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York 1.1

A collection of Critiques of the York Review

SO WHAT'S WRONG WITH THE 'REVIEW'?

by Chris Holdcroft, 21st April 2000 (updated 11th October 2000 & 11th May 2001).

Fluoridation of Drinking Water: a Systematic Review of its Efficacy and Safety. Centre for Research and Dissemination, University of York.

STAGE 1.

On the 16th December, 1998, the Earl Baldwin of Bewdley addressed the House of Lords on the issue of fluoridation. It is a subject which has failed to go away, being debated by both supporters and opponents of fluoridation for many years. Only a full, uncompromising and quality reassessment of this practice would be capable of silencing critics from both parties who each have their own interests in seeing fluoridation extended or abolished. As a consequence, Baldwin lit the blue touch-paper and stated:

"... This is a subject I have been studying for many years, and the predecessor of the noble Baroness, Lady Hayman, the noble Baroness, Lady Jay, in conversation earlier this year, urged me to put down a Motion which could help to clarify thinking on the subject.

There are two strands to my Motion. For the wording of the first part I am indebted to Dr. Iain Chalmers, the head of the UK Cochrane Centre which has a brief for high-quality scientific evidence in health-care, who believes that:

"a group should now be commissioned which is seen to be independent of any particular viewpoint in order to draft a protocol, to be endorsed by both supporters and opponents of fluoridation, for a scientifically defensible systematic review of the available evidence (published and unpublished), and that the results of such a review should be made public".

The second strand recognises the fact that this is not just a scientific matter, but that reaching whole populations through the public water supply involves questions of ethics, social policy, cost and cost-effectiveness, appropriateness of the decision-making process, environmental consequences, and so on. Only through a public inquiry, in an area where feelings have always run extraordinarily high, can such matters be properly addressed." (Lords Hansard, Column 1394).

As Baldwin states, there are two strands to consider. The first is that he suggests that a review is acceptable but concludes in the second strand that only a public enquiry will solve the ethical implications of a possible policy of mandatory fluoridation.

The first compromise was beginning to develop. The findings of the Review can produce only three possible outcomes. (1) Either the Review supports or (2) opposes fluoridation or (3) is inconclusive. If the second or third outcome is determined then there shall be no mandate for compulsory fluoridation. And if there is no conclusion, the third determination, then it is likely that fluoridation in existing communities is likely to continue. In any event, there should be a public enquiry in addition to the Review.

However, the Government has so far shown no desire to hold a public enquiry and will seemingly rely exclusively upon the Department of Health to pass judgement on the Review's findings. This is not satisfactory and allows a Government Department with a self-confessed support of fluoridation, and often observed cynical manipulation of fluoridation data, to act as judge and jury.

It should also be considered that: "CRD has been funded by the *Department of Health to carry out a systematic review into the efficacy and safety of the fluoridation of drinking water, as outlined in the recent Department of Health White Paper 'Saving Lives: Our Healthier Nation'."

*NB. Funding came via the NHS Executive.

So what value and trust can we put in a Review which is hamstrung from the beginning?

It has been reported that Baldwin is quite pleased to have won a review into fluoridation but we have yet to hear the honourable gentleman campaign further for the public enquiry which he considers equally necessary.

STAGE 2.

The Review, which commenced in the second half of 1999, has now almost concluded it's work. Regrettably, a number of incidents have disturbed the equilibrium of what was supposed to be an exercise not just in scientific research, but also political impartiality. These incidents can be itemised accordingly:

The entire review process has three components. There is the (1) Review Panel and the Review Team members based in (2) York and (3) Cardiff. The York and Cardiff Teams are responsible for assessing papers. The assessment takes the form of producing baseline data, results and validation. When this is completed, the findings are published on the Review's dedicated web-site. Unfortunately, the team in Cardiff has at least one element who either supports or is 'sympathetic' to the practice of fluoridation and therefore should not rightly be involved in an 'impartial' review process. The true character of the York team is as yet undetermined.

The Review Panel is similarly supposed to be impartial. While the Review Teams should contain scientific researchers with no impartialities, the Panel differs by bringing together members form opposing camps. There is supposed to be a balance between pro-fluoridationists and anti-fluoridationists - but this is not strictly true. Taking into account those I would loosely describe as 'surrogate pro-fluoridationists', the anti-fluoridationists are outnumbered by about 7 to 3. For the record, I classify a surrogate pro-fluoridationist as someone who does not campaign for fluoridation but has shown support for the practice - either directly or indirectly. One example of an indirect endorsement has come from Pamela Taylor of the organisation 'Water UK':


"... the anti-fluoridationists are outnumbered by about 7 to 3."

