What is the WaterBest Study?

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* New born babies in Kinston are being enrolled in an experimental study involving FLUORIDE.

* Fluoride exposure early in life can harm the developing brains of our children.

* Parents are not receiving proper informed consent when enrolling their children in this study.

What can you do? Spread the word in your community. Help put an end to the study.

 

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The WaterBest fluoridation study, a human experiment on approximately 200 infants, has raised serious ethical concerns. The study, led by dentist Dr. Gary Slade of the University of North Carolina, is intended to help justify expansion of water fluoridation in the US. The parents of the children are not being informed that fluoride can damage children’s developing brains, resulting in reduced IQ at the doses planned for the study.

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The concerns with this study arise under five of the Guiding Principles for Ethical Research set forth by the National Institutes of Health (see guiding principles and ethics) and are detailed in a March 14, 2022, letter sent to the members of the Institutional Review Board (IRB) overseeing this experiment. The letter details how the study violates these requirements:

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• Favorable risk-benefit ratio
• Informed consent
• Independent review
• Fair subject selection
• Scientific validity

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The University of North Carolina IRB has offered no response to these violations, even after three follow-up emails.  Especially concerning is the risk this study will impose directly on the children, and the lack of informed consent from the parents. No mention is made of fluoride’s neurotoxicity in the Parental Consent Form.

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Study Details

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• The Subjects:  Approximately 200 families with infants from two months to six months of age living in Lenoir County, North Carolina, will be recruited. Half will receive bottled fluoridated water, and the others will receive bottled water with a low fluoride concentration. The participants will be encouraged to use the supplied study water. Fingernail and toenail clippings will be taken to provide a biomarker-measure of fluoride intake.

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• The recruitment area for the infants is Lenoir County, one of the poorest regions of North Carolina, with 22% of persons living below the poverty line. That puts it in the top poverty rankings in North Carolina. The community is 41% Black, and 11% Latino and other minorities.

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• The level of fluoride in the provided drinking water: 0.8 mg/L.

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• The “study water” that will be used is fluoridated bottled water: 5-gallon bottles containing water from the New Bern Water Resources Division’s Black Creek aquifer which contains naturally-occurring fluoride in a concentration of approximately 0.8 mg/L F”.

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Study placebo: Non-fluoridated bottled water.

5-gallon bottles containing water from the North Lenoir Water Corporation’s Black Creek aquifer which contains a negligible concentration of fluoride.”

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• The purpose: of the study “fluoridated bottled water represents a publicly-acceptable and potent strategy for dental caries prevention in underserved communities. To provide scientific evidence to justify the strategy, this study will undertake the first ever randomized controlled trial to evaluate dental caries preventive effects of fluoridated bottled drinking water in 3-year-old children.”

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• Dental caries, the primary endpoint, will be determined by a study dentist around the child’s 4th birthday.

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• Informed Consent: The parents will not be informed that fluoride is neurotoxic to infants and children, or of any other risk in this experiment; not even dental fluorosis. The whole family is invited to use free drinking water provided in this experiment. However no warnings will be given to pregnant women in the household.

 

Mother-Offspring fluoride studies show that the fetus and formula-fed infants (Till 2020) are especially vulnerable to fluoride’s neurotoxicity. The warning given to the parents in the Consent form is:

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“It is also possible that your child might consume too much fluoride if he/she uses infant formula powder or concentrate that is mixed with study water which contains fluoride. This risk will be minimized by asking that you use household tap water or other non-study water when you mix water with infant formula. You will also be asked if your child uses infant formula at three monthly interviews and if so, you will be reminded to mix it using non-study water.”

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• The study sponsor is the University of North Carolina at Chapel Hill.

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• The Principal Investigator is Gary Douglas Slade, professor at the University of North Carolina at Chapel Hill, and an avid pro-fluoridationist. Dr. Slade is on the Scientific Advisory Board of the American Fluoridation Society, which is devoted to promoting fluoridation.

