Endemic fluorosis and its health effects

Much of the anti-fluoridation propaganda used by activists rely on studies done in areas of endemic fluorosis. Slide from a presentation by Q. Xiang to an anti-fluoride meeting organised by Paul Connett’s Fluoride Action Network in 2014.

 

The public debate in New Zealand might convince the casual reader that all the science related to fluoride revolves around tooth decay and IQ. But that is certainly not the case on a world scale.

The World Health Organisation gives guidelines for the concentration of fluoride in drinking water recommending it should be in the range 0.5 – 1.5 mg/L. OK, above 0.5 mg/L because of the positive effect it has on oral health, in reducing dental decay. That interests us in New Zealand because our drinking water is more likely to be deficient in fluoride.

But on the world scale, many people are far more interest in the higher limit – or at least in attempting to reduce their drinking water fluoride concentration to below this limit. This is because large areas of the world suffer from the health effects of endemic fluorosis due to the excessive dietary intake of fluoride and the high concentration in their drinking water.

There are significant health effects from endemic fluorosis – effects we don’t’ have here but are important to many countries. So there is plenty of research – both on the health effects and on reducing drinking water concentrations and dietary intake.

In fact, the anti-fluoride campaigners get all the scientific reports they use in “evidence” to oppose community water fluoridation from studies in countries where fluorosis is endemic. Not only is this misrepresenting the science. It is also unbalanced because scientific studies on IQ in areas of endemic fluorosis represent only a small proportion of such health-related studies.

To illustrate this I have done a number of searches on Google Scholar using the terms “endemic fluorosis” and one other term related to a health effect. Here is the resulting table.

“endemic fluorosis” and “?” Hits in Google Scholar
Alone 8810
And “dental fluorosis” 3570
And “bone” 3570
And “skeletal fluorosis” 2910
And “cancer” 1690
And “death” 1180
And “birth” 1170
And “osteoporosis” 1130
And “body weight” 936
And “gastrointestinal” 808
And “Osteoclerosis 697
And “diabetes” 642
And “cardiovascular” 633
And “reproduction” 592
And “IQ” 480
And “cognitive” 331
And “heart disease” 327
And “hypothyroidism” 297
And “Renal failure” 292
And “obesity” 230
And “infertility” 216
And “non-skeletal fluorosis” 183
And “muscoskeletal” 178
And “birth weight” 135
And “birth defects” 86
And “premature birth” 29

40% of the hits related to “dental fluorosis” and another 40% to “bone” while 33% related to “skeletal “fluorosis.” Obviously, these are of big concern in areas of endemic fluorosis so receive a lot of research attention. In fact, the prevalence of these is used to define an area as endemic.

But only 5% of hits related to IQ – clearly of much less concern to researchers. Yet it seems to be all we hear about here and this illustrates how unbalanced most of the media reports we get here are.

To start with, these health effects do not occur in countries like New Zealand using community water fluoridation. They occur in regions where drinking water contains excessive fluoride and where the dietary intake of fluoride is excessive.

But the other fact is that IQ effects receive relatively little attention in health studies from those areas compared with the more obvious, and more crippling, effects like dental and skeletal fluorosis.

Mind you, that doesn’t stop activists making sporadic claims of all sorts of health effects from fluoridation and relying on studies from areas of endemic fluorosis. But the most frequent claims made by activists at the moment relate to IQ. Perhaps this is because it is harder to hide the fact that we don’t see cases fo skeletal fluorosis or severe dental fluorosis in New Zealand. IQ changes are not so obvious and this might make them a more useful tool for anti-fluoride campaigners to use in their scaremongering.

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101 responses to “Endemic fluorosis and its health effects

  1. To put the whole anti fluoride debate on I.Q to bed would be real easy. Just compare the I.Q levels of 2 areas in the same location that have had stable population change One with C.W.F and one without.That should solve it.
    And in another situation Queensland in Aussie is mostly fluoride free.How would that compare to the other states? According to the anti beliefs they should be more intelligent that the rest of Aussie.
    But they wont do that, because they know the results would not support the agenda.
    It is the same as asking for a case history of anyone who has a proven illness or disease caused by C.W.F at .7PPM out of about 500 million people they all run and hide and dont want to know

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  2. There’s plenty of places around the world with populations both fluoride free and experiencing the benefits of Community Water Fluoridation. Think of the UK, USA, New Zealand and Australia as examples.

    So it would be very easy for anti-fluoridationists to take those populations and compare exam results, as a marker for IQ, between populations with and without CWF.

    It would even be possible to compare exam results of a population before and after CWF.

    It makes me wonder why the anti-fluoridationists have never done those comparisons…

    …unless, of course, they’ve done them but the comparisons, as expected, show no difference in exam results between fluoride-free communities and those with CWF?

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  3. Bill Osmunson DDS MPH

    Ken,
    I simply don’t have time to counter all the flaws and misrepresentations presented above.

    #A. The power of the picture is that skeletal and severe dental fluorosis is the most sensitive health effect which most proponents and regulators, (such as EPA, CDC, ADA et al) use to determine harm from excess exposure. In other words, fluoride is safe until severe dental fluorosis or skeletal fluorosis is observed. Perhaps historically, that was the best we knew. But some are harmed with much lower concentrations and more sensitive adverse effects. Proponents historically generally claimed “safe” exposures of fluoride dosages until crippling skeletal fluorosis was diagnosed. In 2006, the NRC included severe dental fluorosis.

    However, 2% of the USA population now has severe dental fluorosis and still these USA organizations refuse to recommend reduce fluoride exposure.

    #B. The definition of “endemic” as cut and pasted from google:

    en·dem·ic
    enˈdemik/Submit
    adjective
    1.
    (of a disease or condition) regularly found among particular people or in a certain area.
    “areas where malaria is endemic”
    2.
    (of a plant or animal) native or restricted to a certain country or area.
    “a marsupial endemic to northeastern Australia”
    noun
    noun: endemic; plural noun: endemics
    1.
    an endemic plant or animal.”

    Ken, Can you name any natural or native water source which does not have fluoride? All natural water has some endemic fluoride. And focusing on water is not scientific, reasonable or ethical. No one lives in a bubble consuming no other fluoride than just the water.

    To only talk about the water is disingenuous. Total exposure, from all sources, including water, air, foods, medications, manufacturing products, etc. must be included. Think of it like calories from food. If a person is over weight and only measures calories from part of their diet, they will not understand the total calorie intake.

    You suggest IQ receives little attention based on web searches. Now that is the peak of scientific discovery, or is it? Over 300 studies of fluoride and neurologic harm. Just starting in the USA, for several reasons. Historically, researchers in the USA lost jobs, funding, and were censured for even doing research on fluoride. Fluoride in the USA is a religious belief, not scientific. Our eyes were really opened with the NRC 2006 report and then the foreign studies translated. Seems like only studies published in English and English Journals were historically considered.

    It has taken decades to change public health policy on risks. Fluoride is no different. However, the days of the addition of fluoride to water are numbered. The unethical, unscientific, policy of forcing everyone to ingest even more fluoride without their consent will stop.

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  4. Bill Osmunson DDS MPH

    Chris,
    Those studies have been done. Read the literature.

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  5. Bill Osmunson DDS MPH

    Quick Facts About the 50 Human IQ Studies and Fluoride: (This is not current)

    Location of Studies: China (32), India (13), Iran (4), and Mexico (1).
    Sources of Fluoride Exposure: 41 of the 50 IQ studies involved communities where the predominant source of fluoride exposure was water; seven studies investigated fluoride exposure from coal burning.
    Fluoride Levels in Water: IQ reductions have been significantly associated with fluoride levels of just 0.7 to 1.2 mg/L (Sudhir 2009); 0.88 mg/L among children with iodine deficiency. (Lin 1991) Other studies have found IQ reductions at 1.4 ppm (Zhang 2015); 1.8 ppm (Xu 1994); 1.9 ppm (Xiang 2003a,b); 0.3-3.0 ppm (Ding 2011); 2.0 ppm (Yao 1996, 1997); 2.1 ppm (Das 2016); 2.1-3.2 ppm (An 1992); 2.2 ppm (Choi 2015); 2.3 ppm (Trivedi 2012); 2.38 ppm (Poureslami 2011); 2.4-3.5 ppm (Nagarajappa 2013); 2.45 ppm (Eswar 2011); 2.5 ppm (Seraj 2006); 2.5-3.5 ppm (Shivaprakash 2011); 2.85 ppm (Hong 2001); 2.97 ppm (Wang 2001, Yang 1994); 3.1 ppm (Seraj 2012); 3.15 ppm (Lu 2000); 3.94 ppm (Karimzade 2014); and 4.12 ppm (Zhao 1996).
    Fluoride Levels in Urine: About a quarter of the IQ studies have provided data on the level of fluoride in the children’s urine, with the majority of these studies reporting that the average urine fluoride level was below 3 mg/L. To put this level in perspective, a study from England found that 5.6% of the adult population in fluoridated areas have urinary fluoride levels exceeding 3 mg/L, and 1.1% have levels exceeding 4 mg/L. (Mansfield 1999) Although there is an appalling absence of urinary fluoride data among children in the United States, the excess ingestion of fluoride toothpaste among some young children is almost certain to produce urinary fluoride levels that exceed 2 ppm in a portion of the child population.
    http://fluoridealert.org/search-results/?q=IQ

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  6. Bill Osmunson DDS MPH

    When considering their consistency with numerous animal studies, it is very unlikely that the 50 human studies finding associations between fluoride and reduced IQ can all be a random fluke. The question today, therefore, is less whether fluoride reduces IQ, but at what dose, at what time, and how this dose and time varies based on an individual’s nutritional status, health status, and exposure to other contaminants (e.g., aluminum, arsenic, lead, etc). Of particular concern is fluoride’s effect on children born to women with suboptimal iodine intake during the time of pregnancy, and/or fluoride’s effects on infants and toddlers with suboptimal iodine intake themselves. According to the U.S. Centers for Disease Control, approximately 12% of the U.S. population has deficient exposure to iodine.

    http://fluoridealert.org/search-results/?q=IQ

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  7. Bill Osmunson DDS MPH

    All studies of science have limitations.

    As both the NRC and Harvard reviews have correctly pointed out, many of the fluoride/IQ studies have used relatively simple designs and have failed to adequately control for all of the factors that can impact a child’s intelligence (e.g., parental education, socioeconomic status, lead and arsenic exposure). For several reasons, however, it is unlikely that these limitations can explain the association between fluoride and IQ.

    First, some of the fluoride/IQ studies have controlled for the key relevant factors, and significant associations between fluoride and reduced IQ were still observed. This fact was confirmed in the Harvard review, which reported that the association between fluoride and IQ remains significant when considering only those studies that controlled for certain key factors (e.g., arsenic, iodine, etc). Indeed, the two studies that controlled for the largest number of factors (Rocha Amador 2007; Xiang 2003a,b) reported some of the largest associations between fluoride and IQ to date.

    Second, the association between fluoride and reduced IQ in children is predicted by, and entirely consistent with, a large body of other evidence. Other human studies, for example, have found associations between fluoride, cognition, and neurobehavior in ways consistent with fluoride being a neurotoxin. In addition, animal studies have repeatedly found that fluoride impairs the learning and memory capacity of rats under carefully controlled laboratory conditions. An even larger body of animal research has found that fluoride can directly damage the brain, a finding that has been confirmed in studies of aborted human fetuses from high-fluoride areas.

    Finally, it is worth considering that before any of the studies finding reduced IQ in humans were known in the western world, a team of U.S. scientists at a Harvard-affiliated research center predicted (based on behavioral effects they observed in fluoride-treated animals) that fluoride might be capable of reducing IQ in humans. (Mullenix 1995)

    Mullenix was harmed because she studied fluoride’s effect on the brain. Other researchers took not and have avoided fluoride research. The bullies in my professions of public health and dentistry do not take kindly to science failing to confirm their belief system.

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  8. Bill Osmunson DDS MPH

    A brief consideration of (Das 2016)
    Citation: Das K, Mondal NK. (2016). Dental fluorosis and urinary fluoride concentration as a reflection of fluoride exposure and its impact on IQ level and BMI of children of Laxmisagar, Simlapal Block of Bankura District, W.B., India. Environmental Monitoring & Assessment 188(4):218.

    Location of Study: West Bengal, India

    Size of Study: 149 schoolchildren

    Age of Subjects: 6 to 18

    Source of Fluoride: Water

    Water Fluoride Level Average = 2.1 mg/L (S.D. = 1.64 mg/L). Note: The subjects did not have as much other exposure to fluoride as USA children. Many USA children swallow toothpaste with fluoride. This is half the USA MCLG set by the EPA.

    Type of IQ Test: Combined Raven’s Test for RuralChina (CRT-RC)

    Results:
    “IQ has anegative significant correlation with dental fluorosis (r=0.253,P<0.01). Dental fluorosis acts as an indicator of decreasing level of IQ. As fluorosis is a consequence of fluoride exposure, so IQ has a negative significant correlation with exposure dose (r =0.343, P<0.01) which was considered as a fluoride input source.”

    “IQ values were plotted against the urinary fluoride concentration and it was found that they have a significant negative correlation (r=0.751, P<0.01).”

    Conclusion “[C]hildren residing in areas with higher than normal water fluoride level demonstrated more impaired development of intelligence and moderate [dental fluorosis]. Millions of children including adults around the world are affected by higher level of fluoride concentration through their drinking water and are therefore potentially at risk. It is concluded that for the benefit of the future generation, urgent attention should be paid on this substantial public health problem.”

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  9. Bill Osmunson DDS MPH

    Here is another stdudy. Mondal D, et al. (2016). Inferring the fluoride hydrogeochemistry and effect of consuming fluoride-contaminated drinking water on human health in some endemic areas of Birbhum district, West Bengal. Environmental Geochemistry & Health 38(2):557-76.

    Location of Study: Birbhum district, India

    Size of Study: 40 children (20 from endemic fluorosis area; 20 from control area)

    Age of Subjects: 10 to 14 years old

    Source of Fluoride: Water

    Water Fluoride Levels: “Mean F concentration in the study area varies from 0.32 to 13.29 mg/L.”
    T
    ype of IQ Test: Raven Standard Theoretical Intelligence Test
    Results: “This study indicates that students exposed to high F (children of Junidpur and Nowapara) show an average IQ of 21.17 ± 6.77 in comparison with low-F exposed students (children of Bilaspur, Mohula, Bhalian) having an average IQ of 26.41 ± 10.46. . . . Statistical analysis (Z test) demonstrates that there is a significant (Z = 2.59) difference in IQ among the high- and low-F area student.”
    Conclusion “[S]tudents of the study area have less IQ than students of non-contaminated area, demonstrating that consumption of F also has a major role with the intellectual development of
    children.”

    This study again confirms harm. The question becomes, what dosage and at what age is the risk greatest. The recent Bashah study from North America reporting harm to the fetus helps us understand IQ loss maybe greatest to the developing fetal brain.

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  10. Bill Osmunson DDS MPH

    Here is another study out of India, larger number of children.