"the decision whether to fluoridate a water supply should lie with the health authority - the current discretion on water operators whether to accede to an application from a Health Authority should be removed." As quoted by: *Baroness Gardner of Parkes (Column 1402, Lords Hansard, 16th December, 199).

*A self-confessed Australian dentist, no less (and "... with no interest to declare.")!

Perhaps Pamela Taylor might think of herself as an independent, I do not know. But when an individual who represents British water companies directly implies that she and / or they merely don't want to reap the consequences of any responsibility (read: potential litigations), then that is being pro-fluoridationist in my book. After all, a paid assassin is an accomplice in every sense of the word. Ms Taylor could escape this accusation if she were to change her statement to something like: "the decision whether to fluoridate a water supply should lie with the population affected after listening to full representation from both genuine and informed supporters and opponents of fluoridation." But I don't think she ever did!

STAGE 3.

It has been seen so far that a review into fluoridation is insufficient and that the Review Body as a whole is not truly representative of the opposing factions. Regardless of the outcome of this review, there remains one outstanding concern.

It is former Health Secretary, Frank Dobson, who arrogantly boasted of a "once-and-for-all" review to settle the matter of fluoridation. No doubt as a supporter of fluoridation himself he felt relatively confident of an outcome which supported his distorted and ill-informed opinions.

During the early stages of this review anything but an endorsement seemed likely. However, from day one of the review, the narrow protocol and practices of the Review Body have swung the review process slowly back towards a pro-fluoride stance.

The first problem has been 'compliant' representation from the anti-fluoridationists on the panel. Unwilling to upset anyone, they have to readily agreed to anything which would have strengthened the anti-fluoridation campaign and have ensured a greater level of impartiality. The first example is animal studies. While being an anti-vivisectionist myself, one of the few times animal studies would have actually done some good was by being admitted for study analysis. Either way these studies would have been, discredited and once again have shown such 'scientific' experiments to be (1) worthless or, (2) have supported the anti-fluoridation campaign and society as a whole by showing that artificial fluorides are toxic even in minute quantities. But animal studies were omitted from the review process! The main verbal excuse of the Review Body is that they had insufficient resources to consider both human AND animal studies due to the vast workload this would have imposed within such a short time. The minutes of the meetings of the Review Panel indicated that animal studies were deemed to be unreliable and this is the excuse that was used to omit such studies.

Considering that the final report of the CRD stated the human studies they had considered were of poor quality is somewhat hypocritical.

The next problem to emerge was a further restriction on study qualification. The quality of work submitted on caries studies in particular is grossly inadequate. It has been observed that the main pitfall of these studies is failure to allow for confounding factors. However, this is not surprising as you cannot put humans into a controlled environment unless you treat them as laboratory animals. Another factor is that with caries studies in particular, you can never account for 'background' influences in fluoridation trials. For example, Brown's 1962 caries study stated: "the recordings so far obtained indicate both a high treatment and an apparently better oral hygiene status of the Brantford (fluoridated) children when compared with the controls, and it is therefore suggested that caution should be exercised in the interpretation of the rates shown. The lack of a pre fluoridation survey on a comparable basis is a further limiting factor in interpreting the results." Source: The Ecologist, Page 233, Volume 16, No. 6, 1986.

This statement STRONGLY emphasises my point that fluoridation studies can be given a helping hand by virtue of greater support for children living in fluoridated areas as opposed to those living in non-fluoridated areas. This claim is further supported by another story from the same magazine involving a manipulated New Zealand study and entitled: "The Hastings Fluoridation Experiment: Science or Swindle?"

In an attempt to analyse the alleged true effect of water fluoridation on populations, I conducted a desktop exercise where I theoretically 'removed' fluoride (both natural and artificial) from all supplies in England. By looking at dmft levels after the removal of fluoride and then comparing them to what would be expected to be observed for each individual community (after allowing for social status), it would be possible to see which communities would normally observe better dental health. Although it was an exercise it was a very useful one and showed that there were very strong regional variations in dental health and sufficiently proved that you cannot compare different communities from different regions - even where the social status is similar (such as equally deprived districts in London, the Midlands and the North West). Even Marian McDonagh of the CRD's York team admitted it was a good piece of work.

