In the light of past experiences with DDT, BSE, thalidomide, et cetera, whenever there is doubt about the safety of any medication now, medical professionals recognise that it is safer to err on the side of caution. This is known as "the precautionary principle".
Doug Cross BSc CBiol MIBiol is a Consulting Ecologist and Expert Witness. In November 2000 he asked the Medicines Control Agency some pertinent questions about the the use of the "precautionary principle" in respect of water fluoridation. Here is his letter and the replies he received:
Dr Gordon Munro
Divisional Director
Medicines Control Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
2nd November, 2000
Dear Dr Munro,
The role of the Medicines Control Agency in the prophylactic administration of fluoride
as a medication in the public drinking water supplies of Great Britain.
I am writing to you as a private individual and professional scientist, and not on the behalf of
any activist organisation. It has recently been reported in the Press that the Medicines Control
Agency has ordered the withdrawal of polio vaccine on the grounds that its use may have been
authorised on the basis of 'misleading information', and that the Agency has invoked the
'precautionary principle' to avoid any possible risk from the use of this vaccine. It is further
reported that the risks posed by this product are in fact "unmeasurably small".
I am concerned that the same degree of precaution is clearly not being applied in other cases in
which the public is being exposed to quite measurably harmful medication.
My particular concern relates to the use of hydrofluorosilicic acid and related compounds as a
prophylactic medication administered in the public water supply of this country and
elsewhere, supposedly for the control of dental caries. (For your convenience in identifying
issues that I would like clarified, I have highlighted the relevant sections in blue.)
1. I am here assuming that the chemicals employed in water fluoridation are recognised as
medicines, and are therefore subject to control and license by the Agency, and my questions
are based on that presumption. If, however, these chemicals are not so licensed, then whilst
the following material may be redundant, I would appreciate an explanation of how the public
is permitted to be exposed to a dangerously cumulative toxic waste product, administered to
them as a Health Service-sponsored remedial treatment for a recognised medical condition,
without such substances falling within the remit of the Medicines Control Agency?
Misleading information used to support the policy of water fluoridation
The recent York University Review of fluoridation has been lambasted as "total scientific
fraud" by Andreas Schuld, head of Parents of Fluoride Poisoned Children. Dr Schuld has
published documentary evidence that he believes supports his claim that the York panel
deliberately misquoted the conclusions of a number of reputable studies on the role of fluoride
in thyroid dysfunction, slipped epiphyses, delayed eruption of teeth, and the role of the
fluoride-aluminium compounds in SDAT. It was also highly selective - and prejudicially so -
in the material that it identified as being within the remit of the Panel to review.
It does appear, therefore, that the York Review, upon which the Government's policy of
adding this medicine to the public water supply is based, itself constitutes 'misleading
information', and of an order of deception far greater than that involved in the recent bovine
serum polio vaccine incident.
I am concerned that its use is not merely continuing, but will expand to affect virtually the
whole of the British public. Putting the interminable scientific controversy regarding its
efficacy as a treatment for dental caries to one side, my research into its use suggests that there
are serious public issues that need to be addressed with some urgency, because fluoridation
violates both the legal requirements and the ethical codes regulating the administration of any
substance to the public as a medicinal product. I have provided the basis of my concern below,
and would be grateful if you could clarify the position of the Medicines Control Agency in
respect of the use of these substances.
Fluoridation of the public water supply as a prophylactic measure for health
management..
Prophylactic medication of the public water supplies using fluoride-containing compounds of
any sort as if they are a medicine is improper both ethically and legally, and licensing its use
may therefore constitute both medical malpractice and an infringement of the rights of the
public. As the official body responsible for the licensing of medicines I would be grateful for
an explanation of the reasons for permitting what appears to be a serious abrogation of the
Agency's responsibilities to the public. My concerns are as follows.
Ethical constraints
Fluoridation violates the protocols set out in the Council of Europe's Convention on Human
Rights and Biomedicine - particularly Articles 3-6 and 15-17, which deal with issues of
consent, disclosure and the imposition of medication on minors and the mentally incompetent,
and the ethical constraints imposed upon medical research.