    Khan SA, et al. (2015). Relationship between dental fluorosis and intelligence quotient of school going children in and around Lucknow district: a cross-sectional study. Journal of Clinical & Diagnostic Research 9(11):ZC10-15.

    Location of Study: Lucknow district, India.

    Size of Study: 429 schoolchildren
    Age of Subjects: 6-12 years old
    Source of Fluoride: Water

    Results: “In this study, on comparison of children at two locations according to IQ grades [Table/Fig-4], majority of the children (74.8%) living in low fluoride area had an IQ grade 2 (definitely above the average in intellectual capacity). None of the children from the low fluoride area had an IQ grade 4 and 5 (definitely below average and intellectually impaired). On the other hand, majority of children (58.1%) from high fluoride area fall under IQ grade 3 (intellectually average). None of the children from high fluoride area had an IQ grade 1 (intellectually superior). This difference in IQ grades of children amongst the two areas was found to be statistically significant (p<0.001).””[I]t is clearly evident that with increase in the grade of fluorosis, a trend of increase in the IQ grade (decrease in intellectual capacity) was observed indicating a strong correlation between fluorosis grade and IQ grade (Spearman’s p=0.766).”
    Conclusion: “The data from this research may support the hypothesis that excess fluoride in drinking water has toxic effects on the nervous system.”

    Another red flag that fluoride reduces IQ

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  11. Bill Osmunson DDS MPH

    Here is another study out of India. Question. Why are we not seeing many studies out of the USA, NZ, AU, Canada where governments add fluoride to water without the patient’s consent? How can these countries say fluoride is safe when they have not even done the studies. It is not the patient’s responsibility to pay for studies. It is those promoting the policy which should provide studies of safety.

    Citation: Sebastian ST, Sunitha S. 2015. A cross-sectional study to assess the intelligence quotient (IQ) of school going children aged 10-12 years in villages of Mysore district, India with different fluoride levels. Journal of the Indian Society of Pedodontics and Preventive Dentistry 33(4):307-11.

    Location of Study: Mysore district, India

    Size of Study: 405 schoolchildren (135 children from high fluoride area; 135 children from “normal” fluoride area; 135 chidren from “low” fluoride area)
    Age of Subjects: 10-12 years old

    Source of Fluoride: Water
    Water Fluoride Levels: High-fluoride: 2.2 mg/L; “Normal” Fluoride: 1.2 mg/L; “Low” Fluoride: 0.4 mg/L

    Type of IQ Test: Raven’s colored Progressive Matrices Test
    Results: “In bivariate analysis, significant relationships were found between water fluoride levels and Intelligence Quotient of school children (P < 0.05). In the high fluoride village, the proportion of children with IQ below 90, i.e. below average IQ was larger compared to normal and low fluoride village. Age, gender, parent education level and family income had no significant association with IQ.”
    Conclusion: “School children residing in area with higher than normal water fluoride level demonstrated more impaired development of intelligence when compared to school children residing in areas with normal and low water fluoride levels.”

    Even a slight increase of fluoride showed decrease in IQ. REMEMBER, these areas did not have a large degree of fluoride from toothpaste like the USA.
    US HHS, PHS, and others suggest in the USA, fluoride from other sources than water, represents about 40% to 60% of a child's total intake. For easy figuring, think of half the fluoride coming from water and half from other sources. Studies such as India and China are often done where there is little or no other sources of fluoride.

    To compare the USA population with these studies, double the water fluoride concentration. 0.7 mg/L is the same as about 1.4 mg/L in other countries. And remember, not everyone drinks the same amount of water. Some drink as much as ten times as much water as other people.

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  12. Bill Osmunson DDS MPH

    Here is another study, this time out of China. Both urine and water fluoride levels were measured and overlapping with the range of urine fluoride concentrations found in the Bashah study of mother’s fluoride urine concentration.

    Choi A, et al. (2015). Association of lifetime exposure to fluoride and cognitive functions in Chinese children: A pilot study. Neurotoxicology & Teratology 47:96-101.

    Location of Study: Southern Sichuan Province, China.

    Size of Study: 51 children from elevated fluoride area

    Age of Subjects: Avg = 7.1 years old
    Source of Fluoride: Water

    Urine Fluoride Levels: Mean = 1.64 mg/L; Range = 0.22 to 5.84 mg/L

    Water Fluoride Levels: Mean = 2.2 mg/L; Range = 1.0 to 4.07 mg/L

    Confounding Factors:
    “In this rural community, social differences are limited. The parents or guardians completed a questionnaire on demographic and personal characteristics including the child’s sex, age at testing, parity, illnesses before age 3, past medical history of the child and caretakers, parental or guardian age, education and occupational histories, and residential history, and household income. It is known that iron deficiency can impair motor and mental developments in children, iron concentration was therefore considered as a covariate. These potential confounders were used for adjustment in the statistical analysis.”

    “Among possible confounders, both arsenic and lead are known to be low in drinking water in the area.”

    Type of Cognitive Tests: WRAML, WISC-R, WRAVMA
    Results: “Results of our pilot study showed that moderate and severe dental fluorosis was significantly associated with deficits in WISC-R digit span. Children with moderate or severe dental fluorosis scored significantly lower in total and backward digit span tests than thosewith normal or questionable fluorosis. These results suggest a deficit in working memory. Scores on other tests did not show significant relationships with indices of fluoride exposure.”
    Conclusion: “Results of our field study raise a concern about the safety of elevated systemic exposure to fluoride from high concentrations in the drinking water.While topical fluoride treatment confers benefits of reducing caries incidence, the systemic exposure should not be so high as to impair children’s neurodevelopment especially during the highly vulnerable windows of brain development in utero and during infancy and childhood and may result in permanent brain injury. We are planning a larger scale study to better understand the dose–effect relationships for fluoride’s developmental neurotoxicity in order to characterize the appropriate means of avoiding neurotoxic risks while securing oral health benefits.”

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  13. Bill Osmunson DDS MPH

    Remember. NHANES 2011 data shows about 20% of USA children have moderate dental fluorosis, 2% severe. The study above by Choi has significance with a large segment of the USA population.

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  14. Bill Osmunson DDS MPH

    This study by Zhang in 2015 is of particular interest to me. Guessing how much fluoride a child is exposed to with water is simply a guess. Then adding guesses and estimates from other sources borders on speculation.

    How does this compare with USA populations? Remember, here about half our fluoride is from other sources and in China they do not have fluoridated toothpaste and fluoride post-harvest fumigants, mechanically deboned meat, and fluoride medications. These are rural communities. So this study with 1.4 mg/L of water is similar to our 0.7 mg/L of artificially fluoridated water. And also remember that the 90th percentile drinks twice as much water as the “average” person. This study is comparable, in a public health consideration, to the USA populations.

    Zhang (2015) is of interest because he MEASURED water, urine and serum fluoride concentrations. Unfortunately, due to the fact that controls were

    Citation: Zhang S, et al. (2015). Modifying Effect of COMT Gene Polymorphism and a Predictive Role for Proteomics Analysis in Children’s Intelligence in Endemic Fluorosis Area in Tianjin, China. Toxicological Sciences 144(2):238-45. April.
    Location of Study: Tianjin City, China
    Size of Study: 180 children (96 from control area; 84 from “high fluoride” area)
    Age of Subjects: Avg = 11 years old

    Source of Fluoride: Water

    Water Fluoride Levels: High = 1.4 mg/L
    Control = 0.63 mg/L

    Urine Fluoride Levels: High = 2.4 + 1.01 mg/L (Bill’s comment; slightly higher than Bashah’s study of mother’s urine concentration)

    Control = 1.10 + 0.67 mg/L.

    Serum Fluoride Levels: High = 0.18 + 0.11 mg/L. (Bill’s comment: The USA EPA reported normal serum fluoride levels less than 0.2 mg/L, higher than the high levels of this study.)

    Control = 0.06 + 0.03 mg/L

    Type of IQ Test: Combined Raven’s Test for Rural China (CRT-RC)
    Confounding Factors: “Covariates included the indicator variables for age, gender, educational levels of parents (primary and below, junior high school, senior high school, and above), and continuous variables for drinking water fluoride (mg/l) and levels of thyroid hormones (T3, T4, and TSH).”
    Results: “[T]he present work demonstrated that the IQ scores of children exposed to high fluoride drinking water were significantly lower than those who lived in control area . . . . [O]ur findings further showed that, across the full range of serum and urinary fluoride, children’s IQ decreased gradually with the increase of fluoride contents in serum and urine, in a dose-dependent manner.”

    Conclusion: “In summary, our data suggest that the intelligence of children is affected by the COMT gene polymorphism and, in particular, this SNP plays a role in modifying the effect of fluoride exposure on cognition. Children with COMT reference allele had a higher risk for cognitive impairments after fluoride exposure. Additionally, proteomics analysis represents early specific markers of developmental fluoride neurotoxicity. Hence, our findings provide certain basis for clarifying the mechanisms and identifying molecular targets of pharmacological interventions for potential delayed therapy.”

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  15. Bill Osmunson DDS MPH

    Although Bad considered coal burning as the source of fluoride, he did measure urine fluoride levels.

    Bashah reminds us, “As part of the NRC’s review of the fluoride drinking-water standard, it was noted that healthy adults exposed to optimally fluoridated water had urinary fluoride concentrations ranging from 0.62 to 1.5 mg/L.”

    Remember the numbers 0.6-1.5 mg/L and compare them to Baa’s 1.96 and 0.54 mg/L range. And consider the studies above which measured urine fluoride concentrations. Reasonably overlapping.

    Bai Z, et al. (2014) Investigation and analysis of the development of intelligence levels and growth of children in areas suffering fluorine and arsenic toxicity from pollution from burning coal. Chinese Journal of Endemiology 33(2):160-163.

    Location of Study: Shaanxi Province, China.

    Size of Study: 303 children (120 children from high-fluoride area; 95 from mid-fluoride area, 98 from low-fluoride area)

    Age of Subjects: 8 to 12 years old

    Source of Fluoride Coal burning
    Urine Fluoride Levels: “The median urinary fluoride levels for children 8–12 years old in the areas of significant, minor and no morbidity were, respectively, 1.96, 0.81 and 0.54 mg/L.”

    Results: “The children’s urinary fluoride and urinary arsenic levels versus intelligence [quotients] were both negatively correlated (r=-0.560, -0.353, all P<0.05).”

    Conclusion “Exposures to fluorine and arsenic are deleterious to the development of intelligence and the development of growth in children”

    Yes, all studies have limitations. No study is proof, in and of itself. We are looking here at a trend and urine, serum water fluoride concentrations.

    For anyone to say that fluoridation is "safe and effective," has not carefully considered the research.

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  16. Bill Osmunson DDS MPH

    The significance of Wei’s study is that even a reduction in fluoride exposure takes a long time to lower fluoride concentrations in the body, due in part to the slow turn over of the bone.

    Wei N, et al. (2014). The effects of comprehensive control measures on intelligence of school-age children in coal-burning-borne endemic fluorosis areas. Chinese Journal of Endemiology 33(3):320-22.
    Location of Study: Bijie City, Guizhou Provinc, China.
    Size of Study: 741 children (104 children from low-fluoride area; 298 children from an endemic fluorosis area with long-term defluoridation measures; 339 children from endemic fluorosis area with short-term defluoridation measures).
    Age of Subjects: 8-12 years old
    Source of Fluoride: Coal
    Urinary Fluoride Levels: Control: 1.34 ± 0.64 mg/L; Long-term defluoridation: 2.33 ± 0.18 mg/L; Short-term defluoridation: 3.03 ± 0.16) mgL.
    Results: “Above average IQ of children in the control group was 97.1% (101/104),which was significantly higher than that of long and short treatment groups; after a lengthy treatment, mental retardation detection rate was significantly lower in the low-age group,8-10 year-old children(x2 =7.542,P < 0.01). Urinary fluoride content was negatively correlated with the level of IQ (r =-0.553,P < 0.01).“
    Conclusion: “The intelligence development of children in coal-burning-borne endemic fluorosis area is significantly delayed. After a certain period of comprehensive treatment,the decreased level of cognition is inhibited and the mental retardation in the low-age group is improved.”

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  17. Bill Osmunson DDS MPH

    Here is a study, again from India. One might say, well the high-fluoride area is three to five times more fluoride in the water than artificial fluoridation. True.
    Now consider that some drink ten times more water than average.
    Also consider these children had less other sources of fluoride.
    And remember the US EPA maximum contaminant goal for fluoride is 4 mg/L (ppm).
    And remember, harm is found and what margin of safety should be used to actually claim the water is safe? A factor of 10? Or 100? The EPA uses a factor of 1. In other words, the EPA does not have any margin of error or uncertainty factor or individual sensitivity.

    Nagarajappa R, et al. (2013). Comparative assessment of intelligence quotient among children living in high and low fluoride areas of Kutch, India: a pilot study. Iranian Journal of Public Health 2(8): 813–818.
    Location of Study: Kutch District, Gujarat, India
    Size of Study: 100 children (50 children from high-fluoride area; 50 children from control area)
    Age of Subjects: 8-10 years old
    Source of Fluoride: Water
    Water Fluoride Levels: High Fluoride: 2.4 to 3.5 mg/L; Control: 0.5mg/L.
    Type of IQ Test: Seguin Form Board Test
    Results: “Mean scores for average, shortest and total timing category were found to be significantly higher (P<0.05) among children living in Mundra (30.45±4.97) than those living in Bhuj (23.20±6.21). Mean differences at 95% confidence interval for these timings were found to be 7.24, 7.28 and 21.78 respectively.”
    Conclusion: “Chronic exposure to high levels of fluoride in water was observed to be associated with lower intelligence quotient.”

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  18. Bill Osmunson DDS MPH

    This study is from Iran. And refuted by . . . please list the USA studies which disagree. USA says fluoridation is safe, based on the absence of studies. Safe in the USA is determined by policy, rumor, gossip, tradition rather than science.

    Karimzade S, et al. (2014). Investigation of intelligence quotient in 9-12-year-old children exposed to high- and low-drinking water fluoride in West Azerbaijan province, Iran. Fluoride 47(1):9-14.
    Location of Study: Poldashi and Piranshahr, West Azerbaijan province, Iran.
    Size of Study: 39 male children (19 from high-fluoride area; 20 from control area)
    Age of Subjects: 9 to 12 year olds
    Source of Fluoride: Water
    Water Fluoride Levels: High Fluoride = 3.94 mg/L
    Control = 0.25 mg/L
    Confounding Factors: No significant differences were found in the potential confounding factors of educational, economic, social, cultural, and general demographic characteristics between the high- and low-F regions.
    Type of IQ Test: Iranian version of the Raymond B Cattell test
    Results: “The IQ of the 19 children in the high-F region was lower (mean±SD: 81.21±16.17), than that of the 20 children in the low-F region (mean±SD: 104.25±20.73, p=0.0004). In the high-F region, 57.8% had scores indicating mental retardation (IQ <70) or borderline intelligence (IQ 70–79), while this figure was only 10% in the low–F region.”
    Conclusions: “The study found that children residing in a region with a high drinking water F level had lower IQs compared to children living in a low drinking water F region (p<0.001). The differences could not be attributed to confounding educational, economic, social, cultural, and general demographic factors.”

