Response to Council on Bioethics report
Public health: ethical issues (November 2007)
1.1 This is a valuable report from a working group comprising experts in philosophy, law, social sciences, health economics, and various branches of medicine. It took evidence and deliberated for more than a year before producing in November 2007 a report of over 200 pages, clearly and readably presented, addressing such questions as the role of the 'nanny state', health prevention, individual freedoms, choice, risk, the nature of evidence, and the protection of vulnerable groups in society. After setting out an ethical framework and going on to look at the development of public health policy and practice, it makes a detailed study of infectious disease, obesity, alcohol and tobacco, and water fluoridation, and points ways forward for decision-making in each case.
1.2 The comments in this paper address only the question of water fluoridation. The author gave evidence to the inquiry, co-chairs the All Party Parliamentary Group Against Fluoridation, and served on the advisory panel to the systematic scientific review of fluoridation conducted in 2000 by the NHS Centre for Reviews and Dissemination at the University of York (the 'York review').
2. Benefits of the report
2.1. It is particularly valuable to have access to the conclusions of a group of experts from several disciplines who have distilled for the average reader much of the current thinking on difficult questions of healthcare in society, and put forward in an undogmatic manner suggestions for action in some areas of contention. Even if one declines to follow some of their conclusions, one can be grateful for the groundwork that has been done.
2.2. For those concerned about fluoridation, certain emphases in the report are most welcome. The York review is given its proper place as the most reliable source of evidence for effectiveness and safety and, almost uniquely among reports in the last seven years, a substantially accurate account is given of what it found. Due stress is laid on the uncertainties surrounding all the questions the review addressed.
2.3. It is good that the UK health departments should be reminded to monitor the effects of fluoridation, and not only for dental fluorosis. Fluoridation policy, says Nuffield should be "objectively reviewed" on a regular basis in the light of monitoring and research, and the conclusions and their basis should routinely be published.
2.4. Nuffield does a service to the integrity which has largely been lacking in fluoridation in drawing attention to the misinformation which has been put about on both sides of the debate. Among proponents they highlight for censure the major dental bodies, and in particular the publication One in a Million funded by the British Fluoridation Society (which in turn received funding from Government). The British Medical Association and the Government were fortunate to escape mention.
2.5. The balance shown by Nuffield is of great help in the debate over fluoridation. If at first sight the problems enumerated below should seem out of scale by comparison, this is because the conclusion that would allow further fluoridation schemes appears a dangerous one in the face of the evidence, and because the care and detail that went into the report deserve equal care and detail in contesting some of the facets of Nuffield that seem less balanced and sure-footed than the rest. There is scope for different views in the field of ethics, and where tenable views have been overlooked or inadequately considered it has seemed important to draw attention to this. The present response is not intended as an update of an earlier submisson to the inquiry, but as a critique of some of Nuffield's arguments in this thoughtful report.
3. Problems with the report's treatment of fluoridation.
3.1 Despite the excellence of much of the report there are significant omissions and errors, as well as doubtful arguments, which call into question its conclusion that decisions on fluoridation can be entrusted to local democratic procedures.
The major problems can be summarised as follows. The numbered paragraphs below address the points in more detail, not necessarily in the same order since the arguments tend to overlap.
- Individual consent, in Nuffield's view, can sometimes be overridden where the measure is a 'public health' one. Its own definition of 'public health' is wide. There is no mention in the report of the narrower treatment of this by the Council of Europe Biomedicine Convention, legally signed up to by over 30 countries, which would almost certainly exclude fluoridation.
- Nuffield does not look in enough depth at the medicinal nature of fluoridation in European law, to which this country is subject, and seems unconcerned that it appears to fall under no category of regulation bar water quality control. This has implications for the quality of evidence demanded, and for the legality of fluoridation itself.
- The question whether there may need to be a difference in approach towards medical interventions (e.g. vaccination, fluoridation) as opposed to non-medical ones (e.g. smoking bans, wearing of seat-belts) is addressed in the context of consent. But there are also issues of standards of evidence, regulatory procedures and the need to know medical histories. It is not clear how Nuffield categorises fluoridation.
- The need for consent is improperly linked to the presence of significant risk. And the fact that individual consent/refusal cannot meaningfully be obtained, as with fluoridation, should not be an argument for overriding it.
- While admirable in highlighting the weakness of the scientific evidence for fluoridation, the report draws a surprising conclusion with unconvincing argument in allowing for new schemes to be put forward; and it may be overoptimistic about cost-effectiveness and potential dangers to bone and other health.
- Nuffield argues that only clear evidence of adverse effects would make individual consent necessary. This changes the normal burden of proof for a physiologically intrusive intervention, and implicitly accepts the adequacy of the low quality and quantity of safety studies despite growing awareness since 2000 of the gaps in knowledge.
- Monitoring of the health effects of fluoridation as advocated by Nuffield is unlikely to prove a satisfactory substitute for good-quality primary research.
