ETHICAL DILEMMAS IN MEDICINE PRESIDENTIAL SYMPOSIUM HELD ON 5th APRIL 1990

While there are many ethical problems in medicine today, this meeting concentrated on two of these - surgery in the newborn and modern drugs. Sir David Innes-Williams, President of the Royal Society of Medicine and a world famous paediatric surgeon, reviewed the many problems in this field, concentraing on broad problems. He was followed by Professor Edward Guiney from Our Lady's Hospital, Crumlin who dealt with the particular problems in dealing with spinal defects. Emeritus Professor Sir Abe Goldberg, former chairman of the UK Committee on Safety with the introduction of new drugs, with particular reference to :he role of regnlatory authorities. This was complemented by Professor Kevin O'Malley's contribution on the ethical problems of drug trials. Each of these topics would merit a full paper, and the important aspects of each presentation are summarised below.

Medical Ethics in Paediatric Surgery Sir David Innes-Williams, London

Medical ethics is a growth industry with a raw material capable of being endlessly recycled and there has never been a time when doctors were so closely and so insistently ques- tioned upon their motivation, their effectiveness and even their integrity. All of us have aconcern for the proper conduct of the care of the child who has a more instant and wide spread appeal to our conscience than the embryo or foetus, but who is for the most part, unable to express coherently personal views of our treatment. We here consider some basic ethical principles and see how, when these are applied to the child in a wide variety of circumstances, they may conflict with one another or be limited in their application by practical re- straints.

The term medical ethics was first publicised in 1803 by Thomas Percival of the medical and surgical staff of the Manchester Royal Infirmary. His instructions were a model on which successive generations including my own would have been proud to practice.

"Hospital physicians and surgeons should minister to the sick with due impressions of the importance of their office reflecting that the ease, the health and the lives of those committed to their charge depend on their skill, attention and fidelity. They should study also in their deportment so to unite tenderness with steadiness and condescension with authority as to inspire the minds of their patients with gratitude, respect and confidence."

Such instructions are now derided as paternalist, elitist, sexist and almost any other derogatory 'ist' that you can think of. That was an ethic governing relationships within the profession. Now that medicine is able to encompass so many more effective interventions we need to broaden the horizon and concern ourselves also with the relationships between the profession and the public. In this area there are wide spread misconceptions, the popular view being that all doctors sub- scribe to the Hippocratic oath and are dedicated before all else to the saving of lives. We need to be more accurate and more specific about our first principles, which are in our contempo- rary culture derived in some part from the Hippocratic tradi- tion, modified by the rabbinical teachings of Judaism, the

doctrines of Christianity as propounded by the liberalist philosophy of the secular West.

Asked for a list of principles the modem ethicist would probably produce something of this sort :

1. Beneficence - the one that we are most at home with,

"I will follow that sys tem. . , which according to my ability and judgement I consider for the benefit of the sick" which not infrequently runs into the restraints imposed by our own ignorance of the consequences of our actions, by the legal framework in which we operate and by the lack of resources to support what we think best.

2. Non-malfeasance - "Primus non nocere".

First of all to do no harm - not a very inspiring principle for one to which we can afford high priority since surgeons often inflict considerable harm, though of course in the hope of ultimate benefit.

3. Preservation of Human Life - in most instances an obvious imperative for the doctor, if not for the soldier, politician or agitator. Yet, even in medicine there are situations where life is so intolerable that the relief of suffering seems more urgent. This is recognised by the Catholic church in the principle of the double effect when measures designed to relieve pain, but almost inexorably shorten life, may be approved. In the dictum on ordinary/extraordinary treatment the former is re- quried in all situations, the latter which may be excessive and burdonesome, only where the prospects for success are good and which may be otherwise omitted allowing nature to take its course. These are factors of the greatest concern in the case of the severely handicapped neonate.

4. Autonomy - This principle is the darling of contempo- rary liberalism although it received little emphasis in earlier systems. It is essentially the product of the Rights Movement which, in its various manifestations, can claim a human right to almost all good things, life, health, welfare, housing, food, even work, regardless of the chances of attaining them. Autonomy is the antithe-

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238 Sir David lnnes Williams IJ.M.$. August, 1990

sis of paternalism, that now unacceptable attitude which doctors adopted from the example of the priests.

One is not sure whether paternalism is truly unethical: it is certainly rejected by the consumerist society in which we work and so we must adapt. But in paediatrics we are mostly dealing only with surrogate autonomy and this gives rise to a host of problems which will be discussed in depth.

