Day 6 of the 2nd Phase of the #FluorideLawsuit is beginning.
FAN Michael Connett starts by telling Judge Chen that a brand new study was published from Health Canada regarding fluoride and IQ. This study is relevant to the discussion yesterday in terms of calculating total intake of fluoride.
Connett says one of the EPA's expert witness, Dr. Savitz, was an advisor on the Health Canada study, but not able to talk about it during deposition. Connett raises this with the court, he would like to ask Dr. Savitz about this & he thinks the court may want it in evidence.
EPA is responding about the study and their concerns about bringing it into evidence. Says Connett misrepresented the study's details.
EPA continues to say Connett is misrepresenting the study. EPA says if there is anything that should be submitted it should be the final conclusions by Health Canada. EPA objects to the document Connett wants to submit.
Connett says he would have no objection with the EPA's preferred doc be submitted so long as Connett's preferred doc is also part of the record.
This will be in play during EPA's expert witness Dr Savitz, Ph.D., who Chaired NASEM’s committee that peer reviewed the NTP’s systematic review, who is likely to start testifying today.
Judge Chen is going to allow both documents - one preferred by FAN, and one preferred by EPA - to be submitted into evidence.
FAN is asking for another 1.5 hours from Judge Chen because they feel like their time has been used up by Judge Chen in questioning, EPA objects says FAN didnt need to give an 1.5 hour opening or call Dr. Berridge as a witness etc.
Judge Chen will grant them an extra hour.
Judge Chen is admonishing the attorneys that he doesnt need a "bunch of stuff repeated, 'Perry Mason' dramatics", etc, Asking attorneys to use their time wisely.
EPA resumes their cross examination of FAN expert witness Dr. Kathleen Thiessen.
EPA is showing Dr. Thiessen court exhibits again, making their point that at some levels the study in question found that exposure to water fluoridation did not show a statistically significant change.
EPA: if you look at the column for all data you see again that its not statistically significant, correct?
Thiessen: the overall conclusion of the meta-analysis is that fluoride exposure is consistent with lower IQ. That's at the end of the abstract at the meta-analysis.
Judge Chen: how is it that you could have statistically significant effects at a higher level and then not at a lower level?
Thiessen offers an explanation. Judge Chen offers some ideas about how this could happen as well. Thiessen agrees with his assessment. EPA continues...
EPA showing various amounts of fluoride intake /L and has Thiessen answer whether or not they found a statistically significant effect for each amount.
EPA pointing Dr. Thiessen to measurements within the NTP monograph asking her to confirm data which he believes make it clear that fluoride exposure at levels recommended by the CDC are safe.
EPA is asking Dr. Thiessen to look at a column looking at each of the models the researchers considered, asks her if its true that in this particular figure, the researchers did not find any statistically significant impact. Thiessen confirms.
Judge Chen asks for an explanation of what these two different methodologies the EPA is going over mean in plain english.
Dr. Thiessen says she is not an expert in those methodologies, but she says the bigger picture is that there is a significant association showing lower IQ.
Judge Chen asks if this means the studies in general, whether statistically significant or not, these studies are "pointing in the same direction".
Dr. Thiessen made a statement about there only being a few studies looking at lower dose exposure to fluoride, EPA attorney seizes on that and asks if that means there's not enough data available, attempting to create doubt in the evidence.
Dr. Thiessen says there is enough data and that we shouldn't wait until we have more data when we know there is harm.
EPA restates, "so you would agree there is a lack of data in the low-dose range?"
Thiessen: it's harder to see the effect, doesnt mean there is no effect.
Dr. Thiessen: "there's uncertainty in the analysis, there's uncertainty in those who try to fit the data to curves."
EPA reads statement from NTP authors that says more dose-response data for the lower levels is needed. Thiessen agrees.
Judge Chen: so low-dose data is based on the WHO recommendation?
Thiessen: not necessarily, this is dependent on each study and doses they are looking at.
Thiessen: when they talk about low or high dose in the NTP study they are speaking relevant to the specific studies they are looking at.
Judge Chen and Dr. Thiessen are going back and forth about the terms low dose and high dose, and how to weigh the evidence that is termed "statistically significant" vs not.
Thiessen says the EPA has been asking her about the "least definitive analyses", but there are better ones. Judge Chen ends questioning.
EPA continues cross...
EPA asking Thiessen about the various models used, and getting her to confirm that the models appeared not to show a statistically significant association.
Judge Chen asking questions to Dr. Thiessen.
She repeats that there is a consistent association of fluoride exposure and lower IQ in different models, even if not "statistically significant". Some models fit better than others she says.
Dr. Thiessen says the linear model is a good fit, but the quadratic model less so.
Judge Chen is asking more questions of Dr. Thiessen, passes it back to the EPA for further cross.
