Publications & Resources

In this series of PSGR discussions (click on the image), JR Bruning talks with physicians and scientists who are independent thinkers and courageous leaders in breaking out of siloed approaches to human and environmental health. PSGR is working to draw attention to expert approaches that, while reflecting knowledge established in the scientific literature, may challenge existing paradigms, commercial perspectives and conventional practice/research patterns.

Go to @PSGRNZ on YouTube or Odysee to watch, and @PSGRNZ on Substack or Spotify to listen to the podcast version.

This work often draws attention to different conceptions of risk and resilience; science and critical scholarship that can navigate open-ended environments; and intractable feedback loops. I.e., systemic uncertainty. This work requires courage, curiosity and the application of different forms of interdisciplinary expertise and judgement that can appear daunting for many.

Interview with Professor Jack Heinemann, Director of the Centre for Integrated Research in Biosafety (INBI), Tessa Hiscox and Andrew McCabe.

Centre for Integrated Research in Biosafety (INBI), at New Zealand's University of Canterbury, & some of the co-authors of INBI's Submission to the Parliament Health Committee on the Gene Technology Bill 2024.

'New Zealand would have the most extreme combination in the world of proposed species breadth (microorganisms, plants, animals) and process (e.g. SDN2) exemptions.'

Professor Julia Rucklidge

Director of Te Puna Toiora, the Mental Health and Nutrition Research Lab at the University of Canterbury.

'What should mums be getting during pregnancy to make sure that their kids have the best opportunity of a good start to life.'

Multinutrients for pregnancy & depression. 1st ever RCT NUTRIMUM trial. Benefits for mum & babies.

Professor Ian Brighthope

Founding Director, World of Wellness International - Beyond surviving, towards thriving. wowintl.org

Founding President ACNEM. Principle lecturer 1980-2007.

'If we mess up the biochemistry then we mess up the genes.'

What advice would an integrative medicine trailblazer give recent graduates?

Professor Ashley Gearhardt, University of Michigan

Clinical Science Area Chair.

'We're seeing those same behavioural indicators of addiction - the loss of control & the intense cravings. The inability to cut down, even if you know you have a life-threatening illness.'

Ultraprocessed food. Can UPFs meet the same benchmarks for an addictive substance as tobacco & alcohol?

Dr Jen Unwin, Chartered Clinical & Health Psychologist - 30 years UK NHS. D.Psy, FBPs, C.Psychol. PhD.

Co-founder: Co-Founder: Food Addiction Solutions (FAS) UK. 2-part interview.

[1] Game-changing UK doctors' clinic. 10 years of reversing diabetes!

[2] If we don't recognise food addiction as a substance use disorder, how can we treat it?

Professor Pablo Gregorini. Lincoln University.

Head of the Centre of Excellence in Designing Future Productive Landscapes and Pastoral Livestock Production Lab. 2-part interview.

[1] Is eating meat ethical? Taking another look at climate & environment & animal production systems.

[2] What happens when we give livestock more choice in a grazing system? Animal plant choice influences human cellular health - Metabolomic profiling & phytonutrients.

Dr Simon Thornley MBChB, MPH (hons), PhD. Public Health Physician, lecturer and researcher in the department of Epidemiology and Biostatistics, University of Auckland.

'If you look at the nutrition world from an insulin-carbohydrate-sugar perspective, there's no discordance between trying to improve your overall metabolic health with a diet that both helps your waistline, your pancreas & your coronary arteries.'

Having a good hard look at the evidence. On public health & locked in med school paradigms.

Professor Grant Schofield, Professor of Public Health at Auckland University of Technology (AUT) & Director of AUT's Human Potential Centre.

'They were right. I should never have been appointed. It's a hopeless job for someone who wants to be outspoken about public policy.'

Extending your health span to live your best (mental & metabolic) life.

Two Part Cancer Series with Dr Anna Goodwin, retired oncologist and secondary prevention consultant.

Part 2: Getting your Best Cancer Outcome.

Part 1: Unravelling the Biological Drivers of Cancer

‘The science of cancer knows that it’s an injury response, but the clinical management of cancer has not yet figured this out for the most part.’

Too busy & just want a quick snapshot? Go here to pick a topic from the playlist.

Professor Philippe Grandjean, University of Southern Denmark (October 2023)

'That's what I think the fluoride decision is. It's outdated. Now we have fluoride in toothpaste.'

2023 study on fluoride & IQ contradicts so-called 'safe' levels in drinking water. Grandjean et al.

Professor Jack Heinemann, University of Canterbury. (January 2023)

Director, Centre for Integrated Research in Biosafety (INBI)

'Where harm can accumulate at scale transition, that's precisely where regulation is a solution to mitigate risks.'

Biotechnology - Risk that scales up as efficiency increases. Heinemann on risk management & policy.

2021 New Zealand GP of the Year Dr Glen Davies (October 2022)

'We can save a lot of money by doing this better.'

Reversing Type 2 Diabetes in New Zealand. Science, support, keto & community-driven change.

Dr Emma Sandford (September 2022)

'The way we have become more sub-specialised in each specialty has assisted in that siloing of understanding, knowledge, experience, exposure - in the clinical setting.'

Eye Health - Beyond Clinical Medicine & Towards Natural Ophthalmology.

Dr Charles 'Merf' Merfield (September 2022)

'Quite simply, intensive agriculture is eating itself.'

Regenerative agroecology organic - how does it all fit together?

FIND US ON LINKEDIN, TWITTER (@PSGRNZ), INSTAGRAM (@PSGRNZ), ODYSEE (@PSGR), SUBSTACK (PSGRNZ) & YOUTUBE (@PSGRNZ).

Introduction Dental "silver" amalgam, a mixture of approximately 50% mercury with a powder of copper, silver, tin and zinc, has been in widespread use since the late 19th century. After considerable initial toxicity concerns by the professions it was soon uncritically endorsed by all western dental associations with successive generations of dental students graduating with a firm belief in amalgam being a safe, effective and durable restoration.

As a restoration for dental decay, it has some useful properties being cheap, durable and easy to use. The tooth does not even need to be dry or the surfaces etched as with the more technically demanding microcrystalline composites. It is therefore a pity that it poisons people as mercury is an accumulative toxic element. The time taken, the degree of harm and the presentation will merely depend on the individual's genetic makeup and the dose.

In 1991, the World Health Organisation (WHO) in an up-date on inorganic mercury, listed dental amalgam as being the largest source of mercury vapour in the non-industrial populations at up to six times the amount from all other combined sources. (1) The WHO based their conclusions on an average of 6-8 fillings. In 1992, the Swedish Government passed legislation to start a 5-year phase-out of dental amalgam that would also allow dentists to be properly trained in safe amalgam removal procedures. In the following decade, the legislation was amended to approve State funded dental treatment when a doctor diagnosed mercury toxicity. However, following escalating complaints that doctors were not helping, the legislation was finally changed so that from 2005 any Swedish citizen could get subsidised amalgam replacement if they thought that they were suffering from adverse mercury effects. This remarkable and so far unique legislation was based on the findings of the Swedish Dental Materials Commission that included representatives from the Swedish Dental Association, the dental schools, the Swedish National Board of Health and Welfare, and the Swedish Association of Dental Mercury Patients. The Commission had tasked Professor Emeritus Maths Berlin with giving an updated risk analysis in environmental medical terms on mercury in dental fillings, based on an overview of scientific literature published between 1997 and 2002 and current knowledge. Berlin had previously led two World Health Organization Task Groups with one on inorganic mercury and the other on methyl-mercury.

The U.S. EPA mercury health standard (2) for elemental mercury exposure (as vapour) is 0.3 micrograms per cubic meter of air (0.3 ug/m3 ). For the average adult breathing 20 m3 of air per day (3) , this amounts to an exposure of 6 micrograms (ug) per day. The corresponding tolerable daily exposure developed in a report for the Canadian Health Agency, Health Canada, is .014 ug/kg body weight or 1 ug/day for average adult. (3) The U.S. Agency for Toxic Substances and Disease Registry (ASTDR) standard Minimum Risk Level (MRL) for chronic- duration inhalation exposure (365 days or more) to mercury vapour is 0.2 ug Hg/m3 , which translates to approximately 4 ug/day for the average adult. (4) The range of mercury exposure levels found in people with amalgam fillings by the World Health Organization Scientific Panel on Mercury was 3 to 70 ug per day (3) , with other medical studies finding up to 200 ug/day in gum chewers or people who grind their teeth. (6) (11) (16) (17) (18) The average exposure was above 10 ug/day3- . (18) The average mercury exposure for a Canadian adult with amalgam fillings was found in the Health Canada study to be 9 ug/day. (2) In a large German University study with 20,000 tested subjects, the average exposure from fillings was over 10 ug/day and over 50% of all those with six or more amalgam fillings had daily exposure exceeding the EPA health guideline. (17)

Studies have consistently found modern high copper non gamma-two amalgams have greater release of mercury vapour than conventional silver amalgams. (21-23) Recent studies have concluded that because of the high mercury release levels of modern amalgams, mercury poisoning from amalgam fillings is widespread throughout the population. (17) (18) (22)

