Janet Radcliffe Richards is as always to the point and radical. We agree with her that “if it is presumptively bad to prevent sales altogether because lives will be lost . . . it is for the same reason presumptively bad to restrict the selling of organs”. Her complaint against our paper is that we are unnecessarily restrictive. John Harris indeed has argued that there are no sound ethical or philosophical reasons for objecting on principle to the sale of live (...) tissue and organs.1 If a scheme can be devised …. (shrink)

NICE must not say people are not worth treatingThe National Institute for Health and Clinical Excellence has proposed that drugs for the treatment of dementia be banned to National Health Service patients on the grounds that their cost is too high and “outside the range of cost effectiveness that might be considered appropriate for the NHS”i.1This is despite NICE’s admission that these drugs are effective in the treatment of Alzheimer’s disease and despite NICE having approved even more expensive treatments. The (...) effect is that thousands of Alzheimer’s patients will be denied the only treatment available. It is difficult to think of this as anything but wickedness or folly or more likely both. At the same time, and with no apparent sense of irony, NICE has launched a public consultation document3 on its guidelines on social value judgments. As we shall see these guidelines are ethically illiterate as well as socially divisive.Assuming permanently scarce resources it is clearly crucial that such healthcare resources as are available are not wasted. This point is often made in terms of cost effectiveness and it is argued, not implausibly, that to talk of cost effectiveness implies that we are able to measure just how cost effective each treatment is. To do so of course we need a standard of measurement. NICE has adopted the ubiquitous, but justly infamous QALY, the Quality Adjusted Life Year.The QALY combines life expectancy after treatment with measures of the expected quality of that life. There are two ways in which QALYS can be used. They might be used to determine which of rival therapies to give to a particular patient or which procedure to use to treat a particular condition, in short which of two different treatments is the more …. (shrink)

The bottom line is that Claxton and Culyer believe, and are on record as saying, that a therapy or procedure is not cost effective if “the health benefits that it is estimated could be gained from the technology are less than those estimated to be forgone by other patients as other procedures are necessarily curtailed or not undertaken. It is this comparison of health gained and health forgone that is at the heart of the rationale of cost-effectiveness analysis”. To estimate (...) whether the gains made …. (shrink)

While people’s lives continue to be put at risk by the dearth of organs available for transplantation, we must give urgent consideration to any option that may make up the shortfall. A market in organs from living donors is one such option. The market should be ethically supportable, and have built into it, for example, safeguards against wrongful exploitation. This can be accomplished by establishing a single purchaser system within a confined marketplace.Statistics can be dehumanising. The following numbers, however, have (...) more impact than most: as of 24th November, during 2002 in the United Kingdom, 667 people have donated organs, 2055 people have received transplants, and 5615 people are still awaiting transplants.1 It is difficult to estimate how many people die prematurely for want of donor organs. “In the world as a whole there are an estimated 700 000 patients on dialysis . . . . In India alone 100 000 new patients present with kidney failure each year”2 . Almost “three million Americans suffer from congestive heart failure . . . deaths related to this condition are estimated at 250 000 each year . . . …. (shrink)

Michael Rawlins and Andrew Dillon start their defence of Nice in fine polemical style, unfortunately polemics is all they have to offer. They totally fail to justify the Nice proposals on dementia treatments nor do they make any more plausible than formerly their use of the notorious QALY. They say:"Harris’s recent editorial, It’s not NICE to discriminate, is long on both polemic and invective – but short on scholarship. He offers nothing to illuminate the debate about allocating healthcare in circumstances (...) of finite resources; he has no understanding of the quality adjusted life year and its use in health economic evaluation; and he makes ill-researched, unsubstantiated and offensive charges against the Institute and its advisory bodies."Accusations are easy to make, difficult to substantiate. There are a number of claims here, only one of which is true. It is true that my editorial was robust, polemical if you like, but editorials are not the same as research papers and these are important issues which deeply affect real lives. Although Rawlins and Dillon affect to take the high ground their own article contains even more vigorous and much more personal invective than my editorial, I make no complaints. But as to the rest of what they say, well, let’s just see!They claim I offer nothing to illuminate resource allocation and that I have no understanding of the QALY. Both of these claims may well be true, but nothing they say goes any way to support these claims or even towards making them plausible. I have studied and written about the QALY for almost 20 years1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 and Rawlins and Dillon show no evidence of any awareness or indeed any understanding of the issues, whether …. (shrink)

