From: Rudolf Ziegelbecker
Graz, Peterstalstrasse 29,
A-8042 Graz/Austria
Tel/Fax: +43 316 471128

To: Professor Jos Kleijnen, Fax: ++44 1904 433661;
Director of NHS CRD e-mail: revdis@york.ac.uk
The University of York
NHS Centre for Reviews and Dissemination (CRD)
York, YO10 5DD, UK

Open Letter:

Systematic Fluoridation Review: Fluoridation of Drinking Water
NHS CRD Final Draft Report of 06/06/00

Dear Professor Kleijnen,

You may know that I have been working on fluoride research and fluoridation since 1968/69; at first as a member of the Research Center for Electron Microscopy at the Technical University Graz and later as a member of the Institute for Environmental Research, Research Centre Graz, before retiring in 1990. I was suggested as a formal external reviewer to your Advisory Panel. My comments of 9/13 April 2000 (41 pages) were sent to the "Fluoridation Systematic Review" via e-mail revdis@york.ac.uk and my “Comments and Response" of 25 June 2000 (11 pages) to your "Final Draft Report" were given in the "Response Form" on the web, via e-mail to revdis@york.ac.uk, pfw2@york.ac.uk and pmw7@york.ac.uk, via Fax: 0044 1904 434556 and Fax: 0044 1904 433661. I assume you have received both my April comments and my response of June 2000.

It is commendable, important and useful for the scientific community and for transparency in science that you have opened the process and data of this systematic review of water fluoridation on the web. After 55 years of artifical water fluoridation it is time for opening the scientific debate on this subject. Dentist's dogma and their doctrin that water fluoridation is a safe and effective public health measure can no longer be defended in science.

Dr. Marian McDonagh of the York review team sent a fax on 15 May, advising me that: "The review team has reviewed your comments. Unfortunately, we do not have time to respond to these comments due to the workload of this review, and other projects requiring our attention".

On 20 June 2000 Paul Wilson, a member of your review team, e-mailed my son advising that my "comments were reviewed and considered by the team. I should point out that we do not and have not passed on any comments received from any interested parties to the advisory panel. The panel comments on draft versions of the report revised in light of comments received. ...An abridged draft was emailed to your father .." - I have not received that abridged draft.

In my answer to Paul Wilson on 20th June my son and I asked three questions:

1. "Why do the members of the Advisory Panel not get the full comments which my father and others made, to enable them to form their own judgement in this matter?

2. Why do you not remove untenable studies from the tables D1 and D2 ? (e.g. Arnold, Ast, Backer Dirks, Blayney, Brown, Kuenzel)?

3. Why do you apparently blindly believe statements made by authors that test-conditions were not changed during the experiments in some studies? How can you assume that groups of children and the conditions were comparable in the fluoride and the control groups? If you use the full published data for every single experiment, you will find that many more confounding factors must be included than were used in the final report and that the test-conditions changed quite often."

To this day (5 August) I have not received any answer from Paul Wilson or any other member of the review team to my questions - you will agree that the questions are significant and essential for the validity of the results and conclusions of the systematic review.

On 21 June Penny Whiting of your review team e-mailed: "I'm sorry that this message (attached below) did not get through to you the first time we sent it. Thank you for the comments on the fluoridation review which you sent several weeks ago, we would very much appreciate any further comments that you have on this updated version of the review (attached), Penny Whiting."

"Dear All, We have been carring out a systematic review on the safety and efficacy of water fluoridation, commissioned by the Department of Health. Further details of the review can be found on our website at: http://www.york.ac.uk/inst/crd/fluorid.htm. The draft report of the review is now complete. Members of the advisory panel established for this review have suggested you as experts in the area who may be willing to peer review the report. I have attached a copy of the findings of the report. The conclusions and discussion are not included to allow you to interpret the results for yourself. We would be very grateful for any comments that you my have on the following aspects of the review: 1. Methodology .... 2. Results by objective .... We are working to a very tight deadline and so would appreciate receiving any comments that you might have by the 25th June at the latest. ... Thank you for your help, Penny Whiting,

Research Fellow, NHS CRD ."

Professor Kleijnen, why were my three questions not answered by the review team? Why do you think that is important not to include the conclusions and discussion to allow us to interpret the results for ourself and why have you not informed the members of the Advisory Panel about our comments and responses so that the members of the panel can compare and interpret the results of the systematic review with our comments and responses for themselves?

You have involved some members (dentists) of the University of Cardiff in your review team to support the York team in terms of quality control and to advise on the technical dental aspects of the review. They are well known as fluoridation promoters. You seem to believe that if everything done in Cardiff was checked by the team in York this would ensure that none of the work they carried out was biased in any way. - You also state: "Because there is a strict protocol defining inclusion criteria and analysis procedures (which has been approved by the advisory panel), the potential for pro- or anti-fluoridation bias is essentially eliminated. In addition, the double checking system in place for all procedures acts as a safety net." Therefore critical researchers in the field of fluoridation were not involved in your review team. See the Minutes of Meetings - Panel Meeting, Friday 30th July 1999.

I feel that your trust in the "strict protocol defining inclusion criteria", in the knowledge of your team in the field of fluoridation research, in the scientific competence of the dentists of Cardiff and in dentists' publications were naive and misplaced.

It is not a good contribution to reliable Evidence-Based Medicine, if false and untenable studies are included in a systematic review, as in doing so the report is given "validity" which is unwarranted.

Many people - statesmen, ministers, politicians, public health officials, and scientists - all have advisors and a personal dentist. They trust them as experts in dental science, dental medicine and in "fluoridation". If these people ask their dentist "Is fluoridation of drinking water benefitial and safe?" the automatic answer will be: "Yes, it is! Water fluoridation is an "example of nature". In the "optimal dose" fluoridation is efficient, reduces dental caries by about 50 to 60% or more and has no side effects". The same answer is repeated then by public health officials, ministers, statesmen, and scientists in this field must "confirm" it. Dentists themselves get no other information and knowledge from their journals, congresses, further training, and from dentists who are "fluoride experts".

Dentists themselves and many other people, including scientists, believe that dentists are scientifically competent in the field of fluoridation and dental health, which includes specialities in epidemiology, statistics, mathematics, biology, medicine, chemistry and physics, as these scientific disciplines are required in the field of fluoridation and dental health. It is a known fact that dentists and especially their "accepted fluoride experts" are "peer reviewers" not only in the dental literature, but also in other scientific literature, which publishes aspects of fluoridation and oral health. Therefore such "peer reviewers" can influence and have influenced publications in favour of fluoridation world-wide in peer reviewed scientific literature for many years, with a high "impact factor" in compliance with the Journal Ranking of the SCI Journal Citation Reports, whilst at the same time they have hindered the publication of critical results in internationally recognised literature.

All the evidence of alleged "benefits" of water fluoridation are based on dentists' statitistics. In Appendix F (Dental Issues) of the draft the review team stated: "In investigating the effects of public water fluoridation, several issues specific to dentistry must be understood. These include issues related ..., the factors known to effect caries development, and the proposed mechanism of fluoride in preventing dental caries:

Factors affecting the development of caries: Many factors are associated with the development of caries. The primary factors are the frequency and amount of non-milk extrinsic sugars in the diet, the presence of micro-organisms in dental plaque, and the amount of fluoride in the oral environment. .....

Proposed mechanisms of fluoride in preventing caries: Two general mechanisms have been proposed, one systemic and on topical. The specific actions of fluoride in these mechanisms are more complex, and not fully understood.... Fluoride interacts with the tooth surface, either by incorporation into the crystal lattice or by binding to crystal surfaces, reducing the solubility of the apatite and encouraging re-mineralisation."

Please note that it is impossible to find a valid chemical, biological, or physical theory for the prevention of caries by fluoride if the "benefits" are the results of statistical artefacts in "dental statistics" and do not really exist.

If you study the dental literature you will find that dental theories have changed over time and that the theories were adapted according to the interest of the market for fluoride products.

There are many theories about the mechanisms of development of dental caries. In the following (in German language) I quote the more recent caries theories:

1. Chemisch-bakteriologische Theorien: Chemoparasitaere (azidolytische) Theorie, Proteolytische Theorie, Endogen-proteolytische Theorie, Proteolyse-Chelations-Theorie, Glykogentheorie.

2. Enzymologische Theorien: Endogen-pulpogene Phosphatasetheorie, Phosphatasetheorie, Sulfatasetheorie, Proteasetheorie.

3. Elektrophysikalische, physikochemische Theorien: Korrosionstheorie, Resistenztheorie, DONNAN-Membranphaenomen. — after E. Sauerwein: Kariologie. Georg Thieme Verlag Stuttgart 1974.

In thirty years of research dentists had not found the cause of "mottled teeth" (dental fluorosis). It was discovered in 1931 by the agricultural-chemists Smith, Lantz, and Smith in Tucson, AZ. How can dentists understand the mechanism of effects of fluoride on teeth and dental caries if they do not fully understand the mechanisms in the development of dental caries and there are so many theories?

Appendix F of your fluoridation systematic review stated that the amount of fluoride in the oral environment was a primary factor for the development of caries. However, your systematic review does not give any evidence under Objective 1 for this claim. Primary factors such as the frequency and amount of non-milk extrinsic sugars in the diet and the presence of micro-organisms in dental plaque - and in saliva ! - were ignored and not investigated in your "systematic review" and by your review team.

