Sat Mar 23, 2024 11:33 pm by globalturbo
Report on Fluoride and Neurotoxicity Moves Closer to Final Publication
Pro-fluoride lobbyists and regulatory agencies for several years have tried to “weaken, delay, or kill” the National Toxicology Program’s draft report, which concluded high exposure to fluoride can reduce IQ in children.
By
Brenda Baletti, Ph.D.
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The National Toxicology Program’s (NTP) draft report concluding high exposure to fluoride can reduce IQ in children last week took one more tentative step toward final publication when the NTP’s Board of Scientific Counselors (BSC) met and voted unanimously to accept its working group’s recommendations on the report.
The BSC is an external committee whose members are appointed by the Secretary of Health and Human Services to advise the NTP. The working group was charged with evaluating the NTP’s response to external peer review and federal agency comments.
The committee members recommended only minor changes to the report.
The BSC working group review may be the final hurdle for this report, which the pro-fluoridation lobby and different actors within the U.S. Department of Health and Human Services (HHS) have tried for several years to water down or suppress.
The NTP — which operates under the HHS’ National Institute of Environmental Health Sciences (NIEHS) and is charged with researching and reporting on environmental toxins — conducted a six-year systematic review to assess scientific studies on fluoride exposure and potential neurodevelopmental and cognitive health effects in humans.
The NTP’s report on fluoride neurotoxicity included a monograph and a meta-analysis of existing studies on fluoride’s neurotoxic effects. The monograph concluded that “higher fluoride exposure is consistently associated with lower IQ in children.’”
The meta-analysis similarly concluded, “The consistency of the data supports an inverse association between fluoride exposure and children’s IQ.”
The NIEHS researchers found more than 50 human studies consistently showing reduced IQ with higher fluoride exposure. Those studies come from across the world, with the most recent funded by the National Institutes of Health in Canada and Mexico.
The findings indicate that fluoride is therefore “presumed to be a cognitive neurodevelopmental hazard to humans.”
The report also is a key document in the ongoing lawsuit filed by Food and Water Watch, the Fluoride Action Network, Moms Against Fluoridation and private individuals against the U.S. Environmental Protection Agency (EPA) seeking to end water fluoridation.
The report was subjected to two rounds of peer review by the National Academies of Science, Engineering, and Medicine (NASEM), another separate expert peer-review process and comments from various officials at the Centers for Disease Control and Prevention (CDC) and the National Institute of Dental and Craniofacial Research (NIDCR).
It was then submitted for another round of review by NTP’s BSC working group to assess whether the NTP sufficiently responded to agency criticism.
The plaintiffs hope the report will be published in final, rather than draft, form prior to the next phase of the trial in January 2024.
No further reviews are scheduled, but neither the BSC nor the NTP director, Richard Woychik, Ph.D., specified the final steps toward report publication at the meeting.
Woychik did not respond to The Defender’s request for comment.
Plaintiffs ‘encouraged’ by BSC’s comments
The BSC working group agreed with most of NTP’s response to reviewers and its chair, David L. Eaton, Ph.D., said that “Overall, the NTP did a very good job.”
The group added that NTP authors could “strengthen the veracity and clarity” of some statements.
Suggested revisions focused on minor issues such as term clarification, bringing the time frame of science analyzed by the monograph and meta-analysis into alignment, and more extensive discussion of any data inconsistencies across the different studies evaluated.
But the meeting also revealed BSC’s own error. In its report, the BSC interpreted an IQ reduction of half a standard deviation to mean half of an IQ point — when in fact half a standard deviation is approximately 7 IQ points. The group voted to correct the error.
Several BSC members stressed the importance of finalizing the report and moving it to final publication. They raised concerns that the literature review would become outdated if not published soon, especially given that new meta-analyses had been published.
BSC working group asked the BSC to include comments on more recent meta-analyses in its final report.
Rick North, former executive vice president of the American Cancer Society’s Oregon Division and Fluoride Action Network board member, told The Defender he was “encouraged” by the BSC’s response to the report, particularly the BSC’s expressed interest in moving toward publication.
