Paul Connett and Bill Osmunson’s ‘Lund Report’ reply

4 From ‘The Lund report’ , Oregon:

Replying to Steve Slott: Rick North, Paul Connett, Bill Osmunson

Jan 14, to 18th

From ‘The Lund report’ , Oregon’s ‘d source of health news’

‘Opinion article has been submitted by the American Fluoridation Society.’ – Steven D. Slott as ‘Response to Fluoridation Claims of Rick North’

Followed by very long comment trail including effectively a debate between Slott and two other proponents with Paul Connett, Bill Osmunson and  and North himself.  Worth checking out if you have the energy.

Just one example  from Paul Connett

When Johnny Johnson repeats his mantra that there have been no studies conducted at 0.7 ppm that have shown that fluoride causes any harm he clearly misses the irony of his position. It should be a source of shame for any one promoting fluoridation that in over 70 years of this program very few health studies have been conducted in artificially fluoridated communities. If you don’t look you don’t find. To conclude as Johnson does that the absence of studies is the same as absence of harm is both ludicrous and irresponsible.

The first study on fluoride and animal behavior appeared in the Western literature in 1995. (Mullenix et al., 1995). The first IQ studies appeared in 1995 and 1996 (Li et al., 1995, Zhao et al., 1996). Why then have so few fluoridated countries in the subsequent 20 years have attempted to reproduce these studies and the many that have followed since? Could it be that the health agencies that have promoted this practice for so many years based largely on an endorsement from the US Public Health Service in 1950 (before a single trial had been completed and before any health studies of any significance had been published), simply do not want to find any problem? Why is it that this program continues with little or no attempt to monitor the daily exposure of citizens to fluoride via urine testing? Why have so few – if any –epidemiological studies been conducted in fluoridated communities using the severity of dental fluorosis as a biomarker for fluoride exposure in children to investigate a whole litany of childhood health concerns (e.g. ADHD, bone fractures, lowered IQ, timing of puberty and thyroid function)?

I could go on, but the point is this, with pro-fluoridation governments doing such a shoddy job of protecting their citizens from this practice, shouldn’t we pay a lot more careful attention to those studies that have been conducted in other countries like India, China, Mexico and Iran, which do not have a water fluoridation policy to protect? Especially when they have areas of moderate to high natural fluoride levels in drinking water that present us with an ideal situation to investigate fluoride’s toxicity in the human context. It is foolish to dismiss studies like those of Xiang et al., 2003,a,b and Wang et al., 2012, out of hand, because they didn’t look at a community with the exact fluoride concentration of 0.7 ppm in their water. In doing so, both Johnson and Slott demonstrate their lack of understanding of toxicology and how risk assessment for toxic substances are conducted.

So let me talk a little more about what these studies actually did in order to see if they are relevant to water fluoridation. Xiang, et al., 2003a divided his high fluoride village population of children into 5 sub-groups labeled A, B, C, D and E (see table 8 in his study). The average concentration is these 5 sub-groups ranged from 0.75 ppm to 4.13 ppm. the authors found two things: 1) as the fluoride concentration went up from 0.75 ppm to 4.13 ppm, the percentage of children with an IQ below 80 (borderline or outright mentally handicapped) went up in a systematic fashion) and 2) as the concentration went up (and dose calculated for the same population by Wang et al, 2012) the mean IQ in the 5 sub-groups went down in essentially a linear fashion. See the graph and discussion on this in the Citizens’ Petition to the EPA on page 7).

There is no apparent threshold in this data. So from a risk assessment perspective we can assume that a concentration as low as 0.75 ppm lowers IQ. So Johnny are you going to hang your hat on a difference of 0.05 ppm (i.e. 0.75 versus 0.70 ppm) to support your argument that this study is not relevant to water fluoridation at 0.07 ppm fluoride? And do so knowing that we can’t control how much water children drink and how much fluoride they get from other sources. This is utter nonsense and irresponsible.

