14

The Ethics and Legality of Fluoridation

Why should everyone be forced to ingest fluoride in their water whether they want to or not. Surely those people who want fluoride can use fluoride toothpaste or tablets?

BFS suggested answer

All water contains some fluoride. Water supplies in some areas, such as Hartlepool, naturally contain just the right amount, and tooth decay rates there are very low. Elsewhere, in Birmingham and Newcastle for example, the natural level is topped up and greatly benefits everyone in terms of better dental health for both young and old.

Drinking fluoride-free water is not a basic human right but a question of individual preference. In society individual preferences must be balanced against the common good.

BFS suggested answer refuted

The debate should not be the merits of fluoridation of the water supply, which is a public health problem, but rather the ethical aspects of universal fluoridation, which creates an untenable situation for those individuals who are intolerant to fluorides. Do we have the moral right to create a situation from which the intolerant individual has no escape? The answer thus becomes very simple. Each individual should be granted the option to choose fluoride prophylaxis depending upon his need and tolerance.

Ben F. Feingold, MD

Fluoridation is bad medicine

Fluoridation is often likened by its proponents to vaccination of children against contagious diseases. Such vaccinations are seldom contested, as it is generally recognised that where diseases are communicable or highly contagious in a public setting, they may lead to a general epidemic. This is the basis for the BFS’s answer.

But dental caries is neither communicable nor contagious. There is therefore no substantial threat to the general public health and safety. Those citizens most susceptible to this noncommunicable disease can seek treatment individually by more discretely targeted means; there is no need to mass medicate the entire citizenry.

The protection of teeth by fluoridation is merely attempting to mitigate the symptoms of disease without first trying to cure the disease. This is not good medicine. If dentists are really concerned about dental caries, why are they not openly addressing the cause: children’s eating of sweets, fizzy drinks and other refined carbohydrates (starches and sugars)?

One of the things on which both sides of the fluoridation debate agree is that too much fluoride can be harmful. It matters not, therefore, whether it is good for teeth or whether it is safe at the correct dosage: if that dosage is uncontrolled, as it is in drinking water, it is possible for people to take an overdose. Proponents will argue that 1 ppm is a controlled dose, but this is a false argument. People drink different amounts of water, depending on the weather or their health or their liking for water. This, surely, must be self-evident, and claims to the contrary cannot be soundly based. Dr Peter Mansfield, director of the Templegarth Trust in the UK, summed up the position well when he said:

No physician in his right senses would prescribe for a person he has never met, whose medical history he does not know, a substance which is intended to create bodily change, with the advice: ‘Take as much as you like, but you will take it for the rest of your life because some children suffer from tooth decay.’ It is a preposterous notion.

Fluoridation is tyranny

Fluoridation is an affront to human dignity, which is explicitly recognised as a major objective in the United Nations Declaration of Human Rights. The foundation of the legal rights and liberties of the individual is the principle of that individual’s responsibility for his conduct and his own interests, chief among which is his health.

Many people believe that in a democracy, if a majority can be persuaded to vote in favour of doing something, then that thing should be done. This belief is a perverse and false view of democracy. The principles of democracy, as enshrined in the UN Declaration, are primarily concerned with the rights of people as individuals, not with dominance by the majority. If 51 per cent of an electorate vote for medication for the entire population, they are denying the other 49 per cent their basic human rights. This is not democracy but tyranny.

If we wish to ensure the survival of democracy in Britain, Ireland and elsewhere, all of us, collectively and as individuals, have a responsibility to ensure that its principles are not undermined. We can enjoy the full benefits of democracy only if we play our individual parts in protecting those rights, both for ourselves and for each other.

In the Anglo-American democratic system of government, members of parliament and local councillors act as our representatives. As such, they have responsibilities to those who elected them. Their primary duty is to protect the basic rights of the individual citizen from possible tyranny by a misled and thoughtless majority. Compulsory fluoridation automatically violates these rights. Thus, whatever individual MPs (or in Ireland, TDs) or local councillors believe about the benefits or otherwise of fluoridation, it is their manifest duty to reject proposals to fluoridate the water.

In the UK, although elected members of parliament enact the laws that permit fluoridation, and elected local councillors are consulted about fluoridation in their areas, it is currently the members of area health authorities who decide whether a particular area shall be fluoridated – and they are not elected. Thus, they can never even claim that they have a democratic right to do such a thing.

Is fluoridation unlawful?

