COVID-19 & the science. Deny, dismiss, divert & displace.
OIA request responses by the Minister of COVID-19 Response; the Department of Prime Minister and Cabinet; Ministry of Health; and the Ministry of Business, Innovation and Employment.
On February 3, 2021, provisional consent was granted to the novel mRNA gene therapy, BNT162b2. By March 2021 the government had entered into agreements to supply population level quantities of the Pfizer/BioNTech product.
It is evident that in May 2021, a predetermined strategy was locked in: the Government’s vaccination goals involved the ‘scaling up’ of injections, as the Controller and Auditor-General John Ryan has stated, ‘in order to vaccinate the general population.’
(See: May 2021, Preparations for the nationwide roll-out of the Covid-19 vaccine.)
Did the entire population require vaccinating? What was the evidence on risk? How would health be protected? Were the government even remotely interested in looking at controversial information that might compromise policy goals, as the Cabinet Manual requires? (Discussed here).
In June I sent Official Information (OIA) Act requests to identify to what degree had the published and peer reviewed literature been studied to understand risk outside the claims of industry, and of other regulators, who also, followed the same pattern, of relying on industry assurance of safety and efficacy of this novel protect:
1. Minister of COVID-19 Response, Hon Chris Hipkins, the
2. Department of Prime Minister and Cabinet
3. Ministry of Health; and the
4. Ministry of Business, Innovation and Employment.
Why 4 separate requests? These four Ministers and authorities have had significant roles in financing and engaging science, in providing access to the novel vaccine and in participating in the production of legislation. Therefore, they should effectively be repositories of scientific information.
THE OIA REQUEST
Before sending the June 17, 2022 OIA request (published here) I searched for documents available to the public that demonstrated that as the months passed, the government were triangulating the knowledge that came from agencies and local data, with the evidence in the peer reviewed literature. I was looking for reviews, which demonstrated sound (i.e. unbiased methodologies) – essentially accountable processes to ensure that uncomfortable or controversial knowledge or facts were being drawn to the attention of the Ministers. I identified substantial modelling activities; cherry picked data to support policy; references to offshore institutions and their decisions – but not work undertaken by local scientists to review the literature.
I put this information in Part [A] of the request so the officials/Ministerials could observe that I had, in good faith, attempted to source such information independently.
In the detailed requests I identified the responsibilities of authorities involved in the production of science, and all task forces and committees I could find. (Appendix below) This was Part [B] of the request.
Part [C] Concerned the actual request. It requested that the Minister/Department supply reviews that were held that were exploring the literature on risk – relating to the safety and efficacy of the novel vaccine; and the availability of treatments that could prevent (vulnerable groups in particular) from hospitalisation and/or death. It did not require a particular parcel of information, more evidence that due diligence was undertaken.
This is critical – as the lawmakers were, fundamentally, the very Ministers with responsibility for creating lockdowns and vaccine and mask mandates. I’ve demonstrated that, with regards to community level mask wearing, the Minister doesn’t hold any reviews of the literature relating to the safety and efficacy of community masking (original OIA request here). I’ve confirmed that bioethics panels were never convened. (Including a bioethicist on a modelling paper doesn’t, as they say, cut the mustard).
We now know, thanks to Chuck Schooner, that prior to May 10, 2022, the Ministry of Health had never conducted a risk-benefit analysis on the novel vaccines and risk-benefit to public health.
UNCOMFORTABLE KNOWLEDGE
The responses reflected various strategies, identified a decade ago by sociologist Steve Rayner, that institutions deploy in order to evade having to deal with uncomfortable knowledge.
Rayner defined unomfortable knowledge as information that could potentially undermine institutional principles, arrangements and goals. In order to avoid dealing with such knowledge that might open them up to criticism and undermine their political and/or social authority, institutions tended to utilise four tacit information management strategies to alter how knowledge was understood
‘Denial represents a refusal to acknowledge or engage with information. Dismissal acknowledges the existence of information, and may involve some minimal engagement up to the point of rebutting it as or irrelevant. Diversion involves the creation of an activity that distracts attention away from an uncomfortable issue. Finally, displacement occurs when an organization engages with an issue, but substitutes management of a representation of a problem (such as a computer model) for management of the represented object or activity’ (Rayner, 2012, p. 113).
This is not merely a minor policy. In 2020 the government approved about $30 billion for the COVID-19 response. By January 2021 this was $62.2 billion.
