EDITORIAL 685

Nice and not so nice otherwise. One obvious lesson is that J Med Ethics: first published as 10.1136/jme.2005.014134 on 30 November 2005. Downloaded from ...... such exercises are fraught with diffi- culty. However, procedural justice does not solve this problem, rather it seeks to Nice and not so nice make the process of failing to solve the problem transparent, and to demon- John Harris strate the reasonableness of the process and only via the reasonableness of the ...... process the reasonableness of the pro- duct of that process, inter alia, so that those who make decisions (such as NICE) can be easily held to account. ichael Rawlins and Andrew editorial I provided arguments for all ‘‘When we lack consensus on principles Dillon start their defence of claims made, none of which are engaged that tell us what is fair, or even when we MNice in fine polemical style, by Rawlins and Dillon. Let’s get down to have general principles but are bur- unfortunately polemics is all they have cases. dened by reasonable disagreements to offer. They totally fail to justify the Rawlins and Dillon seem to think that about how they apply, we may never- Nice proposals on dementia treatments unless I (or anyone) is prepared to offer theless find a process or procedure that nor do they make any more plausible solutions to the problem of distributing most can accept as fair to those who are than formerly their use of the notorious health resources under conditions of affected by such decisions. That fair QALY. They say: scarcity we are not entitled to criticise process the determines for us what the work of those, like NICE, who do. counts as a fair outcome…Our approach Harris’s recent editorial, It’s not Rawlins and Dillon claim: ‘‘He offers in this book is to recast the problem of limit setting as a question about how NICE to discriminate, is long on nothing to illuminate the debate about allocating healthcare in circumstances decisions about limits should be made. both polemic and invective – but of finite resources;… Harris, himself, Specifically under what conditions should short on scholarship. He offers whilst accepting that resources should society grant authority to individuals or nothing to illuminate the debate not be wasted, has offered nothing that institutions to set limits to health care?’’16 about allocating healthcare in cir- approaches a workable solution…. The Daniels/Sabin approach thus makes cumstances of finite resources; he Some constructive suggestions, rather the reasonableness of the process cru- has no understanding of the quality than sniping from the sidelines, would cial. This exchange is centred on the adjusted life year (QALY) and its use be appreciated.’’ As it happens I have question of whether QALYs are or are in health economic evaluation; and had quite a lot to say about these issues1- not an unreasonable part of that process he makes ill-researched, unsubstan- 15 but supposing I hadn’t or that these and hence as to whether or not they tiated and offensive charges against solutions are wrong or unworkable, still vitiate the reasonableness claimed for the Institute and its advisory bodies. what Rawlins and Dillon claim is the process. Rawlins and Dillon fail to absurd. They suggest that no-one can see the irony of complaining when they Accusations are easy to make, diffi- criticise a proposed solution to a pro- are in fact held to account. cult to substantiate. There are a number blem unless they have a better one to of claims here, only one of which is true. offer! That would be like saying that it is QALYS, AGEISM, AND LIFE It is true that my editorial was robust, somehow illegitimate to criticise a pro- EXPECTANCY http://jme.bmj.com/ polemical if you like, but editorials are posed treatment for cancer on the grounds that a) it didn’t cure or palliate not the same as research papers and NICE’s preferred approach, to eco- these are important issues which deeply cancer and b) it actually made cancer nomic evaluation, is cost utility affect real lives. Although Rawlins and patients worse off, unless those critics analysis; and the Institute uses esti- Dillon affect to take the high ground had themselves a better cure for cancer mates of the quality-adjusted life their own article contains even more to offer! The point is that NICE’s year (QALY) as its principal (though vigorous and much more personal recommendations on Alzheimer’s drugs not only) measure of health gain. on October 4, 2021 by guest. Protected copyright. invective than my editorial, I make no will deny people palpable benefits and complaints. But as to the rest of what offer no better (or comparable but The QALY is simple in concept. It