- While Nuffield argues for the potential benefits to one vulnerable group (children in deprived areas), it gives too little recognition to the potential risks to other and larger vulnerable groups (including the very young, the old, and those who drink a large amount of water).
- There is confusion of argument about the factors in fluoridation which may make it a "special case" for coercion, and indeed about whether or not coercion is good in itself.
- Alternatives to water fluoridation are not fully addressed. There is some evidence that behaviours can be modified and that the dental profession has not tried as hard as it might to get messages about tooth-brushing and dental hygiene across. Non-medical alternatives to the prevention of dental decay are not mentioned.
- Little weight is given to the importance of personal responsibility in (dental) health, in harmony with other health initiatives promoted by government (e.g. 'five-a-day').
- "Democratic decision-making procedures", advocated in the report as the best local approach to fluoridation, do not strictly exist under the Water Act 2003 which gives the decision to unelected health authorities. This is particularly problematic as major health bodies have already signed up publicly as campaigners for fluoridation.
- Fluoridation attracts different criteria in the report from other issues. For example, the question is raised with obesity, alcohol and tobacco whether NHS treatment should be automatically available in the absence of behaviour change. With dental caries, where individual behaviour (i.e. diet and hygiene) is every bit as much at cause, Nuffield's question is not about withholding treatment, but about imposing it.
3.2. An underlying difficulty may rest in the fact that three of the case-study chapters are classified by a clinical problem (infectious disease, obesity, alcohol and tobacco), and the fourth, fluoridation, by a solution. This was probably responsible for some of the inconsistencies of treatment in the report; for fluoridation being easily accepted as a given; for consideration of whether or not caries is a serious health problem (under the precautionary principle, Nuffield 3.17), and whether it endangers the non-carious, being overlooked (7.33); and for non-medical approaches to tooth decay being ignored. The logical heading for Chapter 7 is "Dental caries", not "Fluoridation of water", even if fluoridation is under the ethical spotlight. This could have brought into focus the relative unimportance of a low and declining incidence of caries in children in 'public health' terms, beside the greater problems of tobacco and alcohol abuse and obesity. This in turn must have affected the argument about coercion. (See in particular 3.14 below for some problems arising from fluoridation instead of caries as the focus.)
3.3. The weakness of the evidence for fluoridation's benefits and harms, as shown by the York review, is rightly emphasised. For most health procedures a high standard of evidence is demanded, especially where (as here) safety questions have not been resolved and some adverse effects are plausible. This is of course the case where a doctor prescribes one-to-one to the patient. Where extra fluoride is given indiscriminately to populations whose medical histories are unknown one would expect the evidence to be of even higher quality. Yet Nuffield is surprisingly relaxed about the standard of proof required in these risk-laden circumstances (see 3.4 below).
Because fluoridation is seen to fall between two extreme cases - where there is "robust" evidence of a "substantial" likelihood of "significant" harm (when consent would be indispensable), and where there are no harms but clear benefits (when fluoride might be added "by default") - Nuffield places fluoridation in a middle category between universal application and total prohibition, that of local community decision (7.40). But where little attempt has been made to obtain reliable evidence, and harms are seen by recent review bodies as at least plausible ('York', 2000; US National Research Council, 2006), it is surely to stand normal procedure as well as the onus of proof on its head to allow a treatment with fluoride to be imposed. It also needs to be emphasised that the evidence for reducing inequalities in health, an oft-repeated goal in Nuffield's inquiry, was the weakest of all in the York report, with a validity score of a mere 1.6/8, and characterised by the four senior independent scientists involved as "weak, contradictory and unreliable". While Nuffield is not blind to this, it does not draw the adverse conclusion that this lack of good evidence would seem to merit.
Medical evidence as uncertain as this has no place in public decision-making, especially with a general public subjected to the misinformation described in 7.43 - 7.47.
3.4. In 7.1 the question is raised of "The nature and strength of evidence required in arguments about the acceptability of an intervention". But this is not followed through in relation to this medical intervention. Fluoridation has features which are unique among treatments, which the report does not address: indiscriminate distribution to people whose medical histories are not known, an uncontrolled dose, a lifetime's intake unmonitored at the personal level. These surely have relevance to the question of consent, and might argue for the highest possible standards of proof before being allowed as a health measure. Further, Cheng et al. in a paper in the British Medical Journal cited by Nuffield (note 69), quote authority for the view that for "a mass preventive measure in well people, the evidence of net benefit should be greater" than in treating illness. Non-medical health interventions such as the forced wearing of cycle helmets and the banning of public smoking can demand a lower standard of proof, not least because medical histories are not relevant and there is no question of side-effects. These points are not addressed by Nuffield, most notably the key question 'How strong does the evidence have to be for this intervention?' which could have produced a more cautious answer.
