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Appendix A Water Fluoridation Review Joint Report of the Adult Services and Health Scrutiny Panel and the Children and Young People’s Services Scrutiny Panel May 2007 Final – June 2007 PSOC Page 1 CONTENTS EXECUTIVE SUMMARY ……..…………...………………………………………3 1. Original Concerns – why Members wanted to look at this Issue .............. 4 2. Terms of Reference ....................................................................................... 5 3. 2.1 Methodology ......................................................................................... 6 3.1 3.2 National Level ....................................................................................... 8 Local Level.......................................................................................... 10 4.1 4.2 4.3 4.4 History of Fluoridation......................................................................... 12 How Fluoride Works............................................................................ 12 Optimal Fluoride Levels for Drinking Water ........................................ 13 Dental health improvement in recent years......................................... 13 5.1 5.2 5.3 5.4 5.5 Health Inequalities .............................................................................. 14 Pro-Fluoride Lobby ............................................................................. 17 Anti-Fluoride Lobby............................................................................. 18 The York Review: A Systematic Review of Public Water Fluoridation 18 Medical Research Council - Working Group Report: Water fluoridation and health ........................................................................................... 19 Legislative and Policy Context..................................................................... 8 4. Background.................................................................................................. 12 5. Current debate ............................................................................................. 14 6. Findings ....................................................................................................... 19 6.1 6.2 6.3 6.4 6.5 7. Is there evidence that artificial fluoridation of the water supply prevents tooth decay? ....................................................................................... 19 Is it safe to artificially fluoridate the water supply? .............................. 22 Alternatives to Fluoridated Water to improve Dental Health ............... 26 The Ethics of fluoridating Water Supplies ........................................... 28 Are there other Practical Considerations? .......................................... 30 Conclusions drawn from the Evidence ..................................................... 33 7.1 7.2 7.3 7.4 8. Does adding fluoride to water reduce dental decay in children?......... 33 What are the risks?............................................................................. 34 What are the ethics of fluoridating water?........................................... 35 What is the current legal position and route for making changes to the water supplies?................................................................................... 35 Recommendations ...................................................................................... 36 8.1 8.2 8.3 8.4 9. Rotherham Metropolitan Borough Council .......................................... 36 Rotherham PCT.................................................................................. 36 NHS Yorkshire and the Humber (SHA)............................................... 37 Department of Health.......................................................................... 37 Thanks.......................................................................................................... 37 10. Information Sources/References ............................................................... 38 11. ANNEX 1 ....................................................................................................... 39 Final – June 2007 PSOC Page 2 EXECUTIVE SUMMARY The debate about water fluoridation is polarised, with strong views held on both sides. The Department of Health and local health community strongly support water fluoridation, yet there is a strong anti-fluoridation lobby that opposes it for a range of compelling reasons. The review group interviewed expert witnesses. It also looked at a great deal of evidence, finding that the quality of research is variable1 and the conclusions drawn from it are often contradictory. The review group comprised eight lay people with a wide range of experience, but no medical or dental background. However, it has established a view on the basis of the evidence presented from all sides of this complex debate. The review considered the issue of medical ethics and concluded that if water fluoridation is considered to be medical intervention, then either the permission of all those affected is required or there has to be compelling evidence of benefits, with no other way of achieving the outcomes. In Rotherham’s most deprived wards, the level of decay in five year-olds’ teeth has only improved marginally in the last 20 years, missing both local and national targets. The review group was mindful of the urgent need to improve the dental health of Rotherham’s most disadvantaged communities, but in a way that considers the effects on the population as a whole. There seems to be no doubt that fluoride – in very small amounts – strengthens growing teeth and helps them resist decay. Fluoride toothpaste has been widely used in the UK for the last 30 years and appears to have been a major factor in dental health improvements, nationally. However, what is less certain is the best way to get fluoride (and other preventative interventions) to the individuals that would benefit most – i.e. those with the worst dental health. Too much fluoride certainly causes health problems – from minor cosmetic markings on the teeth, to skeletal deformities and possibly other health problems, where fluoride exposure is particularly high. What is more difficult to identify is the optimum amount to produce the benefits without exposing the community to the risks. By adding fluoride to tap water, it would be impossible to control the amount of fluoride taken by each individual and ensure that each individual (whose ability to absorb fluoride may differ widely from the next person’s) receives the optimum level and not too much. The review therefore concluded that that whilst there is evidence of the benefits, the risks have not been sufficiently explored. Furthermore, it would 1 The York Review: A Systematic Review of Public Water Fluoridation (2000) Final – June 2007 PSOC Page 3 appear that significant improvements to dental health may be achieved through other interventions. Although water fluoridation appears to be a cost-effective way of reducing dental caries because of its universal effect, the review group felt that the cost of adding fluoride for the whole borough could be better spent improving the dental health of those communities in greatest need. Given the complexity of the arguments, the review wants to ensure that any future consultation by the Strategic Health Authority provides sufficient information about the benefits and risks of water fluoridation, so that the public can make an informed choice. The review makes a number of recommendations to the local, regional and national health organisations, which, if implemented, should help reduce Rotherham’s unacceptable inequalities in respect of dental health. These are given in section 8 of this report. However, the review’s key recommendation is for Rotherham Council to reaffirm its policy against the fluoridation of its water. 1. ORIGINAL CONCERNS – WHY MEMBERS WANTED TO LOOK AT THIS ISSUE Whether adding fluoride to the water supply would improve Rotherham’s dental health, especially that of children and young people living in areas of social deprivation was raised during a previous Adult Services and Health Scrutiny Panel review on dental care, held on 2 February 20062. A new dental contract was introduced in April 2006, in the context of a national shortage of NHS dentists. Recent reports3 suggest that a year on from this, at least 30,000 people are waiting to find a dentist in Yorkshire. There are now 10 per cent fewer dental practices in the region carrying out NHS dentistry compared with two years ago. The review heard that the dental health of 5 year olds in Rotherham has not changed greatly since 1985 (see graph below4). The vast majority of decay in 5 year olds is not treated (partly due to their reluctance to be treated) and less than half of this group is registered with a dentist. The 2003 target5 for Review of NHS Dental Provision in Rotherham – Adult Services and Health Scrutiny Panel nd 2 February, 2006 (first part of a two stage review) 3 Yorkshire Post, 24 April 2007 4 Source: Dr Nigel Thomas, Director of Dental Public Health 5 Department of Health (1994) Oral Health Strategy for England set a target that five-yearold children should have an average of no more than one decayed, missing or filled tooth and 70% of 5-year-olds should have no decay experience 2 Final – June 2007 PSOC Page 4 this group is less than one dmft6 per patient. Locally, only Bassetlaw and Chesterfield have managed to achieve this. 5 year olds in Rotherham 1985-2005 2 decayed 1 filled extracted 0 19 85 19 87 19 89 19 91 19 93 19 95 19 97 19 99 20 01 20 03 20 05 te e th a ffe c te d 3 year There is a considerable variation in disease levels between wards in Rotherham with the 5 year olds in the more economically disadvantaged wards having three times the level of dental decay than in other wards. This is a reflection of the social economic status of communities, with poverty being closely linked to poor dental health. This is borne out by evidence from a local Rotherham dentist who asserted that dental health among children has not really improved, with old and new patients presenting with very high levels of disease. In his experience sessions of intense oral health education has made little difference to especially those who need it most. Rotherham Primary Care Trust (PCT) proposed that improvements could be made to dental health of children in particular, through water fluoridation. However, recognising that this issue has generated considerable public debate, the Adult Services and Health Scrutiny Panel agreed that a further review would be held to consider the issue in more detail. 2. TERMS OF REFERENCE The following terms of reference were agreed: Tooth decay is more usually reported in the literature as decayed, missing and filled teeth (dmft in primary/baby teeth and DMFT in permanent teeth) 6 Final – June 2007 PSOC Page 5 To consider the arguments for and against the artificial fluoridation of the water supply provided to the people of Rotherham and to reach a view on whether the Panel considers that fluoride should be added to the water supply as a public health action. a) b) c) d) e) to determine whether adding fluoride to water is an effective means of reducing dental decay in children to identify the benefits and risks associated with adding fluoride to water to consider the ethics of fluoridating water supplies to clarify the current legal position and route for making changes to the water supply to agree a view that can be discussed with full Council. 