they say, well, let’s just see! cheaper) alternatives. Indeed if NICE ranks health-related quality of life They claim I offer nothing to illumi- followed the absurd advice of their on a scale of zero (dead) to one (full nate resource allocation and that I have Chair and Chief Executive, they would health), and multiplies this by the no understanding of the QALY. Both of have no basis for rejecting the time (years) during which this these claims may well be true, but Alzheimer’s drugs since they themselves improved state of health is enjoyed. nothing they say goes any way to offer no better alternatives, indeed they If one form of treatment is superior support these claims or even towards do worse than ‘‘snipe from the side- to another, but costs more, the lines’’, they propose, from the sidelines, making them plausible. I have studied incremental cost effectiveness ratio to leave patients untreated. and written about the QALY for almost provides an expression of the addi- 20 years1-15 and Rawlins and Dillon tional money required to achieve an show no evidence of any awareness or In the face of a lack of consensus improvement in health… indeed any understanding of the issues, amongst moral philosophers, NICE whether discussed by me (in 15 papers has adopted the principles of pro- Rawlins and Dillon go on to affirm that: and many more popular pieces) or by cedural justice – ‘‘accountability for ‘‘The QALY is not… inherently ageist’’. others who have found the QALY highly reasonableness’’ Here it is Rawlins and Dillon who problematic. True, these papers have clearly have no understanding of been criticised, but the arguments they I accept that there is no consensus QALYs. One of the chief architects of contain have never been refuted, cer- among philosophers about distributing the QALY described it as ‘‘a simple, tainly not by Rawlins and Dillon. In my scarce resources. I have never suggested versatile, measure of success, which

www.jmedethics.com 686 EDITORIAL

incorporates both life expectancy and patients but this does not show that don’t believe any numerical ratings of J Med Ethics: first published as 10.1136/jme.2005.014134 on 30 November 2005. Downloaded from quality of life’’.17 It is the fact that they are not inherently ageist, only that this sort can be meaningful) and sup- younger people usually (though not there are some cases where the sums pose it is agreed that Jackie’s quality always), have more life expectancy to come out differently and favour older score before illness or accident was 6 gain from treatment than older people patients. The presence of some black and Jill’s was 10. Then to rescue Jill that makes the QALY ‘‘inherently age- officers is no evidence that a police makes a difference of 10, while saving ist’’. One wants to ask which of the two service is not ‘‘inherently racist’’, the Jackie yields only a score of 6. It is surely words ‘‘life’’ and ‘‘expectancy’’ do existence of some cases where QALYs the treatment and the rescue that makes Rawlins and Dillon not understand? may favour older patients is likewise no this difference because without out True, Rawlins and Dillon give some evidence that they are not inherently them Jackie and Jill would score zero. examples in which QALY’s are neutral, ageist. QALYs are of course likely to They would be dead. This shows that the or might indeed favour the aged in the benefit older patients in a range of QALY scores of the treatment are not distribution of health resources. treatments where there is either 1) no meaningfully separable from the QALY Unfortunately Rawlins and Dillon are effect of the treatment on length of life scores of the individual treated, if what not paying attention. In my editorial and the time in which the treatment matters is the QALY expectations of the and indeed in everything I have written works is so short that natural differ- individual after treatment. Indeed, how on QALYs, I distinguish two ways in ences in length of life do not matter (for could it be otherwise, for the point of which QALYs may be used. As I expli- example, analgesia for acute pain), 2) high QALY scores of treatment is to citly noted in my editorial: where old people are significantly more deliver high QALY scores to individuals. likely to die if not treated than young The same is of course true of life The QALY combines life expectancy people or, 3) where old people are expectancy. after treatment with measures of the significantly more likely to require costly Once grant that part of the justifica- support if not treated than young expected quality of that life. There tion for using QALYs as a prioritising people. are two ways in which QALYS can principle