Historic #FluorideLawsuit Happening Right Now: Everything You Need to Know

The first week of the second phase of the long-delayed fluoride lawsuit is over. Here’s what you need to know.

This article was originally published by The Last American Vagabond.

On January 31st, the second phase of the fluoride lawsuit resumed in San Francisco, California after nearly four years of delays. The proceedings are the latest in an eight-year legal battle between the US Environmental Protection Agency (EPA) and the Fluoride Action Network (FAN). The lawsuit began following the EPA’s 2016 decision to deny the plaintiff’s petition under the Toxic Substances Control Act (TSCA). The FAN is attempting to prove that fluoride is a neurotoxin and should be regulated or banned under the TSCA.

The hearings are scheduled for 9 days from January 31st to February 13th. The Last American Vagabond (TLAV) has been in the courtroom daily to report on the proceedings and interview the various witnesses testifying for the plaintiffs and the defense.

The Plaintiff’s Opening Statement

During his opening statements, Fluoride Action Network lead attorney Michael Connett discussed the U.S. Environmental Protection Agency’s (EPA) standards for hazard assessment.

“The observed hazard is the first type of risk,” Connett stated. “But the challenge of risk assessment is this type of risk is rare. When EPA decided to ban lead we didn’t have observed risk in this area, despite there being harms.”

Connett also stated that it is an “undisputed fact that fluoride passes into the placenta (during pregnancy) and into the fetal brain”, noting that the blood-brain barrier is still developing and this period is considered to be a “critical window of development”.

Connett told the court the EPA will present research which did not conclude fluoride is a neurotoxin. However, Connett stated, the researchers behind the studies are “long time promoters of water fluoridation”. Connett zeroed in on one study in particular which will factor into the final days of the hearing, a study led by Dr. Jesus Ibarluzea titled Prenatal exposure to fluoride and neuropsychological development in early childhood.

This study found that fluoride actually increased IQ for boys by 15 points. Connett said these were “implausible findings” and hinted at the reasons the plaintiffs believe the study is not credible.

The EPA’s Opening Statement

Department of Justice attorney Paul Caintic argued for the EPA that Connett was selectively choosing quotes from the NTP’s study to make his points. The EPA focused on the conclusions of the NTP report itself.

The EPA quoted from the NTP’s May 2022 Monograph on IQ which stated, “associations between lower fluoride exposure…. and children’s IQ remain unclear. More studies at lower exposure levels are needed to fully understand potential associations in ranges typically found in the U.S.”

In a preview of the EPA’s arguments, Caintic said the studies which focused on water concentration levels — as opposed to studying levels of fluoride in urine — found no association between lower IQ in children. EPA also argued that because some studies found significant adverse effects on boys, but not girls, they are not reliable.

At one point, Judge Edward Chen asked for clarification of the EPA’s position. The EPA acknowledged that fluoride does cause harm at “higher levels”, but claimed there is no harm at “currently allowable levels” set by the U.S. government.

Caintic noted that most fluoridated communities in the U.S. are receiving fluoride at a concentration of 0.7 milligrams per liter of water, not at 1.5 milligrams per liter, which was the focus of some of the studies mentioned by the Fluoride Action Network. Judge Chen responded that the even if the studies which found an association between IQ and fluoride only looked at water fluoridation levels above the recommended concentration, the EPA must still consider the “margin of error”.

“What I am hearing from the plaintiffs is that even if there is not certainty, you also have evidence that, not too far in the neighborhood above there is a problem. Shouldnt that factor into the risk assessment?”, Judge Chen asked the EPA.

The EPA concluded their opening statements by claiming that the plaintiffs cannot prove to the court that community water fluoridation at a level of 0.7 milligrams per liter poses a neurotoxic harm.

