The ethics of water fluoridation from Dental Law and Ethics

 

The ethics of water fluoridation from Dental Law and Ethics

By Stephen Hudson30 October, 2018Members, Uncategorized

 

Introduction

Water fluoridation is a controversial topic to some people and has, over the decades since its implementation, promoted furious debate, even within the dental profession.  The idea that the dental profession is 100% behind water fluoridation is nonsense, as can be seen by online forums and social
media posts.  It is credited by many as being a public health miracle but is castigated by others who see it as a danger to the public.  So before we start discussing the ethical basis for water fluoridation, I feel it prudent to first briefly outline the legal position in this country that allows for it.
I will admit that I have an inherent bias against water fluoridation based on my own beliefs.  I feel it is therefore ideal to see if my opinions stack up when scrutinised by the ethical principles and the available evidence.

Legal basis

Fluoride in the drinking supply occurs naturally in some areas.  In others, it has been artificially added, and in the UK, the first instances of artificial fluoridation was in the year 1955.  Watford, Kilmarnock and part of Anglesey were chosen as the first sites and a 5-year study done against three control sites.  The results of that study indicated fluoridation lowered the caries rate.  Prior to 1974 responsibility rested with local authorities as part of their duties for promoting public health.  However, in 1974 this responsibility was passed to the newly created health authorities.
In 1985 the government passed the Water (Fluoridation) Act 1985.  This act allowed local health authorities to increase the fluoride content in the water artificially and also outlined what public consultation was required.  Something I find interesting when it considered consultation, is that the act used the word SHALL instead of MUST which suggested that perhaps it wasn’t a mandatory requirement.  Still, the need for public consultation did see the implementation of fluoridation stall, and by 1990 less than 6 million people were drinking fluoridated water.
The 1985 act was possibly a reaction to one of the few court cases regarding water fluoridation.  In Scotland, McColl v Strathclyde Regional Council [1983] S.C. 225, Lord Jauncey found that “It was beyond the council's legal authority to fluoridate, it might harm consumers, it constituted a breach of duty, and that fluoridation was supplying a medicinal product without the required licence”.  He ruled that that fluoridation should fall under the Medicines Act 1968.
The later consolidation of the 1985 act into the Water Industry Act 1991 sections 87 and 88 also impacted this.  It was under the Water Industry Act 1991 that the court case R. (on the application of Milner) v South Central SHA occurred. Here the judge determined that
“Public opposition was only one argument to be weighed in the balance by a health authority in reaching its decision and could not trump any public health argument in favour of fluoridation”
Possibly one of the causes of the lack of fluoridation was the wording of the actual legislation in both the Water Fluoridation Act 1985 and the Water Industry Act 1991, an idea put forward on the British Fluoridation Society website: “To a large extent, it was disagreement between health authorities and water companies over the meaning of the word ’may’ that blocked progress on fluoridation…”
There were further amendments to the law by S.58 of the Water Act 2003.  The judicial stance that public opposition was not a deciding factor in water fluoridation was also adopted in further legislation that impacted fluoridation.  The Health and Social Care Act 2012 amended the Water Industry Act 1991 with the effect that responsibility for conducting public consultations on fluoridation was moved from Strategic Health Authorities (SHAs) to first tier Local Authorities with effect from 1st April 2013, taking everything pretty much back to where it started.  Interestingly, this statutory instrument required the local authority to judge both local support and also the strength of the scientific evidence whilst also considering the cost.  So we can already see some of the four ethical principles creeping into the legislation there.
Finally, we mentioned the 1985 judicial opinion that fluoridation the water supply was the delivery of a medicinal product.   The Medicines and Healthcare Products Regulatory Agency (MHRA) disagrees with this stance: “As drinking water is quite clearly a normal part of the diet the MHRA does not regard it (fluoridation) to be a medicinal product”
This does contradict the European Union’s definition of a medicine - “presented as having properties for treating or preventing disease in human beings” - See infra, Article 1.2 of the EU Directive 2004/27/EC on Medicinal Products for Human Use.  This may however not be relevant two years from now. So because we have differing views, I am not able to reach a conclusion on this particular aspect.