It is my understanding that any application of medical treatment that violates this code,
regardless of whether or not the British Government has endorsed it, is in need of urgent
scrutiny by any national medical profession.
2. Are not actions that are unethical under this Convention liable to be equally so under any
enlightened code of medical ethics and protocols, and expose medical authorities, or their
implementing agents such as the water undertakers, to action in the courts?
General Human Rights infringements
Water fluoridation is in violation of the UN Convention on the Rights of the Child,
specifically with respect to compulsory medication and the requirement for informed consent
by the guardians of minors.
It is also in violation of the Human Rights Act 1998, Articles 3 and 8, relating to inhumane
treatment (including compulsory medication) and consent; this is confirmed in the Home
Office Guidelines on the Human Rights Act.
The new European Charter on Fundamental Rights provides the public with access to the
European Court in cases in which the British Government fails to remedy violations of human
rights, and effectively abolishes the improper exclusions which are included in the Human
Rights Act for pre-existing legislation that permits the Government to continue to violate such
rights. These exclusions would, if retained, include the Water (Fluoridation) Act and the Water
Industry Act, which specifically permit the administration of this medicine to the public
without express consent.
Failure of fluoridation studies to acknowledge the unethical status of the practice
3. The administration of any prophylactic medication (including fluoridation) to the general
public, regardless of their individual need or susceptibility, is unethical. In such cases, should
not the precautionary principle be even more strictly applied, particularly when that
medication is known to present very serious health risks to a considerable proportion of the
exposed population?
4. In this specific instance, the majority of the exposed populations is outside the target group
(young children), and is therefore incapable of benefiting from its alleged primary medical
effect - for example, what 'benefit' does medicating the mainly elderly toothless members of
the public?
It is a repeated observation of independent referees that much if not all of the studies
purporting to validate the use of water fluoridation as a cariostatic intervention are themselves
in breach of medical ethics because they fail to comply with strict requirements for
investigative protocols under which medical research must be carried out.
For example, the American Medical Association states under section E-2.30 - Information
from Unethical Experiments - that
"Should editors and/or authors decide to publish an experiment or data from an
experiment that does not reach standards of contemporary ethical conduct, a
disclaimer should be included. Such disclosure would by no means rectify
unethical conduct or legitimise the methods of collection of data gathered from
unethical experimentation.
"This disclaimer should: (1) clearly describe the unethical nature of the origin of
any material being published; (2) clearly state that publication of the data is needed
in order to save human lives; (3) pay respect to the victims; (4) avoid trivialising
trauma suffered by the participants; (5) acknowledge the unacceptable nature of
the experiments; and (6) endorse higher ethical standards."
Dental caries is not a life-threatening condition, nor is it contagious. I am therefore at a loss to
understand what possible ethical justification there can be for supporting a State-sponsored
policy mandating the exposure of the whole population to this intervention, especially since
alternative - and far more efficacious - remedial treatments are available.
The research on which the pro-fluoridation stance is based is almost all unethical and
misleading, invalidating its acceptance - or event its appraisal - by the recent York Review of
fluoridation.
Vulnerable groups - calcium deficiency in the UK.
Exposing the public at large to a cumulative, persistent and toxic chemical, simply to treat a
minority group for a non-life-threatening condition, fails to cater for those members of the
public who are more susceptible to adverse reactions. To take but one example, the US
Environmental Protection Agency states that fluoridated water may be harming the 44% of
the American population that are calcium-deficient. Since a similar proportion of British
young people is also calcium-deficient, due to their poor diet, the risks to this anonymous (and
large) minority alone are such as to indicate that the indiscriminate administration of a
medicine of dubious efficacy and known toxicity to high-risk members of the public
represents a far higher degree of risk than the "unmeasurably small" risk that precipitated the
removal of the possibly tainted polio vaccine recently.
It does appear to me that that there is a lack of consistency in evaluating medicine safety,
which supports an unfortunate politically motivated intervention that would, if proven,
provide rich grounds for lawyers seeking compensation for fluoride-induced damage to
individual members of the British public.
The need to exercise the precautionary principle for public water supply fluoridation.