5. Justice - we have an obligation not simply to our indi- vidual patient but to a wider community. Justice de- mands equity in the distribution of benefits as well as the greater good of society. It is a principle which some- times conflicts with the principle of beneficence.

6-7. Truthfuness and Contract Keeping -- two laudable principles which have little immediate impact on our present discussion. These are the principles: the practi- cal restraints derive from the law and custom of the society in which we work, from the obtuseness of par- ents, from the insufficiency of resources and from our own lack of knowledge and skill.

Consider again the principle of autonomy about which have been made such unjustifiable scathing remarks. Today's patient must be involved in the decision making process, must have a full explanation of the problems information about the alternative methods of treatment and the right to choose which shall be pursued. Treatment can be refused altogether, even though this may endanger life and legally (and morally) the doctor may only intervene in an emergency in which the patient is unable to make a reasoned decision.

Suicide is no longer a crime in Britain and although our inclination and perhaps our moral duty must always be to prevent that outcome, we have in law (except where there is an implied contract of continuing care) no obligation to interfere. The doctor also has some autonomy and can refuse to carry out procedures which he thinks inappropriate or dangerous.

Children are not usually able to exercise that autonomy on "their own account; it is exercised for them by parents or guardians, but only within strict limits. The law does not altogether trust them and one has only to look at the sorry story of child abuse to agree that the law has good reason. Parents may only propose or consent to treatment which is for the benefit of the child. Who is to judge that benefit? Usually it is the doctor in the t-n'st instance though perhaps in the last resort it is the judges advised by the doctors, so paternalism tends to creep back in.

First of all, consider what a child might understand for himself. In Britain the age of consent for both surgical operation and sexual intercourse is set at 16 but as the Lord Chief Justice remarked, there are many girls under 16 who know full well what it is all about and can properly consent.

Weithorn and Campbell (1983) published some interesting findings in which, on all matters of competence in decision making, 14 year olds scored as high as adults. Nine year olds were as good at making reasoned choices as adults though they scored lower on understanding. Some such I-mdings will not surprise paediatric surgeons who have often found that

children grasp the basic dilemma to be tackled more readily than parents whose preconceptions create a barrier to compre- hension. The Roman Catholic church has traditionally held that moral responsibility begins at age 7 years. There is therefore a clear responsibility, although not a legal one, to seek a child's consent to operation from that age onwards. A decision to overule a child's refusal at the behest of the parents must clearly depend upon the severity of the threat to health and the doctors must ponder deeply upon that question before giving advice.

How far can the parents make a final decision? We ordinarily accept they will decide whether a normal boy is to be circumcised or not, a procedure not entirely without risk and only seldom of benefit to the child's health. We are all inclined to respect conformity with custom and religious belief. By contrast we are outraged by the practice of female circumcision which is illegal in Great Britain, the law specifi- cally stating that no account should be taken of the effect on that person of any belief that the operation is required as a matter of custom or ritual. The principle of benevolence clearly overrides our respect for surrogate autonomy in the religous sphere.

The assignation of sex and the business of appropriate surgery in the intersex eases can tax the knowledge, the investigative resources and the technical skill as well as the ethical integrity of the surgeon. But equally it lays heavy responsibility on the parents whose preconceptions in cases of late diagnosis, whose religious beliefs and whose cultural or emotional attachment to having a son will seem to the doctors to distort a decision on the child's best interests. The matter is complicated by the legal requirement of registration of birth which can be difficult to change. There is clearly an obligation upon the doctors to undertake the fullest investigation at the earliest possible moment and to seek the most expert advice on prognosis; then to explain the matter very fully to the parents so that a joint policy can be determined. There can never be any question of totally overrruling the parent's decision on this matter since that could only result in a rejected child with a most unhappy future.

One has seen many disastrous situations which can result from parents determination, e.g. to continue to treat as a boy a female with congenital adrenal hyperplasia, to insist that a boy with hypoplastic testicles and a micro penis which defies surgical reconstruction should continue in the male role, or, that a male with testicular feminisation and completely femi- nine genitalia should be registered as a boy on the basis of testicular biopsy alone.

