. Confidentiality  Organ donation is not an obligation, not to offer an organ even if needed is not against charity.  Great care should be taken in weighing the merely potential benefits against the actual risk, that is, a brief prolongation of life against a lifelong risk to the donor.  People should not know who gets the kidney.

DETERMINATION OF DEATH  Transplantation requires organs that are wellnourished by oxygenated blood  The team must remove them as soon as possible after death

 Determining the moment of death is a crucial issue  Taking the heart out of a person not yet dead is not an act of organ retrieval but an act of killing someone to get his organs

 Obey the ‘‘dead donor rule’’

SALE OF ORGANS  Selling of human organs is unethical because it is contrary to the dignity of the human being and because need, rather than wealth, should determine who receives an organ  The most rigid moral argument not allowing the sale of donated organs  Reduces the human person to a commodity

*The "dead-donor rule" refers to two widely accepted ethical norms that govern practices of organ procurement for transplantation: 1) Vital organs should be taken only from dead patients 2) Living patients should not be killed for or by organ procurement.

1) FIRST CRITERIA (TRADITIONAL)  Irreversible cessation of CARDIOPULMONARY FUNCTIONS  However, when you rely on this criteria, what viable organ will you get? Wala na, anoxic na. 2) SECOND CRITERIA (MORE POPULAR)  Irreversible cessation of ALL BRAIN FUNCTIONS, including those of the brain stem

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