I would remind you that I have analysed the significant influence of sugar consumption on dental caries worldwide and in the USA in my Comments of 9/13 April 2000, pages 17-20. On page 26 I have illustrated the relationship between dental caries and L. acidophilus - concentration in saliva in children aged 12- 14 years in 10 cities out of 21 in the study by Dean et al, as an indicator for nutritional influences.

Why has the review team not included primary factors, such as the frequency and amount of non-milk extrinsic sugars in the diet and the presence of micro-organisms in dental plaque - and in saliva - as confounding factors to separate the influence of fluoride from other factors?

I would remind you of my comments and response to your Final Draft Report of 25th June. On page 8 I referred to changes of conditions during the experiment and to the influence of consumption of sweets in Basle (Switzerland): "If we analyse more data and consider the conditions in Basle, we can see that dentists set measures to reduce dental caries. The percentage of children eating sweets between breakfast and lunch was reduced from 80% to 42%. Consequently caries decreased".

Your review team also stated that "During the formation of enamel, fluoride is incorporated into the hydroxyapatite crystal. The resulting fluorapatite is of lower solubility and hence more resistant to dissolution in bacterially derived acids. Fluoride interacts with the tooth surface, either by incoporation into the crystal lattice or by binding to crystal surfaces, reducing the solubility of the apatite and encouraging re-mineralisation."

My simple question to these hypotheses is:

Why did natural fluoride of 1.0 ppm in drinking water reduce dental caries always only by about half in relation to fluoride concentrations of 0.0 to 0.1 ppm? Dental statistics show e.g.:

— In Denmark (Moeller 1965) [1] dental caries were reduced "by fluoride" from about 12 DMFT to about 6 DMFT in 12 - 14 years old children. Fluoride "saved" 6 permanent teeth.

— In USA (Dean et al 1942) [2] dental caries were reduced "by fluoride" from about 6 DMFT to about 3 DMFT in 12 - 14 years old children. Fluoride "saved" only 3 permanent teeth. Why did fluoride not "save" all 6 teeth?

— In Hungary (Adler 1951) [3] dental caries were reduced "by fluoride" from about 2 DMFT to about 1 DMFT in 12 - 14 years old children. Fluoride "saved" just 1 permanent tooth. Why did fluoride not "save" both teeth, if it can "save" 6 teeth in Denmark and 3 teeth in the USA ?

There is no plausible answer from dental fluoride experts. My answer is:

Caries differences in these and other important studies and dental statistsics were not caused by fluoride in drinking water. They were results of statistical artefacts caused by selected data (not random and not representative data) and by comparison of incomparable conditions and data and other influences in epidemiological dental studies. It is impossible to find a correct and valid theory to describe physical - chemical - biological mechanisms of fluorides to reduce dental caries if such a "reduction" does not really exist and was merely a statistical artefact in dental studies.

In the search strategy of the NHS CRD the first premise was to find the actual papers with the highest scientific quality and evidence for use in the systematic review of "Fluoridation of Drinking Water". This premise cannot be satisfied by use of the literature on water fluoridation.

The following quoted document was published in Germany 1998: "Deutsche Forschungsgemeinschaft: Vorschlaege zur Sicherung guter wissenschaftlicher Praxis. Empfehlungen der Kommission "Selbstkontrolle in der Wissenschaft". (Proposals for Safeguarding Good Scientific Practice). {This document is printed in German and English}. Recommendations of the Commission on Professional Self Regulation in Science. Denkschrift" DFG, WILEY-VCH 1998.

I quote (p. 47): "A case of scientific misconduct that was widely discussed in public both in Germany and abroad has led the Executive Board of the Deutsche Forschungsgemeinschaft to appoint an international commission chaired by the President with the mandate,

- to explore causes of dishonesty in the science system,

- to discuss preventive measures,

- to examine the existing mechanisms of professional self regulation in science and to make recommendations on how to safeguard them."

I quote (p. 49): "The event that prompted the appointment of the commission was an unusually serious case of scientific misconduct (1). It led to a wide discussion in politics, administration and the general public in Germany whether such events are more frequent than is generally known, and whether science in its institutions has sufficient control mechanisms for quality assurance. How could it happen that the institutions of science were deceived for so long? Nearly all the publications called into question appeared in peer reviewed international journals. All degrees awarded and all appointments relied on the conventional control mechanisms for regulating advancement in the scientific community. There were no procedural failings; yet the irregularities were not discovered. The same was true for research proposals which led to funding by the Deutsche Forschungsgemeinschaft and other funding organizations over a long period of time.

Further questions arose: Is intervention by state authorities necessary? Is there a need for new regulations to protect science, supported with public funds, and society, depending on its results, against abusive research practices?

On the best available knowledge and on the base of all published experience in other countries, these questions may be answered as follows:

The conduct of science rests on basic principles valid in all countries and in all scientific disciplines. The first among these is honesty towards oneself and towards others. Honesty is both an ethical principle and the base for the rules, the details of which differ by discipline, of professional conduct in science, i. e. of good scientific pratice. Conveying the principle of honesty to students and to young scientists and scholars is one of the principal missions of university. Safeguarding its observance in practice is one of the principal tasks of the self-government of science.

The high standard of achievement in the science system provides daily evidence of the successful application of the principles of good scientific practice. Grave cases of scientific dishonesty are rare events. However, every case that occurs is one case too many. For dishonesty - in contrast to error - not only fundamentally contradicts the principle and the essence of scientific work, it is also a grave danger to science itself. It can undermine public confidence in science, and it may destroy the confidence of scientists in each other without which successful scientific work is impossible. ..."

Professor Kleijnen, your NHS CRD review team states in the final draft report that of 3236 papers identified in the search 734 met relevance criteria and 251 of these met full inclusion criteria for one or more Objectives. Of these only 24 studies qualified for Objective 1 (the effect of water fluoridation on dental caries) and only 20 of these were listed in your Appendix C "Caries Study Validity Assessment".

Fifty-five years after water fluoridation was first established in Grand Rapids, USA, none of the 251 included studies were of evidence level A (Highest quality of evidence, minimal risk of bias), criteria defined by your review team. Only 27 of 163 included studies for Validity Assessment in Appendix C were of evidence level B (Evidence of moderate quality, moderate risk of bias), the other 136 included studies were of evidence level C (Lowest quality of evidence, high risk of bias).

Without any doubt we cannot conclude from these studies with the lowest level of evidence and high risk of bias that water fluoridation is safe and has no negative side effects.

On 13 April 2000 I sent my critical comments on results published on your website in March. After studying the tables and results on your website I informed you (i.e. the York NHS CRD) that water fluoridation in 8 European countries and Japan was stopped contrary to the WHO recommendations of 1969, 1975 and 1978, and that subsequently dental caries did not increase but decreased. Furthermore, I cited some remarks which were on your website and gave a short historical overview of water fluoridation and U.S.P.H.S. I then criticised your review process for including/excluding studies in the systematic review and compared the growth rate of dental caries in children with and without water fluoridation in some important experiments. The growth rate of dental caries was higher in children in areas with water fluoridation than in areas without. In my next item of comment I provided evidence that data selection in the Grand Rapids fluoridation experiment was the cause of the "caries reduction" and not the fluoride in drinking water. I then showed the relationship between sugar consumption and dental caries, the relationship between decrease of sugar consumption and dental caries 1970 - 1986 in the U.S.A. and that there is no scientific evidence that the caries decrease in the U.S.A. was caused by increased use of fluoride dentifrices.

With regard to your Objective 2 in the systematic review, today I am also informing you that the RAND CORPORATION (Santa Monica, CA) in an independent large field study with nearly 30,000 children has not found positive effects of use of fluoride dentifrices and other fluoride regimens. Water fluoridation was not investigated. The "National Preventive Dentistry Demonstration Program (NPDDP)" study began in 1976 and finished in 1984. It was carried out to determine the costs and benefits of various types and combinations of school-based preventive dental care procedure. The following four packages were:

—Sealants: Application of sealants to occlusal surfaces and some maxillary lingual surfaces; periodic checking of the sealands, and reapplication as required;

—Prophy/gel: Fluoride paste prophylaxis and fluoride gel treatment;

—Rinse/tablets: Weekly fluoride mouthrinse and, if the site was nonfluoridated, daily systemic fluoride tablets;

—Education: Plaque control (brushing, flossing, and home use of a fluoride dentifrice), diet regulation, and dental health lessons.

The effect of "Plaque control" in this logitudinal-study was negative: In four years the number of tooth surfaces saved per child in the study groups were: + 0.01, -0.24, -0.44, -0.20

The publications of the RAND-study were N-1732-RWJF (Dec 1981); R-2862-RWJ (Apr 1982); R-3072-RWJ (Feb 1984); R-3034-RWJ (Feb 1984); in all 58+87+82+72 = 299 pages.

The results of the RAND-study were not in the interest of dentists and therefore the public was not informed of the outcome. Klein (director of the RAND) said, he viewed the results as important, because he said "we have closed off areas of spending in preventive care that are not promising. That, in itself, represents a significant finding and should save a tremendous amount of money". Another implication of the program was described by the AFDH (American Fund for Dental Health) Advisory Committee Chairman, through Alvin Morris: "Providing routine, standardized, individually applied preventive dentistry procedures to all children can no longer be justified".