Levels found in persons with amalgam fillings can be over 10 times the Health Canada TDI, and more than the EPA health standard for mercury vapour. Thus persons with amalgam fillings have levels of intraoral mercury vapour and body exposure levels higher than the level considered to have significant health risk and proportional to the number and extent of amalgam surfaces, but other factors such as chewing gum and drinking hot liquids influence the intake. Swedish research by Skare et al concluded that the average citizen was conservatively estimated to have 32 micrograms of mercury in faeces daily with an uptake of 12 micrograms of mercury into their bloodstream and tissues every 24 hours. (6) The worst case individual in the study was measured at 190 micrograms per day of mercury in faeces, with an estimated bloodstream and tissue uptake of 70 micrograms per day. Thus the average citizen could have absorbed up to or over 100mg of mercury after 25 years. Skare’s findings need to be compared with the EPA limit of 2 parts per billion for safe drinking water. Notably, the WHO Scientific Panel concluded that a safe level of mercury exposure below which no adverse effects occur has never been established. (3)

The majority of New Zealand children born in the 50-60s have lived with dental amalgam fillings since primary school when the school dental nurses in the “murder houses” drilled and filled any tooth that had the slightest surface defect or even a deep natural groove. This went by the euphemistic name of “filling the valleys” or essentially prophylactic odontotomy, i.e. making a hole and filling it to prevent a hole. Regarding this, a Health Department paper revealed that in 1968 21-year-old adults had an average of 16 amalgam fillings with 15-year-old teenagers averaging 13 fillings. (24)

In 1976, the New Zealand Health Department sent out an unusual notice to all dental personnel that essentially requested that they only drill into teeth showing decay. The underlying reason for this has remained mysterious but there are some interesting and plausible reasons. The first fluoride experiment was carried out in Hastings in the preceding years and had been a complete failure with the control town of Napier actually showing the same or even less dental “decay”. Estimation of decay was based on the numbers of decayed, missing or filled teeth (the DMF score). However, most of the results related to the F or filled teeth. The inspectors thus counted the number of fillings but it was then realised that the dental nurses had been instructed to treat all teeth that had even minor surface defects as being decayed but were essentially non-carious. The research protocol was therefore covertly altered and concealed in the published document.

Some 20 years later a revealing paper appeared in the New Zealand Dental journal where the author euphemistically stated that “changes in dental practice” resulted in a decrease in dental fillings. That decrease was identified as 30% in 1977 and an astounding 64% by 1981. (25) This would have dropped the average from 16 to between 7 and 8 or what is generally accepted as the norm by the WHO. Obviously that decrease in “decay” had far less to do with fluoride than the fact that dental nurses and dentists were no longer making the holes or “filling the valleys”. However, the 1996 Health Canada report on dental amalgam revealed that the maximum tolerable daily intake (TDI) of mercury vapour would be reached from 4 average sized amalgam fillings (or 8 tooth surfaces) for a 70kg adult when based on industrial safety levels (3) and this needs to be additionally considered in view of the current amalgam loading.

The symptoms and signs of mercury toxicity listed by amalgam manufacturers Dentsply-Caulk and IvoclarVivadent in their 1997 Manufacturer’s Safety Data Sheets (MSDS) included the following adverse health effects from chronic inhalation and/or ingestion: tremor, fatigue, headaches, irritability, excitability, depression, insomnia, loss of memory, hallucinations, psychiatric disorders, mental deterioration and resentment of criticism. (26) However, the covert underlying common denominator is usually missed as all of these symptoms and signs can occur with other more readily diagnosable conditions, and as medical students let alone doctors have not been instructed to look at teeth. Mercury release from amalgam has to occur when dissimilar metals are placed in the hot, salty and frequently acidic saliva due to oral galvanism and electrolysis. This is fundamental school chemistry.

Alzheimer's Senile Dementia (AD)

The genetic factor in AD is well known. There is a blood test for AD called Apo-lipoprotein E genotyping or apo-E for short. Two papers on this appeared between ’96 and ‘98 when Dr. Alan Roses from Duke University revealed that Apo-E genotyping was related to the risk of early onset AD. (27) There are 3 genotypes E2, E3 and E4 with 6 possible combinations as we inherit from both parents, i.e. E2/2, E2/3, E2/4, E3/3, E3/4, E4/4. The last of these has the greatest risk at 70% chance of early onset AD before age 70. The onset of AD in those with E3/4 comes about 10 years later and the E3/3 again about 10 years later. Those with the E2 have to live to a very old age before any signs develop. Research subsequently revealed that about 1-2% of the population has the E4/4, 15-20% the E3/4 and 50-60% E3/3. However, the underlying reason remained a mystery and further research only complicated matters. For instance, one paper revealed that Africans in Africa with E4/4 did not get AD but Africans in the USA did and the authors wondered about different diets.

In 1999, Professor Boyd Haley, Chair of Chemistry, at Kentucky University, Lexington, and a leading researcher into mercury, revealed to a group of doctors that there was no mystery about the underlying reason for apo-E genotyping. It lay in the biochemistry. Apo-E has 299 amino acids with different ratios of cysteine and arginine at position 112 and 158. Apo-E2 has 2 cysteines, apo-E3 one cysteine and one arginine, and apo-E4 two arginines. As arginine, unlike cysteine, lacks the sulphydryl (SH) groups to potentially bind bivalent metals such as mercury, lead, copper or zinc, it would be logical to suspect the possibility of increased metal accumulation in those chronically exposed individuals who had not inherited apo-E2. Notably, mercury has been proven to cause all the unique microscopic brain lesions that are found in the AD brain at autopsy. Rats exposed to mercury vapour at levels found in people’s mouths with dental amalgam for a few hours a day, developed AD lesions within 2 weeks (28) and a remarkable research paper came out of Calgary University in 2001 showing how in a nerve cell culture the nerve sheath “melted away” when minute amounts of mercury were placed in the culture solution. (29)

Apo-E genotyping was then performed on hundreds of New Zealand patients considered to be suffering from adverse health effects from their dental amalgam to see if there was a statistically valid association and in 2003, the journal of Alzheimer’s Disease published the first paper showing the association between amalgam and the risk of developing AD. (30) This was followed 3 years later with a second paper showing that chronic fatigue, depression and memory loss were also markedly increased in those with the apo-E4 and amalgam fillings, together with evidence that removal of amalgam combined with proper protection and detoxification resulted in a significant reduction of the symptoms. (31) This research has been independently confirmed by the findings of another research group at Uppsala University, Finland, who also investigated the effects of protected amalgam removal. (32)

It would seem appropriate that all patients with memory loss and the other symptoms listed above need to be evaluated for mercury toxicity from dental amalgam. AD could be either preventable or at least prevented from deteriorating in those with dental amalgam. Proper advice and where to get the best treatment in the USA is available (33) and it is of paramount importance that the process is done correctly. Good science is now therefore proving that mercury is related to the onset of these common problems and, as the WHO had confirmed, that amalgam is the biggest source of mercury vapour in the non-industrially exposed populations1 , we need to seriously look at this dental material.

Mercury and the blood

It is an established fact that approximately 80% of inhaled mercury is retained to then travel to the main target organs, namely, brain, heart and kidneys. However, although levels in the blood may not be significantly elevated, mercury covertly does two highly relevant things. Firstly, it binds to haemoglobin and reduces that red cell’s oxygen binding capacity and secondly, it kills lymphocytes. Unfortunately, standard laboratory tests will detect neither. The laboratory checks total haemoglobin and an assumption is made that the oxyhaemoglobin (OxHb) proportion was normal. However, research at Colorado University with a Co-oximeter differentiating total Hb, OxHb and CarboxyHb has confirmed in some hundreds of symptomatic patients with amalgam that their OxHb levels were at least 20 per cent lower confirming what other research has shown. (34) This would equate to having a litre of blood missing as far as oxygen carrying capacity and would quite likely result in being "tired all the time" or chronic fatigue syndrome, a diagnosis that does nothing to help the patient.

The lymphocyte effect was discovered when fresh blood was centrifuged and the white cell layer removed. A propidium iodide viability stain then identified the viable vs. the non-viable proportion with a significant incidence of the latter being found. Subsequently, a culture of lymphocytes was exposed to a level of mercury usually found in the blood of people with amalgam fillings and considered safe. (35) After 4 days incubation over 80 per cent had become non-viable compared to only 3 per cent in the control culture. This could be a reason why the white blood cell reference range has progressively widened over the past century as the body’s internal monitoring systems may be detecting a lymphocyte “deficiency” as the lymphocyte “policemen” are being eliminated as soon as they leave the academy and go on the beat.

Two papers on cancer with one on breast (36) and another on colon (37) have studied natural Killer (NK) lymphocyte activity and outcome. Both found that those patients with “active” lymphocytes had a much better outcome than those with “inactive” NK cells. There was a 47% 5-year mortality in the breast cancer patients with non-reactive NK cells vs. 4% in those with active NK cells. Neither of the papers' authors discussed what, if anything, could influence activity but a definitive cause is there if this description is changed from active to viable and inactive to dead as non-viable mercury contaminated NK cells would certainly be inactive.