“What I’ve seen [thus far] is the strategy of the fluoridation promoters has been to either one, weaken the NTP statement, or two delay it, or three kill it. That I see as the three-fold strategy of the fluoridation promoters because this all ties into the lawsuit.
“The lawsuit is the 800-pound elephant in the room.
“The judge has said that he is looking to the NTP report for a big part of his decision.”
Michael Connett, lawyer for the plaintiffs in the case against the EPA, also told The Defender, “I was pleased with how it went. I appreciated hearing the BSC talking about the timeliness piece here, and that the NTP really needs to move forward and get this done.”
The 800-pound elephant
The environmental groups sued the EPA after the agency denied their 2016 petition to end water fluoridation based on evidence of health risks associated with fluoride, namely neurotoxicity.
The plaintiffs argued that water fluoridation violates the EPA’s Toxic Substances Control Act and that fluoride is neurotoxic and lowers children’s IQ.
The NTP had separately initiated its investigation into fluoride’s neurotoxicity in 2016 given widespread exposure to fluoride, the growing body of scientific research linking fluoride to neurodevelopmental problems and its own meta-analysis and animal study linking neurotoxicity to fluoride exposure in animals.
Since the first phase of the trial in 2020, U.S. District Judge Edward Chen has been waiting for the systematic review to be finished in order to rule in the case.
The report was held up through an unprecedented number of external reviews and finally was set to be released in final form on May 18, 2022.
But just a few days before it was due to be published, HHS blocked its publication, according to internal emails between the CDC and HHS released in response to a Freedom of Information Act (FOIA) request by the plaintiffs.
The emails revealed that although the NTP scientists considered the report to be finalized, Assistant Secretary of Health Rachel Levine did not want the NTP report to become public and so put a hold on its publication.
In January 2023, Judge Chen rejected the EPA’s request to further delay the case and ordered the NTP report be released in draft form as it continues the review process so the case can move forward.
The NTP posted the report in draft form on its website in March.
Judge Chen, the plaintiffs and the defendants during an April 11 hearing then agreed that the next phase of the trial — which began in 2020 — will start on Jan. 29, 2024.
The second phase of the trial is set to last one to two weeks.
On April 11, Connett informed Judge Chen that he intended to depose more witnesses from the CDC, the office of the Assistant Secretary of Health and the NTP to expose why the HHS blocked the release of the document.
Connett said the plaintiffs sought to “understand why that report, which was considered complete and final by NTP scientists, was not allowed to be published.”
But Judge Chen said that given that the draft report had been released, he didn’t see merit in further investigating the motives behind the release. He said that it was “the science” regarding fluoride’s neurotoxicity, rather than the politics behind the case.
“To me, the science is more important than whether politicians got involved to try to squash the report,” Chen stated.
“It’s reasonable to say, ‘let’s focus on the science,’” Connett told The Defender, “but the science here has been influenced by politics and it is difficult to separate the two.”
He added:
“The political pressures on the NTP did not begin last year when the HHS quashed the report. It began years ago when the CDC and the NIDCR began pushing the NTP to change the wording here and there.
“It has been sort of a continuing process where these agencies have sought to influence the language in the report to make the report more compliant with water fluoridation.”
Separating the politics and the science?
Several former agency officials who worked on the report raised concerns about the effect of politics on “the science.”
The number of reviews the report was subjected to is “unprecedented” for an NTP report, according to several former state officials who offered public comment at the BSC working group hearing.
Former EPA Senior Scientist J. William Hirzy, Ph.D., told the BSC working group, “I am unaware of any other NTP toxicology monograph to be put through five rounds of peer review, including one involving ‘interested agencies,’ before final release.”
He added:
“The National Toxicology Program’s five-round peer review of its fluoride monograph that includes ‘interested agencies’ is today’s classic example of attempts to defang scientific integrity.
“NTP’s statement in 2019 that ‘fluoride is presumed to present a neurotoxic hazard,’ was bound to fall victim to ‘interested agencies’ review, even though passing muster with NTP scientists and outside peer review.
“So, my take on the whole NTP review process at issue today is, if the political establishment disagrees with a peer-reviewed scientific decision made by qualified scientists, keep on reviewing until the politicians are satisfied.”