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Reference: https://clinicaltrials.gov/ct2/show/NCT04893681

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Chris Neurath’s statement for the Lenoir Kinston NAACP Branch forum on the waterBEST experiment

Sept. 8, 2022

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Introduction

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Hello, my name is Chris Neurath and I’m the Science Director for the American Environmental Health Studies Project.

For 37 years I’ve worked on environmental health issues including toxic chemicals like lead, mercury, PCBs, dioxin (Agent Orange), and radiation. Starting 30 years ago I’ve focused on the health effects of fluoride. I do original scientific studies, review the published scientific evidence, and then try to translate that knowledge into education and action.

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Tonight I’ll focus on the fluoride experiment of the UNC Dental School that is recruiting Kinston-area residents, and the reasons we have serious concerns. But first I want to be clear that despite any differences of opinion or facts, all sides share a common goal of ensuring the health of Kinston’s kids, including their dental health.

Concern #1: Harm to the Developing Brain.

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A foremost concern is that the Informed Consent document does not inform parents of the most serious potential risk to their children: harm to their developing brains. There is rapidly emerging science finding that fluoride is neurotoxic and can lower the IQ of children. Several studies have also found fluoride may increase the risk of ADHD (Attention Deficit Hyperactivity Disorder). Several of the most recent studies were done in areas with artificial fluoridation which means they had the same levels of fluoride as is planned in the waterBEST study.

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This emerging scientific evidence raised concern at the NIH’s National Institute of Environmental Health Sciences. They have not only funded many of these studies, but through their National Toxicology Program they have spent the last 5 years gathering and evaluating the evidence and have identified over 150 human studies. They haven’t issued a final report yet, but all their data is available publicly. They have scored 27 of the human studies as high quality and of those 27, 25 found statistically significant adverse neurotoxic effects, mostly lower IQ.

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But don’t take my word for this. Several of the world’s leading researchers in neurotoxic chemicals now are saying that fluoridated water poses a real risk of harming children’s developing brains. Several have equated the risk from fluoride to that from childhood lead exposure. In other words, fluoridated water is as bad as the lead in Flint’s drinking water.

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Fluoridation promoters, most of whom are dentists, will deny or dismiss the science of fluoride’s neurotoxicity. Dr. Slade, in a recent video posted online, said local pediatricians are very upset that we have been trying to warn the Kinston community of the neurotoxic risks of fluoride. Dr. Slade said it was misinformation. Many pediatricians and many dentists including Dr. Slade have been advocating for fluoridation and even prescribing fluoride to their patients for their entire careers. I understand why they are so upset.

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But instead of accusing us of spreading misinformation, I urge them to read the scientific studies and look at what the experts in childhood neurotoxicity are saying. For example, Dr. Linda Birnbaum, PhD, the recently retired director of the National Institutes of Environmental Health Sciences says:

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"New evidence suggests that fluoride is toxic to the developing brain at levels routinely found in the general population."

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Dr. Dimitri Christakis, MD, pediatrician and editor of the Journal of the American Medical Association Pediatrics:

"The effect size [on IQ loss] is on par with lead. ... I would not have my wife drink fluoridated water if she were pregnant.”

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Concern #2: Harm to the Teeth from Dental Fluorosis.

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The waterBEST experiment’s Informed Consent document also fails to inform parents of the risk of dental fluorosis, despite this being a likely consequence of drinking fluoridated water widely recognized by dental researchers. Dental fluorosis appears as white splotches on the teeth caused by disrupted mineralization of the enamel of developing permanent teeth.

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A study published just last year using the latest CDC nation-wide data found that 17% of children in fluoridated areas had the more serious degrees of dental fluorosis, which was a rate three times higher than in non-fluoridated areas [Dong 2021]. They also found an astounding 80% of children with fluoridated water had some degree of dental fluorosis.

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Fluoridation defenders often claim that dental fluorosis from fluoridated water is only what they call a “cosmetic problem”. In plainer language, your teeth and smile do not look as good as they should.

