Published: 30th June 2005
The Christian Medical Fellowship (CMF) is an interdenominational organisation with more than 4,500 British doctors as members. All are Christians who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. Members practise in all branches of the profession, and through the International Christian Medical and Dental Association are linked with like-minded colleagues in over 100 other countries.
CMF regularly makes submissions on ethical and professional matters to Government committees and to other official bodies. All our submissions are available on our website at www.cmf.org.uk
We are very grateful for this opportunity to comment on the proposed NICE guidance on 'Social Value Judgements' and we make these comments both as Christians and as practising clinicians. We are very willing to expand on any of these comments in giving oral evidence to the Institute if required. Our response is given in three parts:
NICE claims to base its conclusions on the 'best available evidence' (1.1) but the consultation document itself is based on a set of controversial presuppositions for which no evidence base is given, namely:
We would submit that these presuppositions are ideologically based rather than evidence based. We can understand their attractiveness but believe them to have fundamental flaws. These flaws are important, because if the document's foundation is unstable, then its conclusions will be also.
The four-principle approach to ethical decision-making was proposed by Beauchamp and Childress and promulgated through the Kennedy Institute of Bioethics at Georgetown University in Washington. It is widely used primarily because so many contemporary ethicists have studied there. Principalism was popularised in the UK by Raanan Gillon, Professor of Bioethics at Imperial College, London, largely as a result of Gillon's enthusiasm and charisma, influence with decision-makers and his prolific contributions to UK ethics literature.[4,5] However, as an ethical theory, it has several serious short-comings:
In summary to choose, apparently arbitrarily, one controversial ethical theory and impose it on a society where there is a huge diversity of worldviews and ideologies is at very least impractical and at worst paternalistic. Beauchamp and Childress' Principalism is not referred to by many ethicists and clinicians as 'the Georgetown mantra' for nothing!
Jeremy Bentham first outlined the moral theory of Utilitarianism in his 1789 work, Introduction to the Principles of Morals and Legislation. The goal of utilitarian ethics is to promote 'the greatest happiness for the greatest number'. Bentham identified happiness with pleasure, which he measured in terms of 'intensity, duration, certainty, propinquity, fecundity, purity, and extent'. The philosopher John Stuart Mill further refined the theory, proposing that the quality of pleasure as well as its quantity should be introduced into Bentham's 'felicific calculus', arguing that there are higher and lower pleasures. Many variations of utilitarianism have since been described; one of its most outspoken contemporary advocates is Peter Singer, currently Ira W DeCamp Professor of Bioethics of Princeton University's Centre for Human Values, USA.
Again Utilitarianism has several widely recognised shortcomings:
In summary, what is the evidence for utilitarianism being the best approach?
QALYs are based on a recognition that good patient management is concerned not only with extending the patient's life but also with improving the quality of that life. Advocates of the QALY claim that medical interventions can be put in rank order of cost-effectiveness.
We would argue that QALYs have several shortcomings:
We are somewhat bemused to see QALYs resurfacing with such prominence in this document given they were effectively discarded by most practitioners after debates of the 1980s about their impracticality and shortcomings.
72% of UK citizens still describe themselves as Christian according to the 2001 census, but there is no mention whatsoever in the document of the Judeo-Christian tradition nor of the historical contributions that Christian thinkers and politicians – coming from a non-utilitarian outlook – have made to the development of healthcare provision. This is a serious omission.
The Christian values that underlie our own clinical decision-making are as follows:
We would like also to sketch out some Christian principles relevant to resource allocation:
All human beings, even in the agony of suffering, or in a twilight mental state, are God-like beings. Any being made in God's image deserves a range of responses: wonder, respect, empathy, and above all protection from abuse, harm, manipulation, and from wilful neglect. In the incarnation, God re-affirmed once and for all the value that he places on humanity, created in his image. Every patient, no matter how deformed the body, deranged the mind or diminished the personality, carries this double hallmark of divine value.