    Like

  19. Bill Osmunson DDS MPH

    Those are about 20% of the HUMAN studies reporting lower IQ from fluoride exposure similar to USA populations.

    Yes, each has limitations.

    Remember, dental fluorosis rates in the USA have increased significantly. When fluoridation started, the public was promised only about 10-15% of the public would get dental fluorosis and non would be severe.

    NHANES 2011, the most recently public available survey, found 2% with severe dental fluorosis and over 60% with some degree of dental fluorosis.

    Many are ingesting too much fluoride. The obvious source to reduce fluoride exposure is from fluoridation. Simply turn off the pumps. Let people swallow toothpaste if they want more fluoride.

    Give people the freedom to choose.

    Like

  20. Bill,

    Lots of studies there from areas with endemic fluorosis, meaning that they’re completely irrelevant to CWF.

    But you don’t seem to have any which compare the IQ of similar populations from CWF and non-CWF areas.

    Can you tell us why you are not prepared to compare IQ of similar populations where the only difference is CWF or non-CWF?

    Like

  21. Bill,

    …or maybe you could do the study Chris suggested?

    Personally, I agree with his comment that you won’t “because they know the results would not support the agenda.”

    Like

  22. Bill Osmunson DDS, MPH

    Stuart,
    It is not the patient’s responsibility to provide the research but the manufacturer’s prior to marketing.

    Like

  23. Bill Osmunson DDS, MPH

    QUESTION Stuart, would you explain how a fluoride ion in water pumped out of the ground (endemic?) is different from a fluoride ion added to the water after it is pumped out (fluoridation).

    Actually, most naturally occurring fluoride in water is a calcium fluoride, considerably less soluable and less toxic than artificial hydrofluorosilicic acid which is added to a low mineral soft water.

    Like

  24. Bill Osmunson DDS, MPH

    However, the biggest knee in the gut with fluoridation is the quantity of research which shows lack of benefit.

    Like

  25. Bill Osmunson DDS, MPH

    I’m always in favor of research. It is the duty of the manufacturers to pay for research before they market.

    Like

  26. I wonder why in all those studies there is not one done in the countries that use Community Water Fluoridation? You would think that to get an accurate assessment without mitigating circumstances like indoor cooking ,pollution or other conditions that can alter results.
    The countries that use it all the time would be able to be more closely monitored
    Once again maybe the results found do not support the agenda.
    The question that also needs to be addressed is. Why if C.W.F causes I.Q problems. In the U.S.A in the last 50 years {during the time that C.W.F is in use } has the average I.Q gone up 15 points, according to The Wechsler Intelligence Scale for Children. One of the best in the world?

    Liked by 1 person

  27. Actually, Bill, if someone is making a claim, it’s up to that person to supply the evidence to justify the claim.

    Since you appear to be making the claim that CWF causes a decrease in IQ, it’s up to you to prove that CWF has caused a decrease in IQ in any of those populations that have benefited from it.

    Where is your evidence of decreased IQ in those populations benefiting from CWF?

    Like

  28. Bill,

    You ask “QUESTION Stuart, would you explain how a fluoride ion in water pumped out of the ground (endemic?) is different from a fluoride ion added to the water after it is pumped out (fluoridation).”

    Are you sure you’re a dentist?

    You should have learned that’s a nonsensical question in your high school chemistry studies prior to starting dentistry.

    Like

  29. Bill Osmunson DDS MPH

    You are making a claim fluoride benefits people. What is your science to support the health claim?

    Like

  30. Bill Osmunson DDS MPH

    Stuart,

    There are over 300 studies, I’ve posted bits of 10 of them. Have you read those? You passed them over without reading and asked a question of what I just posted. Look again.

    Like

  31. Bill Osmunson DDS MPH

    Stuart,

    You have indicated that endemic fluoride is different than artificial fluoridation. What is your evidence? How is it different?

    Like

  32. Bill, there is no such thing as “endemic fluoride” – that is just silly. You, I assume, are referring to the fluoride naturally present in our water sources compared with the fluoride that comes out of your tap when community water fluoridation is practised.

    As a chemist I can assure you the species – the hydrated fluoride anion – is exactly the same.

    Here is a simple article that explains the chemistry – Fluoridation: Some simple chemistry.

    Like

  33. Bill osmunson DDS MPH

    Ken. We agree on the fluoride naturally occurring and added is the same.
    Different contaminants with the fluoride.

    Like

  34. Bill Osmunson DDS MPH

    Ken, Although we agree, that the natural fluoride and added fluoride are the same, Stuart raises a very interesting point which should be discussed.

    the 1989 NIDR data was put in a new computer program which gives us a great deal of information, comparing dental caries AND fluoride AND Magnesium AND calcium.

    I was very surprised to see that any change in all three changes caries rates and all three are not linear but curves, bell or S shaped curves. So increase or decrease one and the other curves change.

    Naturally occurring fluoride is usually found with higher concentrations of both magnesium and calcium. Fluoridation is often added to soft water, such as snow melt here in Seattle. An “optimal” fluoride concentration could only be achieved in a community if the magnesium and calcium content were also regulated. And the “optimal” fluoride concentration with soft water should be between 0.1 and 0.2 ppm. That’s what we have naturally occurring.

    To fixate on fluoride concentration is over simplistic. At least all three should be closely controlled.

    Like

  35. Bill, you seem to be jumping around. After saying the
    endemic” fluoride is different to that used for fluoridating water you now say:

    “We agree on the fluoride naturally occurring and added is the same.”

    Well, I do not agree with that. The most common fluoridating chemicals used are fluorosilicates – which do not exist naturally.

    What is the same is the form of fluoride in natural and fluoridated waters – the hydrated fluoride anion. This is because fluosilicates decompose in water to form this hydrated fluoride anion and silica.

    You go on to say:

    “Different contaminants with the fluoride.”

    But, in practice, this is not really true.

    In natural water systems the hydrated fluoride anion is accompanied by many other ions in solution – many of them we consider contaminants and public water facilities commonly analyse for them to keep them under control.

    All treatment chemicals will contain contaminants – but usually at very low concentrations. And again these are regulated and monitored. Certificates of analysis are required.

    If we calculate the contribution of contaminants like arsenic, lead, etc., from fluoridating chemicals to our tap water we actually find this is less than 1% of the level of contaminants already naturally in the water. I did this calculation for my own city in the article Chemophobic scaremongering: Much ado about absolutely nothing.

    So, in fact, if your tap water is fluoridated or not the contaminants are basically the same and have natural origins.

    Like

  36. Bill, as a chemist I am the last person to fixate on one particular ion like fluoride. Have a read of my article Dental health – it’s not all about fluoride. This describes some Swedish research showing a similar relationship of calcium to fluoride in effects on tooth decay. Not at all surprising to a chemist and I imagine one could also discover phosphate is involved considering our teeth and other bioapatites like bones are composed of apatites which naturally contain fluoride, phosphate and calcium.

    All this talk about soft water etc., is just another attempt by anto-fluoride people to mislead. Fluoride is not a determining factor in calcium and magnesium concentrations in either natural or treated water except at very high fluoride concentrations. (Calcium fluoride, or fluorite, can maintain a concentration if about 8 ppm F and calcium). The amounts of calcium and magnesium in natural and treated waters are usually much higher than the fluoride concentrations, but still not high enough to reduce the fluoride concentrations when F is present at the concentration considered optimum. I wrote about this in my article
    Calcium fluoride and the “soft” water anti-fluoridation myth.

    Like

  37. Bill,

    Your claim is about CWF.

    Your posted studies are about areas with endemic fluorosis and so are irrelevant to CWF.

    CWF has been used for decades, in hundreds if not thousands of populations, millions of people worldwide. Generations have grown up and died with nothing but fluoridated water from their taps.

    Many of those populations have been extensively studied by governmental agencies over the years – not just dental health, but all forms of health; mental health; examination results are available; age profiles; causes of death; incidence of elective and acute surgery; average income; vehicle use… I could go on for ages about the data collected by local and national governments about their populations.

    I suggested exam results as a marker for IQ: easy to get for populations, easy to determine whether that population has CWF or not.

    If CWF is related to IQ, other than the gradual elevation that Chris pointed out, then the data is available to you. All you have to do is the statistical analysis and publish the results.

    There is no need for you to cherry pick among irrelevant small studies from areas with endemic fluorosis – use the data from the millions of people worldwide who benefit from CWF and compare them with the same data from non-fluoridated areas with similar populations.

    That is, unless the large population studies don’t fit your agenda by not showing a decrease in IQ among populations with CWF?

    Like

  38. Bill, you started off your comments on my article here with the statement:

    “I simply don’t have time to counter all the flaws and misrepresentations presented above.”

    Yet, you have since made extensive comments – without pointing out a single flaw or misrepresentation in my article.

    You have simply provided further evidence for my statement:

    “In fact, the anti-fluoride campaigners get all the scientific reports they use in “evidence” to oppose community water fluoridation from studies in countries where fluorosis is endemic. Not only is this misrepresenting the science. It is also unbalanced because scientific studies on IQ in areas of endemic fluorosis represent only a small proportion of such health-related studies.”

    Now, I am as interested as the next scientist in evaluating the scientific worth and meaning of the papers you cite. And this could be useful from the perspective of the problems people in areas of endemic fluorosis face.

    But such a discussion really doesn’t; contribute anything to our understanding of the effectiveness and safety of community water fluoridation.

    Like

  39. Bill Osmunson DDS MPH

    Ken,
    Sorry if you have missed some of the flaws in your article. Let me try again.

    A search of public interest based on web searches has little value other than historical gossip. The concept of fluoride’s effect on IQ has not hit the public yet. Most IQ research is relatively new and proponents have done a great job in quashing media reporting.

    A quote from your article,

    “Mind you, that doesn’t stop activists making sporadic claims of all sorts of health effects from fluoridation and relying on studies from areas of endemic fluorosis.”

    And yet you more recently suggested the term endemic is is silly.

    “Bill, there is no such thing as “endemic fluoride” – that is just silly.”

    Like

  40. Bill Osmunson DDS MPH

    Ken, Until recently, I did not understand how valid your comment is,

    “Bill, as a chemist I am the last person to fixate on one particular ion like fluoride. Have a read of my article Dental health – it’s not all about fluoride.”

    A NIDR survey of about 30,000 children had water concentrations of fluoride, magnesium, and calcium. When put into an interactive computer program, it is very clear an increase or decrease in calcium and magnesium increases or decreases caries significantly, and until about 1.5 ppm fluoride the magnesium and calcium have greater effects on caries than fluoride.

    I was very surprised to see in soft water, a low concentration of magnesium and calcium, at a concentration where the optimal concentration for dental caries is found, the caries rate was a 1.7 regardless of fluoride concentration. In other words, at 0.1 ppm fluoride, caries rates were 1.7/child. At 0.7 ppm caries was 1.7/child and at 1.0 ppm fluoride in the water the caries rate was 0.7 ppm. Increasing above 1 ppm fluoride in water, caries rates started to rapidly increase.

    And with a change in fluoride concentration, the caries incidence curves had significant changes. Below 1 ppm fluoride in water, caries rates did not change much but did with changes in magnesium and calcium concentrations.

    If we really wanted to mitigate caries with water quality, we would measure and adjust calcium and magnesium.

    By the way, your advertisements are causing my computer to constantly hit on them and I can’t type more than one line without it jumping to the ads.

    Like

  41. Bill Osmunson DDS MPH

    Ken,

    “It is beyond my comprehension how you can say,
    But such a discussion really doesn’t; contribute anything to our understanding of the effectiveness and safety of community water fluoridation.”

    Unless you fail to consider that water concentration is not dosage.

    Many of the more than 50 studies have water fluoride concentrations below the EPA’s 4 ppm maximum contaminant level, and several below 2 ppm.

    Not everyone drinks the “median” or “average” amount of water. Some drink over 10 times the “median.” which is just under 1 L/day for adults.

    The 90th percentile is 2 liters/day or double the dosage of fluoride. the 90th percentile would in effect be drinking the same amount of fluoride as a person on 1 liter/day with 1.4 ppm fluoride.

    At the 95th percentile, the person would be drinking as much fluoride because they are drinking more water, as the median in many of the studies reporting harm.

    What percentage of the population do you think is acceptable to be at risk for lower IQ? 5%, 1%?????

    And where is the margin of safety? What margin of safety do you think is acceptable. Our testing is now reporting harm at ever lower dosages, urine concentrations, fluoride exposures. As we get more accurate with ever smaller dosages, synergistic effects of other chemicals, host sensitivities, we must have a margin of safety. What do you recommend?

    Like

  42. Bill,

    “The concept of fluoride’s effect on IQ has not hit the public yet.”

    I wonder why not? Unless, of course, there’s no effect on IQ to “hit the public” with when talking about Community Water Fluoridation?

    Millions of people in hundreds of discrete populations around the world have been benefiting from CWF for over half a century now, without having any change in exam results or IQ other than a gradual improvement. Doesn’t sound like there’s a detrimental effect on IQ from CWF, does it?

    All those epidemiologists monitoring those populations for local and national governments; all those public health doctors and dentists watching those populations for changes in dental, mental and somatic health; all those government statisticians and civil servants monitoring exam results in areas with and without CWF for decades; all of them failing to notice dropping IQs and deteriorating exam results in populations with CWF?

    Maybe it’s because in the real world there is no effect on IQ from CWF?

    As opposed to your having to cherry pick papers with small numbers from areas with endemic fluorosis in order to restate the toxic effects of high dose fluoride that were known decades before CWF started?

    Like

  43. ** high dose fluoride ** = high fluoride water concentration

    I really need to have a coffee before I start typing in the morning!

    Like

  44. Bill, I am surprised you are not familiar with google scholar. It is a way for searching published papers and academic sources for information. While it is, of course, not as accurate as a time-consuming identification of each published paper it is not “historical gossip.” It is not a matter of “hitting the public.” It is a matter of what areas of harm people in areas of endemic fluorosis suffer and the attention research give to this.

    The results are not at all surprising – dental and skeletal fluorosis are the most obvious indicators of endemic fluorosis. IQ deficits is a relatively minor component of this research.

    Perhaps you are tired – or having a Saturday night tipple – but I did not describe the use of the term “endemic” as silly. Just the incorrect use of it as in “endemic fluoride” when you mean “natural fluoride.”

    Like

  45. Bill, you have referred to a ” NIDR survey of about 30,000 children had water concentrations of fluoride, magnesium, and calcium.”

    Could you provide a citation or link for this, please?

    I do not understand what advertisements you refer to – I certainly do not promote any. Perhaps it is something to do with your system.

    Like

  46. Bill, it is hard to accept you have a “comprehension” problem. More like the problem is thta you are just doing your job as director of an activist political anti-fluoride organisation, FAN.

    You are attempting to stretch the research on cognitive deficits in areas of endemic fluorosis to areas of community water fluoridation. In the process, you choose to ignore, or naively condemn, the good quality Canadian, Swedish and New Zealand work where no such deficits have been observed in areas of community water fluoridation or their equivalent.