Arguments for Water Fluoridation

It is unsurprising to find advocates for water fluoridation among the dental profession. But it is not just the dental profession. The American Centre for Disease control and prevention named water fluoridation one of the 10 great public health achievements of the 20^th century.  The American Dental Association have set out the 4 main reasons why they recommend water fluoridation (although they provide no evidence to back up any of their statements).  These reasons are

• Prevents tooth decay, protecting all age groups
• Safe and effective
• Saves money compared to treating tooth decay
• Because fluoride is naturally occurring in some water supplies it can be deemed to be natural

But is there any evidence that it actually works?  This is an important question, because that will greatly impact the ethics behind its use.  There have been several major studies on water fluoridation, and the results have been inconclusive.
Jones (1996) argued that  “low levels of fluoride, less than 0.1 mg l–1, were associated with high levels of dental decay”.   The research done by Whelton and O’Mullane (2003) in Ireland also came to a similar conclusion: “The study shows that decay rates in Northern Ireland (un-fluoridated) are of the order of 50% higher than in the Republic (fluoridated)”
A report by Public health England in 2014 found that 15% fewer five-year-olds experienced decay in fluoridated areas and that 11% fewer 12-year-olds experienced decay.  The report did seem to demonstrate that fluoridation is an effective preventative method for tooth decay However, not all the research found this.  For example, the Cochrane Review did a systemic review into Fluoridation.  They stated that “We did not identify any evidence, meeting the review's inclusion criteria, to determine the effectiveness of water fluoridation for preventing caries”.
Also, the much touted York Review seemed to give a big thumbs up to water fluoridation.  However, when looked at more closely, the results were not as positive as were first thought.  As reported in the British Dental Journal (2002) ^“The review was critical of the body of evidence that was identified”.  The authors of the report even went so far as to write a follow-up statement to their review in the CRD (2003):
“We were unable to discover any reliable good-quality evidence in the fluoridation literature worldwide. What evidence we found suggested that water fluoridation was likely to have a beneficial effect, but that the range could be anywhere from a substantial benefit to a slight disbenefit to children's teeth”
Further research from Saudi Arabia by Dosari (2004) indicated that “There was no linear correlation between water fluoride level and caries experience”.  There are also arguments against water fluoridation, and we shall look at those as we examine the four ethical principles.

The key ethical questions relating to water fluoridation

To my mind there are several key questions that need to be answered

• Is fluoridation mass medication, and if it is, is it acceptable to mass medicate a whole population in a way that makes it almost impossible to avoid without their full consent?
• Do the benefits of fluoridation outweigh any risks?
• If we are mass medicating, is it acceptable to do this when the dose cannot be controlled?
• If the benefits are as described, is it acceptable to deprive fluoridation to those who could benefit from it?
• Is it for the people to decide or the state?
• And the most important question of all: does fluoridation meet the four ethical principles?

I will try and answer these whilst determining how the ethical principles relate to fluoridation.

Does Water Fluoridation respect the concept of autonomy?

For this essay, I will be utilising the Three Condition Theory of autonomy put forward by Beauchamp and Childress to assess whether fluoridation meets this ethical standard.  It would be very easy to get wrapped up in a long discussion on autonomy and whether fluoride is a medicine, but I think what would be easier is to simply accept that fluoride is added due to its reported therapeutic effect.
Intentionality: To meet this standard for autonomy the individual must intend to drink the water for the purpose of obtaining the benefits of fluoridation, even if that is only part of their intention.  If their intention is purely hydration, it could be argued that the addition of fluoride breaches this part of the ethical principle.  If I am thirsty and I drink water that is fluoridated, is my intent even remotely concentrated on the therapeutic benefits of that fluoride?
Understanding: Can the British population, whose average reading age is eleven, understand the proposed benefits of water fluoridation?  And what about people who have not been informed, who do not know the water contains fluoride?  When I bought my practice in 2000, I wrote to the local water supplier to ask if the water they supplied to my practice and the surrounding neighbourhood was artificially fluoridated.  Whilst they did show me that there had been 3 episodes in the last 6 months where the water supply was accidentally contaminated with faecal matter, they were unable to answer my question about fluoride. One would hope matters are different now, but how can the local authority ensure everyone is informed that the water they are drinking has been altered so as to provide a therapeutic effect?  What about people travelling to the area from a non-fluoridated area, businessmen and tourists?  If even one competent adult is drinking the water without the knowledge that it contains fluoride, surely this means again this ethical principle is breached.
Non-Control: There should be no coercion.  The problem arises in that we, as human beings cannot live without water.  It is a requirement for life.  So whilst there are alternatives available (bottled water, filtration systems), these are more expensive than drinking tap supplied potable water, and this discriminates against those of a lower wage.
Also, drinking is not the only way humans consume water.  We use it in cooking and bathing, and there is some speculation that fluoride can be absorbed through the skin, which negates its therapeutic effect. Unfortunately, there is very little that the average person can do to negate this aspect, thus should they wish to avoid fluoridated water completely, as is their autonomous right, it is almost impossible to do so.  This is one of the big arguments against water fluoridation, that it is mass medication of the population without consent, and that argument does seem to hold ground when scrutinised.
As fluoridation is now the decision of the local authority there is the argument that this is part of the democratic process.  But if that is the case:

1.   a large proportion won’t have voted for those representatives

2.   whilst there is a requirement for public consultation, there is no overriding requirement for the publics views to be the primary deciding factor on whether water should be fluoridated.