In his statements to the BSC, Connett read an excerpt of an email obtained through FOIA written by then-Scientific Director of the NTP, Brian Berridge, DVM, Ph.D., who wrote that there was an ongoing attempt to modify the report to satisfy interested actors.
He wrote, “After 17 years in industry, I’ve seen efforts to modify messages to fit commercial interests. I wasn’t party to that there and I’m not game to do that here.”
Berridge also submitted his own remarks. He said as former scientific director of the NTP, he could speak to the care, scientific rigor, balanced representation and clear communication of the work.
“The inordinate and unprecedented challenge and review that have been applied to these products have, in my opinion, been obstructive,” Berridge said, and not consistent with the White House Office of Science and Technology Policy’s policy that aims to protect the integrity and independence of science.
Such delays impact public health, he said, commenting:
“We’ve known for over a decade that we needed more data to better understand the potential for harm to those who are exposed to levels of fluoride most common in the United States. It is regrettable that we haven’t put the effort into generating the data that would have better informed these analyses for those citizens.
“Rather than continuing to challenge this work, the public health policy and research communities should focus on how best to communicate the certainties and uncertainties of this data, inform concerned citizens about possible responses and conduct the studies that would support more certainty. This past year would have been better spent doing those things.”
Former NTP director Linda Birnbaum, Ph.D., didn’t comment at the meeting, but she had previously stated her concerns in a court declaration:
“I am concerned by the recent course of events with the fluoride monograph. The decision to set aside the results of an external peer review process based on concerns expressed by agencies with strong policy interests on fluoride suggest the presence of political interference in what should be a strictly scientific endeavor.”
Representatives from the American Dental Association (ADA) and the American Association for Dental, Oral, and Craniofacial Research (AADOCR) submitted comments challenging the NTP’s findings, calling for an updated meta-analysis, and urging for further review by NASEM, which AADOCR called “the gold standard of independent, nonpartisan, evidence-based advice.”
But emails obtained via FOIA by the plaintiffs reveal the ADA privately hoped to influence the “independent” NASEM.
In one string of emails, several pro-fluoride groups discussed coordinating writing a letter asking the NIEHS to change the way the NTP reports findings were presented on the website.
Tooka Zokaie, MPH, then-manager of Fluoridation and Preventive Health Activities at the ADA, wrote to the group, “I hope to have more updates from Bob Burns after speaking with NASEM directly about the current misuse of the draft Monograph and misleading representations of its status on the website.”
Robert “Bob” Burns is a lobbyist for the ADA.
Earlier this year The New York Times also raised questions about NASEM’s independence, reporting that at the same time NASEM helped shape the federal government’s response to the opioid crisis, it accepted millions of dollars in donations from the Sackler family — owners of Purdue Pharma, the producers of OxyContin.
Commenting on the influence FOIA documents revealed such agencies have on the report Connett told the BSC:
“The FOIA documents show that pressure on the NTP is coming from agencies with very strong partisan interests on fluoride, including the CDC’s Division of Oral Health and NIDCR (National Institute of Dental and Craniofacial Research).
“These agencies have been working hand in glove with private lobbyists and PR professionals to smear and discredit the NTPs work at almost every turn.”
The ADA and public health agencies have endorsed water fluoridation since 1950.
Critics from places like the Fluoride Action Network pointed out that these agencies will suffer serious reputational damage if it were to become generally accepted that fluoride — which they have always maintained was “safe and effective” — is causing neurotoxicity.
The faith the public has in these institutions, North told The Defender, has been one of the major challenges in raising awareness about the dangers of fluoride.
He said:
“In the past, the ones who have been responsible for cover-ups about environmental toxins have been industry — Monsanto, the tobacco industry, the lead industry — but in this case it’s the federal government, it’s the medical establishment — the American Dental Association, the CDC, the American Academy of Pediatrics — they are the ones who are pushing it.
“These are institutions that people trust, so it is a much bigger hurdle to let people know that their trust has been betrayed.”
