What do Lead, PFAS and vaccine manufactures have in common?
Hint, it sounds like the keyhole rule
We studied 512 mother−child pairs enrolled in the MIREC (Maternal Infant Research on Environmental Contaminants) study. The families lived in six Canadian cities; 40% lived in cities with CWF. To our astonishment, we found that higher levels of fluoride in pregnant women and water concentrations were associated with a 3- to 5-point lower IQ score in their 3- to 4-year-old children.8 We thought there may be other factors at play, but this association held up after accounting for important characteristics of the study population and looking at the relationship in many different ways.
In August 2018, we presented our findings at an international meeting held in Ottawa. We were nervous how the results would be received by the audience, which included members from Health Canada and other public health agencies. Afterwards, someone approached me and said, “Congratulations – you have just sabotaged your career before it even started”. Rivka Green
As part of our agreement, our manuscript required approval by the MIREC Biobank before we submitted it for publication. Considering the sensitive nature of the topic, the manuscript was sent to reviewers from various divisions of public health. In over 60 pages, we responded to over 200 specific critiques. The upshot of addressing each critique was that we were able to do better science by refining our methods.
We submitted the manuscript to three top medical journals; two did not send it for peer review because it was “of low research relevance”. As we waited, we hired an independent data analyst to rerun all of the analyses for the third time. In April 2019, JAMA Pediatricsaccepted our paper. We responded to several additional rounds of review by the JAMAeditors until we eventually reached a compromise that reflected the strength of the evidence, as well as their implications for public health.
One year after that conference in Ottawa, our article was published on August 19, 2019. In only 2 months, it was viewed over 100,000 times and ranked among the top 0.0005% of research output scored by Altmetric. We expected our study would reignite the debate about the safety of fluoridation, but we didn’t expect we would be at the crossfire of this political and polarized debate.
The backlash
Outside of our colleagues in environmental epidemiology, who were initially skeptical, the results were met with resistance. Attempts to debunk the data were especially apparent from “experts” who held strong beliefs about the benefits and safety of fluoridation.
There are thousands of articles pointing to the safety of community water fluoridation … this study doesn’t change the benefits of optimally fluoridated water and exposure to fluoride.9 Dr. Braun, chair of the AAP Section on Oral Health Executive Committee
Yet, there are no other prospective studies with biomarkers of fluoride in pregnant women living in regions with CWF. Canada’s national newspaper rang with the headline, “Fluoride won’t make you dumber, but the ‘debate’ about its safety might”.10 Didn’t the NRC deliberately call for more studies to address this “debate”?6
Vitriolic comments and claims with little scientific basis, such as the results are driven by outliers, were made by the American Council on Science and Health11 and the UK-based Science Media Centre,12 both heavily funded by the pharmaceutical and food and beverage industries. In reality, we presented our models with and without outliers and the effect remained. These types of vacuous claims exemplify attempts to manipulate the scientific evidence and manufacture doubt.
So what this study found was just an association. And we know from other areas … they are inherently problematic and inherently complex.13 Timothy Caulfield, University of Alberta
This was not a scholarly debate on the neurotoxicity of fluoride; it was an attack on IQ scores, statistical methodology, and observational studies. Ironically, the evidence showing that CWF protects against tooth decay was largely based on observational or “association” studies, most of which were conducted prior to the introduction of fluoridated toothpaste in the early 1970s.14 Moreover, most landmark studies in public health–including those linking smoking with lung cancer, air pollution with coronary heart disease, and asbestos with mesothelioma—were observational. Indeed, this design is optimal to study many important public health problems, usually in conjunction with toxicological studies.
There is no sensible biochemical reason why fluoride would harm the brains of boys but not those of girls. So, are the authors wrong? Probably.15 Alex Berezow, Ph.D., Vice President of Scientific Affairs, American Council on Science and Health
Our paper continued to be attacked in scientific and public arenas, many of them drawing upon critiques made by the industry-funded groups. Accusations that our data did not support our conclusions spread quickly and were propagated by social media. “Experts” wrote that the association between maternal urinary fluoride and lower IQ in males, but not females, defied plausibility. However, as we noted in our original proposal, males are often more susceptible to toxicants and failure to examine sex-specific effects of fluoride exposure may result in missing a potentially vulnerable group. Further, the NTP in 2016 specifically called for more studies on fluoride exposure with an emphasis on sex-specific associations.16
I’m confused as to why the authors would want to withhold the data.17 Stuart Ritchey, Ph.D.
On October 23, 2019, a letter signed by 30 health-care professionals and scientists from six countries was sent to the Acting Director and Acting Deputy Director of the NIEHS. The letter cited concerns about the replicability of scientific research in general and the need for transparency. Our research team was accused of “refusing to release data”, but we had not refused to release the data. The policies that govern access to the MIREC Biobank and procedures to access it are sent to anyone who requests the data.