3.5. "A more intrusive policy initiative is likely to be publicly acceptable", suggests the report in the Executive Summary, "only if there is a clear indication that it will produce the desired effect". The York report was at pains to state that not even fluoridation's effectiveness could be claimed with "clear confidence". Fluoridation's intrusiveness is near the top end of Box 2 in the Summary. This makes it hard to understand that it should be given the green light for communities to initiate. If a community decides to disregard the finding of the one systematic scientific review in the field, it is questionable how truly "publicly acceptable" this is. (See 3. 26 below for who in fact decides.)
3.6. Fluoridation's proper status is an issue. While Nuffield addresses this it does so without mention of Codified Pharmaceutical Directive 2004/27/EC, the law which determines whether a substance is a medicine or not in the European Union. From the wording of Article 1.2 of the Directive and subsequent case law it is difficult to avoid the conclusion that fluoridated water is a medicinal product, as indeed it was held to be under the Medicines Act 1968 in a celebrated UK case in the 1980s, and that the Medicines and Healthcare products Regulatory Agency has been wrong in not so classifying it. Fluoridation makes medical claims, and is clearly "presented as having properties for treating or preventing disease in human beings", which foods that are a "normal part of the diet" (MHRA's description of fluoridated water, Box 7.6) may not do. Nuffield accepts the MHRA's word on this without argument. The absence of discussion of Directive 2004/27/EC on medicinal status is a significant omission. If fluoridation is covered by this Directive, it would not obtain a licence on present evidence and would be illegal.
3.7. From a reading of Box 7.6 one might best describe fluoridation's status as a hot potato. No one seems to want to hold it. The MHRA will not have it as a medicine. The Food Standards Agency will not have it as a fortified food, though at some point the MHRA seems to suggest it may become a food. It is apparently not a supplement. What is clear, however, is the status of hydrofluoric acid and sodium silicofluoride as poisons under the Poisons Act 1972; the similarities to the hexafluorosilicic acid and disodium hexafluorosilicate specified in the Water Act 2003 may raise questions about the legality of failing to treat artificially fluoridated water in conformity with the provisions for handling poisons. (In the USA fluoridated toothpaste carries the warning that advice should be sought from a poisons centre if a child swallows so much as a pea-sized amount of toothpaste.) The spectre of illegality appears again, but Nuffield does not address this.
3.8. There is a distinction between the type of intervention which effects a direct medical change on the human body (e.g. vaccination, fluoridation), and that which produces effects in a non-medical way not compromising the integrity of the body (e.g. a smoking ban, mandatory wearing of seat-belts). Broadly, one is a treatment and the other is not. The former, being more intrusive, usually has to go through regulatory hoops in our society, chiefly via the Medicines and Healthcare products Regulatory Agency; the latter does not. Nuffield sets out this distinction (2.24) in the context of individual consent, before shading the argument with considerations of substantial risk and harm (see 3. 9 & 10 below); and in 7.20 there is some acceptance of fluoridation as a "medical" intervention, but again with the notion of the absence of "clear evidence about risks", coupled with the difficulty of obtaining consent, negating the "importance of consent" which these interventions attract. Perhaps significantly, none of the existing "coercive" examples in Box 3.3 is of the medical type: it would have been more persuasive if Nuffield had produced a comparable example to fluoridation.
As for evidence, when Nuffield writes (7.42) that "inconclusive evidence by itself is not necessarily a sufficient reason to halt an otherwise promising strategy", this may be true of social measures but not surely of the treatments which traditionally have to be licensed to a high standard before they can be used on the public, not least because of potential side-effects. "We cannot wait for best evidence" is not a view that regulators are heard to propound. Furthermore there is a difference, not referred to by Nuffield, between situations where uncertainty is unavoidable, and those where proponents of a measure have not done the necessary but quite feasible groundwork. In the former case decisions may have to be taken on weak evidence, as was the situation for example before it was known whether babies should be laid on their back or their front; action of one kind or the other had to be taken. In the latter case, as for example with fluoridation, it is reasonable to say to its advocates "Go away and do the accepted scientific studies , and come back to us for approval or otherwise when you have done so". (These examples also illustrate the weakness of equating action with inaction: see 3.18 below). If Nuffield had had these distinctions more clearly in mind when considering fluoridation it might have arrived at a different view about questions such as the standard of evidence required, and the importance of individual consent.
3.9. The question of risk in a disputed health measure is incompletely dealt with. Nuffield writes that individual consent is needed in a 'public health' measure (and, from the wording in 2.23 and 2.25, only needed) where there is "significant risk". But the Declaration of Helsinki which it cites in support (which in fact governs medical research) does not speak of the need for consent to be linked to risk. It contains an introductory statement that "most" procedures "involve risks and burdens" (A.7), and another that "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and[sic] mental condition of the patient" (A.3). This does not form part of the Basic Principles; it is a quotation from a separate code of ethics with no indication whether the Declaration means to adopt it; and it hardly allows the conclusion, in its somewhat opaque formulation, that it is only where there is risk ("might have the effect of weakening the . . patient"), let alone "significant" risk, that the physician must put his patient's interest first (note that it is not that he "shall only act"). Nor is this principle of Nuffield's supported by the Council of Europe Biomedicine Convention (see 3.11 below), which does consider 'public health', nor by the General Medical Council's ethical guidelines under which the subject may refuse what is offered without reference to risk or anything else.