is that we ought to maximise The bottom line is that in QALYs and be used. They might be used to quality as well as quantity of life, then it in NICE’s ‘‘preferred approach, to eco- determine which of rival therapies to clearly defeats the object to draw a nomic evaluation,’’ and ‘‘its principal distinction between quality or quantity, give to a particular patient or which (though not only) measure of health which is independent of treatment and procedure to use to treat a particular gain’’, life years play a pivotal role and quality delivered by treatment where both condition, in short which of two therefore if QALYs play any part at all in affect the outcome. The effects, whether different treatments is the more cost choosing between patients then they measured in QALYs or not, of treating effective, better for patients, better will inevitably tend to weight the choice someone successfully for lethal illness x, for society. However, QALYS are towards greater life expectancy (usually, when he will die a week later of y, are also used to determine not which of though not always) possessed by the the same as a treatment for x, which rival treatments to give a particular younger candidates for treatment. patient or group of patients, but will only yield one weeks’ remission. The temptation to think otherwise whether or not to offer any treatment QUALITY OF LIFE derives from confusing the choice at all to some patients, or whether to Again, when choosing between patients between different therapies for the same offer a particular treatment to some rather than treatments, the ‘‘QA’’ patient and between different patients patients even when no alternatives dimensions of QALYs tend to be vicious. for the same therapy. In the former case are preferred. http://jme.bmj.com/ Imagine twin sisters, Jackie was born it is the QALYs derivable from treatment paralysed from the waist down and Jill that matter because the background I have always affirmed that QALYs was born healthy. Now in their thirties, health state and life expectancy are a are often appropriate for the first use Jackie has established a life for herself constant. In the latter case, if life but most usually vicious and totally that she finds worthwhile and satisfy- expectancy and quality are relevant at inappropriate in the second. However, ing. So has her twin. Both agree, all (which I doubt) it must be the total in every case QALYs are indeed, and by however, that Jackie’s quality of life is QALY score of the person following definition, inherently ageist and also objectively substantially lower and both treatment that is the determining factor. on October 4, 2021 by guest. Protected copyright. favour those with the greater life expec- agree that Jackie’s life expectancy is The point about the issue of age and tancy regardless of age. This must be the substantially the lesser. Both, we will life expectancy also emerges clearly case because length of lifetime to be suppose are now involved in an accident from a mistake Rawlins and Dillon gained, is both valued and built in to the and resources available can only treat make about the meaning of what it is way QALYs are calculated. one before death strikes them both. Or, to ‘‘take something out of context’’. The more life years gained from both are stricken with an illness and They suggest I am: treatment the more ‘‘effective’’ the while treatment could restore both to treatment, that is what QALYs say, the status quo ante, there is only one which is why they inevitably ‘prefer’ intensive care bed available or only one also guilty of misrepresentation. Mr more lifetime whether possessed by the course of drug therapy and hence, only Justice Mars Jones did indeed state: younger candidates or those who hap- one will survive. It seems to me that not ‘‘However gravely ill a man may be pen to have more lifetime to gain from only is it unethical to choose between ….he is entitled in our law to every treatment. them. There is no rational basis for so More lifetime is clearly beneficial doing.18-22 Both want to live, both have hour….that God has granted him. when choosing between treatments, lives they find worthwhile. If we believe That hour or hours may be the most but usually vicious and discriminatory that we should prefer to rescue those precious and important hours of a when choosing between patients, where treatment makes more of an man’s life. There may be business to because different people benefit from improvement in quality of life then we transact, gifts to be given, forgive- the extra years on offer. Rawlins and should surely rescue Jill. Suppose that ness to be made, 101 bits of Dillon have highlighted some cases quality of life is measurable numerically, unfinished business, which have to where QALYs in fact favour older (for reasons not immediately relevant I be concluded’’