Michael E Godfrey, MBBS, FACAM, FACNEM, is Medical Director of the Bay of Plenty Environmental Health Clinic and head of Clinical Thermography, both of Tauranga, New Zealand

With acknowledgement to B Windham PhD, Research Director for DAMS International, for relevant links and references.

References

1. World Health Organization(WHO),1991, Environmental Health criteria 118, Inorganic Mercury, WHO,
Geneva; & W. Craelium, J Epidemiology and Community Health, 32:155-65,1978.
2. U.S. Environmental Protection Agency(EPA), 1996, "Integrated Risk Information System, National Centre
for Environmental Assessment", Cincinnati, Ohio(& web).
3. Mark Richardson, Environmental Health Directorate, Health Canada, Assessment of Mercury Exposure
and Risks from Dental Amalgam, 1995, Final Report, & G.M. Richardson et al, "A Monte Carlo Assessment
of Mercury Exposure and Risks from Dental Amalgam", Human and Ecological Risk Assessment, 2(4): 709-
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4. Agency for Toxic Substances and Disease Registry, U.S. Public Health Service, "Toxicological Profile for
Mercury" (ATSDR TP93/10), March 1999, p 509.
5. I. Skare, "Mass Balance and Systemic Uptake of Mercury Released from Dental Fillings", Water, Air, and
Soil Pollution, 80(1-4):59-67, 1995.
6. I. Skare et al, "Human Exposure to Hg and Ag Released from Dental Amalgam Restorations", Archives of
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Total Environment, v168,n3,1995.
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Trace Elem. Exper. Med., 1990,3, 111-123.
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mercury levels in expired air", 60, 1981, p1668-.
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12. L. Bjorkman et al, "Mercury in saliva and feces after removal of amalgam fillings", Toxicol Appl
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13. M. Molin et al, "kinetics of mercury in blood and urine after mercury removal" J Dent Research, 1995,
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Occup Health 66: 209-212.
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Research, 1996, 75(1): 594-598.
17. P. Kraub et al, Universitat Tubingen,Instit fur Organische Chemie,1997, http://www.uni-
tuebingen.de/KRAUSS/amalgam.html ; & I.Gerhard, E.Roller, et al, Tubingen Univ. Gynecological Clinic,
Heidelberg,1996, BUND Press Release 1997 & Bundesinstitut fur Arzneimittel un Medizinprodukte, 1997.
18. B. Windham, Anotated Bibliography of Exposure and Health Effects from Amalgam Fillings, 1997 (over
400 references).
19. Halbach, 1995,"Estimation of mercury dose ..", Int. Archives of Occupational & Environmental Health,
67:295-300; & G. Sandborgh- Englund, "Pharmacokinetics of mercury from dental amalgam",
Gotab(Stockholm), 1998, 1-49.
20. H.V. Aposhian, Envir. Health Perspectives, Vol 106, Supp 4, Aug, 1998; & H.V. Aposhian et al, FASEB
J, 6: 2472-2476, 1992.
21. J Pleva, "Mercury- A Public Health Hazard", Reviews on Environmental Health, 1994, 10:1-27.
22. A. Berglund, "A study of the release of mercury vapor from different types of amalgam alloys", J Dent
Res, 1993, 72:939-946;.
23. H. Lichtenberg, "Mercury vapor in the oral cavity in relation to the number of amalgam fillings and chronic
mercury poisoning", Journal of Orthomolecular Medicine, 1996, 11:2, 87-94.
24. Beck DR. Dental Health: Status of the New Zealand population in late adolescence and young
adulthood. Dept. of Health Special Series 29 (1968)
25. De Liefde B. The decline in caries in New Zealand over the past 40 years. NZ Dental Journal
1998;94:109-113
26.Manufacturer’s Safety Data Sheets (MSDS) and Directions for Use (DFU) Dentsply/Caulk and Ivoclar
(Europe) http://caulk.com/MSDSDFU/DispersalloyMSDS. Accessed February 1998
27. Roses AD and Saunders AM. Apolipoprotein E genotyping as a diagnostic adjunct for Alzheimer’s
disease. Int. Psychogeriatr. 9 (Suppl.1)(1997):277-288 and 317-321
28. Pendergrass JC, Haley BE, Vimy MJ, Winfield SA and Lorscheider FL. Mercury vapor inhalation inhibits
binding of GTP to tubulin in rat brain. Similarity to molecular lesion in Alzheimer’s disease brain,
Neurotoxicology 1997;18(2):315-324
29. Leong CW, Syed NI and Lorscheider FL. Retrograde degeneration of neurite membrane structural
integrity of nerve growth cones following in vitro exposure to mercury. NeuroReport 12 (2001):733-737
(http://movies.commons.ucalgary.ca/mercury)
30. Godfrey ME, Wojcik DP and Krone CA. Apolipoprotein E genotyping as a potential biomarker for
mercury neurotoxicity. J.Alz.Disease 2003;5:189-195
31. Wojcik DP, Godfrey ME, Christie D and Haley BE. Mercury Toxicity presenting as Chronic Fatigue,
Memory Impairment and Depression : Diagnosis, Treatment, Susceptibility, and Outcomes in a New
Zealand General Practice Setting. (1994- 2005)Neuroendocrinological Letters 2006
32. Lindh U, Hudecek R, Danersund A, Eriksson S, Lindvall A. Removal of dental amalgam and other metal
alloys supported by antioxidant therapy alleviates symptoms and improves quality of life in patients with
amalgam-associated ill health. Neuro Endocrinol Lett. 2002;23(5-6):459-482
33. www.hugnet.com
34. Magos L. Mercury-blood interaction and mercury uptake by the brain after vapor exposure. Environ Res.
1967;1:323–327. MEDLINE | CrossRef
35. Huggins HA Medical Implications of Dental Mercury: A Review. Explore (2007)3; 2:110-117
36. Head J, Wang R, Elliott RL and McCoy JL. Assessment of immunologic competence and host reactivity
against tumor antigens in breast cancer patients. Prognostic value and rationale of immunotherapy
development.Ann. NY Acad. Sci.1993;690:340-2
37. Imai K, Matsuyama S, Miyake S, Suga K, et al. Natural cytotoxic activity of peripheral-blood
lymphocytes and cancer incidence: an 11-year follow-up study of a general population. Lancet. 2000 Nov
25;356(9244):1795-9

Further reading:

Genchi G, Sinicropi M, Carocci A, Lauria G, Catalano A. Mercury Exposure and Heart Diseases

Published: 12 January 2017 International Journal of Environmental Research and Public Health 14(1),74 doi:10.3390/ijerph14010074

SCIENCE ADVOCACY FOR HUMAN & ENVIRONMENTAL HEALTH ... IN SERVICE OF THE PUBLIC'S RIGHT TO BE INDEPENDENTLY INFORMED.

Physicians and Scientists for Global Responsibility (PSGR) work to produce transparent, high quality science information to educate and inform the public. You might not know us - but we've been working on these issues for 25 years! We respond to consultations on new policy and legislation, release white papers and reports, and interview scientists and doctors whose work draws attention to complex scientific issues - that are often not easily inserted into and indeed, are often missing from, government policy.

PSGR place the public interest, and the obligation to protect future generations at the centre of all research and decision-making. To do this involves thinking about how society identify problems in the first place, and then permits meaningful discourse around normal challenges, such as uncertainty and ambiguity in information flows.

PSGR 'wade into' human and environmental health issues that are polarised and controversial. These issues are not well covered by MSM. Why are they controversial? Because they concern human life - and the impact of technology on our health. As humans we interact with a lot of technologies and a lot of substances - so life is - and must be - political!

JUST RELEASED APRIL 2025:

April 27, 2025 - PSGR's submission to the Royal Commission COVID-19 Lessons Learned, Phase 2 Consultation.

THE 'HIJACKING DEMOCRACY' PAPERS

April 16, 2025 - PRESS RELEASE: Has MBIE short-circuited good process in recent government reforms?

PSGR (2025) When powerful agencies hijack democratic systems. Part I: The case of gene technology regulatory reform. Bruning, J.R., Dommisse, E.. Physicians & Scientists for Global Responsibility New Zealand. ISBN 978-1-0670678-0-9
PSGR (2025) When powerful agencies hijack democratic systems. Part II: The case of science system reform. Bruning, J.R.. Physicians & Scientists for Global Responsibility New Zealand. April 2025. ISBN 978-1-0670678-1-6

PSGR have written to the Ombudsman asking that they convene a public inquiry to assess whether officials directly undermined public law conventions and processes to pursue policies and laws in favour of the deregulation of gene editing technology. PSGR have emailed members of Parliament to advise them of the complaint to the Ombudsman.

Why? Read our Part I paper: The case of gene technology regulatory reform.

PSGR are also calling for a ‘transparent and public inquiry’ that can (a) identify the factors leading to the collapse of the capacity of New Zealand’s research, science, innovation and technology system to be adequately resourced to meet the objectives of society at large; and (b) recommend how to transform it into having that capacity, and in doing so serve the public purpose and support the wellbeing of New Zealand, her people, resources and environment.

Why? Read our Part II paper: The case of science system reform.

PSGR's strategic direction is underpinned by legal principles and/or fields of law (including particularly public law) that support decision-making in the public interest so that future generations may be protected.