3.10. Even assuming that risk did play a part, what constitutes "significant" risk? Who decides? Plainly the authorities do, based on the present state of knowledge. What if this knowledge is uncertain because research has been neglected or is of poor quality, or even, as some recent published papers on scientific bias and misconduct in general might suggest, corrupted? How confident can one then be that there are "no substantial health risks" (2.25)? If the US National Research Council describes the evidence for a link between fluoridation and cancer as "tentative and mixed", and the Medical Research Council (both bodies cited by Nuffield) thinks that an updated analysis of UK ecological data on fluoridation and cancer is required, does this give reassurance of an absence of significant risk? And who knows best what may affect this particular subject's body? These are issues which make it dangerous to derogate from an individual's autonomy and to accept the view that consent can be overridden. Fluoridation especially, with its acknowledged toxicity and uncertain evidence on both efficacy and safety, is a poor candidate for coercive distribution.
3.11. There is no reference to the Council of Europe Convention on Human Rights and Biomedicine 1997, which addresses medical aspects of human rights. The great majority of European states have signed up to this although the UK has not. In setting out to codify current practice over consent to interventions the Convention stresses the overriding importance of individual informed consent ("The interests and welfare of the human being shall prevail over the sole interest of society or science"). The only exceptions are in three circumscribed areas: public safety, prevention of crime, and "protection of public health or for the protection of the rights and freedoms of others". It is clear from the Explanatory Note to the Convention that this is about "collective interests" only, and does not extend to the promotion of health or to the protection of the health of individuals, dental or other. ("Compulsory isolation of a patient with a serious infectious disease, where necessary, is a typical example of an exception for reason of the protection of public health.") This is where a fundamental conflict arises with Nuffield.
3.12. In 1.6 and Box 1.4 Nuffield sets out a number of definitions of 'public health'. The one it adopts, in line with its 'stewardship' model, involves the preventing of ill health through the "organised efforts of society". This allows much latitude: 'public health' can mean whatever society wants it to mean at a particular time and place. The crucial point for the fluoridation debate is that under Nuffield's definition a 'public health' designation opens the door to denying individual consent, for the intended greater good of the population. Fluoride need not be the only substance delivered through the water supply where the risk/benefit ratio was thought favourable. The needs of society could take precedence over those of the individual across a wide field. This is in contrast to the Biomedicine Convention which addresses 'public health' exemptions from individual consent in a restricted way, confined to cases where someone's health condition and their actions/inactions in respect of it affect the health of the community at large. This narrower view of 'public health' exemptions, given legal force for its signatories by a prominent European body, is not included for consideration by Nuffield.
3.13. Vaccination would be a 'public health' issue under the Convention as well as Nuffield. Nuffield concludes that for vaccination of individuals where there is no, or only a small, personal benefit, but significant benefits for others, "consent is essential" (4.29); but on the arguments presented it is very hard to see what is so important about dental decay and fluoridation that it is acceptable to override individual consent, where "there is no substantial personal benefit to some of the people who might be included in the [vaccination] programme". For vaccination Nuffield says that risks of the treatment and of the disease itself should be weighed, and "the seriousness of the threat of the disease to the population". There is no equivalent argument in Chaper 7. There is no threat to the population from someone's untreated dental decay, which is the proper comparator (see 3.14 below), though there may be for its treatment, fluoridation; the all-round evidence for fluoridation is probably weaker than for vaccination; and vaccination too would proportionately benefit the vulnerable, in the sense of those with weaker resistance to disease. Yet fluoridation is compulsory once instituted, while vaccination at present is not.
A straight comparison between the features of vaccination and fluoridation could have been instructive, and might have shown up the different standards that have been applied to these two health measures. This is not the only area where Nuffield's conclusions do not seem to follow from their data. Under the Biomedicine Convention fluoridation would not qualify for a 'public health' exemption, for the reason that one man's caries does not affect his neighbours (the 'public').
