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Re: Fluoride - Demand AARP Take Action

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Dr. Bill, 

 

Your quote:  "Unfortunately, you seem to either fail to read my posts or read so fast you miss the answers.  I have responded repeatedly on your two questions.  Please slow down and read carefully."

 

Response:  Actually, I have read your responses, and you were kind enough to repeat them here.  Let's look at what you propose for an RCT for Community Water Fluoridation (CWF).

 

Let's look at your proposal B first.  Your Quote:  "There are communities in the North of Canada/Alaska and other remote communities in countries where water is trucked to the community.  A prospective RCT could be done with these communities. Again, the biggest hurdel would be ethics approval."

 

Response:  You are correct.  Ethics would be a problem here since your proposal is a clear violation of the Safe Drinking Water Act which requires each supplier of drinking water to supply its customers with written notification of the results of analysis on that water.  Under your proposal, people who drink water which is "trucked to the community" would not be privy to analytical results.  That is illegal.  

 

Moreover, your proposal is not an RCT, it is a prospective cohort study.  An RCT invokes random selection from within a population, not comparing 2 self-selected populations, so they would have to combine the names from both town, then randomly select people into the F and non-F groups, and force them to live in their assigned town for 5+ years.  That would split up a lot of families!

 

Now let's look at your proposal A.  Your Quote:  "Easiest to do an RCT with fluoride pills  The intent of fluoridation is to increase fluoride exposure (increase background dosage).  Fluoride pills have the same alleged benefit as putting the fluoride pill in water and swallowing the water. "

Response:  Pills.  You are suggesting that pills would somehow replace authentic community water fluoridation to determine that teeth are protected in the same way as a constant supply of drinking water.  

 

For the readers of this thread who may not be accustomed to your loose relationship with facts, let me illustrate how absurd this idea is.  

 

First of all, any study like this would fail an objecive peer review process.  Why?  

 

They are not the same things.  You want to test apples by applying oranges.  Allow me to illustrate the problem with your idea.  

 

I get up at 3 o'clock in the morning to go to the bathroom, and I drink some fluoridated water which not only neutralizes the acids in my mouth which have been accumulating since 9 pm' these are acids which would normally lead to decay.  Correct?  

 

In your scenario, instead of drinking water at 3 am, 6 am (when I get up), 7 am, in my coffee, and throughout the day in which 0.7 ppm F are bathing and remineralizing my teeth, .  .  .  you suggest that I take a pill once a day.  

 

You are literally nuts.  That is the most insane proposal I have ever heard.  It would in no way ever pass a peer-reviewed process as a substitute for community water fluoridation.  

 

It is simply not the same thing!  

 

So while you whine and say, "It is time for promoters to provide RCT studies," you must realize that your own ill-advised proposals lack any substance whatsoever.  

 

To your second point about FDA approval, I couldn't help notice that you have failed to provide any quotation, any citation, from any Federal Health Authority which has deemed optimally fluoridated water "A Drug."  

 

The only people in this county who call optimally fluroidated water a drug is YOU.  You at the Fluoride Action Network (FAN), which takes money from Alternative Health companies who profit from the paranoia that FAN generates, .  .  .  and You at Fluoride Class Action, you and Dr. Sauerheber, who have your own web pages on that site.  

 

Interesting question. Both you and Dr. Sauerheber are all over the website "Fluoride Class Action."  My question is, how much money has Attorney James Deal taken from prospective clients as part of his fluoride paranoia campaign?  

 

Next question:  How much money has he actually collected from legitimate lawsuites filed against those responsible for the proven health initiative Community Water Fluoridation?  

 

You deceptively cite this from the SDWA:  "SDWA: “No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water."

 

Response:  So What.  All this says - when applied to water fluoridation - is that the federal government can not mandate it.  The Federal government can not require water fluoridation.  It is normally voted upon by the people, and in some cases states can mandate it, but your interpretation is . .  deceptive to say the least. 

 

The following quote from you is a blatant lie.

 

"For clarity, I asked the EPA and EPA in a FOIA request responded,

“The Safe Drinking Water Act prohibits the deliberate addition of any substance to drinking water for health-related purposes other than disinfection of the water.”

 

That is a lie, Dr. Bill.  Please provide documentation of what you just said here.  