www.jmedethics.com EDITORIAL 687

By a curious chain of coincidences not proportionate to the amount of un- budget is. I have also made suggestions J Med Ethics: first published as 10.1136/jme.2005.014134 on 30 November 2005. Downloaded from one of us (MDR) was present in elapsed time that life contains. My point about how to arrive at a given budget, 23 Court, as an expert witness, when is that this is true, not only, if Mars but that is another issue. these words were uttered. But Harris Jones is right in our law, but in our has taken them totally out of context. morality, and that therefore the life Despite Harris’s assertion to the They were spoken during Mars years element of the QALY is not only contrary, the issue of how age might irrelevant, but contrary to morality Jones’ summing up to a jury in the be considered in the allocation of when applied to decisions as to whether trial of a general practitioner healthcare resources is disputed. or not to offer treatment to particular accused of the attempted murder of NICE has taken a principled posi- patients, as in the Alzheimer’s drugs tion… a man who was mortally ill from case. This, after all, was the subject of lung cancer. The case was about as my editorial. I made no such ‘‘assertion to the far removed from ageing or The example of the twins shows this contrary’’ but it is perhaps on this resource allocation as could be is also true of the quality of life occasion partly my fault that I have imagined. dimensions of QALYs. It follows that been misinterpreted. For the record I do QALYs are only contingently relevant to not believe nor have I said that the issue Rawlins and Dillon show that they do choices as to whether or not to treat of how age and life expectancy function not understand the meaning of the term patients (rather than to choices as to is undisputed. I know it is disputed, not ‘‘relevant context’’. Here, the context is which of rival treatments to offer them). least by me! What I actually said was: the connection between life expectancy So far from it being appropriate – right ‘‘The reason for outlawing race discri- and the value of life, not whether or not and proper – that ‘‘NICE’s preferred mination must be that it is clearly the shortness of the life was caused by approach, to economic evaluation, perceived by all to be absolutely morally cancer, or the operation of QALYs or by should be ‘‘cost utility analysis’’ it is unacceptable. And yet the same holds the actions of a criminal defendant . The quite improper and exceedingly for age discrimination as for race dis- point is that shortness of life expec- immoral, and if Mars Jones is right it crimination. Both race and age are in tancy, (fewer QALYs,) does not diminish is also contrary to Legal Principles. some circumstances ‘‘indicators of ben- the value of a life, it is on this that Mars Finally it is worth noting that Rawlins efit or risk’’, some ethnic groups are at Jones and I agree. and Dillon accuse me of holding posi- greater risk of certain genetic conditions It is easy to see why, Rawlins tions that I do not hold and have never contra than others for example, either both held, but rather positions that their and Dillon, the relevant context cannot types of discrimination warrant execra- failure to take seriously what I have be confined to the narrow social, poli- tion as unjust or both should be said leads them falsely to attribute to tical, or legal context in which remarks celebrated as justifiable discrimination me. are made. If it could be so confined on QALY grounds and therefore every time someone quoted the required to fulfil NICE purposes.’’ My American Declaration of Independence, As Harris points out, the Institute’s fault perhaps, but the statement ‘‘And Magna Carta, The Sermon on the Mount guidance recommends that IVF yet the same holds for age discrimina- ,or the Ten Commandments and pointed should be provided by the NHS, to tion as for race discrimination’’ refers contemporary relevance they would be infertile women aged between 23 and is intended to refer to the fact that ‘‘taking things out of context’’. The and 39 years. The evidence shows both age and race are in some circum- context in which I quoted Mars Jones that the success rate in older women stances ‘‘indicators of benefit or risk’’ was the context in which he made his is very small. Harris, though, sug- not to the phrase ‘‘perceived by all to be http://jme.bmj.com/ judgement. Mars Jones was making a gests that this advice is inappropri- absolutely morally unacceptable’’. I am general statement about the value of life ate; and that the NHS should offer not claiming any universal agreement in English law and morality and the fact the chance of IVF to as many women about the unacceptability of age discri- that life expectancy does nothing to as possible. mination. Although also for the record I diminish that value. In this case, the This is the point, of course, where find it unacceptable for reasons I have relevance of life expectancy to the value given.1-15 of life in that a person is entitled to Harris leaves the real world and