    The fact is there is extremely little severe dental fluorosis or skeletal fluorosis in countries like the US and NZ – and such incidence is not due to any community water fluoridation.

    On the other hand, the cognitive deficits reported in areas of endemic fluorosis are clearly linked to fluorosis. In fact, Choi et al(2015) did not find a relationship between water F and cognitive deficits in Chinese children – but did find a relationship with severe dental fluorosis.

    It is not difficult to imagine a biological or psychological mechanism for an association of cognitive deficits with fluorosis while there is no credible mechanism for a chemical toxicity mechanism at low fluoride concentrations.

    So, on the one had the reported IQ deficits seem to be associated with the prevalence of fluorosis (rather than directly to water F) and there is no credible research finding cognitive deficits associated with community water fluoridation.

    Bill, you could give your case a lot more credibility if you could cite a single paper linking cognitive deficits to community water fluoridation – in the absence of endemic fluorosis. You can’t, can you?

    Like

  47. Bill Osmunson DDS MPH

    Stuart

    Above, you say,

    “Millions of people in hundreds of discrete populations around the world have been benefiting from CWF for over half a century now, without having any change in exam results or IQ other than a gradual improvement. Doesn’t sound like there’s a detrimental effect on IQ from CWF, does it?”

    What are your studies reporting the ingestion of fluoride is safe?

    Just because millions of people smoke, does not give proof that smoking is safe.

    And we should see a gradual increase in IQ because we have reduced lead exposure, etc. Would IQ have gone up even faster without fluoridated water?

    I’m looking for your best studies showing fluoride is safe.

    Like

  48. Bill Osmunson DDS MPH

    Ken,

    You state,
    “In the process, you choose to ignore, or naively condemn, the good quality Canadian, Swedish and New Zealand work where no such deficits have been observed in areas of community water fluoridation or their equivalent.”

    The NZ study was garbage. Comparing supplements with fluoridated water found no IQ loss with fluoridated water. OK. No surprise. The power of the study was too small. No measured fluoride concentration in urine.

    Ken, why do you think a study with measured urine fluoride concentrations is so much better than one without measurements.

    As a scientist, you should demand measured evidence.

    And like you agreed, endemic water fluoride concentration of 1 ppm or water fluoridation at 1 ppm is the same fluoride ion concentration.

    Like

  49. Bill Osmunson DDS MPH

    Ken,

    you say,
    “Bill, you could give your case a lot more credibility if you could cite a single paper linking cognitive deficits to community water fluoridation – in the absence of endemic fluorosis. You can’t, can you?”

    That’s not my job. You, the promoter of fluoridation claim it is safe and effective. And to my knowledge, no drug regulatory authority has approved the swallowing of fluoride as either safe or effective. I have not checked with all, but none in Europe, USA, or Australia.

    Like

  50. Bill Osmunson DDS MPH

    Ken,

    You said,
    “Bill, you have referred to a ” NIDR survey of about 30,000 children had water concentrations of fluoride, magnesium, and calcium.”

    Could you provide a citation or link for this, please?

    I do not understand what advertisements you refer to – I certainly do not promote any. Perhaps it is something to do with your system.”

    Must have been my computer, because it is no longer happening.

    NIDR 1986-1987. Raw data. Several have published on the data, but none (to my knowledge) have incorporated the variations in calcium and magnesium concentrations.

    Like

  51. Bill can you provide a proper citation or a link to this – “NIDR 1986-1987. Raw data.”

    I want to look at the data – particularly the calcium and magnesium data you refer to.

    Like

  52. Bill – it is your job. You are making an assertion that fluoridation of water causes cognitive deficits. Your inability to cite a credible study to support that claim is, of course, telling.

    It is unprofessional of you to describe a published study as “garbage” simply because it does not support your position. Most studies in this area, including the Chinese ones you rely on, suffer from small sample numbers and hence reduced power. But within that limitation, the Broadbent study did show an effect from breastfeeding but not from fluoridation.

    The large Swedish study overcame these problems but still showed no effect of fluoride on IQ.

    Yes, I do demand evidence. And I see an avoidance from you (It’s not my job) as demonstrating a complete lack of evidence. Tou cannot cite a single study showing a relationship between cognitive deficits and fluoridation. I am not surprised – I myself am completely unaware of any.Paul Connett loves to cite Malin and Till (2015) but that study has been shown to be wrong.

    Like

  53. Bill,

    You tell us that CWF causes a decrease in IQ. That means that you have to supply the evidence. It’s not up to others to prove you are wrong, it’s up to you to provide evidence to support your claim.

    If you claimed your car could travel at 150mph, it would be up to you to provide the proof. It’s not up to others to prove it can’t. Same goes with your claim of harm from CWF.

    I’ve merely I pointed out that millions of people have had CWF for many decades, in many areas of the world. Hundreds, if not thousands, of researchers have monitored those populations and recorded the effects of CWF over those decades. If CWF really causes a decrease in IQ, the data is available to you.

    Yet, despite those huge amounts of data, you are still unable to provide any evidence to support your belief that CWF causes harm.

    Show us your evidence that CWF has caused harm in any of the populations that have benefited from it for over half a century.

    Like

  54. Bill Osmunson DDS MPH

    Stuart,

    Ethics. Ethics, Ethics and law.

    No law in any land.
    No ethics review board.
    No one I know of requires the victim, the patient, to provide research that a medication is causing harm.

    If you are intentionally doing something to me, you must have the evidence it is correct.

    Lets put this in perspective.
    Fluoride is added to water with the intent to prevent disease, not by the patient, but by the government. I think we agree.

    Why? Because the government was persuaded by good marketing and poor science that it was “safe and effective.” I think we agree. I am simply asking those pushing the chemical to provide evidence of “safety and efficacy.” Promoters, governments, make the claim, they must provide the evidence. And after 70 years, they still have not provided evidence of safety and efficacy.

    The absence of evidence is not proof of safety. Where were the neurotoxicity studies over the last 70 years of fluoridation? We went to court against the EPA and won on all counts. EPA did not have the necessary studies on safety. They weren’t even started till a few years ago.

    The person receiving the medication, treatment, chemical with alleged benefit to prevent disease has not given consent.

    And further, there are other sources of fluoride people can get fluoride if they want. Simply swallow some toothpaste, etc.

    Dental caries is not highly contagious. Yes, public health have strong legal powers to protect the public from highly contagious diseases which are lethal. Dentistry is still considered elective.

    We know some are being harmed with disease.
    We know many are ingesting too much fluoride.
    We know topical fluoride has some benefit, such as toothpaste.
    We know swallowing additional fluoride has no benefit. I keep asking for your recent primary research on efficacy.

    After all, if there is little or no benefit, the waste of money is insane.

    Sort of like climate change. Regardless of whether humans are causing or contributing to climate change, cleaning up the air sure looks better and smells better. I lived in in Los Angeles when the smog was so thick I could hardly see across the street. Seems better now and there are many more cars. Cleaner exhaust makes sense. Cleaner air makes sense. Picking up our trash and garbage makes sense. Is our garbage contributing to climate change. . . the garbage looks bad and smells bad.

    The same with fluoride. If in doubt, at least give people the freedom to choose not to drink fluoride.

    Bill

    Like

  55. Bill,

    CWF is not a medication. No matter what you believe about it. Full stop. Ken and others have pointed that out to you many times, but the fact obviously hasn’t penetrated your belief system. Anti-fluoridationists have gone to court in many places to get that established, but you even ignore those legal findings. CWF is not a medication.

    Now, you’ve got decades of data available to you from millions of people. Hundreds, if not thousands of populations have been drinking CWF for many years, even entire lifetimes. And all that time they have been closely observed by doctors, dentists, epidemiologists, civil servants, etc.

    If CWF has caused harm to any population in those seventy years, feel free to show us the evidence from all of that data.

    Like

  56. Bill,

    You state: “We know some are being harmed with disease.
    We know many are ingesting too much fluoride.”

    If you are talking about areas of endemic fluorosis, no arguments at all. You are correct.

    But if you’re talking about areas with CWF, then I understand the appropriate phrase is .

    Like

  57. …the appropriate phrase is (citation required).

    Perhaps you can find the evidence in the data from those millions of people worldwide drinking CWF for many decades?

    Like

  58. David Fierstien

    Stuartg, you say to Dr. Bill Osmunson: “CWF is not a medication. No matter what you believe about it. Full stop. Ken and others have pointed that out to you many times, but the fact obviously hasn’t penetrated your belief system. Anti-fluoridationists have gone to court in many places to get that established, but you even ignore those legal findings. CWF is not a medication.”

    You are absolutely correct. I asked him 4 times, under the recent post, “Fluoride, pregnancy, and the IQ of offspring,” to show me anything from any U.S. government agency which classifies optimally fluoridated water as a drug or medication. He came up empty, and he knows he came up empty.

    He knows it’s not classified as a drug, but if he says it enough, if people are frightened into believing they are being “mass medicated,” it helps Mercola, one of his donors, sell their shower-head water filters, or expensive fluoride-free toothpaste.

    He is little more than a shill for Mercola. Want proof? Under that same post I asked him to cite one documented case of any harm to any human being from drinking optimally fluoridated water . . even for as much as a lifetime. He responded with the undocumented, and unbelieveable “Kyle’s Story,” which, it turns out, it little more than an advertisement for Mercola’s shower-head filters.

    Like

  59. Hi David,

    I recently read this: http://www.skepticalob.com/2017/09/can-you-tell-the-difference-between-an-expert-and-a-quaxpert.html

    All the way through I was thinking of Mercola. He’s truly a quaxpert!

    Like

  60. David Fierstien

    I don’t know. Dr. Mercola is a Doctor. He has had a formal education. I would be interested in Dr. Osmunson’s opinion on Joseph Mercola. Any thoughts, Bill?

    Like

  61. Bill Osmunson DDS MPH

    I sat down with Dr. Mercola and challenged him on a couple areas we disagreed on. He gave me enough science which I had not seen, to make me be more cautious of my past opinions.

    No one has “the truth.”

    Dr. Woychuk, Deputy Director of NIEHS under NIH was keynote Speaker at our Fluoride Conference a couple weeks ago in DC. He is one amazing geneticist. If I had life to do over, I’d want to become a geneticist.

    I am paraphrasing his response to a question, whether in 2017 we could have any substance placed in water (uncontrolled dosage) administered to everyone (without consent)?

    He responded with a clear no. And explained that we now know so much more how chemicals, medications, react so differently with different people. We are all unique and in effect, one size or one drug, does not fit everyone.

    In the past, animal research consisted of taking one strain of rats and testing them. Now we know the human population is so diverse and several strains of rats for a test is much better.

    In dental school, we were advised not to be the first or the last to try a new material or drug or theory.

    David, Stuart, Ken, Bill, and Marcola, et al. . . we all have different levels of research and data we need before we will accept or try a new therapy, drug, device, procedure.
    Some want absolute proof. Well, we don’t have absolute proof of gravity.
    Some will jump on the first study.

    Dr. Mercola has a large team he works with and has good evidence for what he recommends. I would call him on the leading or cutting edge of science. Like all good scientists, I’m sure he changes his position when new and better research comes out.

    However, if one swallows tradition and compares all science to their current “box” of understanding (government policy and main stream associations), then the world is flat, hand washing is unnecessary prior to surgery, tobacco is safe, humans are not contributing to global warming, ever more ingested fluoride is safe.

    How much research of what quality is needed to change your mind?

    Like

  62. Bill Osmunson DDS MPH

    David and Stuart, I have repeatedly answered that fluoride is a drug. What makes it a drug, legally, is the “intent” of use. If the intent is to prevent, cure, mitigate a disease in humans or animals it is defined by US Federal and State laws as a drug.

    I will post a longer answer next. Please read it carefully.

    Like

  63. Bill Osmunson DDS MPH

    Gerald Steele and I put this together a couple years ago. Looks like the tables/graphs are not included.

    A legal analysis that demonstrates fluoridated waters and chemicals are drugs under the jurisdiction and responsibility of the federal Food and Drug Administrative (FDA) when the intended use is prevention of tooth decay disease.
    Since 1906, the FDA has defined a “drug” as:
    “all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals;”
    In 1952, the FDA announced it would not enforce the FDCA for fluoridated public water regarding water supplies containing fluorine, within the limitations recommended by the Public Health Service, as not actionable under the Federal Food, Drug, and Cosmetic Act.

    In 1962, Congress required drugs to be both “safe and effective.”
    In 1996, the FDA determined that its 1952 regulation was obsolete or no longer necessary and the regulation was revoked after the federal Environmental Protection Agency (“EPA”) announced the “Termination of the Federal Drinking Water Additive Program” effective April 7, 1990.
    FDA regulations provide that any anticaries drug that includes hydrogen fluoride requires approval of safe and effective (NDA).

    All drinking waters are drugs when fluoridation chemicals are added with intent to prevent, mitigate and/or prophylactically treat tooth decay disease
    The definition of the term “drug” has not been changed since 1938 and is adopted by states. A drug means
(A) articles recognized in the official United States Pharmacopoeia . . .; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure of any function of the body of man or other animals; and
 (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
    Based on 21 USC 321(g)(1)(B) when fluoridated drinking water and/or chemicals intended to aid in the prevention, mitigation and/or prophylactic treatment of dental caries disease (tooth decay, cavities) it is a drug under the FDCA. There is nothing in the FDCA that would suggest otherwise and HHS and FDA have not made the claim that there is.
    Water fluoridation . . . . Fluoride is added to water for the public health benefit of preventing and reducing tooth decay

    The FDA advises, in some instances, the mere presence of certain therapeutically active ingredients could make a product a drug even in the absence of drug claims. In these cases, the intended use would be implied because of the known or recognized drug effects of the ingredient (e.g. fluoride in a dentifrice).
    (59 FR 6088.) The intended use of added fluoride in drinking water is also implied and should be presumed.
    The Washington State Board of Health considers it self-evident that the purpose of water fluoridation is to help prevent tooth decay.
    The CDC states, “Tooth decay (dental caries) is an infectious, multifactorial disease.”

    The FDA defines “dental caries” as “A disease of calcified tissues of teeth characterized by demineralization of the inorganic portion and destruction of the organic matrix” and defines “anticaries drug” as ”A drug that aids in the prevention and prophylactic treatment dental cavities (decay, caries).
    In the determination of whether fluoridation products (fluoridated waters (tap or bottled) and fluoridation chemical additives) are drugs, the only question under the [FDCA] is whether the intended use of the product is to prevent disease, not whether the product actually prevents disease.

    Perhaps partly in response to the FDA’s refusal to enforce the FDCA for fluoridated water supplies, Congress adopted the DSHEA in 1994, with explicit statutory language that made fluoride a drug when used with intent to prevent disease. Fluoride, being a mineral, is a dietary supplement under DSHEA. Minerals are normally regulated as foods except when they are drugs.