There is abundant reliable evidence of the dangerous risks to the public of the accumulation of
fluoride in the environment. Although it is not the only source of this contamination,
fluoridating water enables large quantities of it to invade other parts of the environment
directly accessed by the public. This especially includes processed foods, which are a very
significant source of an uncontrolled, and uncontrollable, exposure to what must be classed as
a dangerous medicine.
Emphatically, this is a perfect example of a case in which the 'precautionary principle' should
be applied - if people really want to use this dangerous 'remedy' then they are at liberty to find
alternative sources that will ensure that others are not exposed unwillingly to it.
5. Should not your Agency therefore invoke exactly the same 'precautionary principle' to
protect the vulnerable from adverse effects of exposure to water fluoridation that it has so
recently invoked in the polio vaccine incident on what appears to be far more tenuous
grounds? If I may briefly summarise the position as I understand it now:-
Dental caries is a medical condition, and fluoridation is aimed at treating that
condition. Fluoride is therefore a medicine, and subject to regulation under existing
criteria for assessing the safety of medicines, the specific role of your Agency.
Fluoridation violates the protocols of the Convention on Human Rights and
Biomedicine. It fails to secure informed consent from the subjects, to provide a
choice of the type of intervention, or exercise any control over dosage according to
the individual characteristics of the patient.
The information on which the administration of fluoridation as a medical intervention
is based is misleading and in many cases has been obtained or published
unethically.
Basing Government policy on such flawed documentation is a breach of provisions
dealing with Human Rights, and is vulnerable to action.
The Agency is a 'public authority' under the Human Rights Act, and is not entitled to
exemption of liability since its remit is outside of the scope of the Water
(Fluoridation) Act or the Water Industry Act.
Fluoridation violates Human Rights under a number of International Conventions and
Charters, and is subject to European law - the fact that almost the whole of the
European Community has rejected fluoridation is relevant in any future action.
The role of the Medicines Control Agency.
I would now like to query the role of the Agency.
6. Does not the use of fluoridation as a medical intervention for the control of the condition
of dental caries necessitate the classification of the substances used for this treatment as a
medicine, in exactly the same way that any chemical used to treat any abnormal condition in
humans or animals is a medicine?
I have accessed your Agency's Web Site, and found the material there both interesting and
useful. It implies that all medicines to which the British public is exposed are subject to the
Agency's regulation and quality control procedures.
7. I presume therefore that your Agency has responsibilities for the licensing and regulation
of the use of fluoridation chemicals as medicines? If so, then I also assume that the conditions
under which they are manufactured and their use is licensed therefore meet the stringent
requirements of the relevant Codes of Practice employed for the production of all other
medicines and/or pharmaceutical products, as implied in your own Agency's published
material on its Web Site?
If my assumptions are correct, I would appreciate clarification of some points arising from the
material that appears on your Web Site.
1. Verification
On your Site you state thatthe Division:
exists to verify that medicinal products which patients take have been
manufactured and distributed in such a way that their quality is satisfactory and
complies with the requirement of the marketing authorisation (product licence).
monitors the standards of Good Manufacturing and Distribution Practice
monitors the standards of Good Laboratory Practice
monitors the standards of Good Clinical Practice
It may of course be the case that in fact that the Government or the Dept of Health does not
regard members of the British public at large as 'patients', in which case administration of a
medicine to them without their consent presents some extremely interesting legal questions.
8. Regarding the materials administered to the public in the water supplies, may I inquire if
they
have product licences
comply with the marketing authorisation from your Agency - (if so, could you please
indicate the criteria that were applied in authorising these products)
have been manufactured and distributed in such a way that their quality is satisfactory.
9. What evidence is accessible to the public that the relevant Good Clinical Practise Rules
have been rigorously applied to the clinical appraisal of hydrofluorosilicic acid and related
chemicals for their use as medications?
You also state that your Agency
operates a Defective Medicine Reporting Centre to deal with the rare event that a
product does not meet its quality standard
10. Could you kindly indicate to me what quality standard is applied to these chemicals,
which I understand are in fact waste products, and therefore commercial trade waste, and
whether they have ever been placed on the Register of products that have been reported to the
Medicine Reporting Centre. If so, what action was taken to prevent them giving rise to risk to
the public?
