Some facts about the Human Experiment slated for Lenoir County, North Carolina
• Title of Experiment: Water From Bottles to Establish Strong Teeth (waterBEST).
• The photo used to advertise the experiment – https://waterbeststudy.com/
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:
• Favorable risk-benefit ratio
• Informed consent
• Independent review
• Fair subject selection
• Scientific validity
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.
• 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.
• 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.
• Inducements: Participants will receive $480 in compensation; free bottled water provided for 3 1/2 years for the whole family, and annual dental exams. Families will also receive “dispensers and other supplies to encourage water consumption consistent with nutritional recommendations.”
• The level of fluoride in the provided drinking water: 0.8 mg/L.
• The “Study water” that will be used
“Experimental: Fluoridated bottle 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”
“Placebo Comparator: 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.”
• The purpose:
“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.”
• Dental caries experience, the primary endpoint, will be determined once in a dental examination conducted by a study dentist close to the time of the child’s 4th birthday.”
• 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 the free drinking water provided in this experiment. However no warnings will be given to pregnant women in the household. The 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:
“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.”
• The study sponsor is the University of North Carolina at Chapel Hill.
• The Principal Investigator is Gary Douglas Slade, professor at the University of North Carolina at Chapel Hill, and an avid pro-fluoridationist. Slade is on the Scientific Advisory Board of the American Fluoridation Society, which is devoted to promoting fluoridation.
• The funding agency is the National Institute of Dental and Craniofacial Research (NIDCR). So far, $1.7 million has been committed to this experiment – see here. The NIDCR is a staunch supporter of fluoridation and the largest funder of dental studies in the world.
Information on the project proposal is available from these websites:
NIH project number: 4UH3DE029169-02