THANKS TO: https://childrenshealthdefense.org/defender/report-fluoride-neurotoxicity-closer-final-publication/?utm_source=luminate&utm_medium=email&utm_campaign=defender&utm_id=20230509
Pro-fluoride lobbyists and regulatory agencies for several years have tried to “weaken, delay, or kill” the National Toxicology Program’s draft report, which concluded high exposure to fluoride can reduce IQ in children.
By
Brenda Baletti, Ph.D.
Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
The National Toxicology Program’s (NTP) draft report concluding high exposure to fluoride can reduce IQ in children last week took one more tentative step toward final publication when the NTP’s Board of Scientific Counselors (BSC) met and voted unanimously to accept its working group’s recommendations on the report.
The BSC is an external committee whose members are appointed by the Secretary of Health and Human Services to advise the NTP. The working group was charged with evaluating the NTP’s response to external peer review and federal agency comments.
The committee members recommended only minor changes to the report.
The BSC working group review may be the final hurdle for this report, which the pro-fluoridation lobby and different actors within the U.S. Department of Health and Human Services (HHS) have tried for several years to water down or suppress.
The NTP — which operates under the HHS’ National Institute of Environmental Health Sciences (NIEHS) and is charged with researching and reporting on environmental toxins — conducted a six-year systematic review to assess scientific studies on fluoride exposure and potential neurodevelopmental and cognitive health effects in humans.
The NTP’s report on fluoride neurotoxicity included a monograph and a meta-analysis of existing studies on fluoride’s neurotoxic effects. The monograph concluded that “higher fluoride exposure is consistently associated with lower IQ in children.’”
The meta-analysis similarly concluded, “The consistency of the data supports an inverse association between fluoride exposure and children’s IQ.”
The NIEHS researchers found more than 50 human studies consistently showing reduced IQ with higher fluoride exposure. Those studies come from across the world, with the most recent funded by the National Institutes of Health in Canada and Mexico.
The findings indicate that fluoride is therefore “presumed to be a cognitive neurodevelopmental hazard to humans.”
The report also is a key document in the ongoing lawsuit filed by Food and Water Watch, the Fluoride Action Network, Moms Against Fluoridation and private individuals against the U.S. Environmental Protection Agency (EPA) seeking to end water fluoridation.
The report was subjected to two rounds of peer review by the National Academies of Science, Engineering, and Medicine (NASEM), another separate expert peer-review process and comments from various officials at the Centers for Disease Control and Prevention (CDC) and the National Institute of Dental and Craniofacial Research (NIDCR).
It was then submitted for another round of review by NTP’s BSC working group to assess whether the NTP sufficiently responded to agency criticism.
The plaintiffs hope the report will be published in final, rather than draft, form prior to the next phase of the trial in January 2024.
No further reviews are scheduled, but neither the BSC nor the NTP director, Richard Woychik, Ph.D., specified the final steps toward report publication at the meeting.
Woychik did not respond to The Defender’s request for comment.
Plaintiffs ‘encouraged’ by BSC’s comments
The BSC working group agreed with most of NTP’s response to reviewers and its chair, David L. Eaton, Ph.D., said that “Overall, the NTP did a very good job.”
The group added that NTP authors could “strengthen the veracity and clarity” of some statements.
Suggested revisions focused on minor issues such as term clarification, bringing the time frame of science analyzed by the monograph and meta-analysis into alignment, and more extensive discussion of any data inconsistencies across the different studies evaluated.
But the meeting also revealed BSC’s own error. In its report, the BSC interpreted an IQ reduction of half a standard deviation to mean half of an IQ point — when in fact half a standard deviation is approximately 7 IQ points. The group voted to correct the error.
Several BSC members stressed the importance of finalizing the report and moving it to final publication. They raised concerns that the literature review would become outdated if not published soon, especially given that new meta-analyses had been published.
BSC working group asked the BSC to include comments on more recent meta-analyses in its final report.
Rick North, former executive vice president of the American Cancer Society’s Oregon Division and Fluoride Action Network board member, told The Defender he was “encouraged” by the BSC’s response to the report, particularly the BSC’s expressed interest in moving toward publication.
“What I’ve seen [thus far] is the strategy of the fluoridation promoters has been to either one, weaken the NTP statement, or two delay it, or three kill it. That I see as the three-fold strategy of the fluoridation promoters because this all ties into the lawsuit.