    In 1974, Congress passed the Safe Drinking Water Act (“SDWA”) for the EPA to set standards for the control of contaminants in drinking water. Under the SDWA, national primary drinking water regulations identify contaminants that have adverse effects on human health and specify a maximum contaminant level (“MCL”) for such contaminants and fluoride has an MCL of 4.0 mg/l.
    There is no SDWA statutory provision or implementing regulation that addresses or sets standards for fluoridation chemical additives. Therefore, there is no possible statutory conflict where Congress intended the SDWA to interfere with the FDCA or FDA authority to regulate drugs. If Congress wanted to exempt public drinking water from the definition of drugs, it certainly had the knowledge of how to do it (it had previously exempted “food” from subsection (1)(C)) and it certainly had the opportunity to do it in any one of the more than 20 significant amendments made to the FDCA since 1980.

    Congress gave FDA authority to regulate foods to ensure they are “safe” and drugs to ensure they are “safe and effective.”
    After passage of the SDWA, EPA and FDA were concerned that FDA’s “food” authority and EPA’s “public drinking water” authority might result in “duplicative and inconsistent regulations” so they entered an MOU (Memorandum of Understandin.) In the MOU, FDA agreed not to use its “food” authority to regulate public drinking water, based on a commitment that EPA would adopt federal regulations to control additives in public drinking water.

    There is no mention in the MOU that FDA would, or could, give up its “drug” authority over public drinking water and public drinking water additives. Congress required “drugs” to be “effective,” and Congress never gave EPA authority to regulate drug effectiveness. The MOU in-artfully states:
    [EPA and FDA] have determined that the passage of the SDWA in 1974 implicitly repealed FDA’s authority under the [FDCA] over water used for drinking water purposes.

    Read in context with the other provisions of the MOU this can only possibly be true with respect to FDA’s “food” authority and cannot be true with respect to FDA’s “drug” authority.
    In a subsequent section, the MOU states:
    [EPA and FDA] agreed that the Safe Drinking Water Act’s passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a “food” under the [FDCA].
    Thus the MOU itself clarifies that the MOU only was intended to address FDA’s regulations regarding “food.” The MOU also in-artfully states:
    Under the agreement, EPA now retains exclusive jurisdiction over drinking water served by public water supplies, including any additives in such water.
    In context of the whole agreement, EPA does not have exclusive jurisdiction when public drinking waters, and public drinking water additives, are “drugs” because Congress has given exclusive jurisdiction over drugs to the FDA.
    In 1988, EPA published in the Federal Register a “Notice” that it was terminating EPA’s commitment to FDA to create a federal regulatory drinking water additives program. In this 1988 Notice, EPA admits that it “does not currently regulate the levels of additives in drinking water,” finding resource constraints and the need to implement mandatory provisions of the SDWA precluded the Agency from implementing the comprehensive program originally envisioned . . .
 The Notice describes how EPA was cooperating with a private third-party organization to have that organization take over the development and monitoring of standards for public drinking water additives and explained that it would be “up to the States and utilities to determine the suitability of any ‘third-party’ certification.” EPA stated that “Discontinuance of the additives program at EPA does not relieve the Agency of its statutory responsibilities.”

    However, HHS and FDA interpret the Safe Drinking Water Act of 1974 (SDWA) as removing HHS and FDA jurisdiction over these fluoridation products:
    Congress did not intend for FDA to regulate the addition of fluoride to public drinking water for dental caries prevention as a drug under the FD&C Act. Instead, Congress intended that the U.S. Environmental Protection Agency (EPA) regulate fluoride in public drinking water as a potential contaminant under the Safe Drinking Water Act of 1974 (SDWA).

    HHS and FDA argue that the SDWA provides that within the limits thus set by EPA, state and local governments be permitted, but not required, to fluoridate public drinking water to help prevent dental caries.
    Thus, HHS and FDA argue that under their interpretation of the SDWA, FDA has no responsibility to regulate such fluoridation products that are articles that meet the definition of a drug.

    The fundamental problem with this HHS and FDA interpretation of the SDWA is that it is in conflict with the EPA interpretation of the SDWA. The SDWA gives administrative authority to the EPA. Along with administrative authority comes the sole agency power to interpret the Act.
    Steven M. Neugeboren is the Associate General Counsel in charge of the Water Law Office of the EPA. The Water Law Office is responsible for interpreting the SDWA.4 Mr. Neugeboren states:
    “Under the Safe Drinking Water Act (SDWA), EPA is the lead federal agency with responsibility to regulate the safety of public water supplies. EPA does not have responsibility for substances added to water solely for preventative health care purposes, such as fluoride, other than [to meet maximum contaminant limits.] The Department of Health and Human Services (HHS), acting through the FDA, remains responsible for regulating the addition of drugs to water supplies for health care purposes.”
    Therefore the EPA’s interpretation of the SDWA is that this Act does not affect the responsibility of the FDA “for regulating the addition of drugs to water supplies for health care purposes.” Therefore HHS and FDA misinterpret Congressional intent when they state:

    “Congress did not intend for FDA to regulate the addition of fluoride to public drinking water for dental caries prevention as a drug under the FD&C Act.”
    HHS and FDA are correct that the SDWA does give EPA lead responsibility for regulating the safety of public water supplies to protect against adverse health effects. Except for authorizing regulation of the maximum contaminant level for fluorides, the SDWA does not address state and local governments fluoridating public drinking water to help prevent dental caries. But the state and local governments which fluoridate must comply with all applicable laws and regulations including federal drug laws in the FDCA, state drug and fluoridation laws, federal drug regulations, and state drug and fluoridation regulations. The EPA has determined that state fluoridation regulations are not related to the SDWA.

    Under this analysis and the interpretations of the SDWA by the EPA: HHS and FDA should find that fluoridation products are drugs when they meet the definition of a drug in 21 USC 321(g)(1)(B). HHS, acting through the FDA, has responsibility to regulate these drugs to ensure that they are safe and effective.
    FDA should request registration of all water fluoridation products as drugs pursuant to 21 CFR Part 207

    FDA should find that fluoridation products are not “safe and effective”
    Once it accepts jurisdiction, FDA should find that fluoridation products are not safe and effective as drugs. While this is a subject that will only be addressed after HHS and FDA accept drug jurisdiction over fluoridation products, it is useful to point out the harms that HHS and FDA are allowing to occur because they have not accepted drug jurisdiction over fluoridation products.
    An important overview was provided in the York Review in 2000 (M. McDonagh, P. Whiting, M. Bradley, et al., “A Systematic Review of Water Fluoridation,” NHS Centre for Reviews and Dissemination, The University of York, Report 18 (2000) which is available at: (http://www.york.ac.uk/inst/crd/CRD_Reports/crdreport18.pdf ). The potential harms explored by the York Review include dental fluorosis, hip fracture, other bone fractures, cancer, Down’s syndrome, mortality, senile dementia, goitre, lowered IQ, hypersensitivity, and skeletal fluorosis. (York Review at 52, 54, 59-60.) The York Review concludes that except for dental fluorosis, no “confident statements” can be made regarding these “potential harms.” (York Review at page xiv.) In other words, these other “potential harms” could not be ruled out by the available scientific literature.
    a. Dental fluorosis is an out-of-control harm of water fluoridation
    There is scientific consensus that fluoridated water causes dental fluorosis. HHS reported that 41% of people who were 12 to 15 years old in 1999 to 2004 had dental fluorosis with this dental fluorosis being moderate or severe for 3.6% of these people (one in twenty eight people). (76 FR 2385.) [As I have recently stated, NHANES 2011 reports 60% with dental fluorosis, 20% moderate and 2% severe]. Even if water fluoridation is reduced to 0.7 mg/l fluoride as HHS now recommends, the number of people with dental fluorosis is likely to increase because in 1992 when these people were 0 to 8 years old, only 56% of the people in the United States received fluoridated water. Today a much higher percentage of people receive fluoridated water.
    b. The FDA has already concluded that fluoride OTC products should not be swallowed except under professional supervision
    The FDA has already concluded that fluoride OTC anti-cavity products should not be swallowed except under professional supervision. (21 CFR Part 355.) Fluoridation chemical additives are intended to be mixed with water and swallowed by everyone. At a minimum, fluoridated water is harmful to infants and children under 6. Warnings are required for OTC products to avoid swallowing by infants and even children under six. (21 CFR 355.50.) Bottled water regulations do not even allow a health claim for fluoridated water marketed to infants. (www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073602.htm)
    c. York Review studies repeatedly show that artificial water fluoridation increases risk of hip fracture in people 65+ years old
    The York Review was limited to review of human epidemiological studies of water fluoridation (around 1 mg/l fluoride). Over 3,200 primary studies were identified but only 9 studies met relevance criteria and measured risk of hip fracture for people 65+ years old in fluoridated areas compared to the risk in unfluoridated areas. (York Review at 10 and 48.) For these 9 studies, there were only 4 analyses that produced statistically significant data (i.e. the relative risk of 1.0 was not in the 95% Confidence Interval). Each of these statistically significant analyses show an increased risk of hip fracture for people 65+ years old living in fluoridated areas. The studies are identified in the York Review at page 48 as:

    Relative Risk is defined as the risk of an adverse effect with exposure to a treatment (here fluoridated water) relative to risks for those who do not receive the treatment. (York Review at 99.) A ratio of 1.0 indicates no increased risk over receiving no treatment. (Id.) A ratio greater than 1.0 indicates the risk is higher in the group that did receive the treatment. (Id.) A ratio less than 1.0 indicates the risk of the adverse effect is higher in the group that did not receive treatment. (Id.) A Relative Risk of 1.27 means that there is a 27% higher risk of hip fractures when living in a fluoridated area (for 65+ year old women in the Danielson (1992) analysis).
    Hip fracture for people 65+ years old is a significant health impact in the United States. “About 300,000 Americans are hospitalized for a hip fracture every year.” (Connett (2010) at page 173.) The Irish Forum (2002) (Forum on Fluoridation (Dublin, Ireland: Stationery Office, 2002) online at http://fluoridealert.org/re/fluoridation.forum.2002.pdf found that “Fracture of the hip is a major cause of morbidity and mortality [disease and death] in persons 65 years of age and older.”
    Aside from the fact that one in five patients die within 6 months of the fracture occurring, hip fractures lead to serious disability. Many basic functions such as dressing, climbing stairs, walking and transferring are markedly interfered with following a fracture. This can result in loss of both confidence and independence and an increased risk of development of medical complications.
    (Irish Forum (2002) at 121.)
    d. Fifty human studies agree that higher fluoride exposure is associated with a mental health impact that lowers IQ levels in children
    Lowered IQ in persons who drink fluoridated water as infants and children is a significant mental health concern. The National Research Council (2006) states, “It is apparent that fluorides have the ability to interfere with the functions of the brain.” (NRC, Fluoride in Drinking Water – A Scientific Review of EPA’s Standards (Washington D.C.; The National Academies Press, 2006.) As of September, 2016, 50 of 57 human studies found elevated fluoride exposure is associated with reduced IQ and 45 animal studies have found fluoride exposure impairs the learning and/or memory capacity of animals. (http://fluoridealert.org/studies/brain01/)
    The lowest level at which IQ has been lowered (with borderline iodine deficiency) was at 0.88 ppm [fluoride in drinking water] (Lin et al., 1991) or at 1.26 ppm (without iodine as a complicating factor). It is very clear that there is no margin of safety to protect all children drinking water in the range 0.7 to 1.2 ppm.
    Dec. 12, 2014 email from Paul Connett, PhD., then Director, Fluoride Action Network.
    e. Drinking fluoridated water increases risk of hypothyroidism disorder
    A large observational study was published in the online Journal Of Epidemiology and Community Health, a British Medical Journal (BMJ) publication, on February 24, 2015 that found rates of diagnosed hypothyroidism (underactive thyroid) were at least 30% higher in areas with artificial fluoridation. (Peckham (2015) -J Epidemiol Community Health doi:10.1136/jech-2014- 204971.) The study states that thyroid dysfunction is a common endocrine disorder. The National
    Research Council ((2006) at 223 called fluoride an endocrine disrupter and at 218 expresses concern about “the inverse correlation between asymptomatic hypothyroidism in pregnant mothers and the IQ of the offspring.”
    f. Boys drinking fluoridated water when they are 6 to 8 years old have a five to seven-fold greater risk of contracting bone cancer by the age of twenty
    Regarding cancer, an unrefuted published primary study, Bassin (2006) (Bassin E. B. et al., “Age-specific Fluoride Exposure in Drinking Water and Osteosarcoma (United States),” Cancer Causes and Control 17, no. 4 (May 2006) 421-28) reports that boys who drink fluoridated water when they are 6 to 8 years old will have a five- to sevenfold greater risk of contracting osteosarcoma (bone cancer) by the age of twenty. This is a deadly disease. This result was first suggested by Perry Cohn in 1992. (See Connett (2010) at pages 187-94.) The twofold increase in cortical bone defects in the fluoridated city in the Kingston-Newburgh study (supra at B 20.) was described in 1955 and again in 1977 as being “strikingly similar to that of osteogenic sarcoma [now called osteosarcoma].” (See Connett (2010) at page 181-94.)
    6. FDA has correctly determined that fluoridated bottled water is a drug when there is a claim that “this drinking water is intended for use in the prevention of tooth decay disease”
    In a September 23, 2015 letter (B 74-75 hereto), the FDA found that fluoridated bottled water with 0.7 mg/l fluoride would be a drug if the claim is made that “this drinking water is intended for use in the prevention of tooth decay disease.” In fact, fluoridated bottled water with this claim would be an “anticaries drug” as that term is defined by the FDA in 21 CFR 355.3(c) and (d). (Supra at B 7-8.) Such fluoridated bottled waters when introduced after April 7, 1997 would be required to have an approved New Drug Application (NDA) or Abbreviated NDA
    (ANDA) because they would not be able to meet requirements of 21 CFR Part 355 which do not allow anticaries drugs to be swallowed without professional supervision. (See supra at B 4-5.) Under current law, it would be illegal to distribute such fluoridated bottled water in interstate commerce without an approved NDA or ANDA. Because such fluoridated bottled waters would be drugs, the fluoridation chemical additives, which are a component of such fluoridated bottled waters, would also be drugs. (21 USC 321(g)(1)(D).)
    7. FDA must now find that fluoridated tap water is a drug when there is a claim that “this drinking water is intended for use in the prevention of tooth decay disease”
    FDA must now find that fluoridated tap water is a drug when there is a claim that this drinking water is intended for use in the prevention of tooth decay disease. The FDA must also find that the fluoridation chemical additives, which are a component of such fluoridated tap waters, are also drugs. (USC 321(g)(1)(D).) The FDCA allows no distinction between fluoridated waters with the same contents whether they are served as drinking water either from a bottle or from a tap. Both are anticaries drugs under the FDCA if the drinking water is intended for use in the prevention of tooth decay disease. More generally, fluoridated drinking waters are anticaries drugs if the intended use is to aid “in the prevention and prophylactic treatment of dental cavities (decay, caries).” (21 CFR 355(3)(c).)
    Today, as fluoridated water purveyors modify their fluoridated waters to meet the latest HHS recommendation to add fluoride to get 0.7 mg/l fluoride in the finished water, these water purveyors are making a new drug and are subject to new drug requirements for an approved NDA or ANDA and subject to the FDA requirements to show that their unique products are safe and effective.
    The FDA can no longer rely on its prior reasoning (Infra at B 59 and B 66) that the intent of the SDWA was to eliminate FDA authority and responsibility under the FDCA to regulate substances that qualify as anticaries drugs under the USC and CFR. EPA is the agency with final agency authority to interpret the SDWA, and EPA interprets the SDWA to not remove the authority of HHS, acting through the FDA, regarding “regulating the addition of drugs to water supplies for health care purposes.” (Infra at B 69.)
    So while it is true that state and local governments may be permitted to fluoridate drinking waters to help prevent dental caries, they must do so in compliance with local, state, and federal laws and regulations which include federal requirements to consider such fluoridated waters to be drugs if the drinking waters are “intended for use in the prevention of tooth decay disease” or if the drinking waters otherwise meet the definition of drugs in section 201(g)(1) of the FDCA (21 USC 321(g)(1)). FDA, acting on behalf of HHS, has the authority and responsibility to regulate drugs by implementing the applicable federal laws and regulations and by adopting regulations when necessary to fulfill its responsibilities.
    It is time for the FDA to be responsible and to require fluoridation products (fluoridated waters (tap or bottled) and fluoridation chemical additives) to be federally regulated as drugs when the intended use is prevention of tooth decay disease.

