Thread by @DBrozeLiveFree

First recess is coming to an after Fluoride Action Network attorney Michael Connett wrapped up his opening statements. Resuming in a moment.

Here's the zoom link:

EPA has now begun their opening statement.cand.uscourts.gov/judges/chen-ed…

EPA arguing that the "dose is the poison". Says that FAN Connett selectively chose quotes from the NTP's study to make his points. Says we should look at the NTP's conclusions themselves.

EPA is quoting the NTP's May 2022 Monograph on IQ which said "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"

Remember, this is the NTP study that emails revealed behind the scenes was being stifled by the EPA and CDC.

EPA arguing that when water concentration was used (as opposed to urinary fluoride levels) there is no association between lower IQ in children.

Judge Chen and EPA going back and forth about where the EPA agrees with plaintiffs, and whether or not EPA agrees with the NTP monograph conclusions.

EPA is outlining several statement made by the NTP referring to “low confidence” in certain studies claiming an association between fluoride exposure and lower IQ in children.

EPA: If the court wishes, they can look no further than the NTP mo­nograph to see if the plaintiffs have met the criteria needed for TSCA to be applied.

EPA: the NTP wanted more studies and now we have more studies to reference. Outlinging the Element cohort, the Canadian MIREC study. EPA says MIREC showed significant adverse effect on boys, but not girls and not boys and girls combined.

EPA showing the INMA study from Spanish found no significant adverse effect for boys, girls, or combined.

EPA showing recent Danish Odense Child Cohort study from FAN's expert Dr. Grandjean also found no significant adverse effects on children.

EPA outlining that since 2017 there have been 4 cohort studies now and they claim the evidence does not support a significant adverse effect for fluoride exposure in children.

EPA's strategy seems to be to muddy the waters with recent studies to claim that there is not substantial evidence to confidently claim fluoride is a neurotoxin.

Judge asks for clarification of US Gov view. EPA attorney says there is evidence of fluoride harms at higher levels, but not at currently allowable levels set by the U.S. Gov.

EPA: Under TSCA the goal is to regulate toxins that are in commerce. EPA notes that most communities are fluoridating at . 7 mg/L, not at 1.5 or higher (which some of the studies have looked at).

Judge Chen says we still must consider the margin of error even if the levels of community water fluoridation is below the levels in some of the studies which found an association between fluoride and lower IQ.

Judge Chen: 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?

EPA is arguing that the FAN is using an unfair assessment of risk. Judge Chen: doesnt the fact that there are studies showing both ways, doesnt that infer that there is some level of risk?

EPA: In terms of communicating the results of the NTP monograph, that 1.5 mg/L is a useful statistic. But the literature that is looking at that closer to 1.5 mg dose is "Really not there".

EPA outlines their first witness Dr. David Savitz, professor of epidemiology at Brown U, Chaired 12+ NASEM Committees, and reviewed the NTP's monograph on fluoride and neurodevelopment.

EPA says he is the perfect expert witness bc the EPA has entrusted him to share their views.

EPA says Dr. Savitz will inform the Court that other recent studies on fluoride do not show an association between fluoride exposure and lower IQ in children.

EPA says 2nd witness will be Dr. Jesus Ibarluzea, first author of the INMA studies on low-dose fluoride exposure. He will testify that the studies found no association between low-dose fluoride exposure and adverse effects. He will argue that seafood is not a confounding factor.

EPA says Dr. Jesus Ibarluzea will outline that across all the studies looked at there was never a determination of fluoride causing lower IQ or ADHD.

EPA outlines final witness, Dr. Stanley Barone, Jr, EPA scientist for 30 years, worked extensively on TSCA.

EPA says Barone will point to open questions that the plaintiffs (FAN) have not explained.

EPA: For risk characterization we are using urine fluoride concentration, but how do we account for fluoride exposure from all sources?

Barone will explain why there is no real risk determination.

EPA: TSCA doesnt require that EPA consider a chemicals risk in the aggregate. Plaintiffs petitioned the EPA to see if .7 mg/L presents an unreasonable risk.

Judge retorts but shouldnt we consider the context? If we consider water fluoridation plus other exposures.

EPA is trying to argue that we cant know the difference between exposure via water fluoridation and other sources.

Judge Chen seems genuinely curious about why the court shouldnt consider the impact of all sources of exposure.

EPA: I dont have all the facts on hand for you, your honor, but I can tell you that we will present facts to counter the plaintiffs narrative.

EPA: Over the next 2 weeks, the EPA hopes to provide an unbiased accounting of fluoride exposure, with particular focus on studies from the last couple years. We wont spend our time dragging scientists through the mud...

Judge Chen interrupts to say, "but Dr. Barone (EPA Witness) does agree with the NTP conclusions?"

EPA confirms.

