Get Adobe Flash player

Main Menu

Ethics in Medicine

Medical ethics will appeal to many temperaments: to the thinker and to the doer; to the philosopher and to the woman or man of action. It deals with some of the big moral questions: easing death and the morality of killing, for example. It takes us into the realm of political philosophy. How should health care resources, necessarily limited, be distributed, and what should be the process for deciding? It is concerned with legal issues. Should it always be a crime for a doctor to practise euthanasia? When can a mentally ill person be treated against his will? And it leads us to the major world issue of the proper relationships between rich and poor countries.

(7) Ethics in medicine

Euthanasia - an Ethical Dilemma

MEDICAL ETHICS & EUTHANASIA

Eistein

Einstein used thought experiments as a tool for the scientific understanding of the universe. Thought experiments are a vital tool in ethics as well.

A tool-box for reasoning

Let me add a certain virile reply recorded by De Quincey (Writings XI,n 226). Someone flung a glass of wine in the face of a gentleman during a theological or literary debate. The victim did not show any emotion and said to the offender: ‘This, sir, is a digression: now, if you please, for the argument.’ (The author of that reply, a certain Dr Henderson, died in Oxford around 1787, without leaving us any memory other than those just words: a sufficient and beautiful immortality.)  (J. L. Borges, The Art of Verbal Abuse, 1933)

Medical ethics is, in my view, a questioning and a critically reflective discipline. Doctors, nurses, and other health professionals will normally have good reasons for doing what they do. It would be foolish not to give careful consideration to what experienced practitioners do and think is right. But the role of philosophy is to demand reasons and to subject these reasons to careful critical analysis. Socrates saw himself as an intellectual gad-fly irritating the status quo with awkward questions. Medical practice should be continually improving through subjecting itself to the scrutiny of those twin disciplines, science and philosophy.

Science asks: What is the evidence that this is the best treatment? How good is that evidence? What evidence is there for alternative treatments?

Philosophy demands reasons for the moral choices made: Is it right to help this single woman to conceive a child using methods of assisted reproduction? Should all attempts be made to prolong the life of this patient using the facilities of intensive care, or should she be allowed to die but in as little distress as possible?

Everyone expects philosophical reasoning to be rigorous, to be logically valid. But what makes philosophy in general, and ethics in particular, so exciting is that providing reasons, and giving arguments, requires not only intellectual rigour but also imagination. Ethics uses many tools of reasoning, but it is not just a question of learning how to use the tools: there is always the possibility of a leap of the imagination – of a different perspective or an interesting comparison that puts the whole question in a new light and takes our thinking forward.

The first tool: logic

A valid argument must be logically sound. An argument is a set of reasons supporting a conclusion. A deductive, or logical, argument is a series of statements (called premises) which lead logically to a conclusion. A valid argument is one in which the conclusion follows as a matter of logical necessity from the premises. The conclusion from a valid argument may or may not be true. We put forward a logically valid argument in the form of a syllogism but we claimed that the conclusion was false on the grounds that one of the premises was false.

A syllogism is an argument that can be expressed in the form of two propositions, called premises, and a conclusion that results, as a matter of logic, from the premises. There are two main types of valid syllogism.

Valid syllogism – type 1

Premise 1 (P1) - If p then q (If statement p is true then statement q is true)

Premise 2 (P2) - p (i.e. statement p is true)

Conclusion (C) - q (therefore statement q is true)

The technical name for this type of syllogism is modus ponens. An example is as follows:

P1 - If a foetus is a person it is wrong to kill it

P2 - A foetus is a person

C - It is wrong to kill a foetus

Valid syllogism – type 2

Premise 1 - If p then q (If statement p is true then statement q is true)

Premise 2 - Not q (it is not the case that q is true; q is false)

Conclusion - Not p (therefore statement p is false)

The technical name for this type of syllogism is modus tollens. An example is as follows:

P1 - If a foetus is a person it is wrong to kill it

P2- It is not wrong to kill a foetus

C - A foetus is not a person

There is one type of invalid, or logically false, argument that people often make. It is worth being on the look-out for this.

An invalid argument in the form of a syllogism

Premise 1 - If p then q (If statement p is true then statement q is true)

Premise 2 - Not p (i.e. statement p is false)

False Conclusion - Not q (therefore statement q is false)

An example is as follows:

P1 - If a foetus is a person it is wrong to kill it

P2 - A foetus is not a person

C - It is not wrong to kill a foetus

There may be reasons why it is wrong to kill a foetus other than its being a person.

When you are examining an argument in medical ethics it can be useful to try and boil the argument down to its basic form, as I did in Chapter 2 when discussing what I called ‘playing the Nazi card’.

This enables the premises to be clearly identified – and examined - and will help expose any fallacy in the argument itself. Medical ethics, and applied philosophy more generally, is concerned with constructing arguments about what we should do, based on premises that we should all accept.

The second tool: conceptual analysis

An important component of valid reasoning is conceptual analysis. There are four types of conceptual analysis: providing a definition; elucidating a concept; making distinctions (splitting); and identifying similarities between two different concepts (lumping).

Not that these components can always be kept separate. This process of defining is part and parcel of making distinctions; they are not separate activities. The clarification of concepts is a crucial and demanding task in medical ethics. We often use concepts that are unproblematic in most situations but become quite opaque when applied in a new context.

An important concept in medicine is that of the best interests of a patient. In both English and US law a doctor is usually obliged to treat a patient in his best interests. If the patient is a young man with appendicitis it is pretty clear that his best interests are served by removing the appendix. It is much less clear what management plan is in the best interests of a man with severe Alzheimer’s disease who also has cancer of the bowel. Part of the issue is what factors make up ‘best interests’ in this situation, and who is to make the judgments. The issue is even more problematic when we are talking about the best interests, or the welfare, of a child who may exist in the future.

The third tool: consistency and case comparison

The underlying principle of consistency is that if you conclude that you should make different decisions, or do different things, in two similar situations then you must be able to point to a morally relevant difference between the two situations that accounts for the different decisions. Otherwise you are being inconsistent.

Before we made a comparison between what Dr Cox did (inject potassium chloride) and what many doctors quite legitimately do (inject morphine) in situations similar to that faced by Dr Cox. So why, we asked, should Dr Cox, but not those doctors who inject morphine, face the serious criminal charge of (attempted) murder? Is this inconsistent practice, or is there a morally relevant difference? The obvious difference is that Dr Cox intended that his patient die, whereas those who inject morphine do not intend death although they might foresee it. Whether this distinction between intending and foreseeing is morally relevant is an issue requiring further analysis.

Thought experiments

The cases used for case comparison, or for examining consistency, may be real or hypothetical, or even unrealistic. Philosophers frequently use imaginary cases in testing arguments and in examining concepts. These are called ‘thought experiments’ – like many scientific experiments they are designed to test a theory. We have already used several thought experiments. One of the uses of the imagination is in thinking of thought experiments that take the argument forward, or that challenge our routine ways of thinking.

The fourth tool: reasoning from principles

Several books and many articles organize the analysis of medical ethics around four principles and their scope of application. These principles might best be seen as perspectives rather than as the premises of a logical argument. They can act as a useful check that a full range of perspectives has been taken into account. When considering whether or not a doctor should breach a patient’s confidentiality, for example, it may be helpful to identify the key issues by examining the situation from the perspective of each principle. This is, however, only the beginning. Further conceptual analysis (e.g. what do we mean by best interests in this situation) and judgment will be needed.

Another form of ‘top–down’ reasoning is to argue, not from one of the four principles, but from a general moral theory such as utilitarianism. In essence such top–down reasoning involves identifying a moral theory that you think is generally right and then exploring the implications that that theory would have in the specific situation you are considering.

Reasoning about morality involves, in my view, a continual moving between our moral responses to specific situations (or cases) and our moral theories. Rawls called this process reflective equilibrium.

During the process both the theories and the beliefs about individual situations can undergo revision. When there is lack of agreement between theory and our intuitions about individual cases, there is no algorithm, or computer program, that can tell us which or what we must change. That has to be a matter of judgement.

Four principles in medical ethics

  1. Respect for patient autonomy

Autonomy (literally self-rule) is the capacity to think, decide, and act on the basis of such thought and decision, freely and independently (Gillon 1986). Respect for patient autonomy requires health professionals (and others, including the patient’s family) to help patients to come to their own decisions (e.g. by providing important information) and to respect and follow those decisions (even when the health professional believes that the patient’s decision is wrong).

  1. Beneficence: the promotion of what is best for the patient

This principle emphasizes the moral importance of doing good to others and, in particular in the medical context, doing good to patients. Following this principle would entail doing what was best for the patient. This raises the question of who should be the judge of what is best for the patient. This principle is often interpreted as focusing on what an objective assessment by a relevant health professional would determine as in the patient’s best interests. The patient’s own views are captured by the principle of respect for patient autonomy.

The two principles conflict when a competent patient chooses a course of action which is not in his or her best interests.

  1. Non-maleficence: avoiding harm

This principle is the other side of the coin of the principle of beneficence. It states that we should not harm patients. In most situations this principle does not add anything useful to the principle of beneficence. The main reason for retaining the principle of non-maleficence is that it is generally thought that we have a prima-facie duty not to harm anyone, whereas we owe a duty of beneficence to a limited number of people only.