    Like

  64. Bill Osmunson DDS MPH

    Fluoride is not a cosmetic. . . I assume we agree.
    Fluoride is not a food. There is no physiologic requirement for fluoride.
    Dental caries is not due to the absence of fluoride, a disease of deficiency.
    Teeth with caries and without have a similar range of tooth fluoride concentration.
    The only other designation in the USA is for fluoride to be called a drug and regulated under drug laws.

    he toxicity of fluoride is so great that fluoride is regulated as a poison, under poison laws, unless it is regulated under pesticide laws or drug laws.

    The toothpaste label says, “Drug Facts.”
    The FD&C Act defines drugs as substances used with the intent to prevent disease.
    A FOIA to the FDA received a response to me agreeing fluoride is a drug, but enforcement action was being deferred.

    The burden of proof is on those promoting fluoridation, the manufacturer to provide evidence fluoride used with the intent to prevent disease is NOT a drug.

    Like

  65. Bill,

    CWF is not medication. How much have anti-fluoridationists spent over the years to repeatedly demonstrate that legal finding? You would have a much better idea than me.

    It doesn’t matter what your personal belief is, the courts repeatedly find that CWF is not medication, in spite of the amounts anti-fluoridationists spend to try to reverse that finding.

    You say CWF causes harm. Fine. Show us the evidence.

    There are over seventy years of research into millions of people all over the world who have drunk CWF, even for entire lifetimes.

    Millions of people. Decades of CWF. And all those populations continuously monitored in many, many ways. Surely, if CWF causes harm, then somewhere in those masses of data is the evidence. If there’s no evidence there, then that’s a very strong imputation that CWF does not cause harm.

    So, show us the evidence, from those decades of data, that supports your belief that CWF causes harm.

    Like

  66. David Fierstien

    Dr. Osmunson, Since you’ve entered the discussion about Mercola, for the 3rd time, how much funding did they give you last year?

    Bill O: “David and Stuart, I have repeatedly answered that fluoride is a drug.”

    Irrelevant. I have repeatedly asked you to show me anything from any Federal Agency that identifies or classifies optimally fluoridated water as a “drug” or “medicine.” You have failed to do so thus far.

    Oxygen is a drug which requires a prescription. Air, which contains oxygen, is not a drug. Fluoride may be a drug in high concentrations. Optimally fluoridated water, the issue at hand, is not a drug.

    Bill O.: “The toothpaste label says, “Drug Facts.””

    Irrelevant. You will not find the word “drug” or “medicine” on a bottle of FDA regulated optimally fluoridated water, which, again, is the issue at hand.

    So again, for the 7th time, please show me anything from any Federal Agency, whether it be the EPA, the FDA, the CDC, the USDPH, or anything, which identifies or classifies optimally fluoridated water as a drug.

    The fact that FAN is one of the only US organizations that calls water with 0.7 ppm F a “Drug” is very telling.

    I have had a lengthy discussion about the 1979 MoU between the FDA and the EPA, with your colleague, Sauerheber. When I have the time to take 3 hours out of my life to read your lengthy dissertation above, I will review it, and explain your errors to you, though I doubt it will matter to, since you are in business to generate confusion and paranoia about CWF.

    Like

  67. David Fierstien

    Ahh yes, as I recall, Sauerheber got his information from Gerald Steele also. His evidence that the 1979 MoU had been dissolved, a document which outsourced work to NSF, was laughable. I hope I won’t be seeing this from you also when I review your comment

    Like

  68. David Fierstien

    And here it is. This is your comment:

    Bill O.: “In 1988, EPA published in the Federal Register a “Notice” that it was terminating EPA’s commitment to FDA to create a federal regulatory drinking water additives program. In this 1988 Notice, EPA admits that it “does not currently regulate the levels of additives in drinking water,” . . . ”

    This is a portion of correspondence between Sauerheber and myself.

    Sauerheber: “Moreover, the Memorandum of Understanding (“MOU”), originally made by the FDA in 1979 to have the EPA regulate chemicals added to public water systems, was discontinued in 1988 (see attached pages), thereby relinquishing any authority of the EPA to regulate chemicals being used as drugs, either FDA approved and legal, or not FDA approved and illegal, or any supplement, mineral or additive intended to treat human tissue through ingestion in water.”

    You are both referring to this document: 53 Federal Register 25586.
    http://www.fluoride-class-action.com/wp-content/uploads/53-FR-25586.pdf

    Read it you idiot. Show me any place in this document which even suggests a termination of the 1979 MoU between the EPA & the FDA.

    I’ve said this before . . it would help to make you not look foolish if you would actually read your copy-pastes before posting them.

    Like

  69. David Fierstien

    Bill, this is a blatant lie from you:

    ” In this 1988 Notice, EPA admits that it “does not currently regulate the levels of additives in drinking water,” . . . ”

    This is what this 1988 Notice actually says regarding EPA responsibilities over water additives:

    “• EPA would continue to establish regulations under the SDWA. FIFRA. and/or TSCA. as needed. for chemicals in treated. distributed drinking water that may originate as additives. ”

    Man, do you ever tell the truth?

    Like

  70. Bill Osmunson DDS MPH

    David,
    You don’t understand what you are reading and take statements out of context. Don’t call me a liar when you are not careful of context.

    Bill

    Like

  71. Bill Osmunson DDS MPH

    Contact the EPA and ask them if the MOU was referring to chemicals added with the intent to treat humans. They have said no. The last I checked, the many who worked on the MOU still worked at the EPA. The SDWA prohibits the EPA from regulating any substance intended for the treatment of humans.

    Like

  72. Bill Osmunson DDS MPH

    You guys are hopeless.

    You don’t understand “total exposure.”

    We do not live in isolation where we only get fluoride from fluoridated water. Fluoridated water is only one source of fluoride. Then you demand the patient who does not want the chemical/drug, provide proof that just the fluoride from the water is causing damage.

    The purpose of fluoridation is to increase total exposure.

    I’ve been in public meetings where you guys twist reality and assume fluoride only comes from fluoridated water.

    Get real. Impossible to discuss an issue when the blinders are so closed down that new startling evidence like the concept of “dosage” and “total exposure” and “safety” and individual sensitivity is beyond your comprehension.

    Enough is enough.

    Like

  73. Come off it Bill. Surely the hopeless ones are the groups which refuse to allow discussion on their facebook pages and websites – as your organisation does. If you had any confidence in your claims you would immediately withdraw the bans you have placed on scientists to prevent them commenting on your fora and hence challenging your claims.

    What about it?

    Who the hell around here say F comes only from water? No one. I can only assume your claim is a result of ignorance because you refuse to engage with the scientists who comment here and elsewhere.

    No – what makes it “Impossible to discuss an issue” is the exclusion of rational and informed comment. The censorship you impose indicates that it is you and your organisation where “the blinders are so closed down that new startling evidence like the concept of “dosage” and “total exposure” and “safety” and individual sensitivity is beyond your comprehension.”

    Bill, I have offered you an opportunity for a good faith scientific exchange here along the lines of the one I had with Paul Connett. You have not replied to my email. Can you confirm if you got it?

    Would you be up to it? A good faith exchange with claims supported by good citation and referencing?

    I think the time is right as there is quite a bit of new work worth discussing that has come out since my discussion with Paul in 2013.

    Like

  74. David Fierstien

    Bill Osmunson: “David,
    You don’t understand what you are reading and take statements out of context. Don’t call me a liar when you are not careful of context.”

    Response: So in other words, when I asked you to show me anything in that document which even suggests a termination of the 1979 MoU, you were unable to do so.

    The “context” of that document is the EPA outsourcing some of its responsibilities to the private sector, in particular NSF.

    You are a liar. That document does not terminate the 1979 MoU.

    Like

  75. Bill Osmunson DDS, MPH

    The International Academy of Oral Medicine and Toxicology just released their position paper on fluoride. Worth the time reading.

    http://fluoridealert.org/wp-content/uploads/iaomt.position-paper.july-2017.pdf

    Like

  76. Bill Osmunson DDS, MPH

    Rick North submitted the following for consideration.
    Note: for easy figuring, consider about half the water ingested is excreted in the urine and about half the fluoride ingested is in the water. Urine and water fluoride concentrations, for many, are in a similar range.

    “On September 19, Environmental Health Perspectives, a highly-respected journal, published a study (https://ehp.niehs.nih.gov/ehp655/) linking higher fluoride levels in pregnant women to lower IQ’s in their children.

    The decrease was significant. Each 0.5 part per million (ppm) increase in a pregnant woman’s urine fluoride levels reduced her child’s IQ by 2.5 – 3 points. A child of a mother drinking 1 ppm of fluoridated water, close to the U.S standard of 0.7 ppm, would be expected to have a drop of 5 to 6 IQ points compared to a child of a mother drinking water with close to no fluoride in it.

    This prospective study was funded by the U.S. National Institutes of Health and led by researchers at the University of Toronto School of Public Health.

    It was very strong, following pregnant women in Mexico and their children for 12 years, and measuring individual urine levels, a more precise method to determine fluoride exposure than drinking water concentrations. The results were undiminished even after adjusting for a wide array of confounding factors, including lead, smoking, alcohol, socio-economic status and birth weight.

    The pro-fluoridation lobby, led by the American Dental Association, quickly denied the significance of the study (http://www.ada.org/en/press-room/news-releases/2017-archives/september/ada-responds-to-study-regarding-fluoride-intake-in-mexico), arguing “the findings are not applicable to the U.S.”

    Mexico, like most nations, doesn’t fluoridate its water. The ADA’s stance stems from the fact that the women were mainly getting their fluoride from consuming fluoridated salt or varying natural levels of fluoride in the water. (The ADA ignores the fact that fluoride’s effects are the same once it’s inside the body, no matter the source.)

    Most others felt differently. Lead author Dr. Howard Hu asserted “This is a very rigorous epidemiology study. You just can’t deny it. It’s directly related to whether fluoride is a risk for the neurodevelopment of children. So, to say it has no relevance to the folks in the U.S. seems disingenuous.” (http://nationalpost.com/health/researchers-urge-caution-over-study-linking-fluoride-exposure-in-pregnancy-to-lower-iqs-in-children)

    Dr. Leonardo Trasande, a pediatrician unaffiliated with the study at New York University, agreed, saying that “This is a very well-conducted study, and it raises serious concerns about fluoride supplementation in water.” (http://www.newsweek.com/childrens-iq-could-be-lowered-drinking-tap-water-while-pregnant-667660)

    And according to CNN, Dr. Linda Birnbaum, director of the National Institute of Environmental Health Sciences, “pointed out that it raised significant questions.” (http://www.cnn.com/2017/09/19/health/fluoride-iq-neurotoxin-study/index.html)

    Although this study is new, it has long been recognized that fluoride causes brain damage. The extent of harm is based on the dose, when and how often the exposure occurs, and which individuals are at greater risk.

    In 2006, the National Academy of Science’s National Research Committee (NRC) published Fluoride in Drinking Water (https://www.nap.edu/catalog/11571/fluoride-in-drinking-water-a-scientific-review-of-epas-standards), a review of over 1,000 studies. It’s considered the most well-balanced, comprehensive, authoritative study ever done on fluoride’s toxicity. The 12-member scientific committee leading the effort, including three who favored fluoridation, stated unequivocally that “It is apparent that fluorides have the ability to interfere with the functions of the brain and the body by direct and indirect means.” (p. 222)

    In 2012, a Harvard-funded meta-analysis (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491930/) found that children in China exposed to higher levels of fluoride tested lower for IQ in 26 out of 27 studies. The average difference was significant – 7 IQ points lower. The quality of the studies varied and dealt with higher exposures of fluoride than in the U.S. However, several were methodologically strong, controlling for potential confounders such as lead and arsenic, and had doses close to those typically found here.

    In 2014, in the British medical journal The Lancet (http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(13)70278-3/abstract) , two world-renowned scientists, Philippe Grandjean, MD and Philip Landrigan, MD, added fluoride to the list of 11 chemicals identified as developmental neurotoxins – harming the brains of children. Grandjean, a co-author of the 2012 Harvard study, commented at the time that “Fluoride seems to fit in with lead, mercury and other poisons . . .” (https://www.hsph.harvard.edu/news/features/fluoride-childrens-health-grandjean-choi/)

    Last year, the Fluoride Action Network, American Academy of Environmental Medicine, International Academy of Oral Medicine and Toxicology, Food and Water Watch, Organic Consumers Association and several others, including individual mothers, petitioned the EPA (http://fluoridealert.org/articles/epa_fluoride_petition/) to ban fluoridation chemicals based on their neurotoxicity.

    The petition cited 196 peer-reviewed studies – human, animal, cellular and reviews – published over the last ten years. Virtually all the studies – 189 – found harm, such as lowering IQ or increasing behavioral problems, several at levels consumed by Americans, and more at minimally higher levels.

    The studies with slightly higher levels are quite relevant to common exposures in the U.S. Genetics, environmental and socio-economic factors cause significant variability among humans in their resistance to disease. It’s standard toxicological practice to divide the lowest level of harm detected by at least 10. Many studies show there is typically at least a 10-fold variation in sensitivity to any toxin among humans.

    The NRC 2006 review determined that water fluoride levels of 4.0 ppm are definitely harmful to human health, so dividing by 10 wouldn’t allow more than 0.4 ppm. Yet the CDC recommends 0.7 ppm, nearly double the level, ignoring this established scientific practice.

    In February, the EPA denied the petition, saying there wasn’t conclusive data that fluoride was neurotoxic, in spite of the massive evidence to the contrary. The organizations have sued the agency and the case is now in federal court.

    Hu and his fellow authors don’t say, nor do I, that this one study provides conclusive proof that fluoridating water lowers IQ’s in children. But there’s no denying 30 years of hundreds of studies pointing squarely in that direction and the U. of Toronto results add even more credibility.