EPA: we should not judge the quality of studies based on their conclusions. The weight of a scientific study should be judged on the strength of its methods.

EPA says judge should only consider exposures to fluoride relevant to the U.S., not studies from other nations.

EPA: This court has an important decision to make. The question to this court is whether plaintiffs have presented evidence that .7 mg/L in community water fluoridation poses a neurotoxic harm.

EPA says plaintiffs cannot prove that.

FAN Connett calls first witness, Dr. Howard Hu, principal investigator in the Mexico ELEMENT study on fluoride on neurobehavioral development in the offspring.

FAN witness Dr. Howard Hu outlines his work on toxicity since the 1st phase of the #FluorideLawsuit in 2020. Hu has been working on lead toxicity and anti-social behavior.

FAN Connett asks if Hu is charging an expert fee for his appearance at the court. There appears to be some confusion, Hu says he will be filing an invoice for travel and time, but Connett asks again if he is charging an expert fee (presumably to the plaintiffs). EPA objects.

Dr. Hu explains his previous work and how the peer review process happened. Connett is illustrating how a typical peer review process takes place.

Connett asks Hu how he would compare the peer review process that your fluoride I study underwent with other studies you have published.

Hu: with over 320 peer reviewed papers, thats probably the most extensive peer review process I've experienced.

Dr. Hu says the EPA has incorporated his previous work on toxicity on lead. Connett asks how he would compare the EPA response to his studies on lead and fluoride. EPA objects for relevance, judge Chen over rules, allows Hu to answer.

Hu says when using an "apples to apples comparison" the toxicity of lead and fluoride are "not far apart".

Connett asks Hu whether or not he used a "linear model" when determining the risk of fluoride. The EPA has argued that there are no measurable levels of harm until 1.5 mg/ L or above, but Hu seems to argue the opposite.

Connett with respect to your analysis of the 6-12 year old children, what did you find?

Hu: We found an "inflection point" around .7 or .8.

Connett asks Hu to clarify in "laymans terms" what the connection between the dose-relationship is.

Hu says the levels of IQ harm seem to go downward as the levels of fluoride goes down.

Connett: just to be clear, Dr. Hu, what you just described was specific to the 6-12 year old group. Could you explain what you found with the 4 year old data.

Hu: We found a consistent linear relationship between the higher levels of fluoride and lower IQ.

Connett: At this time your honor, I would like to show the witness Exhibit 67, which is the NTP's monograph study.

As FAN gets the monograph ready, EPA interrupts to say that the witness was brought in to talk about his own studies, not the NTP's monograph. Judge allows FAN to proceed.

Connett reads a statement by the NTP which referenced Dr. Wu's previous work on pre-natal fluoride exposure. Connett asks if he agrees with the NTP's conclusions.

EPA objects, says when previously interviewed for deposition Hu said he had no reason to agree or disagree with NTP

Judge agrees with objection, Connett moves on.

Connett asks Hu about his more recent studies on fluoride exposure.

Hu said his more recent studies had a larger sample size, says from the epidemiological perspective this makes it easier to see "signals above the noise".

Hu explains the criteria for the study, excluded women who had premature babies, kidney dysfunction and other issues that could interfere with their ability to see the relationship between fluoride and pre-natal exposure.

Hu: I believe we have one of the best cohort methodologies in the world. "we feel quite confident to control for cofounders".

Hu: Its not just the fact that we excluded some folks with comorbidities but we couldnt control for folks who might have other factors that could make them more susceptible. We didnt have the means to disentangle if there were some populations of vulnerable people.

Connett asks Hu to explain the findings of his second study on fluoride exposure with pregnant mothers.

Connett: I want to start with the first finding of your study, you were able to observe the effect of fluoride exposure at the different ages.

Hu: this bolsters the confidence of the underlying biological relationship between fluoride exposure and cognition.

Connett: is there in any info as to why fluoride and lead may affect non-verbal IQ abilities more than verbal?

Hu: the leading theory is that verbal abilities are able to be corrected via education, parenting, verbal coaching. Whereas non verbal are not as amenable to education.

Hu: some of the impacts of lead on IQ appear to be less amenable to improving for low income people, this could be because of less access to some of the resources available to other children.

Connett asks Hu if his papers controlled for seafood consumption.

Hu says they did not largely bc seafood consumption in Mexico is lower.

Connett asks if seafood contains elevated levels of fluoride, Hu says yes.

Connett asks Hu if seafood should be considered. EPA objects, says not relevant to Hu's testimony/studies. Judge over rules.

Hu says the fact that seafood contains fluoride and Omega 3 fatty acids its important to control. He discusses studies on mercury and how not controlling for seafood can produce a different outcome.

Dr. Howard Hu: "if we control for seafood and there was substantial seafood consumption, than our assumption is that there will be even greater exposure to fluoride".