                                                                 FOIA Request HQ-FOI-01418-10 "

 

There is no such

 
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Re: Fluoride - Demand AARP Take Action

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Message 842 of 1,450

David.  

 

By your our response I can tell you have not read enough on the web site.  

 

FDA reviews drug applications.   

If no one makes application, no approval or denial on the FDA site will be found.  

 

Look for sodium fluoride pills and no approval will be found.  

 

You will either find approval or nothing.  

 

And the approval is specific with dosage warnings contraindications etc.  

 

listen to tv adds on drugs.  All the warnings and contraindications and side affects.   

 

Nothing on fluoride ingestion but there is on toothpaste.  

 

Your question makes no sense in the drug regulatory process.  

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Re: Fluoride - Demand AARP Take Action

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I have the letter from E. Lovering, the head if the FDA, stating in writing what I posted. Perhaos you could contact the FDA if you refuse to accept the truth from me.

Richard Sauerheber, Ph.D.
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Re: Fluoride - Demand AARP Take Action

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Dr. Sauerheber for your barely legible response.  

 

For the m-teenth time now, could you please provide a link and a citation to an FDA website in which the FDA calls optimally fluoridated water a "drug?"  Since this was the entire premise of your rant, that would be necessary to back up what you were trying to say.

 

You haven't been able to provide such evidence before, so I don't expect miracles now.

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Re: Fluoride - Demand AARP Take Action

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Hi David,

 

Such good questions.  Unfortunately, you seem to either fail to read my posts or read so fast you miss the answers.  I have responded repeatedly on your two questions.  Please slow down and read carefully.

 

To your first question on how to do a prospective RCT, consider several options.  

a.   Easiest to do an RCT with fluoride pills  The intent of fluoridation is to increase fluoride exposure (increase background dosage).  Fluoride pills have the same alleged benefit as putting the fluoride pill in water and swallowing the water.   In other words, have two sets of pills, one a fluoride pill and another a placebo pill.  Give the pills to people and keep track of who gets which pill  If an RCT were done with pills and demonstrated effective at a specific dosage and safe at that dosage, FDA approval could be applied for and approved.   Make swallowing fluoride legal with FDA approval.   If fluoride pills were legal, promoters of fluoridation would have a rather strong case.   The biggest problem would be to gain ethical approval.  With so many studies demonstrating harm, I doubt a university human studies ethics board would approve the study.   If an RCT is unethical, certainly forcing people to ingest the fluoride without consent should be questioned.

 

b.  There are communities in the North of Canada/Alaska and other remote communities in countries where water is trucked to the community.  A prospective RCT could be done with these communities. Again, the biggest hurdel would be ethics approval.  Too many studies showing harm.

 

David, we put a man on the moon, certainly we can make the swallowing of fluoride with the intent to prevent disease. . . legal and supported by the best of science.  The biggest problem to an RCT would be ethics.

 

To your second question of why fluoride used with the intent to prevent disease requires FDA approval.

 

   FDA approval is required by both Federal and all state laws.    21 USC 321 (g)(1)(B) states, "Articles intended for use in the . . . prevention of disease."   

 

The intent of fluoride is to prevent dental caries, a disease.   

If one argues that fluoride is not a drug, then fluoride is regulated under poison laws.  However, fluoride is exempt from poison laws when regulated under drug laws.  No exemption is made when diluted with water.

 

Fluoride is listed as a drug in all Pharmacopias and laws define drugs as those listed in the US Pharmacopia.

Fluoride is called a drug by the FDA.  See FDA.gov.   You can contact the FDA and ask the FDA if ingestion of fluoride is FDA approved whether in pills or liquids or disolved in water.

 

Note:  Drug Digest in 1975 notified 35 fluoride manufacturers:  

“. . .there is no substantial evidence of drug effectiveness as prescribed, recommended or suggested in its labeling. . . marketing is in violation of the new drug provisions of the Federal Food, Drug, and Cosmetic Act; they have, therefore, requested that marketing of these products be discontinued.”        

 

Read the FDA web site on Drug approval.  See FDA.gov Look under "drugs."  Then look at resources on the left side.   Look at how the FDA defines "drugs."  No exception to a drug just because it is diluted with water.  The intent of use defines the substance as a drug.

 

Now look at your toothpaste.  If fluoride is added, the toothpaste has a label, "Drug Facts."

