Extracts from my October 2022 discussion paper: COVID-19 in New Zealand: Ethics & the Setting Aside of Normative Principles. October, 18, 2022. (refs in original paper)
Humanity has a long history of avoiding bringing attention to the ethical mismatch, when lower order rules contradict higher level principles. Actions taken 2020-2022 appear to contradict long established norms enshrined in the Health Act 1956, requiring that Ministry officials act to improve, promote, and protect public health. The Medicines Act is considered the relevant statutory scheme.
However, the Medicines Act is administered by the Ministry of Health. Officials’ powers are derived through the Health Act 1956. The overarching obligation of the Ministry of Health is to engage in operations/activities that have the function of improving, promoting, and protecting public health.
Should obligations in the Health Act guide consideration of activities undertaken within the auspices of the Medicines Act?
Ethically, there is an obligation to consider the evidence more broadly. The Cabinet Manual requires that officials:
‘inform Ministers promptly of matters of significance within their portfolio responsibilities, particularly where these matters may be controversial or may become the subject of public debate.’
The background is a relevant consideration to the case at hand, as Ministers and officials overseeing New Zealand’s COVID-19 response have used the powers secured through the production of a small number of Acts of Parliament with scarce public input.
Following the production of these Acts, dozens, if not hundreds of Orders have been produced without scrutiny to establish whether these interventions would reduce hospitalisation and death.
At no stage was a bioethics panel convened to weigh the ethics of compulsory vaccination and masking, and it is unlikely that bioethics panels have been convened to analyse the ethics of vaccinating young children with a novel mRNA injectable. Instead, the issue of infectivity, transmission of SARS-CoV-2 became to raison d’être for all legislation.
The Legislation Act and Secondary Legislation Act were in place and ensured that the Minister for COVID-19 response could quickly produce Orders. A Minister is entitled to weigh each matter individually, provided has considered all the factors.
The Medicines Act confers protection of confidential supporting information about innovative medicines.
This produces a contradiction – the statutory obligation does not confer an obligation to consider the published scientific literature – yet the bulk of data are hidden from the public. How can the state promise transparency and accountability?
From early 2020, established principles to be taken into account for the management of infectious diseases, long enshrined in the Health Act 1956 were side-lined and ignored. The following principles have been excluded from David Parker’s overarching COVID-19 legislation: Paramount consideration of protection of health; respect for individuals; voluntary compliance; the individual to be informed; principle of proportionality; the least restrictive alternative; and that measures apply no longer than necessary.
In New Zealand 2020-2022, despite substantial quantities of data supplied from applicants to court proceedings over the past 2 years, judicial decision-making struggled to balance the information supplied by the public, which has been drawn from the published and peer reviewed literature, with clinical trial data and regulatory data supplied by officials.
From an early stage, elderly and multimorbid groups were at greatest risk due to weak immune systems, and it was the biological response (as vulnerability or resilience) of the body that produced or prevented a complex cascade of disease responses.
From 2020 it was understood that, rather like acquired immunodeficiency syndrome (AIDS), an individual response following infection by SARS-CoV-2, necessitated complex early treatment to manage disease as it presented in the individual. (See discussion part 9). As with HIV/AIDs public activity played a strong role in shifting the dialogue towards management and early treatment approaches.
Ethical and legal dilemmas presenting in 2020-2020 mirror much of the controversy observed with HIV/AIDs. Brandt, writing in the NEJM observed: ‘The AIDS epidemic demanded the recognition of basic human rights. Early on, lawyers, bioethicists, and policymakers debated the conditions under which traditional civil liberties could be abrogated to protect the public from the threat of infection. Such formulations reflected traditional approaches to public health and the “police powers” of the state, including mandatory testing, isolation, detention, and quarantine.
A fiduciary relationship demands optimum transparency and accountability. Mandates and rights limiting restrictions are rendered unethical when democratic norms are not upheld. For example, when clinical trials remain unfinished, a technology is ‘high risk’, and company data is kept secret.