Is this not classic paternalism, the very opposite of autonomy?, Water is life, and so it can be strongly argued that the coercion, whilst not coming directly from the state, can come indirectly due to our inherent need to consume the product.  One cannot even use the principle of therapeutic privilege here, because the pop, on the whole,e whole could not arguably be harmed by being informed their water is fluoridated.
Up until now, we have been discussing adults who are competent to make decisions about their own health.  If water fluoridation is potentially paternalistic (even if it is more a soft rather than hard form), especially to those on a low income, what about children and those deemed mentally incompetent?  Who decides for them?  The state or those with either parental or legal responsibility?  Does fluoridation risk compelling the incompetent to drink fluoridated water?
My initial opinion, therefore, is that water fluoridation fails the ethical principle of autonomy because the prevention of tooth decay can be achieved by other means that allow for autonomous choice.  A counter-argument to this is that the very alternatives to water fluoridation may not be readily available to those with limited funds or limited understanding of the issues, and I will address this later.
And there is also another issue that comes to mind.  If Fluoridation is done for therapeutic benefit, then does this not set a precedent?  There have already been talks about adding other compounds to the water, for example, Lithium and Statins.  I believe that water fluoridation therefor also risks the nefarious slippery slope of paternalism that threatens the very concept of personal autonomy.  The argument that fluoridation is OK because it occurs naturally in some areas does not hold merit to me, because in its additive form it is far from natural, being in some instances an entirely different compound.
I am therefore in agreement with Cohen and Locker (2001) in their statement that “the demands of moral autonomy cannot be made compatible with what could be regarded as the involuntary medication of populations.”

Does Water Fluoridation respect the concept of Nonmaleficence?

Whatever else, we should do no harm, or the least harm to create the most benefit.  We will therefore need to investigate the safety of water fluoridation because any harm must be outweighed by the benefits (for example a dental anaesthetic injection can be uncomfortable, but it is preferable to the pain that can be caused by its absence).  There are a lot of scare stories on the internet about fluoride and water fluoridation.  The image in the mainstream media is far from favourable.  From conspiracy theorists like David Icke and Alex Jones, to conventional media like the Daily Mail, there is a message that fluoride should be avoided, with headlines like:

• “Is fluoride good for us?” (Briffa)
• “Is your tap water poisoning you? The troubling question on everyone's lips as scientists warn fluoride put in water to protect teeth could spark depression” (Naish 2015)
• “Fluoride 'could give you bone cancer' claim experts as they call for a halt to adding the chemical to drinking water” (Curtis 2015)

It is therefore important to examine the arguments made against fluoridation, which I think are best summed up by Peckham (2014) who suggested that the benefits do not outweigh the risks:
“This review argues that the modest benefits of ingested fluoride in caries prevention are thoroughly counterbalanced by its established and potential diverse adverse impacts on human health”
So what are the reported risks?

Cancer:  Opponents often claim that fluoridated water is carcinogenic in nature, and a lot of research has been done in this area.  From the research I have read, there is no evidence that there is any carcinogenic risk from fluoridated water.  This was a finding backed up by the York Review on page 58 of the report, stating that “from the research evidence presented no association was detected between water fluoridation and mortality from any cancer”
Fluorosis:  Fluoridation causes fluorosis, there is no denying this, and this can vary from mild to severe.  The York Review found high levels of fluorosis, as reported on page 45: “The prevalence of fluorosis at a water fluoride level of 1.0ppm was estimated to be 48%”.  The question then arises, is this an acceptable price to pay for the reported benefits of fluoridation?  As there are alternative approaches to providing fluoride, and as tooth decay could better be addressed by removing the cause, local and central government has a challenge to say that this potentially disfiguring condition is an acceptable price to pay when children can readily access sugar so easily and so often.  As a professional, I am challenged by the lack of public information awareness campaigns, by the prevalence of vending machines in schools and the poor attendance of children at a dental practice.  To think that fluoridation is somehow a silver bullet concerns me.
Hypothyroidism: Professor Peckham, who seems to be an opponent of water fluoridation has done several research papers on the safety of fluoridation.  Whilst not proving a correlation, his 2015 paper did suggest there might be a link between an underactive thyroid and water fluoridation.  I could find no evidence to prove this link, however, and as such, I have chosen to reject this risk.
IQ: “The Nazi’s put in the water to the death camps” is an accusation often hurled at fluoridation, the idea being that it lowered the IQ of the inmates.  I have not been able to find any evidence that the Germans actually did this, but there has been a significant amount of research done on this particular aspect.  Mindal (2016) found that “Children residing in areas with higher than normal water fluoride level demonstrated more impaired development of intelligence and moderate dental fluorosis.”  Sebastian (2015) found that “School children residing in an area with higher than normal water fluoride level demonstrated more impaired development of intelligence when compared to school children residing in areas with normal and low water fluoride levels”.  And Anna (2012) also found that “In conclusion, our results support the possibility of adverse effects of fluoride exposures on children’s neurodevelopment”.  All these conclusions, and dozens more like them, have come post York Review which found that there was no effect on intelligence.
Skeletal Problems: On page 53 of the York Review, the authors showed they found no evidence for this risk, and that there were no associations between water fluoridation and hip fractures.