In the UK, Ireland and many other countries, it is a fundamental legal principle that no doctor may prescribe medical treatment for a sane and competent person without that person’s consent, even if that person is the doctor’s own patient and the doctor knows the patient’s medical history and medical needs. In view of this law, how can it be right, lawful or ethical for health authorities to prescribe medication for persons they have not met, whose past medical histories and medical needs they do not know, where the dose that each individual will take is neither known nor controlled, when it is not known whether the medication will react with other medications being taken, or even whether those persons need the medication at all?

When a medicine is not a medicine

The argument that people have a right not to be medicated without their consent has always been countered by the profluoridationist riposte that fluoridation is not medication.

I wrote to the Medicines Control Agency (MCA) about this. David Carter, Borderline Section manager, Inspection and Enforcement Division, replied that:

One of the duties of the Medicines Control Agency (MCA) is to determine whether or not a product is a medicine as defined in Article 1 of Directive 65/65/EEC. It is the considered view that fluoridated drinking water is not a medicine within that definition. Accordingly fluoridated water is not subject to the controls of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (as amended) or the Medicines Act 1968 and subsidiary legislation.

The definition in Article 1 of Directive 65/65/EEC he referred to is:

2.Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

3.Substance: Any matter, irrespective of origin, which may be:– chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.1

That seems clear and unambiguous. Dental caries is a disease in which a part of the body – the teeth – is damaged by bacterial infection. The sole object of fluoridation is:

1.The prevention of this damage by the strengthening of dental enamel;

2.Its treatment by the killing of the bacteria.

Thus, fluoridation must surely, by the definition above, be a ‘medicinal product’. I can see no other interpretation. So why doesn’t the MCA consider fluoridated water to be a medicine?

I wrote to the MCA again.

This time Mr Carter wrote back: ‘[T]he MCA has determined that the inclusion of fluoride in the water supply, in the concentration in which it is included, does not make that supply a licensable medicinal product within Directive 65/65/EEC.’ (Emphasis in the original)

This despite the facts that fluoride has been used to treat Graves’ disease (overactive thyroid)2 since 1926 at concentrations lower than the 1 mg per litre put in drinking water,3 and that underactive thyroid is treated with doses of thyroxine of the order of micrograms.4

Mr Carter also wrote that Britain and other EC member states consider that ‘such a water supply is not a substance or combination of substances “presented for treating or preventing disease in human beings”’.

I fail to understand why putting fluoride in the water to treat and prevent dental caries is not ‘treating or preventing disease in human beings’.

Am I missing something?

Is fluoridation contrary to the European Convention on Human Rights?

The Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, which came into force on 2 October 2000, defines the medical ethics that apply to the contamination of the public water supply with any substance – regardless of motive.

Water fluoridation is clearly an infringement of Article 1, which states: ‘Parties to this Convention shall . . . guarantee everyone . . . respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.’ This means that anyone who objects to taking a medication has the right to refuse consent and avoid exposure for both themselves and their family.

Article 2 states: ‘The interests and welfare of the human being shall prevail over the sole interest of the society or science.’ This clearly establishes that where there is a conflict of interests, the interests of the individual override those of the State. The current policy, that health authorities and water companies should decide whether fluoride is to be fed to the public at large in the face of objections, is clearly in breach of this.

Article 5 states: ‘An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.’ Water fluoridation has never been introduced with the consent of all the people. It requires only one person to withhold his or her permission for the imposition of water fluoridation to be unethical under the provisions of the Convention, and by association, under any code of medical ethics. This article also requires that: ‘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.’ If the government decides that drinking water is to be fluoridated, every single person within the area to be fluoridated should receive a full, easily understood, balanced and accurate statement of both the advantages and the disadvantages of fluoridation. This must be accompanied by a full risk analysis for a lifetime’s exposure, supported by clear indications of where and how any member of the population could verify that the literature presented was scientifically correct and unbiassed, and that adequate safeguards were in place to protect their interests. Finally, Article 5 states: ‘The person concerned may freely withdraw consent at any time.’ Thus, if any person says he or she no longer wishes to be fluoridated, fluoridation must cease for that person.

The European Convention as it applies to Britain and Ireland

The European Convention, which is now accepted as a reasonable representative framework of public and medical ethics for dealing with medical interventions, was incorporated into the UK’s new Human Rights Act, which also came into force on 2 October 2000. It applies to medical interventions practised both at the individual level and on populations. It requires signatories to establish legislation that includes legal sanctions, and it requires compensation for individuals who have suffered undue damages following any medical treatment or research.

Although the British government is not a signatory to the whole of this Convention, the European Court has ruled that what may once have been an allowable restriction of private rights may not be allowable now, and that courts are now required to interpret the new Civil Procedure Rules in ways that are compatible with the European Convention, and not necessarily with the British interpretation of it.