  1. Justice

There are four components to this principle: distributive justice; respect for the law; rights; and retributive justice. With regard to distributive justice: first, patients in similar situations should normally have access to the same health care; and second, in determining what level of health care should be available for one set of patients we must take into account the effect of such a use of resources on other patients. In other words, we must try to distribute our limited resources (time, money, intensive care beds) fairly.

The second component of justice is whether the fact that some act is, or is not, against the law is of moral relevance. Whilst many people take the view that it may, in some situations, be morally right to break the law, nevertheless if laws are made through a reasonable democratic process they have moral force.

The types and status of rights are much disputed. The fundamental idea is that if a person has a right it gives her a special advantage – a safeguard so that her right is respected even if the overall social good is thereby diminished.

‘Retributive’ justice concerns the fitting of the punishment to the crime. In the medical context this issue is sometimes raised when a person with mental disorder commits a crime.

Spotting fallacies in reasoning

Logicians like to spot, and name, fallacious arguments, rather as ornithologists spot birds. We came across the argumentum ad hominem.  Spotting fallacies is a useful exercise in medical ethics because it helps us to see through a rhetorically powerful but ultimately false argument. Here are two of my favorite fallacies named and defined by Flew (1989).

The No-True Scotsman Move

Someone says: ‘No Scotsman would beat his wife to a shapeless pulp with a blunt instrument’. He is confronted with a falsifying instance: ‘Mr Angus McSporran did just that’. Instead of withdrawing, or at least qualifying, the too rash original claim our patriot insists: ‘Well, no true Scotsman would do such a thing!’

What seems to be a statement of fact (an empirical claim) is made impervious to counter-examples by adapting the meaning of the words so that the statement becomes true by definition and empty of any empirical content.

The Ten-Leaky-Buckets Tactic

This is presenting a series of severally unsound arguments as if their mere conjunction might render them collectively valid: something that needs to be distinguished carefully from the accumulation of evidence, where every item possesses some weight in its own right.

Nature and Playing God

There are two arguments: the argument from Nature and the argument from Playing God.

The argument from Nature

Stated baldly the argument from Nature boils down to the assertion: this is not natural, therefore this is morally wrong. The argument has been used against homosexuality, and it is often brought out in the context of medical ethics, not only when considering euthanasia but also when discussing possibilities arising from modern reproductive technology and genetics. The argument is problematic in at least three ways. First, it is not entirely clear what it means to say that something is unnatural. If about 10 per cent of humans are predominantly homosexual, and homosexual behavior is seen in other species, what is meant by saying that homosexuality is unnatural? Second, it seems quite unclear why it follows from the fact that something is unnatural, that it is morally wrong. What kind of reason could be given in support of this? Third, there are an enormous number of counter-examples, not least from medical practice itself, to the claim that what is unnatural is morally wrong. The life of a child with meningitis may be saved by antibiotics and intensive care. Neither treatment is ‘natural’ by any meaning that can be given to that term. Perhaps it is wrong to help couples to have babies using in-vitro fertilization (IVF) but, if it is wrong, that cannot be on the grounds that IVF is unnatural.

The argument from Playing God

The argument from Playing God can also be stated baldly as: this act is morally wrong because it is playing God. The argument is problematic in ways analogous to the problem with the argument from Nature. What criteria can be used to distinguish between our carrying out God’s will, and our usurping his role? Which of the following is playing God: providing IVF; withdrawing life support; injecting antibiotics; transplanting a kidney? It seems to me that we have first to decide which acts are right or wrong before we can determine those that might be described as playing God. The concept of Playing God is therefore of no help in determining what it is right to do.

The slippery slope argument

I want finally, in this chapter on methods of reasoning, to turn to the slippery slope argument. This is often used in medical ethics. The core of the argument is that once you accept one particular position then it will be extremely difficult, or indeed impossible, not to accept more and more extreme positions. If you do not want to accept the more extreme positions you must not accept the original, less extreme position.

Suppose, for example, that a supporter of voluntary active euthanasia gave an example of a situation when it seemed plausible to agree that euthanasia, in that situation, is acceptable. The case of mercy killing carried out by Dr Cox might be such an example. The slippery slope argument could be used against killing the patient, not on the grounds that it would be wrong as a matter of principle in this case, but on the grounds that allowing killing in this case would inevitably lead to allowing killing in situations where it would be wrong.

The main counter to the slippery slope argument is to claim that a barrier can be placed part way down the slope so that in stepping onto the top of the slope we will not inevitably slide to the bottom – but only as far as the barrier.

There are two types of slippery slope argument: a logical type and an empirical type.

The logical type of slippery slope argument and the sorties paradox

The logical type of slippery slope argument can be seen as consisting in three steps:

Step 1: As a matter of logic, if you accept the (apparently reasonable) proposition, p, then you must also accept the closely related proposition, q. Similarly, if you accept q you must accept proposition r, and so on through propositions s, t, etc. The propositions p, q, r, s, t, etc. form a series of related propositions such that adjacent propositions are more similar to each other than those further apart in the series.

Step 2: This involves showing, or gaining agreement from the other side in the argument, that at some stage in this series the propositions become clearly unacceptable, or false.

Step 3: This involves applying formal logic (modus tollens) to conclude that since one of the later propositions (e.g. proposition t) is false, it follows that the first proposition (p) is false.

In summary, step 1 is to establish the premise: if p then t. Step 2 is to establish the premise: t is false. Step 3 is to point out that from these premises it follows, logically, that p is false. It is the first step in the argument that is special about slippery slopes. The crucial component in the argument is to establish a series of propositions such that adjacent members of the series are so close that there can be no reasonable grounds for holding one proposition true (or false) and its adjacent proposition(s) false (or true).

This logical form of slippery slope argument is related closely to a class of paradoxes known as the ‘sorites paradoxes’ first identified by the ancient Greeks (purportedly by Eubulides).

The name ‘sorites’ comes from the Greek ‘soros’, meaning a heap. An early example of this type of paradox involved arguing that one grain of sand does not make a heap, and adding one grain of sand to something that is not a heap will not make a heap, so you can never have a heap of sand.

These types of paradox arise because many (perhaps most) of the concepts we use have a certain vagueness: if a concept applies to one object then the concept will still apply if there is a very small change in that object. But a casual observation of children playing on the beach will show that heaps of sand do exist and that the logical form of slippery slope argument is unsound. Proposition t may be false while proposition p is true. There are three possible responses to a slippery slope argument.

1. To argue that each small change makes a small, if imperceptible, moral difference (like each grain of sand).

2. To draw the line, or place a barrier, at some stage along the slope. The precise drawing of the line is arbitrary; but it is not arbitrary that a line is drawn. In order to ensure clear policy (and clear laws) it is often sensible to draw precise lines even though the underlying concepts and moral values change more gradually.

3. A third response, which is not always appropriate, is to place a barrier at a position that is not arbitrary but is justified for some principled reason. In the case of euthanasia a proponent might argue that there is a difference between voluntary active euthanasia and other types, such as non-voluntary active euthanasia. In accepting the possibility of voluntary active euthanasia one does not have to slide into accepting non-voluntary, or involuntary, active euthanasia: the logical relationships are more like a stairway than a slippery slope.

The empirical form of slippery slope argument

The second form of slippery slope argument is empirical, or ‘in practice’, not logical. An opponent of voluntary active euthanasia might argue that if we allow doctors to carry out such euthanasia, then, as a matter of fact, in the real world, this will lead to non-voluntary euthanasia (or beyond). Such an opponent might accept that there is no logical reason to slip from the one to the other, but that in practice such slippage will occur. Therefore we should, as a matter of policy not legitimate voluntary active euthanasia even if such euthanasia is not, in principle, wrong.

This empirical form of argument depends on making assumptions about how the world actually is and therefore raises the question of how compelling is the evidence for such assumptions. What will in practice happen will often depend on how precisely the policy is worded, or enforced. It may be possible to prevent slipping down the slope by putting up a barrier; or by careful articulation of the circumstances under which an action is, or is not, legitimate.

In this text we have stepped back from specific issues in medical ethics in order to reflect on some of the tools of reasoning. We will now return to issues and we will claim that the law is unjust in the way it deals with people who are mentally ill. We will start with the claim that the law is inconsistent.

Share

(8) Ethics in medicine

Prof. Lord Robert Winston - Medicine, Ethics and Society

Basic Ethical Principles

EM8

Inconsistencies about madness

43rd day of April in the year 2000: Today we celebrate a most illustrious event! Spain has a king. He has been found. I am this king . . . Now everything has been revealed to me. I see it all as clearly as my own hand. But before this, I don’t know why, before I seemed to see everything through some sort of fog. I think this all can be explained by the ridiculous idea people have that the brain is in the head. Nothing of the kind: it is carried by the wind from the direction of the Caspian Sea.

(Gogol, Diary of a Madman, 1835)

In 1851 Dr Samuel Cartwright published an article in the New Orleans Medical and Surgical Journal describing the mental illness of drapetomania (quoted in Reznek, 1987). This was an illness from which Negro slaves suffered: it was manifest by a tendency to run away from their white masters.

In 1952 the first edition of the US Diagnostic and Statistical Manual of Mental Disorders was published. This is the main US classification of mental illness. Homosexuality was listed as a mental disorder and its status was confirmed in the second edition of the manual in 1968. In 1973 there was debate in the American Psychiatric Association as to the medical status of homosexuality.

By a small majority the Association voted to remove homosexuality from the list of mental disorders.