Hu: if populations are consuming less seafood there is less of a reason to control for seafood as a potential source of fluoride exposure.

Connett asks if the results of studies which found different associations for boys and girls can both be true, and if so, how?

Hu: says yes, bc of different populations, life experiences, etc. Things like gender differences in diet, hormones etc can produce different results.

Connett: would you expect a neurotoxicant, like fluoride, could have different impact on populations?

Hu: yes. We havent 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.

Connett asks Hu to explain how a "well nourished" mother could produce an infant with different outcomes than a mother who isnt?

Hu: yes, your socioeconomic status will determine if you have access to the latest information on health, and can afford to buy healthier products.

Connett: was your study, the Goodman study, published in time to be considered for the NTP monograph?

Hu: no.

Connett confirms that Hu's Goodman study used urinary fluoride exposure to determine potential harm. Connett asks Hu to explain the benefits of using urinary levels as a determinant compared to other methods.

Connett asks Hu about some of the limitations of his studies, including not having access to urinary fluoride levels across all 3 trimesters.

Hu: it means we dont really know the full levels of exposure throughout the pregnancy.

Hu: this means you introduce "noise" that can make it harder to determine outcomes. You're less likely to see a relationship with noise but if there is one the magnitude is decreased.

Connett: the more noise you have the harder it is to hear the signal?

Hu: Correct.

Connett: Are you aware of the impact that adjusting creatinine had on studying fluoride exposure?

Hu: says when you remove adjusting for creatinine all the associations of fluoride harm disappeared.

Connett aks Hu if he has seen anything similar with lead.

Connett moves on to asking Dr. Hu about the Spanish study. Do you have any understanding about the seafood consumption for coastal Spain?

Hu says consumption is high and the Spanish study should have controlled for high seafood consumption.

Hu: If you dont control for seafood consumption you are unable to see the harms caused by fluoride because of the Omega 3s

Connett moves to asking Hu about the Danish cohort study. Can you explain what you did with the pooled analysis vs the separate analysis?

Hu says the pooling was bc the investigators decided to collaborate and do their best to control for confounders.

Connett: would you say a pooled analysis is a more robust analysis than a single sample?

Hu: I think so bc it assumes that the research you are pooling is more rigorous.

Connett asks which he would give more weight - individual studies or the pooled analysis.

Hu says pooled.

Connett: is it harder to detect the effects of a chemical when you are investigating a population with lower exposure?

Hu: with lower exposure, statistically its harder to tease out the ultimate impact of that exposure. He says the Danish ODENSE was less accurate for this reason

Connett: Does the history of lead offer anything to the benefits of having lower and higher exposures to compare?

Hu: Yes, when the EPA regulations first came about we didnt have a range of dose exposures to compare. We now do and that allows for more clarity on impact.

Connett: The EPA says more recent studies contradict the Canadian and Mexico studies. Do you agree with that assessment?

Hu: there are more factors we should consider, rather than a black and white view of whether or not one study is significant and another is not.

Connett: Would you consider the findings from Denmark, with lower exposures, to be inconsistent or contradictory to your findings?

Hu: I would just say they didnt find the same thing.

Connett asks Hu to tell Judge Chen about the cohort study on fluoride he is currently working on.

Hu explains his study is focused on latino, Los Angeles residents, intended to understand the environmental impacts, and to measure behavioral outcomes.

Connett: LA County is an area which adds fluoride to the water. about how many pregnant women were included in your recently published study?

Hu: somewhere above 200.

Connett: you mentioned that the majority of participants are hispanic.

Is there data to indicate that hispanic communities have a greater distrust of tap water?

Hu: yes. some of these folks do not trust the tap water.

Connett introduces Exhibit 1 regarding the MADRES cohort study Dr. Hu participated in.

Connett asks Hu to explain what his study showed.

Hu says his data shows fluoride levels increasing in the 3rd trimester of pregnancy. Hu says its reminiscent of what we saw with lead.

side note: court liason walks around to remind everyone to keep their masks on and above their nose...

Judge Chen asks Hu to explain further his data on fluoride exposure throughout pregnancy and the increase in fluoride in the 3rd trimester.

Hu: We believe this explains the spike in fluoride levels in the their trimester (as the mothers body transfers calcium to baby).

Connett shows Hu graph comparing the Canada MIREC cohort and Hu's more recent MADRES cohort study from the U.S. Both indicate higher levels of fluoride within the urine of pregnant mothers in the 3rd trimsters.

Connett: Dr. Hu you mentioned that you have completed a cohort study on... EPA objects, says study hasnt been approved by court. Connett withdraws the question. Says he is not getting into the content of the study. Connett asks Hu if the study is completed & submitted for review.

Connett says no more questions for Dr. Hu. EPA to begin questioning Dr. Hu after a 15 minute recess.

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