3.14. When Nuffield argues that opponents of fluoridation should not endanger the health of others, what is implied is that they cannot insist on their right to refuse treatment if by doing so they rule out schemes that would help others. But this is not the level at which the other examples are directed. For those in Chapters 4 - 6 of the report who are infectious, or obese, or who smoke or drink, the question is what action if any should be taken to protect them and wider society from their health conditions or behaviours and the harm these may cause (see the examples in 8.6 which illustrate the point). There is not the same debate in Chapter 7. The focus on the solution, fluoridation, instead of the problem, dental caries, has obscured the fact that caries endangers nobody else, which would be one of the justifications for coercive measures. (It is not entirely clear in the report whether simply reducing the risk of ill-health for others, regardless whether people's health behaviour causes other people harm, is seen as sufficient reason to allow fluoridation. It is probably not Nuffield's fault if both propositions appear confusingly in different places: this is, as it states, a complicated subject with interlinking arguments.) And if financial harm is meant, the costs of present levels of caries are not large beside the other cases being considered. The question for Chapter 7 would be whether coercion is appropriate to protect people from dental caries, not whether it should be used to overrule their lack of consent in a democratic decision. The Nuffield report has misdirected itself.
3.15. Another way of putting the same point is that John Stuart Mill's classical harm principle cannot be invoked to support fluoridation, this principle being a matter of "the actions of one person negatively affect[ing] the well-being or interests of one or more others" (8.6). In the defining words of Mill that are cited in 2.13, "good reasons . . for compelling him" can only arise where "the conduct from which it is desired to deter him must be calculated to produce evil to someone else". That conduct cannot itself comprise his refusal to be compelled, for then this refusal becomes the reason for compelling him and there is no substance to the case; it cannot be the unwillingness to be compelled that triggers the compulsion. Unlike the case of an infectious person who resists vaccination or isolation, no actions of a carious person as such can cause harm to others; so the community schemes, which Nuffield says this person may not block, cannot be set in motion on these grounds. The clock, so to speak, does not begin to tick. Nuffield's approach to the harm principle in fluoridation is not only inconsistent with its other cases, but illegitimate.
3.16. There are alternatives to fluoridation in a way that there are not for vaccination. Cheng et al. in the article already cited write of "the availability of other effective methods of prevention", and include a telling graph showing universal reductions of caries among some first-world countries. Some but not all are referred to in Nuffield, which lists "Other means of using fluoride for dental health" (Box 7.4) instead of a more informative "Other means of combating tooth decay". The front-line candidate for this has always been a good low-sugar diet, with publicity to promote it. Neither this nor the free provision to disadvantaged families of toothpaste and brushes is referred to. The alternatives to fluoridation have not been adequately examined, and the implication from Box 7.4 and paragraphs 7.34 - 7.37 that fluorides alone can provide alternatives displays a narrowly medical approach to the problem.
3.17. Fluoridated salt receives a favourable mention, the argument that it would raise general salt consumption being given no weight in the face of evidence to the contrary. Yet it is not advocated over fluoridation, despite its putative effectiveness and lower costs, because "some groups may then choose against fluoridated salt" (and these may include the vulnerable ones). Thus restriction of choice is cited as a reason for, not against a health measure (although in the previous sentence consumer choice is seen, confusingly, as a "particular advantage": 7.36). In 7.35 Nuffield describes fluoridation's "advantage" in "ensuring complete uptake", in other words in eliminating choice.
While one can grasp what Nuffield means, from shifting perspectives, the changes in language sit uneasily with its stated principle of avoiding coercion where possible, and cast doubt on the mindset behind the report (or at least the fluoridation section of it) despite its claim to "An initial liberal framework" (2.20; "revised" 2.44). Coercion appears to be favoured here, on the grounds that nothing short of 100% delivery of this intervention is acceptable.
3.18. There is another argument in support of community fluoridation that presents difficulties. This is the equating of action in health matters with inaction: the suggestion that it is as directive not to intervene as to intervene - to deny the benefits of fluoridation (which like its harms are still scientifically uncertain), as to impose them by democratic decision. While some weight, though surely not equal weight, must be given to the consequences of inaction, which is not coercive - there is no Nuffield 'ladder of non-intervention' - to some people this will sound like academic philosophising: there will not be many in the practical world who regard failure to fluoridate as an example of nanny-statism. It is argued that both action and inaction compromise some groups of people; but those compromised by inaction over fluoridation schemes retain their other treatment choices, whereas those who are fluoridated are compromised more thoroughly. The degrees of disadvantage are unequal, and this is not drawn out in the report.
3.19. There is a most unsatisfactory argument at the end of 7.18. Nuffield discusses promoting the health of children without "[infringing] on the liberties of their parents", these liberties relating to privacy and family life. Infringement would be acceptable in cases of risk of "serious harm" (4.30). "However," they state, "water fluoridation may be a special case in which children could be reached [i.e. treated] directly without major infringements on their parents' liberties." The sense is hard to grasp here. It is true that parents' liberties as defined in 5.39 and 6.15 are infringed less than they would be in the examples of smoking in the home and diet-induced obesity. Yet those parents who objected to the family being fluoridated would suffer a loss of liberty in that respect; and tens of thousands in the community who were without teeth, or else believed that they were sensitive to the concentration of fluoride in the water, or were unwilling to risk other side-effects, would see their liberties infringed, and in a cause where few would argue that "serious" harm to children (by not fluoridating, or by people not treating their own caries in other ways) - the justification for infringing liberties - was at issue. It appears that Nuffield may have wrongly applied its "serious harm" test to the treatment, fluoridation, and not the condition, (unfluoridated) caries.
