A challenge for Sarfati – Is medicated drinking water justified?

A judge has just sent the Director-General of the Ministry of Health Dr Diana Sarfati, back to the drawing board to work out whether the fluoridation of drinking water was a reasonable limit to the right to deny medical treatment.

While there are limits on how deep Sarfati has to dig but there appear to be five fault-lines which centre on contradictory and corrupted processes have potential to impair decision-making and undermine trust in the Ministry of Health.

These fault-lines provide some insight into New Zealand’s democracy problem. Democracy runs on the rails of reciprocal trust. Government agencies must be fair and just, and decision-making processes must be transparent and accountable. To be fair and just requires a certain amount of impartiality – so an important tenet of democracy is that officials must not adopt a predetermined view, and when considering an issue, they must examine all relevant considerations.

Officials must not cherry-pick. Especially when it comes to compulsory medication and human rights. They must inevitably judge complex issues, not just pretend the tricky stuff doesn’t exist.

The fluoride-in-drinking-water debate drives to the heart of these democratic values. Scientific information is just as fallible as any other information. Cherry-picking and selective science undermines trust. When trust is undermined, so is democracy.

Was it right to limit rights?

In November 2023 a High Court judgement, New Health New Zealand Inc v Director-General of Health [2023] NZHC3183 found that then Director General of Health, Ashley Bloomfield, failed to take into account the s.5 of the New Zealand Bill of Rights Act 1990.

Judge Radich invited the parties to make recommendations for relief. Following this process, a judgement was handed down (February 16, 2024).

Judge Radich now requires the Director-General to address the restriction, i.e. that people in each mandated council are obligated to acquiesce and drink fluoridated water; and consider whether that limitation is demonstrably justified (see green below).
Sarfati is limited to assessing (in yellow):

‘whether the directions given to the 14 local authorities under s 116E of the Health Act were in each case … reasonable limits on the right to refuse medical treatment prescribed by law as can be demonstrably justified in a free and democratic society.’

Sarfati is in an unenviable position. If she fails to consider decision-making processes and the extent to which controversial content was included, weighted and judged, how can she legally and ethically understand whether the directions were medically justified?

Restrictions to any freedom require that officials have fundamentally acted in a trustworthy and unbiased manner.

Regulators should undertake risk assessment – but they didn’t

Let’s take a look at these five fault-lines.

Firstly, it might be misleading to believe that the Office of the Prime Minister’s Chief Science Advisor (OPMCSA) has the authority and power to sway policy regarding a toxic substance such as fluoride.

The Director-General’s order to local councils to fluoride in mid-2023 was made on the basis of two reviews made by a political agency, the Office of the Prime Minister’s Chief Science Advisor (OPMCSA).

The OPMCSA is not a regulatory agency. The Office does not undertake risk assessment and has no expertise in undertaking risk assessment. It does not employ toxicologists and endocrinologists over the longer term, experts that might thoroughly review the science understand the mechanisms for neurotoxic risk, in an impartial and procedural manner.

The OPMCSA somewhat extraordinarily, downplayed the importance of the US National Toxicology Programs’ (NTP) finding that there was no known lowest safe level of exposure of fluoride. Children’s fluoride levels in New Zealand have been tested, yet a combinatorial effect of background exposures with drinking water levels was not reviewed by the OPMCSA. The OPMCSA hasn’t considered other forms of dietary intake, such as through tea and pharmaceutical drugs and the additive risk this might produce.

It’s not just neurodevelopmental risk. The OPMCSA papers considered that skeletal fluorosis (SF) isn’t a risk in New Zealand. But who is researching this at the level required? The symptoms of SF can mimic seronegative arthritis. Early SF symptoms include Achilles tendonitis, joint pain, back pain, early morning stiffness and can ‘mislead to a diagnosis of inflammatory arthritis’. Increased serum fluoride levels are associated with increased risk of knee osteoarthritis. And yes, drinking water fluoridation can lead to a high rate of pediatric fractures.

Subsequent US court action has reiterated the ‘no known safe level’ where neurological harm commences. The non-regulator OPMCSA dismissed the NTP and ignored criticism that the New Zealand study (Broadbent et al 2015) they heavily relied on, was considered by the NTP to have high risk of bias.

It’s interesting to note that Broadbent was a peer reviewer of the OPMCSA’s 2021 Update. I am a trustee for Physicians and Scientists for Global Responsibility, and I have presented on behalf of the organisation, expressing concern that the dental and oral health experts and the peer reviewers involved in the OPMCSA process likely held pre-determined positions on the safety of fluoride in drinking water.