The classificatory system of disease that is used in most of Europe, including the UK, is the International Classification of Diseases. The current edition includes fetishism as a mental disorder.

This is described as: Reliance on some non-living object as stimulus for sexual arousal and sexual gratification. Many fetishes are extensions of the human body, such as articles of clothing or footwear. Other common examples are characterized by some particular texture such as rubber, plastic or leather.

The diagnosis of fetishism can be made if the person experiences recurrent intense sexual urges and fantasies involving such objects, if he acts on these, if the preference has been present for more than six months, and if the object is the most important source of sexual stimulation. Will fetishism still be classified as a mental disorder in 20 years’ time?

The social and ethical values that lie behind the diagnosis and classification of mental disorders have been under attack since the anti-psychiatry movement in the 1960s. What we count as ‘healthy’ or ‘unhealthy’ sometimes reflects our value commitments, and these can, and should, be challenged. Although the question of what is a mental illness can raise deep and difficult problems, I am going to put these to one side. Some conditions, such as schizophrenia, do render people out of touch with reality, and cause suffering, to such an extent that I will take for granted that these conditions are the proper concern of the medical specialty of psychiatry. What I want to examine are the different standards used in enforcing treatment and secure accommodation for those with and without mental disorder.

I will argue that those with mental disorder are subject to a double injustice. Most Western countries have special legislation to allow patients with mental disorder to be kept in hospital, and treated, against their will. Such legislation typically addresses two issues: first, when can treatment be imposed on patients with mental illness, for their own sake, in situations where they are refusing treatment; and second, how can society be protected from potentially dangerous people with mental illness? I believe it is mistaken to attempt to do these two different things within one body of legislation.

 Crime and mental illness

It is the criminal law that deals mainly with the question of public protection. It is problematic, however, to treat mentally ill people as criminals when their dangerous and illegal behaviour is a result of mental illness. In English law, as well as in the law of many other countries, for a person to be found guilty of a crime two points have to be proven: that it was this person who carried out the relevant act; and that this person had the state of mind necessary to be held responsible for that act. The first aspect is known as the actus reus (‘guilty act’) and the second as the mens rea (‘guilty mind’). The precise mens rea required varies from crime to crime. For example, to be guilty of murder a person must have had ‘specific intent’, i.e. must have had the intention to kill (or cause serious physical harm to) the victim. To be found guilty of manslaughter it is necessary only to establish that the person showed gross negligence.

It is a long-established liberal principle that a person who suffers from a mental illness may be found ‘not guilty’, even though he committed a criminal act, on the grounds that he should not be held responsible for his behaviour, because of the illness. Crudely put: the person’s body committed the act, but the person’s mind did not commit the crime.

A key English case was that of Daniel McNaughten who, like Shakespeare, spelt his name in many different ways. McNaughten suffered delusional beliefs, including the belief that the British Tory Party was behind a plot to kill him. He decided to kill its leader, Sir Robert Peel. In 1843 he shot Peel’s secretary, Edward Drummond, but was prevented from firing a second shot.

McNaughten was acquitted of murder on the grounds of insanity and was sent to a secure psychiatric hospital (the Bethlem hospital in South London, which is the origin of the word bedlam). The acquittal caused public outrage. The House of Lords asked the judges to draw up rules (now known as the McNaughten rules) for determining when someone should be considered ‘not guilty’ on grounds of insanity.

Protecting society from dangerous people

A person without mental disorder who commits a violent crime of sufficient gravity is typically sent to prison. There are a number of reasons for sending such a person to prison. One reason is as retribution: he deserves to be punished. Another reason is to protect society.

There are two crucial liberal principles that are incorporated into criminal law - and are part of the European law on human rights:

1. A person who has not (yet) committed a crime cannot be detained on the grounds that it is expected that he will commit a crime.

2. A person must be allowed back into the community once he has served his prison sentence, although some crimes may attract a life sentence.

These two principles apply, however, only to those who do not suffer a mental disorder. If you have committed a violent act as a result of mental illness you can be detained in a psychiatric hospital as long as it is thought that you pose sufficient risk to others. This may well be much longer than a mentally healthy criminal would have been detained in prison for a similar violent act. Indeed you may be so detained even if you have not yet committed a violent act. I will use the term ‘preventive detention’ to refer to keeping someone in a secure environment (prison or a secure psychiatric hospital) on grounds of protection of others in one, or both, of the following situations: when the person has not (yet) committed a violent act; and when he has committed such an act and been in a secure environment for the length of the prison sentence appropriate to the act. The two liberal principles stated above can now be rewritten as: ‘A person should not be preventively detained’. What worries me is that this applies to those without mental disorder but not to those with mental disorder. And that is unfair.

There is, of course, an important issue of public policy as to how society should protect itself against people who pose significant risk of harm to others. In the UK this is a particularly live issue in the context of those who pose a threat to children. The argument I want to make is an argument about consistency. If two people, A, who is mentally ill, and B, who is not mentally ill, pose the same risk of harm to others, then, if it is right to preventively detain A (on grounds of this risk of harm) it is right to do so to B. Conversely if it is wrong to preventively detain B (as European legislation states) then it is wrong to detain A. Otherwise we are discriminating against the mentally ill.

Are there any reasons that justify such apparent discrimination? I can think of four possible reasons, but none, in my opinion, justifies a different approach to preventive detention.

1. The mentally ill person is more dangerous.

2. The assessment of risk of harm is more certain in the case of those with mental illness.

3. It may be the case that prolonging detention in hospital will lead to further improvement in the mental illness and further reduction in risk of harm to others. It would be silly to release the patient from the secure psychiatric hospital when a further period in hospital would reduce risk.

4. The final reason depends on a distinction being made between what a person wants when mentally ill, and what the person would want if cured of the mental illness. It is typically the case that those mentally ill patients who are preventively detained remain chronically ill. That is why they remain at risk of harming others, and why they continue to be detained. It is possible, at least in theory, to distinguish between what the ill person wants, and what the person might have wanted if well – even though he remains ill.

It might be argued that his genuine wishes are those he would have when well. Since the danger he poses to others is due to the mental illness, it might reasonably be expected that if he were well he would say that he would like, when ill and a danger to others, to be preventively detained. Thus respecting the authentic wishes and autonomy of the person when well would mean preventively detaining the person when ill (and dangerous).

I will consider each of these four reasons in turn. The first reason is irrelevant. The situation I am considering is where the two people – the person with, and the person without, the mental illness – pose the same risk of harm to others.

The second reason might provide weak grounds for a difference in approach if it were true; but it is not. Assessment of risk of harm to others is notoriously difficult whether we are dealing with mentally disordered people or not. In any case the point at issue is whether risk of harm justifies preventive detention. The level of uncertainty over the estimation of risk might alter the threshold but not the principle of preventive detention.

The third reason does not provide ground for treating those with mental illness differently from those without. In both cases a detained person might pose less of a risk of harm to others if further detained. If this continuing reduction in risk gives grounds for preventive detention in those with mental illness then it also provides grounds for preventive detention of those without. I don’t believe, however, that it gives good grounds in either case. If preventive detention is to be justified then it should be on the grounds of the risk of harm to others. If two people pose similar risks then they should be treated similarly.

The fourth reason provides the best argument but even this is unconvincing. The mentally disordered people we are talking about tend to be either those with chronic mental illness or personality disorder. There is unlikely to be good evidence that the person’s ‘authentic wishes’ would be to continue to be detained. In the absence of such evidence it seems highly dubious to keep the person locked up on the grounds of respecting his autonomy.

I conclude that if we think it right for society to lock away mentally ill people who present a certain level of risk of harm to others then we should do the same for those who are not mentally ill.

Conversely if we think preventive detention is an unacceptable infringement of human rights in the case of people without mental illness, it is an unacceptable infringement of human rights for those with mental illness. I leave open which way we ought to go. The point I want to make is that the current position is untenable, because inconsistent and unjust.

Enforcing treatment for the sake of the mentally ill person I wrote at the beginning of this chapter that those with mental disorder are subject to a double injustice. They are discriminated against not only for the protection of others but also for the protection of themselves. It is a long-standing principle in medical ethics and law that those who are ill may refuse what their doctors and others believe is beneficial treatment. A classic example is when a Jehovah’s Witness refuses blood transfusion even when she is likely to die without the transfusion. It is a principle in many legal systems that a competent adult has a right to refuse any, even lifesaving, treatment. This principle applies to the treatment of physical illness. It does not apply however in many countries to those with mental illness. Take the case of England, where it is the Mental Health Act that governs the compulsory treatment of patients with mental disorder.

Under the English Mental Health Act there are three criteria that need to be met in order for a patient to be detained in hospital for treatment:

(1) He should suffer from a mental disorder;

(2) His mental disorder is ‘of a nature or degree which makes it appropriate to receive medical treatment in a hospital’;

(3) The admission for treatment ‘is necessary for the health or safety of the patient or for the protection of other persons’.

I have already considered the inequities inherent when considering the protection of others. I want now to consider the ‘health and safety’ of the person himself.

What is of note about the Mental Health Act is that a person who has a mental disorder may be treated for his mental disorder despite refusal even if he is competent to give or refuse consent.