Fluoride is approved in toothpaste with the label "Do Not Swallow."   Because, swallowing fluoride is not approved.

 

Now look at the Safe Drinking Water Act:

 

SDWA: “No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water. ”42 USC 300g-1(b)(11):

 

For clarity, I asked the EPA and EPA in a FOIA request responded,

“The Safe Drinking Water Act prohibits the deliberate addition of any substance to drinking water for health-related purposes other than disinfection of the water.”

                                                                 FOIA Request HQ-FOI-01418-10 

 

Some have suggested they are simply adjusting the natural concentration of fluoride in water, and that is true.  But the intent, saying again, "INTENT" of use makes fluoride a drug and drugs are under FDA jurisdiction.   If fluoride were added to kill bacteria, then it would be legal, but fluoride is added to prevent disease.

 

At one time the natural concentration of lithium concentration was considered.  Lithium was considered so safe, safe for everyone, and would help those in need.  But lithium addition to water was stopped because it is a drug and found not safe for everyone.

 

Many other substances are found naturally in water but are not safe in larger quantities, concentrations.

 

Thanks for your questions, go to FDA.gov and they have much more.

 

Bill Osmunson DDS MPH

 

 

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Re: Fluoride - Demand AARP Take Action

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Message 846 of 1,450

This has been addtessed repeatedly in earlier posts. The FEW  ruled that fluoride added into water is an uncontrolled use of an unapproved dtug. 

And regardless of whether one prefers  to call fluoride , which is added to treat human tissue , either a drug or a supplement, is irrelevant since the FDA has sole authority to regulate both drugs and supplements -- regardless of the method of dissemination.

Some argue fluoride is,a food but the FDA ruled that fluoride is not considered safe to add to foods.

Current FDA staff considers fluoride to be a toxic agent under  the toxic substances control act and that the EPA needs to deal with the problem, while  the EPA states that fluoride is added to mitigate caries and thus needs to be regulated by the FDA. Neither agency currently regulates fluoridation. 

This ,is  all old news.

 

 

Richard Sauerheber, Ph.D.
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Re: Fluoride - Demand AARP Take Action

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Message 847 of 1,450

Dr. Bill, 

 

Could you remind us all again how you would undertake an RTC with community water fluoridation?  

 

And why exactly would the practice of community water fluoridation need FDA approval?  Correct me if I am wrong, but aren't we talking about optimally fluoridated water?  Could you show me anywhere on this FDA regulated product (bottled water - the FDA has regulatory authority over bottled water because it is considered a "food") where the word "Drug," or the phrase "Drug Facts" are used?  This is the label from a bottle of optimally fluoridated water.

 

https://nutritiondata.self.com/facts/beverages/9231/2

 

Could you please cite any Federal Regulatory Authority which considers optimally fluoridated water a "Drug"?

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Re: Fluoride - Demand AARP Take Action

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CarryAnne,

 

Thank you for those studies.

 

No one actually reading the research regarding the dosage of fluoride we are getting and the serious harm to our brains from too much fluoride would promote ingesting even more fluoride.  Makes no sense to intentionally harm brains.

 

Combine the current fluoride neurotoxic studies along with past studies and fluoridation will and must stop.  

 

To make matters worse, some attempt to reassure us that fluoride is effective in mitigating dental caries.  Unfortunately the research makes claims more by default, estimates, and assumptions rather than good research evidence.  The claim is often, "caries declined, so the effect must have been fluoride."   

 

It is time for promoters to provide RCT studies and gain FDA approval, show the evidence or stop forcing people to ingest excess fluoride.  

 

Bill Osmunson DDS MPH

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It's not even half way through the month, and look at the newest studies damning fluoridation as a public harm policy in just the past few days. 