“The lawsuit is the 800-pound elephant in the room.
“The judge has said that he is looking to the NTP report for a big part of his decision.”
Michael Connett, lawyer for the plaintiffs in the case against the EPA, also told The Defender, “I was pleased with how it went. I appreciated hearing the BSC talking about the timeliness piece here, and that the NTP really needs to move forward and get this done.”
The 800-pound elephant
The environmental groups sued the EPA after the agency denied their 2016 petition to end water fluoridation based on evidence of health risks associated with fluoride, namely neurotoxicity.
The plaintiffs argued that water fluoridation violates the EPA’s Toxic Substances Control Act and that fluoride is neurotoxic and lowers children’s IQ.
The NTP had separately initiated its investigation into fluoride’s neurotoxicity in 2016 given widespread exposure to fluoride, the growing body of scientific research linking fluoride to neurodevelopmental problems and its own meta-analysis and animal study linking neurotoxicity to fluoride exposure in animals.
Since the first phase of the trial in 2020, U.S. District Judge Edward Chen has been waiting for the systematic review to be finished in order to rule in the case.
The report was held up through an unprecedented number of external reviews and finally was set to be released in final form on May 18, 2022.
But just a few days before it was due to be published, HHS blocked its publication, according to internal emails between the CDC and HHS released in response to a Freedom of Information Act (FOIA) request by the plaintiffs.
The emails revealed that although the NTP scientists considered the report to be finalized, Assistant Secretary of Health Rachel Levine did not want the NTP report to become public and so put a hold on its publication.
In January 2023, Judge Chen rejected the EPA’s request to further delay the case and ordered the NTP report be released in draft form as it continues the review process so the case can move forward.
The NTP posted the report in draft form on its website in March.
Judge Chen, the plaintiffs and the defendants during an April 11 hearing then agreed that the next phase of the trial — which began in 2020 — will start on Jan. 29, 2024.
The second phase of the trial is set to last one to two weeks.
On April 11, Connett informed Judge Chen that he intended to depose more witnesses from the CDC, the office of the Assistant Secretary of Health and the NTP to expose why the HHS blocked the release of the document.
Connett said the plaintiffs sought to “understand why that report, which was considered complete and final by NTP scientists, was not allowed to be published.”
But Judge Chen said that given that the draft report had been released, he didn’t see merit in further investigating the motives behind the release. He said that it was “the science” regarding fluoride’s neurotoxicity, rather than the politics behind the case.
“To me, the science is more important than whether politicians got involved to try to squash the report,” Chen stated.
“It’s reasonable to say, ‘let’s focus on the science,’” Connett told The Defender, “but the science here has been influenced by politics and it is difficult to separate the two.”
He added:
“The political pressures on the NTP did not begin last year when the HHS quashed the report. It began years ago when the CDC and the NIDCR began pushing the NTP to change the wording here and there.
“It has been sort of a continuing process where these agencies have sought to influence the language in the report to make the report more compliant with water fluoridation.”
Separating the politics and the science?
Several former agency officials who worked on the report raised concerns about the effect of politics on “the science.”
The number of reviews the report was subjected to is “unprecedented” for an NTP report, according to several former state officials who offered public comment at the BSC working group hearing.
Former EPA Senior Scientist J. William Hirzy, Ph.D., told the BSC working group, “I am unaware of any other NTP toxicology monograph to be put through five rounds of peer review, including one involving ‘interested agencies,’ before final release.”
He added:
“The National Toxicology Program’s five-round peer review of its fluoride monograph that includes ‘interested agencies’ is today’s classic example of attempts to defang scientific integrity.
“NTP’s statement in 2019 that ‘fluoride is presumed to present a neurotoxic hazard,’ was bound to fall victim to ‘interested agencies’ review, even though passing muster with NTP scientists and outside peer review.
“So, my take on the whole NTP review process at issue today is, if the political establishment disagrees with a peer-reviewed scientific decision made by qualified scientists, keep on reviewing until the politicians are satisfied.”