A competent person with a mental illness can be treated against his will if others (such as a psychiatrist and social worker) think it is appropriate. This is unjust unless anyone with a mental disorder is ipso facto not competent to refuse treatment. But this is not the case. The question of whether someone has a mental disorder is a question left mainly to doctors and it covers many psychological problems which cause distress. Some people with a mental disorder will lack decision-making capacity. Some won’t.

The issue came under legal scrutiny in England in the case of B v Croydon District Health Authority (1994). This concerned a 24-year-old woman who had been admitted to psychiatric hospital with a diagnosis of borderline personality disorder. She had a history of self-harm. She was compulsorily detained under the Mental Health Act following her behavior of trying to cut and hurt herself. In hospital she was prevented from such harmful behavior, but her response was to virtually stop eating and as a result her weight fell to dangerously low levels. By May 1994 her weight was only 32 kilos and her doctor thought that she would die within a few months if she continued to behave as she was doing.

Her doctors wanted to tube feed her in order to prevent her death. She was granted an injunction to prevent this until the case could come to a full legal hearing. Although by the time the case came to a full hearing she was eating, the High Court considered the question of whether tube feeding would have been lawful.

At the High Court the following points were decided: (1) she was found to have the capacity to refuse treatment; but (2) she had a mental disorder, and therefore, despite having the capacity to refuse treatment, she could be treated compulsorily under the Mental Health Act. This was because it was held that she had a mental disorder of a nature and degree that made it appropriate to receive medical treatment in hospital, and that such admission was necessary for her health and safety.

Again it is the different standards being applied to those with mental disorder, compared to those without, that trouble me. It may be right to impose life-saving treatment on a patient who is refusing, and who is competent to refuse, treatment or it may be wrong. But what does not seem right is to change the answer depending on whether the person has a mental disorder. Of course many mental disorders interfere with competence to refuse treatment. Perhaps the High Court was wrong to decide that B had capacity to refuse treatment. We may need to deepen our understanding of how and when mental disorder interferes with such capacity. But what seems unacceptable to me is to bypass this issue altogether and to treat all those with mental disorder paternalistically, while allowing those without mental disorder the freedom to refuse treatment. To do so is to discriminate, once again, against those suffering from a mental illness.

 

Share

(9) Ethics in medicine

Patient Confidentiality: An Ethical Dilemma

The History of Confidentiality in Medicine

confidentiality

How modern genetics is testing traditional confidentiality

What a prodigious thing it is that within the drop of semen which brings us forth there are stamped the characteristics not only of the bodily form of our forefathers but of their ways of thinking and their slant of mind. Where can that drop of fluid lodge such an infinite number of Forms? . . . We can assume that it is to my father that I owe my propensity to the stone, for he died dreadfully afflicted by a large stone in the bladder . . . Now I was born twenty-five years . . . before he fell ill . . . During all that time where did that propensity for this affliction lie a-brooding? When his own illness was still so far off, how did that little piece of his own substance which went to make me manage to transmit so marked a characteristic to me? And how was it so hidden that I only began to be aware of it forty-five years later . . . ?

(Montaigne, ‘On the Resemblance of Children to their Fathers’)

The fifth metacarpal is the bone that runs along the edge of the palm of the hand between the wrist and the base of the little finger. A fracture to this bone near to the knuckle can result in one way only: from punching someone or something with a clenched fist. Patients, of course, may not like to admit this; but the fracture discloses the truth. Modern genetics, increasingly, is able both to reveal the past and to foretell the future. And it goes further. A genetic test from one person can provide information about a relative. This was possible to a limited extent before modern genetics. What is new is the extent to which these possibilities can be realized; and this extent is forcing us to rethink medical confidentiality.

Case 1: Genetic tests reveal secrets of paternity

Let me start with the revealing of secrets. Here is a realistic case from a modern genetics service reported in The Lancet. John and Sarah attend the genetics clinic after the diagnosis of an autosomal recessive condition in their newborn baby. The disorder is severe and debilitating and there is a high chance that the child will die in the first year. The gene for this disorder has just been mapped and there is a possibility that prenatal diagnosis would be possible in a future pregnancy. John and Sarah give their consent for a blood sample to be taken for DNA extraction, from themselves and their affected child.

At the first meeting with the geneticist the couples are told that the chance of any of their future children having the condition is 25 per cent. This is correct on the assumption that John was the biological father of Sarah’s newborn baby. Molecular analyses of the DNA samples, however, reveal that John is not the father of the child. One implication of this is that any future baby, who is the biological child of John and Sarah, is very unlikely indeed to have the debilitating condition. This is because only about one in 1,000 people have the recessive gene. John will almost certainly have the normal gene, and this will prevent his children from having the condition. Should the geneticist disclose, to John, the finding that John is not the father of the newborn baby? One important US report recommends disclosure to both partners in situations like this. But this report stands alone in preferring an honest and open approach. The influential Committee on Assessing Genetics Risks at the Institute of Medicine in the US recommends that in cases like these only the woman should be told and that: ‘Genetic testing should not be used in ways that disrupt families’. Most surveys suggest that most geneticists support this latter approach, both in the US and Europe. A cross-cultural comparison in 1990 argued that ‘Protection of the mother’s confidentiality over rides disclosure of true paternity’. Many geneticists would be prepared to tell a lie or fudge the issue, for example by claiming that the child with the condition has the condition as a result of a new mutation, rather than being honest with their patient. A survey of patients, as opposed to doctors, carried out in the US, suggested that three-quarters thought that the doctor ought to tell the husband that he is not the father of the child, at least if he asked directly. The majority of those in that survey were women.

Medical confidentiality

Hippocrates, known as the Father of Medicine, was born on the Greek island of Cos in about 460 bc. The Hippocratic Oath is one of the earliest known sets of professional guidelines for doctors. Some of the guidelines now seem dated. It is unlikely that the medical students whom I teach would see their obligation to me as quite so significant as Hippocrates’ Oath would require. I will honour the man who teaches me this art as my own parents; I will share my living with him and provide for him in need; I will treat his children as my own brothers and teach them this art, should they wish to learn it, without charge or stipulation . . . But what the Oath says about confidentiality is much more relevant: Whatever I may see or learn about people in the course of my work or in my private life which should not be disclosed I will keep to myself and treat in complete confidence . . . In order to pursue the question of the limits of confidentiality I want to make a case comparison: to consider a case that has some features in common with the one I have just been discussing, but where it is perhaps clearer what a doctor ought to do.

Case 2: Paternity revealed by the mother

 . . . Following a healthy pregnancy and birth Mary visits her general practitioner for her routine 6-week postnatal visit. Mary’s husband, Peter, is registered with the same GP. During the consultation Mary reveals that Peter is not the father of her child. In a case like this it would be widely accepted that the doctor should not breach the confidentiality of Mary. Doctors, and other professionals, have to take professional guidelines seriously into account when deciding what to do. There would need to be very good reasons why an individual doctor would go against his professional guidelines. The General Medical Council is the professional body for UK doctors. Its guidelines state: Disclosure of personal information without consent may be justified where failure to do so may expose the patient or others to risk of death or serious harm. Where third parties are exposed to a risk so serious that it outweighs the patient’s privacy interest, you should seek consent to disclosure where practicable. If it is not practicable, you should disclose information promptly to an appropriate person or authority. You should generally inform the patient before disclosing the information. In applying such guidelines to a particular situation some interpretation is needed. In this case such interpretation seems relatively straightforward. The harm of not telling Peter does not amount to ‘risk of death or serious harm’. The doctor, therefore, should not breach Mary’s confidentiality.

Comparing cases 1 and 2

If the doctor should not breach confidentiality in case 2, does it follow that the geneticist should keep quiet about the question of paternity in case 1? There are important differences between the two cases. In case 1, the fact of non-paternity was discovered as a result of tests for which both John and Sarah gave consent. In case 2 this fact was revealed only by Mary. In case 1, John and Sarah came to the geneticist together to discuss an issue of joint concern. The information concerning paternity is directly relevant to the issue about which John and Sarah came jointly to see the geneticist. Informing Sarah alone does not respect John’s interest in knowing the information.

The foundations of medical confidentiality

The case comparison may leave us in doubt about what the geneticist should do in case 1. Consideration of case 2 provides some reasons why the geneticist should keep information about paternity secret from John. But case 2 differs from case 1 in some important respects that might make all the difference. Perhaps we can be helped by going back to theory and asking what are the fundamental reasons why maintaining medical confidentiality is important. The three most commonly given answers to this question are: respect for patient autonomy; to keep an implied promise; and to bring about the best consequences.

Respect for the right to privacy

 An important principle in medical ethics is respect for patient autonomy. This principle emphasizes the patient’s right to have control over his own life. This principle implies that a person has the right, by and large, to decide who should have access to information about himself – i.e. a right to privacy. On this view the patient who reveals information about himself to the doctor has the right to determine who else, if anyone should know that information. That is why the doctor should not normally pass that information on to a third party without the patient’s permission.

Implied promise

Some argue that the relationship between doctor and patient has elements of an implied contract. One of these elements is that the doctor, by implication, promises not to breach patient confidentiality. Thus patients may reasonably believe that when they come to their doctors there is an understanding that what they say will be kept confidential. On this view, the reason why a doctor should not breach confidentiality is because to do so would involve breaking a promise.

Best consequences

 One of the major theories in moral philosophy claims that the right action in any situation is the one that has the best consequences. On this view, it is important that doctors maintain confidentiality because so doing leads to the best consequences. Only if doctors are strict in maintaining confidentiality will patients trust them. And such trust is vital if patients are to seek and obtain the necessary help from doctors. Do these theories help us in answering the question: should the geneticist tell John that he is not the father of the newborn baby?