In 1993 the Institute of German Dentists (IDZ = Institut Deutscher Zahnaerzte) presented the results of a large-scale study of oral epidemiology conducted between February and May 1992 among a representative cross section of the German residential population of the five new Federal States and East Berlin (i. e., the territory of the former German Democratic Republic) with the assistance of external research partners. .... The random-sample model was constructed in two stages. ....(W. Micheelis, J. Bauch: Mundgesundheitszustand und -verhalten in Ostdeutschland. Ergebnisse des IDZ-Ergaenzungssurvey 1992. (Translation — "State of oral health and oral behaviour in East Gremany. Results of the IDZ Supplementary Survey 1992") IDZ Materialienreihe 11.3. Deutscher Aerzte-Verlag Koeln 1993).

In the abstract is stated:

"In terms of DMF values, significant differences are also observable according to the sex and social status of the subjects. A comparison of data between areas with and without fluoridation of drinking water did not reveal any significant differences; ..."

Professor Kleijnen, such important and relevant studies and results are not included in the York systematic review.

Why have you excluded such studies as the studies of the Rand-Corporation in USA and of Kuenzel about the water fluoridation in Spremberg (GDR)? After 10 years of water fluoridation he could not find any caries reduction in Spremberg and after 13 years of water fluoridation in Chemnitz (Karl-Marx-Stadt) the dental caries began to increase! (Kuenzel W.: Folyamatos es megszakÌtott fluoridadagolas hatasa a carioesviszonyokra. Fogorvosi Szemle 79 295-298 1986; W. Kuenzel et al: Trinkwasserfluoridierung in Spremberg. Ein Beitrag zur Effektivitaetskontrolle komplexer Praeventionsprogramme. (Translation — "Water fluoridation in Spremberg. A contribution for effective control of complex prevention programmes.") Zahn-, Mund, Kieferheilkd. 74 (1986) 443-449)

In the next step in my comments of 9/13 April 2000 I have shown distribution and comparison of dental caries of children without water fluoridation and with life-long water fluoridation in the U.S.A. From these analyses we must conclude that water fluoridation in the U.S.A. did not reduce dental caries in children.

It is obvious that the results of your Objective 2 in your final draft report "If fluoridation is shown to have beneficial effects, what is the effect over and above that offered by the use of alternative interventions and strategies?" are untenable under the above circumstances.

In the Advisory Panel Meeting of 7 February 2000 Mr. Jerry Read, Department of Health, "Reminded panel that ministers would be interested to read about the relationship between fluoridation and social class in the final report".

It is obvious that the results of your Objective 3 in your final draft report "Does fluoridation result in a reduction of caries across social groups and between geographical locations?" are untenable. The ineffectiveness of water fluoridation is independent of social groups and geographical locations.

In my comments of April 2000 I showed that the inverse relationship between the natural fluoride content in drinking water and dental caries of children is a statistical artefact and was constructed by dentists in the U.S. Public Health Service. I showed also the great significance of confounding factors, such as high Lactobacillus acidophilus concentrations in saliva as an indicator for influences of nutrition, delayed eruption of permanent teeth in relation to fluoride in drinking water, east-west decline in dental caries prevalence in the USA as an example for differences between regions, influences of different caries trends in compared communities, possible influences of other components in drinking water other than fluoride (E.g. Sodium (Na)) on dental caries.

The meta-analysis never showed an inverse relation between natural water fluoridation and dental caries in children.

It is obvious that the results of your Objective 5 in your final draft report "Are there differences in the effects of natural and artificial water fluoridation?" are untenable. The non-effectiveness of natural and artificial water fluoridation against dental caries is evident. (The Brantford/Stratford/ Sarnia Study by Brown (1965) is untenable too.)

Additional analyses in my comments of April 2000 show the relationship between fluoride in drinking water and dental fluorosis and that the "optimal dose" of fluoride which was constructed by dentists and pharmacologists does not exist. Also given are some examples of possible influences of fluoride in drinking water on the metabolism of the skeleton, on Downs Syndrome (mongolism), cirrhosis of liver and cancer.

Furthermore, today I cited the following 2 papers: B. Paletta, W. Beyer, E. Rossipal and M. Minauf: Fluoridausscheidung bei Menschen verschiedener Altersgruppen (Human Urinary Fluoride Excretion of Various Ages). Three age groups were investigated (A - 4 to 6 years, B - 25 to 45 years and C - 60 to 70 years). Results: "1. A time drift in urinary fluoride excretion in the direction of delayed fluoride metabolism was seen in group C subjects. 2. A periodic increase in the urinary fluoride values was also seen in these elderly subjects, indicative of an altered regulatory mechanism". Wiener klinische Wochenschrift. 88 (6) 209-212, 1976.

Fratzl P, Rinnerthaler S, Roschger P, Klaushofer K: Mineral Crystals after Fluoride Treatment in Osteoporosis: Summary: "Fluoride therapy may lead to an altered structure of the mineral crystals in bone which, in turn, may affect its mechanical properties. The paper reviews recent work using small-angle x-ray scattering and back-scattered electron imaging to study this question. Characteristic changes occur in the crystallinity and in the size distribution of the mineral cristals. These changes are concentrated on isolated spots in the trabecular structure, probably corresponding to bone forming sites. The number and extension of these spots typically increase with the fluoride dose and there are indications from studies with animal models that these changes in the mineral crystals correlate with a reduced biomechanical strength of bone." OSTEOLOGIE Band 7, Heft 3, 1998, 130-133Verlag Hans Huber, Bern (Switzerland; http://verlag.hanshuber.com/Zeitschriften/Osteo/98/ os9803.html).

Professor Kleijnen, such important results as I have documented and discussed in my critical comments of 9/13 April 2000 on the problem of water fluoridation to the NHS CRD systematic review cannot be ignored in a serious scientific study and review.

You have not sent my comments and those of and others to the members of the Advisory Panel. So they cannot compare and interpret the results of the systematic review and the comments and responses for themselves. You have not considered and incorporated the comments in your tables and results of Objective 1, 2, 3, 5 of your Preliminary Draft Results of May 2000 and in the Final Draft Report of 6th June 2000.

What you or your review team have effectively done is a case of selective and undisclosed rejection of undesired results.

The data extraction by the NHS CRD contradicts the purpose of the systematic review.

In your Final Draft Report you have included only 20 individual caries studies in the Validity Assessment. All studies were produced by dentists. Important studies of these 20 selected studies have been criticised in literature for many years and are well known as invalid as evidence of caries prevention due to fluoride. You have not considered this fact and you have not excluded such studies from your systematic review. Therefore your results of the systematic review are also invalid.

The principal purpose of your systematic review is to compare caries values (% caries free and dmf/DMF - values) of children of different age-groups with and without water fluoridation for some years and then compute the mean differences of these caries -values and their "direction" of "benefit". You have also made a strong reduction of the database in these studies. Many necessary and important data and much information about the single studies and each experiment get lost as evidence in these procedures. The comparability of the compared test and control-groups and the maintenance of test conditions during the experiments are fundamental premises for papers used in correct scientific systematic reviews. You have not analysed the comparability, the test-conditions and the possible data selections by dentists in the 20 caries studies you have reviewed.

In your preliminary and final draft report you have distended the data base for your analyses in order to support concluding evidence for a positive effect. For instance, in Table 4.2 of the final draft report you make 30 analyses of 8 papers and conclude "All of the 30 analyses of the mean difference of the change in dmft/DMFT between the fluoride and control areas suggest a positive effect".

Of the one quoted paper of Arnold (1956) you make 3 "analyses" of the mean difference of the change in dmft/DMFT between the fluoridated and control areas of children aged 8, 12, 15 years. You found 3 "positive effects".

Why have you not "analysed" all available data in the original paper of Arnold (1956)? If you had done so you would have got not only 3 "positive effects" but 21 "positive effects": In the original paper the 10 dmft-values for 4 to 13 years old children were documented and the 11 DMFT-values for the 6 to 16 years old children in 1951 in Grand Rapids after 6 years of water fluoridation and in the control-city Muskegon before fluoridation was started there were also. In all 21 cases the mean differences of the change in dmft/DMFT between the fluoride (Grand Rapids) and control Muskegon) areas were "positive".

I think you know that distending the data base for "analyses" cannot be given more conclusive scientific evidence for positive effects of water fluoridation.

I would remind you that I have shown in my critical comments of April 2000 with data of the same original study of Arnold et al (1956), pages 15/16, Fig. 4 and 5, that the "caries reduction" in Grand Rapids in the first six years was a statistical artefact constructed by data selection in the sample from the well known data of population by the authors (dentists).

Why have you and/or your review team ignored this important fact in your final draft report and why have you not excluded this erroneous study of Arnold (1956) and other untenable studies?

Important confounding factors such as statistical artefacts in dental studies, comparibility of areas and influences other than fluoride, changes of test-conditions during the experiment, nutritional habits (e. g. sugar consumption) and changes of these, trends of caries before water fluoridation was started, were not considered by the NHS CRD. See also my critical comments of April 2000 and my comments and response of 25th June 2000 to your final draft report.