FAN First Witness: Dr. Howard Hu

Dr. Howard Hu was the principal investigator in the Mexico ELEMENT study, a pregnancy and birth cohort on fluoride’s impact on neurobehavioral development. The research was funded by the EPA and the National Institutes of Health. Hu has also been involved in research on lead toxicity and anti-social behavior.

FAN attorney Michael Connett asked Dr. Hu about the fact that some studies have found different associations for boys and girls, and whether or not these studies can all be true. Hu described various factors that can split the data in such a way, including different populations, life experiences, diet, and hormones.

“Would you expect a neurotoxicant, like fluoride, could have different impact on populations?” Connett asked Hu during his testimony. “Yes. We haven’t tried to account for differences with our colleagues in Canada, but there is a whole set of factors that we know could be in play.”

Dr. Hu was also one of the witnesses to testify to the increasing concentration of fluoride which could potentially pass from a pregnant mother to her child. Connett showed Hu a graph compared the Canadian study, known as the MIREC cohort, and Hu’s more recent study in Mexico, known as the MADRES cohort, both of which indicated higher levels of fluoride within the urine of pregnant mothers in the 3rd trimester.

Hu explained a baby in the 3rd trimester typically pulls calcium from the mother’s bones as it develops its skeletal structure. If a mother is receiving fluoride this will be stored in her bones. When her child begins pulling minerals from the mother it will also receive fluoride via the placenta.

Following his testimony to the court, Dr. Howard Hu confirmed to TLAV that he believs fluoride is a neurotoxin.

“Yes. I would say that, in my view, the evidence is quite persuasive that there is a negative impact of fluoride exposure on the neurodevelopment of children, particularly the research that’s been coming out in prenatal exposure.”

FAN Second Witness: Dr. Bruce Lanphear

Bruce Lanphear is a public health physician & pediatric epidemiologist that specializes in environmental exposures including lead & other toxic chemicals. Dr. Lanphear has an M.D. from the University of Missouri at Kansas City and an M.P.H. from the Tulane School of Public Health. He is an expert on lead toxicity whose own work has been used by the EPA to develop their standards on lead.

Lanphear was also asked about the impact of fluoridated water on a pregnant mother, as well as a newborn baby. Lanphear confirmed that consumption of baby formula with fluoridated water was associated with lower IQ later in life.

When asked by FAN attorney Michael Connett whether or not he believed the MIREC study of “relatively well off families” would capture the full range of fluoride’s impacts across the population, Lanphear said it “certainly doesnt capture the full range of vulnerabilities”.

Lanphear told TLAV he also concurs with the NTP’s conclusion on lower IQ in children exposed to higher amounts of fluoride. He also shared about his own studies on IQ.

“Well, what we found, whether we looked at urinary fluoride from the mom as a measure of exposure, or water fluoride, or an estimate of fluoride intake during pregnancy, in every case, we saw IQ deficits in the children.”

As to why it was only the boys who saw signs of deficits, Lanphear said the researchers “can’t explain everything at this point”. He acknowledged that this “raises more questions”, however, he reiterated that the data has “really raised questions about practices like community fluoridation.”

Hypothyroidism

Lanphear told TLAV there is evidence that fluoride appears to impact the thyroid and IQ if a pregnant mother has less iodine available. He noted that the National Research Council’s 2006 report on fluoride found that fluoride is a thyroid disruptor and the problem is likely worse for those with low iodine.

“What we found is that women who are exposed to higher amounts of fluoride, especially if it’s in the water or if it’s a measure of fluoride intake, we saw an increased risk of those women developing hypothyroidism.” Lanphear stated.

“Now, it didn’t all happen during the course of the study, some of the exposure likely happened before the women even showed up. In fact, many of them already came in with a diagnosis of primary hypothyroidism. But because they were in those communities either with fluoridation or not, that seemed to predict why some of them, and it wasn’t a small amount, overall there’s about a 65% increase in hypothyroidism. […] But it raises really important questions about a serious problem.”