The theory of respect for autonomy is ambiguous when we try to apply it to case 1. It all depends on whose autonomy we focus. John’s autonomy is respected by telling John; Sarah’s by keeping it secret from John (unless Sarah gives permission to tell John).

The implied promise theory is similarly problematic. In normal clinical practice, as exemplified by case 2, it is clear that the patient (Mary) can expect the doctor to respect her confidentiality. But it is not so clear what the implied elements of the ‘contract’ are in case 1. John might reasonably expect that all information relevant to future reproductive choices will be shared openly with both him and his wife. A consequentiality account certainly gives reasons for why the doctor should not breach confidentiality on the grounds of the possible deleterious effect on the family. This is the main reason why most geneticists would not tell John that he is not the biological father of Sarah’s child. But it is not entirely clear that the consequences of keeping John ignorant are better than informing him of the truth. Is it right that Sarah needs to be protected from the consequences of her act and will it be better for the family if this remains a secret? This is an example of a major practical problem with consequentialism: even if you think that consequentialism is the right moral theory, it is often impossible to determine with sufficient degree of certainty what the various consequences of different courses of action

are likely to be. It seems that returning to the fundamental theory of what underpins the moral importance of confidentiality has been of no more help than case comparison. We remain uncertain whether the doctor should tell John that he is not the biological father of Sarah’s child. The difficulty, I believe, is that we have been focusing on the wrong aspect of the problem. The key question is not whether there are sufficient grounds, in terms of John’s interests, for breaching Sarah’s confidentiality. The question is whether the information that the newborn baby is not, contrary to John’s current belief, his biological baby, is as much ‘his information’ as Sarah’s. Whose information is it? Let us examine this question through the lens of a further case.

Whose information is it? Case 3: Secrets and sisters

A four year old boy has been diagnosed with Duchenne Muscular Dystrophy (DMD) . . . DMD is a severe, debilitating and progressive muscle-wasting disease in which children become wheelchair bound by their early teens and usually die in their twenties. It is an X-linked recessive condition and whilst it is carried by girls it is only . . . boys who are affected. The boy’s mother, Helen, is shown to be a carrier for the mutation. Women who are carriers do not show symptoms of the condition, but half of their sons will inherit it from them and will be affected.

Helen has a sister, Penelope, who is ten weeks pregnant. Penelope’s obstetrician referred her to the genetics team after she told him that her nephew had speech and development delay. She told him that although she was not close to her sister and had not discussed it with her, she was concerned about the implications for her own pregnancy. In her discussions with the clinical geneticist (who did not know at this stage that both sisters were patients in the same clinic) Penelope made it clear that she would consider terminating a pregnancy if she knew that the fetus was affected with a serious inherited condition. Speech and development delay are features of a range of conditions and would not of them indicate carrier testing for DMD. In addition, because the DMD gene is large and there are a number of possible mutations, testing without information about which mutation is responsible for the nephew’s condition is unlikely to be informative.

At her next meeting with her clinical geneticist, Helen says that she knows that her sister is pregnant and that she understands that the pregnancy could be affected. She also says that she has not discussed this with her sister, partly because they don’t really get on, but also because she suspects that if her sister were to find out, and if the fetus turned out to be affected, she would terminate the pregnancy. Helen feels very strongly that this would be wrong. She knows that her sister does not share her views, but Helen says she has thought long and hard about the issues and has decided that she wants her test results and information about her son to remain confidential. (Parker and Lucassen, Lancet, 357 (2001))

I want to put aside the question of whether Penelope should or should not have a termination if her foetus carried the gene. Parker and Lucassen propose two models: the personal account model and the joint account model.

The personal account model

The personal account model is the conventional view of medical confidentiality. On this view the information about Helen’s genetic state – as a carrier of Duchenne’s muscular dystrophy – ‘belongs’ to Helen, and Helen alone. Respect for such confidentiality is important. It has, however, long been recognized that there are limits to such confidentiality, as has already been highlighted by the GMC guidelines quoted above. But these limits are the exception.

On this view the key question is whether the foreseeable harms to Penelope if the information is not disclosed are sufficiently serious to justify breaching Helen’s confidentiality.

The joint account model

On the joint account model, genetic information, like information about a joint bank account, is shared by more than one person. Helen’s request is not about the appropriate limits of confidentiality – it would be analogous to asking the bank manager not to reveal information about a joint account to the other account holders. On this view genetic information should be seen in a completely different way from most medical information. It is information that should be available to all ‘account holders’ – i.e. to all (close) genetically related family members. That is, unless there are good reasons to withhold the information.

These two models see the onus of proof, with respect to sharing information, in opposite ways. On the conventional, personal account, model we ask: are the harms to Penelope so great that they override Helen’s right to confidentiality? On the joint account model the genetic information, although obtained from Helen’s blood and medical history, ‘belongs’ to the family. Penelope has a right to such information as it is key information to help her to know important aspects of her genetic make-up. There would need to be a very good reason, in terms of Helen’s interests, to justify denying Penelope access to the genetic test for DMD.

Helen knows something not only about herself and her son but also about Penelope and her unborn child. Helen knows that Penelope’s foetus has a significant chance of suffering from DMD; but Penelope does not know this. This asymmetry of knowledge is unfair to Penelope. The personal account model fails to take this fact into account.

Genetic information challenges the individualistic nature of many of the moral assumptions made in discussions of medical ethics in both Northern Europe and North America. Perhaps the cases we have been considering raise a deeper issue about medical confidentiality in some other settings. We are interconnected, both biologically and socially. No man is an island, entire of it. Indeed our connections with each other extend not only to our close genetic relatives but across the globe. 

Share

(10) Ethics in medicine

 Principles of Medical Ethics

MEDICAL ETHICS MANUAL

EM10

Is medical research the new imperialism?

. . . a kind, forgiving, charitable, pleasant time; the only time I know of, in the long calendar of the year, when men and women seem by one consent to open their shut-up hearts freely, and to think of people below them as if they really were fellow-passengers to the grave, and not another race of creatures bound on other journeys.

(Charles Dickens, A Christmas Carol)

Tomorrow’s medicine is today’s research. That is why the question of how we allocate resources to research is at least as important as the question of how we allocate resources to health care itself. But this is not a question that you will find has been the focus of much ethical discussion. Most discussion about the ethics of medical research addresses the question of how research should be regulated. Indeed, medical research is in many ways much more strictly regulated than medical practice. From a perusal of the innumerable guidelines on medical research you could be forgiven for thinking that medical research, like smoking, must be bad for your health; that in a liberal society, since it cannot be altogether banned, strict regulation is needed to minimize the harm that it can do.

The reason for this strict control lies in history. The appalling experiments carried out by some Nazi doctors led, in 1946, to the first internationally agreed guidelines on medical research involving people – the Nuremberg Code. This code consisted of ten principles and these were incorporated by the medical profession into the Declaration of Helsinki, which was first published by the World Medical Association in 1964 and last updated in 2000. The Declaration of Helsinki has many offspring of varying legitimacy in the form of guidelines for medical research. These guidelines highlight four main issues: respect for the autonomy of the potential participants in research; the risk of harm; the value and quality of the research; and aspects of justice. The position taken on the risk of harm is rather interesting. Guidelines agree that research participants should not be put at more than ‘minimal risk of harm’. This is the case even if the participant is a competent adult fully informed about the risks and benefits and who voluntarily agrees to take part. Although it is not entirely clear what is meant by minimal harm, it seems to be set at a level taken by somewhat risk-averse people in their normal lives. In other words the guidelines are highly paternalistic.

Why should risk of harm be more carefully controlled, and more restrictive, in the context of medical research, than it is in other areas of our lives? We do not prevent the sale or purchase of skis, motorbikes, or hang-gliders, although these expose purchasers to moderate risks. Why should the control of medical research be different?

Double standards

This is only one example where the regulation of medical research imposes standards that seem out of keeping with other areas of life. Another example is with regard to the amount of information provided to patients who are being asked to take part in a clinical trial.

Contrast these two situations:

Clinical case

Dr A sees patient B in the outpatient department. B is suffering from depression of a type likely to be helped with antidepressants. There are several slightly different antidepressants available. Dr A advises B to take a particular antidepressant (drug X) – the one with which he is most familiar and which is suitable for B. Dr A informs B about the likely benefits and the side effects of drug X. However, he says nothing about the other antidepressants that he could have prescribed instead.

Research case

A randomized controlled trial is under way to compare two antidepressants: drug X and drug Y. Although Dr A tends to prescribe drug X, on reflection he does not think that there is currently good evidence to prefer X to Y. It could be important to establish the relative effectiveness, and adverse effects, of each. Dr A therefore agrees to ask suitable patients whether they would be prepared to take part in the trial. Dr A sees B in the outpatient department. B is suffering from depression and would be a suitable candidate for the trial. In order to conform to the standards laid down by research ethics guidelines Dr A must obtain valid consent for B to enter the trial. He must inform B about the trial and its purpose. He must also inform B about both drugs X and Y and tell B that a random process will be used to choose which will be prescribed.