There is a fundamental difference between making treatment decisions, and making value-of-life decisions. Health professionals are qualified to make treatment decisions: to decide which treatment is worthwhile and which is not. But doctors are not qualified to make value-of-life decisions: to decide which life is worthwhile and which is not. Doctors may determine whether a treatment is futile, but they can never determine whether a life is futile. When we withdraw or withhold treatment, we must do so in the belief that the treatment is valueless, not that the patient is valueless.
Patients must not be discriminated against on the basis of age, sex, ethnic origin, income, social standing, religious belief, cultural practice, mental capacity, degree of disability or on the grounds that their illness is self-inflicted unless ant of these has a direct bearing on their likelihood to benefit from a given treatment.
The authority, responsibility and resources to provide clinical care should be delegated to those with the appropriate clinical skills. They should be periodically accountable but not micro-managed; provided with evidence-based guidelines, but also given the freedom to exercise their professional judgement. It is better to give care to a patient presently in one's care who one has the power to help, rather than to wait for another possibly more deserving who might not ever come.
We recognise that we are not able to give every treatment to every patient in every circumstance and therefore decisions must be made about what treatments to give and what not to give. At the macro level in a public system this may mean that less effective or expensive treatments are not funded. At the clinical level treatments should be given on the basis of their likely effectiveness which may in some cases be better judged on the basis of past clinical experience than by recourse to research data, which may be deficient or unhelpful in a given specific case.
Whilst public funding may be limited freedom should be given for individual clinical units (Trusts, Departments, Individuals) to 'increase the size of the pie' through seeking funding from other sources – especially donations, grants etc.
As a general rule those with imminently life-threatening conditions and distressing symptoms should be given priority over those with non-life threatening or chronic conditions. Triage is the concept of prioritising patients according to the nature of their need. It determines the time and sequence in which patients should be seen – generally based on an evaluation of the patient and assessment of vital signs.
Despite the many advances in curative medicine the time-honoured maxim of 'heal sometimes, relieve often, console always' remains true. When cure fails, care must continue. Care includes spiritual and emotional care, as well as physical care (food, water and symptom relief).
Not only is each individual human life special, we are also all part of the human family, created to be in community. To think that matters of resource allocation can be decided in isolation, by a single individual, is a dangerous illusion. Whilst recognising that most treatment decisions are clinical rather than ethical, and that therefore the most senior clinicians should be central figures in these decisions, we recognise that sections of the medical profession have in the past embraced unethical practices. Therefore it is essential that doctors remain accountable outside professional bodies to sound ethical principles.
The fundamental principles that underpin the processes by which NICE guidance is developed should be maintained for current, and applied to future, forms of guidance.
The common principles outlined with respect to developing guidance are good but NICE should follow its own advice and explain the reasons it has adopted principalism, utilitarianism and QALYs as fundamental presuppositions in the construction of this document. What is their evidence-base? As outlined above we have serious misgivings about these principles and believe that NICE should draw its ethical principles from a wider variety of sources and worldview perspectives with particular attention to Christian principles given that 72% of British people call themselves Christian.
For both legal and bioethical reasons those undertaking technology appraisals and developing clinical guidelines must take account of economic considerations.
We agree. Resources are limited and treatment decisions are not taken in a vacuum. Guidance is needed to manage resources across the health service. The order that originally established NICE provides that, 'The Institute shall perform such functions in connection with the promotion of clinical excellence and with the efficient use of available resources in the health service'. However, there is still considerable discussion about how such macro-decisions should be made. Similarly the relationship between macro-decisions and the doctor's primary responsibility, which is towards his patient, must be addressed.
As outlined above we question the heavy reliance of the consultation document on:
We urge NICE to take a much wider view of the underpinning principles to their guidance. There are real problems with QALYs, which the report acknowledges. It also acknowledges that 'there is no consensus' (p19). A full literature review taking in alternative ethical models and arguments against QALYs must be undertaken. Evidence indicates that doctors use a much broader basis for making medical decisions. NICE must take account of this and develop guidance that serves best medical practice in the most efficient manner, while also maintaining the perspective of a doctor that the care of his patient should be his first concern. After claiming to reject a strictly utilitarian approach (4.2) NICE must unpack what that means and outline the alternative(s) that will guide their policy decisions.