Jehova's Wimesses are well known for their belief that blood transfusions offend the law of the Almighty; its mem- bers are perfectly entitled to refuse transfusions for them- selves at the risk of life but one questions their right to refuse it for their children. Society in general seems to support the doctors in this and an application for the child to be made ward of court enables a High Court to authorise transfusion; alter- natively an application to a magistrate can result in the child being taken into the care of the local authority with similar effect. In both cases the doctors are advising the judicial authority of the severity of the threat to health, but in making

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that assessment must give very serious consideration to the effects of offending religious susceptibilities upon family relationships. Beneficence is not always straightforward.

The need to consider the family unit as well as the individual child crops up again in relation to very long and burdensome programmes of surgical treatment with repeated hospitalisation which totally disrupts family life and the care of the siblings. The surgeon may be tempted to pursue ideal solutions, for instance the attempt to create a functioning bladder when the child has been born with a miniscule and functionless organ together with a major intestinal defect. The chances of success even after repeated interventions are small, most of the children will be left with at least the need for self- catheterisation whereas the acceptance in the fh'st place of a simple diversion, tolerable if less than optimal, would have been less disruptive to general development and educational progress. But how are advances to be made if surgeons do not at times strive for better solutions and try out the unproved? As with Phase 1 trials of new drugs they must not persist if the first indications are unfavourable.

This leads to a consideration of an even wider beneficence - the good which can be done for subsequent cases and for society in general.

The limits set upon clinical trials in children are naturally tight, legally it is doubful whether parents can authorise any non-therapeutic intervention on a minor, but for the older child and for interventions with minimal risk, e.g. taking blood, there is unlikely to be any objection. It is well known that controlled trials of alternative therapy in Wilm's tumoar have yielded results of great value in planning future treat- ment, indeed in minimising the harm which results from radiotherapy or chemotherapy. The ethical basis of such trials is sometimes questioned. For adults fully informed consent to participation is demanded though on literal interpretation that high standard seems impossible to obtain and there are trials for which recruitment of sufficient numbers becomes impos- sible when this full exposure is attempted. In children there is the additional difficulty that parents have to give the consent although in some cases the law might question their capacity to do so. Yet common sense and responsibility for future cases strongly suggests that when we genuinely do not know which of two treatments is the better we should conduct scientifically controlled trials capable of giving statistically reliable an- swers, relying on jurys to recognise our good faith if we are subsequently involved in litigation.

Our concern for patients other than our own and for society at large brings us to the principle of justice and the equitable distribution of resources. A micro-cephalic idiot with irre- versible renal failure may be the object of the single-minded devotion of his mother, who demands that he should receive the full rigours of haemodialysis and renal transplantation. Some doctors are normally anxious to try everything possible for their patient and customarily responsive to parent's wishes might nevertheless exercise their own autonomy in this situ- ation, judging that life for the child might be so intolerable that nature should be allowed to take its course.

They may well argue that such treatment for a child in this condition would be extraordinary and burdensome within the

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criteria set by the Catholic church. Pope Paul VI said, "the duty of the physician consists more in striving to relieve pain than in prolonging as long as possible with every available means, a life that is no longer fully human and that is naturally coming to its conclusion." That is a judgement which can equally apply to a child with

terminal malignant disease or irreversible renal failure. For other doctors however this case might raise questions of the best use of resources; dialysis is expensive both in terms of money and skilled labour, kidneys available for transplant are seldom sufficiently numerous to meet the needs of all.

If then there is to be rationing, how should it be applied and by whom? Some would claim that a doctor's loyalty is to his individual patient and to him alone. There is nothing about resource allocation in the Hippocratic tradition and if society at large or government in particular fails to allocate enough money to health care, then society or government should take the hard decisions on who should be allowed to die unaided.

Most of us have a gut feeling that we ought to be fair to all parties, there is a principle of justice which we must respect and the doctors having some considerable knowledge of the consequences of alternative action, must have a part to play in the rationing decisions. On a small scale we all recognise this; none of us would hesitate to leave the dressing of a wound of our own patient to attend the urgent need of unknown victims of a road accident outside the hospital. We would not choose the most expensive antibiotic if a cheaper one was equally effective. But on the larger scale difficulties can arise; can the doctor who has cared for our micro-cephalic with renal failure now tell his mother that the funds for dialysis are now required for another child with a better outlook? This is where the principle of beneficence and the principle of justice clash and we have not yet found a full-proof solution to the problem.