Compliance of the production of fluoride waste with Good Manufacturing
Practice (GMP)
Your Web Site states that one of your Agency's roles is to ensure that medicines meet the
requirements for Good Manufacturing Practice, and that
GMP is a quality system incorporating the elements of the international quality
standard ISO 9000 but with additional requirements and recommendations
pertinent to the manufacture of medicines . . (as) described in the Rules and
Guidance for Pharmaceutical Manufacturers and Distributors 1997. This
publication also includes the Code of Practice for Qualified Persons, guidance for
Responsible Persons, extracts from relevant regulation and details of the MCA's
arrangements for dealing with reports of suspected defects in medicines.
Can you please confirm that the chemicals manufactured for water fluoridation comply with
all of the requirements under ISO 9000 and the additional special requirements pertinent to
the manufacture of medicines and pharmaceutical products?
Also, are the persons involved in their manufacture Qualified Persons under this Code of
Practice?
3. Compliance with Good Laboratory Practice (GLP)
You state that
GLP inspectors verify that test facilities which conduct non-clinical safety studies
on pharmaceuticals, agrochemical, industrial chemicals, food and cosmetics meet
GLP requirements to the standards necessary for regulatory purposes.
Can you confirm that the chemical waste used to fluoridate public water supplies has been
tested for safety using the provisions of the UK GLP Regulations (Statutory Instrument
1999/3106) and has in every case been found to comply with the regulatory standards
applied to the use of this material as a pharmaceutical product?
If it is not classified as such, I would be obliged if you could explain the reasons for its
omission, and indicate under what heading it is included.
4. Compliance with Good Clinical Practice (GCP)
Your Web Site quotes the definition of GCP as being
"a standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provides assurance that the data and
reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected".
Fluoridation has been widely defined as a massive experiment upon the public, and the clinical
trials relied upon by the York Panel as deeply flawed.
15. In view of this, what clinical trials which do comply with these 'high standards'
demanded for clinical evaluation does the Agency rely upon in its assessment of the suitability
for the continued use of fluoride waste as a medicine?
5. Compliance with European standards for GCP
Your Web Site indicates that full compliance of British practices with those in the European
Union is expected.
Changes in the legislative requirements for clinical trials on medicinal products are
anticipated, after the proposed EU Directive relating to the implementation of Good
Clinical Practice in the conduct of clinical trials is adopted. The proposed Directive
is intended to harmonise the regulation of clinical trials in the EU and it is
anticipated that it will include a mandatory requirement for EU Member States to
conduct GCP inspections.
Fluoridation of the public water supplies has been rejected in virtually the whole of the EU
(Britain and Ireland appear to be prominently out of line with the rest of Europe on this issue).
16. In view of the rejection of water fluoridation throughout the rest of the European Union,
why is the use of this waste as a medicine sanctioned in the United Kingdom?
17. Would it be correct to assume that British CGP is in some way defective when compared
with the standards expected in other parts of the EU?
I would be most obliged for your kind response to assist me with the clarification of my
extensive lack of understanding in this matter.
Yours sincerely,
Douglas Cross, Environmental Analyst and Forensic Ecologist
Copies to: Liz Vaughan, National Pure Water Association, North West Councils Against
Fluoridation
Jane Jones, National Pure Water Association
The Rt. Hon. Jack Straw, MP, Home Secretary, HM Government
Replies to Doug Cross's letter from the Medicines Control Agency and the NHS.
MEDICINES CONTROL AGENCY
Market Towers
Nine Elms Road
London SW8 5NO
13 November 2000
Dear Mr Cross
THE ROLE OF THE MEDICINES CONTROL AGENCY IN THE PROPHYLACTIC ADMINISTRATION
OF FLUORIDE AS A MEDICINE IN THE PUBLIC DRINKING WATER SUPPLIES OF GREAT
BRITAIN
Thank you for your letter of 2 November to Dr Munro about the fluoridation of drinking water. Your letter that
makes a number of points about the issues are fluoridation not all of which can be answered by this agency. However
I hope the following information will be helpful.
