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Working the system - EU 'Risk Assessments' protect Big Business

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“Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents

Katherine E. Smith, Gary Fooks, Jeff Collin, Heide Weishaar, Sema Mandal, Anna B. Gilmore

Public Library of Science (PLoS) - Medicine, Published January 2010

For the hard but worthwhile slog, go to
and read it for yourself.


This paper is of the utmost importance to those attempting to bring an end to the practice of water fluoridation in Europe. But it is also crucial to understanding why this bizarre and discredited practice has been able to persist in other countries, such as Australia, New Zealand, Canada, the USA and elsewhere, and why its present resurrection and challenge to sanity has such powerful advocates

The techniques used by those pharmaceutical companies who are reliant on the reputation of their brand, 'Fluoride', are practised world-wide to prevent any adverse publicity from attaching to the use of any product containing fluoride.

The authors of this study have examined the influence of British American Tobacco on the policy-makers of the European Commission. They and their associated companies have managed to seduce the Eurocrats into changing the emphasis on the way that chemical products are assessed within the EU system of regulation. The 'risks' that they pose are now assessed not against the risk of damage to the general public, but on the basis of the risk they might pose to the financial investments of the companies themselves.

The authors' findings are entirely consistent with what we have seen of the way that the European Commissioners persistently evade the very significant issues of public health that are associated with water fluoridation. Ignoring all

adverse scientific evidence, they adopt precisely the same inappropriate procedures that are described here by the authors.

This enables them to invent spurious financial comparisons between highly improbable 'benefits' and the supposed costs of implementing the administration of the chemicals they are attempting to market.

But actually, the costs to the Establishment are always identified, though generally in a somewhat relaxed manner. In contrast, the hidden long-term costs to the general public, in terms of impaired health and extreme medical expense, are never mentioned.

I have examined both this document and the SCHER Report on Water Fluoridation (and yes, the latter is exactly the sort of inappropriate 'Cost-Benefit Analysis' that the authors of this paper were referring to), and my commentary on them follows below. For those willing to make the effort to read the original study, please click on the title above, to go to the Public Library of Science where it was first published.

Then consider urgently how we might be able to reverse this unacceptable situation. Until we do so, fluoridation will continue to re-emerge through the back door of pseudo-science and medical quackery, regardless of how often we banish it with apparently overwhelming common sense and sound scientific evidence.



Anti-fluoridation workers have long complained about the apparently inexplicable failure of the EU, UK and Irish medicines regulators to enforce the implementation of the medicines legislation. What they have not been aware of - at least until now - is just how crooked the system really is.

When Eurocrats call for a Risk Assessment on the use of fluoridation chemicals, they are actually asking for an evaluation of the
commercial risks of the product, and not of the health risks to the public.

The latest SCHER study is typical of this approach. Despite its interesting conclusions, the study is infested with commercial assumptions that have no basis in reality or, especially, the protection of public health. It is stuffed full of fundamental errors, of both omission and interpretation, and the economic assessment presented is frankly disastrously inept. Scientific evidence of adverse effects, no matter how reputable and reliable (and even alarming) is down-played to the point of utter causing fury amongst those who have often spend years in investigating their subjects and are acknowledged leaders in their fields.

At the same time, these EU 'experts' implicitly accept the supposed benefits whispered into their ears behind closed doors by the lobbyists for the commercial companies that are hugely reliant on the reputation of their product.

What we expected was an independent and impartial evaluation of the actual health risks of fluoridation to the public, regardless of the commercial vested interests. What we actually got was a highly biased report containing an improper and misleading 'Cost-Benefit Analysis'. This accepted the alleged 'benefits' of fluoridation, often proposed at ludicrously inflated levels, whilst at the same time it kept hidden firmly under the carpet the extreme costs of the damage caused by dental fluorosis to the public consuming their products.