OIA REQUEST RESPONSES
1.a. Hipkins. June 20, 2022.
The subject matter you raised falls within the portfolio responsibilities of the Minister of COVID 19. Your correspondence will therefore be transferred to the office of Hon Ayesha Verrall for her consideration.
1.b. Verrall. June 20, 2022.
This information appears to be more closely associated with the functions and responsibilities of the Ministry of Health and I have been advised the Ministry of Health have already engaged with you on this request.
2. Department of Prime Minister and Cabinet. July 4, 2022.
Their COVID-19 business unit’s responsibilities included:
‘Data analytics, monitoring, reporting and insights - including coordinated reporting to provide a tested, robust and consistent source of information, and provide agencies with cross government developed modelling and operational trends.’
Note they state:
‘the DPMC’s COVID-19 Group does not provide advice relating to public health’.
Excuse, me, but - no kidding?
My request concerned what scientific information and reviews of the science were supplied to and/or held with the department. Such reviews, it could be surmised, would be supplied from the scientists engaged to supply information and evidence to support policy, information dissemination and regulation.
3. Ministry of Health. 29 June 2022.
(a) Letter from Jan Torres.
Interesting, the Ministry does not conduct scientific research or studies, but refers me to PubMed.
(b) Response from J.R. Bruning to Jan Torres
Yes, it’s lengthy, but by golly the response above demonstrated the tactics of deny, dismiss, divert & displace. Thus, never one to let a good opportunity go to waste:
July 4th, 2022
Ref: Official Information Act request, Ministry of Health, no. H202208100
Tēnā koe Jan,
The 29 June 2022 response (H202208100) from yourself has stated that such a request ‘would place an unreasonable degree of strain on the teams responsible and would interfere with the day-to-day workings of the Ministry.’ The Ministry has asked that I consider some information.
There is little indication that comprehensive reviews of the scientific literature to identify the state of scientific evidence during the COVID-19 event have been undertaken. It appears unlikely that I am making a request for ‘a very large volume of information.’
The public have a legitimate expectation that the scientific and scholarly literature will be reviewed in a procedural and methodological manner in order to inform decision-makers and guide policy.
Your response states ‘the Ministry does not conduct scientific research or studies’ and then refers me to PubMed, inferring that as a citizen, I myself can undertake such reviews. Then the response states ‘The Ministry is also constantly reviewing international studies and evidence on COVID-19 and COVID-19 vaccines.’
The Ministry of Health has a fiduciary obligation to ensure that reviews of the scientific and scholarly evidence are undertaken in order to establish a weight of the evidence understanding that will ensure that public health is improved, promoted and protected (Health Act 1956, Part 1, 3A).
Task forces have been established to provide expert evidence to support decision-making. The public have a reasonable expectation that such information surveillance of the scientific and scholarly literature would be undertaken.
As task forces include academic and scientific experts familiar with the scientific method, the public have a right to expect that reviews would have been undertaken, involving unbiased and transparent processes in order to avoid charges of bias in policy-making. This would sustain public trust in decision-making processes and avoid accusations of arbitrariness.
Who has undertaken this surveillance and to what extent has surveillance been undertaken?
That is the purpose of the H202208100 OIA request. H202208100 does not require amendment/change.
The regulatory institutions that the Ministry cite as information sources Science, insights, and monitoring - ‘international organisations including Centres for Disease Control and Prevention, Public Health England, the European Centre for Disease Control and Prevention, Australian jurisdictions’ do not actively engage in rolling and unbiased reviews of the published literature with established and transparent methodological processes of data gathering.
These institutions have close relationships with the industries that they are tasked with regulating. Their funding streams are predominantly industry derived; revolving doors between industry and regulators are common; and fees and even terminology - ‘a vaccines sponsor’ reinforce cultural attitudes that are client centric, including using industry selected data to authorise new technologies and treatments rather than regulatory actions focussed on broader issues of risk and uncertainty.
Civil society observes the regulatory practice of predominant reliance on clinical trial data; and the ‘locking-in’ of reviews that don’t provide evidence of firstly, rigorous methodological processes (which would ensure that challenging or divergent content are swept into reviews/analyse), which are then not, secondly, updated to reflect changing knowledges.