Risk and benefits
Some critics maintained that our conclusion—that pregnant women should reduce their fluoride intake—overstated the implication of the findings and was “dangerous”. Other critics said that we should not change our actions based on “one study”. We agree that no one study is definitive; we should carefully evaluate the collective evidence from multiple studies, as well as the risks and benefits of fluoridation.
Four high-quality, prospective birth cohort studies5,8,18,19 show that fetal exposure to fluoride is associated with diminished cognitive abilities. In November 2019, the National Toxicology Program released a draft report on fluoride concluding that fluoride is presumed to be a cognitive neurodevelopmental hazard. This report was largely ignored by the critics of our study.17,20
Fluoride offers no benefits to the fetus. The beneficial effects of fluoride predominantly occur at the tooth surface, after the teeth have erupted.21,22,23 Accordingly, the Canadian Pediatric Society and the American Academy of Pediatrics advise against fluoride supplements during the first 6 months of life.24
Exposure to fluoride comes from a variety of sources, but for people who live in cities with fluoridated water, the main source of ingestion is drinking water. Importantly, pregnant women and formula-fed babies may not be able to access nonfluoridated water….Dr. Lanphear, a senior scientist on our team who conducted many of the pivotal lead toxicity studies that helped confirm Dr. Needleman’s work, reminded us that it took two decades of research before the CDC declared, “there is no safe level of lead in children’s blood”. Dr. Lanphear wrote, “The critics—who were often paid by industry or simply ignorant about lead toxicity but still willing to offer their ‘expert’ opinion—delayed efforts to prevent lead poisoning by decades”.
https://doi.org/10.1038/s41390-020-0973-8
Ironically, Robert Kehoe was one of those who graduated medical school - supposedly trained to heal people and help them be as healthy as possible - and then went on to work for the lead industry. He also defended Fluoride on behalf of Dupont, Alcoa and US Steele.
I had never heard of the Kehoe Rule until today, when when I read about it, something clicked: This is the same strategy used in every controversial area where I’ve been gaslit, censored or worse.
In yesterday’s post, I had a lively, yet respectful discussion with a reader about Fluoride. We are both smart women who want to see unity and not division and who want to vet the truth the best we can. This reader brought up being more concerned about PFAS than fluoride. The article I was led to about the Kehoe Rule is a PFAS case! PFAS actually is fluorine bonded with carbon and other manmade molecules. According to science notes, “Fluoride is related to fluorine, but the two chemicals are not the same. Fluorine is a chemical element, while fluoride is either the ion of that element or else a compound containing it.” So PFAS is a fluoride. According to the official cancer.gov, NCI, “Fluoride is the name given to a group of compounds that are composed of the naturally occurring element fluorine and one or more other elements.” The kind of fluoride put in water, according to Duck Assistant is most typically (but not always?) “sodium fluoride, fluorosilicic acid, or sodium fluorosilicate” are the usual fluorides added to drinking water.
Back to PFAS:
Sandy Wynn-Stelt and her husband, Joel Stelt, hated the water in their country home on House Street in the Belmont area of Kent County, Michigan. Boiling it to make coffee was especially bad. “You would get this gross film on top,” Wynn-Stelt remembers. They didn’t think much of it though. “We just assumed this was part of the joy of country living,” she says. Then, in early 2016, Stelt went to the hospital for a hernia repair and came out with a diagnosis of stage four liver cancer. Three weeks later he passed away.
A year later, Sara Simmonds, Environmental Health Division director and chief sanitarian at the Kent County Health Department, was staying late at work. Outside her office, she overheard a phone call about approving a well permit in the Belmont area. She knew nothing of Wynn-Stelt’s circumstances, but she had recently heard a Michigan Department of Environmental Quality (DEQ) manager mention that a community group, Concerned Citizens for Responsible Remediation, was concerned about possible PFAS contamination on House Street, which borders a large open area that shoe manufacturer Wolverine World Wide had used as a dumpsite between the 1940s and the 1960s.
PFAS is short for per- and polyfluoroalkyl substances. These chemicals have been used for decades in countless products, including food wrappers, cookware, Scotchgard and firefighting foam. They do not readily break down, but instead build up in the body and environment. And they’re linked to all sorts of health concerns, such as increased risk of high cholesterol, hormone and immune system disruption, and certain kinds of cancer.
Sandy Wynn-Stelt drank contaminated water for years without knowing it. Photo courtesy of Leah Gerber
Simmonds says her “inner alarm system went off.” She blocked the permit approval until the DEQ tested wells in the area for PFAS.