The authors refute Harris’s criticism of the work of NICE and in turn criticise his description of the institute’s positionHarris’s recent editorial,1It’s not NICE to discriminate, is long on both polemic and invective but short on scholarship. He offers nothing to illuminate the debate about allocating health care in circumstances of finite resources; he has no understanding of the quality adjusted life year and its use in health economic evaluation; and he makes ill researched, unsubstantiated charges against the institute and (...) its advisory bodies.ALLOCATING HEALTHCARE RESOURCESThe British National Health Service , like every other healthcare system in the world, has finite resources. How the NHS’s budget should be most appropriately allocated is a very specific example of the more general problem of distributive justice.2The NHS, with its requirement3 to provide all care that is “necessary and appropriate”, was founded with an egalitarian purpose. Yet despite its laudable emphasis on fairness, the implementation of the NHS’s egalitarian approach remains uncertain. What is necessary? What is appropriate? How should the tensions between the service’s egalitarian aspirations, and the need to provide health care from finite resources, be resolved? On what principles should these allocative decisions be made?Utilitarianism, with its goal to maximise overall good, is another approach. Yet experience with the original Oregon plan demonstrated that, when rigidly applied, it can yield solutions that most find unacceptable—for example, tooth capping taking precedence over emergency appendectomy.4 Moreover, some versions of utilitarianism can allow the interests of minorities to be overridden by the majority; and it has next to nothing to offer in eradicating health inequalities.There is no single, broadly accepted, theory of distributive justice …. (shrink)

Correspondence to: John Harris The Centre for Social Ethics and Policy, Institute of Medicine Law and Bioethics, School of Law, University of Manchester, Williamson Building, Oxford Road, Manchester M13 0JH, UK; [email protected] and Culyer1 have written an interesting and considered response, as people intimately connected to the National Institute for Health and Clinical Excellence , to the two editorials that I wrote on recent NICE decisions. Before commenting on their response, I would like to consider a point they made, which (...) echoes a point already made by Rawlins and Dillon,2 about the tone of my editorials. Claxton and Culyer accuse me of making “personally abusive charges”. In my original editorial, I criticised an institution, NICE, in robust terms, but in doing so I was continuing a long and respected tradition in English philosophy. Consider the following extract from Jeremy Bentham:" In English law, fiction is a syphilis, which runs in every vein, and carries into every part of the system the principle of rottenness...Fiction of use to justice? Exactly as swindling is to trade...It affords presumptive and conclusive evidence of moral turpitude in those by whom it was invented and first employed.3"My remarks were not an ad hominem criticism of anyone but directed at the published, but anonymous statements of an institution—a body corporate. In robustly criticising NICE, I no more attacked any individual associated with NICE than I attacked Tony Blair or the various ministers of state who are ultimately responsible for NICE. And, contra Claxton and Culyer’s claims, I have not denigrated the views of people who beg to differ from me.i If the apologists for NICE, whether they are Tony Culyer or Tony Blair, choose to identify themselves with criticism of NICE, that is entirely a matter for them. The only ad hominem remarks in this entire exchange have been made by Rawlins and Dillon, and Claxton and Culyer. The idea that criticism of the anonymously authored publications of …. (shrink)