Without any doubt there is no scientifically sound evidence for "positive effects" and "benefits" of water fluoridation in the NHS CRD systematic review of water fluoridation.

An erroneous use of statistical methods with the aim of drawing other conclusions than those warranted by the available data and distorted interpretation of results or distortion of conclusion is unacceptable in science.

Professor Kleijnen, it is commendable, important and useful for the scientific community and for transparency in science that you have opened the process and data in your systematic review of water fluoridation in the web. I think it is now a good time to discuss the problem of water fluoridation and methods of dentists and public health officials at scientific community level.

I quote from page 80-81 of the document of "Deutsche Forschungsgemeinschaft: Proposals for Safeguarding Good Scientific Practice. Recommendations of the Commission on Professional Self Regulation in Science. Denkschrift" 1998:

"The Danish committee on Scientific Dishonesty (DCSD) was established in 1992

at the initiative of Danish Medical Research Council (DMRC) following recommendations by a working group which had extensively analyzed the causes, the phenomenology and the consequences of dishonesty in science (66). Like the US National Science Foundation, the working group sees the core of scientific dishonesty in the intent to deceive. This may lead to a variety of individual constellations of differing degrees of seriousness both in principle and depending on the circumstances of each case. Examples given for constellations requiring formal investigation are cases of "deliberate ....selective and undisclosed rejection of undesired results,..... erroneous use of statistical methods with the aim of drawing other conclusions than those, .....warranted by the available data, .... distorted interpretation of results or distortion of conclusion. ..... In 1996, the DCSD, with this principle unchanged, was brought under the umbrella of the Danish research ministry, thus preparing the extension of its remit to all fields of science, as its chairman had recommended in the 1996 Annual Report. ...." As you know Denmark has no water fluoridation.

In 1937 the Danish physician Kaj Roholm - a pioneer in research into fluoride intoxication - published his book "FLUORINE INTOXICATION. A Clinical-Hygienic Study. WITH A REVIEW OF THE LITERATURE AND SOME EXPERIMENTAL INVESTIGATIONS. (Nyt Nordisk Forlag, Arnold Busck, Copenhagen, H. K. Lewis & Co. Ltd, 136, Gower Street, London). The book has 375 pages, many tables, 96 pictures, and 893 evaluated literature citations. At this time there were huge problems with fluoride wastes in industry.

Kaj Roholm described various adverse health effects of fluoride, including cardiac and circulatory problems, nervous disorders, and disorders of the liver, kidneys, stomach, intestines, lung, bones, joints, muscles and teeth.

Professor Kleijnen, if you read this book I think you would wonder why dentists and public health officials perpetually try with such fanatism and enthusiasm and in the knowledge that dental caries are not caused by a "deficiency" of fluoride, to put such a toxic substance into the normal drinking water of people. It is a fact that in the human body a fluoride deficiency cannot exist, but too much can accumulate because about the half of all ingested fluoride accumulates in the body. Without any water fluoridation and in concentrations of F- < 0.1 ppm in drinking water the mean concentration of fluoride excreted in urine is about 0.3 ppm F- in man.

Only one year after Kaj Roholm published his book, in 1938 the American dentist and public health official H.Trendley Dean opened the way for water fluoridation. On the one hand at that time Dean had available caries-values from more than 600 communities for his later selection of 21 cities. On the other hand, in 1938 and in the next years Dean did not cite the book of Kaj Roholm about so many toxic adverse health effects of fluorides.

In a Special Report of Chemical & Engineering News (American Chemical Society) of 1st August 1988 it stated that about 143,000 tons per year of fluoride chemicals were put in drinking water. They come from "by-products of fertilizer production" (80,000 to H2SiF6; 60,000 to Na2SiF6; 3,000 to NaF). Only about 1% are ingested by man for "prophylaxis" of dental caries. The other 99% of these highly toxic chemicals get into the environment.

What is the interest of dentists and public health officials to contaminate the drinking water and the environment of people with such toxic chemicals?

I can understand that now it is very difficult for most people, dentists, public health officials, governments and politicians to change their public opinion about fluoride and water fluoridation as a means to reduce dental caries significantly after this was perpetually, enthusiastically and fanatically pushed and propagated as "caries prophylaxis" for 55 years.

The reason for this is that water fluoridation was not established on the basis of reliable scientific evidence of efficacy and especially not of safety. Water fluoridation was established on the basis of "political evidence" (see also my critical comments of April 2000 to the systematic review of NHS CRD). Water fluoridation became a dogma by dentists and public health officials and a doctrine in dental schools.

Most statistics that "proved" an inverse relation between fluoridated water and dental caries in children were produced by dentists. For many decades many studies with bad designs and false statistics and conclusions have been tought in dental schools and universities. In most cases dentists were the peers in peer reviewed journals. They supported papers which "proved" positive effects of water fluoridation, and "refuted" and ignored critical papers. So the dogma of efficacy of water fluoridation was corroborated.

Many peers come from the ORCA (European Organization for Research on Fluorine and Dental Caries Prevention; now: European Organization for Caries Research). This organization was founded in 1952 by dentists from Germany, Austria, and Switzerland with the goal to force the establishment of water fluoridation in Europe and to influence public health officials, governments, expert committees, editors of journals. In the last three decades publishers and editors of journals were called up to suppress critical papers in connection with fluoridation. Members of ORCA (ORCA was sponsored by companies and industries) collaborated with international and national dental organizations and associations and were named as experts and in many cases established by governments in official international organizations such as the WHO, the European Communities, and others in all continents.

Fluoride commissions were founded in academic medical institutions which advised the institutions e. g. the Swiss Academy of Medical Sciences or the Royal College of Physicians. Dentists, well known and recognized as "fluoride experts" steered institutions in the direction of "water fluoridation and fluoride prophylaxis is "beneficial" and "safe"". Members of such institutions trust their "dental experts" in most cases.

In many countries Fluoridation Societies partly with the same persons and similar competences were founded. The Fluoridation Societies often managed the fluoride propaganda and information in the public and advised public health officials and governments.

In 1970 the WHO published the Monograph No. 59 "Fluorides and Human Health". I quote from the Preface:

"Since the late 1940's, the use of fluorides for prevention of dental caries - especially the adjustment of the fluoride content of drinking water - has been a subject of considerable controversy. Public health authorities that have contemplated adopting measures of this kind have encountered strong oppostion and have often had to undertake extensive reviews of the literature in order to reach a decision.

The World Health Organization has been concerned for many years about this situation and, in 1962, it received a specific request from the International Dental Federation "to convene a meeting with a view toward compiling an authoritative and up-to-date report on the metabolism of fluorine". .... It was decided instead to invite experts on questions relating to fluoridation and the effects of fluorides on human health to collaborate in the preparation of a monograph on the subject. .... It is not intended to be a practical guide to the use of fluorides as a health measure, but rather a presentation of the facts to assist public health authorities and other persons to form an objective judgement.

To assist the WHO in planning the monograph and in co-ordinating the various sections prepared by the 29 contributors, Professor Y. Ericsson was appointed as a special consultant and scientific editor...." (Prof. Ericsson was later also editor of the ORCA-Journal "Caries Research"). Many contributions in this monograph were not uncritical — I cited from this book in my comments of April 2000 on page 36 — and many open questions were discussed, but the chapter 9 "Fluorides and Dental Health" by the Hungarian dentist Professor Peter Adler contained many false statistics. Statistical artefacts and false conclusions claimed the inverse relationship between (water) fluoridation and dental caries and "benefits" of water fluoridation.

Only one year after this WHO-monograph was published, in 1971 water fluoridation in Sweden was stopped and forbidden after an open hard discussion between the Swedish dentist and WHO scientific-advisor Prof. Yngve Ericsson and the Swedish pharmacologist and toxicologist Prof. Arvid Carlsson; and in Germany water fluoridation was stopped on 31 March 1971 after my own scientific critique of dentists' wretched fluoridation statistics and constructed "benefits".

Only some weeks after my first paper on water fluoridation was published in April 1969 ("Gesetzmaessigkeiten im Verlauf der Zahnkaries". (Translation — "Regularity in the course of dental caries" — Prophylaxis — Zentralblatt {Main Paper} for Social Hygiene, Preventative Health Care and Boundaries") Prophylaxe - Zentralblatt fuer Sozialhygiene, Gesundheitsvorsorge und Grenzgebiete. Jg. 8 H.4 1 -11, 1969) a campaign by dental, medical, and public health authorities, including the WHO, was started against me because at that time members of the ORCA and the Austrian Dental Association intended to establish water fluoridation in Austria. School fluoride tablet actions were running since 1956. Nevertheless I could place some critical articles in dental periodicals, one in March 1971 in the "Schweizerische Monatsschrift fuer Zahnheilkunde". From then on editors and publishers were pressured not to publish critical papers on fluoridation. Henceforth critiques were suppressed and critical papers were never cited in dental literature. Many interventions were started against me and untrue information and statements circulated.

In 1969 the Czech dentist and member of the ORCA, Dr. J. Kostlan, Regional Officer for Dental Health, WHO Regional Office for Europe, Copenhagen, Denmark, stated to the Austrian Director-General of Public Health: "Since pseudo-scientific articles, similar to this one, can confuse the issue of fluoride prevention."