Not long after, Simmonds sat with Wynn-Stelt at her dining room table. Also present were representatives from the DEQ and GZA, an environmental management company representing Wolverine. Everyone listened while Simmonds explained a page of water testing results to Wynn-Stelt.
The lab had found PFAS in Wynn-Stelt’s well water at concentrations of 27,600 parts per trillion (ppt), and then later when retested, at 37,800 ppt — 540 times the EPA’s 70 ppt recommended maximum.
Innocent Until Proven Guilty
Wynn-Stelt was a victim of an approach to assessing risk known as the Kehoe paradigm that formed the foundation of the U.S. Toxic Substances Control Act (TSCA) when it was passed in 1976.
Named after toxicologist Robert Kehoe, who applied it in the 1920s to justify adding lead to gasoline, the paradigm essentially posits that something is considered innocent until proven guilty of harm. Kehoe drew attention to the uncertainty of danger from leaded gasoline and insisted that proof of harm be demonstrated before companies be required to stop using lead in their product. The paradigm as embodied in the original TSCA essentially allowed Wolverine to dispose of PFAS in what would become Wynn-Stelt’s neighborhood, and to allow it to persist there, because no one had proven that it was a problem.
That same principle can be seen at work in numerous cases throughout U.S. history, including tobacco, asbestos — and, perhaps most notably in recent memory, the case of a city only a couple hours’ drive east of Kent County: Flint, Michigan.
But it wasn’t until pediatrician Mona Hanna-Attisha provided scientific evidence of increased lead in children’s blood samples following the switch that a crisis was declared.Whistleblowers there voiced concern about suspected lead contamination of drinking water after the city switched its intake from Lake Huron to Flint River water in 2014. But it wasn’t until pediatrician Mona Hanna-Attisha provided scientific evidence of increased lead in children’s blood samples following the switch that a crisis was declared. At that point, residents had been using contaminated water for 18 months.
“I had to use the blood of our children for people to finally pay attention to what was happening,” Hanna-Attisha says. “It’s backwards.”
Changing the Paradigm
With lives at risk, what is being done to shift away from the paradigm in the U.S.?
One such move came in 2016, when Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the first update to TSCA since it was created. The law dramatically increases the U.S. Environmental Protection Agency’s (EPA’s) authority to protect public safety. Most notably, the agency no longer needs to prove risk of harm in order to ask for a scientific study of a chemical. The law also tasks the EPA with evaluating previously unchecked chemicals.
Wikipedia’s entry on Robert Kehoe also goes into the Kehoe Rule and how it was applied: it relates to winning no matter what when industry controls the science: Either you win because you get “science” to support that whatever thing is safe or you get to use science to call for a long, long delay while more evidence is gathered, prolonging the exposure of human beings to potentially (and in all likelihood when it’s a chemical, actual) harms, dangers, or even death.
I remember Pfizer tried to delay releasing the data 55 years, til most people who would have been upset were likely to have already moved on to other realms, certainly those who would have been held liable. I remember when Brook Jackson tried to blow the whistle on shoddy trials. If a trial on fluoride - whether the kind used in toothpaste or PFAS - were this shoddy, surely it would be discarded. Why are the rules not equal when industry gets involved?
Robert Kehoe found the keyhole to unlock immunity from consequences for industries like Dupont, Alcoa and US Steele. He may not have realized he also paved the way for Pfizer and others who delay the science that would allow public outcry, twist it with “fact checks” when it comes to light, and throw women scientists under the bus when they call bullshit.
https://www.bmj.com/content/375/bmj.n2635
The Kehoe
Rule
Is just a Tool
To Fool
The Good and Innocent
The Vulnerable
In the name of those who hoard
The Power and the Science
Because they want to be Omnipotent
Hardly A Loving Creator
But a man of Steel
Aluminum
Uranium Enrichment
Secrets of the Coldwar
Predicament
Off gassing Fluorines
Reacting with Everything
His Ass is made of PFAS
Yet he rides
As if he has class
Over the bodies
Riddled and dead
Dumber in the head
He laughs that they can’t parse his cruel joke
He thinks he is the best bloke
And he would, I’m sure tell you the poke
Is safe and effective
Because you can’t prove otherwise
To his satisfaction
While he controls every retraction
What gets funded
What gets action
And manipulates the publics
Reaction
End the traction
Of Kehoe’s Rule
Reclaime Your Sovereign Divinity
Find the Heaven within As Your Tool
To Unwrap
Detox
Find some Charcoal or Tamarind
Relax with some Hops
Until this poisoning of bodies and minds
And the sorcery of chemists mixing spells
Over the wells
Of industry waste
To bind toxins
And your consent
To agree
To let Flouride’s vent
And decree
To put them on by varnish
Or swallow without intent
Stops