If society draws attention to risk from a technology or a substance, there is a financial threat to the corporations that have that technology or substance on the market, or a political threat to the government institutions whose policies say that a technology or substance is beneficial, safe and effective. But for democracy to work, the scientific and technical information used to justify that the tech, or the policy promoting that a tech is safe must be evidence-based. It must be transparent and accountable, and the public must see how the decision was made. Being evidence-based includes updating the evidence as the scientific data on risk changes.

Some of the issues PSGR talk about: fluoride, pesticides and regulatory failure (e.g. glyphosate and chlorpyrifos), the evidence that ultraprocessed food is addictive, antidepressant risk in pregnancy, central bank digital currencies (CBDCs) and why gene edited techniques and organisms are not as safe as authorities imagine. If governments don't use impartial evidence when they're making a decision about a technology or substance, the public really can't trust the data because of the conflicts of interest in the data that is used. When industry-made data (that is secret and confidential) is used to justify keeping a product on the market, perhaps it is more like a form of propaganda?

Democracies have rules and principles in place to ensure that government officials follow good process, and act in the public interest. Important democratic principles can be undermined, and values set aside. Corporate data can be preferred, even if it is secret. The job for society is to stop this happening and to be keenly aware on regulatory capture. People need to step in when officials start to pretend that they do not have to be transparent and accountable, fair and just.

Working out when a technology or substance produces harm, to a small child or an adult, is a difficult process because harm can be acute (immediate) or chronic (slow moving and more difficult to detect). How do decision-makers, scientists and researchers problematise, weigh and consider issues that might be uncertain or ambiguous? How this is undertaken is a reflection of the culture, power-relations and resourcing that surrounds them. It can be easier for an under-funded regulator to default to old, corporate data. If nuanced or difficult issues are dismissed or ignored; and there is no language of probability, risk or precaution, society can end up ignorant - such as failing to understand when an (economic, biological, ecological, political or social) tipping point might be arrived at. Good decisions that support health and resilience require broad-based social, scientific and economic information, recognition of power and politics, and value-based judgement. Talking about these issues can help society understand what our values are and prioritise what is important.

There is a substantial volume of legal literature that underpins and support scientific decision-making in the public interest, these include the precautionary principle, administrative principles of law and the emerging field of earth jurisprudence.

These principles support and reinforce complex decision-making to protect and sustain human and environmental health and the biological integrity of the land, water, food and technology that we depend on.

Our research and educational role focusses on drawing public attention to both human health and ecosystem risks from unanticipated effects of new technologies or environmental pollution. For example, such damage may adversely impact on a genome - whether plant, animal, micro-organism or other - and have the potential to create adverse, unanticipated, and inter-generational consequences that cannot be reversed.

Health risk is not limited to heritability: twenty-first century science continues to unpack the role of environmental influences that impact genetic function. Our work includes research to advance education about assisting body systems to work effectively while minimising their exposure from environmental harms.

It is becoming evident that subtle (and not so subtle) epigenetic modifications to the genome - which does not damage the gene but negatively alters the way the gene functions - play a substantial part in genetic health, because epigenetic regulation influences all biological processes.

Such modifications may arise from pollution, toxicity, nutritional stress, a disrupted gut microbiome and mental stress.

PSGR makes every effort for the data considered in analyses to be unbiased and trustworthy, giving due weight to the precautionary principle and the public interest. That involves making special effort to pay particular attention to evidence-based research that is produced by independent scientists and researchers who are motivated to sustain ecosystem and human health.

The current accelerating erosion of ecosystem and human health might, on the evidence, be assigned reasonably to 'market-science', rather than public interest science.

In recent decades much of government-financed public interest science has declined rapidly: that has led to dominance of 'market-science' because scientists have become funded predominantly from market players and the profession is predominantly dependent on that market funding for its survival.

PSGR welcomes new members - even if you are not scientists or doctors!

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The information, submissions and other contents on this website are provided by PSGR in the public interest and for professional scientific and medical discussion. This does not imply that all of the views expressed are held by all Trustees. Links to other sources of information do not imply an endorsement by PSGR of that organisation.

Precautionary Principle, Knowledge & Tech-Based Risks

In order to protect the environment, the precautionary approach shall be applied widely by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. (UNCED 1992)

When Germany established the Clean Air Act in 1974, it included the requirement for Vorsorgeprinzip, or foresight. This was the first formal application of the precautionary principle.

In 1992 the Precautionary Principle was included in the Rio Declaration on Environment and Development, to aid UN member states with the protection of the environment and the prevention of environmental degradation. The step to incorporate the Precautionary Principle to protect human health, in addition to an obligation to prevent environmental harm, was taken in 2005 by UNESCO:

When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm. Morally unacceptable harm refers to harm to humans or the environment that is:

Threatening to human life or health; or

Serious and effectively irreversible; or

Inequitable to present or future generations; or

Imposed without adequate consideration of the human rights of those affected.

The judgement of plausibility should be grounded in scientific analysis. Analysis should be ongoing so that chosen actions are subject to review. Uncertainty may apply to, but need not be limited to, causality or the bounds of the possible harm.

Actions are interventions that are undertaken before harm occurs that seek to avoid or diminish the harm. Actions should be chosen that are proportional to the seriousness of the potential harm, with consideration of their positive and negative consequences, and with an assessment of the moral implications of both action and inaction. The choice of action should be the result of a participatory process. (UNESCO 2005, p.14)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity reaffirmed the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development (1992).

Principle 15 In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

The objective of the Cartagena Protocol is set out in Article 1 as follows:

In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health, and specifically focusing on transboundary movements.

The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union. The European Commission note that:

Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:

proportional to the chosen level of protection,

non-discriminatory in their application,

consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),

subject to review, in the light of new scientific data, and

capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.

WHY THE PRECAUTIONARY PRINCIPLE IS A USEFUL POLICY TOOL

In 2004 the World Health Organization released a white paper: The precautionary principle: protecting public health, the environment and the future of our children. Key findings (pages 3-6, edited/abridged):

The PP helps people navigate uncertainty. As “modern” potential risk factors become more complex and far-reaching, the precautionary principle addresses uncertain risks and seeks to shift the ways in which science informs policy from a strategy of “reaction” to a strategy of “precaution”. Together with related approaches such as health impact assessment, precaution provides a useful means of guiding public health decisions under conditions of uncertainty, in a manner that appropriately addresses the issues of power, ownership, equity and dignity.

The PP supports policy-makers and officials in decision-making. Substantial evidence supports the conclusion that contemporary environmental health risks result from complex interactions among genetic, nutritional, environmental and socioeconomic factors. The precautionary principle can be used to encourage research, innovation and cross-disciplinary problem-solving in the face of these complex risks.

The PP helps clarify the role of environmental science in policy-making. This includes policy-making and evidence-based decision-making and how to weigh and judge evidence.

There is no contradiction between pursuing scientific progress and taking precautionary action. Indeed, applying precaution demands more rigorous science in order to characterize complex risks, clarify gaps in knowledge and identify early warnings and unintended consequences of actions. It also means using science not only for the diagnosis of environmental hazards but to identify, develop and assess safer alternatives to potentially harmful activities.

The PP is especially important in countries with weaker regulatory jurisdictions, including developing countries. The PP can inform decisions under the great uncertainty that prevails, can help build public confidence, can raise research and innovation capacities, can ensure that mistakes made in the past in industrialized countries are not repeated, and can help shift burdens from the public institutions to those creating the risks.

There is no single recipe for applying precaution. Flexibility in applying precaution is critically important, since each decision is different – with different types of risk, evidence, uncertainty, affected communities, availability of alternatives, and technical and financial resources. Consistency thus comes from using the same precautionary framework and process in each case. What is considered an “acceptable risk” or sufficient evidence to act is a function not only of the level of risk and the strength of evidence and uncertainty, but also of the magnitude, reversibility and distribution of the risk, the availability of opportunities to prevent risk, the public’s risk aversion, society’s culture and values, and the pros and cons of alternative options.

Preventive precautionary actions aim at continuously reducing and if possible, removing exposures to potentially harmful substances, activities and other conditions.

- encourage the replacement of dangerous substances and activities with less dangerous substances or technologies where suitable alternatives are available;

- reconsider production processes, products and human activities so as to minimize significant adverse effects on health and the environment.

- establish public health goals for protecting the health of humans and ecosystems (such as for reducing blood lead levels or improving fisheries);

- provide information and education to the public to promote empowerment and accountability;

- integrate precautionary considerations into the research agenda to facilitate rapid interventions to prevent damage to health; and

- minimize, so far as possible, unintended adverse consequences that may be caused by precautionary actions.

PRECAUTION IN NEW ZEALAND – GMO/HAZARDOUS SUBSTANCES

New Zealand ratified the Cartagena Protocol for Biosafety in 2005. New Zealand was one of the 175 countries who signed the 1992 Rio declaration.

In such an environment, information and guidance on the application of the precautionary principle can support policy and decision-making by officials. In New Zealand, implementation of the precautionary principle is inconsistent and poor. There is no evidence of policy work/briefings undertaken to develop decision-making frameworks and guidelines, and make such information generally available and easily accessible to officials (including legal counsel) across central government agencies, or who work for territorial and local authorities.