In the research case the guidelines and research ethics committees (also called institutional review boards) require Dr A to inform B about both drugs, and about the method of choosing which to prescribe. In the clinical case this standard of informing is not the norm. Is this difference justified? If it is, then the standards are simply different. If it is not then we are operating ‘double standards’ – i.e. standards that are different and where the difference is not justifiable. Double standards are an example of inconsistency. They tell us that at least one of the standards needs to be changed.

Medical research in the Third World

It is a third example of different standards on which I want to focus in this chapter. Under scrutiny here is not a comparison between research and ordinary life, nor between research and medical practice, but between research in rich countries and research in poor countries.

The Council for International Organizations of Medical Sciences laid down the following principle in its 1993 guidelines:

The ethical implications of research involving human subjects are identical in principle wherever the work is undertaken; they relate to respect for the dignity of each individual subject as well as to respect for communities, and protection of the rights and welfare of human subjects.

Marcia Angell, the former editor of the New England Journal of Medicine, wrote: ‘Human subjects in any part of the world should be protected by an irreducible set of ethical standards.’ Was this principle of equity breached by the following research studies? Angell thought that it was.

Preventing HIV transmission to infants in poor countries

The Human Immunovirus (HIV) causes the disease AIDS. A pregnant woman, infected with the HIV, may pass the infection on to her child. This is known as ‘vertical transmission’. Treatment of a pregnant woman, infected with the HIV, with zidovudine (known as the ACTG 076 regimen) reduces the chance of vertical transmission. This regimen involves taking zidovudine by mouth (orally) during pregnancy, and being given it by injection into a vein during labour; and includes further doses to the newborn infant.

This regimen is too expensive to be generally available in poor countries. A cheaper, but effective, regimen would potentially prevent a very large number of babies being infected with the HIV in poor countries. Without a cheaper regimen there is no available treatment in poor countries to prevent vertical transmission of HIV. In 1997 the ACTG 076 regimen was the standard in the US because it was the only one that had been shown to be effective. It was thought possible that a cheaper regimen involving only oral zidovudine might be effective. Two possible designs of trials to be carried out in poor countries are scientifically reasonable. The first is to compare the cheaper regimen with a placebo. The second is to compare the cheaper regimen with the expensive regimen (ACTG 076). The first design is aimed at answering the question: is the cheap treatment better than nothing (placebo)? The second design is aimed at answering the question: is the cheap regimen as effective as the expensive regimen? In this case it was not realistic to introduce the expensive regimen as standard treatment into poor countries so the key question to be answered by the research was whether the cheaper regimen was better than nothing. This question can be answered more quickly, will involve fewer patients, and be cheaper using the first (placebo-controlled) design and it was this design that had been used in several studies, funded by rich countries, but conducted in poor countries.

It is generally accepted that the control group in a treatment trial should receive whatever is standard treatment (i.e. they should not be disadvantaged by the fact of taking part in the trial compared with people who are not in the trial). If you were taking part in a treatment trial in the UK or the US, a trial that was evaluating a new promising blood pressure drug, then you would be treated either with the new drug, or with what is current best treatment.

You would not be given a placebo. That would be unethical because there is already known effective treatment. Thus it would have been unethical in the sponsoring country (the US) to have carried out a placebo-controlled trial of the cheaper regimen because standard treatment in the US is the expensive (ACTG 076) regimen. On the principle of equity, therefore, many commentators thought that it was unethical to carry out a placebo-controlled study in the poor country: a double standard was operating. Furthermore the study was in breach of the Declaration of Helsinki which states that controls in treatment studies should receive the best current treatment.

But there are powerful arguments against this position. If the trial were conducted in a rich country it would be wrong for any patient in the trial to receive placebo, since in normal clinical practice they would be receiving an active treatment. And this active treatment is known to be better than placebo. Now consider the case in a poor country. In normal clinical practice a patient would not receive any treatment. Indeed, many pregnant women infected with HIV would not receive any health care at all. The principle, stated in the Declaration of Helsinki, that those in the control arm should receive current best treatment is ambiguous. Does current best treatment mean best anywhere in the world, or best in the country where the research is being carried out? Those who believe that the placebo-controlled trial in the poor country was unethical think that the responsible ethics committee should not have allowed a trial using placebo control to be undertaken. But without the trial no one in the poor country would be receiving treatment to prevent vertical transmission. No one, therefore, receives worse treatment as a result of the placebo-controlled trial, and several people (those receiving the new treatment regimen) are likely to receive better treatment (although until the trial is carried out we don’t know for certain that the new regimen is beneficial). And this is in marked contrast with the situation if a placebo-controlled trial were being carried out in a rich country, because in that case those given placebo would be worse off than patients not in the trial. In short, no one is harmed as a result of the placebo-controlled trial if it takes place in a poor country and some people stand to benefit. The conclusion from this argument is that it would be better overall, for people in the poor country, that the placebo-controlled trial takes place. Those in the poor country also stand to benefit in the future from the trial as it may lead to the development of a treatment to prevent vertical transmission that is affordable for poor countries. If the trial were prevented from taking place, on the grounds that it is unethical because inequitable to people in poor countries, those in the poor country would be worse off. If equitable treatment means no treatment at all, give me inequitable treatment. Against this it might be argued that, although the placebo controlled trial is better than no trial, it would be better still to use the expensive regimen as control. But this would cost more. Who should pay? Perhaps those in rich countries should pay more to poor countries but it is not clear that this should be imposed on the sponsors of this research. Nor is it clear that the money is best spent on providing expensive HIV treatment for those who are allocated to the control arm of this trial. The extra money might be better spent in other ways – in ways, for example, that have greater beneficial effect on the health of those in poor countries. In conclusion, the placebo study is not unethical – no one is harmed as a result of the study and some benefit. It would be worse for those in the poor country if the study did not take place. The principle stated in the Declaration of Helsinki and quoted above should be interpreted to mean that the control group should receive best treatment in the society in which the study takes place, not best treatment anywhere in the world. There is an ethical issue about the low level of health care available to those in poor countries – this is a major problem of justice. But this question needs to be tackled by governments and industry. This deep underlying and   fundamental inequity should not be used to block research that, overall, benefits those in poor countries.

I have put forward two opposed positions.

1. That it is unethical to use a placebo control in a clinical trial carried out in a poor country when such a control would not be thought ethical had the research been carried out in a rich country. The ethics committee should not have allowed the trial described above to have taken place.

2. That the placebo control was not unethical, even if not ideal, and that it was right that the ethics committee allowed the trial to go ahead.

The first position seems to be on the side of the angels, making a bold claim of principle that those of us in rich countries should not treat people in poor countries any differently from ourselves.

The second position uses the cold knife of rational argument to cut through our humane intuition and show that it is misguided. What should we do when rational argument contradicts humane intuition? The answer must be: re-examine both our intuitions and our arguments. Why does the first position seem to be on the side of the angels? Because we feel that it is treating those who are less privileged than ourselves as we would be treated. If we act according to the second view we have a niggling feeling that we are exploiting the poor. But the criticism of the first position seems valid: that by being precious about setting the same standards in poor countries that we would in rich countries we are making a decision (stopping the research) that will take away benefit from the very people towards whom we are wanting to be fair. The clue to the way out of this impasse lies in the phrase ‘exploiting the poor’. Someone can benefit from something but still be exploited. Consider coffee pickers in South America employed by an international company and paid low wages. Without such employment they may be even worse off. But if the company is making large profits, it is exploiting the pickers. The benefits should be fairly shared: that is what ‘Fair-trade’ is all about. Both of the opposed positions that we have been considering are too narrow.

The first position is right in highlighting the issue of equity, an issue closely related to exploitation. But it is wrong in blindly applying a principle (that controls should be given best treatment) that has been developed in a quite different context. The second position is right in showing that applying the principle is not in the best interests of those in poor countries, but it is wrong in considering only two possibilities. A much broader perspective is needed, and the starting point for that broader perspective is that the overarching ethical concern is the huge disparity in wealth and health care between rich and poor countries.

The implications of this perspective for international medical research include:

(a) That the research must be conducted in ways that provide appropriate benefits to those in the poor country; and the benefits between rich and poor must be appropriately shared;

(b) That a realistic view be taken as to what can be sustained in the poor country in order to properly evaluate how the benefits to poor countries can be maximized;

(c) That the researchers have responsibilities not only to those in the poor countries who take part in the research but to the wider population. A public health perspective is therefore needed. A narrow focus on the best interests of the research participants only, without regard to the population, is excessively individualistic.

Henry Ford famously said: ‘History is more or less bunk’. It has also been said, although I do not by whom: ‘Those who are ignorant of history are condemned to repeat it’. The current international regulation of medical research grows, distorted by the long shadow of the Nazi past. This regulation is reactive, and obsessed with one main concern: to protect research participants from being abused.

Important though this is there has been a failure to tackle the ethical implications of asking the constructive question: how can the good from medical research be maximized? Nowhere is this constructive approach more urgently needed than in research in poor countries.

Benatar and Singer write:

There is thus a need to go beyond the reactive research ethics of the past. A new, proactive research ethics must be concerned with the greatest ethical challenge – the huge inequalities in global health.

Precisely so.