The OPMSCA will not have undertaken the 2021 review, an Update of an earlier 2014 paper, on a whim. They will have been directed. These directions coincided with the release of a Bill that would give power to the Director General to mandate fluoride. It likely that the Office had limited funding. It was unlikely with limited resources that a position would be taken that would contradict new legislation and long-held government policy.

Secondly, New Zealand’s risk assessment agency, the New Zealand Environmental Protection Authority (NZEPA) have evidently washed their hands of the issue of fluoride toxicity. The NZEPA have never undertaken risk assessment of this toxicological substance. It hasn’t assessed fluoride’s neurotoxic potential, nor reviewed the literature on risk and IQ loss. They can’t possibly understand if decades of emissions in waste-water, or bioaccumulation in sludge, is a risk over the long-term to New Zealand freshwater ecosystems (especially in water sediment) and soil.

The public are misled if they are led to believe that the OPMCSA’s selective science is a sufficient substitute for comprehensive risk assessment.

Thirdly, the absence of regulatory oversight tumbles down, producing institutional ignorance at local government level. Remarkably, despite decades of emissions from our biggest fluoridated cities, and a fancy new water policy, there’s no consenting process nor any water policy to require monitoring of surface waters and sediments when hydrofluorosilicic acid is discharged.

It appears that there is no requirement for local councils to receive approval from regional councils to discharge fluoride –the complete formulation that is added to town water – in their wastewater. I speculate that this is because the regional councils don’t have the NZEPA to ‘bounce off’ to confirm the safety of the process.

When the Tauranga City Council was asked how the public would access ‘regional resource consents for fluoride emissions into water, and related information which includes the formulant mixture, not routinely monitor fluoride in sediment or surface water, Kim Boyer responded:

These consent documents may not contain the information you are looking for as we do not specifically consent for fluoride as a discharge.

When I asked about fluoride and government policy on freshwater and national bottom lines I was advised

The NPSFM 2020 does not set national bottom lines for pesticides, trace metals, pharmaceuticals or fluoride.

The fancy policy with lots of Māori words contains nice sounding principles, but pollutant industrial chemicals are completely out of scope. Are local Māori consulted about fluoride emissions to water, and have they been appraised of fluoride’s toxicity? Not likely.

When it comes to neurotoxic risk, local councillors, have to take the OPMCSA’s word for it.
Fourthly, fluoridation is claimed to be a cost-effective public health intervention. Dr Ashley Bloomfields last action as Director General of Health was to ‘mandate’ fluoridation in water. Bloomfield, as stated in the RNZ story:

I’ve actually been a long-time champion of water fluoridation. It’s an incredible effective – one of the most cost effective public health interventions and one of the things about it is that it is a great way to address inequities and outcomes, particularly amongst children.

Bloomfield held a predetermined view on the safety and efficacy of drinking water fluoridation.

The government and the New Zealand Dental Council’s position on the cost benefit is solely based on 2015 and 2016 papers by contracted research group Sapere. Sapere calculated the 2009 New Zealand Oral Health Survey (2010) of 1431, of whom 987 were dentally examined, to claim that fluoridation leads to a 40% reduction in caries. Their calculations are not included in either the 2015 or 2016 report. Sapere stated that:

‘The absolute difference in dental decay was 1.0 less tooth and 1.6 less surfaces for those living in areas with water fluoridation.

Fluoridation might lower incidence but not broadly prevent cavities.

A documentary by Reality Check Radio has recently drawn attention to inconsistencies not highlighted by the government contractor. Sometimes cavities might have been prevented, but this could be highly variable, particularly in the most at-risk group for neurodevelopmental loss.

Sapere did not include contradictory studies in the cost-benefit analysis nor analyse any cost to health if neurodevelopment and IQ loss were present.

Sapere’s discussion supported the government position on fluoridation. A year 2000 meta-analysis cited by Sapere as favourable, was much more marginal and variable in its findings than Sapere communicated:

The reported reduction of percent caries-free from water fluoridation by each of the studies ranged from -5.0 to 64 percent, with a median of 14.6 percent. The median result of 14.6 percent, rounded to 15 percent, is often quoted as the benefit of water fluoridation.

The study stated that 214 studies were included and that the quality of studies was low to moderate.

‘The most serious defect of the studies of possible beneficial effects of water fluoridation was the lack of appropriate design and analysis.’

Sapere ‘interpreted’ the meta-analysis to state ‘reported a 38 percent reduction in dental decay for those children in areas with water fluoridation.’ Sapere did not repeat points emphasised by the authors that:

[R]eductions in the incidence of caries were found, but they were smaller than previously reported.

The prevalence of fluorosis (mottled teeth) is highly associated with the concentration of fluoride in drinking water.

