Wow - NZ never did a meta-analysis to really understand fluoridation & IQ risk to kids.

Were the processes of policy formulation deficient? Does this fail the sniff test?

Edited for clarity.

Judicial review which might ask the question ‘what has gone wrong’, is not conventionally based on reviewing a decision (such as the mandating of fluoride in drinking water) itself - but on an examination of whether public servants followed transparent, accountable and impartial processes which produced a body of knowledge that then resulted in a particular decision.

In November 2021 New Zealand Parliament passed a law that transferred powers away from local drinking water suppliers. Central government was granted powers to direct local authorities to put fluoride in drinking water.

Were the actions of officials - civil servants - (the processes and procedures followed) fair and reasonable - to arrive at a decision that fluoridation of drinking water should be mandated in New Zealand? We should also ask - might the decision only involve some minor or technical effect? I’m not so sure.

I do not believe the processes were adequate, - so that the magnitude of risk that is presented to pregnant mothers and children could be adequately weighted and judged. I.e. I believe processes and procedures instead, led to a downplaying of risk.

Councils are under instruction. The Ministry of Health are not stuffing around.

Eg. for Rotorua:

In accordance with section 116I of the Act, you are required to ensure that by 30 April 2024 you are fluoridating at the optimal levels (between 0.7ppm to 1ppm, parts per million) at the Rotorua Central and Rotorua East supplies. Contravening these requirements, or permitting these requirements to be contravened, constitutes an offence under section 116J of the Act.

A big threat is hanging over local authorities, if that local authority does not comply with the direction by the deadline (s 116I) the local authority (s 116J):

(b) is liable on conviction to a fine not exceeding $200,000; and

(c) if the offence is a continuing one, is liable to a further fine not exceeding $10,000 for every day or part of a day during which the offence continues.

And what is my personal opinion?

That NZ authorities had an obligation to weigh (judge) neurodevelopmental risk appropriately and they failed. The deficiencies of the New Zealand approach have been clearly brought to light by a US September 2022 draft paper. This paper demonstrates, simply through the thoughtfulness of analysis, how deficient, how impulsive, how predetermined, how contrived and how terrible New Zealand’s policy consultations have been.

DRAFT NTP Monograph on the State of the Science Concerning Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects: A Systematic Review. US National Toxicology Program, September 2022.

Civil society are stepping up in response. And I’ve just interviewed (on behalf of PSGR) Professor Philippe Grandjean, the lead author of a recent paper:

PAPER: Grandjean P, Meddis A, Nielsen F, Beck IH, Bilenberg N, Goodman CV, Hu H, Till C, Budtz-Jørgensen E. (2023) Dose dependence of prenatal fluoride exposure associations with cognitive performance at school age in three prospective studies. Eur J Public Health. 2023 Oct 5:ckad170. doi: 10.1093/eurpub/ckad170. PMID: 37798092.

NB: this Substack represents my own personal opinion.

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In the interview, Grandjean described current claimed consensus on the safety of fluoridating drinking water as being ‘outdated.’

Some questions that might shed light on why New Zealand Inc might remain relatively uninformed on this question:

Why has neurodevelopmental delay, and IQ/intelligence loss been downplayed as a relevant consideration by authorities and in the courts? Why have New Zealand scientific authorities failed to conduct a broad study on neurodevelopmental risk in the scientific literature? Why do authorities downplay the fact that babies, prenatally and postnatally are vulnerable to brain toxicants; that babies and young children consume more by bodyweight than adults; and as such, can be more exposed and more harmed by toxicants that might be safe for their fully grown parents?

Why has the relationship between fluoride and IQ been vastly uncertain - but authorities - civil servants - in uncertainty, chose to plaster over that uncertainty, and act as if there is no ‘proof’ for brain harm?

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THE ‘SAFE’ LEVEL FOR ARTIFICIAL FLUORIDATION

Looking back, how did authorities arrive at the 0.7 - 1 ppm level for artificial fluoridation? The WHO in 2002 described a 1983 Canadian study that showed across 320 provinces that mean levels were between 0.73–1.25 mg/L. Australia suggests 0.6 - 1.1 ppm range. Perhaps New Zealand reflects the US Public Health Service advisory recommendations. I can’t find an upper tolerable limit for babies that supported the decision.

