Questions texted to the Kinston/Lenoir County NAACP Community Forum, September 8, 2022

 

On September 8, 2022, the Kinston/Lenoir County NAACP hosted a Community Forum titled “Let’s Talk about the waterBEST Study/Experiment here in Kinston Lenoir County”. The waterBEST team was invited to speak at the Forum which was hosted by Ms. Barbara Sutton and held in person at the Emmanuel Hill Church Fellowship Hall in Kinston, NC. Other people phoned into the Forum and their comments were broadcast to those in attendance. During the Forum, the following questions were sent to the convener, Ms. Barbara Sutton, who forwarded them to the waterBEST study team

This Q&A webpage contains the waterBEST team's answers to those questions.

Q1. What proof can be produced to show that it's not just Black & Brown Kids in this Study?

Our study design requires that we enroll boys and girls of all racial groups and cultural backgrounds.

 

We are approaching all households in Lenoir County with newborn children. Everything done in the waterBEST study must adhere to the study protocol which states “This study has no exclusions based on sex/gender, race, or ethnicity” (https://waterbeststudy.com/wp-content/uploads/2022/09/waterBEST-NIDCRProtocol-v1.2-2022-03-27.pdf) Independent authorities oversee and monitor the study to assure that the protocol is followed. Those authorities include UNC’s Institutional Review Board and a Data and Safety Monitoring Board established by National Institutes of Health.

Q2. The National Toxicology Program determined that out of the 27 highest quality studies, 25 linked higher fluoride with lower IQs, 11 at levels in fluoridated water. Knowing this, how can fluoridation be considered safe?

Initial reports from the National Toxicology Program looked at studies with much higher levels of fluoride than our study. They have not released a final report.

 

In 2019 and 2020, the National Toxicology Program (NTP) produced draft reports on this topic. NTP asked the National Academies of Sciences, Engineering and Medicine to act as a peer reviewer for its report. Peer review is a very important process because it provides an independent evaluation to ensure that the quality of a report is sound and that the writers of the report used consistent standards and did not overlook important details of the research. Typically, a report or study that fails to complete the peer review process is not published.

 

Both drafts of the NTP report were found to be deficient when assessed by an independent panel of the National Academies. The panel was critical of the fact that most of the studies reviewed by NTP involve relatively high fluoride concentrations, far exceeding levels used in public water systems in the United States.  In particular, the panel concluded that the NTP’s second draft report “cannot be used to draw conclusions regarding low fluoride exposure concentrations (less than 1.5 mg/L), including those typically associated with drinking water fluoridation.”  (https://doi.org/10.17226/26030) The NTP was due to produce a final report in May, 2022, but as of September, 2022 it has yet to be released. 

 

In the waterBEST study, the fluoridated water is from a well of the Black Creek aquifer that naturally contains fluoride at the level recommended by the Centers for Disease Control and Prevention for prevention of tooth decay. That level is far below most of the studies reviewed by the NTP.  People in New Bern have been drinking water from the well for decades.  Across the state, approximately 80% of North Carolinians safely drink water that has a similar level of fluoride.

 

Q3. Dr. Slade, have you consulted with any experts in early life neurotoxin exposures to reach your apparent conclusion that fluoride poses no significant risk to developing brains?

Yes, we read expert recommendations and consulted a physician whose job is to make sure the study is safe for children.  

 

The safety of participants in the waterBEST study has been reviewed and approved by experts with a range of relevant medical and scientific qualifications who serve on oversight panels. This includes UNC’s Institutional Review Board, a Data and Safety Monitoring Board, and the study’s medical monitor appointed by the National Institutes of Health.

 

We also considered evidence published by a team of 31 toxicologists and food safety experts who reviewed the evidence related to fluoride’s effect on cognitive development (IQ; neurodevelopment). Those experts concluded in 2020 that the evidence “does not provide sufficient arguments to raise concerns with regard to [water fluoridation] in the range of 0.7–1.0 mg/L.” (https://doi.org/10.1007/s00204-020-02725-2)

 

Q4. Why isn’t the waterBEST study going to do IQ tests and look for dental fluorosis in the children, as side effects of the study?

This was not the purpose of this study.  If the waterBEST study was to study IQ or dental fluorosis it would have to be approved through NIH’s peer review process. 

The waterBEST study is funded by the National Institutes of Health (NIH) to address specific research questions regarding the safety and efficacy of fluoride in bottled water for prevention of tooth decay. Those study aims and the scientific approach to be used in the study were reviewed by an independent scientific review panel that evaluates research grant applications submitted to NIH. Independent scientific review is an essential requirement for NIH funding because it assures that study protocol is rigorous, and the researchers are trustworthy and properly qualified. 