In Britain, with an underfunded but theoretically compre- hensive health service,many doctors have had to face the issue squarely and recognise a collective responsibility. In a private practice setting, it is apt to be dodged but from 1971 the American Medical Association has acknowledged that "The responsibilities of the physician extend not only to the individ- ual but also to society."

Rationing comes in at many levels. At the highest national level the sums allocated to Health Care compete with the claims of welfare, defence, education and all the big spenders. This is true even when as in USA, only a part of health spending is under government control. Here the decisions must be political and the doctor has no special role except to provide information. At lower levels the medical input increases as knowledge of the consequences is essential to the informed division of the global sum between the various forms of care. Still the decision must be with the representa- tives of the community. It is reasonable that the people at large should have a say in, for instance, allocation of funds between long stay homes for mental defectives and "high tech" centres for the immediate care of the injured. At the hospital level the medital view should dominate but it must still be a corporate voice. Rationing which involved life and death decisions cannot be left to the individual doctor, least of all to the one

240 Sir David Innes Williams

who has been personally concerned with the treatment of an individual patient.

A spirited advocacy on behalf of his own patient and his own speciality is to be expected and applauded but, so equally, is ultimate aquiesence in the corporate decision. This prin- ciple is not yet universally accepted. In our current difficul- ties, some doctors' natural response to financial limitations on patient numbers imposed by a Health Authority is to spend to the limit on the first patients to be seen and then use the resulting chaos as a stick to beat the government. This is not the highest form of medical ethics.

There are instances when the doctors and parents agree on a course of action designed to benefit the child but third or fourth parties wish to enter the field, usually social workers whose moral fervour is no doubt stimulated by their ambition to demonstrate their independence from medical domination. This can be a feature of cases of severely handicapped neo- nates of mental defectives. That is an ethical dilemma extensively discussed in medico-legal circles. In a British case some years ago, the mother of an 11 year old girl suffering from Sottos syndrome (epileptic and mentally defective) believed that she should be sterilised so that the management of menstruation should not be added to the problems of her incontinence and so that she could enjoy loving relationships without fear of pregnancy.

The doctor and gynaecologist agreed, but a social worker i~tiated court proceedings and the judge having heard a variety of medical opinion ruled against sterilization before the age of consent. This seems a curious decision since the girl would never reach the mental age of giving informed consent and legal authorities have now told us that not even the courts can authorise an operation on a mental defective over the age of 18 but that the doctors would not be doing anything seriously wrong if they went ahead with the operation any- way.

The difficulties that arise when parents, doctors, social workers and the courts disagree was well illustrated by a case referred to in the literature as 'in reB' (a minor) (wardship and medical treatment). An infant born with Down's syndrome suffered also duodenal atresia, the latter condition being ordinarily fatal but capable of effective surgical treatment.

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The parents refused permission for the operation believing the life of a mongol with intestinal problems to be intolerable. A social worker requested the local authority to apply for court wardship. The court gave permission for treatment but the first surgeon refused to act in the absence of parental consent, after which the court order was rescinded. The local authority appealed and found another surgeon who believed that with good adoptive arrangements a mongol child following sur- gery could have a relatively happy life for 20-30 years. The Court of Appeal ruled that, "The child should be put in the same position as any other mongol child and given the chance to live an existence." Lord Templeman's use of those last words does not suggest he thought much of the prospects, but his judgement condemned the child to live. One cannot be sure who is really right in this case, my sympathies were certainly with the first surgeon; this was relatively straight forward surgery with a reasonable chance of local success. Where the neonate suffers major neural tube defects, where the outcome is doubtful and never likely to be entirely satis- factory, there are problems which Professor Guiney will discuss.

We have started from the proposition that medical ethics are now too important to be left to doctors, that society must decide these issues guided by priests or philosophers. Yet when we come down to the practical problems it turns out to be doctors who must make the judgement and bear the responsibility, not simply in every day situations but in many controversial areas. They must decide whether a treatment is so extraordinary and burdensome that the Pope's pronounce- ment can apply. They must advise the courts on what is to the benefit of the child if the parents' wishes are to be over-ruled. They must advise health authorities in the business of resource allocation, aware that it may disadvantage some of their patients.

Doctors must therefore not only make professional deci- sions but ethical judgements as well: in both spheres they would do well to take note of the contempoary consensus of medical opinion if they are to escape the condemnation of the courts and to counter the criticism of the arm-chair ethicists. Perhaps as Percival said, they will need to "unite tenderness with steadiness and condescension with authority.."