Clinical trials

These are the standard method of assessing the value of a medical treatment. Suppose e.g. that the standard current treatment for disease D is drug X. A new drug, Y, has been developed. Preliminary studies suggest that Y may be an effective treatment for D, and possibly better than X. The best way to find out which drug is better is to give some patients with the disease drug X and others drug Y, and then see which group of patients does better. The group of patients receiving the new experimental drug (Y) is called the ‘experimental’ group. The group receiving the conventional treatment (X) is called the ‘control’ group. It is important that the two groups of patients (the experimental and control groups) are broadly similar. The trial results would be misleading if there were e.g. significantly more severely ill patients in one group than in the other group. The best way of ensuring that there are no significant differences between the groups is to use a random method (‘tossing a coin’) for allocating patients to each group, and to have a large number of patients in the trial. The best clinical trials are large randomized controlled trials (RCTs). When a treatment, such as a drug, is developed (treatment Y) for a condition where there is no current (conventional) treatment, the control group is given a ‘placebo’ – a dummy drug. Thus, if Y is a new drug that is taken as a tablet, the placebo would be a tablet that looks like the tablet containing Y but does not contain the active drug (Y). This is important because, for many conditions, patients can improve to some extent simply by believing that they are receiving active treatment. Doctors, furthermore, can be biased, when assessing a patient’s improvement in health, by knowing whether the patient has been taking active treatment. It is therefore important that neither the patient nor the doctors know whether the patient is in the experimental or control groups.

Share

(11) Ethics in medicine

BIOETHICS RESEARCH LIBRARY

JOURNAL OF MEDICAL ETHICS

EM101

Family medicine meets the House of Lords

Out of timber so crooked as that from which man is made nothing entirely straight can be built.

(Immanuel Kant)

Medical ethics deals, as we have seen, with some of the big issues of life, and death. It faces the extraordinary, both natural and man-made: conjoined twins, madness, assisted reproduction, cloning. Were you to base your understanding of medical ethics on the cases that hit the headlines you might think it a discipline concerned almost exclusively with the bizarre. Doctors need to make judgments involving ethical values in the day-to-day practice of medicine, even in something as mundane as the treatment of raised blood pressure. For example, at what pressure should the patient be offered treatment? A population perspective might suggest that treatment of quite mild hypertension would prevent many people from suffering a stroke. For an individual the small reduction in absolute risk of stroke may not be worth the side effects of treatment. What factors should influence the choice of anti-hypertensive? How many of the possible side effects should the doctor reveal? Is there a danger that by mentioning some of the possible side effects, such as lassitude, the patient will be more likely to suffer them? Should the doctor accept the free dinner, with educational talk, from the manufacturer of one of the principal anti-hypertensive drugs? Might this affect her prescribing decisions for the wrong reasons?

I want to look at two situations that most family doctors will have had to face. The ethical issues do not arise from any modern technology but from a problem only too familiar to health professionals: those families rarely enjoy the uncomplicated, easy, and unremittingly happy relationships that advertisements from the 1950s might lead you to expect. The sixteenth-century essayist, Montaigne, a man who could write as comfortably about male impotence as on the education of children, had 57 maxims carved on the wooden beams of his study. They included Terence’s bold statement, which should perhaps be engraved on the stethoscopes of doctors: ‘Nothing human is alien to me’. Difficult to achieve, of course, but a worthy aspiration for those whose jobs are aimed at helping people through difficult times. A tolerance of, perhaps even a fondness for, human frailty – Kant’s crooked timber of humanity – is an important virtue in a health professional.

The web of our life is of a mingled yarn, good and ill together; our virtues would be proud if our faults whipped them not, and our crimes would despair if they were not cherished by our virtues. (Shakespeare, All’s Well That Ends Well, Act IV. Iii. 68–71)

What should the family doctor do when faced with the following situation?

Case: Dementia

Mr C is a 70-year-old man with dementia and long-standing lung disease (chronic obstructive pulmonary disease). He is cared for at home by his 72-year-old wife. He has frequent chest infections for which he receives antibiotics and he requires oxygen at home because of his lung disease. His most recent chest infection has not responded well to antibiotic tablets and his general condition is deteriorating. He is not eating and is drinking little. It is possible that, with hospital treatment, including intravenous antibiotics and physiotherapy, he may recover from this infection, although he is bound to develop a similar infection again in the near future. Admission to hospital in the past has caused him distress because he does not cope well with changing environments. His wife, however, says that she thinks that he should go to hospital so he can be given maximum treatment.

Imagine that you are the doctor and you think that Mr C’s best interests would be served by his staying at home and being made comfortable. He is likely to die very soon at home; but he is likely to die within a few months whatever happens. Because of his dementia his life is much less rich than the life that he used to lead. A few months of extra life in his state is just not worthwhile, particularly given the distress that hospital admission will cause him.

You think it is best for him to remain at home; his wife wants him in hospital. Where do you go from there?

There are common variations on this situation.

Variation 1

Mr C’s wife agrees with you that the best thing to do would be for Mr C to remain at home, but their daughter, who lives close by, insists that he go into hospital to be given the best chance to recover from this episode of infection. Mrs C seems partly persuaded by her daughter, or perhaps a little bullied.

Variation 2

You, the doctor, think that if he goes into hospital he will recover and return to his usual level of health and that he may live for a year or so longer. You judge his life, although limited because of the dementia, to be nevertheless a happy one. This is partly because his wife looks after him so well. You think that it is in his best interests to go to hospital, but his wife says that she doesn’t want him moved from home. She wants to nurse him, even if he will soon die. Perhaps that is what he would have wanted. How should you think about the question of what is the right thing to do in these situations? In this book I have emphasized rational analysis. On such an approach a good starting place would be to identify some of the issues that might be important. For example, some of the issues that are raised by this case and its variations include the following.

1. Whether Mr C himself is able to form and express a view. This will depend principally on the degree of impairment from the dementia.

2. If Mr C is not now competent to form a view, is it possible to make some judgment about what he would have wanted in this situation?

3. What is in Mr C’s best interests? If Mr C is himself competent to decide then his view of his best interests should normally prevail, but if Mr C is not competent to decide for himself the doctor will have to come to a view on what are Mr C’s best interests. This may be a difficult issue. Is there a danger that the doctor will believe that because of the dementia Mr C’s current life is not worth living and therefore it is better for him to be kept comfortable at home? Or is the danger the reverse: that a doctor feels the imperative to treat the infection and to keep Mr C alive. How can any person who is healthy judge what it is like to suffer dementia?

4. Should Mrs C’s best interests be taken into account by the doctor or should he focus only on the patient’s best interests?

5. Does Mrs C have some kind of right to decide what should happen to Mr C because she is the next of kin?

6. In the case of a disagreement within the family (e.g. a disagreement between Mrs C and her daughter) should the doctor give more weight to the opinion of one person, e.g.

Mrs C, and if so under what circumstances and for what reasons?

Such a list of issues is only the beginning of the analysis. Questions will then arise as to how to balance different aspects; but it makes perfect sense to start with such an analysis.

An alternative to this analytic approach is that of negotiation. Many clinicians would start, not with analysis, but with discussion. Such clinicians might begin by asking Mrs C why she thought that Mr C should go into hospital. What is important for these clinicians is understanding the needs, wishes, and perspectives of all those involved, and working towards an agreed decision that avoids conflicts: not always possible, of course, but with skill and patience it is often successful. In other words, this approach involves negotiation between the key people. It is an approach that most of us are familiar with in our everyday lives. It is how many families might decide what to do on a Sunday afternoon.

The distinction between using analysis and using negotiation in order to come to a decision is not absolute. Both require a mixture of analysis and of discussion. But they are at different ends of a spectrum. Negotiation brings in a perspective on medical ethics that I have not discussed elsewhere in this book. Most of this book, if I can caricature my own position, sees medical ethics as a question of working out the right action to take through reasoning. The reasoning process can be complex and there is no single method for carrying it out. Different problems require different tools. But this view sees medical ethics as essentially an individualistic enterprise: it is for individuals to decide what they believe is the right thing to do. The negotiation approach sees medical ethics – and indeed ethics in general – as essentially a process of interactions between people.

The ways in which health professionals should engage with patients’ families are even more complicated when the patient is not yet fully adult. I want now to consider another situation familiar to family doctors: the case of the 15-year-old pregnant girl.

Case: 15-year-old pregnant girl

A 15-year-old girl comes shyly to her primary care doctor, with a school friend for support. She thinks she is pregnant. Tests reveal that she is: about ten weeks pregnant. She wants an abortion. She is adamant that she does not want her parents to know.

The family doctor should talk to her, of course, although there is an immediate issue of whether the friend should or should not be present. With support and kindness the pregnant girl may come to agree to include her parents in the discussion. Even then the doctor may face difficult ethical issues, for example, the fraught issue of abortion itself. Suppose the doctor has a profound moral objection to abortion, but works in a country where in these circumstances it is legal. If both the girl and her parents want her to be referred to a gynaecologist for an abortion what should the doctor do? Try and persuade the family to change its mind, in which case how persuasive should he be? Or is his moral duty to inform only of the issues and let the family decide? So, lurking behind this case are the complicated issues both of the morality of abortion, and of what doctors should do when faced with a conflict between professional duties and personal morality.

But neither of these issues is the one on which I want to focus. I want to look at the question of whether the doctor should ever refer the 15-year-old pregnant girl for an abortion without the parents’ knowledge. Does the girl have a right to confidentiality? Do the parents have a right to know?

Thucydides’ History of the Peloponnesian Wars, written in the 5th century bc is a treasure trove for those who love practical reasoning. The Athenian citizens expected carefully reasoned argument before waging war on their neighbors - how different from the sound-bite politics of modern democracies.