 

If additional topics are to be studied, such as IQ or dental fluorosis, new specific aims would have to be scientifically reviewed, approved, and funded by NIH. As of September 2022, the waterBEST investigators have not proposed new specific aims for the study.

 

Would you like to learn more about dental fluorosis?

Please read it here: Dental Fluorosis

Q5. So, if a water best study child is diagnosed with ADHD how does someone prove it was the fluoride?

We are not studying ADHA. If a child is diagnosed with it, parents should speak to a doctor.

 

The waterBEST study’s specific aims do not address research questions about attention deficit hyperactivity disorder (ADHD). Therefore, if a child were to develop ADHD, the waterBEST investigators would be unable to comment on possible causes.  Instead, medical advice should be obtained.  Please also note that the study does not provide health care to children in the study. If a child developed ADHD, the investigators would, if requested by the family, help them get health care.

 

No adverse health effects of any sort have been determined to be related to the low fluoride levels in this study, including ADHD or IQ/neurological deficits, except mild dental fluorosis.  Dental fluorosis is a cosmetic change in the enamel of the teeth which is typically only visible to dental professionals under a bright light when the teeth are dried off.

Q6. Slade was paid $22,400 to defend fluoridation in a lawsuit. Can you tell me more about that?

The U.S. Justice Department paid Dr. Slade a usual rate as an expert witness for the work he did over two years.

 

Dr. Slade served as an expert witness in a lawsuit filed against the United States Environmental Protection Agency. Specifically, he was asked to report on the three decades of research studies about water fluoridation and dental decay that he has done. He worked on the case from 2018 to 2020 and was reimbursed by the Department of Justice using a rate that is paid commonly to expert witnesses.

Q7. Why are the Families being insulted with approximately less than $500 over the course of the Study? That’s approximately $9 per Month?

Families are paid because taking part in research places impositions on them. The amount is based on guidelines of the U.S. Department of Health and Human Services for research studies. 

 

To help compensate for their time and effort, families will receive up to $480 if they complete all aspects of the study over the four-year follow-up period. The amount is approved by UNC’s Institutional Review Board which weighs up the impositions required to participate in research with the potential for coercion if payment is excessive. This is consistent with guidance from the Office of Human Research Protections at the U.S. Department of Health and Human Services (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html )

Q8. If UNC has so much faith in this Study, then why is it in the Consent Form it's saying that Families can't file a Lawsuit against the Experiment Team? Stating there is no money for medical care if needed. Families have to cover it themselves. However, they can file one against UNC?

UNC’s Institutional Review Board requires that all clinical trials use that wording.

 

The section of the consent form concerning health care for study participants contains standard text that is required by UNC’s Institutional Review Board for nearly all clinical studies. Regarding a possible lawsuit, the consent form states: “By signing this form, you/your child do not give up your right to seek payment or other rights if your child is harmed as a result of being in this study.” (https://waterbeststudy.com/wp-content/uploads/2022/09/waterBEST_Parental_Permission_Adult_Consent_Form_2021-12-17.pdf )

Q9. How many are already involved in this Study? & what's the Demographics?

The results of the study are reported to the National Institutes of Health and to UNC’s Institutional Review Board.

 

The goal is to enroll and randomize 200 children by the end of 2023. Study results, including enrollment rates, are reported to the National Institutes of Health and to UNC’s IRB.  The study protocol does not provide for interim reports of study results prior to completion of the study.

Q10. There is a lot of money to be made behind this Study. Who gets it? The People employed by this Study?

The waterBEST study team members are paid by UNC. 

 

The University of North Carolina at Chapel Hill has been funded by the National Institutes of Health (NIH) to conduct the waterBEST research study. NIH funding is pursuant to federal regulations 42 USC 241 31 USC 6305 42 CFR 52. UNC manages the funds consistent with federal and state policies (https://research.unc.edu/sponsored-programs/resources/information-sheet/) UNC uses the funds to pay for direct research costs and to support salaries of faculty and staff on the study team. Salaries are consistent with compensation policies of UNC and the state of North Carolina (https://hr.unc.edu/employees/class-comp/policies/ )  Study team members do not get a salary bonus for their work on the study. There is no money left over when a study is completed.

Q11. How do the Black and Brown Community know that We can trust this Study? How do We know that something else isn't being added to the Water?

  • We encourage people to visit our warehouse in the Kinston Plaza and to read about the study at our website https://waterbeststudy.com/.  To add anything besides disinfectant to the water would be against the study design and would be grounds for immediate stoppage of this study.

 

Please visit our study warehouse in the Kinston Plaza to learn all about the study from the waterBEST team and to tour the facility. It is best to phone ahead to plan your visit: 919-445-5140.