Much of what is put out by the anti-fluoride lobby is pure fiction and scaremongering.  They tout the fact that fluoride is a poison but fail to mention that poisons are dose-dependent.  From an ethical stance, we are purely concerned with whether the benefits outweigh the risks. It is my personal opinion that they do not.  It is an imperfect means to provide a benefit which has dubious evidence for its efficacy at best and where there is clear evidence that it can cause harm.  Is it right for the population as a whole to accept those risks for the reported benefits?  I would argue it is not and I feel that I have no option but to take the stance that fluoridation fails the ethical test when it comes to Nonmaleficence.

Does Water Fluoridation respect the concept of Beneficence?

This theory advocates that the best interests of other people are met.  A moral society should do whatever it can to protect and ensure that the next generation (the children) are allowed to grow to their true potential.  I mention this because it is primarily children that fluoridation is aimed at.  However, one cannot escape that, in trying to perform this beneficent act, the fluoridation of water is an imposition on the population at large, with a disproportionate impact on those with lower social status, what some would call the working class.  It thus creates a definite conflict with personal autonomy.  Perhaps a better alternative that respects both autonomy and beneficence is the use of public health campaigns like free toothpaste and supervised brushing in schools.  These directly involve the people involved through education, direct delivery and supervised care, rather than the more haphazard, shotgun blast approach of fluoridation.
Advocates of fluoridation would argue that this treatment benefits everybody equally, but this does not answer this conflict between autonomy and beneficence.  This also presupposes that the benefits of fluoridation have not been exaggerated.  The available evidence seems to indicate that there is a reduction in dental caries experience in fluoridated areas, but the proof is far from definitive, mainly due to the poor quality of the available research.  Really, therefore, before we can show that fluoridation can be used for the benefit of all, the evidence needs to be there.   I do not feel that the benefits significantly outweigh the risks already discussed with the available evidence.  Prove to me that it works, then we can have a proper debate.
Tooth decay causes pain and suffering, but it is rarely life-threatening, and even if the evidence behind fluoridation is to believed, it is not a cure for the disease.  It merely lowers the risk.  Once cannot use the arguments that would be used to combat national medical emergencies because caries is rarely a threat to life. It may be considered that we have a moral duty to protect those who cannot help themselves (children) but is it for the state to do this in this fashion for something that, as we have seen, has been proven to cause definite harm?  Most of Europe has seen marked reductions in caries rates over the decades without having to resort to water fluoridation, something that has been seen across this country also.  I feel the best interests would be met by a national dental public health campaign, with the empathise on sugar reduction.

Does Water Fluoridation respect the concept of Justice?

There are different theories on justice, and there is little room for me to discuss them in this assignment in great detail.  When we come to the four traditional theories of justice:

1.   Utilitarian theory, which states that the greater good goes to the greatest number of people, it would seem at first glance that fluoridation meets this (if we assume it is effective)

2.   Libertarian theory favours an individual’s rights. Clearly, fluoridation contravenes this.

3.   Egalitarian theory, which states that people should be treated the same. Yes, they all get the same water supply, but do we all take delivery of it in the same way?