It’s logical that dental and oral experts would take for granted the maxim that fluoridation is safe and effective. Fluoridation of drinking water supplies commenced in Canada and the US in 1944-45, possibly based on early studies by Dean et al (1941).

where the fluoride level of a water supply was about 1.0 part per million there was approximately 60% fewer decayed teeth than in non-fluoride areas.

There’s a long history of fluoridating water services in the English-speaking west. New Zealand’s 1957 Royal Commission conclusion was quite clear on the safety -

fluoride becomes a toxic substance only at levels much above those relevant to any process of fluoridation.

BODY OF EVIDENCE ON BRAIN RISK KEEPS GETTING LARGER

The potential for fluoride to harm the brain has been slushing around for 60 years.

Yet, since the Cabinet paper mooting fluoridation in 2016, there has been no effort to bring onto scientific committees, a group of scientists with appropriate expertise that might have examined endocrinological (hormone) and neurological risk - particularly in early prenatal/postnatal stages. Committee membership to assess safety has predominantly involved experts in oral and dental health. A single individual on such committees would have no standing against peers with a contrary ‘consensus’ viewpoint.

This process - who was selected, failed the impartiality test.

Scientists have also been exploring the relationship between fluoride and thyroid function Since the 1960s. The potential for skeletal fluorosis and neurological deficits has been recognised since at least since the 1980s. The 2002 WHO paper reviewed two Chinese studies discussing fluoride exposure and IQ (p.117) while thyroid effects were predominantly linked to tumour potential rather than more deeply exploring maternal thyroid production and offspring brain effects.

Studies which could shed light on pathways that harm brain development, have not been funded, such as the potential for fluoride to disrupt thyroid-hormone synthesis.

(See Appendix below for greater discussion on i. Australia, ii. WHO drinking water standards, iii. Which New Zealand councils are ordered to fluoridate drinking water).

Instead, a body of global epidemiological research looking at population-level relationships between fluoride exposures and IQ in children has arisen. The September 2022 US National Toxicology Program paper is perhaps the best iteration of the extent of science in the literature. The New Zealand government since 2016 might have made a similar effort to consider the literature, could have easily funded a meta-analysis of the scientific literature. They didn’t do this.

WHAT NEW ZEALAND SCIENCE SUPPORTS SUCH HARDLINE TACTICS?

What is plainly evident, is that the public submissions to the Inquiry into Supplementary Order Paper No. 38 on the Health (Fluoridation of Drinking Water) Amendment Bill were in the majority, ignored and dismissed. Then the government has relied on spotty studies as relevant scientific information and justification for mandatory fluoridation.

Australia and New Zealand health authorities conventionally emphasise risk from fluoridated drinking water as a balance between failure to prevent dental caries, and fluorosis. Fluoride is framed as a nutrient in policy papers. This misleads the public and officials to infer fluoride is safe. However, only a small margin as an upper limit is recommended due to fluoride’s toxic effects.

While New Zealand officials have plainly failed to address the pervasive contradictions - that babies will be compulsorily exposed prenatally and postnatally to higher levels than either Europe or the US NIH states are safe for babies. The government has failed to appropriately follow process and transparently and impartially consider the burgeoning literature on neurodevelopmental toxicity.

In fact - the processes appear, to me at least, to be breathtakingly inadequate. Do the policy-makers even have an assessment that shows the benchmark daily dose of fluoride and IQ loss?

A. BACKGROUND DOCUMENTS

The Regulatory Impact Statement (2016) mentions ‘safe’ or ‘safety’ eleven times but does not refer to relevant terms which I would consider would be part of an RIS ‘neuro’ ‘IQ’ ‘Intelligence’ ‘babies’. Children are only discussed with reference to dental caries. The ‘only side effect’ that is considered is fluorosis:

The only side effect of fluoridation at levels used in NZ is minimal fluorosis, and this is not of major cosmetic significance.