Hazardous Substances and New Organisms (HSNO) Act 1996 specifies (s.7)

'All persons exercising functions, powers, and duties under this Act including, but not limited to, functions, powers, and duties under sections 28A, 29, 32, 38, 45, and 48, shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects.'

Government officials would be unlikely to consider precaution without guidance.

The Ministry for the Environment administers the HSNO Act, but has not produced guidance material for officials or for the public, relating to their obligation to take caution into account.

Since 1996 the New Zealand Environmental Protection Authority (NZEPA) does not appear to have released guidance for officials in taking a precautionary approach. The NZEPA operates under the HSNO Act, but their Risk Assessment Methodology (Updated 2022) does not provide a decision-making pathway to support decision-making when there is scientific and technical uncertainty about the potential adverse effects from the hazardous substances (biotechnologies and hazardous chemicals) stewarded by that Authority.

The lack of resource materials to support government officials in the use of the Precautionary Principle may not only lead to officials under-appreciating the tool - this may be a determining factor in the Precautionary Principle deliberately being set aside (in 2024-2025) by New Zealand's Attorney General, Judith Collins. Government officials and the Crown Law Office may be deliberately excluding the Precautionary Principle in proposed legislation which will aim to steward the release of biotechnologies into New Zealand's environment. The public, academia and media lack a language/expertise on this issue, and this issue is rarely addressed by public law experts and so push-back is unlikely.

Such an action would likely contradict New Zealand's commitment as per the Cartagena Protocol for Biosafety.

2024 COURT DECISION - SOUTH AFRICA

In a 2024 South African Supreme Court of Appeal judgement, African Centre for Biodiversity NPC v Minister of Agriculture, Forestry and Fisheries and Others five judges unanimously ruled that evidence provided by the applicant (in this case Monsanto) in support of a gene edited maize (MON87460) was inadequate to prove safety of the product. The African Centre for Biodiversity's appeal was upheld:

The thrust of the appellant’s case is that the State respondents accepted, at face value, the claims made by Monsanto and failed to independently and critically evaluate Monsanto’s application to satisfy themselves that the health and safety risks associated with the general release of MON87460 had been properly addressed. The appellant contends that the expert evidence that served before the State respondents, ought to have triggered the application of the precautionary principle enshrined in s 2 of NEMA. This, for two main reasons: first, there was a lack of scientific data from which conclusions about the safety of MON87460 could be drawn; and second, the 7 data that had been made available supported concerns about health risks arising from the use of MON87460.'

The precautionary principle was triggered and ought to have been applied.

WITHOUT MONITORING & RESEARCH FUNDING, ARE WE 'RIDING BLIND'?

Relative ignorance concerning the application of the precautionary principle dovetails with underfunding for monitoring and scientific research on risk of technologies. These issues are two sides of the same coin. While governments have provided funding for biotechnology research and development to support release onto the market of biotechnologies, they have vastly underfunded research to identify risks and harms that might be associated with the development and release of these GMOs, including GMOs created using modern gene editing techniques.

The speed of production and release of novel entities, which include man-made chemicals and genetically modified organisms (GMOs), exceeds the pace of monitoring and risk assessment. A small range of crops have been commercialised globally. In the last 25 years, GM crop production has experienced over 100-fold increase. The pace and scale is particularly notable with newer gene editing techniques, which have amplified development speed and shortened the bench-to-market timeline. Academia has joined with industry in the rush to commercialise the technologies (here and here) used along the development chain. Whether a patented food crop reaches the market is highly dependent on the success of trials, including the extent to which transparency in trial outcomes is demanded by government regulators. Trials should not only test for dietary safety, but should include tests for crop vulnerability to unintended disease outcomes, for impact on non-target organisms and for yield.

If governments can fund research and development using new gene editing technologies, they can fund risk-based research. The New Zealand government does not provide funding for long-term interdisciplinary research. Without recognised expertise, media, officials and the courts cannot develop a language of risk and precaution. They are unlikely to turn repeatedly to a single expert. When very few independent experts, who have no conflicts of interest, are willing to speak about risks, these experts can become sidelined or ostracised, simply for pointing out actual or potential hazards.

Empty funding pots for long term, interdisciplinary, risk-based research is not an exclusive problem for would-be GMO researchers. The funding black hole encompasses a much wider spectrum of technology-based harm. This includes exploring risk from hazardous substances (such as pesticides or fluoride) and risk from electromagnetic radiation (EMR) exposures. The barriers limit discovery into how technology might be impacting productivity and economic growth. For example, without long-term funding, local scientists cannot assess how diets high in ultraprocessed foods drive a wide range of disease including neurological disorders, and explore how ultraprocessed foods hasten environmental degradation.

Funding is available to develop new, gene-manipulated organisms, to create new food-based technologies, and technologies and systems which integrate wireless communication and surveillance technologies. Funding is not available to monitor and assess their risks.

It is important to recognise that the absence of funding pathways creates a dearth of experts who can raise issues about risk from technologies, their emissions and their impact on vulnerable or non-target organisms.

For decades young scientists have studied biology and ecology, often with the thought that by studying how life works, from the cellular to the ecosystem level, their research may support human endeavours to protect planetary life, from the cellular level to the functioning of ecosystems.

People want to monitor and identify how harm is created so that governments are informed, and human health and our ecosystems can be protected. But many young scientists find it impossible to monitor and research these issues, because the funding frameworks instead steer them towards research in innovation and pipeline development.

Research on risk is vital, but it is barely happening. This research needs to be funded and the work carried out a safe distance from the developers and patent-holders.

REGULATORY AGENCIES CAN USE NEW TECHNOLOGIES TO ESTIMATE HOW HARM CAN, AND MIGHT, OCCUR

Governance risks are frequently complex, uncertain and ambiguous. Safe regulation of technologies is an especially complex endeavour. The decisions made by governments, scientists and regulatory authorities are values-based. At what level of potential or demonstrable harm do we say 'no more' when man-made technologies interact with open-ended biological systems?

This depends on expertise and the curiosity and values of the policy-maker and researcher. Does that official have the capacity and willingness to recognise and publicly discuss perhaps-controversial risk-based issues when they arise in the literature? This can include focussing on the developmental origins of health and disease, and integrating new information relating to genetic and epigenetic impacts, neurodevelopmental/neurodegenerative risks, cancer risk and endocrine (hormone-level) impacts when published in the scientific literature.

Precaution is based on our capacity to anticipate harm. While companies use the latest technologies to develop their products, regulatory authorities do not proactively integrate new technologies, such as metabolomics analyses and metabolic enrichment pathway analysis into regulatory assessment to assess risks from the technologies they are charged with stewarding.

Why aren't new technologies adopted to assess the risk from gene edited foods?

The Food Standards Authority of Australia and New Zealand (FSANZ) is currently part of the way through a years long P1055 consultation, where the FSANZ believe that many new gene edited foods are substantially equivalent to conventionally produced foods and do not require (precautionary) pre-market approval. PSGR's submission heavily critiqued this FSANZ belief, emphasising that the reports claiming this by FSANZ lacked appropriate rigor (there were no systematic reviews to demonstrate how potential risk was impartially assessed).

Institutions such as the NZEPA and FSANZ could be doing much more work to explore and understand how pesticides and newer gene edited technologies may produce dietary and ecosystem risks. Hoeppers et al (2024) recently modelled how outdoor gene-editing could impact non-target organisms. The researchers used the in silico tools used by genetic engineers to predict efficacy, to assess the potential for non-target organisms to also be impacted from the outdoor gene-editing process.

Hoepers AM, Heinemann JA, Zanatta CB, Chu P, Hiscox TC, Agapito-Tenfen SZ (2024) Predicted multispecies unintended effects from outdoor genome editing Ecotoxicology and Environmental Safety 282, 1 September 2024, 116707.

In a 2022 Public consultation on the Food Regulatory System Strategic Plan (Australia, 2022) PSGR discussed how omics technologies might be applied in risk assessment science.:

Omics technologies (adductomics, epigenomics, proteomics, metabolomics and transcriptomics) traverse a broader biological space, and can complement the traditional biomarker endpoints and play an important role in understanding mixture effects, and the early molecular events in the pathways leading to disease which to date has been largely excluded from regulatory considerations.

Such technologies can help scientists predict systems level impact, whether at the cellular level, the metabolic and organism level, or at the level of a given system (i.e. an ecosystem or population-based level). But these sorts of technologies are currently outside the skillsets (and funding programmes) of technologies and emissions regulators. These regulatory agencies rarely engage in cross-talk with non-industry scientific experts who research risk, but extensively engage in cross-talk with the industry groups who apply for market access and supply the data for risk assessments.

Karlsson, O., Rocklov, J., Lehoux, A., Bergquist, J., Rutgersson, A., Blunt, M., & Birnbaum, L. (2020). The human exposome and health in the Anthropocene. International Journal of
Epidemiology, 1-12.

ARE REGULATORS HAMSTRUNG BY CONVENTIONS WHICH PRIORITISE INDUSTRY DATA?

Without the autonomy to investigate and review new scientific understandings, regulators default to industry data using regulatory guidelines which ensures that supplied data conforms to guideline parameters.