FAN Third Witness: Dr. Phillipe Grandjean

Philippe Grandjean is a Danish scientist working in environmental medicine. He is the head of the Environmental Medicine Research Unit at the University of Southern Denmark and adjunct professor of environmental health at the Harvard School of Public Health. Grandjean has an extensive history of researching mercury.

In an interview with TLAV following his testimony, Dr. Grandjean explained some of the history of research on fluoride toxicity dating back to the 1930’s in Copenhagen, Denmark.

“It started about 50 years ago because Copenhagen in Denmark, was where fluoride poisoning was discovered in the form of what’s called skeletal fluorosis, which means that the bones become denser, and on the x-ray it looks like marble,” Gradnjean said.  “And way back then, when that was discovered in the 1930s, it was also discovered that the workers who had these high exposures had symptoms from the central nervous system. That is, that fluoride likely was affecting the functions of the brain. So we have now, lately, followed that up in regard to brain development in small children.”

Grandjean said as much during his testimony to the court. He was asked if he would consider a pregnant mother who lived her whole life in a fluoridated area, and suddenly stopped drinking fluoridated water for a couple months before pregnancy, a part of a “non-fluoridated exposure group”. Grandjean answered “No”.

“The problem is that our skeleton is continuously broken down and rebuilt. And during the break down of tissue that happens all the time, everyday, fluoride is released into the body, maybe fluoride that was consumed years ago,” Dr. Grandjean told the court.

Grandjean further corroborated the concerns about fluoride and IQ, stating that, “When we merge all the findings, we can see that there is a tendency, the higher the fluoride exposure during fetal life, that is, from the mother’s exposure, the greater the loss in IQ at school age.” Grandjean also discussed the levels of fluoride increasing the further along a pregnancy, particularly by the 3rd trimester.

During Grandjean and other witnesses testimony much of the conversation focused on what is known as an “uncertainty factor”. The court heard from several witnesses that during a Hazard Assessment under the TSCA, the EPA will apply an “uncertainty factor” of ten. This means that if a hazard is found at a specific level, you multiple that by 10 in consideration of the most vulnerable, and at risk portions of the population. FAN attorney Connett has repeatedly hammered this point home to Judge Chen.

Grandjean was also asked about the Infancia y Medio Ambiente (Childhood and Environment, INMA) project that looked at children in the Basque area of Spain. This is the study by Jesus Ibarluzea which claimed fluoride increases IQ in boys. As previously reported, Dr. Ibarluzea has been found to have lied under oath according to emails obtained by FAN.

Dr. Grandjean made it clear that he believes the Ibarluzea study is “plain wrong” and “was lucky to get published”.”This study, I would not consider valid. I would not use it in a review of the literature,” Dr. Grandjean told the court.

The EPA’s cross examination was focused on impeaching the qualifications of Grandjean and his research. In one line of questioning, the EPA asked Grandjean about a Danish study on fluoride.

EPA: “You ran multiple different models on the Danish OCC study, correct?”.

Grandjean: “Yes.”

EPA: “Across all those models you ran you never found a statistically significant effect, correct?”

Grandjean: “I wouldn’t say never. Explains they ran multiple models and saw diverse results.”

EPA: “You would agree that the studies looking at the association between fluoride and neurological effects beyond IQ are less strong?”

Grandjean: “Yes.”

Corruption at Harvard and the WHO

Following his testimony, I asked Dr. Grandjean about statements he made in the 1st phase of this lawsuit in 2020 regarding threats made against him at Harvard, and the “fluoride lobby” exerting influence over the World Health Organization.

Grandjean told me that after he began researching fluoride and its impacts on IQ, members of the Harvard University staff became concerned.

“A professor from Harvard University came to my office and asked me to sign a statement that my work on fluoride had nothing to do with fluoridation. He actually wrote this draft,” Grandjean stated. “And since I didn’t sign this immediately, he instead went to my dean and had the dean sign a statement that he supported water fluoridation in accordance with the policy of the CDC.”