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 MCA's considered view that fluoridated drinking water is
not a medicine within the definition. Accordingly fluoridated drinking 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.
Products containing fluoride are regulated and then many different regulatory schemes according to their purpose.
For example, oral hygiene products are permitted to contain fluoride up to a maximum strength of 0.15 percent under
Cosmetics legislation. The MCA also understands that fluoride supplements will be included within the scope of the
proposed Food Supplements Directive and also in the proposed Directive on addition of nutrients to foods.
Government policy on the fluoridation of drinking water rests with colleagues in the Health Services Directorate of
the Department of Health. I have copied your letter to them and asked them to reply on the policy and ethical issues
you raise.
Yours sincerely
David Carter Borderline Section Manager
Inspection and Enforcement Division
The argument that people have a right not to be medicated without their consent, has always been countered by profluoridationists' maintaining that fluoridation is not medication. And here we have the MCA backing that stance.
David Carter says that the definition of a medicine is laid down in Article 1 of Directive 65/65/EEC. Here is that Article (The definitions relative to water fluoridation are highlighted in blue.)
365L0065 Council Directive 65/65/EEC of 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
For the purposes of this Directive, the following shall have the meanings hereby assigned to them; 1. Proprietary medicinal product:
Any ready-prepared medicinal product placed on the market under a special name and in a special pack. 2. Medicinal product:
Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.
(1) OJ No 84, 4.6.1963, p. 1571/63. (2) OJ No 158, 16.10.1964, p. 2508/64. 3. Substance:
Any matter irrespective of origin which may be: - human, e.g.
human blood and human blood products;
- animal, e.g.
micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, etc;
- vegetable, e.g.
micro-organisms, plants, parts of plants, vegetable secretions, extracts, etc; - chemical, e.g.
elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
Dental caries is a pathological condition in which a part of the body – the teeth – is damaged by bacterial infection. The sole object of fluoridation is the countering of this damage both by the strengthening of dental enamel and the killing of the bacteria. Thus fluoridation, a prophylactic treatment aimed at preventing this disease must, by definition, be medication.
How can MCA deny it?
Nevertheless, having determined that adding a substance with the specific purpose of changing the body's chemical
composition to prevent a disease is not 'medication', the MCA passed the buck to the NHS.
Here is their reply:
NHS Executive Headquarters
Department of Health
Richmond House
79 Whitehall
London SW1A 2NS
29 November 2000
Dear Mr Cross
Thank you for your letter of 2 November to Dr Munro about fluoridation of water. Your letter has been passed to
the Health Services Directorate. I have been asked to reply.
A review of the evidence on fluoridation and health was undertaken by the University of York. The review report
was published in October and found that the evidence shows that fluoridated water helps to reduce tooth decay. In
areas where overall health is lower than average, dental health is much higher if the water is fluoridated. The
Government will be encouraging the health authorities with particular dental health problems to consider fluoridating
their water as part of their overall oral health strategy.
We have asked the Medical Research Council to draw upon the expertise available to it and explore how - in the light
of the systematic review - any further research could most productively be focused in order to strengthen the
knowledge base concerning water fluoridation and its effects on health.
You expressed concern about the exclusion of certain documents from the review. The review team is committed
to maintaining an unbiased approach and took steps to achieve this. There was a strict protocol defining inclusion
criteria and analysis procedures (which was approved by the advisory panel). In addition, the double checking system
in place for all procedures acted as a safety net.
We consider fluoridation to be an infringement of human rights, no more than denying the known oral health benefits
of fluoride to the majority of people who wanted added to their water supply. The any case, these are preferences,
not rights. The government has a wider responsibility to the health of the nation. Local consultation is carried out
as a compulsory part of the consideration process towards any fluoridation scheme.
I attach an information sheet setting out the government's position, which I hope you will find helpful.
Yours sincerely
S Visvanathan
Health Services Directorate 1
So, if you were in any doubt that the govenment means you to have fluoridated water, whether you want it or not, you should be in no doubt now. To hell with precaution!