PSGR consider that when regulatory guidelines fail to acknowledge new risks, and cling on to antiquated modelling rules instead of integrating new information and acknowledging new pathways of harm, the data supplied by corporate industry may be more accurately be described as propaganda.

‘Propagandistic practices such as secrecy, misdirection and silence effectively corrupt constitutions of countries and therefore their public law principles. These practices effectively allow government officials to abandon legal norms of transparency and accountability.’

We reiterate, in New Zealand, funding pathways to assess actual and potential harms of biotechnologies, hazardous substances and EMR over time do not currently exist. Only overseas data and publications on risk assessment can be used to broaden knowledge on this topic. So, they are unlikely to be studied.

Government officials, and the courts require independent experts, but the lack of funding has hampered this research. The identification of how a technology might be hazardous and cause harm, and the likelihood of a harm occurring (the risk) is challenging, particularly if harms occur at the biochemical level, which can result in slow-moving but significant harms over time (such as inter-generationally, for the species which might be impacted).

Scientists will be familiar with the Mertonian norms - communism, universalism, disinterestedness, and organized scepticism. Regulatory science is an inherently political endeavour - vulnerable to challenges by special interests; predominantly path dependent; culturally situated and dependent on (local and global) peer-group values. These factors (and more) interact to shape how regulatory agencies approach and determine risk and hazard over time.

WHAT HAPPENS WHEN RISK IS NOT RECOGNISED, AND 'REGULATED OUT' OF EXISTENCE?

Aspects of risk can fail to be recognised because such factors are outside guideline. A single class of pesticides which accrue in ground-water is not considered an accumulative risk. Cumulative mixtures of man-made chemicals released in urban waste-water are not assessed for toxicity. Herbicides which synergistically promote antibiotic resistance are not considered in risk assessment. The risks from GMO technologies released at scale and pace are not evaluated. Trials for the COVID-19 genetic vaccine failed to screen for carcinogenicity risk. Non-ionic EMF exposures are not considered a hazard.

This undone science results in regulators not having to apply the precautionary principle with regards to these risks, as scientific knowledge is outside the boundaries of risk.

How might the Precautionary Principle be applied if, for example, the Food Standards Authority of Australia and New Zealand (FSANZ) decides that most gene edited organisms in our food will be of equivalent risk to conventionally bred organisms, and therefore be excluded from pre-market assessment? FSANZ legislation does not require the Precautionary Principle to be applied in their decision-making. It appears as if the Precautionary Principle will be undermined if this decision is taken, as gene edited organisms would likely be recategorized into a different risk bracket.

The FSANZ has arrived at such a belief by producing reports that don't adhere to the fundamental principles that define the advancement of science. No reports transparently declare how the FSANZ searched the scientific literature, reviewed the quality of the publications, so as to arrive at a belief of substantial equivalence. Trust in science is based on the following of fundamental norms which are democratic in nature, they not only promote transparency and accountability, but ensure there is a place where controversial and contested claims can be publicly debated. Regulatory agencies which permit submissions for consultation, but do not address the concerns of submitters, effectively short-circuit this process.

THE PRECAUTIONARY PRINCIPLE DURING COVID-19.

The precautionary principle is relevant to public health,

'because it can help to prevent unintended consequences of well-intentioned public health interventions by ensuring a more thorough assessment of the problems and proposed solutions'.

Historically, the precautionary principle applies to the prevention of a particular activity taking place. Health is protected by reducing or stopping harmful exposures. Kriebel et al (2001) noted the different challenges presented: Concluding a phenomenon or association exists when in truth it does not (a Type I error), failing to detect something that actually does exist (a Type II error). Type I errors are guarded by setting the error rate low (5%) while Type II errors set the error rate higher (20%). 'The test is set up to be more cautious about falsely detecting something than about failing to detect something.' Then there is a Type III error - when one provides an accurate answer to the wrong problem, i.e. looking in the wrong place. Health effects from exposures can be difficult to accurately assess.

Interventions in a public health emergency, to act when information is uncertain to implement a pharmaceutical or non-pharmaceutical intervention broadly across a population, is a misapplication of the precautionary principle. The temptation is to over-state risks from the pathogen, and under-state risks from the intervention, in order to secure public confidence and consequently, public compliance with the measures.

During COVID-19 government policies pivoted to enact rules as interventions at the population level. There was no discretion by age or stage. Vulnerable, young people and children were required to submit to interventions in order to socially interact and to access public institutions. Unfortunately, the problem discussed above, where scientists are not funded to produce information that might contradict the policies of governments, equally applied during COVID-19.

During COVID-19 governments applied the precautionary principle in making decisions about whether to restrict free movement, such as in Canada, by enforcing the mandatory quarantining of travellers who arrive by air in a country, when a global health event has been determined.

In New Zealand Judge Cooke cited the Canadian case of quarantining when discussing the use of the precautionary principle and the importance of acting to protect public health, 'based on the best available scientific evidence'. The Judge noted:

Viewed in light of the precautionary principle, the fact that the Order may not provide perfect protection is not particularly significant. The evidence shows that the challenged measures are a rational response to a real and imminent threat to public health, and any temporary suspension of them would inevitably reduce the effectiveness of this additional layer of protection. This, in turn, would have a significant – perhaps deadly – effect on the wider Canadian public, based on the experience thus far.'

As the New Zealand's judges' comment reveals, the judge viewed COVID-19 in late 2021-early 2022 as a 'real and imminent threat to public health' at the population level. The judiciary and the public were broadly unaware of information in March (and here) and October 2020 that demonstrated that SARS-COV-2 was less harmful than the World Health Organization claimed. The judiciary and the public were possibly unaware that a pandemic could be announced that did not presume a high death rate. Before mandates arrived in New Zealand, it was understood that COVID-19 hospitalisation and death risk was exceedingly low for children and adults. However, it was unlikely that government officials charged with oversight of the pandemic were disclosing this information in the courts, while judges would struggle to value and weight information that contradicted official statements.

Historic understandings that restriction of freedom of movement and compulsory medicalisation could have (often difficult to establish) different adverse consequences by age, stage, socio-economic status and the extent to which isolated people would be socially supported, were set aside. Different sub-groups could be adversely harmed by the states' policies (resulting in net harm - reduced health equity) where they might have been unharmed, or less harmed, if exposed to the pathogen.

A judge that believes a pathogen has broad existential risk across an entire population will view that their action to uphold mandates regarding non-pharmaceutical and pharmaceutical interventions is precautionary, and will be unlikely to interpret precaution from taking contradictory or controversial measures that would conflict with peers in the courts or government.

It is noteworthy that during COVID-19, authorities interpreted the 'best available scientific evidence' but failed to give weight to formerly established public health policies on norms on population management from a highly transmissible respiratory, influenza-type virus, based on changing evidence of risk of hospitalisation and death by age. In 2019, the Global Influenza Programme stressed non-pharmaceutical measures. Contrary to historic norms, in 2020-2023, public health surveillance systems equated risk with infectivity rather than hospitalisation and death risk.

Proportionality, even though outlined in overarching legislation, was not debated, nor was scientifically established evidence relating to the pattern of infectivity, pathogenicity and host-resistance or susceptibility. Historic norms which recognised that healthy people would play a role in a population achieving natural immunity, and that natural immunity provided broad-based protection were not accepted.

Interventions (including the role of employer mandates) excised personal choice and obstructed informed consent, the capacity of a person to judge their own risk and make a decision based on their best available evidence. Early on in the pandemic, respected public health scientists released a statement urging that lockdowns and restrictions cease, because of the risk of creating far more harm, than the harm authorities sought to prevent. They were publicly vilified, despite their respected academic backgrounds.

Drugs and nutrients with a long history of safe use and clear knowledge about side effects, i.e. that reflected long-held precautionary norms held by the medical community, first do no harm, were broadly dismissed by health and regulatory agencies due an absence of randomised control trials specifically concerning COVID-19. As COVID-19 was a respiratory virus with known thrombotic effects, scientists and doctors globally advocated for precautionary measures to prevent viral replication, and reduce the likelihood of disease progression, and hospitalisation in vulnerable groups. They were unsuccessful. Advice from medical doctors urging precaution in submissions to a major New Zealand consultation, went unheeded in the committee report.

Governments were reluctant to permit discussion which might promote public doubt on the states' choice of intervention, and states often created barriers to both declaring an adverse event, but also sourcing information about the possibility of risks and the extent of adverse events. Contamination was an identified risk of biologic drugs (and may be the case with the COVID-19 injection), and their mode of action is different from conventional immunisations. The public probably weren't aware that mandates centred around a biologic drug that encoded genetic information, instructing the body to produce a potentially harmful protein, where the production of that protein (the dose) was uncertain, for which a trial was cut short and the placebo group muddied, and for which efficacy centred around two weeks of not getting a cold after the second dose and for which there were no carcinogenicity studies.

Principles of democratic, constitutional and constitutional equity laws which also define the advancement of science and promotes and sustains trust in governing bodies - transparency, impartiality and accountability - were sidelined.

The government did not undertake systemic reviews of the scientific literature, which would include disclosure on how the scientific information was selected and weighted. 'Science Updates' contained no disclosure of any systemic analysis of the relevant literature. There was no disclosure of the scale of adverse events observed in February 2021 by the company with market access in New Zealand, that was reported to the government, but not publicly disclosed. The under-reporting of vaccine-injury was a recognised problem, and this was a completely novel biotechnology implemented at scale and pace.