The RIS highlighted High Court findings:

New Health New Zealand Inc v South Taranaki District Council [2014] NZHC 395

Safe Water Alternative New Zealand Inc v Hamilton City Council [2014] NZHC 1463.

The potential for IQ/intelligence to be disrupted was not discussed in these court findings.

NZHC 395 was appealed. The decision handed down in 2018 stated:

The Court of Appeal agreed with the High Court Judge that there was a sufficient evidential basis to support the conclusion that the significant advantages of fluoridation outweighed the increased risk of fluorosis, one of the negative effects of fluoridation and that there was also an evidential foundation for concluding that fluoridation did not give rise to any other significant health risk.

The Court of Appeal cited the Gluckman & Skegg 2014 paper, and a 2015 Cochrane Review. Gluckman’s paper did not review the literature on IQ and neurodevelopmental harm and the Cochrane review did not discuss this at all.

By 2014, quite a bit of evidence was already accumulating - but Gluckman & Skegg persistently keep dismissing each study, and failing to honestly address the issue of uncertainty - how do you calculate neurodevelopmental loss?

Move forward to 2022 - and which scientific reports the Ministry of Health cites as evidence for ‘safety and efficacy’:

The Ministry of Health (see discussion in section E below) in their letter to local councils (Appendix, page 4/8) cite the 2014 Gluckman and Skegg paper, the 2021 PMSCA update, the 2015 Cochrane Review as sufficient evidence that fluoridation in drinking water is safe and effective.

I am satisfied that community water fluoridation is a safe and effective public health measure.’ Dr Ashley Bloomfield, Director General of Health, July 2022

B. OFFICE OF THE PRIME MINISTERS’ CHIEF SCIENCE ADVISOR

The New Zealand government and public servants, including the PMCSA in 2014 and 2021, did not carry out any comprehensive and methodological review of the scientific literature to appropriately, in an unbiased and impartial manner, understand the changing science on risk in infancy and childhood from exposures to fluoride. In short - no fair analysis was undertaken.

I asked the office of the PMSCA and can confirm that the Office of the Prime Minister’s Chief Science Adviser in their 2021 ‘Update on the Evidence’ was not underpinned by transparent terms of reference or documented methodology process that might demonstrate that review of the relevant literature was undertaken using a transparent methodology. There was no response to my question ‘could you confirm which of the 2021 authors or reviewers were epidemiologists or endocrinologists’.

In regards to the PMCSA 2021 Update, I’m going to keep it simple and give you 6 points to think about - the relevant section is:

Could fluoride have possible neurodevelopmental and cognitive health effects?

My points:

1. No methodological review of the literature was undertaken to understand the weight of evidence, rather studies were selected.

2. The recommended upper level of intake for infants was reviewed and updated in 2017 - this is derived from 2016 NHMRC work where neuro/cognitive effects were down-weighted (i.e. the critical issues were dental caries and fluorosis) and many papers on intelligence and IQ were excluded.

3. No experts in endocrinology and neurodevelopment were tasked with analysing data.

4. The Peer Reviewers were primarily weighted to expertise in oral and dental health. One reviewer had a conflict of interest as her papers were widely cited by Gerrard and colleagues.

5. In fact, Guth formed the basis for much of the underpinning argument by the Office of the PMCSA in 2021.

6. The PMCSA states:

   The adequate intake values used in Aotearoa New Zealand are broadly similar to those recommended by the United States National Institutes of Health and the European Food Safety Authority

   (However: EFSA provides NO upper tolerable limit for babies and the NIH states 0.01mg as the limit.)

The Ministry of Health has not appropriately considered the potential for neurodevelopmental harm in infancy and childhood, nor the risk to IQ and intelligence.

C. PARLIAMENTARY INQUIRY & THE SELECT COMMITTEE PROCESS

We can observe that, following an Inquiry, the August 2021 Select Committee report did not at all take time to discuss or weigh any of the information from the 2,384 individuals and organisations that referred to the evidence brain risk - such as neurodevelopmental harm and IQ loss. In fact, the report dismissed any submission that did not specifically address the Bill text.