2.1 Methodology 2.1.1 The review was jointly undertaken by members of the Adult Services and Health Scrutiny and Children and Young People’s Scrutiny Panels. The members of the review group were as follows: - Cllr Beryl Billington Cllr Rose McNeely Cllr John Turner George Hewitt (co-optee) - Cllr John Doyle (chair) Cllr John Swift Mick Hall (co-optee) Ben Vergara-Carvallo (co-optee) 2.1.2 The review was supported by a consultant engaged through the Centre for Public Scrutiny ‘expert advisor’ scheme7. The contribution and expertise of Brenda Cook is gratefully acknowledged. In liaison with the Chair, Cllr John Doyle, a panel of experts was selected to give evidence. Each witness was contacted in advance and given a written brief detailing the scope of the review and the process to be followed. 2.1.3 In order to meet the terms of reference, the review focused on the following areas: • • Is there evidence that artificial fluoridation of the water supply prevents tooth decay? If so, Is it safe to artificially fluoridate the water supply, i.e. are there risks attached? Health Scrutiny Committees can access up to 5 days free support from a Centre for Public Scrutiny Advisory Team - a range of health scrutiny experts drawn from across the local government and health sectors. 7 Final – June 2007 PSOC Page 6 • • • Are there alternatives to water fluoridation that can improve the dental health of those individuals and groups that are most at risk from tooth decay? Is there an ethical issue about adding fluoride to the water supply, which to a large extent removes the element of choice? Are there other practical considerations, i.e. costs, consultation? 2.1.4 Acknowledging that the issue of water fluoridation is both a complex and contentious issue, it was agreed that representatives of the pro- and antifluoride lobby should be contacted to give their views. It was also recognised that in order for the panel to make an informed judgement, it was important to understand dental health within Rotherham, particularly in the context of the Borough’s socio-economic circumstances. To this end, both the Director of Dental Public Health and a local dentist were invited to give evidence. A number of other witnesses were called to focus on legal, ethical and other practical considerations. 2.1.5 The review group set aside a morning and afternoon session over a single day, Monday 19 February, to receive oral evidence and question the witnesses. Each representative was asked to focus on their area of expertise and their organisation’s position in relation to fluoridation. Many of the witnesses gave detailed PowerPoint presentations to support their evidence. We would like to thank all the witnesses for their time, co-operation and willingness to engage in this process. Their contributions are gratefully acknowledged. • • • • • • • • Dr Nigel Thomas, Director of Dental Public Health, Rotherham PCT Dr John Beal, Dental Advisor to NHS Yorkshire and the Humber Professor Michael Lennon, British Fluoridation Society Jason Field, Local dentist (Chair of the Local Dental Committee) Dr Mark Taylor, Sheffield Institute of Biotechnological Law and Ethics Elizabeth McDonagh, Chairman and Ian Packington, Vice-Chairman of the National Pure Water Association David Woolloff, Manager of Water Quality, Yorkshire Water Louise Collins, Oral Health Promotion Co-ordinator, Rotherham PCT 2.1.6 Councillors Shaun Wright and Tony Mannion submitted papers outlining their views on the issue, which were considered as part of the review. In addition, Councillor Robin Stonebridge submitted a list of questions which were used when drafting the supplementary questions. 2.1.7 Professor Sheldon was invited to attend the scrutiny review in person, but unfortunately was unable to do so. He kindly agreed to provide a statement and answer supplementary questions from the review group. Final – June 2007 PSOC Page 7 2.1.8 The majority of witnesses were allocated 30 minutes to give their evidence although the pro- and anti-fluoridation organisations were both given 45 minutes each to explain their organisation’s position. 2.1.9 As with the majority of scrutiny meetings (unless confidential information is being discussed), the review was held in public. There were approximately 25 people in the audience, the majority of whom stayed to hear the evidence in its entirety. Given the number of witnesses giving evidence and thus the tight timetable on the day, it was decided not to take questions from the floor. Instead, members of the audience were invited to submit written questions. These were considered by the review group and many were used to inform further questions. 2.1.10 The review generated media interest, with both local press and radio coverage. This reflected the substantial public interest in the subject. 2.1.11 In addition to the questions asked on the day, a series of supplementary questions were identified. These questions focussed on gaps in evidence or pursued lines of questioning arising from the witness’ presentations. 2.1.12 The review group reconvened on Tuesday 13 March to consider the evidence and arrive at their recommendations. These are detailed in Section 8 of the report. 2.1.13 The review was supported by Caroline Webb, Senior Scrutiny Adviser and Delia Watts, Scrutiny Adviser. 3. LEGISLATIVE AND POLICY CONTEXT 3.1 National Level 3.1.1 Since the early 1960s, successive UK Governments have supported water fluoridation. Currently, approximately 10% of the UK population receives fluoridated water from natural or artificial sources8. Arrangements for most fluoridation schemes were made before 1985. 3.1.2 The Water (Fluoridation) Act 1985, consolidated in the Water Industry Act 1991, was intended to regularise the legislative framework, but it proved to be ineffective. Section 87 of the Act stated that, when requested by health authorities, water undertakers (water companies), "...may increase the fluoride content of the water supplied by them within that area”. No new schemes were introduced under this legislation. Water undertakers did not feel equipped to make decisions on what they considered to be a public British Fluoridation Society (2004) One in a Million – The Facts about Water Fluoridation nd 2 ed. Manchester 8 Final – June 2007 PSOC Page 8 health issue and their representatives pressed for the legislation to be amended to make Strategic Health Authorities (SHAs) responsible for these decisions. 3.1.3 As this legislation was largely seen as unworkable, new measures were introduced in the Water Act 2003 (“the Water Act”). Section 58 of the Water Act included wide-ranging amendments to the provisions on fluoridation in section 87 of the Water Industry Act 1991. Most significantly, section 87(1) was amended to impose an obligation on water undertakers and now reads: “If requested in writing to do so by a relevant authority9, a water undertaker shall enter into arrangements with the relevant authority to increase the fluoride content of the water supplied by that undertaker to premises within the area specified in the arrangements.” 3.1.4 In advice given to Strategic Health Authorities and Primary Care Trusts10, Professor Raman Bedi, England’s Chief Dental Officer outlined the process for consultation in line with the legislation. As it is generally Primary Care Trusts who identify concerns about the oral health of their populations, it was felt that they should identify the options for securing improvements. These improvements should be informed by local dental health surveys. If it is felt that fluoridation of water is the most effective solution, the Primary Care Trusts should discuss this with their Strategic Health Authority. 3.1.5 Before going any further, the SHA should consult with the water company/ies to ensure that any proposal is technically feasible. Next, the legislation requires the appropriate Strategic Health Authority to consult locally and ascertain the opinion of local people. This would include every local authority affected, individuals and bodies with an interest (e.g. Public and Patient Involvement forums, voluntary sector health and social care organisations, consumer groups, businesses and environmental organisations) and also the general public (via leaflets, posters, newspapers and other media). 3.1.6 To date, NHS Yorkshire and Humber (the regional Strategic Health Authority) has not undertaken such consultation within Rotherham and therefore how such a consultation would be funded has not been considered. The SHA Prof Bedi, R (2005) Fluoridation of Drinking Water, Guidance from the Chief Dental Officer (Gateway Ref. 5136), Department of Health 9 10 Final – June 2007 PSOC Page 9 3.2 Local Level 3.2.1 Current Council Policy At present the water provided to people within Rotherham MBC area does not have fluoride artificially added, although, along with all UK water, it is naturally present at very low levels. The issue of water fluoridation was initially discussed by the then Environmental Health Committee in July 1988. Following these discussions, a recommendation was made that the Council should oppose water fluoridation. In summary, the Committee reached a view that: • • • • Fluoridation of water is not a substitute for preventative dental care and education from a properly staffed dental service; The presence of other substances in water and food could affect the level of bodily absorption of fluoride and thus its role in fighting tooth decay; Fluoridation of all water would deny consumer choice to those who question the efficacy of mass fluoridation; There was uncertainty that quality assurance could be guaranteed from the newly privatised water industry. The full minute of the meeting is provided at Annex 1. The Committee subsequently noted a letter received by the Chief Executive in January 1997 from Yorkshire Water regarding its decision not to add fluoride to the water supplies in Yorkshire. 3.2.2 It is worth noting that in 200111, the Cabinet supported a pilot project initiated by the PCT to provide fluoridated milk12 to children at a primary school in the Rawmarsh Sure Start area. The following year, they approved the extension of the scheme to the other Sure Start areas in Rotherham. To date, no formal evaluation of this scheme has taken place, and therefore it is difficult to draw conclusion about its effectiveness. However, it is unlikely that the scheme will be expanded due to problems with supply. 3.2.3 Although the Council supported the introduction of the pilot milk fluoridation scheme, there has not been further discussion of water fluoridation within any formal Council meeting since 1997. 