Nevertheless, in March 1973 the fluoride tablet action in schools and Kindergartens in Graz (capital of Styria) was stopped after 17 years. In October 1973 the Styrian Government set up an inquiry with experts for and against fluoridation, including WHO fluoride experts (e.g. also Professor Klaus G. Koenig, Head, Faculty of Medicine, School of Dentistry, University of Nijmegen, Nijmegen, Netherlands; Prof. Koenig was also editor of "Caries Research" the Journal of the ORCA). Members of the inquiries (1973, 1980, 1982, 1991) were dentists, physicians, pharmacologists, physicists, statisticians, lawyers, health authorities, public health officials, representatives of medicine, of schools, of parents' and consumers' organizations. As a result of the inquiry in 1973 the Styrian Government stopped the fluoride tablet action in the Federal State of Styria. Investigations in Graz showed that dental caries in school children increased during the fluoride tablet action. After the end of this systematic "prevention measure" dental caries decreased between 1974 and 1982 in Graz. The level and the decline of dental caries without any fluoridation in Graz was about the same as in children of Basle (Switzerland) of the same ages but with water fluoridation and with additional other fluoridation measures. Both cities, Basel and Graz, have about 230,000 inhabitants and are cities with industry. In 1986 the fluoride tablet action was also stopped in the Federal State of Carinthia and in 1994/95 all over Austria.

In 1976 water fluoridation in the Netherlands was stopped after 23 years. I was involved in these discussions since 1969 and came in contact with the Ministerie van Sociale Zaken en Volksgezondheid. Contrary to dentists' claim (Backer Dirks and others) no conclusive scientific evidence for "benefits" and "safety" of water fluoridation in the Netherlands existed.

In 1977, 32 professors and directors of dental medicine from dental institutes of the Universities in Austria (Prof. Koele, Gausch, Keresztesi), Switzerland (Prof. Baume, Holz, Rateitschak, Regolati, Maeglin, Schroeder, Hotz, Marthaler, Muehlemann), and Germany ( Prof. Naujoks, Sonnabend, Eifinger, Stueben, Triadan, Ketterl, Arnaudow, Sauerwein, Knappwost, H.F.M. Schmidt, Schreiber, Motsch, Newesely, Kroencke, Overdiek, Pantke, Buettner, Riethe, Ahrens, Franke) made declarations to defend fluoridation and its "benefit" and "safety", attacked critics simultaneously very emotionally and disseminated their declarations in all three states.

E.g., German dentists (1977) in their declaration "Oeffentliche Erklaerung gegen ihre Diskriminierung durch unbelehrbare Fanatiker" (Translation — "Public declaration against discrimination due to unconvertible fanatics") called the critics of fluoridation "stubborn fanatics" ("unbelehrbare Fanatiker"). In their declaration Swiss dentists stated: "Wer heute noch gegen die Verwendung von Fluoriden bei der Kariesprophylaxe auftritt, diskriminiert Tausende von Wissenschaftlern, ja stellt die Wissenschaft als solche ueberhaupt in Frage und kann vernuenftigerweise heute auf diesem Gebiet nicht mehr ernst genommen werden" (Translation — "Those who these days still protest against the use of fluoride for the purpose of caries prevention, discriminate against thousands of scientists, in fact they question the science per se, and therefore in all honesty cannot be taken seriously in this area.") This is absolute nonsense and shows the narrow way of thinking of these authorities in the dental field when they believe that critics call into question the "science as such" if criticising fluoridation. We are now in the year 2000 and your NHS CRD systematic review of water fluoridation has not provided a single paper with highest evidence and lowest bias (Level A).

In the following years up to 1976 I had many problems because the international and national fluoridation-lobby (dentists and health authorities and their associations and organizations) intervened at the highest political level with the Federal Government of Austria and Styria and at my Institute to hinder my fluoride research and publications of the results. E.g. they intervened via the Austrian Chancellor Dr. Bruno Kreisky, some Ministers, the Head of Styrian government, some MP's and others.

I thought if they did this, they could only do so with very poor or bad scientific arguments. I wrote to our Chancellor Dr. Kreisky that we have freedom of research and science and freedom of expression of opinion in our Constitution and in the European Human Rights Convention. If they have good and seriously concluded arguments to disprove my research and results in an open and serious scientific discussion, then they can do so.

In my fluoride research I found some cases of dentists' papers where the content or theses were contrary to the contents of their summaries or to the published "benefits" of fluorides.

E.g. on the tube and packing of a well-known fluoride dentifrice we read that the director of the University Clinic of Dentistry Wuerzburg (Germany), Prof. Naujoks, gives clear evidence for the very special prophylactic efficacy of this "fluor super" dentifrice: "Die besondere Wirksamkeit dieser Zahnpaste zur Prophylaxe von Karies wurde an der Universitaetszahnklinik Wuerzburg unter Mitarbeit der Blendax Karies-Forschung eindeutig nachgewiesen. Die regelmaessige Verwendung von Blendax fluor super fuehrt zu einer wesentlichen Verringerung der Kariesbildung. Prof. Dr. Naujoks. Direktor der Universitaetszahnklinik Wuerzburg" (Translation — "The special effectiveness of this toothpaste in the prevention of caries was demonstrated clearly and proven at the University Clinic, Wuerzburg, with cooperation from the Blendax Karies-Research. Regular use of Blendax fluor super leads to a significant reduction in the development of caries; Professor Dr Naujoks, Director of the University Clinic, Wuerzburg"). The summary of the paper of J. Patz and R. Naujoks: Klinische Ueberpruefung einer fluoridhaltigen Zahnpaste bei Erwachsenen. Deutsche Zahnaerztliche Zeitschrift 24, H. 7, p. 614 (1969) (Translation — " The summary of the paper of J Patz and R Naujoks: "Clinical Examination of a fluoride containing toothpaste by adults", German Dental Journal, 24, H.7, p614 (1969)). Read: "Die Reduktion des Zuwachses in der Fluoridgruppe von 0.44 DF (bezogen auf das ganze Gebiss = 7.8%) konnte statistisch nicht gesichert werden (P > 0.1)" (Translation — read: "The reduced increase in the fluoride group of 0.44DF (referring to all teeth = 7.8%) could not be ascertained as statistically significant (p>0.1)". Prof. Naujoks was also president of the "Deutsche Gesellschaft fuer Zahn-, Mund- und Kieferheilkunde" (Translation —"German Society for Teeth, Mouth and Jaws") and 1971-1974 he was chairman of a committee for the introduction of water fluoridation of the Council of Europe In 1976 he intervened with the Austrian Chancellor Dr. Kreisky against me. In 1977 he was an initiator of the declaration of several professors in dentistry and in 1985 Professor Naujoks was my opponent in the hearing about water fluoridation by the German Parliament.

In another case, i. e., 1976/77 a dentist investigated the influence of natural fluoride in drinking water on dental caries of children in 7 communities in the Vulkaneifel (Germany). 6 communities have 0.91 - 1.55 ppm F- (test-groups), 1 community 0.10 ppm F- (control-group). 5 from the 6 test-groups were selected from 11 communities with "fluoride-rich" water (15 communities had been investigated a year before: 11 communities had fluoride-rich water and 4 low-fluoride water) but no control-group was selected from the 4 communities with "fluoride-poor" water. Children from the test-groups were investigated in February/March. In September children of one additional test-group and children of one additional control-group of additional communities were investigated. These children were about six months older. In his thesis of 1980 the dentist showed tables and diagrams with no significant differences between dental caries in children of the 6 test- and 1 control-group. He stated that the 7 groups were taken from the same population and that the caries differences were at random. (The "Statistisches Landesamt Rheinland-Pfalz" helped with the statistical analyses.) Further tables show that the children in the control-community with 0.1 ppm F- had more 6-year and 12-year molars erupted than children in the 6 fluoride-test-communities. Furthermore a questioning showed that children in the control-community had eaten more sweets between breakfast and lunch than the children in the test-communities. These two factors (eruption and sweets) can cause the non-significant higher caries-values in the control-group than in the test-group.

Quite contrary to these results in his thesis-paper the same dentist wrote in his summary, that there is significant evidence for caries prophylactic effect of natural water fluoridation in Germany and that caries were reduced by fluoride by about 40 to 50%. He also wrote that the goal of his thesis was to refute my (Ziegelbecker) criticism on dentists' statistics in German-speaking areas in Europe, to refute the objections of the German Water Works Association (DVGW) against water fluoridation, and to force the establishment of water fluoridation in Germany.

The dentist was awarded a doctorate of dental medicine for his thesis "Die Bedeutung der Fluoride in der Praeventiven Zahnheilkunde am Beispiel eines Gebietes mit erhoehtem F- - Gehalt im natuerlichen Trinkwasser (Laacher See/Vulkaneifel)" (Translation — "The importance of fluoride in preventative oral health care - the example of an area with an increased F- - content in natural drinking water (Laacher See/Vulkaneifel)"), Bonn 1980, and is now a well known Professor (Dr. Johannes Einwag) in dental medicine in Germany. In 1984, with his supervisor Professor Hubertus Buechs of the Universitaetszahnklinik Bonn, the glossy magazine "Neue Revue" 6/1984, p. 90, published: "Schueler in der Eifel. Zahngesundheit aus der Wasserleitung. Grossversuch: Fluor im Trinkwasser. Ein ganzes Dorf ohne Karies" (Translation — "Pupils in the Eifel. Oral health from water pipes. Large-scale trial: Fluoride in drinking water. An entire village without caries.").