    Moreover, there are very few studies finding that fluoride doesn’t lower IQ. The New Zealand study (https://www.ncbi.nlm.nih.gov/pubmed/24832151) most often cited used an unsuitable study group with little contrast in total fluoride exposure. Many kids with unfluoridated water were ingesting fluoride tablets, making their total consumption of fluoride nearly as high as the kids drinking fluoridated water.

    Fluoridation proponents believe the burden of proof is to show conclusively that a substance is harmful before it’s disallowed.

    We’ve seen this misguided thinking before. In 1954, responding to numerous studies showing correlations between smoking and lung cancer, the tobacco industry asserted “there is no proof that cigarette smoking is one of the causes.” (http://tobaccocontrol.bmj.com/content/11/suppl_1/i110) As late as 1994, industry executives again declared at a Congressional hearing that correlation wasn’t enough and smoking hadn’t been proven to be a cause of cancer.

    The opposite point of view – “First do no harm” or “Better safe than sorry” – reasons that a substance should be demonstrated safe before it’s allowed. Obviously, this hasn’t happened with water fluoridation. The NRC (https://www.nap.edu/catalog/11571/fluoride-in-drinking-water-a-scientific-review-of-epas-standards), identified numerous other links to fluoride, including thyroid disease (p. 8), kidney disease (p. 303) and diabetes (p. 260), calling for further research.

    Fluoride is now a known neurotoxin. If you put it in water, how do you control the amount people consume, the age at which they consume it and the harm to those at highest risk – born or unborn? You can’t.

    The amount of this poison you ingest is determined, incredibly, by how thirsty you are. If you’ve concluded this practice is exceedingly unwise, you’re not alone. The vast majority of nations, cities and health organizations worldwide don’t support fluoridation (http://fluoridealert.org/content/bfs-2012/) and ethical concerns loom large as to why so many European nations oppose it (http://fluoridealert.org/content/europe-statements/). In effect, everyone drinking fluoridated water is participating, without their consent, in a continuing medical experiment.

    The CDC and EPA have many qualified, well-meaning people who’ve done a lot of good work. But history is rife with examples of the U.S. government assuring us that substances like leaded paint and gas, asbestos, DDT, DES, cigarettes, etc. were safe.

    It took decades of science finding harm before the government belatedly banned or restricted them. The amount of impairment, suffering, disease and death occurring in that lag time is incalculable – and unnecessary.

    It’s time to be on the right side of history.

    It’s time to end water fluoridation.

    Rick North is the former executive vice president of the Oregon American Cancer Society and former project director for Oregon Physicians for Social Responsibility’s Campaign for Safe Food. Now retired, he’s a volunteer advocate for safe water, safe food and the preservation of democracy. He can be reached at hrnorth@hevanet.com.

    Like

  77. Bill Osmunson DDS, MPH

    Ken,
    You have asked for a credible reference to support the neurotoxicity of fluoride.

    What type of study does the tobacco companies consider “credible” to show their products cause harm? Still none.

    Of course we should always demand more and higher quality studies on every subject.

    This recent Bashah study is one of the best. Does it have limitations? Of course. Do we need more? Of course. Do we have all the answers? No.

    Pile the Bashah study onto the more than 300 neurotoxic studies, add the studies on kidney, bone, thyroid, cancer, diabetes, ADHD, total exposure and above all, add the fact that ingested fluoride has little if any benefit. Then add the consideration of ethics. And lack of cost benefit. And serious increase in dental fluorosis.

    When all is added together, prudent people will want to reduce their total exposure of fluoride. The best place is to give people freedom and turn off the fluoride pumps.

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  78. Bill Osmunson DDS, MPH

    David, read the EPA MOU. It was about public water, not substances added with the intent to treat humans. An historical document. Dig deeper. I’m not going to do your homework for you. You don’t accept any references. Contact the EPA yourself. Contact the FDA yourself.

    Like

  79. Bill, come off it. IOAMT!!

    You guys take in each other’s laundry.

    This is sinking really low.

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  80. Bill,

    “You have asked for a credible reference to support the neurotoxicity of fluoride.”

    No, I understand that Ken asked for a credible reference to support the neurotoxicity of optimally fluoridated water supplies. As did I. As did David.

    Neurotoxicity of fluoride and high water concentrations of fluoride was established in the 19th century. That’s partly why CWF was started at the level it was – below the established level for neurotoxicity as established from areas with endemic fluorosis.

    In the seventy years since CWF was established, millions of people in many populations have drunk CWF for all that time – even entire lifetimes. Doctors, dentists, civil servants, epidemiologists, even anti-fluoridationists, have monitored those populations and that data is available to you.

    Where, in those masses of human data, is there any evidence that CWF causes neurotoxicity? That’s what we’re asking you to provide references for.

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  81. Bill – you misrepresent me (purposely) when you claim that I have asked: “for a credible reference to support the neurotoxicity of fluoride.” I didn’t.

    This is in fact what you are “responding” to:

    “Bill, you could give your case a lot more credibility if you could cite a single paper linking cognitive deficits to community water fluoridation – in the absence of endemic fluorosis. You can’t, can you?”

    I have absolutely no issue with the fact that people in areas of endemic fluorosis suffer a range of ills and cognitive deficits are sometimes one of them. I have questioned the poor evidence linking this to a direct chemical toxicity mechanism – and in fact, the evidence for that is extremely questionable.

    But, all this is not of relevance to areas of community water fluodiation. You simply have nothing to show such effects in such areas and purposely misrepresent the situation.

    It is laughable for you to cite the Mexican study as “one of the best” – community water fluoridation is not used in Mexico, there are areas of endemic fluorosis and one of the faults in this study is that no measurement of fluorosis prevalence in the study group was used (unfortunately). And even then – the huge scatter in data so that the proposed relationship explains only 3% of the variation shows how poor the conclusion is and how blind those who use this study for their own political and ideological reasons are.

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  82. Bill Osmunson DDS, MPH Director, Fluoride Action Network

    Stuart, (and Ken and David appear to agree) state,

    “No, I understand that Ken asked for a credible reference to support the neurotoxicity of optimally fluoridated water supplies. As did I. As did David.”

    Ken also said earlier today,
    “Who the hell around here say F comes only from water? No one. I can only assume your claim is a result of ignorance because you refuse to engage with the scientists who comment here and elsewhere.”

    On the one hand you ask for a study of neurotoxicity of fluoridation. Give me a break. That is the most ignorant question scientists can ask.
    Where is any study on fluoride which isolates out fluoride just from water? None exist. The research would have to eliminate all other sources such as foods, air, medications dental products etc. We don’t even have a RTC on benefits of fluoride.

    So your question is simply preposterous and the only intent is to argue and waste time. The question shows no comprehension of reality or sanity.

    I have been saying the same thing over and over. Total exposure of fluoride is real life, not isolating out one source. Makes no difference what the source of fluoride ion is for an individual’s physiology.

    Total exposure is too high. Over 60% of adolescents have dental fluorosis, NHANES 2011. Where should the excess of total exposure be reduced? Pesticides? Medications? Topical? or stop adding fluoride to water.

    Our understanding of genomics is blasting away the concept of one size fits all, one drug is good for all, etc. Each human is very different from each other and should be treated with individual care, not mass medication without consent.

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  83. David Fierstien

    Bill Osmunson says, ” I’m not going to do your homework for you.”

    That’s a laugh. You can’t even do your own homework! When asked to provide one example of harm to any human being who drank optimally fluoridated water, you literally copy-pasted a Mercola advertisement for shower-head filters – without reading it. Your own lack of preparation must be embarrassing for you.

    Now you are saying, ” “In 1988, EPA published in the Federal Register a “Notice” that it was terminating EPA’s commitment to FDA [the 1979 MoU] to create a federal regulatory drinking water additives program.”

    This, of course, without actually reading 53 Federal Register 25586. (You’re telling Me that You’re not going to do my homework for Me? Hilarious!!)

    Here it is again. You can read it now. http://www.fluoride-class-action.com/wp-content/uploads/53-FR-25586.pdf (Did you guys actually pay Gerald Steele for legal advise on anything?)

    53 Federal Register 25586 is an EPA notice that it intention to formally outsource responsibilities to the private sector, and specifically NSF & the AWWA. It was not a termination of the 1979 MoU as you have claimed.

    And what was your response to being caught in a humiliating and incompetent ineptitude? Naturally you change the subject.

    Bill O.: “David, read the EPA [1979] MOU. It was about public water, not substances added with the intent to treat humans.”

    Who cares. You are now making legal arguments on the internet. Trying to convince me, or anyone on the internet, of the legality of anything is meaningless. You need to take your “legal arguments” to court . . . Oh wait a minute, didn’t you already try that? . . How did that work out for you? . . . Does any Federal Agency consider optimally fluoridated water a drug?

    No.

    Despite your, and Gerald Steele’s, “brilliant arguments” that you copy-pasted above, nobody really bought into it, did they.

    How much humiliation can you endure before you just . . . stop?

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  84. Bill – you are burbling. All; your arguments apply just as much to studies from areas of endemic fluorosis (which you freely cite) as they do to areas where community water fluoridation is used. The fact is there is no credible study showing a relationship between IQ and fluoride in drinking water at the optimum fluoride concentrations.

    As for areas of endemic fluorosis, the reported relationships are extremely weak. Choi et al (2015) found no relation but did find a relationship of cognitive deficits to severe dental fluorosis. This is why I have been suggesting that researchers in this area should widen their horizons and consider the direct effects of fluorosis rather than relying on an unproven direct chemical toxicity effect.

    Even Xiang (2003) who your mate Paul Connett relies heavily on and who claims to have shown a statistically significant relationship with drinking water F (although does not provide either the data or statistical analysis) will have only found a relations explaining about 3% of the IQ variance (see CRITIQUE OF A RISK ANALYSIS AIMED AT ESTABLISHING A SAFE DAILY DOSE OF FLUORIDE FOR CHILDREN)

    As I said, Bill, you are burbling. Ridiculously so.

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  85. But, Bill, there are two questions you studiously attempt to ignore:

    1: Why don’t you allow scientific discussion on the websites and facebook pages your organisation controls? Surely that in itself indicates an unwillingness to either consider the science properly or to support your misrepresentation and distortion of that science.

    2: Why don’t you respond to my offer of a good faith scientific exchange on my blog similar to the one I had with Paul Connett? Sutley, you must agree that there has been sufficient progress in the science over the last 4 years to warrant another such discussion. And as the Director of FAN, you are the appropriate person to be involved in the exchange that I am offering.

    Or, if you feel your grip on the science is inadequate what about suggesting someone else from your FAN team?

    Like

  86. Bill,

    If you persist in maintaining that CWF causes cognitive defects, lowered IQ, call it what you will, it’s very easy for you to provide evidence.

    After all, we’ve got millions of people worldwide drinking CWF, monitored by many scientists and statisticians for over seventy years. If there’s an effect of CWF on IQ, whether it adds to other sources of fluoride or not, the data is there and available to you.

    If the data supporting your claim isn’t there, then, assuming you follow the scientific method, you need to re-think your position. Or is your position one of belief, of faith rather than science?

    Like

  87. Bill Osmunson DDS, MPH

    Stuart,
    Look at the “global” view of fluoride. Put the entire package together before making a judgment.

    You suggest many scientists monitor fluoride. Yes, they monitor the concentration of fluoride in the water and are quite good. But very few consider the current evidence on the benefits, safety and total dosage.

    95% of the world does not receive water fluoridation. Canada had about 2/3 of their population fluoridated, down to about 1/3.

    France had about a third of their salt fluoridated, now a fraction of that and no institutional salt is fluoridated.

    97% of Western Europe is not fluoridated and most developed countries do not fluoridate their water.

    But rather than endorsements, lets look more at the effects of fluoride.

    Yes there is a claim of benefit, for 25 years I thought there was a benefit to fluoridation. However, the current research is incomplete, conflicting and really not strong enough to make a claim of current benefit. Without benefit, this discussion is a waste of time and fluoridation is a waste of money. The lack of significant benefit was a real shocker to me. No RCT studies, and they could be done. The best studies we have are historic and they have serious flaws. We do not have reasonable current studies on benefit.

    Excess exposure. We know, agree, that fluoride at higher dosages (above 2 ppm) increases dental caries. Dental fluorosis is over 60%. Perhaps the reason we are no longer measuring benefit is because too many are ingesting too much fluoride.

    Stuart, you want “evidence based.” So do I. I cannot find the “evidence” of current benefit. In fact, the evidence appears to be showing an increase in dental caries. Could be due to too much fluoride.

    Any potential of risk or expense is unacceptable until we can establish a clear benefit.

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  88. Bill,

    So, still no evidence from you to support your belief that CWF causes cognitive defects, IQ loss and other forms of harm?

    That’s in spite of millions of people worldwide being monitored by hundreds / thousands of doctors, dentists, epidemiologists, civil servants, etc, for over seventy years whilst their water supplies have been optimally fluoridated.

    Maybe the reason that you can’t provide evidence is that CWF doesn’t cause the harm(s) you believe it to do?

    (Would I have been banned from your website or Facebook page by now for pointing out that you haven’t been able to supply any evidence in support of your belief?)

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  89. David Fierstien

    And for the 3rd time, Bill, how much did Mercola fund you last year in your efforts to spread paranoia about tap water . . and help them sell their really expensive water filters?

    Like

  90. Bill Osmunson DDS, MPH

    David, your question is too hostile and unprofessional to answer.

    Like

  91. Bill Osmunson DDS, MPH

    Ken,

    My memory is you raised two or three studies which did not find a reduction in IQ with fluoride. One was Canada. I presume you were thinking of Barberio. I have previously presented my reservations about the NZ study and Broadbent’s comparing fluoridation with fluoride supplements, which lacked power to evaluate IQ.

    Barberio in Canada was not about IQ, but rather learning disability. Although the two conditions may overlap, they are distinct.

    First: No research is perfect and a silver bullet. All have limitations. This research does add to our knowledge and I don’t think it is as bad as Broadbent’s. But has limitations.

    Conclusions overstate their data.

    The Barberio is partly reasonable stating,

    “Overall, with the exception of Broadbent et al.,21 the literature collectively suggests that high fluoride exposure negatively impacts a variety of outcomes related to cognitive functioning. However, these findings should be interpreted with caution due to: 1) substantial methodological limitations (e.g., ecological measurements of fluoride exposure), 2) most research being conducted outside the context of CWF, and 3) a lack of North American studies.”

    A. Remember, Broadbent did not have the power to detect an effect from fluoride because they essentially compared fluoridated water with fluoride pills and found no IQ effect. Therefore, Barberio would suggest the literature is reasonably consistent reporting harm to the developing brain from fluoride. Of course dosage and timing are not firm.

    B. I agree all studies have methodological limitations.
    Caution due to the studies being conducted outside the context of CWF could be viewed two ways, less risk or more risk. And the assumption is that fluoride from CWF has some sort of different effect than fluoride from other sources. No evidence is provided to support this speculation.

    A lack of North American studies. Again, this can be viewed as though there is some genetic superior defense in North America against the effects of fluoride, the rest of the world does not do good research, or simple bias.

    In my opinion, the only valid “caution” Barbario raises is methodological limitations.