Grandjean would later be told by “the leadership at Harvard” that his research on fluoride was “unwanted” and had never been approved by Harvard.

“Because we couldn’t agree on my, what I would consider academic freedom, I left Harvard.”

Grandjean also discussed what he meant by the “fluoride lobby” influencing the WHO. He said he had been invited by the WHO to help develop a “environmental health criteria” document on fluoride. Once he began gathering data, including animal data and epidemiological studies, changes were made to his draft.

“They inserted changes in my draft indicating that fluoride could perhaps be toxic, but only at immense concentrations,” Grandjean said. “I protested and said that in accordance with the scientific documentation, it would be wrong to insert the word immense.”

“And so WHO published a document, without my name because I’d asked to have my name stricken, but then they inserted some other colleague’s name as the author of the draft, which is, of course, erroneous. But that was what WHO felt was necessary in order to protect the interests of water fluoridation.”

FAN Fourth Witness: Dr. Stanley Barone

Dr. Stanley Barone is a risk assessment scientist at the EPA, with the Office of Pollution Prevention and Toxics. Barone was brought in by the FAN to outline the nature of the EPA’s Hazard Assessment process under TSCA.

Interestingly, Barone’s testimony seemed focused on making FAN attorney Michael Connett’s work more difficult. Barone often provided long winded answers which appeared to confuse Judge Chen at points.

Connett asked Barone the specifics about what exactly the TSCA commands of the EPA, including whether the EPA must consider vulnerable populations (they must), and whether 100% certainty in the toxicity of a chemical is necessary (it’s not). Connett was attempting to illustrate to the court that the EPA has acted in the past on hazard risks even without 100% conclusive data.

In a somewhat heated back and forth, Connett attempted to get clarity from Barone regarding the process for risk determination under TSCA. Connett quoted Barone’s own words from his deposition, which Barone took exception to, claiming Connett was misrepresenting his previous statements.

FAN Fifth Witness: Dr. Brian Berridge

Brian Berridge, Ph.D., joined the NIH in January of 2018 as the Associate Director of the National Toxicology Program (NTP). Berridge has a history of employment with the National Institute of Occupational Safety & Health (NIOSH) and the FDA’s National Center for Toxicological Research (NCTR).

Berridge discussed his role at the NTP, specifically as it relates to the NTP’s monograph on fluoride’s potential neurotoxicity. Connett asked Berridge about the extensive review process undergone by the NTP report. Berridge confirmed the NTP report had undergone extensive peer review.

When Connett attempted to ask Berridge if he, as an NTP director, approved of the release of the NTP monograph being published, the EPA objected saying that Berridge was not supposed to testify about the publishing of the NTP report. Connett assured the court that he was only asking about Berridge’s experience as a scientific director and whether or not he believed the report was ready for publication. “It’s not about politics,” Connett told Judge Chen.

The EPA continued to object, but Judge Chen allowed the questioning so long as it didn’t get into the politics of why the NTP monograph was never published in its final form. This is because the plaintiffs came to an agreement with the court that they would not bring up the emails which detail a cover up of the NTP May 2022 report by officials within the CDC and HHS, including Assistant Secretary of Health Rachel Levine.

During the EPA’s cross examination of Dr. Berridge they focused on the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the NTP’s work. The EPA asked Berridge if it was true NASEM was “critical” of the review. Berridge took issue with the term critical, starting that NASEM didnt think the evidence was presented clearly.

However, Berridge added, this did not mean that NASEM didn’t agree with the conclusions of harm associated with water fluoridation. The EPA asked again if NASEM agreed with the NTP’s conclusions, to which Berridge said yes, but once again added that this doesn’t mean NASEM disagreed with the conclusion of harm.