Sapere’s paper citing Ministry of Health data and the meta-analysis downplayed an unfortunate fact. Kids in fluoridated regions are still getting cavities. Kids in poorer regions get more cavities, and this increases risk for other illnesses.

Data continues to be released that contradicts Sapere and the Ministry of Health’s position.

A publicly funded, ten-year, retrospective cohort University of Manchester study by Deborah Moore and colleagues has just been published. The UK-based study reviewed data from 17.8 million patients in the National Health Service, aged 12 years and over. The researchers confirmed only minor benefits from fluoridated drinking water. For example, there were only three per cent less invasive NHS treatments in the optimally fluoridated group. They noted that:

There was no difference in the predicted mean number of missing teeth per person and no compelling evidence that water fluoridation reduced social inequalities in dental health.

Over the ten-year study period only GBP22.26 was saved per person in fluoridated regions.
Does that cost saving ethically justify a restriction on a right to refuse medical treatment?
The above four points coalesce around a final point – government narrative rests us on us believing that fluoridation of drinking water prevents cavities. But, as Moore et al stated, fluoridation merely attenuates the problem.

Adjoining the misleading promise are misleading and compromised processes and knowledge gaps. Neither the NZEPA nor the OPMCSA have attempted to compare and contrast the risk and potential societal costs of neurodevelopmental delay or of lower IQ with any marginal benefit of fluoridation.

The OPMCSA claim neurotoxic risk isn’t ‘a thing’ – yet, unethically to my mind, they haven’t wrestled with the fact that the largest study in the world might be firing warning signals over their black and white parapets.

It’s an ethical minefield.

If the OPMCSA didn’t place the NTP data at arm’s length and instead asked, in uncertainty, how should we balance this risk in the first decade of a child’s life when they are also most at risk of neurodevelopmental toxicity and lowered IQ, we might have brought more experts in, and had a richer conversation.

But they didn’t. The selective science and gaps in judgement on probability and risk leaves local councillors relatively uninformed as to different risk considerations; including the safety of fluoride in water and in human bodies, and unable to judge without falling into polarised debate. Local councillors can elect to follow the ‘it’s all fine, let’s rely on OPMCSA position’. But this position, from multiple perspectives, appears to be problematically biased.

Bloomfield stated (and the clip can be seen in first few minutes of the New Zealand documentary Fluoride on the Brain, by Alistair Harding,

Unfortunately, New Zealand has relatively high rates of preventable tooth decay. Fluoridation is well-proven to be a safe, affordable and effective method of preventing tooth decay that benefits everybody but particularly children, Māori Pasifika and our most vulnerable.’

Yes, we do have high rates of preventable decay. But also of preventable diabetes, preventable obesity, preventable chronic pain and preventable cardiovascular disease.

A richer, more nuanced conversation would help us understand that ‘children, Māori Pasifika and our most vulnerable’ are experiencing higher rates of preventable disease and multimorbidity – including caries – at younger ages, and that the literature informs us that dietary ignorance, poverty and under-regulation is the major driver.

The Ministry of Health have not considered other policy options that might address preventable disease and multimorbidity manifesting at younger and younger ages. Policy responses must be multifactorial. It’s all practical stuff which has been left out of policy for too long. From education and the government supplying toothbrushes and toothpaste to low income affected communities who might benefit from improved dental policy; to supplying nourishing, cooked lunches. From mainstreaming nutrition and cooking education in schools to making biology curriculums gruntier. From increasing the time for doctor consultations after polite chit-chat to more than 6 minutes and funding doctors to include dietary counsellors in their clinics. It just takes a bit of logic.

We can only hope that the Director General of Health will review at length, the findings of the University of Manchester researchers; the controversial NTP findings that inevitably produced a can of worms in the USA, findings from the US court cases and our absence of rigorous risk assessment. That she will adhere to her obligations in law to ensure that she has taken into account all relevant considerations, and her obligation to protect health. As a cancer expert, there is no doubt that she recognises that health is complex and multifactorial, and eminently social and political.

These fault-lines revolve around contradictory and corrupted processes. If they continue to be set aside, the Ministry of Health, and associated agencies, by assuring and assuming a safe and effective position risk promoting mistrust. But not only that, if relevant information is kept at arm’s length, the Ministry risks being accused of disseminating misinformation.

If we return to Moore et al 2024 for a final word:

A dose–response relationship between free-sugars and dental caries is evident at all levels of intake above zero and fluorides merely attenuate this relationship. Average consumption of free sugars in the UK is more than double the recommended level for adolescents, and is almost double for adults. The discovery of water fluoridation made an unparalleled contribution to oral health in the 20st century. In the 21st century, greater impact may be achieved by advocating for upstream, policy level action to address the commercial determinants of health and create supportive food environments.

Image credit: Andres Siimon