Long Covid. The link provided and guidance following the acute phase,and the Journeying through the Fog seminars fail to demonstrate that reviews of the literature have been undertaken to understand existing practices by doctors. Rather than reinventing the wheel with new patented treatments, a review of documented global Long Covid therapies might include targeting patterns of nutrient deficiency and impaired gastrointestinal absorption as a predominant driver of health risk for post viral fatigue; as well as reviewing existing drugs with a long history of safe use, which bind to the antigenic Sars-Cov-2 spike protein, preventing binding to the ACE2 receptor (the critical site for virus/host cell interaction). Have any task forces undertaken such reviews?
Long Covid is an umbrella term that overlaps with a wide compendium of poor-diet-driven metabolic, fatigue related and respiratory health conditions, where low-income families, and particularly Māori and Pasifika are at higher risk. Yet there appear to be no reviews nor any guidance recommending serological testing to identify nutrient deficiency, such as for vitamin D, C, B group vitamins, zinc, magnesium deficiencies which increase risk for post-viral conditions and fatigue. These are major strategic gaps, and New Zealand policy-makers have a long history of excluding nutrition from health policy. We know that the major drug which binds to spike has been suppressed. Medical equity is not health equity, and many people with complex health conditions resist additional medical treatments that potentially carry side effects.
Pregnancy
As per my original OIA request, please demonstrate that comprehensive reviews have been undertaken of the scholarly and scientific literature to effectively gauge risk for pregnant mothers.
The pregnancy references you have provided are narrow in scope, using early data. They do not demonstrate that complex bioethical deliberation, as well as meta-reviews have been undertaken. For example, what are the numbers needed to treat in order to protect hospitalisation and death (including from the mRNA gene therapy – absolute risk reduction) of a healthy pregnant mother without complex health conditions?
The studies supplied in this 29 June response suggest that Ministry of Health staff are cherry-picking to support predetermined policy than undertaking scientifically rigorous reviews. None of these studies looked at the potential for mRNA vaccines to prevent hospitalisation and death by age and health status, nor took into account the ethically problematic policy that normalises exposing babies in utero to mRNA genetic vaccines that have not completed clinical trials. Some studies don’t screen for well-established adverse effects, including cardiac and neurologic (Blakeway et al 2021 Shimabukuro). The Zauche paper is October 2021, well before Omicron and fails to identify risk of adverse event alongside spontaneous abortion. The Bleicher paper is October 2021 and involved use of a questionnaire to under 400 women that was narrow in scope. The November 2021 Trostle paper identified that hypertension doubled from baseline.
Children
As per my original OIA request, please demonstrate that comprehensive reviews have been undertaken of the scholarly and scientific literature to effectively gauge risk for adolescents and children.
Your response for example, provides Pfizer BioNTech and Pfizer funded clinical trial data evaluation for 12-15 age group, rather than demonstrating that the Ministry of Health is reviewing the international literature to understand the risk-benefit profile (and absolute risk reduction) to children. Medsafe’s data sheet contains no reviews of the scientific literature on risk or efficacy, more it appears to be based on data supplied by the sponsor. The Ministries response demonstrates that the Ministry to date, has lurched around the bulk of scientific knowledge – that data that is recorded in the peer reviewed literature.
The underpowered BioNTech and Pfizer funded Walter paper does not have an endpoint of prevention of hospitalisation or death – efficacy is confirmed Covid-19 with onset at least 7 days after the second dose. The study was undertaken before Omicron. What are the numbers needed to vaccinate in order to prevent hospitalisation and/or death? We know that the synthetic mRNA spike protein from vaccination lasts two weeks or more, what is the risk profile for a healthy child?
What we also observe is a tendency to play the pharmaceutical industry game of legitimising immunobridging as a valid denominator. Somewhat contradictorily, the Ministry of Health task forces don’t look as associations where vitamin D improves immunological health and prevents lower respiratory tract infections, but will rely on spurious underpowered and short term data which strangely associates neutralizing titers elicited by BNT162b2 in 5-to-11-year-olds with titers elicited by BNT162b2 in 16-to-25-year-olds (from a BioNTech and Pfizer paper Frenck et al 2021) to claim validity for a gene therapy. Immunobridging is an approach where the effectiveness of a vaccine is inferred from immunogenicity data.
Vaccines traditionally prevented transmission of infection. In 2020-2022 BioNTech and Pfizer studies that lessen symptoms are the proffered for the population using a gene therapy that has all the regulatory indemnity of a vaccine. Historic vaccine parameters have been sidelined for what appears to be not a vaccine, but a standard medical therapy – the lessening or reduction of symptoms.
What are the established correlates of protection?