This is the point on which I believe on October 4, 2021 by guest. Protected copyright. enters a parallel – value and cost ‘‘every hour…that God has granted there needs to be engagement and debate. free – universe. For if the NHS (or him’’ because ‘‘that hour or hours may What is the role of age and life expectancy any other healthcare system in the be the most precious and important in making decisions which determine hours of a man’s life’’, these are remarks world) were to go along his route, who will live and who will die, who will about the connection between life years and provide everything anyone receive medical treatment and who will or in this case ‘‘life hours’’ and the value wanted, it could consume almost not? Rawlins and Dillon say ‘‘NICE has of a life, the fact that they were said in the entirety of a nation’s gross taken a principled position…’’ I do not the trial of a man accused of attempted domestic product with nothing left doubt it, but principled positions are not murder does not mean that they have for any other form of public (or, for necessarily either right or good. It is not a been ‘‘taken out of context’’. that matter, private) expenditure. great virtue to espouse the wrong princi- This is the heart of the issue about ples and one of the purposes of this QALYs and it is not just regrettable but I have never said nor written, nor do I journal is to explore the appropriateness tragic that Rawlins and Dillon totally believe, that the NHS, nor any health of principles used in Medical Ethics. fail to see its relevance and seek to evade care system could or should ‘‘provide Contrary to what Rawlins and Dillon the issue by alleging I have taken Mars everything anyone wanted’’. When I say appear to believe, I made no personal Jones’s remarks out of context. Life the choice is between maximising the attacks in my editorial, I was criticising expectancy – life years gained from number of take home babies and max- NICE and its principles, I do not doubt treatment, are irrelevant when choosing imising the chance to offer IVF to as that Rawlins and Dillon and all their between candidates for treatment pre- many women as possible I am pointing advisors are good men and women acting cisely because, as Mars Jones so elo- out different moral priorities in allocat- in good faith in difficult circumstances. quently points out, the value of a life is ing a given budget, whatever that That is not the point.

www.jmedethics.com 688 EDITORIAL

The point is that the principles and should not be funded by the NHS. This Manchester, Williamson Building, Oxford J Med Ethics: first published as 10.1136/jme.2005.014134 on 30 November 2005. Downloaded from policies NICE have espoused and recom- is not a matter, (as I have argued, in my Road, Manchester, M13 0JH; john.m.harris@ man.ac.uk mended in this case are calculated to have editorial and in many places for nearly very bad consequences for thousands of twenty years) on which QALYs can be Received 23 September 2005 patients and good consequences for none. any help at all. If it is a question to be Accepted for publication 23 September 2005 Again Rawlins and Dillon are not paying decided it is a question in two parts. One attention. They say: ‘‘Harris also stated,1-15 part is the issue of whether or not extra REFERENCES in his editorial, that the preliminary resources should be made available to 1 J Harris. Rationing Life. The Health and Social conclusions of the Institute’s appraisal the NHS. The other is, if we have to Service Journal, June, 1986. 2 J Harris. QALYfying The Value of Life. J Med committee on Alzheimer’s drugs was accept a limited budget, how does say, Ethics 1987;13:117–23. ‘‘wickedness or folly or more likely both’’. the provision of dementia treatments, 3 J Harris. Life: Quality, Value & Justice. Health His use of invective is contemptible’’. I rate in moral importance against the Policy 1988;10:259–66. 