 

THYROID: 18% of people drinking 'optimally' fluoridated water in Canadian communities at risk of low thyroid function because fluoride interferes with iodine. Many of them will be sub-clinical and do not know they have low thyroid, which nevertheless increases their risk for diabetes, high cholesterol, and other problems. Overall 9% of the population is diagnosed with low thyroid. 

https://www.sciencedirect.com/science/article/pii/S016041201830833X

 

PREGNANT WOMEN: Pregnant Canadian women drinking  'optimally' fluoridated water had twice the fluoride exposure per individual testing as compared to pregnant women in non-fluoridated communities - and consistent with the range in the Mexican women whose children had up to 6 points lowered IQ based on prenatal exposure to fluoride (from salt).  https://www.sciencedirect.com/science/article/pii/S0013935116302808

 

LEARNING DISABILITIES: Over 200 children who were individually tested had attention deficit disorder apparently caused by their prenatal exposure to fluoride. This is the 3rd report out of the NIH sponsored 12 year study that seems to have been designed with the intention of showing no ill effect, but instead has three times to date confirmed low dose prenatal exposure to fluoride consistent with exposure in 'optimally' fluoridated communities causes subtle but permanent brain damage. https://www.sciencedirect.com/science/article/pii/S0160412018311814

 

OVERDOSED BABIES: Over one third of babies (37%) in fluoridated American communities consume in unsafe amounts of fluoride in excess of the upper limits of fluoride considered safe per government regulations. Even 4 % of babies in non-fluoridated communities also are overdosed on fluoride. At the very least, this puts these children at high risk for developing dental fluorosis, mottled teeth, a condition associated with more learning disabilities, broken bones and kidney disease. http://jocpd.org/doi/10.17796/1053-4625-43.1.7 

 

GOVERNMENT BIAS: A National Toxicology Program’s animal experiment used the wrong rats, the wrong dose, and the wrong study design in order to manufacture a finding of no prenatal or postnatal effect, apparently in an effort to protect policy instead of people. https://www.sciencedirect.com/science/article/pii/S0306987718308600

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Re: Fluoride - Demand AARP Take Action

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Johnny,

 

Further to the list of studies below evaluating the mechanism of fluoride's neurotoxicity, here are a few studies specifically affecting the fetus.  These become even more significant when we add the Bashash et al study https://www.ncbi.nlm.nih.gov/pubmed/28937959 and their conclusion:

 

"CONCLUSIONS:

In this study, higher prenatal fluoride exposure, in the general range of exposures reported for other general population samples of pregnant women and nonpregnant adults, was associated with lower scores on tests of cognitive function in the offspring at age 4 and 6-12 y. https://doi.org/10.1289/EHP655."

 

They did not report a "no effect" urine fluoride concentration.   

 

Johnny, science has demonstrated for years that brain damage is happening to the developing brain from the increased fluoride exposure caused by fluoridation.  

 

 

 

FETUS

Mechanism of Low Learning and Memory Abilities: Niu (2014)“Both fluoride and lead can cross the blood-brain barrier and produce toxic effects on the central neural system, resulting in low learning and memory abilities, especially in children. In order to identify the proteomic pattern in the cortex of young animals, from the beginning of fertilization to the age of postnatal day 56, pregnant female mice and pups were administrated with 150 mg sodium fluoride/L and/or 300 mg lead acetate/L in their drinking water. Two-dimensional electrophoresis (2-DE) combined with mass spectrometry (MS) was applied to identify differently expressed protein spots. Results showed that there were eight proteins in the cortex that significantly changed, whose biological functions were involved in (1) energy metabolism (Ndufs1, Atp5h, Atp6v1b2), (2) cytoskeleton (Spna2, Tuba1a, Tubb2a), (3) glycation repair (Hdhd2), and (4) cell stress response (Hspa8). Based on the previous and current studies, ATPase, Spna2, and Hspa8 were shared by fluoride and lead both as common target molecules.”

 

Potential Toxicity: NRC (2006) p 164, In general, average cord blood concentrations are approximately 60% of maternal serum concentrations, with proportionally lesser amounts present as higher maternal serum concentrations. . . . Therefore potential toxicity to the developing embryo and fetus in the setting of high maternal ingestion of fluoride has been a concern evaluated in both animal and humans.” 