What level of antibodies - what thresholds are required to keep vulnerable people out of hospital? How long does this so-called parameter persist for someone with an immunodeficiency or metabolic disorder, versus a normal healthy person? What is the stratified risk in these age groups for hospitalisation and death following infection with Omicron? What is the absolute risk ratio when risk from the treatment is taken into account – based on the established literature?
Ethically, where is the higher more rigorous bar to gauge for uncertainty from the mRNA gene therapy and ensure that infants and children with a lifetime in front of them, and demonstrated lower risk for COVID-19, are not disproportionately harmed?
In theory task forces with much greater expertise than myself would be asking such questions – and reviewing the scientific and scholarly literature.
Risk from mRNA gene therapy
Jan Torres, you then state ‘It is important to remember that all medicines contain risk and benefits, however real-world evidence of the use of the vaccine in pregnant woman to date suggests that the benefits are likely to outweigh the risks.’
This is precisely the point of OIA request H202208100. To establish real world evidence.
Over-reliance on financially captured regulatory claims, industry produced data and internal modelling by officials and regulators to underpin and justify policy and claim sufficient evidence for establishing legal rules fails in adherence to norms that require a fair and balanced assessment of facts.
In addition, under-reporting of adverse events is a major problem. This problem of ignorance relating to adverse event risk is exacerbated when the gene therapy technology in use is yet to complete conventional clinical trials.
Hence, the information held in the published and peer reviewed scientific literature constitutes substantial evidence that is of the essence in decision-making. Decision makers must ‘genuinely weigh matters that ought to be taken into account’ (Joseph, 2014 p.949).
Constitutional accountability is critical if New Zealand is to maintain the status of a democracy. We have observed unprecedented, authoritarian-style suppression of extensive ‘coal-face’ expertise by scientists and doctors used to dealing with complex health conditions. Physicians who would normally, during an outbreak of a respiratory virus, exercise autonomy in treating the unique presentation of their patients. Over 2020-2022 the state has actively prevented collegial information-sharing concerning the protection of health and the prevention of severe COVID-19. We have observed the creation of overarching Acts with no - or meagre public consultation. If New Zealand is to remain a democratic state, policy-makers must conform to democratic norms of transparency and accountability. This includes adherence to principles of constitutional and administrative law, such as are enshrined in P.A. Joseph’s Constitutional and Administrative Law in New Zealand (4th Edition, Thomson Reuters, Wellington, 2014).
‘An authority may unlawfully abdicate its statutory function by refusing or failing to act. A public body must not renounce its decision-making responsibility, nor preclude itself from inquiring into matters relevant to its inquiry’ (Joseph, 2014 p.972).
Policy makers and staff that cherry pick data (i.e. apply arbitrary or selective reasoning) to accord with and confirm established or prospective policy and regulation leave themselves open to a challenge of abuse of discretionary power if they do not genuinely weigh matters.
‘the exercise of a discretionary power, even for a proper purpose, may be invalid if the decision-maker fails to take into account relevant considerations, or is influenced by considerations that are legally irrelevant’ (Joseph, 2014 p.948)
The response to COVID-19 has been paradigm shifting and particularly rights limiting, as the bulk of the population have been expected to conform to government rules, in order to secure employment. Covid restrictions, medical guidelines and mandates are enforced in law, patrolled by obedient employers and enforced by the New Zealand Medical Council. The common practice of the Director General to deny exemptions further ensured there were no loopholes where the public might exercise choice. These restrictions have had the effect of overturning and dispensing with historic norms of informed consent, including norms of general practitioner discretion in the care of and prescribing of treatments for patients.
Relying on industry data and the claims of other regulators – while excluding the substantive body of evidence, arguably represents a fundamental failure of due diligence and hence stewardship, in an environment where Covid restrictions, medical guidelines and mandates have been robustly enforced.
The 29 June 2022 response (H202208100) from you, Jan Torres has included much data that I, in the background to this request, had previously outlined – your response demonstrates no evidence of reviews of the scientific literature to interpret risk that is identified in the published and peer reviewed literature.
The request I make is for New Zealand based reviews of the literature to identify, in an unbiased and non-arbitrary manner, evidence that transparent and methodological reviews of the scientific and scholarly literature have been undertaken to recognise the shifting literature on efficacy, harm from the mRNA gene therapy, and evidence of new early treatments that support prevention and protection from the COVID-19.