The difficulty I encountered was that despite the quality of my work and the important information it imparted - it did not meet the protocol of the Review! Furthermore, some ad hoc observations which I included in my study were acceptable and published as a separate study by the Review Body. This was not my original intention and I would not have pushed for their inclusion until I saw a similar submission appear on the Review's web-site. This was a piece of work by 'Gray', dated the year 2000, and was listed as 'notes' on changes in dental health in the West Midlands. Because my 'notes' were based on the same data, I decided to submit them as well (what's sauce for the goose, etc.).

My original understanding was that these notes, from both myself and Gray, would not be treated as proper studies - but that is what happened. Expecting only a mention of these notes in the Review Body's final report, I was amazed to see them presented as a 'stand-alone' study and rated as joint-2nd in the their respective validation table! I find it very embarrassing that a few pages dedicated to basic observations should receive such an accolade and I did try to get them withdrawn. I am told this work will not be excluded. The icing on this very sickly slice of cake is contained in the following statement:

"We are sorry that you feel this way, but cannot remove this material as censorship such as this would severely undermine the integrity of the review. One of the fundamental principles of conducting systematic reviews is the rigorous attempt to include all studies, published or unpublished. As your material was submitted and met inclusion criteria, we cannot justify removing it now." Marian McDonagh, 20th April, 2000.

The third and final problem concerns the lack of inclusion of data which emphasises other confounding factors. I have personally submitted data on receipts, treatments, capitations and community support for children under-18 and since mid-1997. This data is very comprehensive and covers every child in England who has been registered with a dentist and who has also received treatment. Expenditure on child treatments has also been provided.

This data makes a substantial contribution to the Review and I was led to think that it would be taken into consideration towards the end of the review process. At the '11th hour' I have been informed it will not be included in the final report. All I can say about this episode is that if this is the way the Review Body is going to present evidence to the Department of Health, then god help us all.

STAGE 4.

This chapter is a short one. It evaluates the evidence so far and the potential outcome of the review process.

There are numerous shortcomings. A narrow protocol, poor quality submissions, a seemingly heavily biased Review Panel whose members hardly ever seem to know what the Review Team at York is doing or planning, late changes to inclusions in the final report, etc. Isn't there enough here to make the reader wonder where the review process is going?

The final hurdle to be cleared now the draft report is out is the nomination of peer reviewers. Each faction can nominate three candidates. But who in their right mind would want to put their name to such a review? There still exists a great potential for this review to be twisted, turned, spun and reconstituted to the benefit of the supporters of fluoridation. And it is because the anti-fluoridationists have been so successfully sucked in that they risk not only damaging the cause but also their own names and the names of those they wish to stand as peer reviewers.

Life is a gamble. As an experienced gambler, and chess player, I have learned that all eventualities have to be taken into consideration, assessed and weighted accordingly. When the odds are stacked against you do not gamble - its as simple as that. This translates as the following: the review is no longer a worthy risk. The representatives of the anti-fluoridation movement who sit on the Review Panel, Messrs. Baldwin, Gibson and Mansfield, should pull out now.

STAGE 5.

The worst fears of the anti-fluoridationists have been realised. The politically correct Press Release issued by the CRD on the 6th October 2000 confirms this.

Careful to chose their words and terminology, the press release has allowed the media to generally interpret the final report of the CRD as an endorsement for fluoridation.

But what else could we expect? A non-independent review into water fluoridation which has omitted so much important evidence has produced a final report which made very dubious claims based on bad science. So where's the credibility in all of this?

INTERESTING NOTES.

E-Mail To:

Marian S. McDonagh, PharmD, Research Fellow in Health Services, NHS Centre for Reviews and Dissemination, University of York, England.

Dear Marian

Thank you for your e-mails of 14/4/2000. However, I am still concerned about three major points.

It is obvious the draft report does not yet mention the DPB / CDS data (receipts, community services, etc.). Unless it is provided as a supplement to the Draft Report then it obviously cannot be reviewed externally. Therefore, what provisions does the Review Body intend to make so that this data can be examined and commented upon before the Final Report is published? The following quote from Brown's 1962 caries study may also be of interest to you:

"the recordings so far obtained indicate both a high treatment and an apparently better oral hygiene status of the Brantford (fluoridated) children when compared with the controls, and it is therefore suggested that caution should be exercised in the interpretation of the rates shown. The lack of a pre-fluoridation survey on a comparable basis is a further limiting factor in interpreting the results."

Source: The Ecologist, Page 233, Volume 16, No. 6, 1986.