11 12 Minute B211, Cabinet meeting held on 28 November, 2001 With a fluoride content of 2.6 ppm Final – June 2007 PSOC Page 10 3.2.4 Recent Policy Decisions in nearby Local Authorities A number of other Councils within the Yorkshire and Humber region including Calderdale and Bradford have formally resolved to oppose fluoridation (both these decisions were taken in 2003). In early 2005, Leeds City Council agreed a motion to oppose fluoride in water. Following a presentation by Sheffield Director of Dental Health and a representative of the National Pure Water Association, Sheffield City Council reaffirmed its opposition to the fluoridation the public water supply at its meeting of 2 February, 2005. Of Rotherham’s other immediate neighbours, neither Doncaster nor Barnsley Councils have discussed this issue in recent years. 3.2.5 Rotherham PCT The PCT is strongly in favour of water fluoridation and recommends that Rotherham’s water supply is fluoridated13. The Joint Annual Report of the Directors of Public Health in South Yorkshire 2005/614, states that: “Fluoridation is the strongest evidence based strategy for improved dental health, with greatest potential to reduce inequalities in more deprived communities”. The views of individual dentists are not known, but Mr Field, Chair of the Local Dental Committee is not aware of any dentist that opposes the PCT’s line. 3.2.6 NHS Yorkshire and the Humber The SHA has identified the dental health of children as one of the priority areas which needs to be tackled as part of improving health and reducing inequalities. Yorkshire is one of the areas furthest away from the target that 5-year-old children should have no more than an average of one decayed, missing and filled teeth by the year 2003. In South Yorkshire the average was over 2 teeth affected. Dr Beal believes that whilst the PCTs need to implement a range of measures to improve dental health, water fluoridation could be the major contributor to reducing the amount of tooth decay, especially in children - although adults with their own teeth would also benefit. 3.2.7 Rotherham’s Water Providers The overwhelming majority of Rotherham’s domestic or commercial premises and facilities are supplied with water from Yorkshire Water. A very Rotherham PCT (December 2006) Rotherham Oral Health Strategy 2006/09 Section 4.8.1 14 Section 2, p 30 13 Final – June 2007 PSOC Page 11 small number of businesses and households in the south of the Borough receive services from Severn Trent Water. 4. BACKGROUND 4.1 History of Fluoridation 4.1.1 All water supplies contain some fluoride. From observing different patterns of dental decay in areas of differing levels of naturally fluoridated water that the benefits of fluoride were first observed. The protective properties of naturally fluoridated water were identified in America and England in the 1930s, leading to several large scale studies being undertaken. This included the Grand Rapids trial in 1945, a community intervention which tested the hypothesis that artificial fluoridation would reduce incidents of dental decay. On the basis of the trial’s results, a number of American and Canadian towns decided to increase the fluoride content of their water supplies in the late 1940s. In 1953, a group of British scientists examined these studies and recommended to the Ministry of Health that similar research be undertaken in Britain. These studies yielded similar results to those in North America, influencing a number of areas around the country to artificially fluoridate their water supplies. 4.1.2 Approximately 350 million people in over 30 countries currently drink artificially fluoridated water, with a further 50 million drinking naturally fluoridated water. The review group received evidence to suggest that approximately 70% of water in the United States is or will shortly be, fluoridated. Ireland currently fluoridates all mains water where possible. 4.1.3 Although water fluoridation is well established in the UK, it has not been widely adopted. At present, about 10% of the UK population, which mostly reside in either the West Midlands or around Newcastle-upon-Tyne, receives fluoridated water. 4.2 How Fluoride Works Bacteria constantly form on the inside of the mouth. Over time, these bacteria can gradually erode away the enamel (the outer layer) of the tooth. Once this layer is eroded, bacteria attack the soft core of the tooth, causing cavities or other serious damage to teeth and gums. Fluoride combats this process by strengthening the enamel and helping to remineralise the tooth's surface. Once ingested into the body, fluoride travels through the blood supply, where it makes its way into the bones and teeth. Fluoride is easily absorbed into the teeth thanks to their porous outer surface. Although it may be ingested through the public water supply, fluoride also comes in the form of liquid gel or varnish that can be prescribed by a dentist. Final – June 2007 PSOC Page 12 4.3 Optimal Fluoride Levels for Drinking Water In some parts of the world, for example India, China, Thailand, and Kenya, high levels of fluoride naturally present in ground waters causes dental and skeletal fluorosis. Professor Sheldon pointed out that in some of these countries other elements, for example arsenic, are also naturally present and he asserts that an element’s natural occurrence is no guide to its desirability. As a result the World Health Organisation has developed Guidelines15 for drinking water quality and recommends a Guideline Value for fluoride at 1.5 ppm16. Professor Lennon cited that the WHO Guideline value is described as “the concentration of a constituent that does not result in any significant risk to health over a lifetime of consumption including different sensitivities that may occur between life stages”17. In Professor Lennon’s view, governments in countries where there are high levels of naturally occurring fluoride generally recognise both the risks and potential benefits of fluoride and strive to achieve a healthy balance. 4.3.1 Currently around six million people in England receive water, which either has its level of fluoride adjusted to, or has a natural fluoride content of around 1 milligram per litre (one part per million or 1ppm). Half a million people in the UK currently receive water with a naturally occurring fluoride content which is sufficient to benefit their dental health. 4.3.2 In May 2000, the Irish Forum on Fluoridation undertook the first major review of water fluoridation since its introduction in Ireland in 1964. The resulting Report recommended the optimal level of fluoride in drinking water should be amended from the present level (0.8 to 1.0 ppm) to between 0.6 and 0.8 ppm, with a target value of 0.7 ppm. 4.4 Dental health improvement in recent years Professor Sheldon suggested that improvements in dental health and reduction in dental caries in countries that did not fluoridate water should also be taken into consideration, as the increased use of toothpaste, better dental/oral hygiene and nutrition over the years may have all played a role. This point is illustrated by graph below that shows the trends in caries in EU countries over the last few decades and illustrates the similar trends in both water fluoridated and non fluoridated region. World Health Organisation (2006) Briefing on Fluoride in Drinking Water Parts per million 17 Source cited as World Health Organization 2006 15 16 Final – June 2007 PSOC Page 13 Mean number of decayed, missing or filled teeth in 12 year olds in European Union countries (1965 – 2003) 9 — — — — 8 7 No water fluoridation Water fluoridation (% population covered) Salt fluoridation (% population covered) Data not given Mean DMFT 6 5 4 3 2 1 0 1965 Austria Portugal (1%) 1970 1975 Denmark Spain (3%) 1980 Finland UK (9%) 1985 Year Netherlands France (40-50%) 1990 Sweden Belgium 1995 Germany* Greece 2000 2005 Ireland (74%**) Italy * Water fluoridation to 1.9% and salt fluoridation to 20 % of the population of former East Germany. Discontinued after reunification. 2 ** Coverage estimate from Whelon et al † Fluoridation details as stated by WHO Oral Health Country/Area Profile Programme 5. CURRENT DEBATE 5.1 Health Inequalities 5.1.1 Dr Thomas’ argument centred on fluoridation’s role in tackling in oral health inequalities. He quoted the Acheson Inquiry (1998) into Inequalities in Health18, that identified whilst overall dental health in children is improving, the differential in the number of decayed teeth between those in lower social classes and those in classes I, II and III has increased. There is also a geographical variation, with children living in the north having more dental decay than those living in the midlands and the south. Acheson Sir Donald, (1998) Independent Inquiry into Inequalities in Health Report, Section 7, recommendation 22.2, The Stationery Office 18 Final – June 2007 PSOC Page 14 5.1.2 In the most deprived areas, people are less likely to go to the dentist, or take their children to the dentist, until they experience pain. This means that some children do not see a dentist until they have tooth decay and need an extraction or filling. Dr Beal also stated that one of the reasons that children in social classes III, IV and V benefit substantially from fluoridated water is that there is evidence that children in social classes I and II quickly receive and implement health promotion and ill health prevention messages. This contrasts with a delay of 20-40 years in the other social classes before they are seen to adopt health behaviours. With fluoridation of water all people in classes receive the benefit simultaneously. In his view, it is therefore the most cost effective public health measure. 5.1.3 The Dental Health of Rotherham’s Children Within the local region, the dental health of 5 year olds varies considerably, as shown in the graph19 below: Dental health of 5 year olds 2003-2004 South Yorks/South Humber 3 Teeth affected per average child 2.5 2 1.5 1 0.5 decayed teeth missing teeth y B a rn sl e n e l d S h ef fi es t r w D on ca st e r c en tra l r e a s t D PCT on ca st e se on ca st e e l d D S h ef fi e r ha m e ot h R S c un th or p sb y r im G w el d S h ef fi sw S h ef fi el d r fi he st e C B a ss et la w el d 0 filled teeth Dr Thomas commented that all the areas with better oral health than Rotherham were either affluent or had artificially fluoridated water. He also quoted a 2003/2004 survey carried out in association with the British Association for the Study of Community Dentistry which showed that Rotherham 5 year olds had an average dmft of 1.89, with some areas around 4. This contrasts starkly with the national mean of only 1.49. 19 Rotherham PCT (December 2006) Rotherham Oral Health Strategy 2006/09 Final – June 2007 PSOC Page 15 Furthermore, Dr Beal stressed the importance of considering how much tooth decay individuals from some communities may have, rather than focusing on the average dmft rates for the borough as a whole. The distribution of poor oral health generally follows deprivation, with decay rates being highest in Central, Herringthorpe, Park, Boston, Brampton, Melton and Wentworth. (See Map below20 of dmft rates related to wards21.) These communities are amongst those experiencing the highest level of multiple deprivation in Rotherham and are targeted for special action under the Neighbourhood Renewal Strategy22. Rotherham PCT (December 2006) Rotherham Oral Health Strategy 2006/09 Rotherham Council ward boundaries changed in 2004. These figures relate to the old ward boundaries – (note: there is an error in the original map. The left hand ‘Rawmarsh East’ should read ‘Rawmarsh West’) 22 RMBC (2005) Neighbourhood Renewal Strategy 2005-2010, Section 5 20 21 Final – June 2007 PSOC Page 16 The connection between deprivation and poor oral health is to do with the increased likelihood of a poor diet, a less ordered lifestyle and lower educational achievement. In his view, fluoride can therefore help to reduce health inequalities. 