I am afraid so many dentists and health professionals have been taught so little about this subject other than the one-sided treatment that they get at dental and medical school that they take at face value what they are told by their professional bodies and organizations such as the American Fluoridation Society. Such faith is reckless when one sees propagandistic techniques at work, and special economic interests such as the sugar lobby at play.

What I hope Rick North’s article will do is to encourage both dental and medical professionals to open their minds on this topic and actually read what is now in the literature. That is easier to do today because thanks to the Fluoride Action Network a huge fraction of the literature of fluoride’s neurotoxicity has been made readily accessible in the Citizens’ Petition submitted to the US EPA under provisions in the Toxic Substance Control Act. An online video is also available that explains and summarizes the literature on the animal and human studies which underpins the plausibility of fluoride’s potential to lower IQ in children.

Finally, think of what is at stake here. We are adding a known neurotoxic substance to the drinking water of millions of babies and children, largely in the hope that it will reduce tooth decay, especially in families of low-income, even though there is no randomized control trial (RCT) to demonstrate this belief. However, if indeed it lowers IQ, as many studies now suggest, we are hurting the vey children we are targeting for help. The last children who need their IQ lowered are children from low-income families, as they already have too many stripes against them. At the very least one would hope that members of the health community would make a good-faith effort to find out the truth on this matter.

I do not wish to respond to the tirade of silly misinformation being circulated by Slott, Johnson and Co. I would rather that those interested in the matter use their time more effectively by reading the cited literature for themselves.

References

Li XS, et al. 1995. Effect of fluoride exposure on intelligence in children. Fluoride 28(4):189-192.

Mullenix P, et al. 1995. Neurotoxicity of sodium fluoride in rats. Neurotoxicology and Teratology 17(2):169-177.

Wang QJ, et al. 2012. Study on the correlation between daily total fluoride intake and children’s intelligence quotient. Journal of Southeast University (Med Sci Ed) 31(6):743-46. (Translated from Chinese into English by Fluoride Action Network in 2016.)
Xiang Q, et al. 2003a. Effect of fluoride in drinking water on children’s intelligence. Fluoride 36(2):84-94. Full study at http://www.fluoridealert.org/wp-content/uploads/xiang-2003a.pdf
Xiang Q, et al. 2003b. Blood lead of children in Wamiao-Xinhuai intelligence study. Fluoride 36(3):198-199.
Zhao LB, et al. 1996. Effect of high-fluoride water supply on children’s intelligence. Fluoride 29(4):190-192.

Dr. Paul Connett

 

from Karen Spenser

The panels wrote they had low confidence in the results of benefit because of the low quality of those studies…. and when translated to absolute terms, they mean some children, not all, just some, might have one or two few cavities during childhood.

When I considered the Newburgh-Kingston study, I realized this whole statistical deception was based on perhaps as few as twenty first graders, where one group 10 kids is compared against another group of 10 kids in the low SES category with the fluoridated group averaging 1.5 cavities and the non-F group averaging 2 cavities….. that could have been caused by one or two first graders who didn’t brush his teeth and liked candy. The “benefit” was not evident in older kids or in any other group. Not the first time nor last these numbers have been massaged: http://www.slweb.org/hileman.html

“Had the Heath Department continued their survey beyond age 10, they would have found that the percentage of reduction continued down hill to 30%, 20%, 0% and eventually these children had more cavities – not less. The rate of decay is identical, once the children’s teeth erupt. (“Fluoridation Benefits – Statistical Illusion.” Testimony of Konstantin K. Paluev, Research and Development Engineer, Mar 6, 1957)

Karen Spencer

The fluoridationists like to make this about dental effectiveness and to confuse the public with lots of pseudo-science verbiage. The EPA petition focuses on neurotoxicity and TSCA regulations which the EPA is supposed to enforce, but let’s make this simple:

Even if fluoridation was effective in reducing cavities, and even if you ignore that some children have their teeth ruined by dental fluorosis ….. it doesn’t mean artificial fluoridation schemes don’t have other documented consequences such as increasing number of children with learning disabilities, increasing lead in water, increasing diagnosis of low thyroid and of IBD such as Crohn’s and UC, worsening the symptoms of autoimmune and renal disease, etc. It doesn’t mean fluoridation is safe. Fluoridation is unethical in theory and immoral in practice:

“Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.” – UNESCO on Bioethics and Human Rights (2005)

“In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.” – Informed Consent in UNESCO documents on Bioethics and Human Rights, Article 6 (2010)

The 1947 Nuremberg Code includes such principles as informed consent and absence of coercion for any medical procedure; properly formulated scientific experimentation; precautions against even remote risks of injury; and beneficence towards experiment participants. http://www.nejm.org/doi/full/10.1056/NEJM199711133372006

Karen Spencer

And in the ‘last word’ category from Bill Osmunson

Bill. Osmunson DDS, MPH

Fluoride Action Network, Director

 

Steven Slott expresses misconceptions and bias of science and law.

  1. Attacking the messenger rather than the message.

Instead of presenting quality science such as prospective randomized controlled trials on the efficacy, safety, dosage and label of ingesting fluoride to the FDA CDER (US Food and Drug Administration Centers for Drug Evaluation and Research) for their review and approval, promoters choose personal attacks.  Why?  There are no RCT (prospective randomized controlled trials) studies on the efficacy of fluoridation. The FDA CDER has rejected the ingestion of fluoride due to lack of evidence of efficacy.

Promoters have not convinced the FDA CDER and many quality scientists, health departments or governments.  Without adequate science, promoters use personal attacks, endorsements, coercion and policy.

  1. Fluoride ingestion is an unapproved, illegal, misbranded and adulterated legend [prescription] drug. 

Drugs are defined as “articles intended for use in the . . . prevention of disease” [FD&C Act, sec. 201(g)(1)].     “Intended use may be established in a number of ways.  Among them are:. . . .Consumer perception . . . .  Ingredients . . .  have a well known (to the public and industry) therapeutic use.”

For example, fluoride toothpaste is FDA CDER approved as a drug with label including, “Do Not Swallow.”  The FDA CDER has not approved the ingestion of fluoride at any dosage with the intent to prevent dental caries.

Another example is fluoride supplements, pills, are drugs.  Pharmacies require a doctor’s prescription to purchase fluoride pills.  The FDA CDER rejected fluoride supplements due to incomplete evidence of effectiveness.

The FDA sent letters to the Boards of Pharmacy, stating: “Manufacturers of unapproved drugs are usually fully aware that their drugs are marketed illegally, yet they continue to circumvent the law and put consumers’ health at risk.”[1]

  1. Without FDA CDER approval, fluoride ingestion will remain controversial.

Promoters have attempted to turn the tables and expect patients, recipients, those opposed to mass medication to provide high quality science and “proof” of harm.  In fact, the law requires the final manufacturers prior to marketing to gain approval and the FDA CDER judges the evidence; is it effective at a specific dosage, safe at that dosage, and a label is required to protect those at high risk.

In 1975 Drug Therapy reported the FDA CDER had rejected fluoride supplements because of a lack of evidence of efficacy.  In 2016, the FDA CDER confirmed fluoride supplements are not approved.  The FDA has testified to Congress that fluoride is a drug.

If promoters are correct and the evidence is strong for both efficacy and safety, certainly promoters could take the evidence of the last 70 years to the FDA CDER and gain approval for fluoridation and/or fluoride supplements.   FDA was notified of fluoride water bottle claims, but the manufacturers never went through the FDA CDER approval process and evaluation.