EPA wants to talk about the experimental animal and mechanistic studies. "The NTP authors conclude that these studies do not provide clarity, correct?"
EPA pulls up a slide to show Thiessen a specific statement from the NTP May 2022 draft report.
EPA reads from the abstract, under "results". Quotes from NTP.
Thiessen says the NTP haven't given enough weight to other animal studies that exist. "Some of the uncertainty comes in how the animal results compare to IQ in humans, since we dont have IQ tests for rats".
Thiessen: "To totally eliminate the animal studies for fluoride, which is a vast body of data, that calls into all kinds of animal studies on other toxins, psychology, and other areas. I dont think that's what they intended."
EPA: but you agree that the NTP authors were not able to draw any conclusions based on the animal data on fluoride?
Thiessen: I dont think it was so much that they weren't able to, but they chose not to.
EPA: I want to talk about McPherson, 2018, thats a study that NTP researchers conducted on rats, correct?
EPA pulls up the NTP May 2022 draft monograph. Reads a statement:
"although there are too few studies for observing effects on animal, McPherson did not observe an impact between fluoride exposure and cognitive function" (summarizing)
EPA asking Dr. Thiessen if this study observed histological changes (Something she was discussing yesterday in her testimony).
The researchers wrote that they did not.
Thiessen argues that the "long-evans" rat is known not to show a response to fluoride and thus its not a good rat to use when studying fluoride.
EPA going over particulars about Margin of Exposure, Benchmark etc with Dr. Thiessen.
EPA points to Dr. Thiessen's "3rd Supplemental report" and says she did not do a "margin of exposure analysis", correct?
Thiessen: those are examples of what a MOE analysis is.
EPA calls for pulling up Thiessen's deposition.
EPA: Dr. Thiessen you conducted a MOE analysis for human data, you would have had to create a point of departure that could be used for a MOE analysis, but you didn't?
Thiessen offers a qualified yes and explains her work.
EPA repeats the question.
Connett objects and says this isnt going anywhere.
Judge Chen says this isn't help, says he understands what she is saying, and what EPA is saying, "let's move on."
EPA now going over Thiessen's 3rd supplemental report on the NTP's data on fluoride exposure and association with lower IQ.
EPA points to table 4 of her report.
EPA showing her a figure from her table in her report and attempting to pin her down to say that the NTP report represents a lowest-observed-adverse-effect level (LOAEL).
She clarifies her reasoning.
EPA points to a row in the table about Dr. Grandjean's 2020 study.
Sorry, had to step away for a moment. Back at it.
EPA: The values you listed in the Table 4, cannot be used mathematically to calculate a point of departure (POD) for a MOE, is that right?
Thiessen: that is not correct. It is certainly reasonable, and scientifically defenseable, whether or not its EPA's regular practice.
EPA: I want to focus on Dr. Grandjean's BMCL that you used in your report.
Judge Chen: before we go on to Dr. Grandjean, I have a couple questions.
Thiessen explains the process for calculating urinary fluoride, fluoride concentration in the water, and Judge Chen is asking the benefits of measuring concentration vs the various subsets of the population, weight etc.
Dr. Thiessen is talking with Judge Chen still. Having a quite extensive conversation that is eating up the EPA's cross examination.
Some people have asked me my thoughts on how the trial is going. One thought:
Judge Chen seems genuinely interested in getting the science right. He is not simply siding with the govt, and often shuts them down. I think he is about as neutral as you can get and that's good.
Judge Chen has spent several moments asking Dr. Thiessen about the benefits of focusing on broader data vs only looking at the concentration level of fluoride.
Judge Chen finishes and calls for 1st break.
Will return shortly.
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Day 6 of the 2nd phase of the #FluorideLawsuit resumes for the final session of the day with EPA expert witness Dr. David Savitz.
EPA: Dr. Savitz what is your assessment of what this conclusion from the systematic review means?
Savitz: the recommendation from them, was to focus on moderate dental fluorosis based on the research that is available at the time.
EPA: is this consistent with the Health Canada expert panel concluded?
Savitz: I believe so. We reached the judgement that it was not yet appropriate or ready to be used in a manner to judge neurotoxic effects so instead focus on dental fluorosis as the POD.
The final session of Day 5 of the 3nd Phase of the #FluorideLawsuit begins with the EPA cross examining witness Dr. Kathleen Thiessen.
EPA: let's start by talking about the NTP's monograph and the "moderate confidence" in their finding that higher fluoride exposure is associated with lower IQ in children.
EPA says this mention of "higher fluoride exposure" was based on amounts higher than the WHO's guideline.
EPA: you believe that the animal studies support your view that the NTP authors could have been more confident? Thiessen affirms.
EPA: in your view, there's no scientific reason that the NTP's moderate confidence shouldnt be higher? Thiessen affirms.