    C. Barberio states:
    “Primary Outcome Variable: Reported Learning Disability Diagnosis Our primary outcome variable, diagnosis of a learning disability by a health professional, was based on a single item from the household survey asked to all respondents: “Do you have a learning disability?” (Yes/No/Don’t know, Refused).”

    It is not clear how the question “Do you have a learning disability?” asks the parent whether the diagnosis of learning disability was by a health professional. Could be more opinion than professional diagnosis. The authors do not support the “professional” diagnosis.

    D. Barberio states: “When we examined the association between urinary fluoride and reported learning disability diagnosis among the pooled sample (i.e., Cycles 2 and 3 combined), we detected a small but statistically significant association such that for every one unit increase in urinary fluoride ([micro]mol/L), the odds of having a reported learning disability diagnosis increased by 1.02 in the adjusted models, among the fluoride subsample and the constrained fluoride subsample. These significant findings were not observed with creatinine-adjusted urinary fluoride or specific gravity-adjusted urinary fluoride, which are thought to be more accurate because they help to correct for the effect of urinary dilution, which can vary between individuals and different points in time. Accordingly, these adjusted measures help to offset some of the limitations associated with spot urine samples. The finding that the effect was reduced to non-significance when creatinine-adjusted and specific gravity-adjusted urinary fluoride were used, suggests that the association between urinary fluoride and reported learning disability diagnosis may not be robust.”

    Barberio did find harm until adjusted for creatinine. That opens another concern. Is adjusting for creatinine a better measure of fluoride exposure? Or for that matter, is urine a good measure of fluoride exposure? Until we know better, we assume. All research with urine fluoride has the same unknowns. Maybe the kidneys can’t excrete the fluoride and more is remaining in the bones and tissues. We don’t know how the body is handling the fluoride. But urine fluoride measuring is at least an attempt to measure.

    E. Barberio states: “However, we acknowledge that by constraining our sample, we had a smaller sample size and reduced power to detect an effect.”
    Sample size is a concern.

    F. If we consider this study in light of the more recent in utero study which found harm to the fetus, a big question comes up, if fluoride has the most significant negative effect in utero, did the mothers in this study have the same fluoride concentration as the children during pregnancy? Did they move residence?

    Most of the other studies, like China and India, used stable populations and we can assume there was a greater chance of mother’s ingesting similar fluoride concentrations as the children. With the Canadian study, we cannot assume demographic stability.

    Even so, this Barberio study, not directly considering fluorides effect to the fetus, maybe a reasonable addition to our knowledge, pointing the finger at the fetus being most at risk to fluoride exposure.

    The big picture remains consistent with even greater focus on fluorides potential harm to the fetus.

    Moms, don’t ingest fluoride.

    And the effect of fluoride on testosterone is just growing faster.

    Bill

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  92. Bill Osmunson DDS, MPH

    “When Cycles 2 and 3 were combined, a small but statistically significant effect was observed such that children with higher urinary fluoride had higher odds of having a reported learning disability in the adjusted model (p = 0.03).”
    Barberio could have concluded they found harm. Instead they focused on data which did not show harm.

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  93. Thanks, Bill. You have at last engaged with some specific science (the Canadian paper).

    This is the sort of thing I want.

    I need to go out now so will get back to this later but want to suggest that rather than bury the discussion in the middle of a host of comments with deal with this as part of the good faith scientific exchange I have been suggesting.

    Are you up to that?

    Alternatively, if you do not wish to participate in a full-blown exchange I will write a separate post dealing specifically with your criticisms and the scientific issues involved.

    Could you let me know which you would prefer?

    Like

  94. David Fierstien

    DF: “Bill, how much did Mercola fund you last year in your efforts to spread paranoia about tap water . . and help them sell their really expensive water filters?”

    Bill O.: “David, your question is too hostile and unprofessional to answer.”

    Response: I am not a professional. A professional is paid.

    Professional (adjective)
    “2 a :participating for gain or livelihood in an activity or field of endeavor often engaged in by amateurs
    b :having a particular profession as a permanent career
    c :ENGAGED IN BY PERSONS RECEIVING FINANCIAL RETURN”

    Bill, my question goes to definition 2.c. of the word “professional.”

    To your comment, you are quite right. I am not a professional. I am not getting paid to comment here. Apparently, in your effort to distinguish yourself from me, you are saying that you are. Are you?

    Again, for the 4th time, how much did Mercola fund the Fluoride Action Network last year to push your particular brand of paranoia and help them sell their expensive water filters.

    Liked by 1 person

  95. Bill,

    “I have previously presented my reservations about the NZ study and Broadbent’s comparing fluoridation with fluoride supplements, which lacked power to evaluate IQ.”

    Do you think that doctors, dentists, epidemiologists, civil servants, and others, evaluating millions of people in populations with CWF for over seventy years also lack the power to evaluate IQ? If not, what numbers and what duration do you think would be necessary to evaluate the effect of CWF on IQ?

    Personally, I would expect that studying millions of people for over seventy years, even over entire lifetimes, would be sufficient to demonstrate any effect of CWF on IQ.

    Where is your evidence to justify your belief that CWF causes harm to humans by reducing IQ? Or is your belief evidence free?

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  96. Bill,

    “And the assumption is that fluoride from CWF has some sort of different effect than fluoride from other sources. No evidence is provided to support this speculation.”

    That would be your assumption, not that of the paper. Do you have evidence to support your speculation?

    And do you have any evidence from the millions of people worldwide drinking optimally fluoridated water supplies for over seventy years that there is an effect of CWF on IQ, on cognitive function, or even on learning disability (or ability)?

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  97. Bill,

    “Sample size is a concern.”

    Agreed. Do you think millions of people worldwide, drinking optimally fluoridated water supplies for over seventy years, even for entire lifetimes, provides a sufficiently large sample size and duration to evaluate the effects of CWF on IQ?

    If not, how large a sample size and for what duration would you consider sufficient?

    If so, would you please provide evidence from those millions of people for multiple decades that there is an effect on IQ from optimally fluoridated water supplies?

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  98. Bill, I have now posted a detailed response to your critiques of Broadbent et al., and Barberio et al. See Do we need a new fluoride debate?

    I would be pleased to post separately any response you have to this and comments on other studies such as that of Aggeborn & Öhman (2016). Also, anything you could contribute to encourage an ongoing exchange.

    I hope this will develop into a new exchange on CWF – I think this is necessary since there have been several new studies since the last exchange with Paul Connett 4 years ago.

    If you would prefer not to take up your right of reply or to participate in this exchange could you suggest another FAN member who might?

    Like

  99. Bill Osmunson DDS, MPH Director, Fluoride Action Network

    Ken, Here are some considerations on Broadbent.

    Broadbent (2014) reports no association between fluoridation and IQ. There are several cautions which should downgrade this study including the fact that 139 of the 990 cohorts used fluoride supplements. “Double dosing,” receiving both fluoridated water and fluoride supplements (pills), would be contraindicated and unusual. We can reasonably assume many if not all of the 99 “non-fluoridated” cohorts would have been some of the 139 in the study who received fluoride supplements. In effect, Broadbent (2014) may have simply compared the method of fluoride delivery on IQ rather than fluoride’s toxic effect on IQ.

    Ken. Slow down and think about that. 99 controls and 139 on fluoride supplements. For a dentist to give children on fluoridated water additional fluoride for ingestion would be contraindicated and open the dentist to malpractice charges. In fact, most of the 99, if not all, were ingesting additional fluoride.
    When we consider “power” of a study, we need to have a control group. We need a comparison. Perhaps the individual dosage of fluoride in the supplements was less than the dosage water, and maybe not. Were people actually drinking the water? What was their urine or serum or tooth fluoride concentration? So the “power” of this study goes down because Broadbent makes big claims with minimal if any power.

    Philippe Grandjean provides comments on Broadbent’s report. “Fortunately, the controversy has spurred renewed interest in research on the possible implications of elevated fluoride exposure on IQ. Results have just been published from a study in Dunedin, New Zealand. IQ data from almost 1,000 subjects born in 1972-1973 were available, and questionnaire data included past use of fluoride-containing toothpaste or fluoride tablets. Residence information showed that only 99 of the subjects had never lived in an area with fluoridated water, while 22 had never used fluoride toothpaste. The researchers did not find any differences in IQ associated with fluoride exposure indica- tors, also in regard to the IQ at age 38 years. The report does not consider the size of a fluoride effect that would have been detectable in a study of this size, within a narrow range of exposures, and considering the imprecise classification of fluoride exposure. The statistical confidence limits suggest that a loss of 2-3 IQ points could not be excluded by their findings. Nonetheless, the authors conclude that the absence of significant effects can be generalized to similar western populations.
    In support of their results, the authors write: ‘No dramatic historical decreases in IQ have been seen following widespread implementation of [community water fluoridation] or worldwide introduction of fluoride toothpastes; instead, historical comparisons have documented substantial IQ gains across countries since the mid-1900s.’ What to make of this confused linkage of independent facts is difficult to see, though. Still, the New Zealand dentists offer the following advice: ‘Scientists and policy makers should be reminded of the necessity of caution in attributing causality when evidence for it does not exist.’
    Indeed, but we should also be reminded that an adverse effect may well be present, even when it could not be demonstrated in a particular study, especially one that can be characterized as weak or non-informative.”

    I would suggest the study’s small sample size of non-water-fluoridated subjects (99 compared to 891 water-fluoridated subjects) means it has low ability to detect an effect. Even worse, 139 subjects took fluoride tablets. Broadbent’s failure to consider total fluoride exposure may thus explain why he found “no effect”.
    Broadbent falsely criticizes 27 previous studies linking fluoride to children’s lower IQ – implying they didn’t adjust for any potentially confounding variables like lead, iodine, arsenic, nutrition, parent’s IQ, urban/rural and fluoride from other sources. In fact, several of the studies did control for these factors. A good example is Xiang’s work, which has controlled for lead, iodine, arsenic, urban/rural, fluoride from all sources, parent’s education, and socio-economic status (SES). Ironically, Broadbent failed to adjust for most of these factors in his own study despite having access to information on many of them.

    Of the four factors Broadbent did adjust for, most were only crudely controlled. For example, SES was determined solely by the father’s occupation and classified into just 3 levels. Inadequate adjustment for SES could obscure a lowering of IQ caused by fluoride, because almost all of the non-water-fluoridated children came from one outlying town that had lower SES than the fluoridated areas.

    “Broadbent is one of New Zealand’s leading political promoters of fluoridation. He is a dentist not a developmental neurotoxicologist. This study is hardly sufficient to outweigh the substantial body of evidence showing fluoride’s potential to harm the developing brain at relatively low exposure levels.

    Sutton (2015) is a prime example of the limitations when crudely rating studies based on study design rather than weight of the evidence. Sutton (2015) rated the Broadbent (2014) study as “moderate quality” because it was described as a “prospective cohort” study, while all the other fluoride IQ studies were deemed “low quality” because they were ecological and cross-sectional studies. However, Sutton failed to consider the lack of controls.

    In part, the Sutten (2015) study is biased, in part, because the authors were commissioned by the Irish Department of Health which fluoridates most of Ireland.
    2. Calderon (2000)50 did not find lower IQ, but reported fluoride exposure was associated with other indices of neurotoxicity, including impaired visual-spatial organization.
    3. Li (2010)51 did not compare a high fluoride area with a low-fluoride area. Instead, it compared the IQs of children with dental fluorosis in a high-fluoride area with the IQs of children without dental fluorosis in the same high-fluoride area.
    4. Spittle (1998) the current Editor of the Journal Fluoride, evaluated a fluoridated community in New Zealand but did not measure urinary or serum fluoride levels of the children. This is particularly important to do in studies of western populations because of the many sources of fluoride and water sources in developed countries (toothpaste, bottled water, etc.)

    Sutton M, Kiersey R, Farragher L, Long J. Health Effects of Water Fluoridation, An evidence review 2015 for the Irish Department of Health.

    Calderon J, et al. (2000). Influence of fluoride exposure on reaction time and visuospatial organization in
    children. Epidemiology 11(4): S153.

    Li X, et al. (2010). Investigation and Analysis of Children’s IQ and Dental Fluorosis in a High Fluoride
    Area. Chinese Journal of Pest Control 26(3):230-31. [Translated from Chinese to English by FAN] [Chinese text |

    Spittle B, et al. (1998). Intelligence and fluoride exposure in New Zealand Children (abstract). Fluoride 31:S13

    There is now a great deal of overlap in fluoride exposures between children living in fluoridated vs. non-fluoridated communities, sometimes referred to as the “halo effect”. This “halo effect” is due to several facts including:
    (a) frequent prescription of fluoride supplements to children in non-fluoridated areas;
    (b) ingestion of large amounts of fluoride toothpaste;
    (c) exposure to fluoridated water through processed foods and beverages; (d) exposure to fluoride through pesticides; and
    (e) travel and transportation of people and products
    (f) and unknowns. Two of the studies not finding an association are from New Zealand. Perhaps there are unknowns rather unique to New Zealand and similar areas/ cultures which mitigate the effects of fluoride.

    The Broadbent study has little value, other than to demonstrate really bad research.

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  100. Bill, these are the sorts of comments you can include in your first article of the exchange as they are a response to what I have written. I am happy to respond to these, and the critiques of the people you mention if you provide citations and/or links. For example, it is helpful to have the link to Grnadjeans blog article you have copy/pasted – http://braindrain.dk/2014/06/fluoride-good-for-teeth-bad-for-brains/. And really citations are simply a way of respecting the people who have made the comments.

    At this stage, I will only say that I find the comments by Grandjean and Spittle disingenuous. Grandjean refused to allow my critique of the Malin & Till paper in his journal. I consider that extremely unethical and it illustrated to me his bias. Spittle is of course well known for his bias but he similarly engineered things to prevent my critique of the Hirzy et al (2016) paper to be published in his journal. This is again unethical as I think there is an obligation on journal editors to ensure the publication of critiques of papers published in their journals.

    However, please make these points in your response to my article and I can, in turn, deal with them there rather than bury responses in the comments section.

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  101. Bill, I don’t want to divert attention away from your upcoming contribution which will be posted but feel I must comment on your claims about the Xiang study:

    “A good example is Xiang’s work, which has controlled for lead, iodine, arsenic, urban/rural, fluoride from all sources, parent’s education, and socio-economic status (SES).”

    In fact, that is not true – he did not include these possible confounders in any regressions.

    The problem with Xiang’s work was central to my critique of the Hirzy et al paper and probably central to Spittle’s manipulations to prevent publication of my critique (it has now been submitted elsewhere).

    The fact is that while Xiang claimed to have found a significant correlation of IQ with water F (A feature which would have made his work useful) he did not present any data or analysis to support that claim. I don’t question that a statistical analysis was performed – just that the evidence was not presented.

    The only evidence we have is the correlation he found between IQ and urinary F – he presented the analysis and data for that.

    This data showed he was able to explain only about 3% of the variance in IQ using urinary F – a strong indication that he has not found the correct risk-modifying factor.

    The work Xiang presented for these other confounders were simply means for the two separate villages. This does not test correlation or control of these confounders in the regression of IQ against water F he claims to have made.

    Talk about sloppy science – or more correctly, sloppy claims.

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