FAN Sixth Witness: Dr. Kathleen Thiessen

The FAN’s final witness was Dr. Kathleen Thiessen, a risk assessment scientist with a PhD in genetics from the University of Tennessee – Oak Ridge. She has authored several reports on the health effects of environmental contaminants, including for the EPA. She is also the author of a large portion of the 2006 NRC review, and she also worked on the 2009 review.

Dr. Thiessen confirmed to the court that the 2006 NRC report described fluoride as a neurotoxicant chemical and an endocrine disruptor. “Neurotoxicity is a hazard of fluoride exposure, the evidence is abundant,” Dr. Thiessen testified.

Thiessen also emphasized that people who are consuming less than the recommended level of 0.7 milligrams per liter of water will still see similar effects even at the lower consumption levels.

The EPA was quick to attempt to impeach the credibility of Dr. Thiessen. The EPA read a statement from the NTP “State of Science” report which says that it remains “unclear” the association between fluoride exposure at the levels recommended by the WHO.

“Do you disagree with the NTP’s author’s statement about it being unclear?” the EPA asked. To which, Dr. Thiessen responded: “I don’t agree with the statement that it’s unclear. I don’t think it’s as unclear as they claim. Certainly we could always use more evidence, but it’s clear.”

The EPA would show Dr. Thiessen further examples of researchers not finding “statistically significant association” between fluoride exposure and lower IQ. Dr. Thiessen said there is enough data available, and that we shouldn’t “wait until we have more data when we know there is harm”. Judge Chen seemed to agree, stating that it seems like the studies in general, whether statistically significant or not, are “pointing in the same direction”.

The EPA grilled Dr. Thiessen about the data in the “low-dose range”, asking if she agreed there is a “lack of data.” Dr. Thiessen said it’s harder to see the effect, but doesn’t mean there is no effect.

Thiessen also received extensive questions about the usefulness of animal data in drawing conclusions about fluoride’s toxicity. She pushed back against the EPA’s attempts to dismiss the animal data, stating that, “to totally eliminate the animal studies for fluoride, which is a vast body of data, that goes into all kinds of animal studies on other toxins, psychology, and other areas. I don’t think that’s what (the researchers) intended.” “But, you agree that the NTP authors were not able to draw any conclusions based on the animal data on fluoride?”, the EPA asked. “I don’t think it was so much that they weren’t able to, but they chose not to.”

The Plaintiffs Rest Their Case, EPA’s First Witness: Dr. David Savitz

Following testimony from Dr. Thiessen, Michael Connett rested his case for the plaintiffs and the EPA began by calling their first witness, Dr. David Savitz. Dr. David Savitz is a Professor of Epidemiology with extensive experience at NASEM. Savitz was involved in the NASEM peer review of the NTP monograph on fluoride’s impact on neurodevelopment. The EPA is hoping Savitz will be able to put doubt in Judge Chen’s mind regarding the quality of the NTP’s May 2022 draft review.

Dr. Savitz was also a member of Health Canada on the “Health Effects of Fluoride in Drinking Water” in June 2023. Health Canada is the department of the Canadian government focused on health policy. Health Canada organized a team of scientists to study the impact of fluoride on human health, but ultimately decided not to publish the review. However, the journal Critical Reviews in Toxicology published the study this week. Savitz testified that the Health Canada expert panel focused on dental fluorosis rather than neurotoxic effects of fluoride because they believed it “was not yet appropriate” to make such judgements.

What’s next?

On Friday February 9th, court will resume with the EPA’s questioning of Dr. Savitz. The EPA is expected to call two more witnesses, including a prerecorded dialogue with Dr. Jesús Ibarluzea of the Infancia y Medio Ambiente (Childhood and Environment, INMA) project that looked at children in the Basque area of Spain. This is the study that claimed fluoride increases IQ in boys.

Stay tuned for additional interviews and reports from the final 3 days of the 2nd phase of the Fluoride lawsuit. Follow Derrick Broze on Twitter for live tweeting.

This article has been republished with permission from the author, Derrick Broze. It was originally published by The Last American Vagabond.

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