The process in New Zealand of the mandate rollout was legislated via secondary legislation by the Minister in charge, but there was no requirement for a review of the independently published evidence base for safety and efficacy, by age and status for each new tranche of legislation as the months progressed.

In effect, the precautionary principle if applied, was not applied using traditional evidence-based collation of information, that conformed to principles of scientific rigour and that ensured that the principle of first do no harm, would be a guiding value.

The example of COVID-19, where interventions were enacted under emergency provisions, where critical or dissident scientists were not funded to research risk in COVID-19, and not permitted to engage in debate with senior policy-advisers, politicians and the Director-General of Health, where healthy young people were required to submit to the same measures as frail older people, where uncertainty acted in favour of compulsory, population-wide interventions, - this example has potential to serve as a precedent for future public health emergencies.

Providing independent information in matters of science, medicine and technology, particularly those involving genetics has underpinned PSGR’s work for 25 years.

Taking action to be independently informed involves rigorous curiosity - from technology, through to the biological sciences; to toxicology, epidemiology, to chemistry, genetics and epigenetics.

An open-ended approach is necessary. Because the ‘tipping-point’ when a technology or emission trips (or cascades) a human or biological system into ill-health is often, broadly uncertain. How can society best protect health and promote prosperity?

The good news! Democracy is a two-way process - requiring all hands on deck!

Democracy is founded upon a trust-based relationship between society and government. For trust to be sustained, government agencies and officials have to act in such a way that is impartial and fair. This involves making decisions that are transparent and accountable.

But the problem is, our elected officials are under-resourced, and funding for monitoring and assessing risk from technology and pollution is short-term and precarious.

It’s time for the back-up to arrive! How do we do this?

[1] BE CURIOUS, LOGICAL & PERSISTENT

Unravelling the relationships between policy, law and scientific information can take time. It's important to understand that just because an issue or topic is not discussed in legacy media, or included in television and movie streaming services, this does not mean it is not important. Because there is a lack of information regarding the risk posed by technologies this does not mean that they don't present a risk, particularly to babies, children or young people.

When we hear the terms 'disinformation' and 'misinformation' it is important to realise this is an opportunity for enquiry. Information can be disinformation or misinformation if it fails to be impartial and trustworthy. Questions that may be asked include:

Who provided the information and are there political or financial conflicts of interest that compromise the person or organisation who gathered that information?
Does that person talk about risk to children and young people, and long-term risk in a thoughtful and comprehensive way?
Has the data and scientific and technical information that supports that information been published?
Is there appropriate risk-regulation involved - have agencies considered the information not only from the industries that are keen on a technology, but the scientists and researchers (expert and lay) who draw attention to important and relevant considerations?

Industry and governments can make agreements and put in place commercial in confidence agreements. However, when they involve important issues that have potential to impact rights (in the short or long-term) and lead to the abuse of power, it is incumbent upon the public to ask reasonable questions about hidden information, and draw attention to inconsistencies and contradictions.

Otherwise claims that governments are impartial and trustworthy - our social compact - starts to break down.

[2] OFFICIAL INFORMATION ACT REQUESTS

If you don’t understand why a government decision is made, or want to understand an evolving process, at local, regional or central government level, or with a government provider, - start making simple Official Information Act (OIA) requests.

As former New Zealand Prime Minister Sir Geoffrey Palmer and constitutional lawyer Andrew Butler have noted:

‘One of the most critical elements in preventing corruption and engaging the citizens in the affairs of the Government lies in the Official Information Act. This Act is the engine of open government, which is such an important value. Public opinion is one of the checks against arbitrary power, but only if the people know what is going on. As a famous American Judge Louis Brandeis once said:

‘Publicity is justly commended as a remedy for social and industrial diseases. Sunlight is said to be the best of disinfectants; electric light the most important policeman.’ [1]

Government agencies may lack information and so a request may be refused. That can tell you just as much about how environmental and human health policy as it does when they have information!

[3] DIG INTO THE POLICIES AND GUIDELINES THAT SHAPE GOVERNMENT KNOWLEDGE

It can be surprising to understand just how old the scientific and technical information is, or the guidelines are, that underpin and justify current regulations for a technology. Millions may be being put into development of the technology, or release into the environment, while the safety studies and guidelines are decades old and unchanged. It can be a common problem.

Policies and guidelines might exclude or downplay new knowledge that is highly relevant. For example, the potential for chemicals to interfere with and disrupt hormonal processes; for chemicals in the same class to have an additive effect; and for chemical mixtures to exert an additive and cocktail effect; or for telecommunications equipment safety guidelines to exclude non-thermal effects.

Governments globally have scaled up the release of technologies without scaling up monitoring, oversight and research capacity to identify how those technologies might harm. Understanding how a technology is not monitored, how claims of safety fail to be buttressed by local science and research, can help shed light on problems with human and environmental health.

Often the committees and peer reviewers that provide oversight and shape end outcomes of policy have long-term interests in that policy outcome. When this happens, (and it does), or when governments rely on the opinion of industry to make a claim (e.g. glyphosate reduces herbicide resistance instead of considering more complex drivers) the government cannot be said to be impartial. Good governance includes taking account of new knowledge.

Recognise that scientists and researchers working in government may face barriers to producing information that contradicts government policy. This might be due to narrow terms of reference in the duties that they undertake, it might be based on long-held beliefs (such as prioritising toxicological risk assessment) and it may be due to a lack of long-term resources. Regulators could conduct reviews of the literature, or fund biomarker research, or track epidemiological science to understand population-level impact, but they don't.

Scientists and researchers outside regulatory environments with fragile funding trajectories are unlikely to conduct long-term research or conduct research that is seen as politically risky. This is because they do not want to compromise future funding opportunities.

Also downplayed, is the extent to which risk can scale as efficiencies improve in the development and release of technologies. The extent to which pollutant mixtures scale up is relatively unknown, because governments have simply not kept up with resourcing to enable scientists and researchers to do the work.

[4] GET TO UNDERSTAND THE OBLIGATIONS OF MINISTERS & THE CROWN

How do governments act to protect democracy and prevent abuse of power? As stated by Professor Philip Joseph (p.309):

A public servant’s duty is to the government in perpetuity, not the political party or parties in power at any time. [2]

Public servants – including government Ministers, are required to take into account matters which are controversial. This does not include just 'managing' controversial issues, but providing information relating to such controversial matters that reflects democratic values

a. Take time slowly to understand how government works, and decision-making processes work. Read books to understand how government works, such as Palmer and Butler’s approachable Towards Democratic Renewal.

b. Check out the 2023 Cabinet Manual.

‘Employees in the public sector act with a spirit of service to the community and must meet high standards of integrity and conduct in everything they do. In particular, officials must be impartial, accountable, trustworthy, respectful, and responsive.'

'All inquiries must act independently, impartially, and fairly.'

c. Perhaps have a look at the Legislation Design and Advisory Committee Legislation Guidelines 2021 Edition, and particularly, read the section on constitution. As it seems to be being updated frequently, it might also be interesting to look at older versions of the Guidelines, to understand how the language has changed over the years.

d. When policy and law is being made, ask who is producing the information, and look at what that information includes. This includes reviewing Regulatory Impact Statements which can include cost-benefit analyses. Who conducted the RIS, how old is it, what data was used, were other jurisdictions with different approaches considered - were relevant considerations that concern the public, or a topical, included?

If you are legally minded, we suggest you hunt down one of Professor Philip Joseph’s books on constitutional and administrative law, which sheds light on the obligations of government employees (public servants). Joseph sheds light on how to understand whether decision-making can or should be challenged. For example:

An error of law is made if a decision maker applies the wrong legal test, reaches a factually insupportable finding, comes to a conclusion that was not reasonably open to it on the evidence, takes into account irrelevant matters, or fails to take into account legally relevant matters. Manifest unreasonableness also supports findings of error of law as does an unreasonable finding of fact, a failure to make a finding of fact on a key issue of a decision, or a failure to provide reasons for decisions that affect citizens’ rights.

[5] LOOK AT PATTERNS OVERSEAS

New Zealand is a small country. An understanding of how technologies are regulated overseas, including what information is used and permitted, and how old or secret their guidelines are can inform society here. Offshore court cases which include discovery processes can draw out technical and scientific information that is worthy, but has not seen the light of day.

New Zealand regulators do not tend to publicly take into account offshore legal decisions, or the information that is unearthed during the discovery process.

[6] THINK ABOUT COMPLEXITY

i. Consider these questions posed by Sir Austin Bradford Hill:

How in the first place do we detect these relationships between sickness, injury and conditions of work? How do we determine what are physical, chemical and psychological hazards of occupation, and in particular those that are rare and not easily recognised?

