HC 1048-III Health CommitteeWritten evidence from Stephen Peckham (PH 188)
PROPOSALS FOR THE FLUORIDATION OF WATER SUPPLIES
Introduction
1. This submission is focused on an aspect of public health policy that is of particular current relevance but which also is explicitly referred to in consultation documents on the White Paper and has wider implications in England. Water fluoridation has been a controversial policy for many years and despite the commissioning of a systematic review in 1999 the topic remains controversial in terms whether there is sufficient evidence to support policy maker claims of effectiveness and safety, the legislative framework for the introduction of fluoridation schemes and whether fluoridation is ethical given its status as an intervention that is meant to prevent dental decay.
2. The government proposes shifting responsibility for public health from the NHS to local authorities. With respect to water fluoridation this involves changing the responsible authority from the SHA to a unitary or higher tier local authority. This change raises questions about current proposals for the implementation of water fluoridation schemes (in Hampshire and elsewhere) but does little to address problems of water fluoridation policy more generally or the conduct of consultations for water fluoridation proposals highlighted by the recent experience in southern Hampshire.
3. While from an organisational perspective there are many important areas of the current proposals for changes in public health responsibilities, Committee members are requested to give this issue special attention given the numbers of people affected by fluoridation proposals and the specific circumstances of plans to implement fluoridation in the Southampton area.
In considering proposals for public health the Committee is requested to:
(a)
(b)
(c)
The Legislation and Regulations
4. The current legislative framework is embodied in the 2003 Water Act and regulations passed in 2005 relating to the indemnity of Water Companies and public consultation arrangements. The indemnity arrangements were agreed with water Companies who were concerned about potential legal action by their customers over the negative effects of water fluoridation. Public consultation arrangements were agreed following two years of Parliamentary debate and water fluoridation remains unique in health care provision and public health as the only area where specific consultation guidelines have been set by Parliament.
5. The 2003 Water Act makes provision for a specific process to be followed prior to the implementation of water fluoridation. Responsibility for undertaking the feasibility studies and consultation is currently with Strategic Health Authorities. However, public consultation is only undertaken after the SHA has been convinced that water fluoridation is both technically feasible and cost effective. Furthermore the 2005 regulations state that the SHA only has to take account of the results of a consultation but that the final decision is theirs alone. In fact, as currently drafted, the regulations allow for an SHA to decide on a course of action even if all responses to the consultation have not been in favour of the SHA’s decision. As the judge in the recent judicial review on the Southampton case noted—public opinion (including the views of local councils and MPs) is not a relevant consideration for any course of action decided by the SHA—they only have to show that they took such opinion into consideration. Even if 99% of the public responding to a consultation object the SHA can still go ahead. This has important implications for the conduct of public consultations.
6. In parliamentary debates prior to the making of the 2005 regulations Government Ministers consistently stated that no fluoridation schemes would go ahead without local public consent. Clearly this is not the case.
Evidence on effectiveness and safety
Three issues are important here:
(a)
(b)
(c)
7. There have been two major systematic reviews of water fluoridation. The most important of these is the York Review commissioned by the UK government in 1999 to provide a comprehensive review of the evidence on water fluoridation but which only served to create further controversy (McDonagh et al 2000, Cheng et al 2007). The review authors concluded that in fact the studies examined did not give clear evidence of caries reduction and that “The research evidence is of insufficient quality to allow confident statements about other potential harms or whether there is an impact on social inequalities.” (page xiv). The review found that the research evidence on the affect of water fluoridation on dental caries was rather mixed with many studies being old (undertaken when dental decay rates were substantially higher), observational or insufficiently controlling for confounding factors (such as the use of fluoridated toothpaste) and concluded that there was a need for good quality studies to assess the effect of and safety of fluoridation.
8. More recently a review by the US National Research Council provides a thorough analysis of the impact of fluorides in water (including animal and human studies and toxicological research) highlighting many problem areas. It draws similar conclusions to the York Review—that there are probable detrimental health impacts from fluorides and that not enough is yet known about the wider health impacts of fluoridation and further research is needed (NRC 2006).