By concentrating on one type of infringement, which may not appear the most serious type to many of those involved, and perhaps by misapplying the "serious harm" test, Nuffield makes fluoridation a possible "special case". A broader assessment of the situation might suggest the opposite, if only because of the much larger numbers of the public whose liberties are affected.
3.20. Focus on the socially vulnerable, with the admirable aim of reducing unfair health inequalities as a "crucial element of public health policy" (Nuffield 3.27), takes the eye off two groups from all sectors of society who are especially vulnerable in health matters, the very young and the very old. These, together with any who for health or other reasons drink more water than most, will suffer more than most from any toxic effects of fluoride that may emerge; indeed the US National Academy of Sciences in its 2006 report stated that "on a per-body-weight basis, infants and young children have approximately three to four times greater exposure than do adults". Too keen a focus can also take the eye off the actual evidence for the effectiveness of a health intervention, with the understandable wish to carry out Government policy, and to do good and be seen to do good.
3.21. Nuffield gives an excellent account of the York review's findings, notably in its often-overlooked stress on the weakness of the evidence. But some carelessness has crept into 7.31 where the 2000 bone study by Phipps et al, which supposedly shows safety, is treated as new evidence after York. Reference to the York report shows that this paper was included in the systematic review, as a low-ranking 'Level C' study, the reviewers having seen a pre-publication copy. Also, mention of a 2002 Australian review in the same paragraph which suggested that fluoridated water did not adversely affect bones is unlikely to affect York's more cautious assessment of the evidence, unless the most recent study or studies were of an exceptional quality for the fluoridation literature, and the review was a systematic one like York (which was not stated, and is almost certainly not the case). Many reviews before York purported to show fluoride's safety and efficacy, but it took a systematic review to provide the real picture of uncertainty. (Nuffield relies on York because it is the latest major review but not, surprisingly, because it was explicitly a systematic review, which stands at the top of the evidence pyramid. This point is important too when assessing the Medical Research Council's more favourable view of fluorosis in 7.32.) It is most probable that the evidence on bone problems remains of low quality and goes both ways.
3.22. In 7.35 a review by the York Health Economics Consortium in 1998 is said to show fluoridation as "relatively cost-effective". The York systematic review looked briefly at this question (York 12.7.1) in 2000 with the YHEC report to hand; but they could not see any reliable evidence, and decided not to investigate further since their own review had shown fluoridation to be questionably effective, and without the establishment of effectiveness it was not possible to be sure about cost-effectiveness. (Further considerations on efficiency, if not effectiveness, are that almost all fluoridated water misses its target of children's teeth, and that fluoride is now believed to act topically (on the tooth surface) rather than systemically (by ingestion), again making fluoridation a wasteful method of delivery although York did suggest on moderate evidence from only 10 studies (York 5.1) that it probably had an effect over and above other sources of fluoride.) Nuffield makes no great claims for cost-effectiveness, but may still have been overoptimistic.
3.23. Strength of feeling may be worth considering when ethical decisions are made. On daylight saving it was felt in the early 1970s that although a majority in the UK might prefer to keep summer time all the year round, a minority in the north felt so strongly about it that this should not be adopted. How to assess this in the case of fluoridation is not obvious, since there are passions on both sides. Opponents would argue that the objection to being forced to ingest a substance designed to treat or prevent a condition should rate higher than the wish to see children saved from decaying teeth, especially in view of the uncertainties about benefits and harms and the other ways of combating caries. It is intriguing to speculate what might be the situation if a major faith declared treatment via public water to be unacceptable. A serious debate around strength of feeling might need to take place.
3.24. There is another unsatisfactory argument in 8.20. Nuffield believes that "provided these uncertainties [about effectiveness and harm] are openly acknowledged and appropriate monitoring measures are in place", local communities can be allowed to fluoridate. The first part is saying that the evidence underpinning fluoridation is quite poor, but that that does not matter if everybody knows it: a most unusual proposition in a health intervention. The second part, appropriate monitoring, saves the situation to some extent by implying in effect that if fluoridation turns out to cause (e.g.) osteosarcoma that does not matter because the lesson will be learnt for next time. Even if this were an acceptable consolation, the last sentence in 7.31 argues against it in explaining the reasons why "it may be difficult to determine whether particular harms are caused by fluoridation", a point that was graphically made by Cheng at al. in their BMJ paper and which is familiar to most epidemiologists; while 8.29 delineates the extended timeframe over which monitoring must take place, during which harms could accrue to new populations. Combine this with the historical reluctance of dentists and Government to look for adverse effects which could undermine a favoured policy, and one can assess the chances of monitoring providing an effective back-up to the lack of primary evidence as minimal. This would need a radical change of heart and the input of considerable resources, and there is no prospect in sight of either. Lip service, unfortunately, is the most one can expect, and the public may pay with its health.