Bradford Hill created a list aspects of an observed association that he proposed should be especially considered before deciding upon a verdict of causation.

ii. Learn about the Precautionary Principle. Read papers (such as this and this and this). Find out whether officials have policy papers or guidance papers to help them take the Precautionary Principle into account.

iii. Think about whether an emission is PBT - persistent, bioaccumulative and/or toxic. How deeply have these factors are taken into account by decision-makers. The 2013 Late lessons from early warnings report provides a good insight on these overlapping factors.

iv. Does the technology and emission present scalability problems? When the technology can be ramped up quickly, so can risk and potential harm.

v. Is uncertainty honestly and pragmatically addressed? Risk and risk governance often involves taking account of complexity, uncertainty and ambiguity. How is this undertaken in the public - or national interest?

vi. Have officials taken into account the Developmental Origins of Health & Disease (DoHaD)? Environmental factors acting early in life (usually in fetal life) have profound effects on vulnerability to disease later in life, often in adulthood. Pregnant mothers, babies and young children are often unwittingly exposed to new technologies and emissions. Has monitoring, research and scientific analyses thoroughly taken account of risks to young brains and bodies?

vii. Do cost-benefit calculations and modelling scenarios take account of new knowledge?

[7] RECOGNISE THAT OFFSHORE AGREEMENTS REQUIRE SUNLIGHT

Trade ‘agreements’, treaties & ISDS tribunals undermine public interest regulation, threatening health, the environment and democratic sovereignty. Defunding of non-STEM academia have reduced the experts who might look at history, ethics, law and the Treaty of Waitangi to understand and assess the long-term impact of international agreements.

If you look at the backgrounds of many of the public ‘experts’ who appear in media speaking up for global or trade agreements, many have a lobbying background or a narrow field of expertise. The do not extend discussion to concerns and risks in the agreements. While it is fair that representatives of industry groups such as our agricultural produce exporters will often speak up, we lack the public interest voice by experts that may broadly speak to the national interest, human rights and the protection of human and environmental health.

Trade agreements and treaties are increasingly common, and they have been embedded in many of our laws for decades. As Professor Philip Joseph has stated:

'International treaties are increasingly the subject of legislation that makes them a quasi or secondary source of constitutional law.'

In1996 the Law Commission considered that

'approximately one quarter of Parliament's statutes either incorporated international treaty obligations or empower the government to give effect to them'. (p.42) [3]

Over time the ‘power’ or authority of these agreements accrue. But who outside of political government (who are signing the agreements) are tasked to - or have sufficient latitude to - look broadly at agreements, and question the suitability of these agreements for New Zealand? Do the arrangements in the agreements and treaties slowly erode sovereignty and/or human rights and/or health, even slowly over decades?

All too often politicians return from an overseas trip having signed the latest agreement.

Trade agreements used to be broadly covered in legacy media, but this is no longer the case.

Companies work to build in clauses that prevent or limit taxation, that prevent governments capacity to promote local ownership (such as of mining companies), or that prevent government requiring that downstream refining or manufacturing is carried out domestically. Investor protection mechanisms can then enable the injured industry to sue the domestic government.[4]

Trade agreements no longer solely concern physical product, but have expanded to include services and intellectual property (IP) provisions.

Ratchet clauses can erode the regulations around services including in sectors traditionally operated by governments such as in health care and education. Clauses can prevent requirements that a service is locally managed, and clauses can prevent governments taking back control of service provision in sectors even if the management of the service is sub-optimum.

Trade agreement clauses may also prevent pricing limits on essential services.

IP provisions in medicine and biotech can protect patent monopolies and create barriers to use of generic drugs. IP provisions on seeds can create barriers to local seed saving.

When there are challenges to trade agreements the duelling actors can end up in investor–state dispute settlement (ISDS). ISDS are increasingly common. Cooper et al (2014) shed light on the risks:

ISDS tribunals have rejected requests to defer to government regulations when these have been enacted in good faith with no intent to harm corporate profits.

ISDS tribunals' decisions have historically required scientific “proof”. However regulatory bodies/ governments have a duty of care. Acting in the public interest often requires them to employ the precautionary principle (aka prudent avoidance), a valuable tool in public policy-making. Confirming associations can be a slow and difficult process and often takes much time and resources. (Many are eventually proven, with scientific certainty, to be carcinogens, endocrine disruptors, mutagens, environmental toxins etc.)

Investor rights can trump public interest rights. A trade agreement may contain provisions that appear to ensure a government’s ability to protect the environment and public health, may be trumped by other agreement provisions that protect investor rights.

ISDS Tribunals undermine democracy, public discussion and dissent:

a. Early settlement may avoid a big payouts but may result in undemocratic regulation. Settlement prior to ISDS arbitration may still result in environmental or health based settlement decisions or ‘agreed principles’ that, with due consultation in the public sphere, may have not been taken.

b. The tribunals may choose if public can participate or contribute. Public participation in ISDS disputes are decided by a panel of 3 lawyers (only 1 of whom is independent).

c. Trade agreements may create environments hostile to journalists and whistleblowers and may compromise internet freedom. Online action targeting corporate wrongdoing may be prohibited.

ISDS claims frequently target environmental and health policy measures. Analysts noted that “the provisions designed to ensure security and predictability for the investors have now created uncertainty and unpredictability for environmental (and other) regulators.”

It’s simply not democratic. Our judicial system looks after us better. ISDS arbitration mechanisms can undermine domestic public interest regulation - providing the public with greatly limited ability to engage in these disputes. The secrecy and barriers to participation lack key aspects of basic procedural fairness. This compares to the sophisticated procedural tools available to the public within the modern judicial system. Here, specific regulatory by-laws can be developed and become the subject of legal challenges - due process is provided under more transparent legislative and judicial systems.

7. Agreements can be based on estimated future profits – and predominantly multinational corporations engage. ISDS arbitration is only for multinational, and not domestic corporations.

Corporate lawyers lack public policy experience. Tribunal members appointed to adjudicate disputes frequently have a commercial law background. Arbitrators may lack the necessary expertise to consider broader public policy implications.

Local government regulations and by-laws are vulnerable. Local regulations may regulate to benefit local health & local economies. However they can be overridden by a government anxious to reach a less costly settlement.

Tribunals are not bound by rules of precedent. This creates even more uncertainty over ISDS outcomes and a “chilling effect” on government regulation.

Offshore agreements and the chilling effect imposed by the ISDS process can result in human rights being threatened or eroded. One way which has been suggested is for Four Key Human Rights Tests – Trade agreements should:

Contain enforceable human rights conditions.

Be subject to an independent human rights and environmental impact assessment.

Contain enforceable human rights obligations on businesses and investors.

Exclude the investor-state dispute settlement mechanism.

But who in New Zealand could speak to such issues and gain media traction for debate?

However, who doesn’t speak up is just as important – these are the people who might explain what we are agreeing to that might benefit the partner country more than New Zealand. These people are commonly not published in the media.

A final word to Professor Joseph:

The market reforms have reduced the role of government but intensified the need for accountability. … Abuse of dominant position is an abuse, whether it is perpetuated by a publicly owned or a privately owned entity. (p.947)

REFERENCES

[1] Palmer G & Butler A. (2018) Towards Democratic Renewal. Victoria University Press.

[2] Joseph, P. (2021). Joseph on Constitutional and Administrative Law, 5th Ed. Thomson Reuters

[3] Law Commission (1996). Report 34 A New Zealand Guide to International Law and its Sources. Wellington, New Zealand. https://www.lawcom.govt.nz/assets/Publications/Reports/NZLC-R34.pdf

[4] RCEP [2018] A secret deal Trade talks fail the transparency and public participation test. Friends of the Earth International.

[5] Kathleen Cooper, Kyra Bell-Pasht, Ramani Nadarajah, and Theresa McClenaghan, Seeking a Regulatory Chill in Canada: The Dow Agrosciences NAFTA Chapter 11 Challenge to the Quebec Pesticides Management Code, 7 Golden Gate U. Envtl. L.J. 5 (2014).

[6] Samples TR. (2019) Winning and Losing in Investor–State Dispute Settlement. American Business Law Journal 56,1:115-175. DOI 10.1111/ablj.12136

[7] Schill SW. (2017) Reforming Investor–State Dispute Settlement: A (Comparative and International) Constitutional Law Framework, Journal of International Economic Law, 20;3:649–672, DOI 10.1093/jiel/jgx023

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For over 20 years the Physicians and Scientists for Global Responsibility New Zealand Charitable Trust (PSGR) has produced reports and submitted to government Bills and Inquiries.

We’ve been extraordinarily busy over the past 2 years with our work.

This Update aims to inform members and colleagues – and act as a go-to summary of our recent work.

2022 UPDATE - PDF

As well as our recent work All PSGR’s submissions are available to the public on our Submissions pages. In addition, we are now on LinkedIn, Twitter, Odysee & Instagram.

MEMBERSHIP

Please – without your support and membership PSGR cannot do this work. We’ve kept our fees deliberately low because your membership is important to us.

MOVING FORWARD 2022+

The PSGR recognise that the perspectives that have been expressed by the PSGR from 2020 onwards will not necessarily reflect the perspectives of all trustees and all members.

However, we sincerely hope that PSGR’s perspectives are more likely to reflect the perspectives of the majority of our membership and of collegial organisations – which represents a diverse quorum of inquiring minds.

We hope that we have demonstrated a consistency to our work, that reflects and upholds the principles reflected in 20 years of research, information communications and submissions to policy

Reports and Papers

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