5.2 Pro-Fluoride Lobby Adding fluoride to water is credited by many for being responsible for a decline in tooth decay and a reduction in incidents of dental caries. Its supporters assert that it is convenient and as it is added to the water supply, available to the general population, regardless of income. As demonstrated above, children in deprived areas suffer from much higher levels of tooth decay than their peers in more affluent areas. Final – June 2007 PSOC Page 17 Many health specialists, including the World Health Organisation, British Fluoridation Society, British Medical Association, British Dental Association and Royal College of Physicians claim that fluoridated water would address this inequality. 5.3 Anti-Fluoride Lobby Opponents to fluoridation suggest that decreases in dental decay could be better explained by improvement in dental hygiene and diet rather than water fluoridation. Furthermore, they claim that the long-term risks to health or the environment attached to fluoridation have yet to be explored. Consumption of fluoridated water at high concentrations has been proven to cause severe skeletal deformities. Even at recommended levels, fluoridated water can cause dental fluorosis (browning or mottling of the teeth) in young people. In the UK, supporters of the anti-fluoride lobby include the National Pure Water Association, the Green Party and Friends of the Earth. 5.4 The York Review: A Systematic Review of Public Water Fluoridation There has been little objective review of the pros and cons of fluoridating the water supply and the polarised position of both sides has seriously clouded the debate. In 1999, the Department of Health commissioned York University’s NHS Centre for Reviews and Dissemination (CRD), to review the evidence on fluoridation of water. The Review’s steering group was chaired by Professor Trevor Sheldon, and during the course of the review it considered 3000 research papers spanning over 50 years of evidence. The review was published in 200023. The review looked specifically at the effects on dental caries/decay, social inequalities and any harmful effects. It commented on the poor quality of evidence across all the areas it examined. It concluded that the evidence suggested that water fluoridation was likely to have a beneficial effect. This beneficial effect comes at the expense of an increase in the prevalence of fluorosis (mottled teeth). No association between water fluoride and other adverse effects such as cancer, bone fracture and Down's syndrome was found. However, the Review team felt that not enough was known because the quality of the evidence was again poor. The evidence about reducing inequalities in dental health was contradictory and unreliable. However, it should be noted that research has continued to be undertaken in the seven years since the York Review and findings from some of these recent studies are referred to elsewhere in this report. 23 Final – June 2007 PSOC Page 18 5.5 Medical Research Council - Working Group Report: Water fluoridation and health In light of the York Review’s criticism of the quality of research, the Department of Health commissioned the Medical Research Council to consider some of the concerns that have been expressed about the safety of fluoridation and make recommendations for further research. The MRC’s key findings and recommendations include: • • • • • support for the findings of the York Review that fluoridating water may have a beneficial effect on reducing tooth decay the majority of research indicates that water fluoridation reduces inequalities in dental decay between high and low social groups additional information about fluoridation is needed by the public to make informed decisions, particularly on the prevalence of forms of dental fluorosis the evidence does not support claims that fluoridated water affects the immune system, the reproductive system, child development, the kidneys or the gastro-intestinal tract. Consequently the MRC did not recommend any further research in these areas. comparison be made between the amount of fluoride the body absorbs from water supplies in which it occurs naturally and those to which it has been added artificially. The York Review criticised that many studies did not take account of the level of fluoride exposure from other sources, such as toothpastes and other dental health care products containing fluoride, and the potential for fluoride exposure from food sources, for example tea and fish. The MRC proposed future studies on the impact of water fluoridation should take account of this. 6. FINDINGS 6.1 Is there evidence that artificial fluoridation of the water supply prevents tooth decay? 6.1.1 The York Review stated that the best available evidence suggests that fluoridation of drinking water supplies does reduce dental caries. It concluded that water fluoridation can reduce dental health inequalities across social classes; particularly in children aged 5-12. The observational research indicated that there is an increase in the percentage of caries free children in areas with fluoridated water (about 15%). However, Professor Final – June 2007 PSOC Page 19 Sheldon urged caution as these estimates could be skewed and other factors not taken into account. 6.1.2 In support of the benefits of fluoridation, Dr Beal gave examples of findings in the Midlands and North of England in different age groups of children24 : Fluoridated Non-Fluoridated Difference 3 year olds Huddersfield25 dmft = 0.30 Dewsbury25?? dmft = 0.74 59% 5 year olds Newcastle dmft = 1.3 N Manchester dmft = 3.3 61% Bolton DMFT = 3.8 40% 14-15 year olds Birmingham DMFT = 2.3 6.1.3 Similarly, South Yorkshire’s dental health can be compared with that of the Black Country, 97% of which receives fluoridated water26. S Yorkshire Average no. of dmft per 100 five year olds 178 (2003/04) No. of children under ten given a general 2646 anaesthetic for dental treatment (2002/03) Black Country 100 683 Mr Lennon pointed out that children in some relatively deprived areas of the West Midlands have fewer teeth affected by decay than children in parts of the more affluent South East England. 6.1.4 Whilst this evidence supports the benefits of fluoridation, Professor Sheldon pointed out that other data could be available which showed less stark comparisons and may even show no difference between areas with or without fluoride. Source: Dr John Beal, SHA in answer to supplementary questions Yorkshire Water terminated fluoridation at the time of privatisation in 1989 and the dmft rates for 5 year-olds has since increased to 4.6 (Source: Lord Chan in House of Lords debate on Water Act, 9 July 2003) 26 Source: Professor Michael Lennon, British Fluoridation Society in answer to supplementary questions 24 25 Final – June 2007 PSOC Page 20 6.1.5 Although all adults with their own teeth will benefit from fluoridation the greatest benefit will be to those who live in the fluoridated area for much of their life. Dr Beal quoted a series of studies supporting this. In Hartlepool (fluoride at 1 ppm) and York (with negligible fluoride) which found that fluoride reduced decay, tooth extractions and the need for partial dentures in every 5-year age band from 15 to 65 years. In the fluoridated part of Anglesey, lifelong adult residents aged 16-32 years had on average 30% fewer decayed, missing or filled teeth compared to lifelong residents from the non-fluoridated part. In Eire, 45-54 year olds still had 16.4 natural teeth in fluoridated communities compared to only 10.7 in non-fluoridated communities – a 34% difference. Dr Beal believes that there is a lifelong benefit from fluoridation. Professor Lennon explained that as adults reach their 50’s there is an increased risk of tooth decay, therefore fluoride is of benefit to adults as well as children. Treating dental disease in elderly patients can present additional problems, ranging from their ability to attending a surgery to complications with the treatment itself, particularly if they have other complex medical requirements. Root decay is also common in later adulthood. Mr Field suggested that fluoride may help with this form of tooth decay. 6.1.6 A number of witnesses asserted that adding fluoride to water would reduce dental problems and thus the need for intervention. For example, extraction of decayed teeth in children is often done under general anaesthetic due to the discomfort they may experience and their reaction to this. Dr Beal told the review that general anaesthesia for children’s dental treatment is used seven times more often in non-fluoridated South Yorkshire than in fluoridated Birmingham and the Black Country. This costs about £300 per child and has some health risks and can be distressing for the child. Reducing child dental decay would reduce the need for general anaesthesia. Many people’s dental needs in later life are related to their disease pattern when young. More adults are keeping their teeth into later life; fillings have a finite lifespan and therefore having to fill teeth in younger adults/children commits them to a lifetime of treatment needs. 6.1.7 Mr Field also referred to the new dental health contract, and stated that in his view, this made it harder for dentists to undertake preventative work. If less time was spent treating decay, more could be spent on health promotion, preventive work, reducing waiting times, supporting smoking cessation etc. There is a huge dental health need in Rotherham and whilst the NHS tried to improve dental health education, fluoridation would help those who could not access dentists for whatever reason. Mr Field stated that access to dentists was still an issue for people in Rotherham (and elsewhere), and that if the water supply were fluoridated, it was likely that there would be a reduction in the experience of acute pain and long term dental needs. Final – June 2007 PSOC Page 21 6.2 Is it safe to artificially fluoridate the water supply? 