Action against public authorities and individuals

Under the Human Rights Act in the UK, action can be taken only against ‘public authorities’. Under the terms of the Act:

All suppliers of services to the public are considered to be ‘public authorities’: national government, local councils, schools, NHS hospitals, water supply companies, regulatory bodies such as Offwat, public advice services, and the courts. Water companies have an obvious risk under the new Act.

The Act also applies to any individual whose functions are ‘of a public nature’. Thus, dentists and BFS members who advocate fluoridation, and who do so while being funded by government, will be individually liable for damages should their advice result in damage to any person – a position that carries serious potential financial risk.

Food manufacturers and packers will also have to be careful not to use water that may contain fluoride added improperly by a public authority. Although in this case, whether the consumer would bring an action against the water supplier or the food manufacturer could exercise legal minds.

Article 3 requires the State to prevent breaches of the Act by one private individual against another and to prevent violations of rights by private persons – this would apply to corporate entities as well as individual persons. Any exclusion incorporated in new British legislation with the purpose of allowing such compulsory medication as fluoridation, therefore, may well be seen as a breach of the European Convention – and European legislation takes precedent.

The European Charter of Fundamental Rights

While paying lip service to the new Human Rights Act, the British government has not signed up to all its conventions. In so doing, the government believes it can override the law as it applies to fluoridation in England and Wales (the law in Scotland is different), as such laws as the Water (Fluoridation) Act can be retained even though they are clearly contrary to medical ethics.

But on the horizon looms another draft act, the European Charter of Fundamental Rights, which challenges this unilateral declaration of exemption for England. The British government has endorsed this draft act. When it comes into force, any British legislation, such as compulsory medication without consent, that permits the State to violate the rights of the people will be in violation of the European Convention. The situation at present is that the new Human Rights Act as it applies to fluoridation must be tested in the courts. When the Charter comes onto the statute books, that will spell the end of fluoridation in this country, in Ireland and in any other member country of the EU.

Medical experimentation

On 21 February 2001, The Independent reported that children at a dozen nursery and infant schools in South Yorkshire were to be given ‘dental milk’ which had been treated with fluoride.

This was mentioned at the end of Chapter 6 as an example of the lack of knowledge displayed by the BFS. But there is another side to this story — a human rights dimension. The plan is to have specially labelled bottles of fluoridated milk, which will be provided only to children whose parents have given written consent. Herein lies the first legal problem.

Dr John Rental, the British Dental Association’s chairman warned in the article of possible legal action from parents of children given treated milk by mistake. ‘The issue of public health measures is always loaded with problems about consent, safety and liability,’ he said. ‘With fluoride, there is an issue if a parent has not given consent and then their child drinks another’s fluoride milk.’ Sue King of the North and Midlands Against Fluoridation campaign group wants to know how teachers are going to monitor this.

The second legal problem is that, as the BFS cannot have definitive proof of the efficacy and safety of this measure, what they are initiating is an uncontrolled experiment using infants as the guinea pigs. That opens up a whole new field of potential litigation.

Conclusion

Fluoridation as it is now practised has many ethical and legal implications. Health authorities, local councils and their individual members may be liable under the Human Rights Act if they support fluoridation, since the practice clearly violates both medical ethics and human rights. The Act is particularly concerned that the rights of children – the very people at whom fluoridation is aimed – should be protected. Thus, education departments will be in breach of the Act if they permit the use of fluoridated water or milk in schools.

The impact of the new Human Rights Act and the forthcoming European Charter of Fundamental Rights is likely to be far wider than many people realise. It is ironic that the Act states that the State is legally responsible for protecting the rights of the individual – when it is the State that is in violation of the Act in its promotion of fluoridation. Our rulers and decision-makers should consider very carefully the fact that failure of British government bodies to conform to the Convention’s standard of ethics may place them in a very precarious legal position.

References

1.365L0065. Council Directive 65/65/EEC, 26 January 1965, on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products. Chapter I: Definitions and scope, Article 1. This may be accessed at http://europa.eu.int/eur-lex/en/lif/dat/1965/en_365L0065.html.

2.Goldemberg L. Action physiologique des fluorures. Compt Rend Soc Physiol (Paris) 1926; 95: 1169.

3.von Mundy G. Einfluss von Fluor und Jod auf den Stoffwechsel, insbesondere auf die Schilddrüse. Münch Med Wochenschrift 1963; 105: 234–47.

4.Monthly index of medical specialities (MIMS). London: Haymarket Publishing Services, 2001.