Promoters sometimes argue that fluoride is NOT a drug and does not need FDA CDER approval.  However, fluoride is highly toxic, more toxic than lead and less than arsenic. Fluoride toxicity fits within state and Federal laws as a “poison” and has been used as a poison.[2] Poisons are exempt from poison laws when regulated under drug or pesticide laws.  Therefore, IF fluoride is NOT a drug (no intent to prevent disease), ingesting fluoride is not exempt from poison laws.  Poison laws are strict and there is no approval process or minimal concentration for ingesting or dispensing poisons. Promoters must follow the approval process laid out by Congress and gain FDA CDER approval.

I promoted fluoride ingestion for the first 25 years of dental practice.  Several of my family members have dental fluorosis to prove it.  Indeed, about 60% of the USA children now have dental fluorosis, a biomarker of excess fluoride exposure, with 2% showing severe dental fluorosis a known adverse effect.

Listening to my patients, I finally read both sides of the research.  The evidence is like a knee in the gut.  Many are ingesting too much fluoride.  Benefit is not supported by good science. The evidence of serious risk is rapidly growing.  My professions cherry pick the evidence supporting policy rather than people.

Promoters have not determined an “optimal” fluoride concentration for the tooth.  Both caries and caries free teeth have a similar range of fluoride concentrations.  Nor do we have an “optimal” serum or urine fluoride concentration.  To suggest  an “optimal” water fluoride concentration when we don’t know the desired serum or tooth concentration is fake science.

Mother’s milk contains no detectible fluoride in most samples and is optimal for the developing brain. Formula made with fluoride water is excessive.  And to protect the fetus, mothers should lower their fluoride intake.[3]

We should warn our patients not to swallow toothpaste, especially children, use a tiny smear on a brush for children, pregnant mothers to be especially careful not to swallow fluoride or fluoride products, and infants should not have formula made with fluoridated water.

Gaining FDA CDER approval while carefully instructing our patients with balanced evidence will raise everyone’s confidence in our professions.

[1] Compliance News, July 2008 Washington State Board of Pharmacy News Letter at http://www.doh.wa.gov/hsqa/professions/pharmacy/documents/July2008.pdf

[2] Some states define a poison as a substance which causes violent sickness or death in humans with 60 grains (3,889 mg).  Others define a poison as a substance which causes  death with less than 50 mg/kg bw for white rats.  Fluoride is considered lethal for humans at more than 5 mg/kg bw.

[3] Valdez Jime ́nez L, Lo ́pez Guzma ́n OD, Cervantes Flores M, Costilla-Salazar R, Caldero ́n Herna ́ndez J, Alcaraz Contreras Y, Rocha-Amador D.O. In utero exposure to fluoride and cognitive development delay in infants. Neurotoxicology http://dx.doi.org/10.1016/j.neuro.2016.12.011

Bill Osmunson

 

Many do not and should not trust the American Dental Association for scientific information.  Good scientists do not “trust,” but ask for measured evidence.

The ADA exists to protect dentists, and so it should.  The ADA did not write the position on fluoride ingestion.  The fluoridation evidence is about a decade old and seriously biased, presenting only the evidence which supports policy and those funding the ADA.  The dental association is a union of like minded individuals.   The evidence they publish must be sanitized to support their source of income.

Science should not be a “faith based” club and our current understanding of nature should constantly be reviewed and challenged.  Name calling and attacking individuals is not scientific.

Years ago, my mentor reminded me that I would have to learn 80% of what was taught in dental school and 50% of what we were taught is wrong. . . we just don’t know which 50%.  We should all have a healthy respect for the unknown and be open to discovering more rather than trying to prove our bias.

I find the attacks above degrading and are not productive to learning and exploring what science has to offer, hard cold measured evidence.  In the end, we do need to make a judgment on the evidence.

In my opinion, the USA will slowly gravitate to the high standards of the Europeans and most of the world, providing freedom of choice without mass medication of an unapproved highly toxic substance.

Bill Osmunson

https://www.thelundreport.org/content/response-fluoridation-claims-rick-north