3.25. Nuffield may not have sought or received evidence on fluoridation's environmental impact, but this is worth considering for two reasons. Denmark and Sweden, which do not fluoridate, have each cited fluoridation's questionable impact on the environment as a reason for not doing so. The science is particularly weak in this area, but they may have been influenced by the classification of fluorides as deleterious to the aquatic environment under the European Dangerous Substances Directive 76/464/EEC, as well as by the reason that (among others) persuaded the old Czechoslovakia and Switzerland to stop their own schemes, namely that over 99% of fluoridated water misses its target of children's teeth. While for these last two countries this was a matter of fluoride's inefficiency as a treatment, the escape of added fluoride into the surface groundwater via sprinklers, cattle troughs etc., and leaks in the water mains (a substantial problem in some areas), may give pause for thought. Whether this impacts on human health is not known. A 2006 review of the developmental neurotoxicity of industrial chemicals (Lancet on-line, 8th November) flagged fluoride as deserving "particular attention". The Copenhagen Charter in 2000 appealed to the EU to phase out bioaccumulative chemicals and stop releases to the environment of hazardous substances by 2020.
Also, Nuffield's criteria include promoting general conditions conducive to good 'public health'. But it does not consider the above factors, and suggests that fluoridation may be environmentally positive through its direct health-giving properties. This argument that fluoridation might be said to "sustain good health" through the "environmental conditions" it creates (7.16) stretches legitimacy. Fluoridation's action, as Lord Jauncey found in a law case in 1983, is a medicinal one, the water being a mere carrier. To argue that it has "environmental" benefits in addition to the health benefits Nuffield already relies on is to overegg the pudding: they are the same argument. Nuffield has not shown great caution over other aspects of putting hexafluorosilicic acid at the unusually high level (in ground-water terms) of 1 ppm in the public water supply, so might have chosen to follow the UK Government in being untroubled by the Scandinavian example. (It has proved difficult even to make Government aware of this example.) Others in this environmentally conscious age may think differently, and may see it as another reason not to take chances in overriding individual consent.
3.26. Nuffield concludes in 7.40 that "The most appropriate way of deciding whether fluoride should be added to water supplies is to rely on democratic decision-making procedures . . at the local and regional . . level . ." Unfortunately, as the law stands, these do not strictly exist. The Water Act 2003 provides for consultation procedures at local level when new schemes are proposed. But it is the unelected Health Authorities that decide whether the case has been made; and this is not helped by the admitted pro-fluoridation stance of health bodies such as the UK Public Health Association, the British Medical Association, the British Dental Association, the NHS Confederation and over 60 Primary Care Trusts, as evidenced by their status as signed-up campaigners for fluoridation under the National Alliance for Equity in Dental Health (www.bfsweb.org then follow links to the NAEDH and its list of supporting organisations). Attempts during the passage of the 2003 Act to place the decision with elected Councils were defeated. Whether Nuffield took this into account is not clear, but their key recommendation about fluoridation is flawed because of the democratic deficit involved and the patent bias of the decision-makers. This is a serious matter.
3.27. Nuffield's approach to fluoridation discourages improvements in health behaviour in the population and runs counter to other health advice in our society which promotes personal responsibility, e.g. in taking exercise, or eating 'five-a-day' portions of fruit and vegetables. As noted above, there is no mention of other means of combating tooth decay through personal action which is less intrusive or 'nannying' than fluoridation, and for which supporting evidence exists. Families will pay less attention to diet and dental hygiene if the water supply does the work for them. While healthy behaviour costs money to promote, it should save the health service money in the long run. This must further weaken the case for allowing fluoridation schemes to proceed.
4.1. It is not easy to be clear-sighted about fluoridation, even if one has no attachment to a particular view. Fluoridation is well established, having been heavily promoted within the few countries that practise it widely since the Second World War; yet its scientific basis is thin and its ethics and legality debatable. This lack of evidence is seen as a fatal flaw by some; to others, it gives justification for overriding consent in the common cause since no harm has been proved. It has been hailed by the US Centers for Disease Control as one of the ten most important health measures of the last century; yet its impact on the current burden of serious disease is comparatively small. It looks like a treatment to some, since it makes medical claims and fulfils the criteria of the relevant Directive; to others it does not, as it takes place outside the clinical setting and the MHRA will not regulate it. For some the setting is a reason to be more rather than less cautious over safeguards involving dosage, length of treatment, medical supervision and consent; for others, it is a reason to dispense with consent. Folic acid supplementation has been approached with scientific caution over its theoretical risks; fluoride, which is not an essential nutrient, is intended to help with a less serious condition, and is far more toxic, has been put in the water supply with unsupported assurances of safety. Fluoridation is strongly supported by the health authorities; yet it is bitterly attacked by a cross-section of the population. Because it takes place outside the surgery, doctors can support it at arms' length without fear of confrontation with angry patients.