However, in our report we have not commented on submissions that were supportive of, or opposed to, fluoridation generally, but that did not provide specific feedback on changes to the bill proposed by the SOP.

The Select Committee elected to ignore issues raised by the public that considered risk to health. According to the Select Committee such information was out of scope. This was not an honest Inquiry. The Select Committee would only accept information directly relating to the Bill text. They therefore dismissed any suggestion that the Bill authors might be developing legislation based on an incomplete body of knowledge. One assumes their position on ‘safety’ was predetermined. Due to their incomplete knowledge they were then participating in the drafting of legislation that could plausibly result in harm to health.

Under the Health Act 1956 these civil servants have an obligation

the Ministry shall have the function of improving, promoting, and protecting public health.

Why did the Select Committee narrow their focus to just considering the text of the proposed legislation?

D. WHERE DOES THE NZ EPA STAND IN ALL THIS?

You might ask why hasn’t the NZ EPA stepped into risk assess for environmental and human health risk? My guess is that fluoride is in a liminal space - the 2022 methodology document leans on corporate industry to supply the data to provide evidence of safety for release onto the market.

Normally corporate industry would supply a bunch of toxicological studies (to EFSA, to the NZ EPA, to the FAO/WHO JMPR) which would arrive at a claimed safe dose milligrams per kilogram of bodyweight for example. Industry would be incentivised to do this as they own the IP.

Fluoride is outside this scope. There’s no IP for fluoride. So I speculate that it falls through the cracks. It’s governments that want to release the stuff.

So even though I understand that the NZ EPA is consenting to releases into our freshwater - they haven’t conducted a risk analysis.

The NZ EPA could be a site of thoughtful research and analysis, similar to work the US NTP undertakes - but our NZ EPA are not independent from industry, and they’re not adequately funded.

Regional councils can ignore the political fracas - but Māori and pakeha alike are let down when the NZ EPA approves local authorities to jettison fluoride into our rivers and streams without conducting due diligence around risk to vertebrates.

(Please - if readers can shed more light on the EPA’s role, I’d be grateful).

E. WHICH SCIENCE IS ‘EVIDENCE’ USED BY THE DIRECTOR-GENERAL OF HEALTH?

In letters to local councils, the Director General (In Appendix 1 of each letter) makes claims that adding fluoride to water is safe and effective.

Criterion 1. Scientific evidence on the effectiveness of adding fluoride to drinking water in reducing the prevalence and severity of dental decay.

But it is important to understand - none of the papers with the ‘evidence’ demonstrate to the New Zealand people that a comprehensive analysis of neurodevelopmental risk - including harm to IQ/intelligence was carried out.

In the letter to local councils - the evidence was based on 3 papers:

Evidence: The Ministry has considered the following information:

• Fluoridation: an evidence update | Office of the Prime Minister's Chief Science Advisor (June 2021)

• Gluckman PD and Skegg D. Health effects of water fluoridation: A review of the scientific evidence. Office of the Prime Minister’s Chief Science Advisor and the Royal Society of New Zealand, August 2014.

• Water fluoridation to prevent tooth decay | Cochrane Collaboration (June 2015)

Analysis: Fluoridation: An update on evidence (PMCSA 2021) examines new evidence on water fluoridation published since the Royal Society Te Apārangi report in 2014.

The Cochrane Collaboration’s water fluoridation to prevent tooth decay (2015) is a high-quality scientific meta-analysis of a large number of high-quality research studies conducted over a long period worldwide. Analysis The sources of evidence referred to above are reviews that examine substantial bodies of research generated over periods of time on the safety of community water fluoridation (CWF) and its effectiveness at reducing dental decay. Considered together, these reports provide an up-to-date and high-quality scientific assessment of the state of the scientific evidence on the health effects of CWF. They find that the provision of CWF at a level of 0.7-1 mg/L is safe and significantly reduces the prevalence and severity of dental decay. The summary analysis of evidence stated above justifies the conclusion that provision of CWF at a level of 0.7-1 mg/L in the Tauranga water supply would be safe and effective at significantly reducing the prevalence and severity of dental decay in the populations serviced by this water supply.