6.2.1 Professor Sheldon was struck by how poor the quality of existing research was, whether it focussed on beneficial or adverse effects. There is a tendency for research to be less rigorous when the research body is trying to prove a point – in this case, whether strongly pro or anti-fluoridation. Despite the plethora of research undertaken, none has been conducted using the rigorous ‘randomised control standards’. This standard enables the researcher to evaluate whether the intervention itself, as opposed to other factors, causes the observed outcomes. Until high quality studies are undertaken providing more definite evidence, there will continue to be legitimate scientific controversy over the likely effects and costs of water fluoridation. Professor Sheldon concluded that whilst there are likely to be some, but maybe modest, benefits, there may be potential harm associated with water fluoridation. Current research does not allow for confident judgement on either the risks or benefits. In Professor Sheldon’s view, people need to be able to make an informed judgement of the risks and benefits of fluoridated water and the quality of evidence available at the moment does not allow for this. 6.2.2 In Dr Thomas’ view fluoridation was safe, and this was supported through research evidence, disputing some of Professor Sheldon’s statements regarding the quality of evidence. A fluoride concentration of 1ppm equates broadly to the fluoride naturally occurring in a cup of tea. He also quoted that the safety of fluoridated water is supported by a number of key health organisations27 and believes that members of the public support fluoridation, citing positive responses in recent public surveys (although detailed findings were not considered as part of this review). 6.2.3 Dental Fluorosis 6.2.3.1 Concerns were raised by the review group about the incidence of dental fluorosis in children, which has been shown to be approximately twice as prevalent in fluoridated Newcastle than in fluoride deficient Northumberland28. The York Review found evidence that adding fluoride to water does increase the risk of fluorosis to the teeth. In areas of fluoridated water of 1.0ppm, These include World Health Organisation, British Medical Association, British Dental Association and Royal College of Physicians 28 Rock, P (2000) A prevalence study of dental fluorosis in infancy, British Dental Journal 26 August 2000, volume 189 27 Final – June 2007 PSOC Page 22 there is likely to be an estimated 48% prevalence of dental fluorosis, although the prevalence of fluorosis of significant aesthetic concern is likely to be 12%. Mr Field’s explained that in his experience, visible fluorosis is rare and in many cases is only detectable by dentists. Even where it is visible, he believes it to be a cosmetic issue as opposed to tooth decay, which is a health issue. In extreme cases, the marks on teeth can be hidden either by tooth coloured filling or porcelain covers (veneers) on the most visible teeth. 6.2.3.2 In the US, advice29 had recently given to parents not to mix fluoridated water and baby milk together as this can lead to babies being exposed to fluoride at 200 times the level naturally occurring in breast milk. It is suggested that this could lead to dental fluorosis in permanent teeth. However, Dr Beal asserts that there is no evidence of any adverse health effects from feeding infants using fluoridated water. It has been known for a long time that there is a small risk of dental fluorosis. The dental public health consultants would endorse the advice given elsewhere, namely that parents who are concerned can reduce even further the already small risk of dental fluorosis by (preferably) breast feeding or using a ready-to-use infant formula or making the powdered formula up with a suitable bottled water. 6.2.3.3 In the UK, all parents (regardless of whether their water is fluoridated) are advised that children’s tooth brushing should be done using a smear or small pea sized amount of fluoride toothpaste. Tooth brushing should be supervised up to the age of 6 or 7 years. Parents of young children who are at low risk of caries and living in a fluoridated area may consider using a toothpaste with a lower level of fluoride (less than 600 ppm). Indicators of low risk include little evidence of past tooth decay, no history of tooth decay among siblings and good oral hygiene30. 6.2.3.4 Although some view dental fluorosis as a largely cosmetic issue, NPWA believes that not only can it have a psychological effect on sufferers, but it is also a key marker for developmental toxicity31, with an adverse effect on dental, skeletal and brain tissues. 6.2.4 Whilst the risk of dental fluorosis is proven, other risks and their extent are not clear. Because the quality of evidence was poor, it was difficult to make informed conclusions about any other risks or potential harm. Professor Sheldon suggested that even if there was a modest risk attached to water fluoridation, as the population as a whole will be exposed to fluoride over a prolonged period of time, a small risk could still equate to a large number of people affected (if all water in England was fluoridated and there was 20% risk, this would mean that 10,000 people could be affected across the American Dental Association interim guidelines, 9 November 2006 Levine, RS and Stillman-Lowe, CR, (2004) The scientific basis of oral health education, 31 DenBesten, P. 1999 cited by NPWA 29 30 Final – June 2007 PSOC Page 23 country). Professor Sheldon summarised the problems as follows: that it is difficult to measure the total exposure to fluoride because water is not the only source; there may be a long period of exposure required before an outcome is seen, which makes it difficult to identify the risk; there are a lot of ‘confounders’, i.e. other issues that may impact on the findings such as environmental or health factors. 6.2.5 Mrs McDonagh states that although fluoride has low levels of acute toxicity, it is not clear what the risks are when ingested over time. She also pointed out that that if fluoride is not specifically looked for as a causal factor for medical conditions, it will not be found. This is not routinely tested for in England. 6.2.6 NPWA has concerns about the levels of fluoride ingested by people receiving fluoridated water, particularly as the amount of water drunk can vary hugely from one person to another. Also, as fluoride is found in other sources, e.g. fish, tea and other foods as well as toothpaste, toiletries and medicines, an individual is not able to control his/her individual intake of fluoride. 6.2.7 Ian Packington asserted that one of the reasons that the Government was promoting the fluoridation of water was to mask the levels of fluoride pollution emitted by industry. He pointed out that the first UK cities to have artificially fluoridated water were already the sites of heavy industry. No specific evidence was provided to substantiate this claim at the review meeting itself, but reference was made to a book which expounds this theory and provides evidence to support it32. 6.2.8 Other potential Effects on Health 6.2.8.1 There is considerable evidence to link high fluoride levels in water in areas of the developing world to bone spurs and skeletal deformities33. These problems are exacerbated by poor diet. As the York Review found, it is difficult to find evidence of skeletal fluorosis occurring in developed countries that have fluoridated water supplies, whether artificial or naturally occurring. Mrs McDonagh quoted the work of Dr Peter Mansfield that suggested that there are higher concentrations of skeletal fluorosis in fluoridated areas Bryson, C (2004) The Fluoride Deception, Seven Stories Press, U.S. Skeletal fluorosis is found in people in India who have consumed naturally occurring fluoride in doses ranging from 4 to 11 parts per million, although this is higher than the amount permitted within the EU 32 33 Final – June 2007 PSOC Page 24 (namely the West Midlands). He asserts that the skeletal fluorosis, often attributed to arthritis, can have a detrimental effect of joints and tissue function, including chronic back pain. 6.2.8.2 NPWA believes that ingestion of fluoride may lead to a wide range of health problems including adverse thyroid function, irritable bowel syndrome, neurological effects, renal problems, damaged sperm production, diabetes and cancer. It also asserts that fluoridated water is linked to birth deformities, cot death and still birth. The Association provided extensive information to support these claims, however, the review group found it difficult to develop an informed view due to conflicting evidence. The York Review34 found that whilst many of these claims could not be substantiated, this was mainly due to the poor quality of research rather than empirical findings. 6.2.8.3 Mrs McDonagh quoted a study35 that found that hip fracture prevalence is 30% higher in fluoridated areas than those without fluoride added to the water. However this is not supported by research by the Medical Research Council36 and subsequent research showed that this level should be revised downwards37. She quotes the view of Dr Hardy Limeback, Professor of Preventative Dentistry at Toronto University is that “the evidence that fluoridation is more harmful than beneficial is now overwhelming”. He makes a link between fluoride and bone fractures and bone pain and asserts that fluoride is not safe for individuals who cannot control their dose or in people who retain too much fluoride38. 6.2.9 Plumbosolvency A number of Rotherham households still have lead water pipes. The review group was concerned that fluoridating Rotherham’s water may have an effect on how much lead is absorbed these. Mr Woolloff stated that adding fluoride is not expected to have any effect as all of Rotherham’s water is conditioned with a small quantity of phosphate to minimise plumbosolvency. It should be borne in mind that the York Review was limited to evaluating studies into the effectiveness and possible harm of artificial fluoridation closest to the level of 1ppm 35 Water Fluoride Concentration on Fracture of the Proximal Femur (1990) Cooper, C et al 36 Professor David Coggon et al, (2000) Fluoride in drinking water and risk of hip fracture in the UK: A case-control study, Medical Research Council (MRC) Southampton University, 37 Cooper C Wickham C Lacey R Barker D “ Water fluoride concentration and fracture of the proximal femur” J. Epidemiol. Commun. Health (1990) 44: 17-19 c.f. subsequent letter to JAMA: Cooper C Wickham C Barker D Jacobsen S “Water fluoridation and hip fracture” JAMA (1991) 266: 513-514, where the original conclusion that “there is no significant increase in hip fracture rates in the artificially fluoridated areas of the U.K.” had to be revised to reflect a likely increase of incidence in the region of 15% 38 http://www.southcoasttoday.com/daily05-06/05-14-06/02opinion.htm, 14 May 2006 (link no longer available) 34 Final – June 2007 PSOC Page 25 6.3 Alternatives to Fluoridated Water to improve Dental Health 6.3.1 Screening and Prevention Non-interventive treatments include tooth-scaling to remove plaque and fissure sealants on the biting surfaces of molars. However, these approaches are preventative and cannot treat existing decay. As part of its supplementary information NPWA submitted a paper which suggested that screening and preventative work could best be provided in schools39. Ms Collins stated that although there is evidence that input by oral health promotion workers does increase knowledge around caring for teeth and gums, it does not appear to affects dental disease levels. 6.3.2 Education 6.3.2.1 Although oral health can be achieved through education and improved hygiene, Mr Field emphasised the difficulty in teaching children to brush their teeth effectively. Ms Collins confirmed this by stating that one of the biggest challenges for health promotion is the difficulty in encouraging people to follow good practice when their lives may be chaotic and tooth brushing, reducing sugar or buying toothpaste may not be their highest priority. 