In his statements to the BSC, Connett read an excerpt of an email obtained through FOIA written by then-Scientific Director of the NTP, Brian Berridge, DVM, Ph.D., who wrote that there was an ongoing attempt to modify the report to satisfy interested actors.
He wrote, “After 17 years in industry, I’ve seen efforts to modify messages to fit commercial interests. I wasn’t party to that there and I’m not game to do that here.”
Berridge also submitted his own remarks. He said as former scientific director of the NTP, he could speak to the care, scientific rigor, balanced representation and clear communication of the work.
“The inordinate and unprecedented challenge and review that have been applied to these products have, in my opinion, been obstructive,” Berridge said, and not consistent with the White House Office of Science and Technology Policy’s policy that aims to protect the integrity and independence of science.
Such delays impact public health, he said, commenting:
“We’ve known for over a decade that we needed more data to better understand the potential for harm to those who are exposed to levels of fluoride most common in the United States. It is regrettable that we haven’t put the effort into generating the data that would have better informed these analyses for those citizens.
“Rather than continuing to challenge this work, the public health policy and research communities should focus on how best to communicate the certainties and uncertainties of this data, inform concerned citizens about possible responses and conduct the studies that would support more certainty. This past year would have been better spent doing those things.”
Former NTP director Linda Birnbaum, Ph.D., didn’t comment at the meeting, but she had previously stated her concerns in a court declaration:
“I am concerned by the recent course of events with the fluoride monograph. The decision to set aside the results of an external peer review process based on concerns expressed by agencies with strong policy interests on fluoride suggest the presence of political interference in what should be a strictly scientific endeavor.”
Representatives from the American Dental Association (ADA) and the American Association for Dental, Oral, and Craniofacial Research (AADOCR) submitted comments challenging the NTP’s findings, calling for an updated meta-analysis, and urging for further review by NASEM, which AADOCR called “the gold standard of independent, nonpartisan, evidence-based advice.”
But emails obtained via FOIA by the plaintiffs reveal the ADA privately hoped to influence the “independent” NASEM.
In one string of emails, several pro-fluoride groups discussed coordinating writing a letter asking the NIEHS to change the way the NTP reports findings were presented on the website.
Tooka Zokaie, MPH, then-manager of Fluoridation and Preventive Health Activities at the ADA, wrote to the group, “I hope to have more updates from Bob Burns after speaking with NASEM directly about the current misuse of the draft Monograph and misleading representations of its status on the website.”
Robert “Bob” Burns is a lobbyist for the ADA.
Earlier this year The New York Times also raised questions about NASEM’s independence, reporting that at the same time NASEM helped shape the federal government’s response to the opioid crisis, it accepted millions of dollars in donations from the Sackler family — owners of Purdue Pharma, the producers of OxyContin.
Commenting on the influence FOIA documents revealed such agencies have on the report Connett told the BSC:
“The FOIA documents show that pressure on the NTP is coming from agencies with very strong partisan interests on fluoride, including the CDC’s Division of Oral Health and NIDCR (National Institute of Dental and Craniofacial Research).
“These agencies have been working hand in glove with private lobbyists and PR professionals to smear and discredit the NTPs work at almost every turn.”
The ADA and public health agencies have endorsed water fluoridation since 1950.
Critics from places like the Fluoride Action Network pointed out that these agencies will suffer serious reputational damage if it were to become generally accepted that fluoride — which they have always maintained was “safe and effective” — is causing neurotoxicity.
The faith the public has in these institutions, North told The Defender, has been one of the major challenges in raising awareness about the dangers of fluoride.
He said:
“In the past, the ones who have been responsible for cover-ups about environmental toxins have been industry — Monsanto, the tobacco industry, the lead industry — but in this case it’s the federal government, it’s the medical establishment — the American Dental Association, the CDC, the American Academy of Pediatrics — they are the ones who are pushing it.
“These are institutions that people trust, so it is a much bigger hurdle to let people know that their trust has been betrayed.”
THANKS TO: https://childrenshealthdefense.org/defender/report-fluoride-neurotoxicity-closer-final-publication/?utm_source=luminate&utm_medium=email&utm_campaign=defender&utm_id=20230509