The damage to tooth enamel happens in the permanent teeth, unseen until they emerge, starting around age 6 years as they replace baby teeth.

 

The waterBEST study stops at 4 years of age, so parents and children won’t realize the teeth have dental fluorosis until years after the experiment has finished.

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Cosmetic dentistry to improve the appearance of dental fluorosis is expensive and is not covered by dental insurance or Medicaid. And don’t expect the waterBEST study or UNC to compensate any participants for dental fluorosis. Here is what the Informed Consent document says:

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“All research involves a chance that something bad might happen to your child. ... the University of North Carolina at Chapel Hill has not set aside funds to pay you or your child for any ... injuries, illnesses or reactions, or for ... related medical care.”

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Neither UNC nor insurance will pay for treating dental fluorosis. They also won’t pay anything for lowered IQ.

Concern #3. The experiment violates rules for Protection of Research Subjects.

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The waterBEST study is funded by the dental division of the National Institutes of Health, or NIH. NIH has rules for the Protection of Research Subjects. One of the rules applies to the Institutional Review Board, or IRB, that is responsible for overseeing the safety and ethical conduct of studies. The rule states that the membership of the IRB committee should be racially diverse to, “... promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.” [from 45 CFR 46.107(a)]

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There are 22 IRB members in the two UNC-Chapel Hill IRB panels overseeing dental studies. 21 of those IRB members are White and 1 is Asian-American.

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Another NIH rule for Protecting Human Subjects requires that extra attention be given to:

“... the special problems of research that involves ... subjects who are vulnerable to coercion or undue influence, such as children, prisoners, [several other types are listed ... and] ... economically ... disadvantaged persons.”

[from 45 CFR 46.111(a)(3)]

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This brings me to our concern that the waterBEST study is offering as inducement for participating families $480. Even for people who are not struggling financially, if they have a new baby, they could see that offer of $480 and think “that could pay for a lot of diapers, groceries, and other things”.

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Concern #4. The reasons given for choosing Kinston appear false.

Dr. Slade, on the NIH grant website, says the reason he chose Lenoir County and Kinston is because it is:

“... the state’s community with the largest non-fluoridated public water system where caries prevalence exceeds the state average.” [NIH Reporter webpage]

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But this is simply not true. Annual Water Quality Reports for the Kinston Water Department are available online. Every report for the last 14 years says: “fluoride is added at the WASA plant to aid in the prevention of tooth decay.” WASA is the Neuse River Water and Sewer Authority. The manager of the Kinston Water Department told us that about 60% of the city receives fluoridated water from WASA, and the rest gets non-fluoridated water from wells.

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Dr. Slade’s claim that Kinston has a large non-fluoridated population is also contradicted by his own data set, which he compiled for two papers on fluoridation in the United States [Slade 2018, Sanders 2019]. His data set lists Lenoir County as only 29.5% non-fluoridated and less than 17,000 persons non-fluoridated. When I looked at all 100 counties in North Carolina, I found that 52 of them had both higher percentage and higher populations non-fluoridated than Lenoir. Any of those 52 counties would have better matched Dr. Slade’s claimed goal of finding a large non-fluoridated population. Many would also have above average rates of tooth decay, his other criteria. Why were Kinston and Lenoir County chosen when there are dozens of places in North Carolina that would appear to better meet the study’s goals?

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CONCLUSION

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I’d like to conclude by urging parents of newborns and the entire community to learn about the current science on fluoride’s risks. We have tried to make the most scientifically rigorous and factually accurate information available, on our websites, and in materials like our brochure. We are more than happy to supply information and answer questions now or at any time. Please ask the waterBEST proponents lots of questions. Ask us questions.

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Finally, I want to sincerely thank Barbara Sutton, the Lenoir NAACP Branch, and the Emmanuel Hill Memorial Church for facilitating this discussion to help inform the community.

Thank you.