4 J Harris. The Ethics of Resource Allocation. emphatically did not say this, what I in other priorities of the NHS and how J Epidemiol Community Health 1990;44. fact said was: ‘‘It is difficult to think of this as should such conflicts be resolved? This 5 J Harris. Unprincipled QALYs. J Med Ethics anything but wickedness or folly or more is something that I have tried to say 1991;17:185–88. 6 J Harris. Is gene therapy a form of eugenics? likely both.’’ This was an invitation to something about. I may have failed to Bioethics. 1993;7: 178–187, [Reprinted in R NICE to demonstrate that there are other offer anything to illuminate this debate S Downie, ed. Medical Ethics Dartmouth, ways of thinking about it, not a claim that but it cannot be said that I have not Aldershot, 1996.]. 7 J Harris. Does Justice Require that we be Ageist? itmustbethoughtofinthisway. tried to do so. What can definitively be Bioethics 1994;8:74–84. I accept there is no intended wicked- said is that Rawlins and Dillon have 8 J Harris. Double Jeopardy and the Veil of ness, but it is surely folly to apply bad offered nothing which approaches Ignorance. J Med Ethics 1995;21:151–7. either a discussion of the points I have 9 J Harris. Would Aristotle have played Russian principles in discredited ways. Roulette? J Med Ethics 1996;22:209–215. NICE represents another worrying made, either in the editorial or in this 10 M Brazier, J Harris. Public Health and Private danger. I am not convinced it is playing journal or elsewhere, let alone a rebuttal Lives. The Medical Law Review 1996;4:171–92. of them. 11 J Harris. Could we hold people responsible for a role that should be played at all. NICE their own adverse health? J Contemp Health Law is the ‘‘National Institute for Clinical NICE is a public body, making deci- Policy 1996;1:100–6. Excellence’’, implying that its brief is to sions which affect the lives and life 12 J Harris. What is the good of health care? chances of real people, that is a hot place Bioethics 1996;10:269–92. promote clinical excellence, not to 13 J Harris. What the principal objective of the NHS (sometimes) stand between patients to be, and those who occupy such a should really be. BMJ 997;314:669–72, [Re- and the only available treatment. NICE place do so from choice, unlike the printed in Bill New, ed. Rationing: talk and action patients whose fate their decisions in health care. London: BMJ Publishing Group, also stands between patients and all 1997:100–6.]. treatments it considers in another way. determine. As this exchange demon- 14 J Harris. Justice and Equal Opportunities in Because of the time NICE takes to strates, those who write in journals also Health Care. Bioethics 1999;13:392–405. voluntarily occupy a hot place, a place 15 J Harris. The Age Indifference Principle and review drugs or treatments that are Equality. Camb Q Healthc Ethics 2005;14:93–9. already available, patients are often where what they say and do is not only 16 N Daniels, JE Sabin. Setting Limits Fairly. Oxford: forced to wait up to 2 years or more open to public scrutiny and criticism but Oxford University Press, 2002:4. which positively invites it. Sometimes 17 Williams A. The value of QALYS. Health and before NICE gets around to finalising its social service journal 1985. approval. These delays add considerable heat sheds light, I hope that this is one 18 J Harris. Rationing Life: Quality or Justice? In: costs to the patients and arguably to the of those occasions. The phrase ‘‘if you M Ockelton, ed. Medicine, Ethics And Law, can’t stand the heat, stay out of the ARSP, Beiheft Nr. 32. Steiner 1987:104–12. health care system. Inevitably some 19 J Harris, EQALYty In: Peter Byrne, ed. Health http://jme.bmj.com/ patients will die before the treatment kitchen’’ is often attributed to U.S. Rights & Resources, King’s Fund and OUP. that might have saved them or made President Harry Truman, but I have 1988:100–28. been unable to find a definitive source 20 ‘‘More, Better Justice’’ in Sue Mendus, Martin Bell, their last days more comfortable is eds. Philosophy And Medical Welfare, permitted. This notwithstanding, my for this quotation. Cambridge, Cambridge University Press, J Med Ethics 2005;31:685–688. 1988:75–97. own view is that in the case we have 21 J Harris. Rationing Life. The Health and Social been discussing, if there is a proper role doi: 10.1136/jme.2005.014134 Service Journal 1986. for NICE, it is to say that it is not a 22 J Harris. QALYfying The Value of Life. J Med Correspondence to: John Harris, The Centre for Ethics 1987;13:117–23. on October 4, 2021 by guest. Protected copyright. matter of clinical excellence to deter- Social Ethics and Policy, Institute of Medicine 23 J Harris. What is the good of health care? mine that the only available treatment Law and Bioethics, School of Law, University of Bioethics 1996;10:269–92.

www.jmedethics.com