4.   The Communitarian theory asks “is what I am doing make society better?” It is all about the good of society

In basic terms though, Justice is concerned with fairness and equality.  Is water fluoridation a just way of distributing resources?  Well if it works, then it will reduce dental caries.  Roughly forty-five thousand, six hundred children had teeth extracted in hospital under general anaesthetic in the 2013-2014 tax year in England, costing tens of millions of pounds.  This was also theatre space that could have been used for other conditions, thus stretching available resources and delaying operations.  For a condition that is predominantly preventable, this is an unacceptable burden on socialised medicine, not to mention the burden it imposes on the young bodies undergoing the procedure.
Surgical intervention is always going to be the more costly form of dealing with the problem.  But it is very easy to concentrate on tooth decay, rather than what is causing it, the predominant causative factor being dietary sugars.  As we know there is a recent surge in empathise that sugar is a cause of a great many of our ills.  Heart disease, high blood pressure, obesity and diabetes are all linked to high sugar intake and wreak havoc within the health service costing it billions.  Whilst water fluoridation (if the advocates are to be believed) reduces caries and thus saves money from dentistry, does it perhaps add a perverse incentive?  An understanding of human nature might suggest that, if people felt that there was some “magical” protective chemical in their water, they might not be so inclined to reduce their sugar intake, thus increasing the risk of other, more serious diseases.
Fluoridation might not be as fair as we think.  From a cost perspective in treatments avoided and the relative cheapness of its implementation (Studies in the USA show that, in 2017, fluoridation costs an estimated $1.04 per person-year on the average) it may appear at first glance that it might be the most cost-effective use of available resources (reportedly lowering surgical intervention for tooth decay).  It could, however, be argued that this cost saving is offset by the later need to intervene and treat fluorosis.  This might not even be an impact on the public purse, because as we hear time and again from the NHS (NHS Choices. 2017), cosmetic dentistry is not generally available.  So if the state is not willing to repair the damage caused by their intervention, is this not again impacting the lower social classes?  Where is the fairness there?

Summary

One of the conclusions I have come to is that fluoridation is a form of mass medication.  It is not an essential nutrient; in fact, the human body limits the amount in human breast milk no matter what the concentration of that consumed by the mother.  The only reason to add it is for its therapeutic effects. And I would argue that no health professional would want to prescribe a medication without some means of controlling the dose.  This cannot be done with water fluoridation.
So to answer the highlighted key ethical questions:
1) Is fluoridation mass medication, and if it is, is it acceptable to mass medicate a whole population in a way that makes it almost impossible to avoid without their full consent?  From the research I have done I would argue that it is.  Whilst beneficence is often placed above autonomy when it comes to matters of public health, they have to be taken together with the other ethical principles.  With the harm that is potentially caused, and the lack of any definitive evidence, I cannot see how the autonomy of the individual can be overridden through mass medication that allows the wealthy to escape its impacts should they wish to.
2) Do the benefits of fluoridation outweigh any risks?  No.  I feel that the evidence for fluoridations benefits are poor, whilst the evidence for its evident risk of harm are strong.
3) If we are mass medicating, is it acceptable to do this when the dose cannot be controlled?  For fluoridation to be effective, the water has to be consumed, and like with any medication that is taken outside of direct medical supervision, there is no way to control this.  So there is no way to determine if the people it is aimed at are even drinking it.  I have often heard the comment from a parent that their child “doesn’t drink water”.  Whilst at one part per million there is very little risk of overdoes from the water itself, we have to remember this is not the only source of fluoride, and that the effects could be cumulative.  If we are going to argue that fluoridation is a form of medication, then it’s dose must be controlled, and this cannot be done through the public water supply.
4) If the benefits are as described, is it acceptable to deprive fluoridation to those who could benefit from it?  Fluoride is limited in breast milk and it is not an essential nutrient suggesting it is not required for health.  To just rely on water fluoridation is lazy and risks being ineffective.  From an initial cost benefit it appears attractive, but as I have stated, I believe that this in itself is a form of inequality.  To use the emotional argument that its “for the children” deflects from the public duty that we as a society should be doing more for our children than dumping fluoride in the water they might not even be drinking.  I think it actually risks harming proper oral health delivery.
5) Is it for the people to decide or the state?  Our constitutional monarchy states that the people, through their elected representatives have the final say in how the country is run.  However, it is fair to say that the average person, with a reading age of 11, might not be able to understand complex medical issues and that policy should be guided by experts in the field.  Until definitive evidence is discovered the proves water fluoridation works however, I feel it is for local populations to decide on fluoridation.
6) Does fluoridation meet the four ethical principles?  From what I have found, I don’t believe it does.  It definitely doesn’t meet the principle of autonomy.  Its lack of clear evidence puts a question mark on its beneficence and the fact that it has been proven to cause harm indicates it fails the Nonmaleficence test.  I could not reach an opinion with regards to Justice.

I Therefor reject the concept of water fluoridation as unsound when based against all four principles of medical ethics.

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