We can see that on June 30 the Minister for COVID-19 Response, Ayesha Verrall removed the requirement for boosters for most workers at corrections prisons and workers at managed isolation and quarantine facilities, affected airports, and affected ships, or who handle items from those places (certain border workers). However, workers in the health and disability sector remain required to be vaccinated and to have received a booster dose.
Where are the rolling reviews of the scientific literature that ensures that this requirement is not health damaging, that the ongoing boostering of workers is health protective rather than arbitrary, and does not instead, promote harm and disability, and increase risk for immune escape?
My reason for seeking the information is to ensure that all relevant considerations are made in order to benefit the public interest. This public interest is explicitly recognised in section 4(a)(i) of the OIA, which says that the purpose of that Act is ’to increase progressively the availability of official information to the people of New Zealand in order to enable their more effective participation in the making and administration of laws and policies.'
The 29 June response from yourself does not assure me that satisfactory information has been gleaned from the scholarly and scientific literature in the public interest.
The original Official Information Act request H202208100 does not need to be refined. As I stated in the body of the request, $473 million has been set aside for a fourth booster.
Where is the evidence that the independent scientific literature has been reviewed?
Kind regards | Ngā mihi
(c) Torres response. July 14, 2022.
Request denied as it requires substantial collation.
4. Ministry of Business, Innovation and Employment.
We can see below that the MBIE’s responsibilities were limited to leading the COVID-19 Vaccine Strategy Taskforce from May 2020- March 2021. This was limited to acquisition of vaccines.
MBIE attached the STAG Terms of Reference. Included in the purpose of the Vaccine Strategy Taskforce, is the assurance that they will provide scientific and technical advice on safety. However, MBIE’s role ended March 2021.
MBIE supplied the information summary, we can only guess, that was assembled by the STAG relating to Astrazeneca, Janssen, Novovax and Pfizer/BioNTech vaccines
Let’s zoom in on the OVERVIEW OF THE CANDIDATE section. I.e. Information and advice to officials in January 2021:
• Candidate: BNT162b2 (aka COMIRNATY®), Pfizer as developer and supplier, BioNTech as manufacturer, funding from German Federal Ministry of Education and Research [BioNTech]
• Platform: RNA, lipid nanoparticle formulated nucleoside-modified mRNA, encoding pre-fusion stabilised SARS-CoV-2 full-length spike glycoprotein [Pfizer]
• Adjuvants: None added, spike protein mRNA acts as adjuvant
• Diluent: 1.8 mL of 0.9% sodium chloride injection per multi-dose vial for reconstitution [CDC]
• Mechanism: RNA vaccines contain a strip of genetic material within a lipid bubble. Once inside the cell, the RNA generates a protein found on the surface of the virus. The immune system, presented with the protein, learns to recognise the virus [Stuff]
• Administration: 2 doses intramuscularly, 21 days apart [Pfizer]
• Storage and transport: Shipping via ultra-cold chain (UCC) at -60 to -80 °C; up to 6 months storage in UCC; stable for up to 5 days at 2-8 °C after removal from UCC [Pfizer]
• Interactions: None known or expected
• Known or theoretical advantages: Required dose is small and the production capacity is high; no serious safety concerns; vaccine might reduce infectiousness; trials are being conducted in a range of demographics and countries; trial will measure efficacy against asymptomatic infection; appears to be effective against N501Y mutation in new variants
• Known or theoretical disadvantages/risks: New vaccine platform, which may affect public perception of safety in particular; requires ultra-cold storage; needs to be used within a few hours of opening [SCR]; theoretical risk of disease enhancement
• Demographic suitability: Results to date suggest that this vaccine is suitable for adults aged 16+; Phase III trials are recruiting ages as young as 12 years but results TBA.
Right then, Stuff.
https://www.stuff.co.nz/national/health/coronavirus/300087321/coronavirus-top-vaccine-technologies-to-watch
In January 2021, the main advice held with the MBIE, the government purchaser for a multibillion dollar budget was for a vaccine that ‘might reduce infectiousness’.
I’ll let you consider what might be missing from the ‘Known or theoretical disadvantages/risks’ comment that might be considered relevant information in a court of law.
Note: The January 2021 overview appears to be the evidence (apart from the secret Pfizer agreement) on the public record, that guided MBIE. It came from a vaccine taskforce led by the Chief Science Advisor to the Ministry of Health, Ian Town for the most severe pandemic in 100 years. I would assume, if this Overview would be accompanied by underpinning literature, but then if they’re looking up Stuff, perhaps not.
This is extraordinary.