6.3.2.2 Ms Collins explained that the role of her team is to reduce inequalities in dental disease experience, using a range of different interventions. These include focusing on healthy diet and weaning, a dental milk scheme, the ‘brushing for life’ scheme and other group interventions, targeting groups that were most at risk. The combined effect of this work has shown some improvement in one area40, but that the reduction in tooth decay is less than the fluoridation of water could achieve, and was not universal. 6.3.2.3 The most comprehensive evaluation carried out to date is that of the input into the Rawmarsh Sure Start area (which included a fluoridated milk scheme). It shows that an intensive approach to oral health promotion, the inclusion of food work within the oral health promoter’s role and flooding the area with training and resources can affect the disease levels in an area – but only by 10%, i.e. average dmft dropped from 5 to 4.541. However, the cost over the 7 years the project has run is £77,520 in wages (over 5 years) and £28,146 in resource, staff development and travel money giving a total of £105,666 for the life of the project to date. Therefore there must be caution as this approach is time and cost intensive and not guaranteed to work in the many other areas of Rotherham where there is the equivalent Holdcroft C (2002) Preventative Dental Treatment and Dental Health Expenditure in Wolverhampton 1997-2002, NPWA 40 Average dmft reduction of 0.5 41 Source: interim report - the official end of programme report is due out at the end of 2007 39 Final – June 2007 PSOC Page 26 level of need. 6.3.2.4 The review group was told that interventions often rely upon short term funding, yet it takes some time to be able to demonstrate improvement. Funding for some of the current projects is about to change, and whilst the team tries hard to work with other agencies, there is a packed health promotion agenda and dental health is only a small part of it. It is therefore difficult to sustain the work continuously at an adequate level. 6.3.3 Sharing Good Practice 6.3.3.1 Ms Collins explained that there is a local support group for oral health promotion workers in Barnsley, Rotherham, Sheffield and Doncaster. Members of the local group provide two study days for oral health promotion workers from local area each year and are part of the National Oral Health Promotion Group as well. These groups share practice that works and issues within oral health and general health promotion. Rotherham’s Oral Health Promotion Team also has links with the Department of Health to share its experiences and absorb expertise into the work of the team. The Team also works with many different teams and agencies and therefore picks up good practice points from other areas as well as ensuring its practice is incorporated into theirs. 6.3.4 Other Fluoride Treatments 6.3.4.1 ‘Fluoride paint’, i.e. fluoride painted onto the surface of the teeth does provide some protection against dental caries, but it is not something that can be done on a regular basis. Mr Field’s view is that it could not be as effective as fluoridation of drinking water. 6.3.4.2 Alternative fluoride treatments (including toothpastes, gels, drops and tablets) can also be prescribed, but Mr Field questioned whether they reached the target groups. When asked about any risks attached to children and adults ingesting fluoride from toothpaste, he explained that the advice for children was to use very small amounts of toothpaste and that there was special toothpaste for milk teeth that contained a lower level of fluoride42. Children need to be taught how to brush their teeth properly and to use the correct amount of toothpaste. 6.3.5 Delay or Prevention of Streptococcus mutans Dental caries (tooth decay) is basically an infectious disease. When the first teeth erupt, they can be colonized by Streptococcus mutans, the predominant bacteria of dental plaque. This bacterium converts sugars and 42 Typically 500 ppm Final – June 2007 PSOC Page 27 carbohydrates in the mouth to acid, which dissolves and weakens the tooth enamel - tooth decay. Babies mainly pick up the Strep. mutans germ from their mothers during delivery (it is also found in the genitourinary tract) or after birth by kissing or other direct contact with saliva, coughing, sneezing or handling). The most vulnerable time for infection is between 6 and 31 months. Mothers with high levels of Strep. mutans infection due to poor oral hygiene are most likely to infect their children. The later in childhood that a child becomes infected, the lower his lifetime risk of infection43 . Thus prevention of tooth decay in children requires delay or prevention of Streptococcus mutans infection, or suppressing the germ's activity, together with attention to mother's oral health before and after childbirth, since she is the prime source of infection. In Sweden since the 1970s there has been a programme targeted at pregnant women and children from disadvantaged communities aiming to remove Strep. mutans by using a range of preventative interventions44. This has been shown to be effective in reducing dental decay in over a long period. 6.3.5.1 Although there were animal studies in the early 1980s45, no vaccine is currently available in UK against dental caries based on the mutans streptococci antigen. In addition, such a vaccine is highly unlikely to be of benefit as research has shown that if one variety of bacteria is removed from the mouth, other bacteria tend to increase their colonisation to compensate. Dr Thomas and Dr Beal both pointed out that bacteria other than Streptococcus mutans (such as the lactobacilli) also cause dental caries. However, if all bacteria are eliminated from the mouth, it may become colonised by yeasts, leading to an unpleasant condition called ‘Black Hairy Tongue’. 6.4 The Ethics of fluoridating Water Supplies Whether or not water fluoridation reduces dental caries in children has been subject to considerable debate. Much of the evidence is scientific rather than moral and centres on the benefits and risks of adding fluoride to water supplies. However, there is a clear moral dimension surrounding the Source: http://www.drhull.com/EncyMaster/C/caries.html Cited by NPWA: Varmland Experiment - Axelsson P, Paulander J, Svärdström G, Tollskog G, Nordensten S: Integrated caries prevention: The effect of a needs-related preventive program on dental caries in children – County of Värmland, Sweden – Results after 12 years. Caries Res 1993, 27(suppl 1):83-84. 45 funded by the Department of Health 43 44 Final – June 2007 PSOC Page 28 fluoridation issue arising from questions of informed consent and autonomy to make decisions, particularly in the context of public health policies. Dr Taylor explained that every decision that we make reflects a value judgement. Mostly these are taken in one’s own self-interest. However, it is important that consideration is also given to the interests of others, even where conflict occurs. Ethics is the branch of philosophy that explores value-laden decision making and conduct. Decisions made in public health policy should be a reflection of the values and beliefs of individual decision makers and of society as a whole, balancing the potential benefits and harms of all alternatives. Bioethics is the study of the moral, social and political problems that arise from medicine and the life sciences, that involve human well-being. 6.4.1 Dr Taylor suggested that the UNESCO Universal Declaration on Bioethics and Human Rights (2005) was an appropriate tool to assist in the understanding of bioethical issues. Dr Taylor explained that Article 3 of the UNESCO declaration, states that the freedom, dignity and autonomy of the individual must be respected and they have the right to make their own decisions. Article 6 considers the issue of ‘consent’ and states that: “any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice”. 6.4.2 However, Dr Thomas explained that Article 27 of the Declaration qualifies that the basic principles may be limited by law, in the interests of public safety, for the protection of public health or for the protection of the rights and freedoms of others. 6.4.3 In arriving at its conclusions, Dr Taylor urged the review group to be mindful of the basic principle to protect autonomy and the individual’s right to give consent. If supporting fluoridation, the review group must be confident that the interests of those who would be positively affected are higher than those who would be negatively affected, and that these interests must be shared. The UNESCO Declaration makes it clear that choice should only be restricted if there are clear benefits in doing so and if it can be demonstrated that the benefits are greater than any harm caused. The primary question is which is the more significant interest? 6.4.4 There is intense argument about whether fluoride constitutes a medicinal product. Many say as it is a natural occurring substance, it should not be Final – June 2007 PSOC Page 29 classified as a medicine46. Professor Lennon was asked whether fluoridation constituted mass medication. He answered that he did not believe that it was as there were parts of Britain that received their fluoride naturally, such as Hartlepool. Instead, he stated that fluoridation of the water supply required people to take fluoride for the benefit of others. He explained that he saw the decision to fluoridate as not being an individual’s decision but a decision on behalf of the collective good. 6.4.5 A contrary position suggests that because fluoride has a biological effect and is being used to prevent disease, it should be considered as a medicine. If this is the case, Professor Sheldon argues that its safety and efficacy should rely on the same standards of proof for other licensed medicines. On the basis of the evidence presented to the York Review, he suggests that would be unlikely that fluoride would receive a license if it was being considered as a drug/medicinal product as its risks and benefits have not been demonstrated with sufficient rigorous research. In his view, if fluoride is a medicine in the form of fluoridated water, it is being provided in an uncontrollable dose and without consent. It is also given to people who cannot benefit (i.e. those without teeth) as well as those who may benefit from it. He cited that the principle of informed consent i.e. every individual has the right to refuse treatment, is enshrined in the Council of Europe’s Convention on Human Rights and Biomedicine 199747. However, the same convention allows exceptions to this in the interest of public safety and the protection of public health. Many members of the anti-fluoride lobby, including the NPWA, believe that fluoride is a medicine and therefore as consent has not been sought, its provision contravenes the European Convention on Human Rights and Biomedicine. 6.5 Are there other Practical Considerations? 