NICE guidance should not support the use of interventions for which evidence of clinical effectiveness is either absent or too weak for reasonable conclusions to be reached.
We agree with the proviso that, as quoted in the document, lack of evidence of effectiveness is not the same as evidence of lack of effectiveness. There must be a clear commitment to ongoing research in the light of which guidelines may be changed.
Cost–utility analysis in the economic evaluation of particular interventions is a necessary, but insufficient, basis for decisions about cost effectiveness.
There are well-known concerns around undue reliance on QALYs as outlined in the literature[14,15] and above – for example the distortion that increasing age has, and the range of values that patients with disease place on their quality of life. Even staunch utilitarians have criticisms of the QALY - particularly in relation to the results it produces for disabled people. There should be a robust assessment of the strengths and weaknesses of alternative ways of assessing cost-utility, and when these might be appropriate. It doesn't follow that someone in less than perfect physical health values his or her life any less than someone in perfect physical health. And a small-observed change in function to a patient might be a big change to them. Patient acceptability is important – a new treatment might not be acceptable to patients – though bear in mind often it's the other way round, patients demand a new treatment even though the evidence is lacking.
NICE guidance should explain, explicitly, reasons for recommending – as cost effective – those interventions with an incremental cost-effectiveness ratio over £20,000 to £30,000 per QALY.
The weakness of the QALY system affects this recommendation in that, if QALYs are not rational units then it will be misleading to use them as a guide. However, if they are to be used in any way at all, then a range of examples of specific interventions in every specialty should be given along with their cost to give these financial figures meaning in the minds of frontline clinical staff.
Patients must be able to trust doctors with their lives and well-being. To justify that trust, we as a profession have a duty to maintain a good standard of practice and care and to show respect for human life. In particular as a doctor you must:
In all these matters you must never discriminate unfairly against your patients or colleagues. And you must always be prepared to justify your actions to them.
The duties of a doctor registered with the GMC already make it clear that a doctor should not discriminate against patients. Decisions made by the doctor must always be in a patient's best medical interests. We would expect a similar rule to apply at the macro decision level. We therefore find these recommendations somewhat superflous. In making specific anti-discrimination recommendations, however, we are particularly concerned by what the consultation doesn't include, rather than what it does. Religious belief, mental capacity and type and degree of disability must be included.
Recommendation 6 (section 5.1)
With respect to age: • health should not be valued more highly in some age groups rather than others • individuals' social roles, at different ages, should not influence considerations of cost effectiveness • however, where age is an indicator of benefit or risk, age discrimination is appropriate.
There needs to be clear evidence of increased benefit (or risk) in the different age groups. This requires clinical trials to be undertaken in the appropriate age groups (though paradoxically the elderly and children - the groups that often might gain the most - are the very groups that trials exclude for a variety of reasons). At present, patients are excluded from certain cost-effective interventions – for example, women over 70 are not routinely invited for breast screening even though they would benefit, and they are entitled to request screening, though many are unaware of this.
Recommendation 7 (section 5.2)
When setting priorities there is no case for discrimination on the basis of gender or sexual orientation unless these are risk factors for benefits, risks, or both.
We agree but find it strange that sexual orientation is mentioned when religious belief, mental capacity and disability are not.
Recommendation 8 (section 5.3)
Neither income, nor social class, nor position in life should be used in setting priorities.
Recommendation 9 (section 5.4)
There is no case for discrimination on racial (ethnic) grounds, either deliberately or inadvertently, in any NICE guidance.
We agree with the proviso that in some cases it may be appropriate on evidence grounds to give treatments shown to be more effective in one ethnic group than another only to that group. Discrimination on ethnic grounds might be justified where a treatment has been shown to be effective in one group over another. However, the group in which the treatment is less effective could easily claim discrimination so such decisions must not be taken lightly.
Recommendation 10 (section 5.5)
Discrimination against patients with conditions that are, or may be, self-inflicted (in part or in whole) should be avoided. If, however, self-inflicted cause(s) of the condition influence the likely outcome of the use of an intervention, it may be appropriate to take this into account.