Director of Public Health advice: Informed by the findings of the reviews noted in ‘Criterion 1 Evidence’ above on CWF, my assessment is that there is strong evidence that CWF is a safe and effective way to improve oral health outcomes, by reducing and preventing dental decay. I also consider that this strong evidence applies to the communities served by the Tauranga water supply.

As you can see above, the Ministry of Health’s analysis does not discuss developmental neurotoxicity, IQ or intelligence loss.

As I said above in section (B) - Cochrane did not consider neurodevelopmental/IQ harm, and the 2014 Gluckman & Skegg paper only cited a limited amount of papers. The 2014 and 2021 OPMCSA papers both push the Broadbent et al (2015) paper, while the 2022 NTP draft is less effusive.

What remains unsaid is the potential for toxicity at under 1 mg/L, and the differing vulnerability in early life stages.

Funnily enough fluoride levels in urine have been recently studied (p.19), and I speculate that they are not ‘that’ low. I really can’t understand why the Ministry of Health or the Office of the Prime Minister’s Chief Science Advisor has not included this in their analysis. Yet another issue that hasn’t been taken into account.

The rule of law depends on principles of fairness and impartiality in the processes that create laws, so as to prevent predetermined or arbitrary decisions, and the abuse of power.

Do you consider the processes that led to the claim ‘mandatory fluoride in drinking water is ‘safe and effective’’ were appropriate - or is it just me?

APPENDIX

i. WHAT ABOUT THE AUSTRALIAN NHMRC?

In 2016 Australian NHMRC clinical trials centre released 2 reports, managing to dismiss a great deal of evidence on the neurotoxic effects of fluoride. This information was then further downplayed in a 2017 administrative report.

These three papers demonstrate that neurodevelopmental risk was down-weighted (see the discussion on GRADE), in comparison to the claimed more important risk of dental caries and fluorosis. In addition, the Technical Report excluded many relevant studies.

• 2016 AUSTRALIA. Jack, B., Ayson, M., Lewis, S., Irving, A., Agresta, B., Ko, H., Stoklosa, A. 2016, Health Effects of Water Fluoridation: Technical Report, report to the National Health and Medical Research Council, Canberra.

• 2016 AUSTRALIA. Jack, B., Ayson, M., Lewis, S., Irving, A., Agresta, B., Ko, H., Stoklosa, A. 2016, Health Effects of Water Fluoridation: Evidence Evaluation Report, report to the National Health and Medical Research Council, Canberra.

• 2016 NZ & AUST. National Health and Medical Research Council, Australian Government Department of Health and Ageing, New Zealand Ministry of Health. Nutrient Reference Values for Australia and New Zealand. Canberra: National Health and Medical Research Council; 2006. Updated 2016.

ii. THEN … THE WHO DRINKING WATER GUIDELINES?

The guideline value is from 1984.

In 2008 the WHO Guidelines for Drinking-water Quality (3rd edition, Vol 1 Recommendations) drew on a 1984 Environmental Health Criteria 36 to state (p.378) that:

There is no evidence to suggest that the guideline value of 1.5 mg/litre set in 1984 and reaffirmed in 1993 needs to be revised.

The artificial fluoridation level is different. In 2019 the WHO explained that

The guideline value for fluoride in drinking-water is 1.5 mg/L, based on increasing risk of dental fluorosis at higher concentrations and that progressively higher levels lead to increasing risks of skeletal fluorosis. This value is higher than that recommended for artificial fluoridation of water supplies for prevention of dental caries, which is usually 0.5–1.0 mg/L. WHO recommends that, in setting a standard, Member States should take into account drinking-water consumption and the intake of fluoride from other sources.

What the heck is a guideline value anyway?

Guideline values such as those for concentrations in air or water, are derived after allocation of the guidance value or reference dose among the different possible media (routes) of exposure.

Please go to WHO Risk Assessment toolkit: Section 3.3.3 Hazard characterization/guidance or guideline value identification - from page 17 onwards:

So, the current guideline value is based on work done in 1984. Righto.

That process has not been undertaken - it can’t - because the 1984 doc has the most important/relevant information.