In the light of the Denkschrift "Proposals for Safeguarding Good Scientific Practice. Recommendations of the Commission on Professional Self Regulation in Science." of the "Deutsche Forschungsgemeinschaft" 1998 I feel that this case is a case of scientific misconduct appropriate for discussion on the level of science community.

I know cases where dentists become academic graduates and/or get academic honours for false statistics, results or conclusions if those are "positive" for the promotion of fluoride and its "benefits".

Professor Kleijnen, why do I tell you this long story in my Open Letter in connection with your NHS CRD systematic review of water fluoridation?

I have read that, contrary to the dentists' team from Cardiff, "The NHS Centre for Reviews and Dissemination has not been involved in the fluoridation debate/issue before." Therefore, I think that you and the York review team have insufficient insight into what goes on behind the scenes.

Therefore, finally I will inform you that there is often scientific misconduct and dishonesty in authentic papers on fluoridation and alleged "benefits" of fluoridation are constructed by dentists, based on three examples. In my view there is also improper use of the WHO and other official organizations by dentists and "accepted fluoride experts" in order to defend water fluoridation.

Professor Murray, a member of your Advisory Panel in the Water Fluoridation Systematic Review, was also member of the College Committee on the Fluoridation of Water Supplies in 1973. The report "Fluoride, Teeth & Health" of the Royal College of Physicians was published in London, 1976.

In my Open Letter I mentioned above the WHO-Monograph "Fluorides and Human Health" (1970) that the goal was "rather a presentation of the facts to assist public health authorities and other persons to form an objective judgement to encountered strong opposition."

In 1982 an international conference with the same goal was held in Vienna. In 1986 the WHO published the book "Appropriate use of fluorides for human health". The book was edited by Professor J.J. Murray, Professor of Child Dental Health, and Dental Postgraduate Sub-Dean, University of Newcastle-upon-Tyne, England, "on the basis of a Conference on Fluorides that was held in Vienna, Austria, from 3rd to 5th October 1982 under the joint sponsorship of the FedÈration Dentaire Internationale (FDI), the W. K. Kellogg Foundation and the World Health Organization. The majority of the papers presented at the Conference have been collated in document ORH-82 issued by the Pan American Health Organization/WHO Regional Office for the Americas, Washington DC, USA (1984)".

The "Conclusions and Recommendations of the FDI/WHO/KELLOGG Foundation Conference on Fluorides, Vienna, 3-5 October 1982" were published in Annex 1 and the List of participants in the ... Conference .... were published in Annex 2 of this book. The intention of this conference in Vienna (1982) and the book (1986) is clearly described in the foreword:

"In spite of the overwhelming evidence that the administration of small quantities of fluoride significantly lowers the incidence of dental caries without risk to health, this simple public health measure has not yet been implemented on the scale it deserves. This is due in part to the often misguided opposition to community fluoridation programmes and in part to uncertainty in choosing among the various alternative methods in places where community water fluoridation is not practicable or is unacceptable."

"The purpose of this book is to help public health authorities and dental practitioners to decide which methods of ensuring an optimal intake of fluoride are most appropriate to the circumstances of a particular community and to provide advice on the practical aspects of those methods. It is thus complementary to the book published by the WHO 1970 entitled 'Fluorides and Human Health', which dealt mainly with the physiology, distribution, dosage, and safety of fluorides."

The Conference had 49 participants from all over the world. From the WHO came Dr. Barmes (Chief Oral Health, WHO Headquaters, Geneva) and Mrs. Infirri, Dr. Moeller (Regional Adviser, Oral Health, WHO Regional Office Copenhagen), Dr. Leous (Oral Health, WHO Geneva), Dr. Gillespie and Dr. Roviralta (WHO Regional Office for the Americas/Pan American Sanitary Bureau, Washington DC). From the FDI came Dr. Aggeryd (FDI-President, Stockholm) and Dr. Ahlberg (Executive Director FDI, London). From NIDR (National Institute of Dental Research, USA) cames Dr. Horowitz and Dr. Small. The other prominent participants (virtually all dentists) came from England, USA, Switzerland, Canada, Peru, Austria, Syria, Brazil, New Zealand, Luxembourg, Sweden, Norway, Nigeria, German Democratic Republic, Netherlands, Kenya, Colombia, Wales (Cardiff), India, Thailand, Finland, Hungary, Bermuda, Australia. (Unable to attend: Dr. Schamschula, Australia).

This concentration and composition of dentists ensured that the goals and claims of this "Fluoride Conference" in Vienna were disseminated in most governments and health associations and authorities all over the world.

When he openned the Conference of 1982, Dr. Barmes (WHO) said that questions of the efficacy and safety of fluorides are not to be discussed because these questions had been indisputably decided for a long time. The purpose of this Conference was only the development of methods for distribution of fluorides among people.

Professor Kleijnen, before I discuss the scientific misconduct of dentists in this conference and in the book of the WHO, edited by professor Murray, I will give you two examples of how dentists constructed "benefits" of fluoridation.

In March 1973 fluoridation (F- - tablets in schools and kindergartens) in Graz and in November also in the Federal State of Styria was stopped. Since that time official fluoride promoters (dentists, pediatricians, physicians, health officials, health authorities and their organizations, politicians) pressured the government unsuccessfully year by year to re-establish fluoridation in Graz and Styria. 1982 they hoped their time was coming.

Some days after the Fluoride Conference in Vienna of 3 - 5 October 1982, after a press conference in the Chamber of Physicians (medical association), the Fluoride-Lobby trumped-up in newspapers and other media that dental caries of children in Graz had increased by 500% since fluoridation was stopped. They presented figures that children aged 10 in 1970/71 during the fluoride tablets action in Graz had only 0.48 decayed teeth per child but in 1980/81 after the end of the fluoride treatment children (of the same age) had 2.50 decayed teeth per child. These figures were officially given by the chief dentist of the "Stadtschulamt Graz, Schulzahnambulatorium" (Translation — "Municipal Education Authority, Graz, School Dental Otpatient Dept.") with backing of the Fluoride-Lobby and some politicians. Newspapers headed e.g.: "Front der Zahnaerzte und WHO-Experten: Groflangriff auf Fluorgegner in der Steiermark" (Translation — "Confrontation by dentists and WHO experts: Major assault on fluoride opponents in Styria")

But these figures were not comparable. The chief dentist of the school dental clinic had compared decayed teeth without missing and extracted teeth in 1970/71 with decayed + missing + filled teeth in 1980/81. It is deplorable that this chief dentist was assisted by an official of the health ministry, a professor of dentistry, the President of the Austrian Dental Association, and a member of the Upper House of the Austrian Parliament for such an inadmissible comparison in order to deceive the people.

The "fluoride lobby" attacked me saying I would harm children. However, a simple logical reflection on this comparison of the two published figures tells us: If a chemical substance (fluoride) reduces the danger for teeth by half (- 50%) how can the loss of this chemical substance produce quintuple danger (+500%)? — In fact dental caries of children decreased at that time after the end of fluoridation.

I therefore notified this case of deception to the municipal authorities in Graz. All relevant data on children from the school dental clinic were transferred to the office of the Magistratsdirektor and kept under lock and key to hinder data abuse. Lawyers of the municipal director's office reviewed the data themselves. On 23 August 1985 the director general of the municipal authorities, Dr. Horst Bogner, informed me that on 14 August 1985 the "Rathauskorrespondenz" in agreement with the Mayor of Graz and the "Stadtschulamt" had given an official statement of the City of Graz under the headline "Kein Fluor in Grazer Schulen" ("No fluoride in the schools of Graz") to the media:

"Rathauskorrespondenz Graz 1985 08 14

Kein Fluor in Grazer Schulen

Bei einer Pressekonferenz im Oktober 1982 zum Thema 'Zahnkaries bei Kindern - Fluortabletten fuer Schueler', veranstaltet von der Gesellschaft fuer Gesundheitsschutz in der Grazer Aerztekammer, wurden von einem Vertreter der Stadt Graz Zahlen ueber Kariesschaeden bei Grazer Schulkindern bekanntgegeben, die sowohl in den Medien als auch bei bundesdeutschen Stellen zu irrefuehrenden Vergleichen gefuehrt haben. Es wurden bei diesem Anlass Zahlen bekanntgegeben, die nicht miteinander vergleichbar sind, sodass die daraus gezogenen Schlussfolgerungen (verfuenffachtes Auftreten von Karies nach Absetzen der Fluortablettenaktion) falsch sein muflten.

Hierzu wird festgestellt, dass die Stadt Graz zwar an allen Forschungen auf dem Gebiet der Zahnkaries-Prophylaxe grundsaetzlich interessiert ist, jedoch auf Grund der gegenwaertigen Gegebenheiten keine Veranlassung sieht, den Beschluss ueber die Einstellung der Fluortabletten-Aktion zur Diskussion oder in Frage zu stellen."