6.5.1 Cost-effectiveness The UK Government does not classify fluoridated water as a medicinal product. Water intended for human consumption falls within the definition of food and is thus regulated partly under the Food Safety Act 1990 and partly under water legislation. Reference, Hansard, 12 May 1999. Available from http://www.publications.parliament.uk/pa/ld199899/ldhansrd/vo990512/text/90512w01.htm 47 Article 5 of the Convention stipulates that “an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time”. However, the UK Government is not a signatory to the Convention and its principles have not been incorporated into domestic law. 46 Final – June 2007 PSOC Page 30 A cost effectiveness evaluation would be an important part of the background work that the SHA would undertake as part of the process of identifying potential fluoridation schemes. That work would be done before the SHA took a decision to proceed with a public consultation on fluoridation. Whilst surprisingly little is known about the cost-effectiveness of many common healthcare interventions, the cost-effectiveness of water fluoridation has been studied extensively over many years. Both Dr Beal and Dr Thomas referred to a study commissioned by the former Yorkshire and Trent Regional Health Authorities48 that concluded: “in terms of cost, effect and the certainty of that effect, the most cost-effective policy is fluoridation of water supplies.” In 1998 the University of York Health Economics Consortium undertook a further, detailed, examination of the costs and benefits of water fluoridation and concluded: “In areas where the average number of decayed, missing or filled teeth per child (dmft) is 2.0 or more (and especially if there are districts where it is greater than 2.6), and where the local water treatment works serve populations of at least 200,000 people, the benefits of water fluoridation are likely to be significantly greater than the costs.” To date, the PCT has not costed the benefits identified in dental health improvement arising from water fluoridation. This work was undertaken in the past by the Trent and Yorkshire Regional Health Authorities, and would need to be updated prior to any consultation on water fluoridation taking place. The World Health Organisation’s view is that “Community water fluoridation is safe and cost-effective and should be introduced and maintained wherever it is socially acceptable and feasible”49. 6.5.2 Capital and Revenue Costs Dr Beal stated that the capital costs for fluoridating Rotherham’s water is not currently known and would have to be fully costed by Yorkshire Water prior to any consultation being undertaken. Given that local water supply areas are not co-terminus with PCT boundaries, this feasibility study would be jointly commissioned by PCTs in the Yorkshire and Humber region. Sanderson, D and Wilson, A, (1994) The cost effectiveness of fluoridation, York Health Economics Consortium, University of York 49 World Health Organisation (1994) Fluorides and oral health: report of a WHO expert committee on oral health status and fluoride use. World Health Organisation, Geneva 48 Final – June 2007 PSOC Page 31 Both Dr Beal and Dr Thomas suggested that based on experience elsewhere, the capital costs would be around £2 per head of the population served and the revenue costs about 50p per head per year. For Rotherham’s population of 253,000, that would equate to £126,500 per year. This is less than the gross cost of a single additional dentist in Rotherham (annual contract value average £145,000) or the much greater cost of treating any dental disease which would otherwise have occurred. When Mr Woolloff was asked to comment on the possible costs of fluoridating the water supply, he explained that he had not done any formal costing recently, but his rough estimation was that it would cost between £2.50 and £3.00 per million litres per day. This would equate to about £150 - £200 per day for Rotherham, plus significant capital costs which would be likely to be between £2.5 and £5 million. Subject to the availability of funding, the Department of Health will contribute up to 60% of the capital costs50. The remainder of the capital would come from the NHS locally, as would the revenue. Dr Beal stated that the apportionment between SHA and PCTs has not been discussed but this would be set out in any consultation which took place, but the savings in treatment costs would benefit the NHS locally. 6.5.3 Public Consultation Dr Thomas explained that the PCT cannot formally ask the SHA to consider water fluoridation until a feasibility study has been undertaken and the probable costs estimated by Yorkshire Water. Only once this has been done would the SHA undertake a full public consultation on proposals to fluoridate the water supply. It is likely that such a consultation would be across the whole of the Yorkshire and Humber region. 6.5.4 Practicalities of fluoridating Rotherham’s Water Supply 6.5.4.1 Mr Woolloff explained that it would be hard to fluoridate Rotherham’s water without including Sheffield’s due to close links between the supplies. He stated that the actual process of adding fluoride was quite straightforward and similar to other processes already undertaken by water providers. It would involve bulk storage of the chemicals, dilution, metering, and control systems. The health and safety risks would also be similar to risks already dealt with by water providers as they already deal with difficult chemicals such as chlorine. 6.5.4.2 When asked whether artificial fluoride was any different from natural fluoride, Mr Woolloff explained that hexafluorosilicic acid would be used to fluoridate drinking water and as a chemical it is corrosive. However, once it is diluted 50 Under section, 89(6) of the Water Act Final – June 2007 PSOC Page 32 the lime and calcium in water neutralise the acid and it is no different from natural fluoride. He confirmed that it is virtually impossible for people to remove fluoride from their domestic supply if the water was fluoridated and they didn’t want it to be. Insofar as public liability insurance is concerned, the Government has accepted the principle that Water Undertakers should be indemnified against any future claims that may arise from fluoridation (other than acts of negligence). 7. CONCLUSIONS DRAWN FROM THE EVIDENCE The review group is aware that the debate about water fluoridation is polarised, the quality of research is variable and the conclusions drawn, are often contradictory. The review group comprised eight lay people with a wide range of experience, but no medical or dental background. It nonetheless endeavoured to establish a view on the basis of the evidence presented from all sides of this complex debate. 7.1 Does adding fluoride to water reduce dental decay in children? 7.1.1 There is evidence that that fluoridated water reduces dental caries rates across all communities – but will be of particular benefit to children from living in areas of deprivation and disadvantage. 7.1.2 There has been no significant improvement in dental health of 4-5 year olds in Rotherham over the last twenty years. Furthermore, many children will have significant levels of dmft well above the borough average. However, evidence suggests a slight improvement in the dental health of 12 year olds. It is not clear what factors have influenced this improvement, which has taken place without water fluoridation, but the use of fluoride toothpaste is likely to be one. 7.1.3 Access to local dentists is an issue in Rotherham. Fluoridation of water has the advantage of targeting the entire community, including those who may not access dental care and may have a poorer diet. 7.1.4 Across the UK population as a whole, dental health has been steadily improving. However, it is difficult to identify whether the improvements in dental health in fluoridated areas can be attributed solely to water fluoridation or if they are the result of general improvements to dental health. These include increased use of fluoride products, higher levels of awareness about dental hygiene, more preventative dental care etc. 7.1.5 In many respects water fluoridation is the easiest and most cost effective way of preventing dental caries in children and young people, however there are concerns, because fluoridation is the ‘cheapest’ option, that it could be seen as an alternative to investing in possibly more costly, targeted preventative interventions. 7.1.6 Preventative interventions take time to demonstrate improvements but often Final – June 2007 PSOC Page 33 rely upon short term funding, competing with other health promotion work for resources. Given the uncertainty about funding, it is therefore difficult to sustain the work continuously at an adequate level. 7.1.7 It appears that reducing the Strep. mutans bacterium in both mothers and children reduces dental caries in those children. This can be done through a combination of oral health education and the use of antibacterial mouthwashes. This may be a viable alternative to water fluoridation that carries fewer risks. 7.1.8 The review group had concerns about the diet of children and young people, particularly the consumption of sugary foods and fizzy drinks, and the effect on dental caries. They were not convinced that water fluoridation would necessarily provide adequate protection if children continued to have a poor diet and may not drink sufficient quantities of tap water. 7.1.9 Within the scope of this review, the review group did not consider in any depth other models of dental health from comparative countries. However, many European countries have made great improvements in the dental health of young people without fluoridating the water supply. The review group thought there may be some merit in further exploration of these interventions. 7.2 What are the risks? 7.2.1 There is compelling evidence from elsewhere in the country to support water fluoridation as a means of reducing dental caries particularly in younger children. However, the review group was not satisfied that long term risks had been explored sufficiently, particularly in respect of human and environmental impact. 7.2.2 The risk of dental fluorosis is significant, ranging from minor occurrence to incidents that are of significant concern to the individual affected and may require cosmetic dental treatment. However, when fluorosis does occur, it is often only visible to a dental professional. It is relatively rare for fluorosis to be present at a level that affects an individual cosmetically. 7.2.3 The review group also had concerns about the effect of fluoridation on bottle fed infants. It was not satisfied that the answers outlined in 6.2.3.2 offered reassurance of safety. 7.2.4 The review group had serious concerns about the levels of fluoride ingested by people receiving fluoridated water, particularly as the amount of water drunk can vary hugely from one person to another. Also, as fluoride is found in other products, an individual is not able to control his/her individual intake of fluoride. 7.2.5 A review of fluoridation in Ireland recommended a reduction in the concentration to an optimal level of 0.7ppm. In the UK, the recommended optimal level has remained the same (at 1 ppm) for many years and the review group is concerned that it might no longer be appropriate as fluoride is now ingested through a variety of sources. Final – June 2007 PSOC Page 34 7.3 What are the ethics of fluoridating water? 