 

Harm to Fetus: Yu (1996 and English 2008) “The mothers of the ten fetuses that formed the subject group for this study all had dental fluorosis, with a corresponding increase in urinary fluoride, indicating that these pregnant women were suffering from chronic fluoride poisoning. The excess fluoride of the mother was passed through the placental barrier into the fetus, and from there through the blood-brain barrier to accumulate in the fetal brain, leading to a significant rise in bone and brain fluoride levels. Our results are consistent with earlier reports. Previous experiments have shown that the brains of fetuses from endemic fluorosis areas as well as fluoride-poisoned rats manifest morphological changes. Following experimental testing of the monoamine neurotransmitters in fetuses from fluorosis endemic areas, the present study found lowered levels of norepinephrine and elevated levels of epinephrine. The presence of norepinephrine in the brain allows the organism to become alert, and guards against the intensification of reflex reactions and other behavior. Norepinephrine also plays a role in the regulation of complex response mechanisms, emotions, cerebrocardiovascular function, etc. When norepinephrine levels drop the ability to maintain an appropriate state of activation in the central nervous system is weakened. The elevated levels of epinephrine could be due to a blockage of the pathway that transforms epinephrine into norepinephrine or possibly due to suppression of the relevant metabolic enzymes, causing the brain levels of epinephrine to increase, and the levels of norepinephrine to decrease.”

 

Mechanism of Harm to Fetus:  Dong (1993) “The contents of five types of amino-acid neurotransmitters and three types of monoamine neurotransmitters in the brains of fetuses aborted through induced labor in a chronic fluorosis-endemic area were determined. Findings revealed that the content of the excitatory amino acid, aspartic acid, was significantly lower than in the fetuses from the non-endemic area whereas the content of the inhibitory amino acid, taurine, was significantly higher; the content of the major spinal cord-inhibitory glycine was significantly reduced. Among the monoamine neurotransmitters, the content of norepinephrine was significantly reduced; the contents of 5-hydroxytryptamine in the frontal and the occipital lobes were elevated and the content of 5-hydroxytryptamine in the parietal lobe (precentral and postcentral gyri) was reduced.”

 

Harm to Fetus with Stunted Neuronal Development: Du (1992) “It is known that fluoride can cross the placenta from the mother’s blood to the developing fetus. However, the theory there is a direct link between fluoride effects and brain cell damage is still controversial due to lack of adequate evidence. In order to determine if there are any adverse effects on the developing human brain, especially starting from formation of the embryo, fetuses from an endemic fluorosis area at the 5th–8th month of gestation were compared with those from a non-endemic area. RESULTS: Normal Purkinje cells from the non-endemic fluorosis area were observed in single or parallel lines and were well organized in the fetal cerebellum. Purkinje cells of fetuses from the endemic fluorosis area were abnormally disorganized and had a thicker granulated layer in the cerebellum. Other dysmorphology, including higher nucleus-cytoplasm ratio of brain cones, hippocampus cones, and Purkinje cone cells, supports the theory that fluoride has an adverse effect on brain development. SEM analysis also found reduced neurons of brain cortex, decreased numerical density, volume density, and surface density in those fetuses from the endemic fluorosis area. In summary, the passage of fluorine through the placenta of mothers with chronic fluorosis and its accumulation within the brain of the fetus impacts the developing central nervous system and stunts neuron development.

 

Toxic to Nerve Development:  Li (2004) “The effects of excessive fluoride intake during pregnancy on neonatal neurobehavioral development and the neurodevelopment toxicity of fluoride were evaluated. Ninety-one normal neonates delivered at the department of obstetrics and gynecology in five hospitals of Zhaozhou County, Heilongjiang Province, China were randomly selected from December 2002 to January 2003. The subjects were divided into two groups (high fluoride and control) based on the fluoride content in the drinking water of the pregnant women. . . . There were significant differences in the neonatal behavioral neurological assessment score and neonatal behavioral score between the subjects in the endemic fluoride areas and the control group. . . . [N]eurobehavioural capability and agonistic muscle tension from the high fluoride group were impaired, resulting in a statistically significant lower overall (total) assessment score than in the control group (p<0.05). . . . [V]arious neurobehavioral capabilities, such as non-biological visual, biological visual, and auditory directional reactions of the neonates from the high fluoride group lagged behind those of the control group with differences that are statistically significant (p<0.05). . . . NBNA examination can help to detect mild damage to brain functions. The results of the examination indicate that high fluoride levels can cause adverse effects in the neurobehavioral development of neonates. . . . The present observations indicate that fluoride, as a toxic material to nerve development, can have an adverse impact on the neurobehavioral development of neonates and can cause abnormal changes of neurobehavioral capability during the neonate period with a negative impact on the future development of both the body and intelligence of the neonate. Therefore, in endemic fluoride areas, great effort should be made to reduce fluoride level in the water.

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