9. There is no requirement to ingest fluoride as fluoride contributes to, but is not necessary for, the remineralisation process in the enamel of the tooth surface and high levels of fluoride kill the bacteria that create the acids that damage the tooth enamel. Recent studies have demonstrated that there is little or no difference in rates of dental caries between children consuming fluoridated and un-fluoridated water and that in fluoridated areas. (Warren et al 2006)
10. In the UK the Government and advocates of water fluoridation continue to promote 1ppm as the “optimum level” of fluoride despite the fact that the “optimum level” in Canada is 0.7ppm, in Eire it is 0.8ppm and in Hong Kong it is 0.5ppm and most recently, the USA has proposed lowering the maximum allowed level of fluoride to 0.7ppm.
11. The “optimum dose” of fluoride is only relevant in discussions about prevention of dental caries as there is no physiological requirement for fluoride in the human body. It is argued that water fluoridation does not lead to levels in excess of these limits based on reference dose (achieved by using average weight for an adult or child), but as water fluoridation delivers fluoride by level of concentration in water the individual dose of fluoride received by the individual is not controlled and depends on how much water you use for bathing, drinking, cooking etc and also on your weight. Also, water is not the only source of fluoride as we now use fluoridated toothpaste and other dental products, fluoride is also found in tea, processed food (from fluoridated countries), pesticides (residues of which remain on food) etc (SCHER 2010). A recent analysis of fluoride exposure in the UK National Diet and Nutrition Survey suggests that we should be concerned about increasing fluoride levels with over 15% of people consuming more than 5mg of fluoride a day (the figure that World Health Organisation (WHO) considers adverse health effects can occur in adults). For children the situation is more worrying. In the USA a study in Iowa found that 90% of three-month-olds consumed over their recommended upper limits Some babies ingest over six mg fluoride daily, above what the Environmental Protection Agency and the WHO say is safe to avoid crippling skeletal fluorosis (Levy et al 2001). Since the 1980’s numerous studies have highlighted over consumption of fluoride and recommend using fluoride free water for reconstituting infant formula (Clarkson 2000, Bazalef et al 2001, Siew et al 2009)—advice also given by the American Pediatric Society and the American Dental Association.
12. Warren et al (2009) have highlighted the complexity of quantifying fluoride intake in areas where there is widespread water fluoridation and increased availability of fluoride containing products. They argue that “…it is doubtful that parents or clinicians could adequately track children’s fluoride intake and compare it with the recommended level, rendering the concept of an “optimal” or target intake relatively moot.” (p114). Their conclusion supports Burk and Eklund’s (2005) view that the term optimal fluoride intake be dropped from common usage and Ismail and Hasson (2008) also argue that “We believe that dentists should dismiss the misconception that there is a balance between dental caries and fluorosis, because patients can accrue the benefits of topical fluorides without developing fluorosis and without systemic intake.” (1465). The inability to control individual dose renders the notion of an “optimum dose” obsolete.
13. In fluoridated areas over a third of children have dental fluorosis, with studies in Newcastle UK and Hong Kong identifying levels of 54%, and studies have shown that between 2 and 7% of children have mild to severe brown staining (Irish Forum on Fluoridation 2002, Levy et al 2006, Lo and Wong 2006, Tabari et al 2000). Most recently the US Department of Health and Human Services has proposed substantially reducing the maximum permissible level of fluoride from 1.2ppm to 0.7ppm as a direct response to research showing that 41% of 12–15 year-olds experience dental fluorosis (Associated Press 2011).
14. In their recent review of water fluoridation the EU Scientific Committee on Health and Environmental Risks highlight that young children are likely to exceed the upper tolerable limits for fluoride consumption in areas with water fluoridation greater than 0.8ppm and using fluoride toothpaste although the estimates of ingestion are probably underestimated as they are based on ingestion from food and beverages in non fluoridated areas (SCHER 2010).