Informed consent was distorted by the government’s continued ‘safe and effective’ claim which undermined the public’s capacity to weigh options and conduct their own risk-benefit analysis.
The effect produces a moral hazard, whereby the vaccine recipient is required to accept the physical, social and economic risk, which may be short or long term for which it may be difficult to establish a clear causative link. As with exposure to any medicine, identification of risk is often uncertain, complex and nebulous. This produces barriers to justice when an individual is harmed.
Failure to consider the such nuances can be observed in Ian Town’s Completed summary of evidence of COVID-19, transmission risk and vaccination in 5–11-year-olds –
Identifying harm in a child from a medical intervention is more difficult than identifying harm in an adult.
Where Town integrates published literature, there is no evidence of methodological surveillance. Prima facie, the content appears designed to support an argument for vaccination. Town’s report does not traverse broader issues of risk. This includes neurological, inflammatory, allergenic. Much evidence associates risk with the persistence of the synthetically produced spike protein in the body that may persist for months. The numbers needed to treat (NNT) discussion is based on earlier Delta data and Town ignores the potential for infection via the nasopharynx.
Judicial decisions struggle to place weight on affidavits supplied by individuals with extensive expertise in the matter at hand. For example, the judicial decision in MKD and Seven Others v the Minister of Health, Justice Gendall considers the referral by Medsafe’s evaluation team of the Provisional Consent application for the Paediatric Vaccine to the Medicines Assessment Advisory Committee (MAAC). Justice Gendall notes that MAAC is headed by a diabetes specialist, Dr Paul Tomlinson, and advises that the MAAC panel includes broad expertise, but does not confirm that any members have expertise in cardiology.
Justice Gendall’s deliberations do not focus on the gap in consideration, the failure of the MAAC to receive reviews (as informational intelligence) that consider cost-benefit to children, which might include assessments considering the likelihood of an adverse event, including hospitalisation and death, in contrast to the risk of hospitalisation and death following exposure to the Omicron variant.
Justice Gendall does not consider a predominant issue of concern, the potential risk to heart function. None of the expert committee appear to have authoritative expertise in this field. It is my understanding that the applicants forwarded an affidavit from Dr Peter McCullough. McCullough has published over 600 peer reviewed articles in his area of expertise. He has an H index of 95. He is the top ranked expert in this field. Members of the MAAC were not privy to such high-ranking expertise, and Medsafe and the Ministry of Health do not conduct comprehensive reviews to balance risk as identified across the published literature.
ETHICAL AND MORAL PRINCIPLES
Bioethical principles assist health professionals and public policymakers to recognize moral dilemmas in health care and biomedical research and provide a compass, principles and moral rules with which to navigate through these dilemmas. Maintaining principles and demonstrating they are adhered to promotes trust in the governors by the governed.
However, morally difficult situations have arisen over the pandemic, possibly the most divisive and ethically questionable dilemma has surrounded the role of modelling studies in declaring that the population at large, and particularly high transmitting age groups (young adults and adolescents) should be vaccinated in order to protect at-risk older adults.The precedent used was influenza. No clinical trials studied the potential for the mRNA gene therapy to prevent transmission of infection – there was no clinical evidence of meaningful prevent of transmission.
Officials have a responsibility to improve and promote health, and they have a responsibility to ‘remove from policy debate programs that are unethical, whether because of insufficient data, clearly discriminatory procedures, or unjustified limitations on personal liberties.’
Principles assist to direct panels to consider broader uncertainties and ethical dilemmas outside their areas of expertise, for ‘while experts might have deep knowledge and insight in their own fields, their narrow perspectives can be poison for public policy.’
The stoking of fear is associated with decreased physical and environmental wellbeing.[1] In 2020 it was understood that individuals that perceived the virus to be severe, had worse mental health outcomes.[2]
With these considerations in mind, four historic ethical principles[3] [4] guide governing decisions and promote the protection of health. They are broadly reflected in the Health Act 1956. They are accepted norms for health professionals, directed at the higher order purpose of maintaining and improving health.