Each side is given time to put its case without interruption. We can still enjoy this measured oral tradition of ethical reasoning in the legal judgments of our more senior courts.

Parental rights and medical consent, with respect to children under 16 years, was at the heart of a key English legal judgment: the Gillick case.

The Gillick case

 The facts

 In England, in the early 1980s the government department responsible for the National Health Service (NHS) – the Department of Health and Social Security (DHSS) – issued written advice for doctors about family planning services. This advice included two statements.

(a) That a doctor would not be acting unlawfully if he prescribed contraceptives for a girl under 16 years old, provided that he was acting in good faith to protect her against the harmful effects of sexual intercourse.

(b) That a doctor should normally only give contraception to a girl under 16 with the consent of the parents and that he should try to persuade the girl to involve her parents. Nevertheless, in exceptional cases a doctor could prescribe contraceptives without consulting the parents or obtaining their consent if in the doctor’s clinical judgement it was desirable to prescribe contraceptives.

A private citizen, Mrs Victoria Gillick, sought assurance that none of her daughters would be given contraception without her knowledge and consent while they were under 16 years. The relevant NHS authority refused to give such assurance, saying that the issue was part of the clinical judgment for doctors. Mrs Gillick then brought legal action against the DHSS on the grounds that the advice to doctors was unlawful in allowing doctors to provide contraception to girls less than 16 years without parental consent.

The case was eventually heard in England’s highest court (equivalent to the US Supreme Court): the House of Lords. Five judges heard the case. There is no requirement that the judges agree. The final decision goes with the majority of judges. Each judge delivers his judgment, giving not only his decision but also the reasoning for it. Although the judges are answering the question of what is the correct legal position, and not the question: what is ethically right, the judgments are superb examples of ethical reasoning.

The judgments

 Lord Brandon

Lord Brandon came down on the side of Mrs Gillick. Indeed he went further. He concluded that to give contraception to a girl under 16 years, even with the knowledge and consent of the parent(s), was unlawful. His argument, in a nutshell, was as follows:

1. It is a legal fact (because of a statute in English law) that a man who has sexual intercourse with a girl under 16 years, even with the consent of the girl, commits a criminal act.

2. It is also a criminal act to encourage or facilitate a criminal act.

3. Giving a girl contraception or advice about contraception involves encouraging the girl to have sexual intercourse with a man. It amounts to encouraging a criminal act.

4. Some might argue that some girls will have intercourse whether or not they are given contraception, and in such a case the giving of contraception is not encouraging the girl to have intercourse. But this is mistaken for two reasons. First, the fact that the girl is seeking contraception shows that she is aware of, and potentially discouraged from intercourse by, the risk of unwanted pregnancy. Thus, Brandon argues, she and her partner are more likely to ‘indulge their desire’ if contraception is given. Second, if the law allows a girl under 16 years to get contraception if she convinces her parents and doctor that she will have (unlawful) intercourse anyway, then the girl can essentially blackmail or threaten her parents and doctor to get her own way. Brandon writes: ‘The only answer which the law should give to such a threat is, ‘‘Wait till you are 16’’ ’.

Lord Templeman

Lord Templeman also supported Gillick, although he took a different position from Lord Brandon. He did not consider it necessarily illegal for a girl less than 16 years to be given contraception if both the doctor and the parent(s) agree that this is in her best interests. He believed that there might be situations where a girl cannot be deterred from illegal sexual intercourse and that providing contraception for the purpose of avoiding an unwanted pregnancy was not encouraging or aiding the illegal act. But he did not believe that doctors should have the clinical discretion to provide contraception in this situation without the parents’ consent. He based this position on four arguments.

1. That a girl under 16 years is not competent to give consent to contraception. He wrote: ‘I doubt whether a girl under the age of 16 is capable of a balanced judgment to embark on . . . sexual intercourse.’ He gave legal reasons for this position. He argued that, since it is illegal for a man to have sexual intercourse with a girl under 16 years old even with that girl’s consent the law must consider such consent as invalid.

2. That the doctor can never be in a position to properly judge whether or not it is in the best interests of the girl to be given contraception without information from the parents.

3. One of the duties of parents is to protect their children from illegal intercourse through persuasion, the exercise of parental power, or through influencing the relevant man.

If the doctor gives contraception without informing the parents then he is interfering with the parents’ ability to carry out their duty.

4. That parents have rights to know by virtue of being parents.

. . . the parent who knows most about the girl and ought to have the most influence with the girl is entitled to exercise parental rights of control, supervision, guidance and advice in order that the girl may, if possible, avoid sexual intercourse until she is older. For a doctor to keep the girl’s confidence ‘would constitute an unlawful interference with the rights of the parent’ to make that decision and with ‘the right of the parent to influence the conduct of the girl by the exercise of parental power of control, guidance, and advice’.

‘There are many things which a girl under 16 needs to practice’, he writes, ‘but sex is not one of them’. I suppose he was thinking of piano practice.

Two judges in favour of Gillick. Three judges to go.

Lord Fraser

Lord Fraser disagreed with both the previous judges and with Gillick and came down in favour of the DHSS. He distinguishes three strands of argument.

1. Whether a girl under the age of 16 has the legal capacity to give valid consent to contraceptive advice and treatment.

2. Whether the giving of such advice and treatment to a girl under 16 without her parents’ consent infringes the parents’ rights.

3. Whether a doctor who gives such advice or treatment to a girl under 16 without her parents’ consent incurs criminal liability.

He considers these in order. On the question of legal capacity to give valid consent Lord Fraser considers various pieces of legislation and concludes that none gives legal grounds for necessarily considering someone under 16 as lacking capacity to consent to medical treatment, including contraceptive treatment. With regard to the argument made by Lord Templeman he draws the opposite conclusion. He argues that ‘a girl under 16 can give sufficiently effective consent to sexual intercourse to lead to the legal result that the man involved does not commit the crime of rape’ (although he still commits a lesser crime).

Lord Fraser argues that the legal basis for parental rights to control a child exists for the benefit of the child and they are justified only in so far as they enable the parent to perform his duties towards the child. . . . the degree of parental control actually exercised over a particular child does in practice vary considerably according to his understanding and intelligence and it would, in my opinion, be unrealistic for the courts not to recognize these facts. Social customs change, and the law ought to, and does in fact, have regard to such changes when they are of major importance.

After considering various previous judgments Lord Fraser goes on to write: Once the rule of parents’ absolute authority over minor children is abandoned, the solution to the problem in this appeal can no longer be found by referring to rigid parental rights at any particular age. The solution depends on a judgment of what is best for the welfare of the particular child. Nobody doubts, certainly I do not doubt, that in the overwhelming majority of cases the best judges of a child’s welfare are his or her parents. Nor do I doubt that any important medical treatment of a child under 16 would normally only be carried out with the parents’ approval. But . . .

Mrs Gillick . . . has to justify the absolute right of veto in a parent. But there may be circumstances in which a doctor is a better judge of the medical advice and treatment which will conduce to a girl’s welfare than her parents. It is notorious that children of both sexes are often reluctant to confide in their parents about sexual matters . . . There may well be . . . cases where the doctor feels that . . . there is no realistic prospect of her [the girl under 16] abstaining from intercourse. If that is right it points strongly to the desirability of the doctor being entitled in some cases, in the girl’s best interest, to give her contraceptive advice and treatment if necessary without the consent or even the knowledge of her parents.

He dismisses the view held by Lord Brandon that a doctor would be committing a criminal offence under the Sexual Offences Act 1956 by aiding and abetting the commission of unlawful sexual intercourse in giving contraception, or contraceptive advice, to girls under 16.

It would depend on the doctor’s intentions; this appeal is concerned with doctors who honestly intend to act in the best interests of the girl, and I think it is unlikely that a doctor who gives contraceptive advice or treatment with that intention would commit an offence . . .

Lord Scarman

Lord Scarman considers the issue of the capacity of children under 16 years in more detail than Lord Fraser: I would hold that as a matter of law the parental right to determine whether or not their minor child below the age of 16 will have medical treatment terminates if and when the child achieves a sufficient understanding and intelligence to enable him or her to understand fully what is proposed. He concludes that the guidance from the DHSS can be followed without involving the doctor in any infringement of parental right. Scarman is in agreement with Fraser. Two all with one to go.

Lord Bridge

Lord Bridge raises an issue that is not covered directly in any of the other judgments. He is concerned with the role of legal judgment in cases where there are ethical and social issues, as in the case being examined. He writes: if a government department . . . promulgates . . . advice which is erroneous in law, then the court . . . has jurisdiction to correct the error of law . . . In cases where any proposition of law . . . is interwoven with questions of social and ethical controversy, the court should, in my opinion, exercise its jurisdiction with the utmost restraint, confine itself to deciding whether the proposition of law is erroneous and avoid . . . expressing ex cathedra opinions in areas of social and ethical controversy in which it has no claim to speak with authority . . .

Having given this warning he takes issue with Lord Brandon and agrees with Lords Fraser and Scarman. The DHSS wins, Gillick loses: three Lords to two.

Share

Google+

googleplus sm

Translate

ar bg ca zh-chs zh-cht cs da nl en et fi fr de el ht he hi hu id it ja ko lv lt no pl pt ro ru sk sl es sv th tr uk

Verse of the Day

Global Map