15. It is suggested that long term ingestion of fluoride can lead to other more long term health problems but here the evidence is also unclear (McDonagh et al 2000, NRC 2006). The National Research Council (NRC) review was a wide ranging examination of over 1000 studies on the effects of fluoride in water. While the focus of the review was to examine the effects of water fluoridation at between 2 and 4ppm, it identified a number of studies demonstrating health effects at levels lower than 2ppm including effects to the central nervous system and brain at 1.8ppm, brittle bones at <1.2ppm, osteosarcoma in young boys at 1ppm, thyroid gland at 1ppm and hypersensitivity reactions of 1% at 0.25ppm (NRC 2006). The NRC review authors were particularly concerned about thyroid effects and there are strong clinical grounds that support this view. Osteosarcoma has also been highlighted by SCHER (2010) as an area where there is evidence of problems requiring further research.
Summary
16. The evidence on the effectiveness and safety of water fluoridation is generally of poor quality and current monitoring (in the UK and other countries) has not been developed to adequately assess any health impacts. Most studies demonstrating effectiveness are methodologically flawed. Those that control most for confounding factors show little of no benefit. Water fluoridation has led to very high levels of dental fluorosis with potentially 3–7% of children suffering moderate to severe fluorosis than can lead to tooth damage. Dental fluorosis is not simply an aesthetic problem. Evidence on over ingestion in young children and babies is very strong and is giving increasing cause for concern in other countries where water is fluoridated.
Proposals in the White Paper
17. The consultation document on commissioning for public health issued by the Department of Health in conjunction with the White Paper makes provision for local authorities to take responsibility for decisions about water fluoridation after HSAs are abolished. Such an approach with regard to water fluoridation is supported by the findings of the Nuffield Council (2007) report on public health ethics. In fact government ministers have consistently argued that it is important that an issue such as water fluoridation should be decided locally and that proper account needs to be taken of local people’s views—reflecting ministerial statements in the House between 2003 and 2005.
18. Giving responsibility to local authorities provides a more locally accountable solution than at present. However, if councils operate within the current regulations (as approved in 2005 and CDOs letter of 2008) they do not have to heed the outcome of any local consultation. There is also a question about what majority is required where more than one council is involved in a proposal. For example in the Southampton case there are 4 district councils, one county, one unitary and a town council involved—in this case all opposed to current proposals for implementation but with one calling for a referendum.
Implications for Current Developments
19. Currently the South Central Strategic Health Authority is pressing forward with plans to fluoridate in the face of widespread local public opposition and opposition from local councils and MPs. This stance is being supported by the Department of Health despite the fact that they have highlighted the crucial importance of local authorities and local people being able to take decisions about water fluoridation.
20. Implementation is being based on arguments and analyses made in 2008. This ignores changing proposals re public health, improved dental health figures in the city, recent concerns about appropriate and safe levels of fluoride and the objections of local people and councils. If the decision was made under the proposals for public health currently being suggested then no fluoridation would take place.
21. In Southampton this means that it will be the only scheme that has been imposed by a non-elected body without local support or consent. Given the paucity of good quality evidence on effectiveness and safety this is, as defined by the Nuffield Council report, as unethical. Indeed given that fluoride is added to prevent a disease (dental decay) the dosing of water without consent is unethical anyway.
Broader Implications
22. Issues about consultation and decision making are crucial in relation to public health decision making. Currently while public health involves important decisions about individual lifestyles, legislation on water fluoridation gives the final say to unelected bodies and public health professionals. Such bodies and professionals have been happy to ignore relevant evidence in order to maintain their own policy position in the face of growing evidence and local political decisions. This places untenable and unaccountable power in the hands of professionals.
23. The addition of fluoride is done for prevention of disease and there are very clear and important issues of consent here. Fluorides in water are unregulated despite claims that they have a medicinal effect (ie prevention of dental caries). Current processes for implementation have no mechanisms for proving public or individual consent.
Summary and Conclusion
24. While the evidence of effectiveness and safety of water fluoridation is highly contestable the proposal to shift responsibility to local authorities is welcomed. Ideally the provisions in the 2003 Water Act and the 2005 regulations should be repealed and the Government’s commitment to expand water fluoridation dropped on the basis that this is a policy that is not supported by good evidence and is likely to cause harm.
25. Recommendations to be considered by the committee:
(a)
(b)
(c)
(d)
(e)
References
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June 2011