This statement STRONGLY emphasises my point that fluoridation studies can be given a helping hand by virtue of greater support for children living in fluoridated areas as opposed to those living in non-fluoridated areas. This claim is further supported by another story from the same magazine involving a manipulated New Zealand study and entitled: "The Hastings Fluoridation Experiment: Science or Swindle?"

My second point is that the observations I made on changes in 'dmft' levels in the West Midlands, 1985-95, were general notes only. As you are aware, it was not intended as a 'stand alone' study and therefore I should have (yes, my fault!) previously insisted that they be represented in a slightly different way. As a consequence, and before the Final Report is published, I would like something along the lines of the following to be added:

"The data submitted by Holdcroft (1999) represented only a small part of a larger study which did not meet the Protocol of the Review Process. This larger study considered numerous aspects of dental health in England where fluoride is assumed effective and removed from all water supplies."

NB. The Jarman Scores I used were from the 1991 census (from the 1995 Public Health Common Data Set) and published by Pitts N B & Palmer J D (BASCD, 1995). Apologies for not making that clear.

My third and final point is this. What allowances have you made for other flaws in caries studies bearing in mind the observations I made in my interim study entitled: "Dental Health Expenditure in England, 1998 to 1999. The correlation between NHS expenditure, Community Dental Services and the findings of the British Association for the Study of Community Dentistry"?

I refer to differences in natural and artificial water supplies and the fact that potentially seriously damaged teeth are counted as 'sound' if the damage is attributable to excess fluoride consumption.

Yours sincerely, Chris

Re: my e-mail to Marian McDonagh on 14/04/00 ...

From: Paul Wilson, NHS Centre for Reviews & Dissemination. 17/4/00

... no economic studies/data will be presented in the review because a systematic search of these has not been undertaken.

Evidence of lack of support from the anti-fluoridationists for the Review process ...

Peter Mansfield. 14/4/00, e-mail reply.

... As to representativeness (sic), I am constantly reminded that I represent nobody but myself in this review advisory process. Actually it's easier that way.

Evidence of interference from the DoH ( why did they want to delay publication of the final report? ).

10:06 am, 20th September

Hi Chris

The Department of Health has been in contact with the BMJ and requested to postpone publication until the issue of 7th October to which the BMJ has agreed. ...

Paul Wilson, NHS Centre for Reviews & Dissemination

Salient Points:

  • The Protocol of the 'Review' was altered and as a consequence rejected a great deal of important evidence.

  • The 'anti-fluoridationists' on the Review Panel were ineffective, weak and compliant - and did not have the support of the anti-fluoridation lobby. They were also effectively outnumbered 7-3.
  • My own evidence of other interventions in dmft (decayed, missing & filled teeth) studies was refused consideration. It is easy to improve dmft rates if you know the tricks of the trade and you want to make it appear that fluoride in water is the sole reason for such improvements.
  • My own dmft study was misrepresented and taken out of context.
  • The Review reported that their findings were based on poor quality research. One of the papers which was open to bias and only achieved an average rating was the one written by Phipps. Phipps study commenced in 1986 and finished in 1995 - so why has it taken so long for this American study to see the light of day and why was it not previously published in an American scientific Journal? Perhaps it was not of adequate quality - yes?
  • The claim of 2.25 teeth saved is subject to serious question as methods used to measure dmft (in the UK at least) counts badly fluorosed teeth as being sound and present (see pictures). And as with my 2nd point, other interventions were deliberately not evaluated.
  • The Review reported that 48% of an exposed population would be afflicted by fluorosis of which 12.5% would be badly affected. Nothing mentioned about the psychological trauma caused to children I note.
  • Fluorosis is also a condition which costs a King's ransom to temporarily cosmetically conceal - lots of extra cash for the dentists I would say. After all, what would you like to do, fill or pull a few teeth for a few quid or rake in £100's or £1,000s for cosmetic treatments?
  • The BMJ (British Medical Journal) deliberately picked out the Phipps study for publication when it could easily have picked a better study. But the BMJ is notoriously pro-fluoride.
  • The Review's authors the CRD (Centre for Reviews and Dissemination) at York also failed to mention that three peer reviewers heavily criticised the Review's findings.
  • The CRD's boast that the Review's findings were "the final word on fluoride" is outrageous and a classic example of an exercise in controlled propagandist disinformation. The final word on fluoride does not lie with the CRD - it lies with the victims of fluoride poisoning.

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