7.3.1 As community leaders, it is important that Councillors make an informed view of the ethical implications of water fluoridation, particular given the controversy about whether this would constitute mass medication. Dr Taylor’s evidence was key in informing the review group’s opinion. In line with Article 6 of the UNESCO declaration, if water fluoridation does equate to medical intervention, then the permission of all those affected is required or have compelling evidence of benefits and there is no other way of achieving outcomes. 7.3.2 The review group believes that whilst there is evidence of the benefits, the risks have not been sufficiently explored. Furthermore, it would appear that significant improvements to dental health may be achieved through other interventions. 7.3.3 Although water fluoridation appears to be a cost-effective way of reducing dental caries because of its universal effect, the review group questioned whether the cost of adding fluoride for the whole borough could be better spent improving the dental health of those communities in greatest need. 7.4 What is the current legal position and route for making changes to the water supplies? 7.4.1 In recent years the Government has supported the principle of water fluoridation to reduce dental caries and its Chief Dental Officer recommends that PCTs and SHAs consider it as a realistic option to reduce health inequalities51. 7.4.2 Rotherham PCT (together with other PCTs in the Yorkshire and Humber Region) is in the preliminary stages of exploring the feasibility of water fluoridation, but has yet to commission a full feasibility study. 7.4.3 It is not clear what the resource implications of water fluoridation would be for the PCT, particularly as the Department of Health would only contribute up to 60% of the capital costs and none of the revenue. However, any substantial reduction in dental caries may result in reduced dental treatment costs for the PCT. 7.4.4 For practical reasons it would be difficult to fluoridate Rotherham’s water without that of Sheffield’s and other neighbouring areas. The current policy of Sheffield City Council is to oppose water fluoridation. Prof Bedi, R (2005) Fluoridation of Drinking Water. guidance from the Chief Dental Officer (Gateway Ref. 5136), Department of Health 51 Final – June 2007 PSOC Page 35 8. RECOMMENDATIONS 8.1 Rotherham Metropolitan Borough Council The review group considers that although water fluoridation could benefit dental health (particularly for children in deprived communities), the longterm consequences are not sufficiently known. In addition, it is unhappy with the ethical implications of universally adding fluoride to the water supply, rather than offering fluoride supplements (and other preventative care) to those in greatest need – particularly as such an intervention would not be of universal benefit. This report therefore recommends that: 8.1.1 The Council’s current policy of opposing water fluoridation be reaffirmed. 8.1.2 The Council supports the principle of targeted intervention to reduced dental health inequalities in those communities of greatest need. 8.1.3 That this report be included as part of the Council’s response in any future formal consultation on proposals to fluoridate Rotherham’s water. 8.2 Rotherham PCT 8.2.1 Bring a report to Scrutiny on the current oral education work within the borough, its cost and effectiveness and what factors have influenced the improvements in the dental health of 12 year olds that have taken place without water fluoridation. The report should include an indication of the level of funding and staff resources that have been invested and how sustainable these elements are in future service planning and also the feasibility of improving dental health education in Rotherham, especially for young children and for the most economically disadvantaged areas. 8.2.2 Given the link between diet and dental health, the review group suggests that an assessment of the impact of recently-introduced healthy eating initiatives52 on dental health be undertaken. 8.2.3 Report the evaluation of the targeted interventions in the Rawmarsh Sure Start area (section 6.3.2.3)53 to Scrutiny, including an assessment of the feasibility of extending this approach to other communities of need. 8.2.4 Evaluate the feasibility of targeting pregnant women in communities with poor dental health, both before and after childbirth, to delay or prevent Streptococcus mutans infection. 52 53 e.g. national 5-a-day campaign and healthy food in schools initiatives At the end of 2007 Final – June 2007 PSOC Page 36 8.3 NHS Yorkshire and the Humber (SHA) 8.3.1 Prior to undertaking any formal consultation on fluoridating Rotherham’s water, seek additional evidence to address concerns about the possible harmful effects. 8.3.2 Any consultation should reflect both the benefits, costs and risks associated with water fluoridation so the general public can make an informed decision about the issue. 8.3.3 Work with the relevant local authorities when identifying the list of consultees. 8.3.4 That any consultation on proposals to fluoridate Rotherham’s water supply takes place over at least a three month period. 8.3.5 Any decision to approve fluoridation should address the issues of informed consent and autonomy and be considered in light of the UNESCO Declaration54. 8.4 Department of Health 8.4.1 When reviewing the new dental contract, examine how preventative work in children can be increased and targeted more effectively and ensure that the resources invested are sustainable over time. 8.4.2 Continue to work with food manufacturers to further reduce sugar levels in food and drink – and particularly those aimed at children. 8.4.3 Evaluate European alternatives to water fluoridation that could reduce health inequalities in respect of children’s dental health. 8.4.4 In light of the increased use of fluoride products since the 1ppm optimal level was set for the UK, reassess the appropriateness of this level. 8.4.5 Ensure that any further commissioned research into the effects of fluoride on children’s dental health also considers the longer term impact on the health of the adult population. 9. THANKS • 54 Dr John Beal, Dental Advisor to NHS Yorkshire and the Humber UNESCO (2005) Universal Declaration on Bioethics and Human Rights Final – June 2007 PSOC Page 37 • • • • • • • • • • 10. Louise Collins, Oral Health Promotion Co-ordinator, Rotherham PCT Brenda Cook, EAT Consultant, Centre for Public Scrutiny Elizabeth McDonagh, Chairman and Ian Packington, Vice-Chairman of the National Pure Water Association Jason Field, Local dentist (Chair of the Local Dental Committee) Professor Michael Lennon, British Fluoridation Professor Trevor Sheldon, University of York Dr Mark Taylor, Sheffield Institute of Biotechnological Law and Ethics Dr Nigel Thomas, Director of Dental Public Health, Rotherham PCT David Woolloff, Manager of Water Quality, Yorkshire Water Cllrs Tony Mannion, Robin Stonebridge and Shaun Wright INFORMATION SOURCES/REFERENCES • • • • • • • • • • • Acheson Sir Donald, (1998) Independent Inquiry into Inequalities in Health Report, Section 7, The Stationery Office, London American Dental Association, (2006) Interim Guidance on Fluoride Intake for Infants and Young Children [online] Available from <http://www.ada.org/public/topics/fluoride/infantsformula.asp> Accessed on 24 April 2007 British Fluoridation Society (2004) One in a Million – The Facts about Water Fluoridation 2nd ed. Manchester Directors of Public Health in South Yorkshire (2006) Improving Health - Narrowing the Divide: A Joint Annual Report of the Directors of Public Health In South Yorkshire, 2005/2006 Rotherham Primary Care Trust Government of Ireland, (2002) Forum on Fluoridation, Stationery Office, Dublin Hull, J (2007) Caries, dental (tooth decay) [online] Available from <http://www.drhull.com/EncyMaster/C/caries.html> Accessed on 24 April 2007 Medical Research Council, (2002): Working Group Report Water Fluoridation and Health. MRC London. Prof Bedi, R (2005) Fluoridation of Drinking Water, Guidance from the Chief Dental Officer (Gateway Ref. 5136), Department of Health Rotherham Partnership (2005) Neighbourhood Renewal Strategy 2005-2010 RMBC Adult Services and Health Scrutiny Panel (2006) Review of NHS Dental Provision in Rotherham –2nd February, 2006 (first part of a two stage review) Rotherham PCT (2006) Rotherham Oral Health Strategy 2006/09 Final – June 2007 PSOC Page 38 • • • • • 11. Rock, P (2000) A prevalence study of dental fluorosis in infancy, British Dental Journal 26 August 2000, volume 189 World Health Organisation (2006) Briefing on Fluoride in Drinking Water [online]. Available from: <http://www.who.int/oral_health/events/oral%20healtha.pdf> Accessed 20 February 2007 UNESCO (2005) Universal Declaration on Bioethics and Human Rights [online] Available from <http://unesdoc.unesco.org/images/0014/001461/146180E.pdf> Accessed 20 February 2007 University of York CRD, (2000): Fluoridation of the Water Supply: a Systematic Review of its Efficacy and Safety. University of York. UK. University of York, CRD (2003) What the 'York Review' on the fluoridation of drinking water really found [online] Available from http://www.york.ac.uk/inst/crd/fluoridnew.htm Accessed 13 March 2007 ANNEX 1 In 1988 the Environmental Health Committee recommended55 that subject to the approval of the Policy and Resources Committee that: 1. This council requests that the Trent Regional Health Authority refrain from any further action to add fluoride to the public water supply in the Rotherham area, which the Borough Council opposes on the following grounds: a) Fluoridation of water is not a substitute for preventative dental care and education - free and upon demand for all members of the community from a properly staffed dental service; b) The presence of dietary aluminium from water and other food sources throws into question the level of bodily absorption of fluoride and thus its role in fighting tooth decay c) Unadulterated water should community as a whole, and with the means to purchase consumer choice to those fluoridation; 55 be available to meet the needs of the not as a commodity available to those it. Fluoridation of all water would deny who question the efficacy of mass Minute 563, July 1988 Final – June 2007 PSOC Page 39 d) No quality assurance parameters exist that would safeguard the supply from a privatised water industry placing profits before standards. Until such time as the Water Authorities can control undesirable elements in the supply to comply with EEC and World Health Organisation standards it would be unrealistic to expect an ability to comply in relation to fluoride monitoring. 2. This Council urges the Association of Metropolitan Authorities to press HM Government to include water in proposals to further safeguard food quality standards. For further information about this report please contact: Caroline Webb, Senior Scrutiny Adviser or Delia Watts, Scrutiny Adviser Chief Executive’s Directorate, RMBC The Eric Manns Building, 45 Moorgate Street, Rotherham, S60 2RB tel: (01709) 822765 email: [email protected] Final – June 2007 PSOC Page 40