(Translation - "Townhall Correspondence, Graz, 1985 08 14 No fluoride in the schools of Graz

At a press Conference in October 1982 on the subject "Dental caries in children - Fluoride tablets for pupils", arranged by the Society for Health Protection in the Medical Chamber of Graz, a representative from the city of Graz announced data on dental caries amongst schoolchildren in Graz, which led to the citing of misleading comparisons both in the media as well as with federal German institutions. On that occasion incomparable data were given, which led to conclusions drawn on these results (i.e. a quintupling of caries after sessation of use of fluoride tablets, which must be false. It has now been established that whilst the city of Graz is basically interested in all research in the field of caries prophylaxis, based on the present circumstances it can see no reason to discuss or question the decision to stop the fluoride-tablet action.")

In my lecture "Zur Beurteilung der Fluoridbelastung in der Umwelt" (Translation — "A critical examiniation of the burden of fluoride in the environment") at the IVth international conference BIOINDICATORES DETERIORISATIONIS REGIONIS of the Czechoslovak Academy of Sciences in Liblice near Prague on 28th June - 2nd July 1982 I showed the increase of dental caries in school children during the fluoride tablet action and the decrease of caries after the end of the fluoride action in Graz. My lecture was published in full in the Proceedings of the conference, edited by J. Paukert, et al.; Ceske Budejovice 1986, part II, p. 355-371, Fig. 2 on p. 359.

Professor Kleijnen, I hope you can see from this case how irresponsible the methods of fluoride promoters among dentists and public health officials are to defend their claim of "benefits" of fluoridation.

In the next case I will show scientific misconduct by the Swiss dentists - Professor Thomas M. Marthaler and Klaus G. Koenig in a fluoride tablet study. Professor Marthaler was a member of the "WHO Scientific Group in the Etiology and Prevention of Dental caries" of Geneva, from 30th November - 6th December 1971, and a member of the FDI/WHO/KELLOGG Foundation Conference on Fluorides, Vienna, 3rd-5th October 1982. Dentist professor Koenig was editor of "Caries Research" (Journal of the ORCA), member of the "Arbeitsgruppe ueber die Probleme im Zusammenhang mit der Durchfuehrung der Trinkwasserfluoridierung in Europa" (Translation — "Working Group on problems associated with the implementation of water fluoridation in Europe") 1971 of the European Council (chairman of this work-group was the dentist professor Naujoks, see above), and a member of the FDI/WHO/ KELLOGG Foundation Conference on Fluorides, Vienna, 3-5 October 1982.

In the book "Appropriate use of fluorides for human health", edited by professor J. J. Murray and published by the WHO 1986, on page 120 it was stated:

"Epidemiological research into the effects of fluoride-bearing drinking-waters did not even, at that time, have the benefit of the principle of "blind" comparative trials. This important deficiency in research design was compensated for later, however, by consistent supporting evidence, including "blind" studies (8)."

The cited literature (8) was: Marthaler T. M. & Koenig, K. G.: Der Einfluss von Fluortablettengaben in der Schule auf den Kariesbefall 6-15jaehriger Kinder. [Influence of school distribution of fluoride tablets on the caries attack rate in 6-15-year old children], Schweizerische Monatsschrift fuer Zahnheilkunde, 77: 539-554 (1967).

I have analysed this study several times between 1970 and 1974 and published criticism. At the symposion "Zahnkaries und Fluoride" (Translation — "Dental Caries and Fluoride") of the "Wissenschaftliche Vereinigung fuer Zahnheilkunde Stuttgart" (Translation — "Scientific Union for Dental Health Care, Stuttgart") in Lindau/Bodensee (Germany) on 13 September 1973 I gave a lecture on "Rechtfertigen kariesprophylaktische Erfolge in der Relation zur Schadensmoeglichkeit Fluoreinsatz?" (Translation — "Justifying prophylactic caries (prevention) successes in relation of harm due to use of fluoride"). I have criticized the study of Marthaler & Koenig. Professor Koenig was my follow-up speaker and professor Marthaler sat in the audience. Neither has discussed or refuted my hard criticism of their study. My lecture of 13th September 1973 was published in full including annexes in "U. Rheinwald

: Zahnkaries und Fluoride - ein Diskussionsgespraech. (Translation — "Dental caries and fluoride - a discussion") A.W. Gentner Verlag Stuttgart 1974, p. 53 - 106". At the inquiry by the Styrian Government of 8th October 1973 I have also discussed this paper with the author dentist Professor Koenig. He could not weaken or refute my arguments against his study and his conclusions.

In 1974 a widely published folder — "Zahngesundheit aktuell" (Dental Health Actual) 1/1974 of the "Sektion Jugendzahnpflege der Oesterreichischen Arbeitsgemeinschaft fuer Volksgesundheit (OeAV)" (Translation — "Section Youth Dental Care of the Austrian Workers' Community for People's Health") — at that time the "Austrian Fluoridation Society" - the study of Marthaler and Koenig was cited as "clinical evidence" that fluoride tablets reduced dental caries in children by about 45%. The folder was signed by three Ministers (Health and Environment; Science and Research; Teaching and Culture), by the president of Social Securities, by the president of the Austrian Working Group for Public Health, by the chiefs of University Dental Hospitals of Graz, Innsbruck, and Vienna, by the president of the Austrian Medical Society, by the president of Austrian Dentists Association, by the president of Dental Technicians.

This folder was edited by the Austrian most prominent fluoride promoter and "expert", dentist Dr. Kurt Binder, chief of school dental clinics of Vienna. He was also a member of ORCA, member of the work-group of the WHO Regional Office of Europe (May 1972 in London) about "Cost and Benefit of Fluoride in the Prevention of Dental Caries" edited by G. N. Davies (Australia), published by the WHO, Geneva 1974. Dentist Dr. Binder was also member of the inquiry of the Styrian Government on 8th October 1973 in Graz. The criticism on the fluoride tablet study of Marthaler and Koenig was well known to Dr. Binder. In 1982 Dr Binder was also a member of the FDI/WHO/KELLOGG Foundation Conference on Fluorides, Vienna, 3-5 October 1982 and a member of the press conference of 18 October 1982 in Graz where he supported the presentation of not comparable figures and the false conclusions and deception of people.

After that folder was published in May 1974 I made a comprehensive scientific analysis of the Swiss fluoride tablet study of Marthaler and Koenig (1967) for the Styrian Government. The paper of Marthaler and Koenig and my analysis were reviewed by 15 scientist of various disciplines.

The reviewers were 10 professors of universities: U. Dieter (mathematical statistics, Graz), C. Geyer (dentistry, Detmold/Berlin), E. Harndt (dentistry, Berlin), A. Holasek (medical biochemistry, Graz), Th. Kenner (physiology, Graz), P. Marquardt (nutrition and toxicology, Freiburg), G. Plischka (dentistry, Graz), U. Rheinwald (dentistry, Stuttgart), R. Gunzert (statistics, Frankfurt/Main), W. Zimmermann (hygiene and microbiology, Homburg/Saar). Further 5 reviewers were: A. Celedin (dentistry, at that time chief physician of school-dental-ambulanz, Graz), W.P. Roelofs (chemistry, Soest/Netherlands), G.Saller (expert witness in physics, Graz), J. Theurl (advanced mathematics and information technology, Graz), Ch. Weber (biochemistry, Graz).

All 15 reviewers corroborated my scientific critique of the Swiss fluoride tablet study of Marthaler and Koenig (1967) and some of them added critiques of the paper of both authors.

In their clinical "blind"-study Marthaler and Koenig claimed a statistical significant "caries reduction" of 36% to 45% caused only by fluoride tablets as "clinical evidence" for the "benefit" of fluoride.

Now, what is the essential and understandable scientific critique of the "blind"-study of Marthaler and Koenig (1967)?

Between 1963 and 1965 the dentists Marthaler and Koenig investigated dental caries of children in 50 communities in the Swiss Cantons Bern (BE) and Zurich (ZH). From these 50 communities they selected one test-community and one control-community in Canton Bern in 1965 and after the same scheme they selected two communities in Canton Zurich. If we sorted these communities in relation to dental caries of children than we could find the two test-communities (with fluoride tablets) on the side of the scale with lowest caries values and the control-communities (without fluoride tablets) on the side of the scale with highest caries values as result of data selections by the authors. Other possible selections of communities had given other results.

The examinations were in Rohrbach/Eriswil on 26/27 April 1965 and in Wiesendangen/Rickenbach on 9/10 December 1965. All children 6 - 15 years old not absent from schools on these days were examined.

Marthaler and Koenig did not have the caries-values of the control-groups and of the test-groups before or shortly after the start of fluoride tablet distribution in the test-groups 1954/57, because they had no basic examination data. Therefore, they could not say that the groups were comparable in all other factors except for fluoride tablets. Furthermore, they did not know the caries-trends before their "final" examination in 1965.

To solve this problem Marthaler and Koenig had the idea to investigate in 1965 not only the permanent teeth but also the primary teeth in children aged 6 and 7 years. They concluded: If children aged 6/7 years have about the same caries-values (dmft) in primary teeth in the control- and test-groups in 1965 then the children aged 6-15 of the test- and control-groups had the same conditions in their permanent teeth from 1954/57 and in the following years up to 1965. In this way the dentists Marthaler and Koenig concluded and "proved" that the control- and test-communities were comparable between 1954/57 and 1965 in all factors except fluoride tablets. Such a conclusion is nonsense.