Cadaver organs should be automatically availableThe shortage of donor organs and tissue for transplantation constitutes an acute emergency which demands radical rethinking of our policies and radical measures. While estimates vary and are difficult to arrive at there is no doubt that the donor organ shortage costs literally hundreds of thousands of lives every year. “In the world as a whole there are an estimated 700 000 patients on dialysis . . .. In India alone 100 000 new patients present (...) with kidney failure each year” . Almost “three million Americans suffer from congestive heart failure . . . deaths related to this condition are estimated at 250 000 each year . . . 27 000 patients die annually from liver disease . . .. In Western Europe as a whole 40 000 patients await a kidney but only . . . 10 000 kidneys”1 become available. Nobody knows how many people fail to make it onto the waiting lists and fail to register in the statistics. “As of 24th November 2002 in the United Kingdom 667 people have donated organs, 2055 people have received transplants, and 5615 people are still awaiting transplants.”2Conscious of the terrible and unnecessary tragedy that figures like these represent I have been advocating for more than 20 years now some radical measures to stem this appalling waste of human life. The measure which is the subject of Hamer and Rivlin’s paper 3 concerns the automatic availability of all cadaver organs—a measure, which I first advocated publicly in 1983.4THE AUTOMATIC AVAILABILITY OF DONOR ORGANSWe need to begin by being clear about just what it is I propose and why. At the moment in the United Kingdom we …. (shrink)

A rebuttal is provided to each of the arguments adduced by John Harris, an Editor-in-Chief of the Journal of Medical Ethics, in two editorials in the journal in support of the view that National Institute for Health and Clinical Excellence’s procedures and methods for making recommendations about healthcare procedures for use in the National Health Service in England and Wales are the product of “wickedness or folly or more likely both”, “ethically illiterate as well as socially divisive”, responsible for the (...) “perversion of science as well as of morality” and are “contrary to basic morality and contrary to human rights”. (shrink)

Some very bad old arguments need removing from NICE’s latest reportLet me begin this editorial by reassuring readers that the journal does not hold any deep seated grudge against the National Institute for Health and Clinical Excellence . However, because the pronouncements of NICE are of great importance to the future of health care in England, and to a lesser extent in the other nations of the United Kingdom, and because NICE is often held up as a model for other (...) countries to follow we feel that we have to comment when these pronouncements are less than ethically excellent. And in 2005 NICE just happened to have a particularly bad year with regard to the cogency of its ethical arguments, and this flow of bad argument extended right to the end of the year.In December 2005 NICE published a report with the title Social Value Judgments—Principles for the Development of NICE Guidance, which considered whether social background, age, or lifestyle choices should ever influence NICE guidance concerning the health care provided by the National Health Service .1 This report was endorsed by the NICE board and its guidelines are binding on all panels developing specific NICE guidance.Here I want to focus on three areas of this report: The relevance of self inflicted conditions The relevance of socioeconomic status The relevance of stigmaI will not comment on NICE’s methodology in coming to these conclusions, since that is the subject of a paper by John McMillan and colleagues, which is published in this issue of the journal.2With regard to self inflicted conditions NICE has now bound itself to the following principle:PRINCIPLE 10Principle 10 states that:"NICE and its advisory bodies should avoid denying care to patients with conditions that are, or may be, self … ". (shrink)

Harris’ reply to our defence of the National Institute for Clinical Excellence’s (NICE) current cost-effectiveness procedures contains two further errors. First, he wrongly draws a conclusion from the fact that NICE does not and cannot evaluate all possible uses of healthcare resources at any one time and generally cannot know which National Health Service (NHS) activities would be displaced or which groups of patients would have to forgo health benefits: the inference is that no estimate is or can be made (...) by NICE of the benefits to be forgone. This is a non-sequitur. Second, he asserts that it is a flaw at the heart of the use of quality-adjusted life years (QALYs) as an outcome measure that comparisons between people need to be made. Such comparisons do indeed have to be made, but this is not a consequence of the choice of any particular outcome measure, be it the QALY or anything else. (shrink)