The deliberate subversion of the gullible Eurocrats by Big Business is the subject of this hugely important study. This paper is important because it exposes at last the fundamental
process that have become established, at the undercover prompting of Big Business interests, whereby a number of clearly irrational public health policies are being implemented at the levels of both the EU itself and at that of some Member States.

In the process of assessment, all caution has been thrown to the winds - the protection of the economic interests of the commercial sectors takes firm precedent over the issue of the safety of the general public.

And until this corrupt system itself is torn down and replaced by one that reflects the original objectives of the European Community, the use of such cynical and corrupt techniques will continue to protect Big Business at the expense of us, the general public.

In attempting to understand why the Commission and the UK and Irish Medicines Regulators have consistently refused to implement the Medicines Directive in respect of the use of fluorosilicates in water fluoridation, for example, the legal issues are quite clear-cut. They are used to prevent dental caries, and as such the product must be regulated as a medicine. This has been established both in the original Directives and in specific judgments .of the European Court of Justice.

The scientific evidence of the damage caused by water fluoridation to the public is overwhelming, and the proof of any benefit highly unreliable. But the risk assessments carried out on this practice invariably emphasise the alleged ‘uncertainty’ of

adverse scientific evidence, and provide instead IAs based primarily on commercially relevant Cost-Benefit Analyses.

The latest example in this area is the EC’s Scientific Committee on Health and Environmental Risks (SCHER) review of Water Fluoridation, due for public comment in September this year. This, like most previous studies, over-estimates the claimed social benefits, yet entirely fails to include the social costs of treating the damage caused by fluoridation to around half of every fluoridated population.

The scale of the distortion of the CBA due to this biased assessment is not trivial. The epidemic of dental fluorosis that develops in all fluoridated countries results in an average of one child in eight requiring remedial dental treatment to conceal what is euphemistically referred to as a ‘mild’ cosmetic effect, mere ‘fluorosis of aesthetic concern’. At around UK£30,000 for a lifetime’s treatment for dental veneers and, eventually, crowns, this is a huge but totally concealed social burden that never appears on the deficit side of the CBA or the Business Impact Assessment.

Those organisations that carry out dental health surveys in the UK and in Australia refrain from reporting on the prevalence of dental fluorosis - probably the most common form of dental disease in such locations. Perhaps unsurprisingly, they have very close links with the manufacturers of fluoridated toothpastes.

The bias towards the use of this highly skewed and improper form of BIA rather than a balanced form of HIA is entirely consistent with the authors’ conclusion that this form of Risk Assessment favours commercial vested interests, but does little to protect the health of the community.

It is undoubtedly of direct financial benefit to those most visibly promoting the practice - the dental and public health sectors. But at the wider level, the commercial interests of those pharmaceutical companies that rely heavily on the brand ‘Fluoride’ are well served. They have effectively manipulated the dental and public health sectors to act as their proxies, to carry out the own lobbying of the EC and national legislatures, and so reducing their own visibility.

The result has been that decidedly unhealthy policies that have been accepted and implemented in the UK and Ireland, and apparently endorsed by the EC itself, are now used to influence other States outside the EU. For example, both Australia and New Zealand cite the adoption of water fluoridation in the UK and the Irish Republic as an important endorsement of the practice. Their politicians are encouraged to follow suit by senior pro-fluoridation advocates from the UK whose financial links with multinational toothpaste manufacturers suggest that their interests may not be entirely disinterested.

The authors have done communities around the world a substantial service in exposing the process whereby such commercial lobbies have been able to manipulate the regulatory authorities into endorsing assessment practices that benefit at the expense of the general public. They establish incontrovertibly that public health policies may be, and indeed are, manipulated in a manner that is not merely unjust but manifestly dangerous, and are to be applauded for their efforts to document this case.

Perhaps now others will follow their lead, and expose instances where similar threats to public health are endorsed for the commercial benefit of those industries whose business interests appear to be held to be superior to their ethical concerns over the health of the public.


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