At the warehouse, you can see where we bottle the water which we obtain locally, from two wells of the Black Creek aquifer. At our warehouse, we do a final ozone disinfection of the water prior to bottling, but we do not add anything to the water.  You can see the bottling system in operation in this video:  https://videos.files.wordpress.com/3l0taJzX/waterbest-cut-one-v1-5-22.mp4

 

You can read the study protocol and learn about all other aspects of the study at our website: https://waterbeststudy.com/

 

Please also speak with trusted community leaders in Kinston and Lenoir County including the Lenoir County Health Department and the Kinston Community Health Center. Your dentist and pediatrician can also be helpful resources to learn more about fluoride.

 

The safety and wellbeing of children and families in waterBEST is assured by many independent groups that supervise all aspects of the study, including the study investigators. Those groups are accountable to state or federal government agencies and, in turn, to our elected officials. The oversight groups include:

·         UNC’s Institutional Review Board: phone 919-966-3113, email  IRB_subjects@unc.edu.

·         UNC’s Office of Research: https://research.unc.edu/about/

 

·         National Institutes of Health/National Institute of Dental and Craniofacial Research: https://www.nidcr.nih.gov/

Q12. Are the waterBEST Pamphlets being left in other places? or are they only being left at the Lenoir County Health Department and the Community Center? Which is where mostly Black and Brown People go.

We are leaving pamphlets all over Kinston and Lenoir County so that all families learn about the study.

 

waterBEST pamphlets and other publicity are available at locations throughout Kinston and Lenoir County.  This map shows locations in Kinston.

 

We are doing our best to place flyers throughout the community. Please tell us if you know of another place that will help with study promotion.  We want to enroll infants of ALL races, ALL ethnicities and ALL genders living in Lenoir County.

Q13. Why does the waterBEST building have more black & brown kids? It only has one white kid. Is this because that’s who is really being targeted?

In Kinston, 68% of people are African American according to the 2020 Census.  The mural was painted to reflect the racial and ethnic diversity of the community.

 

When the artist, Mr. Seraphim Smith, designed the mural for our study warehouse in the Kinston Plaza, he took care to create images of four young children to reflect the city’s racial and ethnic diversity.  In the 2020 census, the City of Kinston comprised 68% Blacks/African Americans, 25% Whites and 7% other races or ethnicities.

Kinston-based artist, Seraphim Smith, who is also an active culinary teacher and documentary filmmaker says, “I designed the waterBEST mural to include a local representation of our population based upon true percentages. I was tasked to include children who were between one and four years old, a representation of the City of Kinston buildings, and the tooth logo with the words waterBEST. Diversity, especially in my home of Kinston, is extremely important to me. I can’t stand it when people are glossed over and pushed down and so it was imperative for me to try to get a true reflection of who we are in Kinston. It’s about respect. For way too long, Black and Brown persons as well as people of Asian descent have not been given fair representation in television media, commercials, magazines and toys… to name just a few things. For this reason, I have two Black children – a female and male, a non-binary Native-Latinx child, and a Caucasian male child. As a 6 year member of smART Kinston, I was familiar with some of the interior mural work which some of my smART colleagues performed at Rochelle Middle School a few years ago. I knew I wanted a community component and I love working with teenagers, so for me, it was a great thing to be able to work with these awesome students to create the fish in the ocean. I was especially moved to create with them when I had found out that they did not have an art teacher. Art has always been such a huge part of my life – I would have hated to not have had that resource at their age. I had taught teenagers how to cook at both the North Carolina School of Science and Mathematics and at an eating disorders hospital in Durham, NC. I hope it shows that I really value the brilliance and creativity of our youth. I will be working on another collaborative mural with our local young teenagers in 2023 and am looking forward to it. “

Q14. What happens with the Study if waterBEST doesn’t get 200 Kids?

We wouldn’t know the impact until after the study has been completed.

 

When studies enroll fewer participants than planned, it sometimes restricts the conclusions that can be drawn from the results. The actual impact cannot be known until the study has been completed. 

Q15. How can the effectiveness be measured? What if a Family is participating and they are one of the Families with the Fluoridation in the water, but they aren’t really drinking it. But You can’t tell that they aren’t drinking it, but it appears as if they are?

We record how much water and fluoride children consume so that we can answer those questions.

 

We are carefully monitoring water consumption by all participants in the study. We are also assessing children’s total fluoride intake which we measure using fingernail and toenail clippings. We will use the information to compare the two study groups at the end of the study to see if average water consumption differs between the two study groups.

Would you like to learn more?

Please read about the background to the waterBEST study here: waterBEST: the first study of its kind