4.2. The wide and often passionate support for fluoridation among health professionals brings its own problems. A senior member of the US National Academy of Sciences committee that reported on the potential risks of fluoridation in 2006 pointed to the pronouncement by the Centers for Disease Control, cited above, as an inhibiting factor in even a reputable body being heard to cast doubt on fluoridation. It is hard to restart with a clean slate, and Government's response has consistently been to interpret any new evidence in the light of its firm belief in fluoridation, and to prioritise the kind of research that addresses peripheral issues, such as consistency in diagnosing caries, or to claim strong support from work such as the 2004 Newcastle bioavailability study which suffered from very small numbers and poor methodology.
Government undoubtedly funded the York review in the expectation that it would validate its long-held position on fluoridation, and instructed the reviewers to give no guidance in their 2000 report on whether they felt a fluoridation policy was justified. This was a reasonable restriction on a purely scientific body. But if a body as eminent and wide-ranging as Nuffield had committed itself to the view that a treatment as weakly based as fluoridation, for a condition that was no threat to the rest of society, where the risk of plausible harms had not been adequately explored, should not be offered to the public, the repercussions would have been momentous and might well have signalled the beginning of the end for fluoridation in this country. This would not have been a comfortable option.
4.3. How does fluoridation meet Nuffield's goals for a 'public health' programme under its seven headings of a stewardship model (Nuffield 2.44)?
- Under the first aim, there are no risks that untreated caries can impose on others;
- Under the second aim, fluoridation's environmental impact (as distinct from its direct health effects) is at best neutral and at worst negative;
- Under the third aim, fluoridation would help the young and other vulnerable people (those that still had teeth) so long as the evidence for its effectiveness and safety were clear. But this is not the case at present; and if there turn out to be safety issues, the young and vulnerable (notably the aged, who are largely overlooked) will suffer most;
- (Aims four, five and six relate to advice and to voluntary measures;)
- Under the seventh aim, the evidence for reducing unfair health inequalities is, in the words of the NHS Centre for Reviews and Dissemination following the York review, "of poor quality, contradictory and unreliable".
Nuffield also sets out a precautionary approach (Nuffield 3.15 - 3.19).
- Under risk and uncertainties, fluoridation does not show up well. It is true that no serious harms have been proved. It is worrying that this satisfies Nuffield in allowing a treatment with so few of the normal medical safeguards to be imposed on populations that include the very young and the old and infirm, in the face of the acknowledged need (by 'York', US NRC and others) to know more about a range of possible harms. The risk profile of a substance as toxic as fluoride is of a different order from that of essential nutrients, and indeed of many medical drugs. If Nuffield is saying in 7.38 that fluoridation has "a very low risk of harm" - and it does not attempt to quantify that risk elsewhere - this claim is based on belief rather than evidence;
- Under fairness and consistency, it is likewise questionable. The aim is fair. As a treatment fluoridation is inconsistent with other such interventions in its lack of choice, safeguards over individual dosage, length of exposure, monitoring, and knowledge of medical history;
- Under costs and benefits, reviews from York have come to different conclusions on weak evidence;
- Under transparency, fluoridation will meet this aim even if local knowledge of fluoridation status is at present minimal;
- Proportionality, the fifth criterion, has three aspects.
- The balancing test considers the importance of the health goal, which in turn brings in the seriousness and urgency of the condition. However large childhood caries in a small and declining sector of the population looms for the dental profession, it can surely not be reckoned a health scourge of a nature to sanction a uniquely coercive treatment in the absence of any danger (e.g. infection, or insanity) to justify it;
- The suitability test cannot be properly answered, since the degree to which fluoridation will achieve its end is unknown. The York review gave a possible range of a 64% benefit to a 5% disbenefit (but was unsuccessful in dissuading readers from holding to a median figure of 15%);
- The necessity test is also hard to satisfy. There are other means of achieving the objective that are not intrusive, but whether they can be as effective as fluoridation is a matter of legitimate debate. A recent World Health Organisation graph showing an equal decline in caries in some major non-fluoridating countries suggests that fluoridation's usefulness, such as it was, is probably now past.
By Nuffield's criteria there is no convincing case for allowing dental caries to be addressed through water fluoridation. The risks of this approach could prove significant.
4.4. From the perspective of water fluoridation the Nuffield Council's report is something of a curate's egg. It draws the reader back to the firm foundation of the York systematic review of the scientific evidence; criticises the widespread misrepresentations of this in the last seven years; and points to the Government's duty to monitor, review, research and publish, which are both common sense and good practice in health measures of this kind. But its conclusion that decisions whether to fluoridate should be left to local communities is open to many objections. While these may carry varying degrees of weight, and some are matters of judgement, taken together they render Nuffield's conclusion unsustainable in the present state of the science, the law, and accepted practice in Western society.