We are concerned about the exception in recommendation 6 of 'where age is an indicator of risk' (and similarly in recommendation 7 for gender and sexual orientation). It is noticeable that for social class, income and racial background there is no such exception and yet clearly, from an epidemiological point of view, ethnic background and income have a large effect on heath and thus on risk and benefit. Again we are concerned that there is no anti-discrimination recommendation for disabled and mentally incapacitated patients or on grounds of religious belief. One must be included. The Declaration of Geneva (1948) includes the statement, 'I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patients' and is a good guide.
Although respect for autonomy and individual choice are important for the NHS and its users, this should not have the consequence of having an unacceptable opportunity cost or of promoting the use of interventions that are clinically and/or cost ineffective.
We agree that this is a useful check and balance with respect to social responsibility - individuals can't always get what they want, especially in an age where patient autonomy trumps all other principles. But by the same token this should not be used as a justification for discriminating against someone with genuine need.
Attempts to influence judgements about clinical and cost effectiveness by methods that are not within the Institute's published processes should be ignored.
This is important to protect NICE from undue influence by powerful people and interested parties. However, NICE must also be careful that it doesn't become a shield against reasonable concerns raised by people who have not been consulted on an issue. We would like to learn more about the specific concerns that NICE has in this area. Who does it anticipate will attempt to influence judgments? More transparency is needed here. NICE itself must be open to scrutiny and criticism of its procedures.
Considerable care should be taken when applying the 'rule of rescue'.
This could be true of any rule. NICE should unpack the rule of rescue more and offer positive support for it. This rule should be analysed with the same openness as QALYs; whereas it appears that cost-utility has been endorsed and adopted by default, while caution is urged on the rule of rescue. Sometimes we have to accept that patients will die and that it can be unfair to expect patients (or relatives) to make the decision whether to give a treatment that is unlikely to be of benefit. It is unfair to create unrealistic expectations that clinicians then fail to deliver on. We need to help people accept the reality of death and the fact that medicines won't always cure patients and that not all treatments can be available in a publicly funded health service.
Priority for patients with conditions associated with social stigma should only be considered if the additional psychological burdens have not been adequately taken into account in the cost–utility analyses.
It is potentially good that stigmatising conditions are given preference, though clearly that cannot be taken to extremes at the expense of more common conditions. There is also great variation between individuals personal experience of 'stigma' in relation to a condition. While one patient with dermatitis of the hands will be greatly distressed and feel stigmatised, a patient with the same condition in a more extreme state may feel less stigma. Mental illness and sexually transmitted disease are not the only causes of stigma – and are in fact becoming more acceptable. Obesity and smoking attract much more stigma now than they once did. How does NICE decide which conditions are stigmatising, and to whom? Some diseases are stigmatising to some people but not others. More transparency here please.
Special consideration should be given to innovations that provide significant improvements in health for previously untreatable conditions (that is, beyond 'best supportive care'), but taking account of the prognosis, the magnitude of the gain in health, and the cost.
We agree. Clearly there needs to be scope for experimental treatments, otherwise we will be confined to only using treatments already in the clinical repertoire.
We welcome the opportunity to contribute to this consultation and would be very willing to help further in giving oral evidence, or to enlarge of any of the points made.
We have grave reservation about some of the presuppositions underlying the document – especially principalism, utilitarianism and QALYs – we believe them to be ideology rather than evidence based.
We have outlined some Christian principles on resource allocation that we think should be incorporated into the document given that the UK is a society where most people describe themselves as Christian.
We have responded to each of the specific recommendations above – but would especially request that religious belief, mental capacity and disability should be added to the list of criteria for non-discrimination.
We would ask for more transparency from NICE about what lies behind specific questions and guidelines in the areas indicated.
Christian Medical Fellowship
6 Marshalsea Road
Tel: 020 7234 9660
30 June 2005
Steven Fouch (CMF Head of Communications) 020 7234 9668
Alistair Thompson on 07970 162 225
Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.
CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.