The number of children used for the study of the "fluoride effect" was found in a further paper of Marthaler two years later (Marthaler T.M.: Caries-inhibiting Effect of Fluoride Tablets. Helv. Odont. Acta 13, 1-13, 1969). In the same paper I also found the caries results of the 50 communities from which Marthaler and Koenig had selected the "test- and control-communities".

The number of 6 and 7 years old children used by Marthaler and Koenig for the "test of comparability" of the test- and control-groups (1965) you can see from the following table.

The "blind" dental investigations of children by dentists attribute a quality to this study which it does not have. The positive results are practically predestined by data selection and study design.

I have criticised the method of data selection by Marthaler also in my lecture on - "the problem of data selections in fluoridation statistics" at the XVIth Conference of the International Society for Fluoride Research in Nyon (Switzerland), August 31 - September 2, 1987. Marthaler was there but as an "accepted fluoride expert" of the WHO and the Swiss Academy of Medical Sciences and of the public health officials and health authorities he ignored the critique.

Additionally I remark that professor Kuenzel in a good controlled fluoride tablet study with more then 7000 children in the German Democratic Republic in Cottbus/Luebben and Grevesmuehlen/ Doberan has not found any positive effect of fluoride tablets after 4 1/2 years of controlled distribution. See W. Kuenzel, F. Maier, E. Kleine: Zur Kollektivprophylaxe der Karies mit Fluoridtabletten. (Translation — On collective prophylaxis of caries (prevention) with fluoride tablets") Dtsch. Stomat. 18: 300-312, 1968.

At the IVth international conference BIOINDICATORES DETERIORISATIONIS REGIONIS of the Czechoslovak Academy of Sciences in Liblice near Prague on 28 June - 2 July 1982 in my lecture — "Zur Beurteilung der Fluoridbelastung in der Umwelt", (Translation — "Judging the burden of fluoride in the environment") I showed that dental caries of children in the fluoride and control-groups in Cottbus/Grevesmuehlen and Luebben/Doberan was about the same in the basis investigation and that the caries decline during these 4 1/2 years was also the same in the control- and test-groups. Therefore the caries-values in the final investigation were also about the same in both groups. My lecture was fully published in the Proceedings of the conference, edited by J. Paukert, V. Ruzicka, J. Bohac, Institute of landscape ecology, Czechoslovak Academy of Sciences, Ceske Budejovice 1986, part II, p. 355-371, Fig. 3 on p. 360.

Professor Kleijnen, in my opinion it is clear misconduct in science that under the above conditions in the book "Appropriate use of fluorides for human health", edited by professor J. J. Murray and published by the WHO 1986, on page 120 the following is stated:

"Epidemiological research into the effects of fluoride-bearing drinking-waters did not even, at that time, have the benefit of the principle of "blind" comparative trials. This important deficiency in research design was compensated later, however, by consistent supporting evidence, including "blind" studies (8)."

I think it is a case for the scientific community with in the meaning of the "Denkschrift: Proposals for Safeguarding Good Scientific Practice. Recommendations of the Commission on Professional Self Regulation in Science." of the Deutsche Forschungsgemeinschaft. DFG, WILEY-VCH 1998.

In Objective 2 of your systematic review in the final draft report there is the question: "If fluoridation is shown to have beneficial effects, what is the effect over and above that offered by the use of alternative interventions and strategies?"

In the last 30 years I have analysed many individual studies of water fluoridation and alternative interventions and strategies. I have not found any study that gives conclusive scientific evidence of "benefits"of water fluoridation or alternatives.

I think you will agree that such errors and omissions in fluoridation studies as I have shown above and in my comments of April 2000 and in my response of 25 June 2000 are serious and that the method used in "Water Fluoridation Systematic Review of its Efficacy and Safety" and in "Caries Study Validity Assessment" cannot find evidence for "benefits" of water fluoridation in such studies.

If caries studies included in the systematic review are false and untenable then your systematic review also produces false and untenable results and conclusions. Therefore it is necessary to exclude such studies and to review all included studies individually before making meta-regression analyses.

Professor Kleijnen, it is a fact that "benefits" of water fluoridation are based only on faulty caries statistics done by dentists.

The fundamental fluoridation statistic is the "21-cities-study" by H.T. Dean et al from 1942. It was the basis of all artificial water fluoridation experiments first in USA and Canada and then also in Europe and all over the world. This study is cited in most (dentists and physicians) experts' opinions and recommendations of water fluoridation and other fluoridation strategies by governments, WHO and dental associations.

Dentists' "experts", authorized by governments of member states of the WHO, repeated the figures and conclusions of this study of Dean et al in 1942 for many decades. Before 1969 all of the promoters of water fluoridation but the opponents believed that the inverse relation between fluoride and dental caries was supported by strong evidence in this study.

In 1969 and in the following years I analysed the study of H.T. Dean et al ("21-cities-study") and other studies with similar study design from various scientific perspectives. I found that the "inverse relationship between natural fluoride drinking water and dental caries of children" is a statistical artefact and constructed by the authors (dentists).

My first critique of the Dean-study and other studies was published in my lecture "Kritischer Beitrag zu den Grundlagen der Kariesprophylaxe durch Fluoride" (Translation — Critical Contribution to the Basis of Prophylaxis of Dental Caries by Means of Fluorides) on the 15. International Convention of the International Society for Research on Civilisation Diseases and Vital Substances in Hannover (Germany) on 8 - 14 September 1969 (published in 1969 in the International Journal Vitalstoffe - Zivilsationskrankheiten 14 (6) 229-233 1969).

For discussion of this theme see my critical comments of April 2000 to the NHS CRD Water Fluoridation Systematic Review, pages 25 - 36, and the cited literature in my comments No.: 2, 5, 6, 9, 10, 11, 12, 24, 25, 31, 32, 36, and my "Open Letter" of August 17, 1983 to Lord Jauncey c/o Court of Session, Parliament SQ 1, Edinburgh, Scotland.

My scientific critique on water fluoridation studies is well known to dentists, their accepted "fluoride experts", ORCA, FDI, public health officials, and WHO since I began researching and publishing in this field. None of them has refuted my critique on the very important Dean-study and other similar studies on a scientific level. What they have done is hindered further publications and tried to suppress and ignore them.

In September 1969, the Norwegian mathematician and statistician professor Per Ottestad, Vollebekk, independent of me and without any knowledge of each other, analysed the Dean-study (USA) and the similar study of I. Moeller (Denmark) and submitted his critique "Re-Fluoridation of Drinking Water in Norway" in September 1969 to the Ministry of Social Welfare of Norway. The submission of professor Ottestad was published in 1970 in the International Journal Vitalstoffe - Zivilsationskrankheiten 15 (4) 145-149 1970.

In the summary professor Ottestad in 1970 wrote:

"In this letter the author deals critically with the most important statistical investigations the results of which have been used as a basis for promotions of fluoridation. It is found that these investigations suffer from grave errors and that the results afford a deficient basis for a standpoint for or against fluoridation of drinking water in Norway. The results are quite inadequate for the estimation of the effect of fluoridation in North America and most certainly in Norway. There is no doubt that other factors also play a part. The Norwegian committee that has reported on the question, is criticized because it has relied too much on authorities. The committee has not undertaken any independent evaluation. It is suggested that an independent Norwegian investigation be carried out."

In the preface of his 1970 publication Prof. Ottestad wrote:

".... I repeat that, in my opinion, no satisfactory investigation has been carried out which can give us reliable guidance on what would happen it we were to take such a drastic step as to fluoridate drinking water in Sweden and Norway. I have therefore suggested that an independent investigation be carried out. ... No one who is in close contact with sound research and who has seriously considered the question of research method, would accept the so-called scientific basis that is advanced for promotion of fluoridation....".

Similar scientific critiques were made of artificial fluoridation studies, e.g. the Grand Rapids-Muskegon-study in the following years.

These critiques were well known to the dentists and their "fluoride experts" but were suppressed and no important independent statistical study was made in the following years.

To the contrary, the prestige and authority of institutions such as the WHO (1982/86), the "Europa-Komitee fuer Gesundheitswesen des Europarates" (1974), the Royal College of Physicians of London (1976), were abused by "accepted dental fluoride experts" for statements such as "The only question is how to implement it". E.g. see "Appropriate use of fluorides for human health" edited by Prof. J.J. Murray, published by WHO 1986, p. 124/25 "World Health Organization policy on fluorides".

In the book of the FDI/WHO/KELLOGG Foundation Conference on Fluorides, Vienna, 3-5 October 1982, edited by Prof. J.J.Murray, again the false and misleading uncorrected data were published, results and conclusions from Dean (USA), Moeller (Denmark), and from a Swedish study (pages 38/39, Fig. 7 of the book). This is a clear case of scientific misconduct. See e.g. the "Denkschrift" of the Deutsche Forschungsgemeinschaft 1998.

I think it is necessary to investigate why dentists and "fluoride experts" of the WHO published false and untenable statistics, results and conclusions of water fluoridation and other fluoridation methods with the prestige and authority of the WHO for so many years and did not correct them.

Professor Kleijnen, I respect the hard and useful work of your team in the systematic review. This systematic review of many papers of water fluoridation showed that there is not any paper with evidence of highest level A after 55 years of fluoridation. The level B (evidence of moderate quality) of caries studies, however, is also untenabl