But the ‘artificial’ fluoridation of water supplies - 0.5-1.0 mg/L. When was that derived?

It’s referred to in the WHO 2022 p.403 Guidelines for Drinking Water - referring to a 2003 assessment date. The principal references are given as:

• Fawell et al. (2006) Fluoride in drinking-water

• IPCS (2002) Fluorides (no mention 0.5-1.0 mg/L)

• USNRC (2006) Fluoride in drinking water

• WHO (2004) Fluoride in drinking-water

However, I cannot establish where those specifications came from.

There are other concerns, such as the fact that committees might be biased to fluoridation. For example, the primary author of the next 2002 Environmental Health Criteria 227 was Dr R Liteplo. In 1994 his evaluation supported the safety of fluoride, hardly an independent evaluator.

Liteplo RG, Meek ME, Gomes R, & Savard S (1994) Inorganic fluoride:  evaluation of risks to health from environmental exposure to fluoride in Canada.  Environ Carcinog & Ecotox Revs. c12(2): 327-344.

iii EVIDENCE THAT FLUORIDE IS IMPORTANT FOR HEALTH IS WEAK

The WHO’s claim that fluoride is a physiologically important function can be traced back to this 1996 Trace elements in human nutrition and health paper (p.4):

Since the Expert Consultation considered resistance to dental caries to be a physiologically important function, the element fluorine was regarded as essential.

Deficiency which can be evaluated for common nutrients, has never been proven. The paper stated (p.191):

Although fluoride should probably be regarded as essential, there is no evidence so far from human studies that overt clinical signs of fluoride deficiency exist. No specifically diagnostic clinical or biochemical parameters have been related to fluoride inadequacy.

Interestingly this paper stated

Total intakes at 1,2 and 3 years of age should, if possible, be limited to 0.5, 1.0 and 1.5 mg/day respectively, with not more than 75% in the form of the highly soluble fluorides of drinking-water.

They understood in 1996 that one-year olds should not be exposed to more than 0.5 mg/day. They also understood that fluoride accumulates in bones, and evidence on skeletal fluorosis continues to accumulate.

iii NEW ZEALAND AUTHORITIES ORDERED TO FLUORIDATE

The Health (Fluoridation of Drinking Water) Amendment Act 2021 transferred responsibility for decision-making authority on community water fluoridation from local authorities to the Director-General of Health. In July 2022 the Director General, Ashley Bloomfield issued 14 directions to local authorities:

• Whangārei District Council (pdf, 423 KB)

• Western Bay of Plenty District Council (pdf, 418 KB)

• Waitaki District Council (pdf, 412.33 KB)

• Waipa District Council (pdf, 415 KB)

• Tauranga City Council (pdf, 416 KB)

• Tararua District Council (pdf, 407 KB)

• Rotorua Lakes Council (pdf, 418 KB)

• New Plymouth District Council (pdf, 371 KB)

• Nelson City Council (pdf, 412 KB)

• Kawerau District Council (pdf, 367 KB)

• Horowhenua District Council (pdf, 366 KB)

• Hastings District Council (pdf, 371 KB)

• Far North District (pdf, 372 KB)

• Auckland Council (pdf, 383 KB)

As PSGR noted in their submission to the Inquiry into Supplementary Order Paper No. 38 on the Health (Fluoridation of Drinking Water) Amendment Bill, fluoride is not a nutrient, and might be more appropriately classed as a toxin, as, unlike most vitamins and nutrients, higher doses may be harmful.

Can the processes of consideration and evaluation of the safety of fluoride be demonstrated to be deficient? Public servants have plainly failed to give the potential risk of neurodevelopmental harm - IQ loss - the consideration that is deserved.

…Many years ago, Sir Peter Gluckman was a coauthor of an important paper focussing on the Developmental Origins of Health and Disease (DOHaD)… it’s worth a read.

Barouki R, Gluckman PD, Grandjean P, Hanson M, Heindel JJ. Developmental origins of noncommunicable disease: implications for research and public health. Environ Health. 2012;11:42. [PMC free article] [PubMed] [Google Scholar]