- Autonomy. Deliberated self-rule; ‘the ability and tendency to think for oneself, to make decisions for oneself about the way one wishes to lead one’s life based on that thinking, and then to enact those decisions.’
- Autonomy, as free will, intersects with a moral compass, human endeavour and the exercise of personal responsibility. ‘Respect for autonomy is an important moral constraining principle, both on paternalistic clinical beneficence, and on paternalistic global beneficence.’
- Non-maleficence – Has origins in the Hippocratic ‘primum nil nocere’– first of all, do no harm.’ Non-maleficence asserts that health professionals should take all steps to avoid and minimise harms (either through omission or commission). Dr. Julie Ponesse has argued that the actions of an individual in taking a vaccine with possible adverse effects, so that others are protected, violates this principle.
- Beneficence – Encompasses a ‘moral obligation to act for the others’ benefit, helping them to further their important and legitimate interests, often by preventing or removing possible harms.’ Beneficence is recognised as an imperfect obligation, requiring judgement so as to be in accord with a common morality or ethical norm.
- Justice – Justice demands equal opportunities, however there is an important nuance, as justice demands the fair distribution of health outcomes, or health equity. ‘Accounting for human heterogeneity is important: justice requires aiding people in proportion to their degree of disadvantage, according to Aristotle’s proportionality principle. Additionally, health capability determinants vary across societies, and assessing health capability inequalities must account for these differences.’
The principle of autonomy is considered the overarching principle, ensuring that a person may make informed voluntary choices for themselves, ‘under the influence of as little bias, coercion, pressure or duress as possible; it is also understood as ‘first among equals’ of the four ethical principles.
The New Zealand Medical Association draw on these principles as a foundation for their Code of Ethics, which emphasises the maintenance of a trust relationship between doctor and patient.
In New Zealand public health ethics encompass an obligation to adhere to the principles of te Tiriti o Waitangi and the special obligations to Māori to ensure equity and active protection.
Legislative principles were disestablished in the pandemic. New Zealand publications suggest that these long-established principles – especially that of individual autonomy – have been jettisoned by Ministers and officials during 2020-2022.
This has established a startling precedent for extensive medical coercion and lockdown policies. The pandemic was never associated with a high case fatality rate across all population groups. 2020-2022 evidenced unprecedented and paradigm shifting approaches to governance in an emergency event. Coercive promotion urging vaccination in the generally healthy; injection of a novel technology which skipped many historic clinical trial processes.
These patterns suggest that without giving effect to autonomy, decisions by Ministers and officials can rapidly place large swathes of the population at substantial health risk, when they were not at risk previously.
Respect for autonomy places an ethical requirement that ‘all eggs are not placed in one basket.’ Human failure is real, and the scholars are already expressing concern that improperly regulated biotechnology presents a fundamental – and existential – health risk.
Historic shifts by the World Health Organization (WHO) in 2009, established the preconditions for the pandemic declaration in March 2020 with relatively low death rates, which then informed the purpose of the Acts for the New Zealand response.
However, an obligation that consideration of a pandemic would necessarily entail a high mortality rate was removed in 20090 when the World Health Organization (WHO) decoupled severe critical risk factors considered integral to the category of ‘pandemic’. The WHO pandemic phase descriptions emphasised phase risk predicated on viral outbreaks.
Requirements did not include a classification which would capture severe disease (as high case fatality rate in traditionally healthy populations) within the definition required before a pandemic could be announced was demonstrated to classify an influenza/respiratory infection as pandemic status to placing more emphasis on disruption to social and economic life.
Instead, the conventional health indicators of severity, case fatality rate, unusually severe morbidity, unexpected mortality pattern and unusual complications were removed as a high-level recommendation. These indicators were repositioned as lower order considerations. Therefore, the narrative that was established in 2009, that transmission of the virus, not potential death was the central risk factor to be managed.
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